Cost-effectiveness of a transitional pharmaceutical care program for patients discharged from the hospital

PubMed Central

van der Knaap, Ronald; Bouhannouch, Fatiha; Borgsteede, Sander D.; Janssen, Marjo J. A.; Siegert, Carl E. H.; Egberts, Toine C. G.; van den Bemt, Patricia M. L. A.; van Wier, Marieke F.; Bosmans, Judith E.

2017-01-01

Background To improve continuity of care at hospital admission and discharge and to decrease medication errors pharmaceutical care programs are developed. This study aims to determine the cost-effectiveness of the COACH program in comparison with usual care from a societal perspective. Methods A controlled clinical trial was performed at the Internal Medicine department of a general teaching hospital. All admitted patients using at least one prescription drug were included. The COACH program consisted of medication reconciliation, patient counselling at discharge, and communication to healthcare providers in primary care. The primary outcome was the proportion of patients with an unplanned rehospitalisation within three months after discharge. Also, the number of quality-adjusted life-years (QALYs) was assessed. Cost data were collected using cost diaries. Uncertainty surrounding cost differences and incremental cost-effectiveness ratios between the groups was estimated by bootstrapping. Results In the COACH program, 168 patients were included and in usual care 151 patients. There was no significant difference in the proportion of patients with unplanned rehospitalisations (mean difference 0.17%, 95% CI -8.85;8.51), and in QALYs (mean difference -0.0085, 95% CI -0.0170;0.0001). Total costs for the COACH program were non-significantly lower than usual care (-€1160, 95% CI -3168;847). Cost-effectiveness planes showed that the program was not cost-effective compared with usual care for unplanned rehospitalisations and QALYs gained. Conclusion The COACH program was not cost-effective in comparison with usual care. Future studies should focus on high risk patients and include other outcomes (e.g. adverse drug events) as this may increase the chances of a cost-effective intervention. Dutch trial register NTR1519 PMID:28445474

Complementary health care: a welcome addition to an employee benefits program.

PubMed

DeVries, George

2003-09-01

One up-and-coming approach to controlling health care costs is complementary health care, which does not rely on advances in high-tech, invasive technology or expensive new pharmaceuticals, but rather focuses much more on the high-touch, direct practitioner care. It often offers lower cost alternatives to traditional medicine.

Pharmacist care plans and documentation of follow-up before the Iowa Pharmaceutical Case Management program.

PubMed

Becker, CoraLynn; Bjornson, Darrel C; Kuhle, Julie W

2004-01-01

To document drug therapy problems and their causes and assess pharmacist follow-up of patients with identified drug therapy problems. Cross-sectional analysis. Iowa. 160 pharmacists who submitted 754 pharmaceutical care plans in an effort to qualify for participation in the Iowa Pharmaceutical Case Management program. Care plans were assessed for drug therapy problems and causes and for documentation of pharmacist follow-up (actual, none, or intent to follow up). Pharmacists documented a wide variety of drug therapy problems and causes, including adverse drug reactions (20.1% of care plans), need for additional drug therapy (18.9%), lack of patient adherence to therapy (16.3%), incorrect medication being prescribed (14.1%), and drug dose too high (10.0%). Pharmacist follow-up with patients was not optimal, with 31% of care plans providing documentation of actual follow-up. Another 42.2% of plans indicated that the pharmacist intended to contact the patient for follow-up but either did not do so or did not record the intervention. No actual follow-up or intent to follow up was recorded in 26.8% of care plans. Pharmacists practicing in independent pharmacies followed up with patients more frequently than those in other settings (36.4% of care plans, compared with 22.7%, 23.2%, and 28.4% for chain, clinic, and franchise pharmacies). Pharmacists were more likely to follow up when the identified problem involved drug safety rather than effectiveness (36.2% versus 28.3% of care plans). Documentation of pharmacist follow-up with patients was less than optimal. In addition to identifying drug therapy problems and causes, pharmacists must complete the care continuum through documentation of patient monitoring and follow-up to transform the philosophy and vision of the pharmaceutical care concept into a practice of pharmacy recognized and rewarded by patients and payers.

Impact of distance education on academic performance in a pharmaceutical care course

PubMed Central

Bem, Tamires; Carneiro, Mára Lucia Fernandes; de Castro, Mauro Silveira

2017-01-01

The objective of this study was to compare the performance of pharmacy students from a Pharmaceutical Care course, taught in both distance education (DE) and campus-based formats using active methodologies. For two semesters, students (n = 82) taking the course studied half the subject in the distance education format and half in person. Questionnaires were applied at the beginning of the semester aimed to outline the demographic profile of the students. Their grade in the course was evaluated to determine their performance. The Module 1 (Information on Medication) average on the campus-based was 7.1225 and on DE was 7.5519, (p = 0.117). The Module 2 (Pharmaceutical Services) average on the campus-based was 7.1595 and on distance education was 7.7025, (p = 0.027*). There was a difference in learning outcomes in the Pharmaceutical Care Course between face-to-face and distant education. Therefore, the student performance was better in the distance education module, indicating distance education can be satisfactorily used in Pharmacy Programs. PMID:28384362

Impact of a pharmaceutical care program on clinical evolution and antiretroviral treatment adherence: a 5-year study

PubMed Central

Arroyo, María Jesús Hernández; Figueroa, Salvador Enrique Cabrera; Correa, Rosa Sepúlveda; de la Paz Valverde Merino, María; Gómez, Alicia Iglesias; Hurlé, Alfonso Domínguez-Gil

2013-01-01

Background Antiretroviral treatments (ART) form the basis of adequate clinical control in human immunodeficiency virus-infected patients, and adherence plays a primary role in the grade and duration of the antiviral response. The objectives of this study are: (1) to determine the impact of the implementation of a pharmaceutical care program on improvement of ART adherence and on the immunovirological response of the patients; and (2) to detect possible correlations between different adherence evaluation measurements. Methods A 60-month long retrospective study was conducted. Adherence measures used were: therapeutic drug monitoring, a simplified medication adherence questionnaire, and antiretroviral dispensation records (DR). The number of interviews and interventions related to adherence made for each patient in yearly periods was related to the changes in the adherence variable (measured with DR) in these same yearly periods. The dates when the laboratory tests were drawn were grouped according to proximity with the study assessment periods (February–May, 2005–2010). Results A total of 528 patients were included in the study. A significant relationship was observed between the simplified medication adherence questionnaire and DR over the 60-month study period (P < 0.01). Improvement was observed in the mean adherence level (P < 0.001), and there was a considerable decrease in the percentage of patients with CD4+ lymphocytes less than 200 cells/mm3 (P < 0.001). A relationship was found between the number of patients with optimum adherence levels and the time that plasma viral load remained undetected. The number of interviews and interventions performed in each patient in the first 12 months from the onset of the pharmaceutical care program (month 6), was related to a significant increase in adherence during this same time period. Conclusion The results suggest that the establishment and permanence of a pharmaceutical care program may increase ART adherence, increase permanence time of the patient with undetectable plasma viral loads, and improve patients’ lymphocyte count. PMID:23983457

Online Doctor of Pharmacy Program for Pharmacy Practitioners: Development and Evaluation of Six Pilot Courses.

ERIC Educational Resources Information Center

O'Neil, Christine K.; Poirier, Therese I.

2000-01-01

The first six courses of this online program successfully increased participants' knowledge and perceived preparedness to provide pharmaceutical care. This success provided the stimulus for the development of the entire online Doctor of Pharmacy program. Participants felt that the online program facilitated more active and enhanced learning and…

In Vitro Screening of 1877 Industrial and Consumer Chemicals, Pesticides and Pharmaceuticals in up to 782 Assays: ToxCast Phase I and II (SOT)

EPA Science Inventory

In Phase II of the ToxCast program, the U.S. EPA and Tox21 partners screened 1,877 chemicals, including pesticides; food, cosmetics and personal care ingredients; pharmaceuticals; and industrial chemicals. Testing used a 782 in vitro assays across 7 technologies and multiple bi...

Pharmaceutical care of elderly patients with poorly controlled type 2 diabetes mellitus: a randomized controlled trial.

PubMed

Chen, Jyun-Hong; Ou, Huang-Tz; Lin, Tzu-Chieh; Lai, Edward Chia-Cheng; Kao, Yea-Huei Yang

2016-02-01

Care of the elderly with diabetes is more complicated than that for other age groups. The elderly and/or those with multiple comorbidities are often excluded from randomized controlled trials of treatments for diabetes. The heterogeneity of health status of the elderly also increases the difficulty in diabetes care; therefore, diabetes care for the elderly should be individualized. Motivated patients educated about diabetes benefit the most from collaborating with a multidisciplinary patient-care team. A pharmacist is an important team member by serving as an educator, coach, healthcare manager, and pharmaceutical care provider. To evaluate the effects of pharmaceutical care on glycemic control of ambulatory elderly patients with type 2 diabetes. A 421-bed district hospital in Nantou City, Taiwan. We conducted a randomized controlled clinical trial involving 100 patients with type 2 diabetes with poor glycemic control (HbA1c levels of ≥9.0 %) aged ≥65 years over 6 months. Participants were randomly assigned to a standard-care (control, n = 50) or pharmaceutical-care (intervention, n = 50) group. Pharmaceutical care was provided by a certified diabetes-educator pharmacist who identified and resolved drug-related problems and established a procedure for consultations pertaining to medication. The Mann–Whitney test was used to evaluate nonparametric quantitative data. Statistical significance was defined as P < 0.05. The change in the mean HbA1c level from the baseline to the next level within 6 months after recruiting. Nonparametric data (Mann–Whitney test) showed that the mean HbA1c level significantly decreased (0.83 %) after 6 months for the intervention group compared with an increase of 0.43 % for the control group (P ≤ 0.001). Medical expenses between groups did not significantly differ (−624.06 vs. −418.7, P = 0.767). There was no significant difference in hospitalization rates between groups. The pharmacist intervention program provided pharmaceutical services that improved long-term, safe control of blood sugar levels for ambulatory elderly patients with diabetes and did not increase medical expenses.

Proposed model for interaction between residents and residency training programs, and pharmaceutical industry.

PubMed

Razack, S; Arbour, L; Hutcheon, R

1999-03-01

Medical residents in training are as much targets of pharmaceutical-industry marketing as are physicians in practice. This interaction is often subtle and takes the form of sponsorship of meals at academic events, support for conference travel, books, and items such as pens and notepads. Most residency programs direct little time towards training in ethics and the critical analysis of pharmaceutical-industry marketing. We propose a model for the relationship between residents and residency programs, and the pharmaceutical industry that addresses the need for such interaction to be viewed in light of the patient-centered ethic of professional conduct and the ideal of unbiased medical practice. A committee of residents at different levels of training and two staff physicians received the mandate to examine this issue. The committee developed a set of guidelines and a proposed schema for the handling of funds from pharmaceutical companies (still not implemented). Each residency program would develop a common fund for money donated by pharmaceutical companies. This fund would be administered by a committee with defined priorities. The presence of residents on this committee under staff preceptorship would serve as a springboard for education on the subject. Guidelines for acknowledgement of sponsorship, solicitation of funds, gifts for care of patients, ongoing education, and the wider applicability of these proposals were also developed. Residents' interaction with the pharmaceutical industry during training could have lifelong influence on medical practice. We hope that our model will promote critical appraisal of the potential risks and benefits of this interaction.

Using a virtual patient system for the teaching of pharmaceutical care.

PubMed

Menendez, Elisa; Balisa-Rocha, Blície; Jabbur-Lopes, Monique; Costa, Wanderson; Nascimento, José Rafael; Dósea, Marcos; Silva, Leila; Lyra Junior, Divaldo

2015-09-01

The communication skills of pharmacists are essential for the identification and reduction of patient́s drug related problems. Therefore, Pharmacy courses started the process of teaching Pharmaceutical Care to students in order to improve their communication skills. The use of virtual patients (VP) has been a widely used technique in health care courses, but many of the VP tools in Pharmacy field are in English and do not have clinical cases that are common in tropical countries, such as Brazil. The aim of this work is to describe the PharmaVP system, developed with the purpose of training Latin America students in Pharmaceutical Care. The main differential of PharmaVP is the availability in three languages (Portuguese, English and Spanish) and the possibility of clinical case evolution, simulating several visits made by the patient. The system was developed according to an incremental and interactive methodology, well suited for conducting multidisciplinary projects. Real clinical cases were collected from a Pharmaceutical Care program and added in PharmaVP to simulate the virtual patients. Then, 31 students of a Pharmacy course were trained and invited to participate of the evaluation study. They used the software and answered adapted instruments that assess the students' acceptance of, use of, learning of, and satisfaction with the system. The results showed that the students found the cases realistic and learned significantly using the software. Another positive point is that the application process of PharmaVP did not consume much time. We can conclude that the virtual patient tool contributed to the development of the skills required for the practice of Pharmaceutical Care, but should be used as complementary technique. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Care ideologies reflected in 4 conceptions of pharmaceutical care.

PubMed

Björkman, Ingeborg K; Bernsten, Cecilia B; Sanner, Margareta A

2008-12-01

Different ways to practice pharmaceutical care have been developed. One expression of this fact is the existence of many different classification systems to document drug-related problems (DRPs). Evidence suggests that classification systems have different characteristics and that these characteristics reflect different conceptions of pharmaceutical care. To increase the understanding of conceptions of pharmaceutical care, underlying values and beliefs (ideologies) can be explored. To explore various conceptions of pharmaceutical care to identify the care ideologies on which these conceptions are based. Representatives of 4 selected conceptions of pharmaceutical care were interviewed in face-to-face meetings. During the interviews, 4 basic questions were asked. Three were focused on pharmaceutical care and 1 on DRPs. Interview transcripts were analyzed by an inductive method inspired by grounded theory. The conceptions studied were Strand, Granada-II, PCNE v5.0, and Apoteket. In Strand, patients are given a more active role in the pharmaceutical care process, as compared to Granada-II, PCNE v5.0, and Apoteket. Pharmacists in all the conceptions of pharmaceutical care assume they have special knowledge that patients benefit from. However, they use their knowledge in different ways in the various pharmaceutical care conceptions. In Strand, individual goals of drug therapy are established together with the patient, whereas in Granada-II, PCNE, and Apoteket goals are not explicitly discussed. The identified differences correspond to different care ideologies. The pharmaceutical care conceptions are based on different care ideologies. The ideology is expressed in how therapy goals are set and patient needs defined. Strand is based on a patient-centered ideology; patient therapy goals and needs are defined by the patient together with the practitioners. Granada-II, PCNE, and Apoteket are based on an evidence-based medicine approach; patient therapy goals and needs are defined by the practitioners, based on available scientific knowledge.

[A contribution safety on using low molecular weight heparin in patients with renal failure].

PubMed

Gea Rodríguez, E; Barral Viñals, N; Manso Mardones, P; Indo Berges, O

2004-01-01

1. To promote safe and appropriate use of low molecular weight heparins in patients with renal failure. 2. To analyze results from a pharmaceutical intervention program. Data from a prospective, 16-month study are presented. The entire adult population of a general hospital with 41,792 stays/year is included. An intensive monitoring program for low molecular weight heparin prescriptions in patients with renal failure is implemented. This program identifies patients using a computerized unit dose system, and is aided by a software able to calculate creatinine clearance using the Cockroft-Gault formula from an interphase between laboratory, pharmacy and admissions data, and by an algorithm to establish a recommended pharmaceutical intervention according to renal failure severity and low molecular weight heparin indication, either with prophylactic or therapeutic purposes. In all, 221 patients were identified, corresponding to 2.9% of admitted patients and 25.5% of patients with renal failure. Answers were assessable for 128 patients (61%). Extent of program acceptance according to physician-accepted pharmaceutical interventions was proportional to renal failure severity and therapy intensiveness. An acceptance of 70% was obtained for treatments with clearance < 30 mL/min, of 41.8% for treatments with 30-60 mL/min, of 31.5% for prophylaxis, and of 21.4% for low-risk patients. 1. Program repercussions improve prescription safety. 2. Scarce literature and a belief in low molecular weight heparin safety account for responses regarding pharmaceutical intervention. 3. Integrated computerized systems are essential for the implementation of intensive pharmaceutical care programs.

Tendering for outpatient prescription pharmaceuticals: what can be learned from current practices in Europe?

PubMed

Dylst, Pieter; Vulto, Arnold; Simoens, Steven

2011-07-01

To explore the current status (2010) of tendering programs for outpatient pharmaceuticals in the European countries and how these programs operate. A survey was designed to assess the features of tendering programs in European countries. All 27 countries of the European Union plus Norway were included in the study. The survey was sent to national representatives of authorities and organizations and to academic researchers with expertise in the domain. Nineteen of the 28 countries have responded to the questionnaire (68%). Seven countries have adopted tendering programs for pharmaceuticals in ambulatory care. Tendering was more popular in countries with a mature generic medicines market (54%) than in countries with a developing generic medicines market (12.5%). A legal basis, criteria to grant the tender, the number of winners and the duration of the tender were amongst the features for the program to work. Tendering programs can achieve savings in the short term. There are however some problems allied with the policy and the effects in the long term are still unclear. It can be concluded that the policy can work, but the features of the programs have to be well-thought-out. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Dual Degree Programs at the University of Kentucky College of Pharmacy

PubMed Central

Senft, Sandra L.; Thompson, Chad

2008-01-01

The rapid growth and evolution of the pharmacy profession has created a wide array of opportunities for graduating pharmacists beyond traditional community pharmacy or hospital practice. Management and leadership positions in federal and state healthcare agencies, pharmaceutical companies, hospitals, retail pharmacies, academia and managed care organizations increasingly require the pharmaceutical knowledge obtained through a doctor of pharmacy (PharmD) degree combined with financial, organizational, and management skills. In these innovative positions, pharmacists are being called upon to assume responsibilities as executives and administrators in systems providing pharmacist care services to patients. To endow students with knowledge and skills required to perform the duties required in these decision-making positions, the University of Kentucky College of Pharmacy has established 3 joint degree programs: the PharmD/Master of Business Administration (PharmD/MBA), PharmD/Master of Public Administration (PharmD/MPA), and PharmD/Master of Science in Economics (PharmD/MS). This paper describes these joint degree programs. PMID:18322574

Pharmaceutical care education in Kuwait: pharmacy students’ perspectives

PubMed Central

Katoue, Maram G.; Awad, Abdelmoneim I.; Schwinghammer, Terry L.; Kombian, Samuel B.

2014-01-01

Background Pharmaceutical care is defined as the responsible provision of medication therapy to achieve definite outcomes that improve patients’ quality of life. Pharmacy education should equip students with the knowledge, skills, and attitudes they need to practise pharmaceutical care competently. Objective To investigate pharmacy students’ attitudes towards pharmaceutical care, perceptions of their preparedness to perform pharmaceutical care competencies, opinions about the importance of the various pharmaceutical care activities, and the barriers to its implementation in Kuwait. Methods A descriptive, cross-sectional survey of pharmacy students (n=126) was conducted at Faculty of Pharmacy, Kuwait University. Data were collected via a pre-tested self-administered questionnaire. Descriptive statistics including percentages, medians and means Likert scale rating (SD) were calculated and compared using SPSS, version 19. Statistical significance was accepted at a p value of 0.05 or lower. Results The response rate was 99.2%. Pharmacy students expressed overall positive attitudes towards pharmaceutical care. They felt prepared to implement the various aspects of pharmaceutical care, with the least preparedness in the administrative/management aspects. Perceived pharmaceutical care competencies grew as students progressed through the curriculum. The students also appreciated the importance of the various pharmaceutical care competencies. They agreed/strongly agreed that the major barriers to the integration of pharmaceutical care into practice were lack of private counseling areas or inappropriate pharmacy layout (95.2%), lack of pharmacist time (83.3%), organizational obstacles (82.6%), and pharmacists’ physical separation from patient care areas (82.6%). Conclusion Pharmacy students’ attitudes and perceived preparedness can serve as needs assessment tools to guide curricular change and improvement. Student pharmacists at Kuwait University understand and advocate implementation of pharmaceutical care while also recognizing the barriers to its widespread adoption. The education and training provided at Kuwait University Faculty of Pharmacy is designed to develop students to be the change agents who can advance pharmacist-provided direct patient care. PMID:25243027

Corporate social responsibility to improve access to medicines: the case of Brazil.

PubMed

Thorsteinsdóttir, Halla; Ovtcharenko, Natasha; Kohler, Jillian Clare

2017-02-21

Access to medicines and the development of a strong national pharmaceutical industry are two longstanding pillars of health policy in Brazil. This is reflected in a clear emphasis by Brazil's Federal Government on improving access to medicine in national health plans and industrial policies aimed at promoting domestic pharmaceutical development. This research proposes that such policies may act as incentives for companies to pursue a strategic Corporate Social Responsibility (CSR) agenda. CSR that supports Governmental priorities could help companies to benefit significantly from the Governmental industrial policy. We sought to determine whether CSR activities of Brazilian pharmaceutical firms are currently aligned with the Federal Government's health prioritization. To do so we examined key Brazilian health related policies since 2004, including the specific priorities of Brazil's 2012-2015 Health Plan, and compared these with CSR initiatives that are reported on the websites of select pharmaceutical firms in Brazil. Brazil's national health plans and industrial policies demonstrated that the Federal Government has followed diverse approaches for improving access to medicines, including strengthening health care infrastructure, increasing transparency, and supporting product development partnerships. Case studies of six pharmaceutical firms, representing both public and private companies of varying size, support the perspective that CSR is a priority for firms. However, while many programs target issues such as health infrastructure, health care training, and drug donation, more programs focus on areas other than health and do not seem to be connected to Governmental prioritization. This research suggests that there are loose connections between Governmental priorities and pharmaceutical firm CSR. However, there remains a significant opportunity for greater alignment, which could improve access to medicines in the country and foster a stronger relationship between the Government and industry.

Patients' willingness to pay for pharmaceutical care.

PubMed

Larson, R A

2000-01-01

To determine the level at which patients receive pharmaceutical care services and their willingness to pay for comprehensive pharmaceutical care services. A mail survey was sent to 2,500 adults in the United States. Surveys were mailed to subjects' homes. Subjects were randomly selected from a marketing database that included representation from each of the 50 states of the United States. The survey provided a description of comprehensive pharmaceutical care, and survey items asked about the level of care subjects were receiving and their willingness to pay for these services. Level of various pharmacy services subjects reported receiving, and the dollar amount subjects were willing to pay for comprehensive pharmaceutical care. The majority of the subjects were not receiving pharmaceutical care services. The average amount all respondents were willing to pay for these services was $13 for a one-time consultation and $28 for this plus 1 year of monitoring. Looking only at those respondents willing to pay (56%), the means rise to $23 and $50, respectively. A majority of patients are willing to pay for pharmaceutical care services, even if they are not now receiving this level of care. Direct payment from patients who recognize the therapeutic benefits of pharmaceutical care may be a more viable option than is generally believed, at least until the profession can prove pharmaceutical care's utility and cost-effectiveness to third party payers.

Pharmaceutical cost containment and innovation in the United States.

PubMed

Kane, N M

1997-09-01

In the United States, government has played a limited role in containing the costs of pharmaceuticals. There are no price controls, no national drug formularies, no universal cost-sharing policies, and perhaps most important, no national coverage of prescription drugs. Rather, pharmaceutical cost containment was historically left to private insurers and managed care companies, while consumers paid out of pocket for close to 62% of all drug expenditures. US utilization has historically been relatively low and prices by far the highest of the four industrialized countries. The major change in pharmaceutical cost containment in the 1990s has been the consolidation of purchaser power at the level of the insurer and managed care companies. These 'whole sale' purchasers now represent 70% of direct manufacturer sales, and they are demanding and receiving deeper price discounts. Meanwhile these same players are implementing formulary policies, utilization controls, and disease management programs, the outcomes of which have not yet been systematically evaluated. Failure to pass on savings to consumers, cost shifting by manufacturers to vulnerable consumer groups, and potential under-utilization of cost-effective drugs remain of concern.

Introduction to Pharmaceuticals and Personal Care Products (PPCPS)

EPA Science Inventory

Those chemical pollutants that are regulated under various international, federal, and state programs represent but a small fraction of the universe of chemicals that occur in the environment as a result of both natural processes and human influence.

Does pharmacist-supervised intervention through pharmaceutical care program influence direct healthcare cost burden of newly diagnosed diabetics in a tertiary care teaching hospital in Nepal: a non-clinical randomised controlled trial approach.

PubMed

Upadhyay, Dinesh Kumar; Ibrahim, Mohamed Izham Mohamed; Mishra, Pranaya; Alurkar, Vijay M; Ansari, Mukhtar

2016-02-29

Cost is a vital component for people with chronic diseases as treatment is expected to be long or even lifelong in some diseases. Pharmacist contributions in decreasing the healthcare cost burden of chronic patients are not well described due to lack of sufficient evidences worldwide. In developing countries like Nepal, the estimation of direct healthcare cost burden among newly diagnosed diabetics is still a challenge for healthcare professionals, and pharmacist role in patient care is still theoretical and practically non-existent. This study reports the impact of pharmacist-supervised intervention through pharmaceutical care program on direct healthcare costs burden of newly diagnosed diabetics in Nepal through a non-clinical randomised controlled trial approach. An interventional, pre-post non-clinical randomised controlled study was conducted among randomly distributed 162 [control (n = 54), test 1 (n = 54) and test 2 (n = 54) groups] newly diagnosed diabetics by a consecutive sampling method for 18 months. Direct healthcare costs (direct medical and non-medical costs) from patients perspective was estimated by 'bottom up' approach to identify their out-of-pocket expenses (1USD = NPR 73.38) before and after intervention at the baseline, 3, 6, 9 and 12 months follow-ups. Test groups' patients were nourished with pharmaceutical care intervention while control group patients only received care from physician/nurses. Non-parametric tests i.e. Friedman test, Mann-Whitney U test and Wilcoxon signed rank test were used to find the differences in direct healthcare costs among the groups before and after the intervention (p ≤ 0.05). Friedman test identified significant differences in direct healthcare cost of test 1 (p < 0.001) and test 2 (p < 0.001) groups patients. However, Mann-Whitney U test justified significant differences in direct healthcare cost between control group and test 1 group, and test 2 group patients at 6-months (p = 0.009, p = 0.010 respectively), 9-months (p = 0.005, p = 0.001 respectively) and 12-months (p < 0.001, p < 0.001 respectively). Pharmacist supervised intervention through pharmaceutical care program significantly decreased direct healthcare costs of diabetics in test groups compared to control group and hence describes pharmacist's contribution in minimizing direct healthcare cost burden of patients.

Creating a new class of pharmaceutical services provider for underserved areas: the Tanzania accredited drug dispensing outlet experience.

PubMed

Rutta, Edmund; Senauer, Katie; Johnson, Keith; Adeya, Grace; Mbwasi, Romuald; Liana, Jafary; Kimatta, Suleiman; Sigonda, Margareth; Alphonce, Emmanuel

2009-01-01

In developing countries, the most accessible source of treatment for common conditions is often an informal drug shop, where drug sellers are untrained and operations are unmonitored. We sought to describe a public-private initiative in Tanzania that created a new class of provider in government-accredited drug outlets, which improved the quality of medicines and pharmaceutical services in previously underserved areas. The accredited drug-dispensing outlet program combines changing behavior and expectations of community members who use, own, regulate, and work in drug shops. Success resulted from including community stakeholders from the beginning of the process. Addressing shortages in qualified health care providers by training and accrediting private sector drug dispensers to recognize common conditions and provide quality pharmaceutical products and services is feasible in a developing country, when supported by an appropriate policy and regulatory environment. Scaling up and sustaining the program will be a challenge.

PHARMACEUTICALS & PERSONAL CARE PRODUCTS AS ENVIRONMENTAL POLLUTANTS FROM EVERYDAY ACTIVITIES

EPA Science Inventory

Those chemical pollutants that are regulated under various international, federal, and state programs represent but a small fraction of the universe of chemicals that occur in the environment as a result of both natural processes and human influence.

Qatar pharmacists' understanding, attitudes, practice and perceived barriers related to providing pharmaceutical care.

PubMed

El Hajj, Maguy Saffouh; Al-Saeed, Hassna Sohil; Khaja, Maryam

2016-04-01

Pharmaceutical care (PC) is the philosophy of practice that includes identifying and resolving medication therapy problems to improve patient outcomes. The study objectives were to examine the extent of pharmaceutical care practice and the barriers to pharmaceutical care provision as perceived by Qatar pharmacists and to assess their level of understanding of pharmaceutical care and their attitudes about pharmaceutical care provision. Setting Qatar pharmacies. A cross sectional survey of all pharmacists in Qatar was made. Consenting pharmacists were given the option to complete the survey either online using an online software or as paper by fax or by hand. 1. Extent of pharmaceutical care practice in Qatar. 2. Barriers to pharmaceutical care provision in Qatar. 3. Qatar pharmacists' level of understanding of pharmaceutical care. 4. Qatar pharmacists' attitudes toward pharmaceutical care provision. Over 8 weeks, 274 surveys were collected (34 % response rate). More than 80 % of respondents had correct understanding of the aim of PC and of the pharmacist role in PC. However, only 47 % recognized the patient role in PC and only 35 % were aware of the differences between clinical pharmacy and PC. Yet, more than 80 % believed that they could be advocates when it comes to patients' medications and health matters. Concerning their practice, respondents reported spending little time on PC activities. Offering feedback to the physician about the patient progress was always or most of the time performed by 21 % of respondents. The top perceived barriers for PC provision included inconvenient access to patient medical information (78 %) and lack of staff and time (77 and 74 % respectively). Although PC is not incorporated into pharmacy practice, Qatar pharmacists showed positive attitudes toward PC provision. Further work should focus on improving their PC understanding and on overcoming all barriers.

Considerations in pharmaceutical conversion: focus on antihistamines.

PubMed

Garbus, S B; Moulton, B W; Meltzer, E O; Reich, P R; Weinreb, L F; Friedman, J A; Orland, B I

1997-04-01

The practice of pharmaceutical conversion, which encompasses three types of drug interchange (generic, brand, and therapeutic substitution), is increasing in managed care settings. Pharmaceutical conversion has numerous implications for managed care organizations, their healthcare providers, and their customers. Although drug cost may be a driving consideration in pharmaceutical conversion, a number of other considerations are of equal or greater importance in the decision-making process may affect the overall cost of patient care. Among these considerations are clinical, psychosocial, and safety issues; patient adherence; patient satisfaction; and legal implications of pharmaceutical conversion. Patient-centered care must always remain central to decisions about pharmaceutical conversion. This article discusses the issues related to, and implications of, pharmaceutical conversion utilizing the antihistamines class of drugs as the case situation.

Perceived needs of pharmaceutical care services among healthcare professionals in South Korea: a qualitative study.

PubMed

Lee, Iyn-Hyang; Rhie, Sandy Jeong; Je, Nam Kyung; Rhew, Ki Yon; Ji, Eunhee; Oh, Jung Mi; Lee, Euni; Yoon, Jeong-Hyun

2016-10-01

Purpose To explore the need for pharmaceutical care services, key features of desirable pharmacy services, and perceived barriers for advancing the services in hospital environments with doctors and nurses who are key co-workers of the interdisciplinary team care services.Methods Semi-structured, in-depth interviews with eighteen doctors and fifteen nurses employing purposive and snowballing sampling strategies were conducted in ten hospitals in South Korea. Results The level of pharmaceutical care was varied across regions or institutions in South Korea. The concept of pharmaceutical care was insufficiently defined, and tended to be limited to some parts of medication counseling. Through pharmaceutical care services, doctors desired to acquire comprehensive drug information from and to share clinical responsibilities with pharmacists. Nurses wished to lower their burdens of medication counseling services from their daily practices. Doctors and nurses asked for pharmacists providing essential and carefully selected medication information to their patients in a patient-centered manner. The listed barriers to pharmaceutical care included the lack of appropriate systems for reward, insufficient accessibility to patient records by pharmacists, ambiguous role descriptions of pharmacist, and absence of effective communication among professionals. Conclusion A successful pharmaceutical care service model should allow efficient exchange of information among healthcare professionals to build inter-professional trust and to provide a continuity of care both in terms of time and setting. As prerequisites of such system, it was warranted to develop clinical evidence and an appropriate reward system for pharmaceutical care services.

Pharmaceutical Care and the Role of a Pharmacist in Space Medicine

NASA Technical Reports Server (NTRS)

Bayuse, Tina

2007-01-01

Space medicine is primarily preventative medicine Outcomes of space medicine pharmaceutical care are: a) Elimination or reduction of a patient's symptomatology; b) Arresting or slowing of long term effects from microgravity; and c) Preventing long term effects or symptomatology as a result of microgravity. Space medicine pharmaceutical care is about both the patient and the mission. Pharmaceutical care in the area of space medicine is evolving. A pharmacist serves a critical role in this care. Commercial space travel will require pharmacist involvement.

Contaminants of Emerging Concern including Pharmaceuticals and Personal Care Products

EPA Pesticide Factsheets

Both the Office of Pesticide Programs (OPP) and the Office of Water (OW) assess the effects of pesticides on aquatic ecosystems using approaches that afford a high degree of protection for aquatic life and that were developed with high quality data.

Unique issues raised by drug benefit design.

PubMed

Berndt, Ernst R

2004-01-01

In this Perspective on the preceding paper by Joseph Newhouse, I point out a number of features of the pharmaceutical industry that differentiate it from other health care sectors. These differences help explain why it has proved to be so very difficult to construct policies that simultaneously contain health care costs, provide patients with high-quality care, and generate continued incentives for innovation. I then summarize Newhouse's preferred Medicare prescription drug benefit program and the issues it raises.

[Essential drugs and pharmaceutical care: reflection on the access to drugs through lawsuits in Brazil].

PubMed

Sant'ana, João Maurício Brambati; Pepe, Vera Lúcia Edais; Osorio-de-Castro, Claudia Garcia Serpa; Ventura, Miriam

2011-02-01

The guarantee of pharmaceutical care as a legal right established by the Brazilian federal constitution of 1988 led to an increase in lawsuits to put that right into practice. This phenomenon has been dubbed the judicialization of pharmaceutical care. Studies on this topic have revealed, on the one hand, deficiencies in the access of Unified Health Care (SUS) users to drugs included in Ministry of Health pharmaceutical care lists, and, on the other hand, limitations of the legal system to deal with the situation. The present article addresses these issues in the context of the conceptual framework that supports the Brazilian drug policy and pharmaceutical care policy, especially the notions of essential drugs and allocation of scarce resources.

[Pharmaceutical care strategies to prevent medication errors].

PubMed

Ucha-Samartín, Marisol; Martínez-López de Castro, Noemí; Troncoso-Mariño, Amelia; Campelo-Sánchez, Eva; Vázquez-López, Cristina; Inaraja-Bobo, María Teresa

2009-08-01

To evaluate the impact of implementing new programs to improve the quality of the pharmaceutical care and unit-dose distribution system for in-patients. An observational and prospective study was carried out in a general hospital during two different six-monthly period. Transcription and dispensation errors were evaluated in twelve wards during the first six months. Then, two new measures were introduced: the first- reference ward-pharmacist and the second-a new protocol for checking medication on the ward. Results were evaluated by SPSS v. 14 program. In the transcription evaluation, units without a ward pharmacist did not improve. Transcription errors significantly decreased in three units: gynaecology-urology (3.24% vs. 0.52%), orthopaedic (2% vs. 1.69%) and neurology-pneumology (2.81% vs. 2.02%). In dispensing, only units with the new protocol decreased their medication errors (1.77% vs. 1.24%). The participation of pharmacists in multidisciplinary teams and exhaustive protocols for dispensing medication were effective in detecting and decreasing medication errors in patients.

Mitigating pharmaceutical waste exposures: policy and program considerations.

PubMed

Amster, Eric D

2016-01-01

Pharmaceutical disposal and the environmental fate of medication metabolites directly impacts the public's health in two significant ways: accidental medication ingestion of pharmaceuticals that were not disposed of properly results in inadvertent toxicity; and environmental health consequences of pharmaceuticals that were inappropriately disposed and which contaminate municipal water supply. In reviewing the effectiveness of medication disposal policy globally, it is crucial to not only determine which policies are effective but also to assess why they are effective. By assessing the root causes for a specific policy's effectiveness it can be determined if those successes could be translated to another country with a different health care system, unique culture and divergent policy ecosystem. Any intervention regarding pharmaceutical disposal would require a multifaceted approach beyond raising awareness and coordinating pharmaceutical disposal on a national level. While consumer participation is important, effective primary prevention would also include research on drug development that is designed to biodegrade in the environment as opposed to medications that persist and accumulate in the natural environment even when properly disposed. Countries that lack a nationalized disposal policy should leverage the resources and infrastructure already in place in the national health care system to implement a unified policy to address medication disposal in the short-term. In tandem, efforts should be made to recruit the biotechnology sector in high-tech and academia to develop new technologies in medication design and water filtration to decrease exposures in the long-term.

Competency, Programming, and Emerging Innovation in Graduate Education within Schools of Pharmacy: The Report of the 2016-2017 Research and Graduate Affairs Committee.

PubMed

Poloyac, Samuel M; Block, Kirsten F; Cavanaugh, Jane E; Dwoskin, Linda P; Melchert, Russell B; Nemire, Ruth E; O'Donnell, James M; Priefer, Ronny; Touchette, Daniel R

2017-10-01

Graduate education in the pharmaceutical sciences is a cornerstone of research within pharmacy schools. Pharmaceutical scientists are critical contributors to addressing the challenges of new drug discovery, delivery, and optimal care in order to ensure improved therapeutic outcomes in populations of patients. The American Association of Colleges of Pharmacy (AACP) charged the 2016-2017 Research and Graduate Affairs Committee (RGAC) to define the competencies necessary for graduate education in the pharmaceutical sciences (Charge 1), recommend collaborative curricular development across schools of pharmacy (Charge 2), recommend AACP programing for graduate education (Charge 3), and provide guidance on emerging areas for innovation in graduate education (Charge 4). With respect to Charges 1 and 2, the RGAC committee developed six domains of core competencies for graduate education in the pharmaceutical sciences as well as recommendations for shared programming. For Charge 3, the committee made 3 specific programming recommendations that include AACP sponsored regional research symposia, a professional development forum at the AACP INterim Meeting, and the addition of a graduate research and education poster session at the AACP Annual Meeting. For Charge 4, the committee recommended that AACP develop a standing committee of graduate program deans and directors to provide guidance to member schools in support of graduate program representation at AACP meetings, develop skills for interprofessional teamwork and augment research through integration of Pharm.D., Ph.D., postdoctoral associates, resident, and fellow experiences. Two proposed policy statements by the committee are that AACP believes core competencies are essential components of graduate education and AACP supports the inclusion of research and graduate education focuses in its portfolio of meetings and programs.

Competency, Programming, and Emerging Innovation in Graduate Education within Schools of Pharmacy: The Report of the 2016-2017 Research and Graduate Affairs Committee

PubMed Central

Poloyac, Samuel M.; Block, Kirsten F.; Cavanaugh, Jane E.; Dwoskin, Linda P.; Melchert, Russell B.; Nemire, Ruth E.; O’Donnell, James M.; Priefer, Ronny; Touchette, Daniel R.

2017-01-01

EXECUTIVE SUMMARY Graduate education in the pharmaceutical sciences is a cornerstone of research within pharmacy schools. Pharmaceutical scientists are critical contributors to addressing the challenges of new drug discovery, delivery, and optimal care in order to ensure improved therapeutic outcomes in populations of patients. The American Association of Colleges of Pharmacy (AACP) charged the 2016-2017 Research and Graduate Affairs Committee (RGAC) to define the competencies necessary for graduate education in the pharmaceutical sciences (Charge 1), recommend collaborative curricular development across schools of pharmacy (Charge 2), recommend AACP programing for graduate education (Charge 3), and provide guidance on emerging areas for innovation in graduate education (Charge 4). With respect to Charges 1 and 2, the RGAC committee developed six domains of core competencies for graduate education in the pharmaceutical sciences as well as recommendations for shared programming. For Charge 3, the committee made 3 specific programming recommendations that include AACP sponsored regional research symposia, a professional development forum at the AACP INterim Meeting, and the addition of a graduate research and education poster session at the AACP Annual Meeting. For Charge 4, the committee recommended that AACP develop a standing committee of graduate program deans and directors to provide guidance to member schools in support of graduate program representation at AACP meetings, develop skills for interprofessional teamwork and augment research through integration of Pharm.D., Ph.D., postdoctoral associates, resident, and fellow experiences. Two proposed policy statements by the committee are that AACP believes core competencies are essential components of graduate education and AACP supports the inclusion of research and graduate education focuses in its portfolio of meetings and programs. PMID:29200459

[Assessment of the pharmaceutical expenditure in Hungary].

PubMed

Inotai, András; Merész, Gergo; Kaló, Zoltán

2010-01-01

Scarcity of health care resources draws attention to the expenditure on pharmaceuticals, as drugs are considered to be one of the major growth drivers of health care spending. This article assesses the Hungarian expenditure on pharmaceuticals by taking into account the economic status of the country and benchmarks from other OECD countries with special focus on indicators of Visegrad V4 countries (Czech Republic, Slovakia, Poland and Hungary). Our results highlight the heterogeneity of pharmaceutical expenditure data derived from different indicators among observed countries. Pharmaceutical spending is relatively higher in middle-income countries, mainly due the price convergence of innovative drug's, on contrary manpower cost of health care services are adjusted to local price levels, therefore the price differential of health care services between middle income and developed countries is greater. International trends of the global pharmaceutical market are also valid in Hungary. Increased private funding, mainly out of pocket payments above the average of V4 countries, has been the major growth driver of pharmaceutical expenditure recently in Hungary. Increased private pharmaceutical expenditure was mainly derived from the severe cost-containment measures in 2006. The annual growth rate of the National Health Insurance Fund's pharmaceutical budget for drug reimbursement was 1.37% in real terms between 1994 and 2009. This is much beneath the expansion of global pharmaceutical market. Consequently, cost-containment of public pharmaceutical spending was very successful in the last fifteen years, and the burden of market growth has been shifted to households. Public health programmes, investment into preventive care, with consideration on unfavourable Hungarian morbidity and mortality indicators, however, necessitate the increase of public pharmaceutical budget. In order to improve the allocative efficiency of health care spending, available resources should be spent only on effective, cost-effective, economically affordable medicines.

Technology-dependent children and the demand for pharmaceutical care.

PubMed

Okido, Aline Cristiane Cavicchioli; Cunha, Suelen Teles da; Neves, Eliane Tatsch; Dupas, Giselle; Lima, Regina Aparecida Garcia de

2016-01-01

to understand the experience of mothers of technology-dependent children as regards pharmaceutical care. this was a qualitative, descriptive-exploratory study developed based on open interviews using a structured characterization tool, and applied during home visits to 12 mothers caring for technology-dependent children. The data was submitted to inductive content analysis. this study is split into two themes: (i) maternal overload during pharmaceutical care, demonstrating the need to administer drugs continuously and the repercussions of this exhaustive care on the caregivers; (ii) the ease or difficulty of access to the medicines required, showing informal strategies and support networks. pharmaceutical care is a daily challenge expressed in maternal overload and difficulty accessing the drugs, made worse by failures in the care network and coordinated care.

77 FR 65581 - Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division, East Operating...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-80,490] Novartis Pharmaceuticals... Workers of Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division, East... for Worker Adjustment Assistance on January 6, 2012, applicable to workers of Novartis Pharmaceuticals...

78 FR 3030 - Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division, East Operating...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-01-15

... DEPARTMENT OF LABOR Employment and Training Administration [TA-W-80,490] Novartis Pharmaceuticals... Healthcare, and Pro Unlimited, East Hanover, NJ and Off-Site Workers of Novartis Pharmaceuticals Corporation..., applicable to workers of Novartis Pharmaceuticals Corporation, Primary Care Business Unit (Sales) Division...

Equipment, supplies, and pharmaceuticals: how much might it cost to achieve basic surge capacity?

PubMed

Hanfling, Dan

2006-11-01

The ability to deliver optimal medical care in the setting of a disaster event, regardless of its cause, will in large part be contingent on an immediately available supply of key medical equipment, supplies, and pharmaceuticals. Although the Department of Health and Human Services Strategic National Stockpile program makes these available through its 12-hour "push packs" and vendor-managed inventory, every local community should be funded to create a local cache for these items. This report explores the funding requirements for this suggested approach. Furthermore, the response to a surge in demand for care will be contingent on keeping available staff close to the hospitals for a sustained period. A proposal for accomplishing this, with associated costs, is discussed as well.

The transition to medication adoption in publicly funded substance use disorder treatment programs: organizational structure, culture, and resources.

PubMed

Knudsen, Hannah K; Roman, Paul M

2014-05-01

Medications for the treatment of substance use disorders (SUDs) are not widely available in publicly funded SUD treatment programs. Few studies have drawn on longitudinal data to examine the organizational characteristics associated with programs transitioning from not delivering any pharmacotherapy to adopting at least one SUD medication. Using two waves of panel longitudinal data collected over a 5-year period, we measured the transition to medication adoption in a cohort of 190 publicly funded treatment organizations that offered no SUD medications at baseline. Independent variables included organizational characteristics, medical resources, funding, treatment culture, and detailing activities by pharmaceutical companies. Of 190 programs not offering SUD pharmacotherapy at baseline, 22.6% transitioned to offering at least one SUD medication at follow-up approximately 5 years later. Multivariate logistic regression results indicated that the employment of at least one physician at baseline, having a greater proportion of Medicaid clients, and pharmaceutical detailing were positively associated with medication adoption. Adoption of pharmacotherapy was more likely in programs that had greater medical resources, Medicaid funding, and contact with pharmaceutical companies. Given the potential expansion of Medicaid under the Affordable Care Act, patients served by publicly funded programs may gain greater access to such treatments, but research is needed to document health reform's impact on this sector of the treatment system.

Pharmacy Utilization and the Medicare Modernization Act

PubMed Central

Maio, Vittorio; Pizzi, Laura; Roumm, Adam R; Clarke, Janice; Goldfarb, Neil I; Nash, David B; Chess, David

2005-01-01

To control expenditures and use medications appropriately, the Medicare drug coverage program has established pharmacy utilization management (PUM) measures. This article assesses the effects of these strategies on the care of seniors. The literature suggests that although caps on drug benefits lower pharmaceutical costs, they may also increase the use of other health care services and hurt health outcomes. Our review raises concerns regarding the potential unintended effects of the Medicare drug program's PUM policies for beneficiaries. Therefore, the economic and clinical impact of PUM measures on seniors should be studied further to help policymakers design better drug benefit plans. PMID:15787955

The Effect of Active Learning Methodologies on the Teaching of Pharmaceutical Care in a Brazilian Pharmacy Faculty

PubMed Central

2015-01-01

Background In recent years, pharmacists have been involved in expanded patient care responsibilities, for example patient counseling in self-medication, medication review and pharmaceutical care, which require graduates to develop the necessary competences. Consequently, reorientation of pharmacy education has become necessary. As such, active learning strategies have been introduced into classrooms to increase problem-solving and critical thinking skills of students. The objective of this study was to evaluate the performance and perceptions of competency of students in a new pharmaceutical care course that uses active learning methodologies. Methods This pharmaceutical care course was conducted in the first semester of 2014, in the Federal University of Sergipe. In the pharmaceutical care course, active learning methods were used, consisting of dialogic classroom expository, simulation and case studies. Student learning was evaluated using classroom tests and instruments that evaluated the perception of competency in pharmaceutical care practice. Furthermore, students' satisfaction with the course was evaluated. Results Thirty-three students completed the four evaluations used in the course (i.e., a discursive written exam, seminars, OSCE, and virtual patient); 25 were female (75.75%), and the median age was 23.43 (SD 2.82) years. The overall mean of student scores, in all evaluation methods was 7.97 (SD 0.59) on a scale of 0 to 10 points, and student performance on the virtual patient method was statistically superior to other methods. With respect to the perception of competency in pharmaceutical care practice, a comparison of pre- and post-test scores revealed statistically significant improvement for all evaluated competences. At the end of the semester, the students presented positive opinions of the pharmaceutical care course. Conclusions The results suggest that an active learning course can enhance the learning of pharmaceutical care competences. In future studies it will be necessary to compare active learning to traditional methods. PMID:25969991

The effect of active learning methodologies on the teaching of pharmaceutical care in a Brazilian pharmacy faculty.

PubMed

Mesquita, Alessandra R; Souza, Werlissandra M; Boaventura, Thays C; Barros, Izadora M C; Antoniolli, Angelo R; Silva, Wellington B; Lyra Júnior, Divaldo P

2015-01-01

In recent years, pharmacists have been involved in expanded patient care responsibilities, for example patient counseling in self-medication, medication review and pharmaceutical care, which require graduates to develop the necessary competences. Consequently, reorientation of pharmacy education has become necessary. As such, active learning strategies have been introduced into classrooms to increase problem-solving and critical thinking skills of students. The objective of this study was to evaluate the performance and perceptions of competency of students in a new pharmaceutical care course that uses active learning methodologies. This pharmaceutical care course was conducted in the first semester of 2014, in the Federal University of Sergipe. In the pharmaceutical care course, active learning methods were used, consisting of dialogic classroom expository, simulation and case studies. Student learning was evaluated using classroom tests and instruments that evaluated the perception of competency in pharmaceutical care practice. Furthermore, students' satisfaction with the course was evaluated. Thirty-three students completed the four evaluations used in the course (i.e., a discursive written exam, seminars, OSCE, and virtual patient); 25 were female (75.75%), and the median age was 23.43 (SD 2.82) years. The overall mean of student scores, in all evaluation methods was 7.97 (SD 0.59) on a scale of 0 to 10 points, and student performance on the virtual patient method was statistically superior to other methods. With respect to the perception of competency in pharmaceutical care practice, a comparison of pre- and post-test scores revealed statistically significant improvement for all evaluated competences. At the end of the semester, the students presented positive opinions of the pharmaceutical care course. The results suggest that an active learning course can enhance the learning of pharmaceutical care competences. In future studies it will be necessary to compare active learning to traditional methods.

Opportunities and Challenges of Multinational Pharmaceutical Enterprises in Transforming Pharmaceutical Market in China.

PubMed

Hu, Linfeng; Yu, Zhong; Yuan, Qingwen; Hu, Yuanjia; Ung, Carolina Oi Lam

2018-01-01

The surging costs of health care in China is highly related to the high expenses in pharmaceutical costs. Since the Government of China launched the health care reform in 2009, the issue of growing pharmaceutical expenditure continues to grasp policy makers' attention. Since 2015, an ongoing series of drug-related policies have been revised or developed, resulting in profound impact on the overall pharmaceutical market in China, and the dynamic is still evolving. As China has become the second largest pharmaceutical market in the world, any volatility in the Chinese pharmaceutical market may have great implications to multinational pharmaceutical markets that have had their products launched in China or plan to extend their business to the Chinese market. Based on a comprehensive analysis of the most recent health care reform policies in China, the objectives of this study were to identify the major opportunities appealed to and the challenges confronted by multinational pharmaceutical enterprises in the current Chinese pharmaceutical market.

Iatrogenic disease management: moderating medication errors and risks in a pharmacy benefit management environment.

PubMed

Nair, Vinit; Salmon, J Warren; Kaul, Alan F

2007-12-01

Disease Management (DM) programs have advanced to address costly chronic disease patterns in populations. This is in part due to the programs' significant clinical and economical value, coupled with interest by pharmaceutical manufacturers, managed care organizations, and pharmacy benefit management firms. While cost containment realizations for many such interventions have been less than anticipated, this article explores potentials in marrying Medication Error Risk Reduction into DM programs within managed care environments. Medication errors are an emergent serious problem now gaining attention in US health policy. They represent a failure within population-based health programs because they remain significant cost drivers. Therefore, medication errors should be addressed in an organized fashion, with DM being a worthy candidate for piggybacking such programs to achieve the best synergistic effects.

Distributional consequences of the transition from age-based to income-based prescription drug coverage in British Columbia, Canada.

PubMed

Hanley, Gillian E; Morgan, Steve; Hurley, Jeremiah; van Doorslaer, Eddy

2008-12-01

In May, 2003, British Columbia transitioned from an age-based public drug program, with public subsidy primarily based on age, to an age-irrelevant income-based drug program, in which public subsidy is based primarily on household income. As one of the specific aims of the policy change was to improve fairness by increasing the extent to which payment for drugs is based on ability to pay, we measure the progressivity of pharmaceutical financing before and after the policy change in BC using Kakwani indices. Our results suggest that pharmaceutical financing became less regressive after the policy change. However, this decrease in regressivity arose primarily because high-income seniors were making greater direct contributions to pharmaceutical financing and not because low-income households were making smaller direct contributions. Our results also suggest that if the public financing of pharmaceuticals were maintained or increased, a change from age-based to income-based eligibility can unambiguously improve equity in finance. As populations in developed countries age, governments will increasingly consider reforms to publicly financed health-care programs with age-based eligibility. In assessing policy options, financial equity is likely to be a key consideration. These results suggest that income-based pharmacare can improve financial equity especially when implemented with a commitment to maintain or increase public funding for prescription drugs.

Provision of pharmaceutical care by community pharmacists across Europe: Is it developing and spreading?

PubMed

Costa, Filipa A; Scullin, Claire; Al-Taani, Ghaith; Hawwa, Ahmed F; Anderson, Claire; Bezverhni, Zinaida; Binakaj, Zahida; Cordina, Maria; Foulon, Veerle; Garcia de Bikuña, Borja; de Gier, Han; Granås, Anne Gerd; Grinstova, Olga; Griese-Mammen, Nina; Grincevicius, Jonas; Grinceviciene, Svitrigaile; Kaae, Susanne; Kubiliene, Loreta; Mariño, Eduardo L; Martins, Silvia; Modamio, Pilar; Nadin, Giancarlo; Nørgaard, Lotte Stig; Obarcanin, Emina; Tadic, Ivana; Tasic, Ljiljana; McElnay, James C; Hersberger, Kurt E; Westerlund, Tommy

2017-12-01

Pharmaceutical care involves patient-centred pharmacist activity to improve medicines management by patients. The implementation of this service in a comprehensive manner, however, requires considerable organisation and effort, and indeed, it is often not fully implemented in care settings. The main objective was to assess how pharmaceutical care provision within community pharmacy has evolved over time in Europe. A cross-sectional questionnaire-based survey of community pharmacies, using a modified version of the Behavioural Pharmaceutical Care Scale (BPCS) was conducted in late 2012/early 2013 within 16 European countries and compared with an earlier assessment conducted in 2006. The provision of comprehensive pharmaceutical care has slightly improved in all European countries that participated in both editions of this survey (n = 8) with progress being made particularly in Denmark and Switzerland. Moreover, there was a wider country uptake, indicating spread of the concept. However, due to a number of limitations, the results should be interpreted with caution. Using combined data from participating countries, the provision of pharmaceutical care was positively correlated with the participation of the community pharmacists in patient-centred activities, routine use of pharmacy software with access to clinical data, participation in multidisciplinary team meetings, and having specialized education. The present study demonstrated a slight evolution in self-reported provision of pharmaceutical care by community pharmacists across Europe, as measured by the BPCS. The slow progress suggests a range of barriers, which are preventing pharmacists moving beyond traditional roles. Support from professional bodies and more patient-centred community pharmacy contracts, including remuneration for pharmaceutical care services, are likely to be required if quicker progress is to be made in the future. © 2017 John Wiley & Sons, Ltd.

Pharmaceutical care for elderly patients shared between community pharmacists and general practitioners: a randomised evaluation. RESPECT (Randomised Evaluation of Shared Prescribing for Elderly people in the Community over Time) [ISRCTN16932128

PubMed Central

Wong, I; Campion, P; Coulton, S; Cross, B; Edmondson, H; Farrin, A; Hill, G; Hilton, A; Philips, Z; Richmond, S; Russell, I

2004-01-01

Background This trial aims to investigate the effectiveness and cost implications of 'pharmaceutical care' provided by community pharmacists to elderly patients in the community. As the UK government has proposed that by 2004 pharmaceutical care services should extend nationwide, this provides an opportunity to evaluate the effect of pharmaceutical care for the elderly. Design The trial design is a randomised multiple interrupted time series. We aim to recruit 700 patients from about 20 general practices, each associated with about three community pharmacies, from each of the five Primary Care Trusts in North and East Yorkshire. We shall randomise the five resulting groups of practices, pharmacies and patients to begin pharmaceutical care in five successive phases. All five will act as controls until they receive the intervention in a random sequence. Until they receive training community pharmacists will provide their usual dispensing services and so act as controls. The community pharmacists and general practitioners will receive training in pharmaceutical care for the elderly. Once trained, community pharmacists will meet recruited patients, either in their pharmacies (in a consultation room or dispensary to preserve confidentiality) or at home. They will identify drug-related issues/problems, and design a pharmaceutical care plan in conjunction with both the GP and the patient. They will implement, monitor, and update this plan monthly. The primary outcome measure is the 'Medication Appropriateness Index'. Secondary measures include adverse events, quality of life, and patient knowledge and compliance. We shall also investigate the cost of pharmaceutical care to the NHS, to patients and to society as a whole. PMID:15182379

ASHP national survey of hospital-based pharmaceutical services--1992.

PubMed

Crawford, S Y; Myers, C E

1993-07-01

The results of a national mail survey of pharmaceutical services in community hospitals conducted by ASHP during summer 1992 are reported and compared with the results of earlier ASHP surveys. A simple random sample of community hospitals (short-term, nonfederal) was selected from community hospitals registered by the American Hospital Association. Questionnaires were mailed to each director of pharmacy. The adjusted gross sample size was 889. The net response rate was 58% (518 usable replies). The average number of hours of pharmacy operation per week was 105. Complete unit dose drug distribution was offered by 90% of the respondents, and 67% offered complete, comprehensive i.v. admixture programs. A total of 73% of the hospitals had centralized pharmaceutical services. Some 83% provided services to ambulatory-care patients, including clinic patients, emergency room patients, patients being discharged, employees, home care patients, and the general public. A computerized pharmacy system was present in 75% of the departments, and 86% had at least one microcomputer. More than 90% participated in adverse drug reaction, drug-use evaluation, drug therapy monitoring, and medication error management programs. Two thirds of the respondents regularly provided written documentation of pharmacist interventions in patients' medical records, and the same proportion provided patient education or counseling. One third provided drug management of medical emergencies. One fifth provided drug therapy management planning, and 17% provided written histories. Pharmacokinetic consultations were provided by 57% and nutritional support consultations by 37%; three fourths of pharmacist recommendations were adopted by prescribers. A well-controlled formulary system was in place in 51% of the hospitals; therapeutic interchange was practiced by 69%. A total of 99% participated in group purchasing, and 95% used a prime vendor. The 1992 ASHP survey revealed a continuation of the changes in many hospital-based pharmaceutical services documented in earlier surveys (e.g., growth in clinical services, ambulatory-care services, computerization) and identified static areas that merit the attention of pharmacy leaders (e.g., provision of complete, comprehensive i.v. services).

A Cost Analysis of the Iowa Medicaid Primary Care Case Management Program

PubMed Central

Momany, Elizabeth T; Flach, Stephen D; Nelson, Forrest D; Damiano, Peter C

2006-01-01

Objective To determine the cost savings attributable to the implementation and expansion of a primary care case management (PCCM) program on Medicaid costs per member in Iowa from 1989 to 1997. Data Sources Medicaid administrative data from Iowa aggregated at the county level. Study Design Longitudinal analysis of costs per member per month, analyzed by category of medical expense using weighted least squares. We compared the actual costs with the expected costs (in the absence of the PCCM program) to estimate cost savings attributable to the PCCM program. Principal Findings We estimated that the PCCM program was associated with a savings of $66 million to the state of Iowa over the study period. Medicaid expenses were 3.8 percent less than what they would have been in the absence of the PCCM program. Effects of the PCCM program appeared to grow stronger over time. Use of the PCCM program was associated with increases in outpatient care and pharmaceutical expenses, but a decrease in hospital and physician expenses. Conclusions Use of a Medicaid PCCM program was associated with substantial aggregate cost savings over an 8-year period, and this effect became stronger over time. Cost reductions appear to have been mediated by substituting outpatient care for inpatient care. PMID:16899012

Pharmaceutical high profits: the value of R&D, or oligopolistic rents?

PubMed

Spitz, Janet; Wickham, Mark

2012-01-01

Pharmaceutical firms attribute high prices and high profits to costs associated with researching and developing the next generation of life-saving drugs. Using data from annual reports, this article tests the validity of this claim. We find that while pharmaceutical firms do invest in R&D, they also enjoy strong rents; between 1988 and 2009, pharmaceuticals enjoyed profits of 3 to 37 times the all-industry average, depending on the years, while investing proportionately less in R&D than other high-R&D firms. Costs of pharmaceutical drugs have successfully flown below the radar in much of the current health care debate, with producers managing to obstruct alternative sourcing as well as payment cuts. While health care is examined for savings in other areas, sustained high pharmaceutical profits suggest that as a new health care policy develops in the U.S., the pharmaceutical industry should not be excluded from examination for significant savings in health care costs.

Big Pharma on the Farm: Students Are Exposed to Pharmaceutical Marketing More Often in Rural Clinics.

PubMed

Evans, David V; Keys, Toby; Desnick, Laurel; A Andrilla, C Holly; Bienz, Danielle; Rosenblatt, Roger

2016-07-01

Pharmaceutical marketing techniques are effective in changing the behavior of health care providers in ways that deviate from evidence-based practices. To mitigate the influence of pharmaceutical marketing on learners, academic medical centers (AMCs) have adopted policies to limit student/industry interaction. Many clinical experiences occur outside of the AMC. The purpose of this study was to compare medical students' exposure to pharmaceutical marketing in off-campus rural and urban underserved clinical sites. The University of Washington School of Medicine Rural and Underserved Opportunities Program (RUOP) places rising second-year medical students in underserved clinical sites in five northwestern states. We surveyed RUOP students to evaluate their exposure to pharmaceutical marketing. Of 120 students, 86 (72%) completed surveys. Sixty-five (76%) did their RUOP rotation in rural areas. Students in rural locations were more likely to report exposure to pharmaceutical marketing. Distribution of free drug samples was reportedly three times higher in rural than urban sites (54% versus 15%). Doctors meeting with sales representatives were reported as four times higher in rural clinics (40% versus 10%). Students at rural sites reported exposure to pharmaceutical marketing more than those in urban settings. Rural medical educators should provide faculty development for community clinicians on the influences of pharmaceutical marketing on learners. Medical schools must review local clinic and institution-wide policies to limit pharmaceutical marketing exposure to learners in the rural learning environment.

Community pharmacists' perceptions about pharmaceutical care of OTC western medicine: a survey in Harbin of China.

PubMed

Song, Menghuan; Ung, Carolina Oi Lam; Hu, Hao; Wang, Yitao

2015-12-01

In China, increasingly OTC-western medicine is obtained at the community pharmacy. It is unknown which care the community pharmacists in China provides with such medicines. This study investigated community pharmacists' attitude, practice and perceived barriers about pharmaceutical care of over-the-counter western medicine. Moreover, community pharmacists' suggestions of improvement measures were also collected. Questionnaire survey targeting community pharmacist. Respondents generally showed positive attitude towards pharmaceutical care. About 30 % of the respondents reported that they provided pharmaceutical care "whenever necessary", while about 40 % did it "as frequent as possible" or "to all consumers". Respondents considered "ambiguity of the professional role of pharmacists" (50.7 %), "Lack of scientific evidence of over-the-counter western medicine" (42.9), and "Lack of time" (40.0 %) as the main barriers. The 3 most important improvement measures suggested were "Formulating or refining legislation to clarify the legal professional role of pharmacists with respect to western medicine" (63.2 %), "Promoting public education of pharmacist role" (50.7 %), and "Formulating or refining the standards of pharmacists' practice with respect to western medicine" (50.7 %). Community pharmacists in Harbin of China have a relatively positive attitude and intention to provide pharmaceutical care of OTC western medicine. However, lack of professional role definition, limited pharmaceutical knowledge and lack of human and financial resources limited the provision of pharmaceutical care by community pharmacists.

Analysis of Pharmaceutical and Personal Care Compounds in Wastewater Sludge and Aqueous Samples using GC-MS/MS

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zhong, Lirong; Mitroshkov, Alexandre V.; Gilmore, Tyler J.

The Bioenergy Program at Pacific Northwest National Laboratory (PNNL) is evaluating the feasibility of converting wastewater sludge materials to fuels. Wastewater sludge from various municipalities will be used in the evaluation process and as with any municipal waste, there is the potential for residual contaminates to remain in the sludge following wastewater treatment. Many surveys and studies have confirmed the presence of pharmaceuticals in municipal wastewater and effluents (World Health Organization, 2011). Determination of the presence and concentrations of the contaminants is required to define the proper handling of this sludge. A list of targeted compounds was acquired from themore » literature and an analytical method was developed for the pharmaceutical and personal care compounds. The presence of organics complicated the analytical techniques and, in some cases, the precision of the results. However, residual concentrations of a range of compounds were detected in the wastewater sludge and the presence and concentrations of these compounds will be considered in identifying the appropriate handling of this material in conduct of research.« less

[Research survey on the information gathering methods, attitudes, and requests from care managers about the pharmaceutical service by pharmacists in home care].

PubMed

Nanaumi, Yoko; Onda, Mitsuko; Sakurai, Hidehiko; Tanaka, Rie; Tsubota, Kenichi; Matoba, Shunya; Mukai, Yusuke; Arakawa, Yukio; Hayase, Yukitoshi

2011-01-01

Care Managers (CMs) were surveyed to clarify the issues involving the promotion of cooperation between care managers and pharmacists in long-term-care and explore solutions. The length of work experience, occupational background, experience of pharmaceutical service; pharmacist visit patients' home for providing medicine and pharmaceutical care into a care plan, degree of understanding on pharmaceutical service, and awareness of work involved in pharmaceutical service were studied to see whether there made differences in the requests from CMs for information on pharmacists and for information gathering methods. The χ(2) test was used to this end. The opinions and requests described by the CMs were validated through text mining. More CMs tended to obtain information and knowledge through training sessions and professional magazines than those who did so through cooperation with pharmacists on a practical level. However, the survey strongly indicated that CMs with high level of understanding and awareness of pharmaceutical service wished to obtain information on pharmacists through cooperation with them on a practical level, and CMs with low level of understanding and awareness of pharmaceutical service wished to obtain such information through training sessions and professional magazines. Results of text mining showed that CMs wished pharmacists to strengthen the cooperation with physicians and provide information on pharmaceutical service. These findings have led to the conclusion that the issues surrounding the promotion of cooperation between CMs and pharmacists centered around "work cooperation on a practical level" and "provision of information to CMs about the roles of pharmacies and pharmacists and their work."

Association of over-the-counter pharmaceutical sales with influenza-like-illnesses to patient volume in an urgent care setting.

PubMed

Liu, Timothy Y; Sanders, Jason L; Tsui, Fu-Chiang; Espino, Jeremy U; Dato, Virginia M; Suyama, Joe

2013-01-01

We studied the association between OTC pharmaceutical sales and volume of patients with influenza-like-illnesses (ILI) at an urgent care center over one year. OTC pharmaceutical sales explain 36% of the variance in the patient volume, and each standard deviation increase is associated with 4.7 more patient visits to the urgent care center (p<0.0001). Cross-correlation function analysis demonstrated that OTC pharmaceutical sales are significantly associated with patient volume during non-flu season (p<0.0001), but only the sales of cough and cold (p<0.0001) and thermometer (p<0.0001) categories were significant during flu season with a lag of two and one days, respectively. Our study is the first study to demonstrate and measure the relationship between OTC pharmaceutical sales and urgent care center patient volume, and presents strong evidence that OTC sales predict urgent care center patient volume year round.

Introduction: Interprofessional Education (IPE) and Pharmaceutical Education: Saitama Interprofessional Education Project.

PubMed

Hosoya, Osamu

2017-01-01

In 2002, the Centre for the Advancement of Interprofessional Education (CAIPE) defined interprofessional education (IPE) as: Interprofessional Education occurs when two or more professions learn with, from, and about each other to improve collaboration and the quality of care. Since 2005, also in Japan, IPE has been introduced within educational institutions to train professionals in healthcare and welfare. Within pharmaceutical education, to acquire the "10 qualities required for pharmacists" indicated by revised model core curricula for pharmaceutical education in 2015, IPE is thought quite important. Meanwhile, highly advanced medical treatment is rapidly developing, and as a consequence home healthcare and long-term care must also be enlarged. As a countermeasure, an integrated community care system must be established, and pharmacists will be responsible for urgent tasks within the system. Four universities-Prefectural University, Saitama Medical University, Josai University, and the Nippon Institute of Technology-decided to implement a collaborative project with the philosophy of "realizing high-quality lifestyles for local residents". This project was adopted by the Ministry of Education, Culture, Sports, Science and Technology as a Program for Promoting Inter-University Collaborative Education for fiscal year 2012. In this symposium, I report on the relationship between this initiative and pharmacy education, as well as discuss expectations of IPE for pharmacist education in the future.

Student Attitudes on Sociomedical Issues: A Follow-Up Survey.

ERIC Educational Resources Information Center

Kilwein, John H.; Kilwein, John C.

1990-01-01

A study compared student attitudes in the first and last years of a pharmaceutical program toward the health care system, environmental protection, abortion, euthanasia, use of tranquilizers, and family vs. career. On some issues there was considerable change by the final year, while attitudes on other issues remained stable. Females showed the…

Design and Implementation of an Interdepartmental Biotechnology Program across Engineering Technology Curricula

ERIC Educational Resources Information Center

Clase, Kari

2008-01-01

The health industry is an important and growing economic engine. Advances are being made in pharmaceutical and biotechnology discoveries and their applications (including manufacturing), as well as in health care services. As a result, there is an increasing sophistication of the products and services available and being developed, with an…

Specialty pharmacy cost management strategies of private health care payers.

PubMed

Stern, Debbie; Reissman, Debi

2006-01-01

The rate of increase in spending on specialty pharmaceuticals is outpacing by far the rate of increase in spending for other drugs. To explore the strategies payers are using in response to challenges related to coverage, cost, clinical management, and access of specialty pharmaceuticals and to describe the potential implications for key stakeholders, including patients, physicians, and health care purchasers. Sources of information were identified in the course of providing consulting services in the subject area of specialty pharmaceuticals to health plans, pharmacy benefit managers, employers, and pharmaceutical manufacturers. Specialty pharmaceuticals represent the fastest growing segment of drug spending due to new product approvals, high unit costs, and increasing use. Health care payers are faced with significant challenges related to coverage, cost, clinical management, and access. A variety of short- and long-term strategies have been employed to address these challenges. Current management techniques for specialty pharmaceuticals often represent a stop-gap approach for controlling rising drug costs. Optimum cost and care management methods will evolve as further research identifies the true clinical and economic value of various specialty pharmaceuticals.

[Effects of practical training to increase motivation for learning and related factors].

PubMed

Yamaguchi, Takumi; Akiyama, Shinji; Sagara, Hidenori; Tanaka, Akihiro; Miyauchi, Yoshirou; Araki, Hiroaki; Shibata, Kazuhiko; Izushi, Fumio; Namba, Hiroyuki

2014-01-01

Under the six-year pharmaceutical education system that was initiated in April 2006, students who had completed the course in March 2012 became the first graduates. The six-year system encourages students to develop a well-rounded personality, a deep sense of ethics, knowledge required for health care professionals, abilities to identify and solve problems, and practical skills required in clinical settings, as well as basic knowledge and skills. Under the new education system based on the "pharmaceutical education model core curriculums" and "practical training model core curriculums", general pharmaceutical education is implemented in each college, and five-month practical training is conducted in clinical settings. Clinical tasks experienced by students for the first time are expected to significantly influence their motivation to learn and future prospects. In the present survey research, students who had completed practical training evaluated the training program, and correspondence and logistic regression analyses of the results were conducted to examine the future effects and influences of the training on the students. The results suggest that the students viewed the practical training program positively. In addition, clinical experience during the training sessions not only influenced their decisions on future careers, but also significantly increased their motivation to learn. Furthermore, their motivation for learning was increased most by the enthusiasm of pharmacists who advised them in clinical settings, rather than the training program itself. To improve pharmaceutical clinical learning, it is important to develop teaching and working environments for pharmacists in charge of advising students in clinical training.

Palliative Care Development in Mongolia.

PubMed

Davaasuren, Odontuya; Ferris, Frank D

2018-02-01

Since the year 2000, Mongolia has established the foundation measures for a national palliative care program and has made several significant achievements. Systematic reviews and observational studies on palliative care development in Mongolia have taken place over the past 16 years. Mongolia began palliative care development in 2000 with the creation of the Mongolian Palliative Care Society and the Palliative Care Department. Palliative care is included in the Mongolia's Health Law, Health Insurance Law, Social Welfare Law, National Cancer Control Program, and the National Program for Non-Communicable Diseases, and has approved Palliative Care Standards and Pain Management Guidelines. Palliative care education is included in the undergraduate and postgraduate curriculum in all medical universities. Six hospice units in Ulaanbaatar have 50 beds; each of the nine districts and all 21 provinces have up to four to five palliative beds, and there are 36 palliative care units, for a total 190 beds for three million people. In 2014, a pediatric palliative care inpatient unit was established with five beds. Essential drugs for palliative care have been available in Mongolia since 2015. The pharmaceutical company IVCO produces morphine, codeine, pethidine, and oxycodone in Ulaanbaatar. Mongolia has made real progress in integrating palliative care into the health system. Copyright © 2017. Published by Elsevier Inc.

A non-clinical randomised controlled trial to assess the impact of pharmaceutical care intervention on satisfaction level of newly diagnosed diabetes mellitus patients in a tertiary care teaching hospital in Nepal.

PubMed

Upadhyay, Dinesh Kumar; Mohamed Ibrahim, Mohamed Izham; Mishra, Pranaya; Alurkar, Vijay M

2015-02-12

Patient satisfaction is the ultimate goal of healthcare system which can be achieved from good patient-healthcare professional relationship and quality of healthcare services provided. Study was conducted to determine the baseline satisfaction level of newly diagnosed diabetics and to explore the impact of pharmaceutical care intervention on patients' satisfaction during their follow-ups in a tertiary care teaching hospital in Nepal. An interventional, pre-post non-clinical randomised controlled study was designed among randomly distributed 162 [control group (n = 54), test 1 group (n = 54) and test 2 group (n = 54)] newly diagnosed diabetes mellitus patients by consecutive sampling method for 18 months. Diabetes Patient Satisfaction Questionnaire was used to evaluate patient's satisfaction scores at baseline, three, six, nine and, twelve months' follow-ups. Test groups patients were provided pharmaceutical care whereas control group patients only received their usual care from physician/nurses. The responses were entered in SPSS version 16. Data distribution was not normal on Kolmogorov-Smirnov test. Non-parametric tests i.e. Friedman test, Mann-Whitney U test and Wilcoxon signed rank test were used to find the differences among the groups before and after the intervention (p ≤0.05). There were significant (p < 0.001) improvements in patients' satisfaction scores in the test groups on Friedman test. Mann-Whitney U test identified the significant differences in satisfaction scores between test 1 and test 2 groups, control and test 1 groups and, control and test 2 groups at 3-months (p = 0.008), (p < 0.001) and (p < 0.001), 6-months (p = 0.010), (p < 0.001) and (p < 0.001), 9-months (p < 0.001), (p < 0.001) and (p < 0.001) and, 12-months (p < 0.001), (p < 0.001) and (p < 0.001) follow-ups respectively. Pharmaceutical care intervention significantly improved the satisfaction level of diabetics in the test groups compare to the control group. Diabetic kit demonstration strengthened the satisfaction level among the test 2 group patients. Therefore, pharmacist can act as a counsellor through pharmaceutical care program and assist the patients in managing their disease. This will not only modify the patients' related outcomes and their level of satisfaction but also improve the healthcare system.

What variables should be considered in allocating Primary health care Pharmaceutical budgets to districts in Uganda?

PubMed

Mujasi, Paschal N; Puig-Junoy, Jaume

2015-01-01

A key policy question for the government of Uganda is how to equitably allocate primary health care pharmaceutical budgets to districts. This paper seeks to identify variables influencing current primary health care pharmaceutical expenditure and their usefulness in allocating prospective pharmaceutical budgets to districts. This was a cross sectional, retrospective observational study using secondary administrative data. We collected data on the value of pharmaceuticals procured by primary health care facilities in each district from National Medical Stores for the financial year 2011/2012. The dependent variable was expressed as per capita district pharmaceutical expenditure. By reviewing literature we identified 26 potential explanatory variables. They include supply, need and demand, and health system organization variables that may influence the demand and supply of health services and the corresponding pharmaceutical expenditure. We collected secondary data for these variables for all the districts in Uganda (n = 112). We performed econometric analysis to estimate parameters of various regression models. There is a significant correlation between per capita district pharmaceutical expenditure and total district population, rural poverty, access to drinking water and outpatient department (OPD) per capita utilisation.(P < 0.01). The percentage of health centre IIIs (HC III) among each district's health facilities is significantly correlated with per capita pharmaceutical expenditure (P < 0.05). OPD per capita utilisation has a relatively strong correlation with per capita pharmaceutical expenditure (r = 0.498); all the other significant factors are weakly correlated with per capita pharmaceutical expenditure (r < 0.5). From several iterations of an initially developed model, the proposed final model for explaining per capita pharmaceutical expenditure explains about 53% of the variation in pharmaceutical expenditure among districts in Uganda (Adjusted R(2) = 0.528). All variables in the model are significant (p < 0.01). From evaluation of the various models, proposed variables to consider in allocating prospective primary health care pharmaceutical budgets to districts in Uganda are: district outpatient department attendance per capita, total district population, total number of government health facilities in the district and the district human poverty index.

Survey of Pharmaceutical Promotion in a Family Medicine Training Program

PubMed Central

Fogel, Martin L.

1989-01-01

Some researchers have shown that advertising by the pharmaceutical industry has a significant impact on the prescribing habits of physicians. Promotional material invades the practice of physicians in many guises, including journal advertisements, drug samples, clinical symposia sponsored by drug manufacturers, and the ever-diligent detail person. The author analyzed the prevalence of drug advertising, and found that promotional material was present in all the offices and examining rooms of clinicians in a Canadian family practice teaching centre. On average, 10.5 promotional items were present in each individual patient care area and almost 750 items were found in each physician's office. PMID:21248863

Association of Over-The-Counter Pharmaceutical Sales with Influenza-Like-Illnesses to Patient Volume in an Urgent Care Setting

PubMed Central

Liu, Timothy Y.; Sanders, Jason L.; Tsui, Fu-Chiang; Espino, Jeremy U.; Dato, Virginia M.; Suyama, Joe

2013-01-01

We studied the association between OTC pharmaceutical sales and volume of patients with influenza-like-illnesses (ILI) at an urgent care center over one year. OTC pharmaceutical sales explain 36% of the variance in the patient volume, and each standard deviation increase is associated with 4.7 more patient visits to the urgent care center (p<0.0001). Cross-correlation function analysis demonstrated that OTC pharmaceutical sales are significantly associated with patient volume during non-flu season (p<0.0001), but only the sales of cough and cold (p<0.0001) and thermometer (p<0.0001) categories were significant during flu season with a lag of two and one days, respectively. Our study is the first study to demonstrate and measure the relationship between OTC pharmaceutical sales and urgent care center patient volume, and presents strong evidence that OTC sales predict urgent care center patient volume year round. PMID:23555647

Independent Community Pharmacists' Perspectives on Compounding in Contemporary Pharmacy Education

PubMed Central

McPherson, Timothy B.; Fontane, Patrick E.; Berry, Tricia; Chereson, Rasma; Bilger, Rhonda

2009-01-01

Objectives To identify compounding practices of independent community pharmacy practitioners in order to make recommendations for the development of curricular objectives for doctor of pharmacy (PharmD) programs. Methods Independent community practitioners were asked about compounding regarding their motivations, common activities, educational exposures, and recommendations for PharmD education. Results Most respondents (69%) accepted compounding as a component of pharmaceutical care and compounded dermatological preparations for local effects, oral solutions, and suspensions at least once a week. Ninety-five percent were exposed to compounding in required pharmacy school courses and most (98%) who identified compounding as a professional service offered in their pharmacy sought additional postgraduate compounding education. Regardless of the extent of compounding emphasis in the practices surveyed, 84% stated that PharmD curricula should include compounding. Conclusions Pharmacy schools should define compounding curricular objectives and develop compounding abilities in a required laboratory course to prepare graduates for pharmaceutical care practice. PMID:19564997

The excess health care costs of KardioPro, an integrated care program for coronary heart disease prevention.

PubMed

Becker, Christian; Holle, Rolf; Stollenwerk, Björn

2015-06-01

Coronary heart disease (CHD) is a major cause of death and important driver of health care costs. Recent German health care reforms have promoted integrated care contracts allowing statutory health insurance providers more room to organize health care provision. One provider offers KardioPro, an integrated primary care-based CHD prevention program. As insurance providers should be aware of the financial consequences when developing optional programs, this study aims to analyze the costs associated with KardioPro participation. 13,264 KardioPro participants were compared with a propensity score-matched control group. Post-enrollment health care costs were calculated based on routine data over a follow-up period of up to 4 years. For those people who incurred costs, KardioPro participation was significantly associated with increased physician costs (by 33%), reduced hospital costs (by 19%), and reduced pharmaceutical costs (by 16%). Overall costs were increased by 4%, but this was not significant. Total excess costs per observation year were €131 per person (95% confidence interval: [€-36.5; €296]). Overall, KardioPro likely affected treatment as the program increased costs of physician services and reduced costs of hospital services. Further effects of substituting potential inpatient care with increased outpatient care might become fully apparent only over a longer time horizon. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Predictors of primary health care pharmaceutical expenditure by districts in Uganda and implications for budget setting and allocation.

PubMed

Mujasi, Paschal N; Puig-Junoy, Jaume

2015-08-20

There is need for the Uganda Ministry of Health to understand predictors of primary health care pharmaceutical expenditure among districts in order to guide budget setting and to improve efficiency in allocation of the set budget among districts. Cross sectional, retrospective observational study using secondary data. The value of pharmaceuticals procured by primary health care facilities in 87 randomly selected districts for the Financial Year 2011/2012 was collected. Various specifications of the dependent variable (pharmaceutical expenditure) were used: total pharmaceutical expenditure, Per capita district pharmaceutical expenditure, pharmaceutical expenditure per district health facility and pharmaceutical expenditure per outpatient department visit. Andersen's behaviour model of health services utilisation was used as conceptual framework to identify independent variables likely to influence health care utilisation and hence pharmaceutical expenditure. Econometric analysis was conducted to estimate parameters of various regression models. All models were significant overall (P < 0.01), with explanatory power ranging from 51 to 82%. The log linear model for total pharmaceutical expenditure explained about 80% of the observed variation in total pharmaceutical expenditure (Adjusted R(2) = 0.797) and contained the following variables: Immunisation coverage, Total outpatient department attendance, Urbanisation, Total number of government health facilities and total number of Health Centre IIs. The model based on Per capita Pharmaceutical expenditure explained about 50% of the observed variation in per capita pharmaceutical expenditure (Adjusted R(2) = 0.513) and was more balanced with the following variables: Outpatient per capita attendance, percentage of rural population below poverty line 2005, Male Literacy rate, Whether a district is characterised by MOH as difficult to reach or not and the Human poverty index. The log-linear model based on total pharmaceutical expenditure works acceptably well and can be considered useful for predicting future total pharmaceutical expenditure following observed trends. It can be used as a simple tool for rough estimation of the potential overall national primary health pharmaceutical expenditure to guide budget setting. The model based on pharmaceutical expenditure per capita is a more balanced model containing both need and enabling factor variables. These variables would be useful in allocating any set budget to districts.

75 FR 54627 - Best Management Practices for Unused Pharmaceuticals at Health Care Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-08

... at Health Care Facilities AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: EPA... Unused Pharmaceuticals at Health Care Facilities. The guidance is targeted at hospitals, medical clinics... drafted a guidance document for health care facilities, which describes: Techniques for reducing or...

Contracting by managed care systems for pharmaceutical products and services.

PubMed

Sharp, W T; Strandberg, L R

1990-11-01

The health care delivery system has received criticism because of its rapidly increasing costs. In an attempt to control costs, the administrators of managed care organizations are searching for cost control mechanisms. Thus, the administrators of managed care organizations appear to be searching carefully for any alternative method to lower the cost of delivering medical care to plan members. In this environment pharmacists must be extremely careful to study the cost of providing prescription services to managed care organizations, because they will be constrained by the obligations indicated in the contractual relationship. Any decisions to provide pharmaceutical services should be studied in detail after careful discussion with administrators of a managed care organization. Only after a careful analysis should a pharmacist make a decision to offer or not offer pharmaceutical services to a managed care organization.

[Kampo Medicine in the New Model Core Curriculum of Pharmaceutical Education].

PubMed

Kobayashi, Yoshinori

2016-01-01

What should we educate for Kampo medicine in the model core curriculum of pharmaceutical education? The curricular core should be discussed considering the points mentioned below. (1) Positioning of Kampo medicine in the Japanese medical care system. Kampo medicine is an authorized medical care category in the National Health Insurance (NHI) program in Japan. The NHI drug price list carries 148 Kampo formulations. According to the report of the Japan Kampo Medicines Manufacturers Association in 2011, approximately 90% of Japanese physicians prescribe Kampo medicines. (2) Differences between Kampo medicine and western medicine: In Kampo medicine, the most suitable formula among various Kampo formulas to normalize the psychophysical state of individual patients is selected. In other words, if there is a complaint, there are always some treatments. (3) A strong point of Kampo medicine: Kampo medicine enables physicians to deal with difficult-to-treat conditions by western medicine alone. Also, by using the scale of Kampo medicine, each patient can grasp his or her own systemic state and improve their lifestyle. To extend healthy life expectancy, a basic knowledge of Kampo medicine may play a significant role in integrated health care. "The guide book of the approval standards for OTC Kampo products", "the pharmaceutical advanced educational guideline", and "the manual of the exam questions preparation for registered sales clerks" should also be consulted before selecting the area and contents that should be covered.

Can Walmart make us healthier? Prescription drug prices and health care utilization.

PubMed

Borrescio-Higa, Florencia

2015-12-01

This paper analyzes how prices in the retail pharmaceutical market affect health care utilization. Specifically, I study the impact of Walmart's $4 Prescription Drug Program on utilization of antihypertensive drugs and on hospitalizations for conditions amenable to drug therapy. Identification relies on the change in the availability of cheap drugs introduced by Walmart's program, exploiting variation in the distance to the nearest Walmart across ZIP codes in a difference-in-differences framework. I find that living close to a source of cheap drugs increases utilization of antihypertensive medications by 7 percent and decreases the probability of an avoidable hospitalization by 6.2 percent. Copyright © 2015 Elsevier B.V. All rights reserved.

Financial analysis of cardiovascular wellness program provided to self-insured company from pharmaceutical care provider's perspective.

PubMed

Wilson, Justin B; Osterhaus, Matt C; Farris, Karen B; Doucette, William R; Currie, Jay D; Bullock, Tammy; Kumbera, Patty

2005-01-01

To perform a retrospective financial analysis on the implementation of a self-insured company's wellness program from the pharmaceutical care provider's perspective and conduct sensitivity analyses to estimate costs versus revenues for pharmacies without resident pharmacists, program implementation for a second employer, the second year of the program, and a range of pharmacist wages. Cost-benefit and sensitivity analyses. Self-insured employer with headquarters in Canton, N.C. 36 employees at facility in Clinton, Iowa. Pharmacist-provided cardiovascular wellness program. Costs and revenues collected from pharmacy records, including pharmacy purchasing records, billing records, and pharmacists' time estimates. All costs and revenues were calculated for the development and first year of the intervention program. Costs included initial and follow-up screening supplies, office supplies, screening/group presentation time, service provision time, documentation/preparation time, travel expenses, claims submission time, and administrative fees. Revenues included initial screening revenues, follow-up screening revenues, group session revenues, and Heart Smart program revenues. For the development and first year of Heart Smart, net benefit to the pharmacy (revenues minus costs) amounted to dollars 2,413. All sensitivity analyses showed a net benefit. For pharmacies without a resident pharmacist, the net benefit was dollars 106; for Heart Smart in a second employer, the net benefit was dollars 6,024; for the second year, the projected net benefit was dollars 6,844; factoring in a lower pharmacist salary, the net benefit was dollars 2,905; and for a higher pharmacist salary, the net benefit was dollars 1,265. For the development and first year of Heart Smart, the revenues of the wellness program in a self-insured company outweighed the costs.

[Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

PubMed

Nakajima, Toshifusa

2016-04-01

Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

Healthcare Resource Uses and Out-of-Pocket Expenses Associated with Pulmonary TB Treatment in Thailand.

PubMed

Tanvejsilp, Pimwara; Loeb, Mark; Dushoff, Jonathan; Xie, Feng

2017-08-22

In Thailand, pharmaceutical care has been recently introduced to a tertiary hospital as an approach to improve adherence to tuberculosis (TB) treatment in addition to home visit and modified directly observed therapy (DOT). However, the economic impact of pharmaceutical care is not known. The aim of this study was to estimate healthcare resource uses and costs associated with pharmaceutical care compared with home visit and modified DOT in pulmonary TB patients in Thailand from a healthcare sector perspective inclusive of out-of-pocket expenditures. We conducted a retrospective study using data abstracted from the hospital billing database associated with pulmonary TB patients who began treatment between 2010 and 2013 in three hospitals in Thailand. We used generalized linear models to compare the costs by accounting for baseline characteristics. All costs were converted to international dollars (Intl$) RESULTS: The mean direct healthcare costs to the public payer were $519.96 (95%confidence interval [CI] 437.31-625.58) associated with pharmaceutical care, $1020.39 (95% CI 911.13-1154.11) for home visit, and $887.79 (95% CI 824.28-955.91) for modified DOT. The mean costs to patients were $175.45 (95% CI 130.26-230.48) for those receiving pharmaceutical care, $53.77 (95% CI 33.25-79.44) for home visit, and $49.33 (95% CI 34.03-69.30) for modified DOT. After adjustment for baseline characteristics, pharmaceutical care was associated with lower total direct costs compared with home visit (-$354.95; 95% CI -285.67 to -424.23) and modified DOT (-$264.61; 95% CI -198.76 to -330.46). After adjustment for baseline characteristics, pharmaceutical care was associated with lower direct costs compared with home visit and modified DOT.

Pharmaceutical care: the PCNE definition 2013.

PubMed

Allemann, Samuel S; van Mil, J W Foppe; Botermann, Lea; Berger, Karin; Griese, Nina; Hersberger, Kurt E

2014-06-01

Twenty-three years after Hepler and Strand published their well-known definition of Pharmaceutical Care (PhC), confusion remains about what the term includes and how to differentiate it from other terms. The board of the Pharmaceutical Care Network Europe (PCNE) felt the need to redefine PhC and to answer the question: "What is Pharmaceutical Care in 2013". The aims of this paper were to review existing definitions of PhC and to describe the process of developing a redefined definition. A literature search was conducted in the MEDLINE database (1964-January 2013). Keywords included "Pharmaceutical Care", "Medication (Therapy) Management", "Medicine Management", and "Pharmacist Care" in the title or abstract together with the term "defin*". To ease comparison between definitions, we developed a standardised syntax to paraphrase the definitions. During a dedicated meeting, a moderated discussion about the definition of PhC was organised. The initial literature search produced 186 hits, with eight unique PhC definitions. Hand searching identified a further 11 unique definitions. These 19 definitions were paraphrased using the standardised syntax (provider, recipient, subject, outcome, activities). Fourteen members of PCNE and 10 additional experts attended the moderated discussion. Working groups of increasing size developed intermediate definitions, which had similarities and differences to those retrieved in the literature search. At the end of the session, participants reached a consensus on a "PCNE definition of Pharmaceutical Care" reading: "Pharmaceutical Care is the pharmacist's contribution to the care of individuals in order to optimize medicines use and improve health outcomes". It was possible to paraphrase definitions of PhC using a standardised syntax focusing on the provider, recipient, subject, outcomes, and activities included in PhC practice. During a one-day workshop, experts in PhC research agreed on a definition, intended to be applicable for the present time, representative for various work settings, and valid for countries inside and outside of Europe.

Present Conditions and Problems of Home Care Education in Pharmaceutical Education: Through the Activities of "the Working Group to Create Home Clinical Cases for Education".

PubMed

Kobuke, Yuko

2017-01-01

In the pharmaceutical education model core curriculums revision, "basic qualities required as a pharmacist" are clearly shown, and "the method based on learning outcomes" has been adopted. One of the 10 qualities (No. 7) is "Practical ability of the health and medical care in the community". In the large item "F. Pharmaceutical clinical" of the model core curriculums, "participation in the home (visit) medical care and nursing care" is written in "participation in the health, medical care, and welfare of the community", and it is an important problem to offer opportunities of home medical care education at university. In our university, we launched a working group to create "home clinical cases for education" from the educational point of view to pharmacy students to learn home medical care, in collaboration with university faculty members and pharmacists, who are practitioners of home care. Through its working group activities, we would like to organize the present conditions and problems of home care education in pharmaceutical education and to examine the possibility of using "home clinical case studies" in home care education at university.

[Preservation of ability to work and securing vocational participation : non-pharmaceutical support options for rheumatologists].

PubMed

Drambyan, Y; Parthier, K

2014-02-01

For patients of working age with chronic rheumatic diseases preservation of the ability to work and therefore for equal participation in professional life is of particular importance. Significant supporting actions by rheumatologists include non-pharmaceutical and non-medical interventions in addition to drug therapy. Measures aiming at sustained working capacity such as physiotherapy, occupational therapy, medical rehabilitation and stepwise return to work have to be utilized. This support can include referral to a counseling service and assistance with the application for medical or vocational rehabilitation programs. In order to ensure sustainable success of the initiated measures it is essential that follow-up care and function-related interventions are supervised by a rheumatologist.

Impact of pharmaceutical care on knowledge, quality of life and satisfaction of postmenopausal women with osteoporosis.

PubMed

Lai, Pauline Siew Mei; Chua, Siew Siang; Chan, Siew Pheng

2013-08-01

This study describes the analysis of secondary outcomes from a previously published randomised controlled trial, which assessed the effects of pharmaceutical care on medication adherence, persistence and bone turnover markers. The main focus of this manuscript is the effect of the provision of pharmaceutical care on these secondary outcomes, and details on the design of the intervention provided, the osteoporosis care plan and materials used to deliver the intervention. To evaluate the effects of pharmaceutical care on knowledge, quality of life (QOL) and satisfaction of postmenopausal osteoporotic women prescribed bisphosphonates, and their associating factors. Randomised controlled trial, performed at an osteoporosis clinic of a tertiary hospital in Malaysia. Postmenopausal women diagnosed with osteoporosis (T-score ≤-2.5/lowtrauma fracture), just been prescribed weekly alendronate/risedronate were randomly allocated to receive intervention or standard care (controls). Intervention participants received a medication review, education on osteoporosis, risk factors, lifestyle modifications, goals of therapy, side effects and the importance of medication adherence at months 0, 3, 6 and 12. Knowledge, QOL and satisfaction. A total of 198 postmenopausal osteoporotic women were recruited: intervention = 100 and control = 98. Intervention participants reported significantly higher knowledge scores at months 3 (72.50 vs. 62.50 %), 6 (75.00 vs. 65.00 %) and 12 (78.75 vs. 68.75 %) compared to control participants. QOL scores were also lower (which indicates better QOL) at months 3 (29.33 vs. 38.41), 6 (27.50 vs. 36.56) and 12 (27.53 vs. 37.56) compared to control participants. Similarly, satisfaction score was higher in intervention participants (93.67 vs. 84.83 %). More educated women, with back pain, who were provided pharmaceutical care had better knowledge levels. Similarly, older, more educated women, with previous falls and back pain tend to have poorer QOL, whilst women who exercised more frequently and were provided pharmaceutical care had better QOL. Satisfaction also increased as QOL increases and when provided pharmaceutical care. The provision of pharmaceutical care improved knowledge, QOL and satisfaction in Malaysian postmenopausal osteoporotic women, showing that pharmacists have the potential to improve patients' overall bone health. Policymakers should consider placing a clinical pharmacist in the osteoporosis clinic to provide counselling to improve these outcomes.

[Coordination between pharmaceutical services for integrated pharmacotherapy: the case of Catalonia].

PubMed

Costa, Karen Sarmento; Goldbaum, Moisés; Guayta-Escolies, Rafel; Modamio, Pilar; Mariño, Eduardo Luis; Tolsá, José Luis Segú

2017-08-01

Pharmaceutical policies have been considered strategies to contribute to the guarantee of care coordination and clinical integration. This study sought to describe the pharmaceutical services developed at different levels of care in the health network in Catalonia, as well as to identify and analyze the mechanisms and instruments that act as facilitators and/or barriers to the coordination of pharmacotherapy. This is a descriptive study of 12 cases of hospital pharmacy services, primary care and community pharmacies. Advances related to the perception, formalization and clinical and assistance coordination of the pharmaceutical services were identified. However, weaknesses and potential improvements in coordination were observed. The conclusion drawn was that the different tools and instruments implemented appear to facilitate a greater possibility of integration between pharmaceutical services and the latter with the health services network to contribute to integrated pharmacotherapy.

[Pharmaceutical care: conceptual and critical basis to a Brazilian model].

PubMed

Angonesi, Daniela; Sevalho, Gil

2010-11-01

The Pharmaceutical Care concepts were analyzed from their origins in the United States and the later contributions which came from Spain and from the effort of sistematization by the World Health Organization to understand the processs that has been happening in Brasil. After the abandon of the communitarian pharmacy, the Brazilian pharmacists hope that this new model of practicing is the way to get back his/her social role. The philosophy which directs the Pharmaceutical Care, having the focus on patient, in our understanding, must support philosophical and conceptually the rebuilding of pharmaceutical practicing in Brazil in order to get back the lost relation between the pharmacist and patient at communitarian pharmacy.

Questionnaire to assess patient satisfaction with pharmaceutical care in Spanish language.

PubMed

Traverso, María Luz; Salamano, Mercedes; Botta, Carina; Colautti, Marisel; Palchik, Valeria; Pérez, Beatriz

2007-08-01

To develop and validate a questionnaire, in Spanish, for assessing patient satisfaction with pharmaceutical care received in community pharmacies. Selection and translation of questionnaire's items; definition of response scale and demographic questions. Evaluation of face and content validity, feasibility, factor structure, reliability and construct validity. Forty-one community pharmacies of the province of Santa Fe. Argentina. Questionnaire administered to patients receiving pharmaceutical care or traditional pharmacy services. Pilot test to assess feasibility. Factor analysis used principal components and varimax rotation. Reliability established using internal consistency with Cronbach's alpha. Construct validity determined with extreme group method. A self-administered questionnaire with 27 items, 5-point Likert response scale and demographic questions was designed considering multidimensional structure of patient satisfaction. Questionnaire evaluates cumulative experience of patients with comprehensive pharmaceutical care practice in community pharmacies. Two hundred and seventy-four complete questionnaires were obtained. Factor analysis resulted in three factors: Managing therapy, Interpersonal relationship and General satisfaction, with a cumulative variance of 62.51%. Cronbach's alpha for the whole questionnaire was 0.96, and 0.95, 0.88 and 0.76 for the three factors, respectively. Mann-Whitney test for construct validity did not showed significant differences between pharmacies that provide pharmaceutical care and those that do not, however, 23 items showed significant differences between the two groups of pharmacies. The questionnaire developed can be a reliable and valid instrument to assess patient satisfaction with pharmaceutical care in community pharmacies in Spanish. Further research is needed to deepen the validation process.

Occurrence of pharmaceuticals and personal care products in fish: results of a national pilot study in the United States.

PubMed

Ramirez, Alejandro J; Brain, Richard A; Usenko, Sascha; Mottaleb, Mohammad A; O'Donnell, John G; Stahl, Leanne L; Wathen, John B; Snyder, Blaine D; Pitt, Jennifer L; Perez-Hurtado, Pilar; Dobbins, Laura L; Brooks, Bryan W; Chambliss, C Kevin

2009-12-01

Pharmaceuticals and personal care products are being increasingly reported in a variety of biological matrices, including fish tissue; however, screening studies have presently not encompassed broad geographical areas. A national pilot study was initiated in the United States to assess the accumulation of pharmaceuticals and personal care products in fish sampled from five effluent-dominated rivers that receive direct discharge from wastewater treatment facilities in Chicago, Illinois; Dallas, Texas; Orlando, Florida; Phoenix, Arizona; and West Chester, Pennsylvania, USA. Fish were also collected from the Gila River, New Mexico, USA, as a reference condition expected to be minimally impacted by anthropogenic influence. High performance liquid chromatography-tandem mass spectrometry analysis of pharmaceuticals revealed the presence of norfluoxetine, sertraline, diphenhydramine, diltiazem, and carbamazepine at nanogram-per-gram concentrations in fillet composites from effluent-dominated sampling locations; the additional presence of fluoxetine and gemfibrozil was confirmed in liver tissue. Sertraline was detected at concentrations as high as 19 and 545 ng/g in fillet and liver tissue, respectively. Gas chromatography-tandem mass spectrometry analysis of personal care products in fillet composites revealed the presence of galaxolide and tonalide at maximum concentrations of 2,100 and 290 ng/g, respectively, and trace levels of triclosan. In general, more pharmaceuticals were detected at higher concentrations and with greater frequency in liver than in fillet tissues. Higher lipid content in liver tissue could not account for this discrepancy as no significant positive correlations were found between accumulated pharmaceutical concentrations and lipid content for either tissue type from any sampling site. In contrast, accumulation of the personal care products galaxolide and tonalide was significantly related to lipid content. Results suggest that the detection of pharmaceuticals and personal care products was dependent on the degree of wastewater treatment employed.

Internet pharmaceutical sales: attributes, concerns, and future forecast.

PubMed

Bruckel, Katy; Capozzoli, Ernest A

2003-01-01

Internet pharmaceutical sales continue to skyrocket as healthcare providers and consumers are increasingly relying on the efficiencies and convenience that is available via such transactions. Managed care companies, increasing demands to reduce healthcare inefficiencies while maximizing the quality of patient care is a significant contributing factor to the expanding utilization and success of online pharmaceutical sales. However, with the expansion of Internet pharmaceutical sales, healthcare providers, pharmacy benefit management and insurance companies, and consumers realize new opportunities and risks. This paper will review the attributes and concerns associated with online pharmaceutical sales, discussing current and pending legislation intended to more effectively manage these parameters.

Pharmaceutical health care and Inuit language communications in Nunavut, Canada.

PubMed

Romain, Sandra J

2013-01-01

Pharmaceutical communication is an essential component of pharmaceutical health care, optimally ensuring patients understand the proper administration and side effects of their medications. Communication can often be complicated by language and culture, but with pharmaceuticals, misunderstandings can prove particularly harmful. In Nunavut, to ensure the preservation and revitalization of Inuit languages, the Inuit Language Protection Act and Official Languages Act were passed requiring that all public and private sector essential services offer verbal and written communication in Inuit languages (Inuktitut and Inuinnaqtun) by 2012. While the legislation mandates compliance, policy implementation for pharmaceutical services is problematic. Not a single pharmacist in Nunavut is fluent in either of the Inuit languages. Pharmacists have indicated challenges in formally translating written documentation into Inuit languages based on concerns for patient safety. These challenges of negotiating the joint requirements of language legislation and patient safety have resulted in pharmacies using verbal on-site translation as a tenuous solution regardless of its many limitations. The complex issues of pharmaceutical health care and communication among the Inuit of Nunavut are best examined through multimethod research to encompass a wide range of perspectives. This methodology combines the richness of ethnographic data, the targeted depth of interviews with key informants and the breadth of cross-Canada policy and financial analyses. The analysis of this information would provide valuable insights into the current relationships between health care providers, pharmacists and Inuit patients and suggest future directions for policy that will improve the efficacy of pharmaceuticals and health care spending for the Inuit in Canada.

Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial

PubMed Central

2012-01-01

Background Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas heart disease are high, especially if this heart disease is complicated by heart failure. In this setting, we hypothesize that pharmaceutical care might be an important tool for the clinical management of these patients by improving their quality of life, as a better compliance to their treatment and the avoidance and prompt correction of drug-related problems will minimize their symptoms, improve their functional class, and decrease the number of hospital admissions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure. Methods/design A prospective, single-center randomized clinical trial will be conducted in patients with Chagas heart disease complicated by heart failure. A total of 88 patients will be randomly assigned into two parallel groups: an intervention group will receive standard care and pharmaceutical care, and a control group will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems, exercise tolerance as measured by the standard six-minute-walk test, and compliance. Discussion Patients with Chagas heart disease complicated by heart failure under pharmaceutical care are expected to improve their quality of life, present with a lower incidence of drug-related problems, improve their functional capacity, and improve in their compliance to treatment. Trial registration ClinicalTrials.gov Identifier: NCT01566617 PMID:23270509

Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial.

PubMed

Sperandio da Silva, Gilberto M; Chambela, Mayara C; Sousa, Andrea S; Sangenis, Luiz Henrique C; Xavier, Sergio S; Costa, Andréa R; Brasil, Pedro Emmanuel A A; Hasslocher-Moreno, Alejandro M; Saraiva, Roberto M

2012-12-27

Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas heart disease are high, especially if this heart disease is complicated by heart failure. In this setting, we hypothesize that pharmaceutical care might be an important tool for the clinical management of these patients by improving their quality of life, as a better compliance to their treatment and the avoidance and prompt correction of drug-related problems will minimize their symptoms, improve their functional class, and decrease the number of hospital admissions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure. A prospective, single-center randomized clinical trial will be conducted in patients with Chagas heart disease complicated by heart failure. A total of 88 patients will be randomly assigned into two parallel groups: an intervention group will receive standard care and pharmaceutical care, and a control group will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems, exercise tolerance as measured by the standard six-minute-walk test, and compliance. Patients with Chagas heart disease complicated by heart failure under pharmaceutical care are expected to improve their quality of life, present with a lower incidence of drug-related problems, improve their functional capacity, and improve in their compliance to treatment. ClinicalTrials.gov Identifier: NCT01566617.

Code of ethics for the national pharmaceutical system: Codifying and compilation

PubMed Central

Salari, Pooneh; Namazi, Hamidreza; Abdollahi, Mohammad; Khansari, Fatemeh; Nikfar, Shekoufeh; Larijani, Bagher; Araminia, Behin

2013-01-01

Pharmacists as one of health-care providers face ethical issues in terms of pharmaceutical care, relationship with patients and cooperation with the health-care team. Other than pharmacy, there are pharmaceutical companies in various fields of manufacturing, importing or distributing that have their own ethical issues. Therefore, pharmacy practice is vulnerable to ethical challenges and needs special code of conducts. On feeling the need, based on a shared project between experts of the ethics from relevant research centers, all the needs were fully recognized and then specified code of conduct for each was written. The code of conduct was subject to comments of all experts involved in the pharmaceutical sector and thus criticized in several meetings. The prepared code of conduct is comprised of professional code of ethics for pharmacists, ethics guideline for pharmaceutical manufacturers, ethics guideline for pharmaceutical importers, ethics guideline for pharmaceutical distributors, and ethics guideline for policy makers. The document was compiled based on the principles of bioethics and professionalism. The compiling the code of ethics for the national pharmaceutical system is the first step in implementing ethics in pharmacy practice and further attempts into teaching the professionalism and the ethical code as the necessary and complementary effort are highly recommended. PMID:24174954

[Hospital pharmaceutical practice in prison].

PubMed

Harcouët, L

2010-09-01

Since 1994, hospital pharmaceutical teams have been in charge of pharmaceutical tasks in "unités de consultation et de soins ambulatoires" (UCSA), which are hospital consulting care units in French prisons. In 2008, pharmaceutical team in Parisian prisons received 6500 prescriptions and prepared 85,000 nominative bags containing drugs. Prisoners were 1.3% to receive treatments against HIV, 8.2% cardiovascular drugs, 7.2% opioid substitution treatments, and 52.9% psychoactive drugs, including 39.3% hypnotics, 40.5% anxiolytics, 11.3% antidepressants and 12.2% neuroleptics. In prison, the dichotomy between somatic and mental care is marked, attitudes of prisoners about their medicines are complex (important claims, embezzlement, etc.) and it is difficult for law defendants to maintain treatment confidentiality and to prepare prison outing in terms of health. To attenuate the heterogeneity of drug distribution systems in French prisons, we propose pharmaceutical analysis of prescriptions and nominative dispensation, computerization in UCSA in coordination with hospitals, a better contribution of prison medical and pharmaceutical staff in hospital "drug committees" and the redaction of pharmaceutical guidelines. Acting in concert with multidisciplinary medical staff in UCSA, pharmaceutical teams have to develop epidemiological studies to improve knowledge in prisoner's health and also prevention and health care in prison. Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Pharmacy staff training and development: upside-down thinking in a changing profession.

PubMed

Sawyer, W T; Hughes, T F; Eckel, F M

1992-04-01

We suggest that the most fundamental change in staff development that must occur is recognition of the need for a professional belief system as the basis for any pharmaceutical care activity. Values derived from fundamental moral ideals and professional beliefs foster the development of attitudes and behaviors. It would be wrong to suggest or imply that such a change need only occur in postbaccalaureate training. The development of personal and professional value systems in existing primary professional training programs is inadequate--we do not yet do enough to develop people before they enter practice. Nevertheless, to say that this failure of the professional education system precludes us from taking action within professional departments is unwise. The primary skills that must be developed during the next decade involve the ability of the practitioner to competently make informed, patient-specific decisions necessary for effective pharmaceutical care. Such decisions are made not only on the basis of a practitioner's knowledge but on the basis of his or her beliefs and values as well. The practitioner also must be willing to assume responsibility for the consequences of those decisions. The pharmacist who professes to deliver pharmaceutical care can no longer be shielded by assigning to the physician the ultimate responsibility for the patient's drug-therapy outcomes. Facilitating the development of a value system and attitude that enhance the pharmacist's ability to make such decisions must be a principal focus of staff training and development in the coming years.(ABSTRACT TRUNCATED AT 250 WORDS)

How drug life-cycle management patent strategies may impact formulary management.

PubMed

Berger, Jan; Dunn, Jeffrey D; Johnson, Margaret M; Karst, Kurt R; Shear, W Chad

2016-10-01

Drug manufacturers may employ various life-cycle management patent strategies, which may impact managed care decision making regarding formulary planning and management strategies when single-source, branded oral pharmaceutical products move to generic status. Passage of the Hatch-Waxman Act enabled more rapid access to generic medications through the abbreviated new drug application process. Patent expirations of small-molecule medications and approvals of generic versions have led to substantial cost savings for health plans, government programs, insurers, pharmacy benefits managers, and their customers. However, considering that the cost of developing a single medication is estimated at $2.6 billion (2013 dollars), pharmaceutical patent protection enables companies to recoup investments, creating an incentive for innovation. Under current law, patent protection holds for 20 years from time of patent filing, although much of this time is spent in product development and regulatory review, leaving an effective remaining patent life of 7 to 10 years at the time of approval. To extend the product life cycle, drug manufacturers may develop variations of originator products and file for patents on isomers, metabolites, prodrugs, new drug formulations (eg, extended-release versions), and fixed-dose combinations. These additional patents and the complexities surrounding the timing of generic availability create challenges for managed care stakeholders attempting to gauge when generics may enter the market. An understanding of pharmaceutical patents and how intellectual property protection may be extended would benefit managed care stakeholders and help inform decisions regarding benefit management.

Pharmaceutical Care: Need of the Hour in India

PubMed Central

Tumkur, A; Muragundi, PM; Shetty, R; Naik, A

2012-01-01

Pharmaceutical care signifies a shift of practice in pharmacy from being drug product-oriented to the one that is patient-oriented to achieve definite outcomes that improves patients’ quality of life. In order to achieve pharmaceutical care, pharmacists have to assume the role of caregiver, communicator, decision-maker, teacher, researcher, life-long learner, leader, and manager, which will help him to provide individualized care. As the patients visit community pharmacists more often, they can play a major role in providing individual care to the patients especially in the management of chronic noncommunicable diseases (NCDs). Community pharmacists have to upgrade their expertise in drug product orientation to that of clinical orientation to provide patient oriented care. Hence pharmacists have a larger role to play in managing NCDs which are rapidly increasing in India. PMID:23493228

Public perceptions of health care professionals' participation in pharmaceutical marketing.

PubMed

Crigger, Nancy J; Courter, Laura; Hayes, Kristen; Shepherd, K

2009-09-01

Trust in the nurse-patient relationship is maintained not by how professionals perceive their actions but rather by how the public perceives them. However, little is known about the public's view of nurses and other health care professionals who participate in pharmaceutical marketing. Our study describes public perceptions of health care providers' role in pharmaceutical marketing and compares their responses with those of a random sample of licensed family nurse practitioners. The family nurse practitioners perceived their participation in marketing activities as significantly more ethically appropriate than did the public responders. Further research is warranted before conclusions can be drawn, but these early findings suggest that nurse practitioners should consider a conservative approach to participating in pharmaceutical marketing.

Integrality of the therapeutic and pharmaceutical care: a necessary debate

PubMed Central

Vieira, Fabiola Sulpino

2017-01-01

ABSTRACT The controversy surrounding the different interpretations on the integrality of therapeutic and pharmaceutical care has led to the delimitation of its scope by a law, but the issue has not been completely pacified. As a contribution to this debate, we aim to discuss the challenges to ensure the integrality of the therapeutic and pharmaceutical care, based on a conceptual approach on the meanings of integrality in the Brazilian Unified Health System (SUS). We identified important challenges to ensure the integrality of the therapeutic and pharmaceutical care in the SUS. These challenges are related to professional practices, the organization of actions and services, and the governmental response to health problems or to the treatment of specific population groups. For this end, governments need to carry out structuring actions and be efficient in using available resources so that existing problems can be overcome. PMID:29236879

Russian-American pharmaceutical relations, 1900-1945.

PubMed

Conroy, Mary Schaeffer

2004-01-01

Many books and articles have focused on Soviet health-care. But there are no studies of the Soviet pharmaceutical industry, which was a lynch-pin of Soviet medicine, for without therapies physicians and health-care personnel can only diagnose, not treat. The present paper, part of such a study, opens a window onto one small aspect of the Soviet pharmaceutical industry - points of congruence, divergence, and reconvergence in the pharmaceutical sector with an on-again, off-again political and economic rival. This paper briefly reviews the Russian and the Soviet pharmaceutical systems, so that American audiences can make a comparison of them with our own. It then examines American-Russian/Soviet interaction in trade, joint ventures, research and development, product mix, and connections during World War II to illustrate similarities and differences. During the last decade, although the Soviet and American pharmaceutical systems each had a different trajectory of development, ironically their pharmaceutical industries again are finding points in common.

[Pharmaceutical care of patients with diabetes mellitus and its relationship to clinical pharmacy].

PubMed

Vlcek, J; Malý, J; Dosedel, M

2009-04-01

Pharmaceutical care develops both at universities in the Czech Republic and in daily practice, and is focused on drug-related issues as a pharmacist has the broadest knowledge of the drug and offers such knowledge to other persons involved in patient care. Pharmaceutical care is part of health care and although the pharmacist is considered to be a health service officer by legislation, health insurance companies--probably due to the fact the pharmacist is paid based on the margin obtained in business activities from the purchase and sale of prescribed drugs--do not see the pharmacist as such and they need to be convinced that such activity is necessary for the patient and is positive within the medical team. The aim of the article is to define what pharmaceutical care is, where it can be provided, why it is necessary within medical and nursing care, and to point out drug-related issues occurring in diabetic patients as well as the method for identifying and resolving them. The method is the answer to the following questions: Where to class pharmaceutical care and how to define the knowledge preconditions for such activity? Where is pharmaceutical care provided and what is its objective? How and where is pharmaceutical care taught? How can pharmaceutical care be applied in diabetology? The answers to the questions raised are based on literature and the authors' own teaching experience and activities performed in the position of clinical pharmacist at the 2nd Department of Internal Medicine of the University Hospital in Hradec Králové. Another method was the analysis of the incidence of drug issues related to the prescription of antidiabetics identified by 66 pharmacists over 2 months of active recording of drug-related issues and detected in hospitalized patients of the 2nd Department of Internal Medicine, both in outpatient and inpatient care. Another method was the monitoring of physicians' opinions about the doctor-pharmacist cooperation in the form of an interactive lecture at the spring congress of physicians in Prague in 2008. The basic method of pharmaceutical care is the maximization of benefits (instructions, how to use the drug correctly, how to support the patient's compliance, change in lifestyle) and the minimization of risks (to look for risk signals and to help resolve them; to resolve them directly with the OTC drug). Pharmacists can do this, in particular, if they are educated in clinical pharmacy and have sufficient training in pharmaceutical care--which nowadays is not an inaccessible activity. Pharmacists have identified, within the analysis of drug-related mistakes, 38 drug issues related to antidiabetics--which represent approximately 3 percent of all detected drug-related issues. The following problems were identified in diabetic patients at the 2nd Department of Internal Medicine: high doses of hydrochlorothiazide administered to diabetic patients, the administration of beta-blockers to diabetic patients with hypoglycemic attacks, the administration of metformin to a patient with malfunctioning kidneys, the reduction of corticoids without sufficient diabetes control. Most of the interviewed physicians (approx. 200) supported active cooperation with pharmacists not only in economic but also in professional issues. A pharmacist is able, within pharmaceutical care, to identify the first signs of the disease and to recommend the patient for a medical examination. He can detect drug-related issues thus minimising risks. He can maximise the effect by supporting drug compliance, repeating instructions for use of the drug and recommending a change in lifestyle; he can also help detect and minimise the impact of various risk factors. All these activities (in the strategic alliance of doctor-patient-pharmacist) can reduce the incidence of complications, which are expensive for the payers and reduce the quality of the patient's life.

Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved

PubMed Central

Morrato, Elaine H; Smith, Meredith Y

2015-01-01

Pharmaceutical risk minimization programs are now an established requirement in the regulatory landscape. However, pharmaceutical companies have been slow to recognize and embrace the significant potential these programs offer in terms of enhancing trust with health care professionals and patients, and for providing a mechanism for bringing products to the market that might not otherwise have been approved. Pitfalls of the current drug development process include risk minimization programs that are not data driven; missed opportunities to incorporate pragmatic methods and market-based insights, outmoded tools and data sources, lack of rapid evaluative learning to support timely adaption, lack of systematic approaches for patient engagement, and questions on staffing and organizational infrastructure. We propose better integration of risk minimization with clinical drug development and commercialization work streams throughout the product lifecycle. We articulate a vision and propose broad adoption of organizational models for incorporating risk minimization expertise into the drug development process. Three organizational models are discussed and compared: outsource/external vendor, embedded risk management specialist model, and Center of Excellence. PMID:25750537

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS (PPCPS) AS ENVIRONMENTAL POLLUTANTS

EPA Science Inventory

The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typical...

Paying pharmacists for patient care

PubMed Central

Houle, Sherilyn K. D.; Grindrod, Kelly A.; Chatterley, Trish; Tsuyuki, Ross T.

2014-01-01

Background: Expansion of scope of practice and diminishing revenues from dispensing are requiring pharmacists to increasingly adopt clinical care services into their practices. Pharmacists must be able to receive payment in order for provision of clinical care to be sustainable. The objective of this study is to update a previous systematic review by identifying remunerated pharmacist clinical care programs worldwide and reporting on uptake and patient care outcomes observed as a result. Methods: Literature searches were performed in several databases, including MEDLINE, Embase and International Pharmaceutical Abstracts, for papers referencing remuneration, pharmacy and cognitive services. Searches of the grey literature and Internet were also conducted. Papers and programs were identified up to December 2012 and were included if they were not reported in our previous review. One author performed data abstraction, which was independently reviewed by a second author. All results are presented descriptively. Results: Sixty new remunerated programs were identified across Canada, the United States, Europe, Australia and New Zealand, ranging in complexity from emergency contraception counseling to minor ailments schemes and comprehensive medication management. In North America, the average fee provided for a medication review is $68.86 (all figures are given in Canadian dollars), with $23.37 offered for a follow-up visit and $15.16 for prescription adaptations. Time-dependent fees were reimbursed at $93.60 per hour on average. Few programs evaluated uptake and outcomes of these services but, when available, indicated slow uptake but improved chronic disease markers and cost savings. Discussion: Remuneration for pharmacists’ clinical care services is highly variable, with few programs reporting program outcomes. Programs and pharmacists are encouraged to examine the time required to perform these activities and the outcomes achieved to ensure that fees are adequate to sustain these patient care activities. PMID:25360148

The changing face of pharmacy practice and the need for a new model of pharmacy education.

PubMed

Toklu, Hale Zerrin; Hussain, Azhar

2013-06-01

Pharmacy profession has evolved from its conventional and traditional drug focused basis to an advanced patient focused basis over the years. In the past century the pharmacists were more involved in compounding and manufacturing of medicines, but this role has significantly reduced over time. This advancement in the role of pharmacist calls for them to be the part of the broader health care team working for providing better health care for the patients, thus contributing in achieving the global millennium development goals. To match up, the role of today's pharmacists needs to be expanded to include pharmaceutical care concepts, making the pharmacist a health care professional rather than a drug seller in a commercial enterprise. Therefore, pharmacy schools should prepare a program that has competence with the changing role of the pharmacist. The education should provide ability for critical thinking, improve problem-solving skills and decision making during pharmacotherapy. The student should be trained to create, transmit, and apply new knowledge based on cutting-edge research in the pharmaceutical, social, and clinical sciences; collaborate with other health professionals and learn to enhance the quality of life through improved health for the people of local society and as well as the global community.

Responsive regulation of Internet pharmacy practice.

PubMed

Brushwood, D B

2001-01-01

Professor Brushwood discusses the effectiveness of the Internet as a medium for carrying out pharmaceutical care. A proponent of Internet pharmacy, Professor Brushwood argues that pharmacy regulators could best protect and promote public health through responsive Internet regulation. Wary of state paternalism, the article advocates the Verified Internet Pharmacy Practice Site program of the National Association of Boards of Pharmacy as a model method for regulating pharmacy practices over the Internet.

Impact of Practice-Based Instruction on Graduate Programs in the Pharmaceutical Sciences.

ERIC Educational Resources Information Center

Zografi, George

1979-01-01

Graduate education in the pharmaceutical sciences is examined. It is suggested that greater flexibility and quality of masters and PhD programs in pharmacy could increase enrollment levels in the graduate pharmaceutical studies. (SF)

Pharmaceutical Education in Nigeria.

ERIC Educational Resources Information Center

Oyegbile, F. Rachel

1988-01-01

Nigeria has six pharmacy schools, most offering graduate programs. The undergraduate program is being expanded from four to five years. Although behavioral and clinical sciences are offered, emphasis is on the pharmaceutical sciences. Overall, pharmaceutical education is oriented toward hospice practice. (Author/MSE)

Impact of pharmacy worker training and deployment on access to essential medicines and health outcomes in Malawi: protocol for a cluster quasi-experimental evaluation.

PubMed

Lubinga, Solomon J; Jenny, Alisa M; Larsen-Cooper, Erin; Crawford, Jessica; Matemba, Charles; Stergachis, Andy; Babigumira, Joseph B

2014-10-11

Access to essential medicines is core to saving lives and improving health outcomes of people worldwide, particularly in the low- and middle-income countries. Having a trained pharmacy workforce to manage the supply chain and safely dispense medicines is critical to ensuring timely access to quality pharmaceuticals and improving child health outcomes. This study measures the impact of an innovative pharmacy assistant training program in the low-income country of Malawi on access to medicines and health outcomes. We employ a cluster quasi-experimental design with pre-and post-samples and decision analytic modeling to examine access to and the use of medicines for malaria, pneumonia, and diarrhea for children less than 5 years of age. Two intervention districts, with newly trained and deployed pharmacy assistants, and two usual care comparison districts, matched on socio-economic, geographic, and health-care utilization indicators, were selected for the study. A baseline household survey was conducted in March 2014, prior to the deployment of pharmacy assistants to the intervention district health centers. Follow-up surveys are planned at 12- and 24-months post-deployment. In addition, interviews are planned with caregivers, and time-motion studies will be conducted with health-care providers at the health centers to estimate costs and resources use. This impact evaluation is designed to provide data on the effects of a novel pharmacy assistant program on pharmaceutical systems performance, and morbidity and mortality for the most common causes of death for children under five. The results of this study should contribute to policy decisions about whether and how to scale up the health systems strengthening workforce development program to have the greatest impact on the supply chain and health outcomes in Malawi.

The good pharmacy practice on Einstein Program at Paraisópolis Community.

PubMed

Oliveira, Lara Tânia de Assumpção Domingues Gonçalves de; Silva, Camila Pontes da; Guedes, Maria das Vitorias; Sousa, Ana Célia de Oliveira; Sarno, Flávio

2016-01-01

To describe indicators and processes developed and implemented for pharmaceutical assistance at the Einstein Program at Paraisópolis Community pharmacy. This was a descriptive study of retrospective data from January 2012 to December 2015. Data were obtained from spreadsheets developed for monitoring the productivity and care quality provided at the pharmacy. The evaluated variables were pharmaceutical assistance to prescription, pharmaceutical intervention, orientation (standard and pharmaceutical) and pharmaceutical orientation rate. The pharmacy assisted, on average, 2,308 prescriptions monthly, dispensing 4,871 items, including medications, materials and food supplements. Since March 2015, virtually, the pharmacist analyzed all prescriptions, prior to dispensing. In the analyzed period, there was an increase in monthly pharmaceutical interventions from 7 to 32 on average, and, although there was a decrease in the number of standard orientation, the pharmaceutical orientation had an increase, causing a rise of pharmaceutical orientation rate from 4 to 11%. The processes developed and implemented at the program pharmacy sought to follow the good pharmacy practice, and help patients to make the best use of their medications. Descrever os indicadores e os processos desenvolvidos e implantados para assistência farmacêutica na farmácia do Programa Einstein na Comunidade de Paraisópolis. Tratase de um estudo descritivo de dados retrospectivos de janeiro de 2012 a dezembro de 2015. Os dados foram obtidos de planilhas desenvolvidas para acompanhamento da produtividade e da qualidade de assistência prestada na farmácia. As variáveis avaliadas foram: atenção farmacêutica à prescrição, intervenção farmacêutica, orientação (padrão e farmacêutica) e taxa de orientação farmacêutica. A farmácia atendeu, em média, 2.308 prescrições ao mês, dispensando 4.871 itens, incluindo medicamentos, materiais e suplementos alimentares. Desde março de 2015, praticamente todas as prescrições foram analisadas pelo farmacêutico antes da dispensação. Houve incremento nas intervenções farmacêuticas mensais, de 7 para 32 em média e, apesar de ter havido diminuição no número de orientações padrão, a orientação farmacêutica aumentou, fazendo com que a taxa de orientação subisse de 4 para 11%. Os indicadores e os processos desenvolvidos e implantados na farmácia do programa procuraram seguir as boas práticas de farmácia e ajudar os pacientes a fazerem melhor uso de seus medicamentos.

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS: DIVERSE GALAXY OF ENVIRONMENTAL POLLUTANTS

EPA Science Inventory

The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typical...

Marketing Residential Treatment Programs for Eating Disorders: A Call for Transparency.

PubMed

Attia, Evelyn; Blackwood, Kristy L; Guarda, Angela S; Marcus, Marsha D; Rothman, David J

2016-06-01

Residential behavioral treatment is a growing sector of the health care industry and is used by a large proportion of adolescent and adult patients with eating disorders. These programs and the organizations that own them have developed extensive marketing strategies that target clinicians and include promotional gifts, meals, travel reimbursement, and continuing education credit. Legislation and policy changes have limited these types of activities when conducted by the pharmaceutical industry, and awareness of conflicts of interest associated with clinician-targeted advertising of drugs and devices has increased. However, similar practices by the behavioral health care industry have evolved without oversight. The authors urge clinicians to consider how marketing strategies by treatment facilities may influence their referral behaviors and call for improved transparency regarding gifts and payments from treatment facilities.

International scientists’ priorities for research on pharmaceutical and personal care products in the environment

EPA Science Inventory

Pharmaceuticals and personal care products (PPCPs) are widely discharged into the environment via diverse pathways. The effects of PPCPs in the environment have potentially important human and ecosystem health implications, so credible, salient, and legitimate scientific evidence...

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS (PPCP'S) AS ENVIRONMENTAL POLLUTANTS: POLLUTION FROM PERSONAL ACTIONS

EPA Science Inventory

The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typical...

ORIGINS AND RAMIFICATIONS OF PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and their environ...

POLLUTION FROM PERSONAL ACTIONS AND ACTIVITIES - PHARMACEUTICALS AND PERSONAL CARE PRODUCTS (PPCPS)

EPA Science Inventory

The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typical...

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS (PPCPS) AS ENVIRONMENTAL POLLUTANTS: POLLUTION FROM PERSONAL ACTIONS

EPA Science Inventory

The occurrence of pharmaceuticals and personal care products (PPCPs) as trace environmental pollutants is a multifaceted issue whose scope of concerns continues to expand. PPCPs comprise thousands of distinct chemicals from numerous therapeutic and consumer classes. They typicall...

How the Trans Pacific Partnership Agreement could undermine PHARMAC and threaten access to affordable medicines and health equity in New Zealand.

PubMed

Gleeson, Deborah; Lopert, Ruth; Reid, Papaarangi

2013-10-01

New Zealand's Pharmaceutical Management Agency (PHARMAC) has been highly successful in facilitating affordable access to medicines through a combination of aggressive price negotiations, innovative procurement mechanisms, and careful evaluation of value for money. Recently the US government, through the establishment of a series of bilateral and plurilateral "free" trade agreements, has attempted to constrain the pharmaceutical access programs of other countries in order to promote the interests of the pharmaceutical industry. The Trans Pacific Partnership Agreement (TPPA) represents the latest example; through the TPPA the US is seeking to eliminate therapeutic reference pricing, introduce appeals processes for pharmaceutical companies to challenge formulary listing and pricing decisions, and introduce onerous disclosure and "transparency" provisions that facilitate industry involvement in decision-making around coverage and pricing of medicines (and medical devices). This paper argues that the US agenda, if successfully prosecuted, would be likely to increase costs and reduce access to affordable medicines for New Zealanders. This would in turn be likely to exacerbate known inequities in access to medicines and thus disproportionately affect disadvantaged population groups, including Māori and Pacific peoples. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Prescription drug coupons: evolution and need for regulation in direct-to-consumer advertising.

PubMed

Mackey, Tim K; Yagi, Nozomi; Liang, Bryan A

2014-01-01

Pharmaceutical marketing in the United States had undergone a shift from largely exclusively targeting physicians to considerable efforts in targeting patients through various forms of direct-to-consumer advertising ("DTCA"). This includes the use of DTCA in prescription drug coupons ("PDCs"), a new form of DTCA that offers discounts and rebates directly to consumers to lower costs of drug purchasing. Our examination of PDCs reveals that the use and types of PDC programs is expanding and includes promotion of the vast majority of top grossing pharmaceuticals. However, controversy regarding this emerging form of DTCA has given rise to health policy concerns about their overall impact on prescription drug expenditures for consumers, payers, and the health care system, and whether they lead to optimal long-term utilization of pharmaceuticals. In response to these concerns and the growing popularity of PDCs, what we propose here are clearer regulation and regulatory guidance for PDC DTCA use. This would include review for appropriate disclosure of marketing claims, increased transparency in PDC use for pharmaceutical pricing, and leveraging potential positive benefits of PDC use for vulnerable or underserved patient populations. Copyright © 2014 Elsevier Inc. All rights reserved.

Specialty pharmaceuticals: developing a management plan.

PubMed

Willcutts, Dave

2002-01-01

This is the first in a series of articles that address the complex issues associated with specialty pharmaceuticals in the development of a successful specialty pharmaceutical program, a critical component of managing this high-cost and highly fragmented sector. This article focuses on how to define specialty pharmaceuticals. Other articles in this series will explore such topics as the mechanics of developing and managing a specialty pharmaceutical program, how and when to establish clinical protocols and authorizations, the importance of data management, and the benefits from automated processes.

Pharmaco-economic impact of demographic change on pharmaceutical expenses in Germany and France

PubMed Central

2012-01-01

Background Most European health care systems are suffering from the impact of demographic change. In short, aging of society is leading to higher costs of treatment per capita, while reproduction rates below 2.1 children per woman lead to a reduced number of younger people to provide for the necessary contributions into the health insurance system. This research paper addresses the questions what impact the demographic development will have on one particular spending area, what are pharmaceutical expenditure in two of Europe’s largest health care systems, Germany and France, and what the implications are for pharmaceutical companies. Methods The research is based on publicly available data from German and French health ministries, the OECD, and institutes which focus on projection of demographic development in those countries. In a first step, data was clustered into age groups, and average spending on pharmaceuticals was allocated to that. In the second step, these figures were extrapolated, based on the projected change in the demographic structure of the countries from 2004 until 2050. This leads to a deeper understanding of demand for pharmaceutical products in the future due to the demographic development as a single driving factor. Results Pharmaceutical expenses per head (patient) will grow only slightly until 2050 (0.5% p.a. in both countries). Demographic change alone only provides for a slowly growing market for pharmaceutical companies both in Germany and in France, but for a relevant change in the consumption mix of pharmaceutical products, based on a shift of relevance of different age groups. Conclusions Despite demographic changes pharmaceutical expenses per head (patient) and the overall pharmaceutical markets will grow only slightly until 2050 in Germany as well as in France. Nevertheless, the aging of society implies different challenges for pharmaceutical companies and also for the health care system. Companies have to cope with the shift of relevance of different age groups and within the health care system new options for financing the slowly growing expenses have to be found. PMID:23092314

"Partners in Science": A Model Cooperative Program Introducing High School Teachers and Students to Leading-Edge Pharmaceutical Science

ERIC Educational Resources Information Center

Woska, Joseph R., Jr.; Collins, Danielle M.; Canney, Brian J.; Arcario, Erin L.; Reilly, Patricia L.

2005-01-01

"Partners in Science" is a cooperative program between Boehringer Ingelheim Pharmaceuticals, Inc. and area high schools in the community surrounding our Connecticut campus. It is a two-phase program that introduces high school students and teachers to the world of drug discovery and leading-edge pharmaceutical research. Phase 1 involves…

Availability and perceived value of masters of business administration degree programs in pharmaceutical marketing and management.

PubMed

Alkhateeb, Fadi M; Clauson, Kevin A; Latif, David A

2012-05-10

To examine pharmacist-targeted master of business administration (MBA) degree programs and investigate pharmacists' perceptions regarding them. Specialized MBA programs in pharmaceutical marketing and management offered at US colleges and schools of pharmacy were identified in the literature and compared. Pharmacists' perceptions of MBA programs were evaluated through a survey of clinical preceptors affiliated with a school of pharmacy. Seven US universities that offer an MBA program in pharmaceutical marketing and management were identified. Thirty-three percent of the 57 pharmacist preceptors who responded to the survey reported plans to pursue an MBA degree program. Respondents preferred MBA programs related to healthcare or pharmacy (66%) over general MBA programs (33%). An MBA in pharmaceutical marketing and management could provide pharmacists with advanced knowledge of the operational and strategic business aspects of pharmacy practice and give pharmacy graduates an advantage in an increasingly competitive job market.

Availability and Perceived Value of Masters of Business Administration Degree Programs in Pharmaceutical Marketing and Management

PubMed Central

Clauson, Kevin A.; Latif, David A.

2012-01-01

Objectives. To examine pharmacist-targeted master of business administration (MBA) degree programs and investigate pharmacists’ perceptions regarding them. Methods. Specialized MBA programs in pharmaceutical marketing and management offered at US colleges and schools of pharmacy were identified in the literature and compared. Pharmacists’ perceptions of MBA programs were evaluated through a survey of clinical preceptors affiliated with a school of pharmacy. Results. Seven US universities that offer an MBA program in pharmaceutical marketing and management were identified. Thirty-three percent of the 57 pharmacist preceptors who responded to the survey reported plans to pursue an MBA degree program. Respondents preferred MBA programs related to healthcare or pharmacy (66%) over general MBA programs (33%). Conclusion. An MBA in pharmaceutical marketing and management could provide pharmacists with advanced knowledge of the operational and strategic business aspects of pharmacy practice and give pharmacy graduates an advantage in an increasingly competitive job market. PMID:22611273

PHARMACEUTICAL AND PERSONAL CARE PRODUCTS AS UBIQUITOUS POLLUTANTS FROM PERSONAL USE AND ACTIVITIES

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In...

An Innovative Pharmaceutical Care Practical Course

ERIC Educational Resources Information Center

Bulatova, N. R.; Aburuz, S.; Yousef, A. M.

2007-01-01

The innovative practical course was developed to improve the students' ability to acquire pharmaceutical care skills. The primary components of the course were in-school training using small group discussions and hospital experience including identification, analysis, prevention and resolution of drug-therapy problems, patient counseling on their…

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS AS UBIQUITOUS POLLUTANTS FROM PERSONAL USE AND ACTIVITIES

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. In...

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

EPA Pesticide Factsheets

While the point-source emissions of pollutants from manufacturing waste streams have long been monitored and subject to controls, the environmental impact of the public's (i.e., the individual's) activities regarding the use of chemicals is more difficult to assess. Of particular question is the widespread release to sewage and surface/ground waters of pharmaceuticals and personal care products after their ingestion, external application, or disposal. Certain pharmaceutically active compounds (e.g., caffeine, nicotine, and aspirin) have been known for over 20 years to enter the environment by a variety of routes - primarily via treated and untreated sewage effluent. A larger picture, however, has emerged only more recently, where it is evident that numerous personal care products (such as fragrances and sunscreens) and drugs from a wide spectrum of therapeutic classes can occur in the environment and drinking water (albeit at very low concentrations), especially in natural waters receiving sewage. Nearly all ecological monitoring studies for pharmaceuticals and personal care products (informally referred to as

Stretching the managed care dollar in the new millennium: the practice of detailing primary care physicians.

PubMed

Hill, Cynthia D; Bunn, Douglas N; Hawkins, Jenny Rae

2002-01-01

Pharmaceutical expenditures in this country are on the rise and the increase is expected to continue at double-digit rates in the foreseeable future. This study focuses on the ways in which the managed care industry can impact pharmaceutical costs through peer-to-peer data sharing or academic detailing. Making use of analysis in conjunction with a major Midwestern Health Maintenance Organization, we evaluate the immediate impacts of academic detailing efforts, and find it to have a substantial mitigating impact on pharmaceutical trends. Moreover, we find academic detailing to be cost-effective means of altering physician-prescribing behavior.

Online Pharmaceutical Care Provision: Full-Implementation of an eHealth Service Using Design Science Research.

PubMed

Gregório, João; Pizarro, Ângela; Cavaco, Afonso; Wipfli, Rolf; Lovis, Christian; Mira da Silva, Miguel; Lapão, Luís Velez

2015-01-01

Chronic diseases are pressing health systems to introduce reforms, focused on primary care and multidisciplinary models. Community pharmacists have developed a new role, addressing pharmaceutical care and services. Information systems and technologies (IST) will have an important role in shaping future healthcare provision. However, the best way to design and implement an IST for pharmaceutical service provision is still an open research question. In this paper, we present a possible strategy based on the use of Design Science Research Methodology (DSRM). The application of the DSRM six stages is described, from the definition and characterization of the problem to the evaluation of the artefact.

Impact of Practice-Based Instruction on Graduate Programs in the Pharmaceutical Sciences--A Response.

ERIC Educational Resources Information Center

Gourley, Dick R.

1979-01-01

Issues concerning graduate programs in the pharmaceutical sciences are discussed, including: recent trends, recruitment, clinical instruction, doctoral programs, graduate faculty, master's programs, competition, supply and demand, and professional education of professionals. (SF)

Medicare and Medicaid fraud and abuse regulations.

PubMed

Liang, F Z; Black, B L

1991-11-01

Specific business arrangements that are protected under legislation and regulations governing parties doing business with Medicare or Medicaid are discussed. Regulations implementing the Medicare and Medicaid Patient Protection Act of 1987 specify practices and activities that are not subject to criminal penalties under the antikickback provisions of the Social Security Act or to exclusion from Medicare or state health-care programs. As of July 29, 1991, all organized health-care settings that receive payments from either Medicare or state health-care programs must comply with these regulations. The final rule sets forth "safe harbors"--exceptions to prohibitions against (1) kickbacks, bribes, rebates, and other illegal activities involving remunerations for patient referrals and (2) inducements to purchase or lease goods paid for by Medicare or state health-care programs. The safe harbors comprise 11 broad categories--investment interests, space rental, equipment rental, personal services and management contracts, purchase of a medical practice, referral services, warranties, discounts, employees, group purchasing organizations, and waiver of deductibles and coinsurance. Implications for pharmacy are discussed. These regulations will affect the purchase of pharmaceuticals by institutional pharmacies. Each institution should review its current practices to determine whether they are within the safe harbors.

POLLUTION FROM PERSONAL ACTIONS, ACTIVITIES, AND BEHAVIORS: PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPs) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and their environ...

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT: POLLUTION FROM PERSONAL ACTIONS, ACTIVITIES, AND BEHAVIORS

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environ...

POLLUTION FROM PERSONAL ACTIONS, ACTIVITIES, AND BEHAVIORS: PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and their environ...

The Role of PharmEcovigilance in Reducing the Environmental Footprint of Pharmaceuticals

EPA Science Inventory

The prescribing and usage of medications have ramifications extending far beyond conventional medical care. The pharmaceutical and healthcare industries have an environmental footprint because the active pharmaceutical ingredients (APIs) can enter the environment as contaminants ...

"Risk, respect, responsibility": educational strategies to promote safe medicine use.

PubMed

Rucker, N Lee

2003-12-01

Nearly four billion outpatient prescriptions will be dispensed in the United States by 2005. Many people using these medicines will be targeted for educational programs promoting their safe, appropriate use. Such programs have been, or soon will be, developed by virtually all major health care system stakeholders, including: government agencies, the pharmaceutical industry, non-profit organizations and coalitions. After examining changes in 1) health professionals' communication of patient medicine information, and 2) consumers' roles and attitudes, an overview of recent U.S. and international consumer education programs is presented. Despite the proliferation of these programs, most share a weak link in evaluating success and in affecting behavior change. Finally, suggestions for future initiatives are offered, particularly regarding improving evaluation methods.

Pharmacists' medicines-related interventions for people with intellectual disabilities: a narrative review.

PubMed

O'Dwyer, Máire; Meštrović, Arijana; Henman, Martin

2015-08-01

People with intellectual disabilities (ID) have complex pharmaceutical care needs due to a high prevalence of multimorbidity, a notable degree of polypharmacy and a high risk of adverse drug reactions. Despite this, people with ID often experience significant health disparities compared to the general population. In most developed countries, increasing emphasis on deinstitutionalisation and community integration also means greater utilisation of primary health care services where general practitioners, pharmacists and carers may lack appropriate information about the pharmaceutical needs of this population. Aim of the review To explore what type of pharmaceutical care interventions were being undertaken for people with ID and how pharmacists' contributed to the care of people with ID as part of multidisciplinary teams. Systematic searches of the following electronic databases were carried out; CINAHL, Pubmed, Medline, Embase, Cochrane library, Science Direct and International Pharmaceutical Abstracts. Results were limited to the period 1994-2014 using search terms 'learning disabilities', 'intellectual disabilities', 'mental retardation', 'developmental disabilities', 'learning difficulties' and 'pharmacist intervention', 'pharmaceutical care', 'primary care', 'pharmacy' "pharmacists" "pharmacy technicians". Agreement on studies to be included was arrived at by consensus and by using a pre-determined set of inclusion criteria. Due to the heterogeneous nature of the study aims, methods and presentation of study outcomes found, a narrative review was considered appropriate. In total, after removal of duplicates, 70 abstracts were identified and screened from the initial search. After screening and consensus agreement, eight articles which met the inclusion criteria were included in the review and were analysed under the following three themes; pharmacist interventions, pharmacists collaboration in provision of care, qualitative studies relating to patient, carers, and pharmacist views on care of people with ID. The limited evidence available in the literature suggests that pharmacists can make positive interventions in relation to the quality of the medication use process, in collaboration with other healthcare professionals, carers and patients with ID. However, further research will be required to increase the evidence base with regard to the benefits of providing pharmaceutical care to patients with intellectual disability and to inform future policy and planning.

Got CER? Educating Pharmacists for Practice in the Future: New Tools for New Challenges.

PubMed

Perfetto, Eleanor M; Anyanwu, Chinenye; Pickering, Matthew K; Zaghab, Roxanne Ward; Graff, Jennifer S; Eichelberger, Bernadette

2016-06-01

Understanding how treatments work in the real world and in real patients is an important and complex task. In recent years, comparative effectiveness research (CER) studies have become more available for health care providers to inform evidence-based decision making. There is variability in the strengths and limitations of this new evidence, and researchers and decision makers are faced with challenges when assessing the quality of these new methods and CER studies. To (a) describe an online tool developed by the CER Collaborative, composed of the Academy of Managed Care Pharmacy, the International Society for Pharmacoeconomics and Outcomes Research, and the National Pharmaceutical Council, and (b) provide an early evaluation of the training program impact on learners' self-reported abilities to evaluate and incorporate CER studies into their decision making. To encourage greater transparency, consistency, and uniformity in the development and assessment of CER studies, the CER Collaborative developed an online tool to assist researchers, new and experienced clinicians, and decision makers in producing and evaluating CER studies. A training program that supports the use of the online tool was developed to improve the ability and confidence of individuals to apply CER study findings in their daily work. Seventy-one health care professionals enrolled in 3 separate cohorts for the training program. Upon completion, learners assessed their abilities to interpret and apply findings from CER studies by completing on online evaluation questionnaire. The first 3 cohorts of learners to complete the training program consisted of 71 current and future health care practitioners and researchers. At completion, learners indicated high confidence in their CER evidence assessment abilities (mean = 4.2). Learners reported a 27.43%-59.86% improvement in capabilities to evaluate various CER studies and identify study design flaws (mean evaluation before CER Certificate Program [CCP] scores = 1.86-3.14 and post-CCP scores = 3.92-4.24). Additionally, 63% of learners indicated that they expected to increase their use of evidence from CER studies in at least 1-2 problem decisions per month. The CER Collaborative has responded to the need for increased practitioner training to improve understanding and application of new CER studies. The CER Collaborative tool and certificate training program are innovative solutions to help decision makers meet the challenges they face in honing their skills to best incorporate credible and relevant CER evidence into their decision making. The CER Collaborative, the development of the questionnaires and web-based tool, and the development of the CER Certificate Program were supported by grants and in-kind contributions from the Academy of Managed Care Pharmacy (AMCP), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), and the National Pharmaceutical Council (NPC). The University of Maryland School of Pharmacy conducted its work under a contract with the AMCP Foundation and grant funding from the NPC. Perfetto is employed by the University of Maryland and the National Health Council and serves as assistant editor for the Journal of Managed Care & Specialty Pharmacy, consults for Avelere, and serves as a member of advisory boards for the PQA and CMTP. Pickering received support from the NPC for activities related to this research. Eichelberger is employed by the Academy of Managed Care Pharmacy. Eichelberger and Graff are with the CER Collaborative. Graff is employed by the National Pharmaceutical Council. Study concept and design were primarily contributed by Perfetto, Graff, and Eichelberger, along with Anyanwu and assisted by Pickering and Ward Zaghab. Pickering and Ward Zaghab took the lead in data collection, with assistance from the other authors, and data interpretation was performed by Perfetto, Graff, Pickering, and Ward Zaghab, with assistance from the other authors. The manuscript was written by Perfetto and Anyanwu, with assistance from the other authors, and revised by Graff, Perfetto, Anyanwu, and Pickering, assisted by Eichelberger and Ward Zaghab.

Pharmaceutical care in community pharmacies: practice and research in Sweden.

PubMed

Westerlund, Lo Tommy; Björk, H Thony

2006-06-01

To describe the organization and delivery of community pharmacy and medical care, as well as pharmaceutical care practice and research, in Sweden. The Swedish retail pharmacy system of 800 community pharmacies and nearly 80 hospital pharmacies is unique in that it is organized into one single, government-owned chain, known as Apoteket AB. The pharmacy staff consists of pharmacists, prescriptionists, and pharmacy technicians. Some activities related to pharmaceutical care have been directed toward specific patient groups during annual theme campaigns. In the past few years, there has been a growing emphasis on the identification, resolution, and documentation of drug-related problems (DRPs) in Swedish pharmacy practice. A classification system for documenting DRPs and pharmacy interventions was developed in 1995 and incorporated into the software of all community pharmacies in 2001. A national DRP database (SWE-DRP) was established in 2004 to collect and analyze DRPs and interventions on a nationwide basis. Recently, a new counseling technique composed of key questions to facilitate the detection of DRPs has been tested successfully. Patient medication profiles are kept in 160 pharmacies, and a new national register of drugs dispensed to patients became available in 2006. Most pharmaceutical care studies in Sweden have focused on DRPs and resulting pharmacy interventions. Swedish community pharmacy DRP work is in the international forefront but there is a potential for further developing cognitive services, given the beneficial organization of the country's pharmacies into one single pharmacy chain. The introduction of patient medication profiles has been both late and slow and has only had a marginal effect on pharmaceutical care practice so far. The universities do not appear to have any desire to influence the practice of pharmacy and could potentially take on a more active role in preparing pharmacy students for patient-oriented services. Current threats to pharmaceutical care practice and research include organizational changes, budget cuts, and reduced manpower of Apoteket AB. The identification, resolution, and documentation of DRPs are central to community pharmacy practice in Sweden, resulting in a number of research studies. A national DRP database, patient medication profiles, and a new national register of drugs dispensed to patients provide opportunities for growth in pharmaceutical care practice and research in the country.

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT: AN OVERVIEW - POLLUTION FROM PERSONAL ACTIONS, ACTIVITIES, AND BEHAVIORS

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the individual activities of consumers and their environment. I...

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT: AN OVERVIEW - POLLUTION FROM PERSONAL ACTIONS, ACTIVITES, AND BEHAVIORS

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPs) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and their environ...

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT: AN OVERVIEW - POLLUTION FROM PERSONAL ACTIONS, ACTIVITIES, AND BEHAVIORS

EPA Science Inventory

Perhaps more so than with any other class of pollutants, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and their...

Pharmaceuticals and Personal Care Products in the Environment: What are the Big Questions?

EPA Science Inventory

Over the past 10-15 years, a significant amount of work has been done by the scientific, regulatory and business communities into effects and risks of pharmaceuticals and personal care products (PPCPs) in the environment. It is now timely to review the current knowledge and to...

Potential Upstream Strategies for the Mitigation of Pharmaceuticals in the Aquatic Environment: a Brief Review.

PubMed

Blair, Benjamin D

2016-06-01

Active pharmaceutical ingredients represent a class of pollutants of emerging concern, and there is growing evidence that these pollutants can cause damage to the aquatic environment. As regulations to address these concerns are expected in developed nations, decision-makers are looking to the scientific community for potential solutions. To inform these regulatory efforts, further information on the potential strategies to reduce the levels of pharmaceuticals entering the aquatic environment is needed. End-of-pipe (i.e., wastewater treatment) technologies that can remove pharmaceuticals exist; however, they are costly to install and operate. Thus, the goal of this brief review is to look beyond end-of-pipe solutions and present various upstream mitigation strategies discussed within the scientific literature. Programs such as pharmaceutical take-back programs currently exist to attempt to reduce pharmaceutical concentrations in the environment, although access and coverage are often limited for many programs. Other potential strategies include redesigning pharmaceuticals to minimize aquatic toxicity, increasing the percent of the pharmaceuticals metabolized in the body, selecting less harmful pharmaceuticals for use, starting new prescriptions at lower dosages, selecting pharmaceuticals with lower excretion rates, and implementing source treatment such as urine separating toilets. Overall, this brief review presents a summary of the upstream preventative recommendations to mitigate pharmaceuticals from entering the aquatic environment with an emphasis on regulatory efforts in the USA and concludes with priorities for further research.

Pharmaceutical regulation in 15 European countries review.

PubMed

Panteli, Dimitra; Arickx, Francis; Cleemput, Irina; Dedet, Guillaume; Eckhardt, Helen; Fogarty, Emer; Gerkens, Sophie; Henschke, Cornelia; Hislop, Jennifer; Jommi, Claudio; Kaitelidou, Daphne; Kawalec, Pawel; Keskimaki, Ilmo; Kroneman, Madelon; Lopez Bastida, Julio; Pita Barros, Pedro; Ramsberg, Joakim; Schneider, Peter; Spillane, Susan; Vogler, Sabine; Vuorenkoski, Lauri; Wallach Kildemoes, Helle; Wouters, Olivier; Busse, Reinhard

2016-10-01

In the context of pharmaceutical care, policy-makers repeatedly face the challenge of balancing patient access to effective medicines with affordability and rising costs. With the aim of guiding the health policy discourse towards questions that are important to actual and potential patients, this study investigates a broad range of regulatory measures, spanning marketing authorization to generic substitution and resulting price levels in a sample of 16 European health systems (Austria, Belgium, Denmark, England, Finland, France, Germany, Greece, Ireland, Italy, the Netherlands, Poland, Portugal, Scotland, Spain and Sweden). All countries employ a mix of regulatory mechanisms to contain pharmaceutical expenditure and ensure quality and efficiency in pharmaceutical care, albeit with varying configurations and rigour. This variation also influences the extent of publicly financed pharmaceutical costs. Overall, observed differences in pharmaceutical expenditure should be interpreted in conjunction with the differing volume and composition of consumption and price levels, as well as dispensation practices and their impact on measurement of pharmaceutical costs. No definitive evidence has yet been produced on the effects of different cost-containment measures on patient outcomes. Depending on the foremost policy concerns in each country, different levers will have to be used to enable the delivery of appropriate care at affordable prices. World Health Organization 2016 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).

It’s Time to Shine the Light on Direct-to-Consumer Advertising

PubMed Central

Mackey, Tim K.; Liang, Bryan A.

2015-01-01

Pharmaceutical marketing is undergoing a transition as the business, delivery, and consumption of health care have increasingly become part of a growing digital landscape. Changes in pharmaceutical promotion also coincide with federal “sunshine” regulations newly implemented under the Affordable Care Act that require disclosure of certain marketing and industry payments to physicians. Collectively, these trends could lead to fundamental shifts in physician-directed and direct-to-consumer advertising (DTCA) that have yet to be adequately identified or explored. In response, we advocate for greater DTCA transparency, especially in the emerging digital forms of DTCA, to complement forthcoming sunshine transparency data. This will allow more robust study and understanding of changes in overall pharmaceutical marketing trends and their impact on health care consumption and behavior. This can also lead to more targeted state and federal policy interventions leveraging existing federal transparency regulations to ensure appropriate marketing, sales, and consumption of pharmaceutical products. PMID:25583897

[The experience of public guarantees of free-of-charge medical care foreign countries].

PubMed

Ulumbekova, G E

2010-01-01

The article deals with the analysis of the volumes of financing of public guarantees program of free-of-charge medical care and its algorithm of its elaboration in foreign countries. In the advanced countries, the higher financing of public health permit to ensure factually overall population the full free-of-charge spectrum of up-to-date medical interventions as a "public guarantees pack". It includes the pharmaceuticals supply in outpatient conditions and in most cases the long-term care services. In economically advanced countries, the general trend is the transfer from fundamental principles ("everything needed") to the more transparent approaches in case of implementation of the guarantees to achieve the balance between actual financial resources and stated population guarantees.

Strategic planning for clinical services: St. Joseph Hospital and Health Care Center.

PubMed

Linggi, A; Pelham, L D

1986-09-01

A pharmacy department at a 340-bed community hospital based its strategic plan for developing patient-oriented services on a sound drug distribution system, a credible work-measurement program, and fiscal responsibility. In 1982 the department of pharmacy and i.v. therapy implemented a strategic plan for improving pharmaceutical services. The plan involved developing goals and objectives for the department; marketing the department's services and fiscal management to hospital administrators, medical staff, and nursing staff; building teamwork among the pharmacy staff; and improving the drug distribution system before instituting clinical services. Hiring of additional pharmacy staff was justified on the basis of work-measurement data. By adjusting staffing levels every two weeks based on work-measurement data, the department increased the efficiency of drug distribution activities; the pharmacy also implemented cost-saving programs like selection of therapeutic alternates and formulary restrictions. The savings were then reinvested in labor-intensive patient-oriented pharmaceutical services. A staff development program using staff pharmacists as preceptors expanded the breadth and depth of pharmacists' clinical skills. The planning efforts were successful because the needs of hospital administrators, the pharmacy department, and staff members were addressed.

[Investigation of cost and medical service fee for pharmaceutical management in home medical care].

PubMed

Honma, Katsuaki; Sakai, Ritsuko; Takeshima, Akiko; Shimamori, Yoshimitsu; Hayase, Yukitoshi

2004-10-01

Due to the evolvement of the aged society and the steep rise in medical costs, the environment encircling the medical care industry has been changing remarkably. For this reason, it has become both necessary and fundamental for a community pharmacist to participate in home medical care through the pharmaceutical management service. We have studied the associated costs and medical service fees for pharmaceutical management in home medical care. The costs and medical service fees were calculated based on the pharmaceutical management service data collected during the three years from November 1998 to October 2001. As a result, the medical service fees were calculated using the old system which lasted until March 2002. Calculations using this system took into account 550 points per visit, up to two visits per month. Under the new system which started in April 2002, the number of visits taken into account is four times a month, 500 points for the first visit, 300 points from the second through to the forth visit. Then, we simulated a break-even point (BEP). It is clear that it is difficult for any community pharmacy to be specialized in home medical care. In order for the pharmacist to actively participate in home medical care in the future, it is necessary to further improve the system.

Using design science research to develop online enhanced pharmaceutical care services.

PubMed

Lapão, Luís Velez; Gregório, João; Mello, Diogo; Cavaco, Afonso; Mira Da Silva, Miguel; Lovis, Christian

2014-01-01

The ePharmaCare project aims at assessing the potential of eHealth services for the provision of pharmaceutical services interacting actively with patients. The results presented here focus on the first three steps of Design Science Research Methodology. A mixed methods approach was used with an online survey to collect data on use of information technologies in community pharmacy, followed by an exploratory observational time and business processes study, which use the shadowing method to identify and assess the opportunity to lunch online services. Combining this with the Service Experiment Blueprint and the Dáder method an enhanced pharmaceutical service was designed. Next, an artifact is developed and a prototype is implemented to demonstrate the value of online pharmaceutical services' delivery. This new service could represent a new perspective for pharmaceutical services integration within the health system.

Future European health care: cost containment, health care reform and scientific progress in drug research.

PubMed

Emilien, G

1997-01-01

The cost of the development of a new pharmaceutical product from its conception and synthesis through to the regulatory approval process has more than quadrupled in the last 20 years. Both clinical and total development times have increased substantially. To amortize the costs incurred, the pharmaceutical industry has taken an international dimension. The incentives for pharmaceutical firms to discover and develop new drugs depend on the length of the development and regulatory review process plus the potential market size. Recent regulatory, economic and political changes may have significant implications for the future of new drug developments in Europe. The European Union industrial policy felt that there is a need for convergence in the area of pricing. It is recommended that the policy should aim to contain growth in pharmaceutical expenses by means specific to reimbursement rather than direct price controls. By encouraging doctors to prescribe and customers to use generics, competition is enhanced to bring down drug prices. More emphasis is being laid by government in educating customers to cost-awareness and cost-benefit ratios with regard to pharmaceuticals. Concerning clinical trials, European harmonization has been achieved by significant developments: the rights and integrity of the trial subjects are protected; the credibility of the data is established; and the ethical, scientific and technical quality of the trials has improved. Future European health care forecasts a whole change in the pharmaceutical business. Important issues in cost and outcome measurement should be carefully planned and considered in drug development. Due to important mergers and acquisitions, the pharmaceutical sector will consist mainly of important multinational corporations. In this way, valuable new products may be brought to the market.

Unlicensed pharmaceutical preparations for clinical patient care: Ensuring safety.

PubMed

de Wilde, Sofieke; de Jong, Maria G H; Le Brun, Paul P H; Guchelaar, Henk-Jan; Schimmel, Kirsten J M

2018-01-01

Most medicinal products dispensed to patients have marketing authorization (MA) to ensure high quality of the product, safety, and efficacy. However, in daily practice, to treat patients adequately, there is a medical need for drugs that do not hold MA. To meet this medical need, medicinal products are used in clinical care without MA (unlicensed), such as products prepared by (local) pharmacies: the pharmaceutical preparations. Three types of pharmaceutical preparations are distinguished: (i) reconstitution in excess of summary of product characteristics; (ii) adaptation of a licensed medicinal product (outside its official labeling); (iii) medicinal products from an active pharmaceutical ingredient. Although unlicensed, patients may expect the same quality for these unlicensed pharmaceutical preparations as for the licensed medicinal products. To assure this quality, a proper risk-benefit assessment and proper documentation in (centralized) patient registries and linking to a national pharmacovigilance database should be in place. Based on a risk assessment matrix, requirements for quality assurance can be determined, which has impact on the level of documentation of a pharmaceutical preparation. In this paper, the approach for good documentation including quality assurance and benefit-risk assessment will be discussed and possibilities for patient registries are described to make these crucial preparations available for regular patient care. KEY POINTS Ensuring pharmaceutical quality and performing a proper benefit-risk assessment will guarantee safe use of pharmaceutical preparations. Good documentation of (ultra-)orphan treatments can be collected in centralized patient registries and should be combined with existing information in (inter)national databases and self-reflection of patients. Linking patient registries to a centralized database for adverse drug events is highly recommended as it increases safety control of the (ultra) orphan pharmaceutical preparations. Copyright © 2017 John Wiley & Sons, Ltd.

Implementing US-style anti-fraud laws in the Australian pharmaceutical and health care industries.

PubMed

Faunce, Thomas A; Urbas, Gregor; Skillen, Lesley

2011-05-02

This article critically analyses the prospects for introducing United States anti-fraud (or anti-false claims) laws in the Australian health care setting. Australian governments spend billions of dollars each year on medicines and health care. A recent report estimates that the money lost to corporate fraud in Australia is growing at an annual rate of 7%, but that only a third of the losses are currently being detected. In the US, qui tam provisions - the component of anti-fraud or anti-false claims laws involving payments to whistleblowers - have been particularly successful in providing critical evidence allowing public prosecutors to recover damages for fraud and false claims made by corporations in relation to federal and state health care programs. The US continues to strengthen such anti-fraud measures and to successfully apply them to a widening range of areas involving large public investment. Australia still suffers from the absence of any comprehensive scheme that not only allows treble damages recovery for fraud on the public purse, but crucially supports such actions by providing financial encouragement for whistleblowing corporate insiders to expose evidence of fraud. Potential areas of application could include direct and indirect government expenditure on health care service provision, pharmaceuticals, medical devices, defence, carbon emissions compensation and tobacco-related illness. The creation in Australia of an equivalent to US anti-false claims legislation should be a policy priority, particularly in a period of financial stringency.

Higher Priced Older Pharmaceuticals: How Should We Respond?

PubMed

Irwin, Richard S; Manaker, Scott; Metersky, Mark L; Baughman, Robert P; Otulana, Tunde; Weinberger, Steven E; Sussman, Andrew J; McGrath, Norine A

2018-01-01

We and our patients have been aware of the high cost of medications in the United States for decades; however, we are now witnessing a relatively new phenomenon: exponential price increases for some older pharmaceuticals that have been available for years. To assist practitioners in how to respond to the issue of higher priced pharmaceuticals, an interprofessional session was developed and held at CHEST 2016 in Los Angeles. The session proceedings and a few updates are presented here to summarize what pulmonologists; a sarcoidosis expert; a retired executive of a medical society, an executive of a pharmaceutical company and of a pharmacy; and an ethicist advise that we do about the problem. Because the comments presented at the session and in this manuscript represent the opinions of each author, this commentary in essence is a compilation of nine editorials. It does not represent a comprehensive discussion of the field of pricing of drugs. In reflecting upon the answers to the questions posed, and regardless of their sector of health care, all participants stated that they focused on the patient. However, actually providing patient-focused care (ie, the care defined from the patient's perspective) is another matter. To significantly improve patient satisfaction and health-care outcomes, patient-focused care needs to embody the 3 Cs of (1) communication, (2) continuity of care, and (3) concordance of expectations (ie, finding the common ground). Therefore, we discuss how the 3 Cs apply to responses to higher priced pharmaceuticals. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

The crucial role of the private sector.

PubMed

Barberis, M; Paxman, J M

1986-12-01

Private support for the development of family planning programs continues to grow and now includes industries that provide family planning services, commercial outlets that distribute contraceptives, community groups that help to build demand, private medical practitioners who include contraception as a part of health care, organizations that provide technical and financial assistance to developing country programs, pharmaceutical firms, and foundations that underwrite contraceptive research. Although the mix of private and public programs differs from country to country, these 2 family planning programs complement each other and often work in close partnership. The private sector has the advantages of being able to pioneer innovative programs the public sector is unwilling or unable to pursue, to bring foreign financial and technical assistance to developing countries without political implications, and to achieve financially self-sustaining family planning efforts that are linked to other development efforts. In many countries, the private sector has been instrumental in developing a national family planning program and in eliminating barriers to family planning in countries with restrictive laws and policies. The private sector has been especially important in pioneering grassroots programs that improve the status of women through education, health care, training, and economic opportunity.

Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Bipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals. Pharmacists can contribute to the management of BD-I, mainly with the use of effective and safe drugs, and improve the patient’s life quality through pharmaceutical care. Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses; however, to our knowledge, there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD. The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I. Methods/design Randomized, controlled, prospective, single-center clinical trial with duration of 12 months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic. Patients diagnosed with BD-I aged between 18 and 65 years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic (Antioquia, Colombia) will be included. Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists, or into the control group who will receive usual care and verbal-written counseling regarding BD. Study outcomes will be assessed at baseline and at 3, 6, 9, and 12 months after randomization. The primary outcome will be to measure the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits. Effectiveness, safety, adherence, and quality of life will be assessed as secondary outcomes. Statistical analyses will be performed using two-tailed McNemar tests, Pearson chi-square tests, and Student’s t-tests; a P value <0.05 will be considered as statistically significant. Discussion As far as we know, this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals, solution of drug-related problems, and adherence. Trial registration Registration number NCT01750255 on August 6, 2012. First patient randomized on 24 November 2011. PMID:24885673

ANALYTICAL CHEMISTRY RESEARCH NEEDS FOR MAPPING TRENDS OF PHARMACEUTICAL AND PERSONAL CARE PRODUCT POLLUTION FROM PERSONAL USE

EPA Science Inventory

The consensus among environmental scientists and risk assessors is that the fate and effects of pharmaceutical and personal care products (PPCPS) in the environment are poorly understood. Many classes of PPCPs have yet to be investigated. Acquisition of trends data for a suite of...

POLLUTION FROM PERSONAL ACTIONS, ACTIVITIES, AND BEHAVIORS: PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT MULTIDIMENSIONAL SCIENCE ISSUES RELEVANT TO REGULATORY CONSIDERATIONS

EPA Science Inventory

Perhaps more so than with any other class of anthropogenic chemicals, the occurrence of pharmaceuticals and personal care products (PPCPS) in the environment highlights the immediate, intimate, and inseparable connection between the personal activities of individual citizens and ...

ENVIRONMENTAL ANALYTICAL CHEMISTRY OF PHARMACEUTICAL AND PERSONAL CARE PRODUCTS: THE SEPARATIONS FOCUS TURNS TO POLAR ANALYTES

EPA Science Inventory

Within the scope of a number of emerging contaminant issues in environmental analysis, one area that has received a great deal of public interest has been the assessment of the role of pharmaceuticals and personal care products (PPCPs) as stressors and agents of change in ecosyst...

International trade regulation and publicly funded health care in Canada.

PubMed

Ostry, A S

2001-01-01

The World Trade Organization (WTO) creates new challenges for the Canadian health care system, arguably one of the most "socialized" systems in the world today. In particular, the WTO's enhanced trade dispute resolution powers, enforceable with sanctions, may make Canadian health care vulnerable to corporate penetration, particularly in the pharmaceutical and private health services delivery sectors. The Free Trade Agreement and its extension, the North American Free Trade Agreement, gave multinational pharmaceutical companies greater freedom in Canada at the expense of the Canadian generic drug industry. Recent challenges by the WTO have continued this process, which will limit the health care system's ability to control drug costs. And pressure is growing, through WTO's General Agreement on Trade in Services and moves by the Alberta provincial government to privatize health care delivery, to open up the Canadian system to corporate penetration. New WTO agreements will bring increasing pressure to privatize Canada's public health care system and limit government's ability to control pharmaceutical costs.

PNAUM: integrated approach to Pharmaceutical Services, Science, Technology and Innovation

PubMed Central

Gadelha, Carlos Augusto Grabois; Costa, Karen Sarmento; do Nascimento, José Miguel; Soeiro, Orlando Mário; Mengue, Sotero Serrate; da Motta, Márcia Luz; de Carvalho, Antônio Carlos Campos

2016-01-01

ABSTRACT This paper describes the development process of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines) based on an integrated approach to pharmaceutical services, science, technology and innovation. It starts by contextualizing health and development in Brazil and features elements of the National Policy for Science, Technology and Innovation in Health in Brazil and the National Policy for Pharmaceutical Services. On presenting pharmaceutical policy guidelines, it stresses the lack of nationwide data. This survey, commissioned by the Brazilian Ministry of Health, has two components: household survey and evaluation of pharmaceutical services in primary care. The findings point to perspectives that represent, besides the enhancement of public policy for pharmaceutical services and public health, results of government action aimed at developing the economic and industrial health care complex to improve the health conditions of the Brazilian population. PMID:27982379

Exposure of medical students to pharmaceutical marketing in primary care settings: frequent and influential.

PubMed

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-12-01

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts. Considering the move toward early clinical encounters and community-based education, which expose students early to pharmaceutical representatives, the influence of those gifts is becoming a matter of concern. This study examines the frequency and influence of student exposure to drug marketing in primary care settings, as well as student perceptions of physician-pharmaceutical company relationships. This was a two-phase study consisting of qualitative research followed by a cross-sectional survey. Clinical experience logbooks of 280 second-year students in one school were analysed, and the themes that emerged were used to develop a survey that was administered to 308 third-year students from two medical schools. Survey results showed a 91.2% exposure to any type of marketing, and 56.8% of students were exposed to all classes of marketing methods studied. Deliberate targeting of students by pharmaceutical representatives, in particular, was correlated with being less sensitive to the negative effects of and having positive opinions about interactions with pharmaceutical companies. The vast majority of students are exposed to drug marketing in primary care settings, and may become more vulnerable to that strategy. Considering that medical students are vulnerable and are targeted deliberately by pharmaceutical companies, interventions aimed at developing skills in the rational use of medicines and in strategies for coping with drug marketing should be devised.

Impact of Practice-Based Instruction on Graduate Programs in the Pharmaceutical Sciences.

ERIC Educational Resources Information Center

Schumacher, Gerald E.

1979-01-01

A practice- and science-based program of graduate education and scholarship for pharmaceutical science is proposed. Recommendations include the elimination of weak graduate programs, increased industrial support, and development of the clinical scientist. (SF)

Conceptions on pharmaceutical services in Brazilian primary health care

PubMed Central

Costa, Ediná Alves; Araújo, Patrícia Sodré; Penaforte, Thais Rodrigues; Barreto, Joslene Lacerda; Guerra, Augusto Afonso; Acurcio, Francisco de Assis; Guibu, Ione Aquemi; Alvares, Juliana; Costa, Karen Sarmento; Karnikowski, Margô Gomes de Oliveira; Soeiro, Orlando Mario; Leite, Silvana Nair

2017-01-01

ABSTRACT OBJECTIVE To identify and discuss the conceptions of pharmaceutical services in Brazilian Primary Health Care, according to different subjects. METHODS This study is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015), which is composed of an information survey in a representative sample of cities, stratified according to Brazilian regions, and a subsample of primary health care services. Municipal secretaries of health, those responsible for pharmaceutical services, and those responsible for medicine delivery in pharmacies/dispensing units of the selected services were interviewed. The questionnaires included one question about the understanding of the interviewee regarding pharmaceutical services. The content analysis technique was used to apprehend, in the statements, the meanings attributed to pharmaceutical services, which were subsequently classified into categories according to their main conceptions. RESULTS Among the wide diversity of conceptions on pharmaceutical services (PS), we highlight the ones focused on 1) logistic control of medicines with activities concerning guidance or information on their use and 2) guidance or information to users on the use of medicine. The findings reveal a shifting tendency from a medicine-focused conception to one that considers the users and their needs as the final recipient of these actions. However, the lack of references to conceptions regarding care management and integrality point out the slowness of this change; after all, this is a social and historical process that comprises the production of meanings that transcend legal, logistic, and technical arrangements in pharmaceutical services. CONCLUSIONS The diversity of conceptions expresses the several meanings attributed to pharmaceutical services; we also identified, in their reorientation process, a movement that reflects a gradual shift in the technical paradigm, from the focus on medicine logistics to a user-oriented approach of health services. PMID:29160453

Comparison of factors influencing patient choice of community pharmacy in Poland and in the UK, and identification of components of pharmaceutical care

PubMed Central

Merks, Piotr; Kaźmierczak, Justyna; Olszewska, Aleksandra Elzbieta; Kołtowska-Häggström, Maria

2014-01-01

Background Several factors, which are components of pharmaceutical care, can influence a patient’s choice of a community pharmacy store and contribute to frequent visits to the same pharmacy. Objectives To compare factors that influence a patient’s choice of pharmacy in Poland and in the UK, to identify which of them are components of pharmaceutical care, and to relate them to patient loyalty to the same pharmacy. Methods A self-administered, anonymous questionnaire was distributed to clients visiting pharmacies in Poland and the UK January–August 2011. Comparisons were performed using chi-square tests and logistic regression. All statistical analyses were performed using SPSS 20.0. Results The response rate was 55.6% (n=417/750; 36 pharmacies) and 54.0% (n=405/750; 56 pharmacies) in Poland and in the UK, respectively. The most frequently reported factors, as defined by a percentage of responders, were in Poland: 1) location (84%); 2) professional and high-quality of service (82%); 3) good price of medicines (78%); and 4) promotions on medicines (66%). In the UK, the most commonly reported factors were: 1) professional and high quality of service (90%); 2) location (89%); 3) good advice received from the pharmacist (86%); and 4) option of discussing and consulting all health issues in a consultation room (80%). Good advice and an option of discussing personal concerns with a pharmacist are components of pharmaceutical care. Thirty-eight percent of patients in Poland and 61% in the UK declared visiting the same pharmacy. Conclusion Components of pharmaceutical care are important factors influencing the patient’s choice of pharmacy in the UK and, to a lesser degree, in Poland. Additionally, more patients in the UK than in Poland are committed to a single pharmacy. Therefore, implementing the full pharmaceutical care in Poland may contribute to an increase in patient loyalty and thus strengthen competitiveness of pharmacy businesses. PMID:24868150

Investigating the relationship between the practice of pharmaceutical care, construed external image, organizational identification, and job turnover intention of community pharmacists.

PubMed

O'Neill, Jessica L; Gaither, Caroline A

2007-12-01

Pharmacy employers are being challenged to recruit and retain qualified employees. Our study hypothesized that pharmacists who practice pharmaceutical care have an attractive construed external image (how employees think outsiders view their organization), which strengthens their organizational identification (perceptions of oneness with or belongingness to the organization) and decreases job turnover intention (thoughts of quitting/searching for another job). A 7-page questionnaire was mailed to the homes of a random sample of 759 licensed pharmacists practicing in the United States. Participants had the option of returning the completed survey via postal mail or a Web site. The study variables were measured with previously validated scales. Structural equation modeling with latent variables evaluated the hypothesized relationships. Several demographic variables were included. Responses were received from 252 subjects (33%); 121 were community pharmacists. As hypothesized, organizational identification and job turnover intention were significantly related (B=-0.24) as well as construed external image and organizational identification (B=0.41). The practice of pharmaceutical care and construed external image were not significantly correlated (B=0.10). Although not hypothesized, construed external image was directly related to job turnover intention (B=-0.25). The effects of the practice of pharmaceutical care on job turnover intention were mediated through organizational identification. Position had significant effects. One additional benefit to the practice of pharmaceutical care may be strengthened organizational identification. Pharmacists' perception of the image of their employer may increase organizational identification and decrease job turnover intention. An understanding of the organizational identification of pharmacists would be useful in decreasing job turnover intention. Given the current demand for pharmacists, this is a worthwhile endeavor. Future research should focus on other predictors of construed external image and ways to enhance organizational identification. Encouraging the practice of pharmaceutical care may be 1 such way.

Quality Improvement Initiatives: The Missed Opportunity for Health Plans

PubMed Central

Fernandez-Lopez, Sara; Lennert, Barbara

2009-01-01

Background The increase in healthcare cost without direct improvements in health outcomes, coupled with a desire to expand access to the large uninsured population, has underscored the importance of quality initiatives and organizations that provide more affordable healthcare by maximizing value. Objectives To determine the knowledge of managed care organizations about quality organizations and initiatives and to identify potential opportunities in which pharmaceutical companies could collaborate with health plans in the development and implementation of quality initiatives. Methods We conducted a survey of 36 pharmacy directors and 15 medical directors of different plans during a Managed Care Network meeting in 2008. The represented plans cover almost 74 million lives in commercial, Medicare, and Medicaid programs, or a combination of them. Results The responses show limited knowledge among pharmacy and medical directors about current quality organizations and initiatives, except for quality organizations that provide health plan quality accreditation. The results also reveal an opportunity for pharmaceutical companies to collaborate with private health plans in the development of quality initiatives, especially those related to drug utilization, such as patient adherence and education and correct drug utilization. Conclusion Our survey shows clearly that today's focus for managed care organizations is mostly limited to the organizations that provide health plan quality accreditation, with less focus on other organizations. PMID:25126303

Quality improvement initiatives: the missed opportunity for health plans.

PubMed

Fernandez-Lopez, Sara; Lennert, Barbara

2009-11-01

The increase in healthcare cost without direct improvements in health outcomes, coupled with a desire to expand access to the large uninsured population, has underscored the importance of quality initiatives and organizations that provide more affordable healthcare by maximizing value. To determine the knowledge of managed care organizations about quality organizations and initiatives and to identify potential opportunities in which pharmaceutical companies could collaborate with health plans in the development and implementation of quality initiatives. We conducted a survey of 36 pharmacy directors and 15 medical directors of different plans during a Managed Care Network meeting in 2008. The represented plans cover almost 74 million lives in commercial, Medicare, and Medicaid programs, or a combination of them. The responses show limited knowledge among pharmacy and medical directors about current quality organizations and initiatives, except for quality organizations that provide health plan quality accreditation. The results also reveal an opportunity for pharmaceutical companies to collaborate with private health plans in the development of quality initiatives, especially those related to drug utilization, such as patient adherence and education and correct drug utilization. Our survey shows clearly that today's focus for managed care organizations is mostly limited to the organizations that provide health plan quality accreditation, with less focus on other organizations.

The Daniel K. Inouye College of Pharmacy Scripts

PubMed Central

Pezzuto, John M; Ma, Carolyn SJ; Ma, Carolyn

2015-01-01

In partnership with the Hawai‘i Journal of Medicine & Public Health, the Daniel K. Inouye College of Pharmacy (DKICP) is pleased to provide Scripts on a regular basis. In the inaugural “Script,” a brief history of the profession in Hawai‘i was presented up to the founding of the DKICP, Hawai‘i's only academic pharmacy program. In this second part of the inaugural article, we describe some key accomplishments to date. The mission of the College is to educate pharmacy practitioners and leaders to serve as a catalyst for innovations and discoveries in pharmaceutical sciences and practice for promoting health and well-being, and to provide community service, including quality patient care. Examples are given to support the stated goals of the mission. With 341 graduates to date, and a 96% pass rate on the national licensing board exams, the college has played a significant role in improving healthcare in Hawai‘i and throughout the Pacific Region. Additionally, a PhD program with substantial research programs in both pharmacy practice and the pharmaceutical science has been launched. Considerable extramural funding has been garnered from organizations such as the National Institutes of Health and Centers for Medicare and Medicaid Services. The economic impact of the College is estimated to be over $50 million each year. With over 200 signed clinical affiliation agreements within the state as well as nationally and internationally, the DKICP has helped to ameliorate the shortage of pharmacists in the state, and has enhanced the profile and practice standard of the pharmacist's role on interprofessional health care teams. PMID:25821655

Pharmaceutical services cost analysis using time-driven activity-based costing: A contribution to improve community pharmacies' management.

PubMed

Gregório, João; Russo, Giuliano; Lapão, Luís Velez

2016-01-01

The current financial crisis is pressing health systems to reduce costs while looking to improve service standards. In this context, the necessity to optimize health care systems management has become an imperative. However, little research has been conducted on health care and pharmaceutical services cost management. Pharmaceutical services optimization requires a comprehensive understanding of resources usage and its costs. This study explores the development of a time-driven activity-based costing (TDABC) model, with the objective of calculating the cost of pharmaceutical services to help inform policy-making. Pharmaceutical services supply patterns were studied in three pharmacies during a weekday through an observational study. Details of each activity's execution were recorded, including time spent per activity performed by pharmacists. Data on pharmacy costs was obtained through pharmacies' accounting records. The calculated cost of a dispensing service in these pharmacies ranged from €3.16 to €4.29. The cost of a counseling service when no medicine was supplied ranged from €1.24 to €1.46. The cost of health screening services ranged from €2.86 to €4.55. The presented TDABC model gives us new insights on management and costs of community pharmacies. This study shows the importance of cost analysis for health care services, specifically on pharmaceutical services, in order to better inform pharmacies' management and the elaboration of pharmaceutical policies. Copyright © 2016 Elsevier Inc. All rights reserved.

Pharmacy participation and claim characteristics in the Wisconsin Medicaid Pharmaceutical Care Program from 1996 to 2007.

PubMed

Look, Kevin A; Mott, David A; Leedham, Robert K; Kreling, David H; Hermansen-Kobulnicky, Carol J

2012-03-01

Under the 1995 Wisconsin Act 27, the biennial budget, Wisconsin Medicaid was required to develop an incentive-based pharmacy payment system for pharmaceutical care (PC) services. Started on July 1, 1996, the Wisconsin Medicaid Pharmaceutical Care Program (WMPCP) is the longest currently ongoing Medicaid program to compensate pharmacists for nondispensing services. The program reimburses pharmacies for providing PC services that increase patient compliance or prevent potential adverse drug problems by paying an enhanced PC dispensing fee. Pharmacists can bill for PC services provided to Wisconsin Medicaid fee-for-service and SeniorCare (i.e., state prescription drug assistance program for low-income seniors) beneficiaries. To examine trends in (a) the number of pharmacies participating in the WMPCP and the intensity of participation among participating pharmacies; and (b) frequencies of reason, action, result, and level-of-service (time) codes associated with PC service claims from July 1, 1996, through June 30, 2007, which represents Wisconsin state fiscal years (SFYs) 1997 through 2007. A retrospective, longitudinal, and descriptive research design was used to analyze all paid claims for PC services provided to Wisconsin Medicaid fee-for-service and SeniorCare recipients during SFYs 1997 through 2007. The total number of paid PC claims and the average number of claims paid per pharmacy were examined to determine trends in pharmacy participation. Mean annual reimbursement amounts for PC per claim and per pharmacy were calculated. Reason, action, result, and level-of-service (time) codes that appeared in the claims were grouped into categories and analyzed to characterize the total number of claims paid overall and per SFY. During the study period, one-half (n = 601) of the approximately 1,200 licensed pharmacies in the state of Wisconsin were paid for a claim through the WMPCP. However, intensity of participation in the WMPCP was low, with 57% of all participating pharmacies being paid for 10 or fewer PC claims and 19% paid for only 1 PC claim over the 11-year study period. The growth in claims per year coupled with smaller growth in the number of participating pharmacies resulted in a trend of growth in the mean number of claims per participating pharmacy in the program. The proportion of total WMPCP claims accounted for by the top 10 pharmacies with the highest volume of PC claims varied from 46.6% to 80.2% per year. Patient behaviors (e.g., early or late refills) and drug use issues/problems (e.g., patient complaints or symptoms) were the most common reasons for pharmacists to provide PC services (62% of all PC claims), although drug choice reasons (e.g., product selection opportunity) were more common after 2004. The majority (55.1%) of PC services took 15 minutes or less of pharmacists' time. The total dollar amount paid to pharmacies for PC services was $876,822 between SFYs 1997 and 2007, with an overall mean of $1,459 paid per participating pharmacy. Trends in pharmacy participation and claims volume showed growth, albeit limited, in PC program participation with a majority of paid claims dealing with patient behaviors and drug use issues or problems that consumed a small amount of pharmacists' time (15 minutes or less). The intensity of participation (claims per pharmacy) increased over time, suggesting that some pharmacies may have developed effective systems for participating and successfully submitting claims to WMPCP for enhanced dispensing fees. Further evaluation of the impact and implications of this program for patients, pharmacists, and the state is needed to gauge overall program success and provide evidence or guidance for continued or expanded PC initiatives.

Innovative Product Development Partnership Reduced Neonatal Mortality In Nepal Through Improved Umbilical Cord Care.

PubMed

Oyloe, Peter; Khanal, Leela; Hodgins, Stephen; Pradhan, Sabita T; Dawson, Penny

2017-11-01

Approximately 40 percent of all newborn deaths in Nepal are attributable to neonatal infections. A randomized controlled trial conducted in Nepal in the period 2002-05 on the application of a solution of the disinfectant chlorhexidine to umbilical cord stumps of newborns showed a reduced risk of infections and death. In response to these results, the Government of Nepal and various partners mobilized to deliver this simple, low-cost intervention on a national scale. We describe the design, development, and maturation of a partnership among the government, technical assistance agencies, and a local pharmaceutical company to create a suitable, commercially available gel product to reduce newborn infections. Essential contributors to the partnership's effectiveness included having a for-profit pharmaceutical company as a fully engaged partner; having responsive, flexible relationships among the partners that evolved over time; and paying attention to competition within the private sector. A less formalized arrangement among partners allowed them to build trust in each other over time. Government stewardship of the program throughout the scale-up process ensured that policy and systems integration were aligned as the program matured.

Exposure of Medical Students to Pharmaceutical Marketing in Primary Care Settings: Frequent and Influential

ERIC Educational Resources Information Center

Sarikaya, Ozlem; Civaner, Murat; Vatansever, Kevser

2009-01-01

It is known that interaction between pharmaceutical companies and medical professionals may lead to corruption of professional values, irrational use of medicine, and negative effects on the patient-physician relationship. Medical students frequently interact with pharmaceutical company representatives and increasingly accept their gifts.…

Sulfite-containing Canadian pharmaceutical products available in 1991.

PubMed Central

Miyata, M; Schuster, B; Schellenberg, R

1992-01-01

OBJECTIVE: To compile an inclusive list of Canadian pharmaceutical products available in 1991 that contained sulfites. DATA SOURCES: Written and oral responses from 94 pharmaceutical companies selected from the 1989 Compendium of Pharmaceuticals and Specialties. RESULTS: A list of sulfite-containing pharmaceutical products was compiled from data supplied by the 90 responding companies. Companies whose products contained no sulfites were separately identified. CONCLUSIONS: Sulfites are present in many pharmaceutical products and are one of many excipients and additives that have been reported to cause severe adverse reactions. The provided list should be a useful aid for health care practitioners when prescribing pharmaceutical products for sulfite-sensitive patients. PMID:1483237

The impact of specialty pharmaceuticals as drivers of health care costs.

PubMed

Hirsch, Bradford R; Balu, Suresh; Schulman, Kevin A

2014-10-01

The pharmaceutical industry is shifting its focus from blockbuster small molecules to specialty pharmaceuticals. Specialty pharmaceuticals are novel drugs and biologic agents that require special handling and ongoing monitoring, are administered by injection or infusion, and are sold in the marketplace by a small number of distributors. They are frequently identified by having a cost to payers and patients of $600 or more per treatment. The total costs of the new agents are likely to have a substantial impact on overall health care costs and on patients during the next decade, unless steps are taken to align competing interests. We examine the economic and policy issues related to specialty pharmaceuticals, taking care to consider the impact on patients. We assess the role of cost-sharing provisions, legislation that is promoting realignment within the market, the role of biosimilars in price competition, and the potential for novel drug development paradigms to help bend the cost curve. The economic aspects of this analysis highlight the need for a far-reaching discussion of potential novel approaches to innovation pathways in our quest for both affordability and new technology. Project HOPE—The People-to-People Health Foundation, Inc.

It's time to shine the light on direct-to-consumer advertising.

PubMed

Mackey, Tim K; Liang, Bryan A

2015-01-01

Pharmaceutical marketing is undergoing a transition as the business, delivery, and consumption of health care have increasingly become part of a growing digital landscape. Changes in pharmaceutical promotion also coincide with federal "sunshine" regulations newly implemented under the Affordable Care Act that require disclosure of certain marketing and industry payments to physicians. Collectively, these trends could lead to fundamental shifts in physician-directed and direct-to-consumer advertising (DTCA) that have yet to be adequately identified or explored. In response, we advocate for greater DTCA transparency, especially in the emerging digital forms of DTCA, to complement forthcoming sunshine transparency data. This will allow more robust study and understanding of changes in overall pharmaceutical marketing trends and their impact on health care consumption and behavior. This can also lead to more targeted state and federal policy interventions leveraging existing federal transparency regulations to ensure appropriate marketing, sales, and consumption of pharmaceutical products. © 2015 Annals of Family Medicine, Inc.

Connecting pills and people: an ethnography of the pharmaceutical nexus in Odisha, India.

PubMed

Seeberg, Jens

2012-06-01

This article explores the impact of intensive competition within the pharmaceutical industry and among private providers on health care in an Indian city. In-depth interviewing and clinical observation were used over a period of 18 months. Private practitioners and chemists who provided regular services to inhabitants of a poor neighborhood in central Bhubaneswar were included. Fierce competition in private health in Odisha, India, reduced quality of care for the poor. The pharmaceutical industry exploited weak links in the health system to push drugs aggressively, including through illegal channels. The private health market is organized in small "network molecules" that maximize profit at the cost of health. The large private share of health care in India and stiff competition are detrimental for primary care in urban India. Free government services are urgently needed and a planned health insurance scheme should be linked to quality control measures.

Clinical skill development for community pharmacists.

PubMed

Barnette, D J; Murphy, C M; Carter, B L

1996-09-01

The importance of establishing clinical pharmacy services in the community cannot be understated in light of current challenges to the traditional dispensing role as the primary service of the community pharmacist. Advancements in automated dispensing technology and declining prescription fee reimbursement are rapidly forcing pharmacists to seek alternative sources of revenue. Providing pharmaceutical care is a viable option to increase customer loyalty job satisfaction, and reimbursement. To support the development of clinical services, academic institutions are forming partnerships with individual community practitioners to overcome perceived educational and training barriers. The authors describe the design and development of two unique clinical skill development programs at the University of Illinois at Chicago. This paper also outlines the patient focused services that the participants have established upon completing the training. These programs successfully enhanced participants' therapeutic knowledge base and facilitated development of the clinical skills necessary for direct patient care.

Using peer teaching to introduce the Pharmaceutical Care Model to incoming pharmacy students.

PubMed

Kolar, Claire; Hager, Keri; Janke, Kristin K

2018-02-01

The aim of this initiative was to design and evaluate a peer teaching activity where pairs of second-year pharmacy students introduced the Pharmaceutical Care Model and discussed success in the broader first-year pharmacy curriculum with pairs of first year students. Second-year pharmacy students individually created concept maps illustrating the main components of pharmaceutical care to be used as teaching tools with first-year students. First-year students were given a brief introduction to pharmaceutical care by faculty and prepared questions to ask their second-year colleagues. Two second-year students were then matched with two first-year students for a two-part peer teaching event. Each student completed documentation of the peer experience, which included questions about the effectiveness of the teaching, changes to be made in the future, and the usefulness of the exercise. The documentation was analyzed via content analysis and instructors evaluated the concept maps based on their effectiveness as a teaching tool for novices. A rubric was used to evaluate 166 concept maps of which 145 were rated good, 18 were rated as better, and 3 as best. Themes emerging from the content analysis included: positive impact of teaching and learning pharmaceutical care, value of broader curriculum discussion, and beneficial first- and second-year connections. A structured peer teaching event outside the traditional classroom setting can create a space for: teaching and learning to occur, student-student connections to be made, and advice on the curriculum to be shared. Copyright © 2017 Elsevier Inc. All rights reserved.

Population health management guiding principles to stimulate collaboration and improve pharmaceutical care.

PubMed

Steenkamer, Betty; Baan, Caroline; Putters, Kim; van Oers, Hans; Drewes, Hanneke

2018-04-09

Purpose A range of strategies to improve pharmaceutical care has been implemented by population health management (PHM) initiatives. However, which strategies generate the desired outcomes is largely unknown. The purpose of this paper is to identify guiding principles underlying collaborative strategies to improve pharmaceutical care and the contextual factors and mechanisms through which these principles operate. Design/methodology/approach The evaluation was informed by a realist methodology examining the links between PHM strategies, their outcomes and the contexts and mechanisms by which these strategies operate. Guiding principles were identified by grouping context-specific strategies with specific outcomes. Findings In total, ten guiding principles were identified: create agreement and commitment based on a long-term vision; foster cooperation and representation at the board level; use layered governance structures; create awareness at all levels; enable interpersonal links at all levels; create learning environments; organize shared responsibility; adjust financial strategies to market contexts; organize mutual gains; and align regional agreements with national policies and regulations. Contextual factors such as shared savings influenced the effectiveness of the guiding principles. Mechanisms by which these guiding principles operate were, for instance, fostering trust and creating a shared sense of the problem. Practical implications The guiding principles highlight how collaboration can be stimulated to improve pharmaceutical care while taking into account local constraints and possibilities. The interdependency of these principles necessitates effectuating them together in order to realize the best possible improvements and outcomes. Originality/value This is the first study using a realist approach to understand the guiding principles underlying collaboration to improve pharmaceutical care.

Education in Medical Biochemistry in Serbia.

PubMed

Majkic-Sing, Nada

2010-06-01

Medical biochemistry is the usual name for clinical biochemistry or clinical chemistry in Serbia. Medical biochemistry laboratories and medical biochemists as a profession are part of Health Care System and are regulated through: the Health Care Law and rules issued by the Chamber of Medical Biochemists of Serbia. The first continuous and organized education for Medical Biochemists in Serbia dates from 1945, when Department of Medical Biochemistry was established at Pharmaceutical Faculty in Belgrade. In 1987 at the same Faculty a five years undergraduate branch was established, educating Medical Biochemists under a special program. Since 2006 the new five year undergraduate (according to Bologna Declaration) and postgraduate program of four-year specialization according to EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine has been established. The Ministry of Education and Ministry of Public Health accredits the programs. There are four requirements for practicing medical biochemistry in the Health Care System: University Diploma of the Faculty of Pharmacy (Medical Biochemistry), successful completion of the profession exam at the Ministry of Health after completion of one additional year of obligatory practical training in medical laboratories, membership in the Serbian Chamber of Medical Biochemists and licence for skilled work issued by Serbian Chamber of Medical Biochemists.

Impact of Practice-Based Instruction on Graduate Programs in the Pharmaceutical Sciences--Another Response.

ERIC Educational Resources Information Center

Gerald, Michael C.

1979-01-01

The impact of practice-based programs on graduate education in pharmaceutical science is discussed. It is suggested that graduate programs remain flexible in order to accommodate the role of the pharmacist-scientist and to help in attracting qualified students. (SF)

APPLICATION OF U.S. EPA METHODS TO THE ANALYSIS OF PHARMACEUTICALS AND PERSONAL CARE PRODUCTS IN THE ENVIRONMENT: DETERMINATION OF CLOFIBRIC ACID IN SEWAGE EFFLUENT BY GC-MS

EPA Science Inventory

An emerging area of research concerns pharmaceuticals and personal care products in the
environment and their possible impact on biota and ecosystems. The long term effects of
constant perfusion of PPCPs into the aquatic environment are presently unknown. Some
compoun...

3D Printing Pharmaceuticals: Drug Development to Frontline Care.

PubMed

Trenfield, Sarah J; Awad, Atheer; Goyanes, Alvaro; Gaisford, Simon; Basit, Abdul W

2018-05-01

3D printing (3DP) is forecast to be a highly revolutionary technology within the pharmaceutical sector. In particular, the main benefits of 3DP lie in the production of small batches of medicines, each with tailored dosages, shapes, sizes and release characteristics. The manufacture of medicines in this way may finally lead to the concept of personalised medicines becoming a reality. In the shorter term, 3DP could be extended throughout the drug development process, ranging from preclinical development and clinical trials, through to frontline medical care. In this review, we provide a timely perspective on the motivations and potential applications of 3DP pharmaceuticals, as well as a practical viewpoint on how 3DP could be integrated across the pharmaceutical space. Copyright © 2018 Elsevier Ltd. All rights reserved.

[Legal Framework of Autologous Fat Usage in Point-of-Care Treatments in Plastic and Aesthetic Surgery - Risks of Criminal Prosecution and Infringement of Medical Law Due to Pharmaceutical Regulations].

PubMed

Faltus, T

2016-08-01

The use of autologous fat, especially for (stem) cell-assisted lipotransfer in plastic and aesthetic surgery, has regularly been regarded as the manufacture and application of so called Advanced Therapy Medicinal Products (ATMP). However, the in-house production of such pharmaceuticals at the point-of-care (PoC) in the surgeon's practice is not permitted without an official manufacturing license. Therefore, before beginning such treatments, a pharmaceutical manufacturing license has to be granted to the surgeon to avoid criminal prosecution and negative consequences due to infringement of professional regulations. Because such a license is linked to compliance with GMP standard, in-house manufacturing of such pharmaceuticals also implies extra technical and personnel expenses. The surgeon is obliged to check that the available autologous fat based applications are in compliance with pharmaceutical legislation. Repeated infringements of pharmaceutical regulations are incompatible with medical reliability - a prerequisite for the license to practice medicine. © Georg Thieme Verlag KG Stuttgart · New York.

Evaluation of Team-Based Care in an Urban Free Clinic Setting.

PubMed

Iddins, Brenda W; Frank, Jennifer Sandson; Kannar, Pegah; Curry, William A; Mullins, Melissa; Hites, Lisle; Selleck, Cynthia

2015-01-01

This article reports the experiences of a school of nursing, academic health center, and community-based organization working via an interprofessional collaborative practice model to meet the mutual goal of serving the health care needs of an indigent, largely minority population in Birmingham, Alabama. The population suffers disproportionately from chronic health problems including diabetes, obesity, cardiovascular disease, asthma, and mental health disorders. The program emphasizes diabetes management because the academic health center recognized the need for transitional and primary care, including mental health services, for the increasing numbers of uninsured patients with diabetes and its comorbidities. Half of the clinicians involved in this project had no prior experience with interprofessional collaborative practice, and there was confusion regarding the roles of team members from the partnering institutions. Activities involving care coordination consistently received low scores on weekly rating scales leading to the creation of positions for a nurse care manager and pharmaceutical patient assistance program coordinator. Conversely, shared decision making and cooperation ratings were consistently high. Evaluation identified the need for reliable, accessible data and data analysis to target clinically effective interventions and care coordination and to assess cost effectiveness. The strengths, challenges, lessons learned, and next steps required for sustainability of this alignment are discussed.

Assessment of Household Disposal of Pharmaceuticals in Lebanon: Management Options to Protect Water Quality and Public Health

NASA Astrophysics Data System (ADS)

Massoud, May A.; Chami, Ghida; Al-Hindi, Mahmoud; Alameddine, Ibrahim

2016-05-01

Pharmaceuticals comprise an extensive group of compounds whose release into the environment has potential adverse impacts on human health and aquatic ecosystems. In many developing countries the extent of the problem and the occurrence of pharmaceuticals in water bodies are generally unknown. While thousands of tons of pharmaceutical substances are used annually, little information is known about their final fate after their intended use. This paper focuses on better understanding the management of human-use pharmaceutical wastes generated at the residential level within the Administrative Beirut Area. A survey encompassing 300 households was conducted. Results revealed that the majority of respondents were found to dispose of their unwanted medications, mainly through the domestic solid waste stream. Willingness to participate in a future collection program was found to be a function of age, medical expenditure, and the respondents' views towards awareness and the importance of establishing a collection system for pharmaceutical wastes. Respondents who stated a willingness to participate in a collection program and/or those who believed in the need for awareness programs on the dangers of improper medical waste disposal tended to favor more collection programs managed by the government as compared to a program run by pharmacies or to the act of re-gifting medication to people in need. Ultimately, collaboration and coordination between concerned stakeholders are essential for developing a successful national collection plan.

Case histories in pharmaceutical risk management.

PubMed

McCormick, Cynthia G; Henningfield, Jack E; Haddox, J David; Varughese, Sajan; Lindholm, Anders; Rosen, Susan; Wissel, Janne; Waxman, Deborah; Carter, Lawrence P; Seeger, Vickie; Johnson, Rolley E

2009-12-01

The development and implementation of programs in the U.S. to minimize risks and assess unintended consequences of new medications has been increasingly required by the Food and Drug Administration (FDA) since the mid 1990s. This paper provides four case histories of risk management and post-marketing surveillance programs utilized recently to address problems associated with possible abuse, dependence and diversion. The pharmaceutical sponsors of each of these drugs were invited to present their programs and followed a similar template for their summaries that are included in this article. The drugs and presenting companies were OxyContin, an analgesic marketed by Purdue Pharma L.P., Daytrana and Vyvanse, ADHD medications marketed by Shire Pharmaceuticals, Xyrem for narcolepsy marketed by Jazz Pharmaceuticals, and Subutex and Suboxone for opioid dependence marketed by Reckitt Benckiser Pharmaceuticals Inc. These case histories and subsequent discussions provide invaluable real-world examples and illustrate both the promise of risk management programs in providing a path to market and/or for keeping on the market drugs with serious potential risks. They also illustrate the limitations of such programs in actually controlling unintended consequences, as well as the challenge of finding the right balance of reducing risks without posing undue barriers to patient access. These experiences are highly relevant as the FDA increasingly requires pharmaceutical sponsors to develop and implement the more formalized and enforceable versions of the risk management term Risk Evaluation and Mitigation Strategies (REMS).

Community Pharmacists' Perceptions about Pharmaceutical Care of Traditional Medicine Products: A Questionnaire-Based Cross-Sectional Study in Guangzhou, China

PubMed Central

Chen, Xi; Ung, Carolina Oi Lam; Hu, Hao; Liu, Xiaodan; Zhao, Jing; Hu, Yuanjia; Li, Peng; Yang, Qing

2016-01-01

This study aimed to investigate community pharmacists' perceived responsibility, practice behaviors, knowledge, perceived barriers, and improvement measures towards provision of pharmaceutical care in relation to traditional medicine (TM) products in Guangzhou, China. A self-completion questionnaire was used to survey licensed pharmacists working at community pharmacies. This study found that the community pharmacists in Guangzhou, China, were involved in the provision of TM products during their daily practice but only provided pharmaceutical care in this area with a passive attitude. Extrinsic barriers such as lack of scientific evidence for the safety and efficacy of TM products and unclear definition of their roles and responsibilities were highlighted while intrinsic factors such as insufficient TM knowledge were identified. PMID:27066101

Ranking of healthcare programmes based on health outcome, health costs and safe delivery of care in hospital pharmacy practice.

PubMed

Brisseau, Lionel; Bussières, Jean-François; Bois, Denis; Vallée, Marc; Racine, Marie-Claude; Bonnici, André

2013-02-01

To establish a consensual and coherent ranking of healthcare programmes that involve the presence of ward-based and clinic-based clinical pharmacists, based on health outcome, health costs and safe delivery of care. This descriptive study was derived from a structured dialogue (Delphi technique) among directors of pharmacy department. We established a quantitative profile of healthcare programmes at five sites that involved the provision of ward-based and clinic-based pharmaceutical care. A summary table of evidence established a unique quality rating per inpatient (clinic-based) or outpatient (ward-based) healthcare programme. Each director rated the perceived impact of pharmaceutical care per inpatient or outpatient healthcare programme on three fields: health outcome, health costs and safe delivery of care. They agreed by consensus on the final ranking of healthcare programmes. A ranking was assigned for each of the 18 healthcare programmes for outpatient care and the 17 healthcare programmes for inpatient care involving the presence of pharmacists, based on health outcome, health costs and safe delivery of care. There was a good correlation between ranking based on data from a 2007-2008 Canadian report on hospital pharmacy practice and the ranking proposed by directors of pharmacy department. Given the often limited human and financial resources, managers should consider the best evidence available on a profession's impact to plan healthcare services within an organization. Data are few on ranking healthcare programmes in order to prioritize which healthcare programme would mostly benefit from the delivery of pharmaceutical care by ward-based and clinic-based pharmacists. © 2012 The Authors. IJPP © 2012 Royal Pharmaceutical Society.

A focus group study of patient's perspective and experiences of type 2 diabetes and its management in Jordan.

PubMed

Jarab, Anan S; Mukattash, Tareq L; Al-Azayzih, Ahmad; Khdour, Maher

2018-03-01

Diabetes is increasingly becoming a major health problem in Jordan and glycemic goals are often not achieved. To explore the patients' perspectives regarding type 2 diabetes and its management in order to "fine-tune" future pharmaceutical care intervention programs. Focus groups method was used to explore views from individuals with type 2 diabetes attending outpatient diabetes clinic at the Royal Medical Services Hospital. All interviews were recorded, transcribed and analyzed using a thematic analysis approach. A total of 6 focus groups, with 6 participants in each one, were conducted. Participants in the present study demonstrated a great information needs about diabetes and the prescribed treatment. Medication regimen characteristics including rout of administration, number of prescribed medications and dosage frequency in addition to perceived side effects represented the major barriers to medication adherence. In addition to demonstrating negative beliefs about the illness and the prescribed medications, participants showed negative attitudes and low self-efficacy to adhere to necessary self-care activities including diet, physical activity and self-monitoring of blood glucose. Future pharmaceutical care interventions designed to improve patients' adherence and health outcomes in patients with type 2 diabetes should consider improving patients' understanding of type 2 diabetes and its management, simplifying dosage regimen, improving patient's beliefs and attitudes toward type 2 diabetes, prescribed medications and different self-care activities in addition to improving patient's self efficacy to perform different treatment recommendations.

[Share of health care activities in the Brazilian economy: information on Health Accounts from 2000 to 2007].

PubMed

dos Santos, Maria Angelica Borges; de Moraes, Ricardo Montes; Holguin, Tássia Gazé; Palis, Rebeca de La Rocque

2012-02-01

To describe the share of health care activities in the Brazilian economy between 2000 and 2007 in terms of economic value added and creation of jobs. Secondary data from the Brazilian Institute of Geography and Statistics (IBGE) for the years 2000 to 2007 were employed. The following health care activities were analyzed: public health, production of private health services and private social services, health insurance, the pharmaceutical industry, medical equipment manufacturing, and medical and pharmaceutical product sales. The share of each activity in the total economy and in the health care sector was calculated, as well as the percentage share of value-added components from the perspective of income for health care activities and the real growth in value added by health care activity. To complement the analysis, the average income of workers and the number of jobs per activity were established. The participation of the health care sector in the economy ranged from 5.2% to 5.8%. The share of public health increased from 1.7% to 2.0%, and that of private healthcare services fell from 2.4% to 2.2%. The average annual growth of 3.5% for the sector was close to the 3.4% annual growth recorded for the economy. The share of medical and pharmaceutical product commerce in the sector increased from 9.1% to 13.2%. The activities with the highest accumulated growth were: manufacture of medical/hospital devices (42.7%), public health (39.4%), and health insurance (35.8%). Health care represented 4.1% of jobs in the economy in 2000 vs. 4.4% in 2007, with 1 million new jobs. Income from labor represented 6.7% of the total economy in 2000 and 7.5% in 2007. The health care sector has an important stake in the Brazilian economy, although this share is still lower than that observed in high-income countries. The rising share of public services in the sector's added value, the relative growth of medical and pharmaceutical product sales margins, and a real growth below the average for the pharmaceutical industry should be monitored.

The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group

PubMed Central

Gobburu, Jogarao; O’Barr, Stephen; Shah, Kumar; Huber, Jason; Weiner, Daniel

2013-01-01

Despite pharma's recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences graduate programs are currently maintaining traditional methods for master's and doctoral student education. The literature on graduate education in the biomedical sciences has long been advocating educating students to hone soft skills like communication and teamwork, in addition to maintaining excellent basic skills in research. However, recommendations to date have not taken into account the future trends in the pharmaceutical industry. The AACP Graduate Education Special Interest Group has completed a literature survey of the trends in the pharmaceutical industry and graduate education in order to determine whether our graduate programs are strategically positioned to prepare our graduates for successful careers in the next few decades. We recommend that our pharmaceutical sciences graduate programs take a proactive leadership role in meeting the needs of our future graduates and employers. Our graduate programs should bring to education the innovation and collaboration that our industry also requires to be successful and relevant in this century. PMID:23716757

The future of the pharmaceutical sciences and graduate education: recommendations from the AACP Graduate Education Special Interest Group.

PubMed

Wu-Pong, Susanna; Gobburu, Jogarao; O'Barr, Stephen; Shah, Kumar; Huber, Jason; Weiner, Daniel

2013-05-13

Despite pharma's recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences graduate programs are currently maintaining traditional methods for master's and doctoral student education. The literature on graduate education in the biomedical sciences has long been advocating educating students to hone soft skills like communication and teamwork, in addition to maintaining excellent basic skills in research. However, recommendations to date have not taken into account the future trends in the pharmaceutical industry. The AACP Graduate Education Special Interest Group has completed a literature survey of the trends in the pharmaceutical industry and graduate education in order to determine whether our graduate programs are strategically positioned to prepare our graduates for successful careers in the next few decades. We recommend that our pharmaceutical sciences graduate programs take a proactive leadership role in meeting the needs of our future graduates and employers. Our graduate programs should bring to education the innovation and collaboration that our industry also requires to be successful and relevant in this century.

Curing the disobedient patient: medication adherence programs as pharmaceutical marketing tools.

PubMed

Lamkin, Matt; Elliott, Carl

2014-01-01

Pharmaceutical companies have long focused their marketing strategies on getting doctors to write more prescriptions. But they lose billions in potential sales when patients do not take their prescribed drugs. Getting patients to "adhere" to drug therapies that have unpleasant side effects and questionable efficacy requires more than mere ad campaigns urging patients to talk to their doctors. It requires changing patients' beliefs and attitudes about their medications through repeated contact from people patients trust. Since patients do not trust drug companies, these companies are delivering their marketing messages through nurses, pharmacists, and even other patients--leveraging patients' trust in these intermediaries to persuade them to consume more brand name drugs. Armed with the premise that better adherence improves patients' health, drug companies justify manipulating patients by reframing reasonable decisions to decline therapy as pathological, and promote brand loyalty in the guise of offering medical care. © 2014 American Society of Law, Medicine & Ethics, Inc.

Determination of ruthenium in pharmaceutical compounds by graphite furnace atomic absorption spectroscopy.

PubMed

Jia, Xiujuan; Wang, Tiebang; Bu, Xiaodong; Tu, Qiang; Spencer, Sandra

2006-04-11

A graphite furnace atomic absorption (GFAA) spectrometric method for the determination of ruthenium (Rh) in solid and liquid pharmaceutical compounds has been developed. Samples are dissolved or diluted in dimethyl sulfoxide (DMSO) without any other treatment before they were analyzed by GFAA with a carefully designed heating program to avoid pre-atomization signal loss and to achieve suitable sensitivity. Various inorganic and organic solvents were tested and compared and DMSO was found to be the most suitable. In addition, ruthenium was found to be stable in DMSO for at least 5 days. Spike recoveries ranged from 81 to 100% and the limit of quantitation (LOQ) was determined to be 0.5 microg g(-1) for solid samples or 0.005 microg ml(-1) for liquid samples based a 100-fold dilution. The same set of samples was also analyzed by ICP-MS with a different sample preparation method, and excellent agreement was achieved.

Basics of Compounding: Clinical Pharmaceutics, Part 2.

PubMed

Allen, Loyd V

2016-01-01

This article represents part 2 of a 2-part article on the topic of clinical pharmaceutics. Pharmaceutics is relevant far beyond the pharmaceutical industry, compounding, and the laboratory. Pharmaceutics can be used to solve many clinical problems in medication therapy. A pharmacists' knowledge of the physicochemical aspects of drugs and drug products should help the patient, physician, and healthcare professionals resolve issues in the increasingly complex world of modern medicine. Part 1 of this series of articles discussed incompatibilities which can directly affect a clinical outcome and utilized pharmaceutics case examples of the application and importance of clinical pharmaceutics covering different characteristics. Part 2 continues to illustrate the scientific principles and clinical effects involved in clinical pharmaceutics. Also covered in this article are many of the scientific principles in typical to patient care. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

Foresight scanning: future directions of clinical and pharmaceutical research.

PubMed

Foster, Brian C

2008-01-01

Foresight Scanning: Future Directions of Clinical and Pharmaceutical Research. Brian C. Foster, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario, Canada ABSTRACT The Canadian Society for Pharmaceutical Sciences Satellite Symposium on Foresight Scanning, May 26 and 27, 2008, Nordegg, Alberta, Canada, focussed on the future directions of clinical and pharmaceutical research. The symposium brought together a group of clinicians, regulatory scientists, researchers and students to examine where clinical, pharmaceutical, and regulatory science might be in 10 to 15 years. Industry, regulatory, analytical, and clinical perspectives were presented and discussed, as well as the impact of exogenous (indirect) and endogenous (direct) change drivers. Unconditional funding was provided by Bayer HealthCare; they had no input on the direction of the meeting or selection of speakers. It was envisioned that the more important endogenous drivers may not be new information or changes in technology, policy, regulation, or health care delivery, but amplification of long-term underlying trends by emergence of new technologies, convergence of existing technologies or new communication and collaboration vehicles such as Web 2.0.

Recent Trends on the Future of Graduate Education in the Pharmaceutical Sciences and Research

PubMed Central

Kushwaha, KSS; Kushwaha, N; Rai, AK

2010-01-01

Harmonization of pharmacy education has to be made a global agenda that will encompass the developments that have taken place in basic, medical, pharmaceutical sciences in serving the needs and expectations of the society. The professional pharmacy curriculum is designed to produce pharmacists who have the abilities and skills to provide drug information, education, and pharmaceutical care to patients; manage the pharmacy and its medication distribution and control systems; and promote public health. Required coursework for all pharmacy students includes pharmaceutical chemistry; pharmaceutics (drug dosage forms, delivery, and disposition in the human body) pharmacology; therapeutics (the clinical use of drugs and dietary supplements in patients); drug information and analysis; pharmacy administration (including pharmacy law, bioethics, health systems, pharmacoeconomics, medical informatics); clinical skills (physical assessment, patient counseling, drug therapy monitoring for appropriate selection, dose, effect, interactions, use); and clinical pharmacy practice in pharmacies, industry, health maintenance organizations, hospital wards, and ambulatory care clinics. PMID:21264127

Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

PubMed

Dreischulte, Tobias; Fernandez-Llimos, Fernando

2016-12-01

Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (<80% agreement among all participants) regarding 'Clinical Pharmacy' activities, whether non-pharmacists could provide 'Clinical Pharmacy' services, and whether such services could be provided in non-hospital settings. There was disagreement (<80% agreement among those linking items to Clinical Pharmacy) as to whether Pharmaceutical care also encompassed certain professional activities, constituted a scientific discipline and targeted cost effectiveness. The proportions of participants willing to accept legal responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20.3%/44.0%). Conclusions The survey identified key disagreements around the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care', which future discussions around a harmonised definition of 'Clinical Pharmacy' should aim to resolve. Further research is required to understand barriers and facilitators to pharmacists accepting responsibility for drug therapy outcomes.

Pharmaceutical Use among Older Adults: Using Administrative Data to Examine Medication-Related Issues

ERIC Educational Resources Information Center

Metge, Colleen Jane; Grymonpre, Ruby; Yogendran, Marina

2005-01-01

Medication use is recognized as the least expensive, most cost-effective health care intervention. In older adults this is especially important, as they are the largest consumer of prescription medications. We describe the use of a linked data set including pharmaceutical, medical, and hospital claims to examine pharmaceutical use in the…

Issues in drug pricing, reimbursement, and access in China with references to other Asia-Pacific region.

PubMed

Chen, Yingyao; Schweitzer, Stuart O

2008-03-01

Pharmaceutical policies have become paramount in China and other countries of the Asia-Pacific region because of rapidly rising expenditures on drugs. The problems are especially acute in China because expenditures on drugs are typically so large. This article intends to review effects of the policy of drug expenditure containment with primary reference to China, and it proposes some measures to deal with rising pharmaceutical expenditures. This article overviews the issues of pharmaceutical pricing, reimbursement, and access in China, and there are a number of policies or measures to control pharmaceutical expenditures. Nevertheless, the effect of those policies of containing drug expenditure is ambiguous so far, and some policies have negative impacts to the manufacturers, providers, and patients. Some underlying reasons are identified. First, the policy's focus on health-care costs is, to some extent, neglected. Second, the governance of the health sector, including pharmaceutical sector, needs to be improved by both the government and the market. This article proposes some suggestions to change policies in drug pricing, reimbursement, and access, and make policies more responsive to the main problem of rising health-care expenditures rather than that of pharmaceutical expenditures alone. The policy suggestions include those of setting the reasonable price for pharmaceuticals, instituting reasonable incentives for all health decision-makers to encourage efficient use of pharmaceuticals and other health resources, and making pharmaceutical markets more efficient, either in the demand or the supply side.

Pharmaceutical management in ProCare Health Limited.

PubMed

Malcolm, L; Barry, M; MacLean, I

2001-06-22

To review pharmaceutical budget holding and management in ProCare Health Limited by; describing budget holding strategies implemented in 1995/6, identifying prescribing savings achieved, analysing variation in prescribing behaviour and comparing the findings with experience elsewhere. With 340 members, ProCare is one of the largest and most progressive of New Zealand's independent practitioner associations (IPAs). Data were obtained for the three years 1994 to 1996 to determine pharmaceutical expenditure against budget and against national trends, by member and general medical services (GMS) consultations. ProCare has established a classical, quality focussed pharmaceutical management strategy. Savings against the agreed budget was 9.5% comparing 1996 with 1995 but 5.7% compared, with national trends. Wide variation in per capita and per consultation costs was not reduced and was entirely explained by prescribing volumes not drug prices. The most important finding is that general practitioners (GPs), working collaboratively, can establish a strategy of clinical and corporate governance which may be exerting a wide ranging influence over clinical behaviour. Although there may be doubts about the actual levels of saving these appeared to be well in excess of the financial investment in the strategy. Greater savings appear possible with a focus on addressing the large and apparently inappropriate per capita prescribing volume variation between practices. Understanding and successfully addressing this variation will be one of the key issues facing the implementation of the government's primary health care strategy.

Health promotion and disease prevention: a look at demand management programs.

PubMed

Fronstin, P

1996-09-01

This Issue Brief describes employers' efforts to contain health expenditures through demand management programs. These programs are designed to reduce utilization by focusing on disease prevention and health promotion. Demand management includes work site health promotion, wellness programs, and access management. Work site health promotion is a comprehensive approach to improving health and includes awareness, health education, behavioral change, and organizational health initiatives. Wellness programs usually include stress management, smoking cessation, weight management, back care, health screenings, nutrition education, work place safety, prenatal and well baby care, CPR and first aid classes, and employee assistance programs (EAPs). These programs are often viewed positively by workers and can have long-term benefits for employers above and beyond health care cost containment. Demand management can benefit employers by increasing productivity, employee retention, and employee morale and by reducing turnover, absenteeism, future medical claims, and ultimately expenditures on health care. Even though a growing number of employers are offering wellness programs, only 37 percent of full-time workers employed in medium and large private establishments were eligible for wellness programs by 1993. However, a recent survey found that 88 percent of major employers have introduced some form of health promotion, disease prevention, or early intervention initiative to encourage healthy lifestyles among their salaried employees. Distinctions must be drawn between short- and long-term strategies. Demand management can be thought of as a short-term strategy when the focus of the program is on creating more appropriate and efficient health care utilization. Disease prevention is characterized by longer-term health improvement objectives. Whether the purpose is to reduce utilization in the short term or in the long term, the ultimate goal remains the same: to reduce health care expenditures while improving overall health. This goal can be achieved through the use of health risk appraisals, organizational health risk appraisals, high risk programs, awareness programs, medical call centers, return to work programs, EAPs, and smoking cessation programs. Studies of a health program's cost effectiveness must disentangle the effects of many competing factors on cost effectiveness. For example, a health risk appraisal program may identify health problems of which the patient and the health care provider were unaware, resulting in the treatment of these health problems. At the same time, the employer may have switched from a nonmanaged pharmaceutical program to a managed program with incentives for participants to utilize generic and/or mail order drugs. As a result, when evaluating a health promotion program, the long-run impact on the program's cost effectiveness is most important.

Group purchasing of pharmaceuticals and medical supplies by the Gulf Cooperation Council states.

PubMed

Khoja, T A M; Bawazir, S A

2005-01-01

An important issue in health care today is the cost of essential pharmaceuticals and medical supplies. To control the increase of health care expenses, in 1976 the Gulf Cooperation Council states began to study the idea of establishing a group purchasing programme for pharmaceuticals and medical supplies. This paper demonstrates the elements of the programme, how it works, what obstacles it faces and how other countries can profit from this experience. It also discusses the future of the group purchasing programme in the light of globalization and how the international changes under the World Trade Organization agreements will affect the programme in future.

Impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes: Randomized controlled trial.

PubMed

Wishah, Ruba A; Al-Khawaldeh, Omar A; Albsoul, Abla M

2015-01-01

The primary aim of this study was to evaluate the impact of pharmaceutical care interventions on glycemic control and other health-related clinical outcomes in patients with type 2 diabetes patients in Jordan. A randomized controlled clinical trial was conducted on 106 patients with uncontrolled type 2 diabetes seeking care in the diabetes clinics at Jordan University Hospital. Patients were randomly allocated into control and intervention group. The intervention group patients received pharmaceutical care interventions developed by the clinical pharmacist in collaboration with the physician while the control group patients received usual care without clinical pharmacist's input. Fasting blood glucose and HbA1c were measured at the baseline, at three months, and six months intervals for both intervention and control groups. After the six months follow-up, mean of HbA1c and FBS of the patients in the intervention group decreased significantly compared to the control group patients (P<0.05). Also, the results indicated that mean scores of patients' knowledge about medications, knowledge about diabetes and adherence to medications and diabetes self-care activities of the patients in the intervention group increased significantly compared to the control group (P<0.05). This study demonstrated an improvement in HbA1c, FBS, and lipid profile, in addition to self-reported medication adherence, diabetes knowledge, and diabetes self-care activities in patients with type 2 diabetes who received pharmaceutical care interventions. The results suggest the benefits of integrating clinical pharmacist services in multidisciplinary healthcare team and diabetes management in Jordan. Copyright © 2014 Diabetes India. Published by Elsevier Ltd. All rights reserved.

Chapter 5. Essential equipment, pharmaceuticals and supplies. Recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza epidemic or mass disaster.

PubMed

Sprung, Charles L; Kesecioglu, Jozef

2010-04-01

To provide recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza pandemic or mass disaster with a specific focus on essential equipment, pharmaceuticals and supplies. Based on a literature review and expert opinion, a Delphi process was used to define the essential topics including essential equipment, pharmaceuticals and supplies. Key recommendations include: (1) ensure that adequate essential medical equipment, pharmaceuticals and important supplies are available during a disaster; (2) develop a communication and coordination system between health care facilities and local/regional/state/country governmental authorities for the provision of additional support; (3) determine the required resources, order and stockpile adequate resources, and judiciously distribute them; (4) acquire additional mechanical ventilators that are portable, provide adequate gas exchange for a range of clinical conditions, function with low-flow oxygen and without high pressure, and are safe for patients and staff; (5) provide advanced ventilatory support and rescue therapies including high levels of inspired oxygen and positive end-expiratory pressure, volume and pressure control ventilation, inhaled nitric oxide, high-frequency ventilation, prone positioning ventilation and extracorporeal membrane oxygenation; (6) triage scarce resources including equipment, pharmaceuticals and supplies based on those who are likely to benefit most or on a 'first come, first served' basis. Judicious planning and adoption of protocols for providing adequate equipment, pharmaceuticals and supplies are necessary to optimize outcomes during a pandemic.

The service blueprint as a tool for designing innovative pharmaceutical services.

PubMed

Holdford, D A; Kennedy, D T

1999-01-01

To describe service blueprints, discuss their need and design, and provide examples of their use in advancing pharmaceutical care. Service blueprints are pictures or maps of service processes that permit the people involved in designing, providing, managing, and using the service to better understand them and deal with them objectively. A service blueprint simultaneously depicts the service process and the roles of consumers, service providers, and supporting services. Service blueprints can be useful in pharmacy because many of the obstacles to pharmaceutical care are a result of insufficient planning by service designers and/or poor communication between those designing services and those implementing them. One consequence of this poor design and communication is that many consumers and third party payers are uninformed about pharmacist roles. Service blueprints can be used by pharmacists to promote the value of pharmaceutical care to consumers and other decision makers. They can also assist in designing better pharmaceutical services. Blueprints are designed by identifying and mapping a process from the consumer's point of view, mapping employee actions and support activities, and adding visible evidence of service at each consumer action step. Key components of service blueprints are consumer actions, "onstage" and "backstage" employee actions, and support processes. Blueprints can help pharmacy managers identify and correct problems with the service process, provide pharmacy employees an opportunity to offer feedback in the planning stages of services, and demonstrate the value of pharmaceutical services to consumers. Service blueprints can be a valuable tool for designing, implementing, and evaluating pharmacy services.

CORRUPTION IN MEDICAL PRACTICE: WHERE DO WE STAND?

PubMed

Yousafzai, Abdul Wahab

2015-01-01

Corruption in health care sector affects all countries, including the United States, China and India. Pakistan is no exception. It is preventing people from having access to the quality medical care. Corruption in medical practice include ordering unnecessary investigations, and procedures for kickbacks and commissions; significant absenteeism, which adversely affects patient care; and the conflict of interest within the physician-pharmaceutical nexus, which exploits patients. To overcome corruption there is need to establish a framework for accountability, eliminating the physician-pharmaceutical nexus; and emphasizing medical ethics at the undergraduate and postgraduate levels. It is also important to open a dialogue amongst health care professionals and encourage the establishment of an ethical health care system in Pakistan.

Norwegian physicians' knowledge of the prices of pharmaceuticals: a survey.

PubMed

Eriksen, Ida Iren; Melberg, Hans Olav; Bringedal, Berit

2013-01-01

The objectives of this study are to measure physicians' knowledge of the prices of pharmaceuticals, and investigate whether there are differences in knowledge of prices between groups of physicians. This article reports on a survey study of physicians' knowledge of the prices of pharmaceuticals conducted on a representative sample of Norwegian physicians in the autumn of 2010. The importance of physicians' knowledge of costs derives from their influence on total spending and allocation of limited health-care resources. Physicians are important drivers in the effort to contain costs in health care, but only if they have the knowledge needed to choose the most cost-effective treatment options. A survey was sent to 1543 Norwegian physicians, asking them for price estimates and their opinions on the importance of considering the cost of treatment to society as a decision factor when treating their patients. This article deals with a subsection in which the physicians were asked to estimate the price of five pharmaceuticals: simvastatin, alendronate (Fosamax), infliximab (Remicade), natalizumab (Tysabri) and escitalopram (Cipralex). The response rate was 65%. For all the five pharmaceuticals, more than 50% and as many as 83% gave responses that differed more than 50% from the actual drug price. The price of more expensive pharmaceuticals was underestimated, while the opposite was the case for less expensive medicines. The data show that physicians in general have poor knowledge of the prices of the pharmaceuticals they offer their patients. However, the physicians who frequently deal with a drug have better knowledge of its price than those who do not handle a medication as often. The data also suggest that those physicians who agree that cost of care to society is an important decision factor have better knowledge of drug prices.

Management of pharmaceutical services in the Brazilian primary health care

PubMed Central

Gerlack, Letícia Farias; Karnikowski, Margô Gomes de Oliveira; Areda, Camila Alves; Galato, Dayani; de Oliveira, Aline Gomes; Álvares, Juliana; Leite, Silvana Nair; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Costa, Karen Sarmento; Guerra, Augusto Afonso; Acurcio, Francisco de Assis

2017-01-01

ABSTRACT OBJECTIVE To identify limiting factors in the management of pharmaceutical services in the primary health care provided by the Brazilian Unified Health System (SUS). METHODS This study was based on the data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines), and it was conducted by interviews with professionals responsible for pharmaceutical services in Brazilian cities, in 2015. To identify the management limiting factors, we considered the organizational, operational, and sustainability indicators of the management. For the analyses, we included the weights and structure of analysis plan for complex samples. The results were expressed by frequencies and measures of central tendency with 95% confidence interval, considering the Brazilian geographic regions. RESULTS We identified the following limiting factors: lack of pharmaceutical services in the Municipal Health Secretariat organization chart (24%) and in the health plan (18%); lack of participation of managers in the Health Board and the absence of reference to this topic in the agenda of meetings (58.4%); lack of financial autonomy (61.5%) and lack of knowledge on the available values (81.7%); lack of adoption of operational procedures (about 50%) for selection, scheduling, and acquisition; and the fact that most professionals evaluate the organization of pharmaceutical services as good and great (58.8%), despite the worrisome indicators. CONCLUSIONS Pharmaceutical services management is currently supported by a legal and political framework that should guide and contribute to improve the pharmaceutical services in the Brazilian Unified Health System primary health care. However, there is a mismatch between the goals established by these guidelines and what is actually happening. PMID:29160449

Norwegian Physicians’ Knowledge of the Prices of Pharmaceuticals: A Survey

PubMed Central

Eriksen, Ida Iren; Melberg, Hans Olav; Bringedal, Berit

2013-01-01

The objectives of this study are to measure physicians’ knowledge of the prices of pharmaceuticals, and investigate whether there are differences in knowledge of prices between groups of physicians. This article reports on a survey study of physicians’ knowledge of the prices of pharmaceuticals conducted on a representative sample of Norwegian physicians in the autumn of 2010. The importance of physicians’ knowledge of costs derives from their influence on total spending and allocation of limited health-care resources. Physicians are important drivers in the effort to contain costs in health care, but only if they have the knowledge needed to choose the most cost-effective treatment options. A survey was sent to 1 543 Norwegian physicians, asking them for price estimates and their opinions on the importance of considering the cost of treatment to society as a decision factor when treating their patients. This article deals with a subsection in which the physicians were asked to estimate the price of five pharmaceuticals: simvastatin, alendronate (Fosamax), infliximab (Remicade), natalizumab (Tysabri) and escitalopram (Cipralex). The response rate was 65%. For all the five pharmaceuticals, more than 50% and as many as 83% gave responses that differed more than 50% from the actual drug price. The price of more expensive pharmaceuticals was underestimated, while the opposite was the case for less expensive medicines. The data show that physicians in general have poor knowledge of the prices of the pharmaceuticals they offer their patients. However, the physicians who frequently deal with a drug have better knowledge of its price than those who do not handle a medication as often. The data also suggest that those physicians who agree that cost of care to society is an important decision factor have better knowledge of drug prices. PMID:24040402

Management of pharmaceutical services in the Brazilian primary health care.

PubMed

Gerlack, Letícia Farias; Karnikowski, Margô Gomes de Oliveira; Areda, Camila Alves; Galato, Dayani; Oliveira, Aline Gomes de; Álvares, Juliana; Leite, Silvana Nair; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Costa, Karen Sarmento; Guerra, Augusto Afonso; Acurcio, Francisco de Assis

2017-11-13

To identify limiting factors in the management of pharmaceutical services in the primary health care provided by the Brazilian Unified Health System (SUS). This study was based on the data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines), and it was conducted by interviews with professionals responsible for pharmaceutical services in Brazilian cities, in 2015. To identify the management limiting factors, we considered the organizational, operational, and sustainability indicators of the management. For the analyses, we included the weights and structure of analysis plan for complex samples. The results were expressed by frequencies and measures of central tendency with 95% confidence interval, considering the Brazilian geographic regions. We identified the following limiting factors: lack of pharmaceutical services in the Municipal Health Secretariat organization chart (24%) and in the health plan (18%); lack of participation of managers in the Health Board and the absence of reference to this topic in the agenda of meetings (58.4%); lack of financial autonomy (61.5%) and lack of knowledge on the available values (81.7%); lack of adoption of operational procedures (about 50%) for selection, scheduling, and acquisition; and the fact that most professionals evaluate the organization of pharmaceutical services as good and great (58.8%), despite the worrisome indicators. Pharmaceutical services management is currently supported by a legal and political framework that should guide and contribute to improve the pharmaceutical services in the Brazilian Unified Health System primary health care. However, there is a mismatch between the goals established by these guidelines and what is actually happening.

A renal transplantation advanced pharmacy practice experience.

PubMed

Chisholm, Marie A

2006-02-15

To establish and evaluate an ambulatory care renal transplantation clinic advanced pharmacy practice experience (APPE). Students spend 5 weeks performing pharmaceutical care activities for renal transplant patients, presenting health-related topics, and conducting research. A paired t test was used to determine differences between students' pre- and post-APPE test scores. Standardized evaluations completed by the preceptor and the students were used to evaluate learning and the APPE. Posttest scores were significantly higher than pretest scores (n = 17; 88.2 +/- 7.3 vs 55.9 +/- 22.4; p < 0.001). Overall, students found this APPE enjoyable and believed that it increased their knowledge concerning transplant medicine and patient care. With the recommendation that all transplant programs have clinical pharmacy services, it is imperative to train students to care for transplant patients. Information in this manuscript can be used as a guide for utilizing the combined resources from schools of pharmacy and transplantation centers to implement a renal transplant ambulatory care APPE.

[Case Study - A Successful Outpatient Design of Cross-Professional Pharmaceutical Cooperation in Home Health Care - Reduction of Financial and Care-Related Burden by Shifting to R-Compound Enteral Semisolid Formulation].

PubMed

Takeda, Namihiro; Hamana, Tomoko; Oka, Toyoka; Matsuyama, Narihisa; Hirohara, Masayoshi; Kushida, Kazuki

2015-12-01

Among patients who receive enteral nutrition through a gastric fistula, some are concomitantly administered viscosity modifiers to avoid aspiration pneumonitis caused by gastroesophageal reflux. These patients(and families)often bear the high economic and care burdens associated with enteral nutritional management. We developed an outpatient-based pharmacy service through multidisciplinary cooperation, facilitating a shift from enteral nutrition to semi-solid formula. This shift is expected to reduce the economic burden by approximately 120 thousand yen, and the hours of care by about 550 hours annually. Owing to family circumstances or economic conditions, some patients(and families)do not receive at-home guidance of pharmaceutical management by pharmacists. The family members of such patients visit the pharmacy to obtain the prescribed medications. Such patients and families could be supported within the outpatient-based pharmacy services, through proactively participating in home health care daily(collaborative relationship with the local community)and re-counting experiences of providing home guidance of pharmaceutical management.

Billing third party payers for pharmaceutical care services.

PubMed

Poirier, S; Buffington, D E; Memoli, G A

1999-01-01

To describe the steps pharmacists must complete when seeking compensation from third party payers for pharmaceutical care services. Government publications; professional publications, including manuals and newsletters; authors' personal experience. Pharmacists in increasing numbers are meeting with success in getting reimbursed by third party payers for patient care activities. However, many pharmacists remain reluctant to seek compensation because they do not understand the steps involved. Preparatory steps include obtaining a provider/supplier number, procuring appropriate claim forms, developing data collection and documentation systems, establishing professional fees, creating a marketing plan, and developing an accounting system. To bill for specific patient care services, pharmacists need to collect the patient's insurance information, obtain a statement of medical necessity from the patient's physician, complete the appropriate claim form accurately, and submit the claim with supporting documentation to the insurer. Although many claims from pharmacists are rejected initially, pharmacists who work with third party payers to understand the reasons for denial of payment often receive compensation when claims are resubmitted. Pharmacists who follow these guidelines for billing third party payers for pharmaceutical care services should notice an increase in the number of paid claims.

The Health Technology Assessment of companion diagnostics: experience of NICE.

PubMed

Byron, Sarah K; Crabb, Nick; George, Elisabeth; Marlow, Mirella; Newland, Adrian

2014-03-15

Companion diagnostics are used to aid clinical decision making to identify patients who are most likely to respond to treatment. They are becoming increasingly important as more new pharmaceuticals receive licensed indications that require the use of a companion diagnostic to identify the appropriate patient subgroup for treatment. These pharmaceuticals have proven benefit in the treatment of some cancers and other diseases, and also have potential to precisely tailor treatments to the individual in the future. However, the increasing use of companion diagnostics could place a substantial burden on health system resources to provide potentially high volumes of testing. This situation, in part, has led policy makers and Health Technology Assessment (HTA) bodies to review the policies and methods used to make reimbursement decisions for pharmaceuticals requiring companion diagnostics. The assessment of a pharmaceutical alongside the companion diagnostic used in the clinical trials may be relatively straightforward, although there are a number of challenges associated with assessing pharmaceuticals where a range of alternative companion diagnostics are available for use in routine clinical practice. The UK HTA body, the National Institute for Health and Care Excellence (NICE), has developed policy for considering companion diagnostics using its Technology Appraisal and Diagnostics Assessment Programs. Some HTA bodies in other countries have also adapted their policies and methods to accommodate the assessment of companion diagnostics. Here, we provide insight into the HTA of companion diagnostics for reimbursement decisions and how the associated challenges are being addressed, in particular by NICE. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

[Cooperation of medical and pharmaceutical sciences between private and national universities to educate professionals in the fields of drug development and rational pharmacotherapy].

PubMed

Iwakawa, Seigo

2012-01-01

Cooperation in education and research in medical and pharmaceutical sciences between Kobe Pharmaceutical University and Kobe University was started in 2008 for training professionals in drug development and rational pharmacotherapy. Initially, we started a two-year pharmacy residency program. Our pharmacy residents can attend lectures at our universities, and they also help pharmacist preceptors educate undergraduate pharmacy students in practical training. As curricula for cooperative education of pharmacy, nursing and medical students, we developed two new elective subjects (early exposure to clinical training for first year students and IPW (inter-professional work) seminar for fifth year pharmacy students) to learn about the roles of health care professionals in a medical team. Cooperative research between faculty members and graduate students is also in progress. For faculty and staff developments, invited lectures by clinical pharmacy and medical professors from the United States on the clinical education system in pharmacy and medicine in the United States have been held. This systematic cooperation will contribute to the promotion of a new curriculum for inter-professional education in the health-science fields.

Implementation of a pharmaceutical care programme for patients receiving new molecular-targeted agents in a clinical trial unit.

PubMed

Riu, G; Gaba, L; Victoria, I; Molas, G; do Pazo, F; Gómez, B; Creus, N; Vidal, L

2018-01-01

A pharmaceutical care programme was implemented at our hospital in early 2013. The main objectives were to analyse and describe the pharmaceutical interventions made, to calculate adherence, interventions and to evaluate patient satisfaction with the care programme. We performed a single-centre descriptive and prospective intervention in cancer patients who received oral chemotherapy as part of a clinical trial in 2013. Eighty-three patients were included. Median age was 58 years (range, 31-80) and 42 patients (50.6%) were men. We recorded 23 interventions, 13 of which were associated with drug interactions. The mean percentage of adherence was 98.9%. The interview with the pharmacist was considered to be very important by 84.6% of the respondents. A total of 92.3% said that they would like to speak to the pharmacist at subsequent visits. The doubts detected during the visits enable us to conclude that the information patients receive with respect to their study medication is usually incomplete. An integrated pharmaceutical care programme for cancer patients participating in clinical trials with oral cytostatic drugs was successful in terms of adherence and patient satisfaction and makes it possible to guarantee the safety and effectiveness of treatment on an individual basis. © 2016 John Wiley & Sons Ltd.

Access to Care in the Wake of Hurricane Sandy, New Jersey, 2012.

PubMed

Davidow, Amy L; Thomas, Pauline; Kim, Soyeon; Passannante, Marian; Tsai, Stella; Tan, Christina

2016-06-01

Evacuation and damage following a widespread natural disaster may affect short-term access to medical care. We estimated medical care needs in New Jersey following Hurricane Sandy in 2012. Hurricane Sandy-related questions regarding medical needs included in the Behavioral Risk Factor Surveillance System survey were administered to survey respondents living in New Jersey when Sandy occurred. Recently arrived foreign-born residents were more likely than US-born residents to need medical care following Sandy. Others with greater medical needs included the uninsured and evacuees. Persons who evacuated or lived in areas that experienced the greatest hurricane impact were less likely to be able to fill a prescription. Only 15% of New Jerseyans were aware of the Emergency Pharmaceutical Assistance Program (EPAP), a federal program which allows prescription refills for the uninsured following a disaster. Recently arrived foreign-born residents and the uninsured were less frequently aware of EPAP: 8.7% and 10.9%. Populations with impaired access to care in normal times-such as the recently arrived foreign-born and the uninsured-were also at risk of compromised access in the hurricane's aftermath. Measures to address prescription refills during a disaster need better promotion among at-risk populations. (Disaster Med Public Health Preparedness. 2016;10:485-491).

Portugal: Health System Review.

PubMed

de Almeida Simoes, Jorge; Augusto, Goncalo Figueiredo; Fronteira, Ines; Hernandez-Quevedo, Cristina

2017-03-01

This analysis of the Portuguese health system reviews recent developments in organization and governance, health financing, health care provision, health reforms and health system performance. Overall health indicators such as life expectancy at birth and at age 65 years have shown a notable improvement over the last decades. However, these improvements have not been followed at the same pace by other important dimensions of health: child poverty and its consequences, mental health and quality of life after 65. Health inequalities remain a general problem in the country. All residents in Portugal have access to health care provided by the National Health Service (NHS), financed mainly through taxation. Out-of-pocket payments have been increasing over time, not only co-payments, but particularly direct payments for private outpatient consultations, examinations and pharmaceuticals. The level of cost-sharing is highest for pharmaceutical products. Between one-fifth and one-quarter of the population has a second (or more) layer of health insurance coverage through health subsystems (for specific sectors or occupations) and voluntary health insurance (VHI). VHI coverage varies between schemes, with basic schemes covering a basic package of services, whereas more expensive schemes cover a broader set of services, including higher ceilings of health care expenses. Health care delivery is by both public and private providers. Public provision is predominant in primary care and hospital care, with a gate-keeping system in place for access to hospital care. Pharmaceutical products, diagnostic technologies and private practice by physicians constitute the bulk of private health care provision. In May 2011, the economic crisis led Portugal to sign a Memorandum of Understanding with the International Monetary Fund, the European Commission and the European Central Bank, in exchange for a loan of 78 billion euros. The agreed Economic and Financial Adjustment Programme included 34 measures aimed at increasing cost-containment, improving efficiency and increasing regulation in the health sector. Reforms implemented since 2011 by the Ministry of Health include: improving regulation and governance, health promotion (launch of priority health programmes such as for diabetes and mental health), rebalancing the pharmaceutical market (new rules for price setting, reduction in the prices of pharmaceuticals, increasing use of generic drugs), expanding and coordinating long-term and palliative care, and strengthening primary and hospital care. World Health Organization 2017 (acting as the host organization for, and secretariat of, the European Observatory on Health Systems and Policies).

Accrediting retail drug shops to strengthen Tanzania's public health system: an ADDO case study.

PubMed

Rutta, Edmund; Liana, Jafary; Embrey, Martha; Johnson, Keith; Kimatta, Suleiman; Valimba, Richard; Lieber, Rachel; Shekalaghe, Elizabeth; Sillo, Hiiti

2015-01-01

Retail drug sellers are a major source of health care and medicines in many countries. In Tanzania, drug shops are widely used, particularly in rural and underserved areas. Previously, the shops were allowed to sell only over-the-counter medicines, but sellers who were untrained and unqualified often illegally sold prescription drugs of questionable quality. In 2003, we worked with Tanzania's Ministry of Health and Social Welfare to develop a public-private partnership based on a holistic approach that builds the capacity of owners, dispensers, and institutions that regulate, own, or work in retail drug shops. For shop owners and dispensers, this was achieved by combining training, business incentives, supervision, and regulatory enforcement with efforts to increase client demand for and expectations of quality products and services. The accredited drug dispensing outlet (ADDO) program's goal is to improve access to affordable, quality medicines and pharmaceutical services in retail drug outlets in rural or peri-urban areas with few or no registered pharmacies. The case study characterizes how the ADDO program achieved that goal based on the World Health Organization's health system strengthening building blocks: 1) service delivery, 2) health workforce, 3) health information systems, 4) access to essential medicines, 5) financing, and 6) leadership and governance. The ADDO program has proven to be scalable, sustainable, and transferable: Tanzania has rolled out the program nationwide; the ADDO program has been institutionalized as part of the country's health system; shops are profitable and meeting consumer demands; and the ADDO model has been adapted and implemented in Uganda and Liberia. The critical element that was essential to the ADDO program's success is stakeholder engagement-the successful buy-in and sustained commitment came directly from the effort, time, and resources spent to fully connect with vital stakeholders at all levels. Beyond improving the quality of medicines and dispensing services, availability of essential medicines, and the regulatory system, the impact of a nationwide accredited drug seller approach on the pharmaceutical sector promises to provide a model framework for private-sector pharmaceutical delivery in the developing world that is sustainable without ongoing donor support.

Quality improvement in the use of medications through a drug use evaluation service.

PubMed

Stevenson, J G; Bakst, C M; Zaran, F K; Rybak, M J; Smolarek, R T; Alexander, M R

1992-10-01

Continuous quality improvement methods have the potential to improve processes that cross several disciplines. The medication system is one in which coordination of activities between physicians, pharmacists, and nurses is essential for optimal therapy to occur. DUE services can play an important role in helping to ensure that patients receive high-quality pharmaceutical care. It is necessary for pharmacy managers to review the structure, goals, and outcomes of their DUE programs to ensure that they are consistent with a philosophy of continuous improvement in the quality of drug therapy.

OVERVIEW OF VOLUNTARY STEWARDSHIP EFFORTS TO ADDRESS PHARMACEUTICAL DISPOSAL

EPA Science Inventory

This presentation will provide an overview of current federal regulatory guidance for pharmaceutical disposal, currently funded pilot programs for take-back pilot studies, and state programs. The EPA Office of Water's role is to protect our Nation's watersheds and drinking water ...

The Purpose and Scope of Pedagogy in Pharmaceutical Education.

PubMed

Nakamura, Akihiro

2017-01-01

The WHO and International Pharmaceutical Federation (FIP) introduced the concept of the "seven-star pharmacist" in which a pharmacist is described as a caregiver, communicator, decision-maker, teacher, lifelong learner, leader and manager. In six-year pharmaceutical education programs, which have been provided in schools of pharmacy since 2006, 5th year students participate in on-site practice experiences in hospitals and community pharmacies. Thus, Japanese pharmacists also began to have a role in pharmaceutical education as teachers in clinical settings. Not only pharmacists in clinical settings, but also faculty members of pharmacy schools, had not previously been familiar with evidence-based education, and therefore they often teach in the way they were taught. Since research on teaching and learning has not been well developed in Japanese pharmaceutical education, both the model core curriculum for six-year programs and the subject benchmark statement for four-year programs are based on insufficient scientific evidence. We should promote the scholarship of teaching and learning, which promotes teaching as a scholarly endeavor and a worthy subject for research. In this review, I will summarize the needs and expectations for the establishment of pedagogy in pharmaceutical education.

The changing face of chronic illness management in primary care: a qualitative study of underlying influences and unintended outcomes.

PubMed

Hunt, Linda M; Kreiner, Meta; Brody, Howard

2012-01-01

Recently, there has been dramatic increase in the diagnosis and pharmaceutical management of common chronic illnesses. Using qualitative data collected in primary care clinics, we assessed how these trends play out in clinical care. This qualitative study focused on management of type 2 diabetes and hypertension in 44 primary care clinics in Michigan and was based on interviews with 58 clinicians and 70 of their patients, and observations of 107 clinical consultations. We assessed clinicians' treatment strategies and discussions of factors influencing treatment decisions, and patients' understandings and experiences in managing these illnesses. Clinicians focused on helping patients achieve test results recommended by national guidelines, and most reported combining 2 or more medications per condition to reach targets. Medication selection and management was the central focus of the consultations we observed. Polypharmacy was common among patients, with more than one-half taking 5 or more medications. Patient interviews indicated that heavy reliance on pharmaceuticals presents challenges to patient well-being, including financial costs and experiences of adverse health effects. Factors promoting heavy use of pharmaceuticals include lower diagnostic and treatment thresholds, clinician-auditing and reward systems, and the prescribing cascade, whereby more medications are prescribed to control the effects of already-prescribed medications. We present a conceptual model, the inverse benefit law, to provide insight into the impact of pharmaceutical marketing efforts on the observed trends. We make recommendations about limiting the influence of the pharmaceutical industry on clinical practice, toward improving the well-being of patients with chronic illness.

Rising Cost of Cancer Pharmaceuticals: Cost Issues and Interventions to Control Costs.

PubMed

Glode, Ashley E; May, Megan Brafford

2017-01-01

The rising cost of pharmaceuticals and, in particular, cancer drugs has made headline news in recent years. Several factors contribute to increasing costs and the burden this places on the health care system and patients. Some of these factors include costly cancer pharmaceutical research and development, longer clinical trials required to achieve drug approval, manufacturing costs for complex compounds, and the economic principles surrounding oncology drug pricing. Strategies to control costs have been proposed, and some have already been implemented to mitigate cancer drug costs such as the use of clinical treatment pathways and tools to facilitate cost discussions with patients. In this article, we briefly review some of the potential factors contributing to increasing cancer pharmaceutical costs and interventions to mitigate costs, and touch on the role of health care providers in addressing this important issue. © 2016 Pharmacotherapy Publications, Inc.

The role of healthcare communications agencies in maintaining compliance when working with the pharmaceutical industry and healthcare professionals.

PubMed

Cairns, Angela; Yarker, Yvonne E

2008-05-01

Relationships between the pharmaceutical industry and healthcare professionals continue to drive discussion about the potential for conflicts of interest. Despite greater regulation and oversight, there are still calls for increased transparency and further restrictions on these relationships. Regulatory authorities, the pharmaceutical industry, professional societies, and other interested parties have responded by developing robust guidelines for interactions between the pharmaceutical industry and healthcare professionals. This, in turn, is driving change in the way that healthcare communications agencies work, increasing the need for them to visibly demonstrate processes that ensure their employees comply with relevant laws, regulations, and guidelines. In our group of healthcare communications agencies we have established an internal compliance program and developed a policy that reflects the services we provide, and we recommend that other agencies adopt a similar program. Compliance training, implemented by a nominated compliance team, can be enforced by including compulsory tests for employees who interact with the pharmaceutical industry and healthcare professionals, with annual reassessment. The compliance team also has an important role to play in ensuring ongoing communication and staff education, including awareness of new legal and best practice developments. Management of the compliance program is essential, with clear mechanisms for auditing and evaluation, and the inclusion of compliance adherence in staff performance objectives. A visible framework for handling potential compliance issues should also be developed, with clear definitions of different levels of noncompliance and potential associated consequences. Compliance programs may also include other elements, such as terminology and documentation guidance, so that the program becomes an integral tool used by employees on a daily basis. With a robust internal compliance program, healthcare communication agencies can play a significant role in helping maintain appropriate pharmaceutical industry-healthcare professional relationships in an increasingly regulated and scrutinized environment.

Comprehensive taxonomy and worldwide trends in pharmaceutical policies in relation to country income status.

PubMed

Maniadakis, N; Kourlaba, G; Shen, J; Holtorf, A

2017-05-25

Rapidly evolving socioeconomic and technological trends make it challenging to improve access, effectiveness and efficiency in the use of pharmaceuticals. This paper identifies and systematically classifies the prevailing pharmaceutical policies worldwide in relation to a country's income status. A literature search was undertaken to identify and taxonomize prevailing policies worldwide. Countries that apply those policies and those that do not were then grouped by income status. Pharmaceutical policies are linked to a country's socioeconomics. Developed countries have universal coverage and control pharmaceuticals with external and internal price referencing systems, and indirect price-cost controls; they carry out health technology assessments and demand utilization controls. Price-volume and risk-sharing agreements are also evolving. Developing countries are underperforming in terms of coverage and they rely mostly on restrictive state controls to regulate prices and expenditure. There are significant disparities worldwide in the access to pharmaceuticals, their use, and the reimbursement of costs. The challenge in high-income countries is to maintain access to care whilst dealing with trends in technology and aging. Essential drugs should be available to all; however, many low- and middle-income countries still provide most of their population with only poor access to medicines. As economies grow, there should be greater investment in pharmaceutical care, looking to the policies of high-income countries to increase efficiency. Pharmaceutical companies could also develop special access schemes with low prices to facilitate coverage in low-income countries.

Drug tendering: drug supply and shortage implications for the uptake of biosimilars

PubMed Central

Dranitsaris, George; Jacobs, Ira; Kirchhoff, Carol; Popovian, Robert; Shane, Lesley G

2017-01-01

Due to the continued increase in global spending on health care, payers have introduced a number of programs, policies, and agreements on pharmaceutical pricing in order to control costs. While incentives to increase generic drug use have achieved significant savings, other cost-containment measures are required. Tendering is a formal procedure to purchase medications using competitive bidding for a particular contract. Although useful for cost containment, tendering can lead to decreased competition in a given market. Consequently, drug shortages can occur, resulting in changes to treatment plans to products that may have lower efficacy and/or an increased risk of adverse effects. Therefore, care must be taken to ensure that tendering does not negatively impact patient care or the health care system. A large and expanding portion of total pharmaceutical expenditure is for biologic therapies. These agents have revolutionized the treatment of many diseases, including cancer and inflammatory conditions; however, patient access to biologic drugs can be limited due to availability, insurance coverage, and cost. As branded biologic therapies reach the end of patent- and data-protection periods, biosimilars are being approved as lower-cost alternatives. Biosimilars are products that are highly similar to the originator product with no clinically meaningful differences in terms of safety, purity, or potency. As more biosimilars receive regulatory approval and adoption increases, these therapies are expected to have an impact on global health care spending and should result in overall savings. However, the use of tendering to maximize the potential benefits of biosimilars has varied across the world. Therefore, the objectives of this review are to examine the drug-tendering process and its implications on drug supply and drug shortages, as well as to describe biosimilars and how tendering may influence their uptake. PMID:29033595

Pharmaceutical care in community pharmacies: practice and research in the US.

PubMed

Christensen, Dale B; Farris, Karen B

2006-01-01

To describe the state of community pharmacy, including patient care services, in the US. Chain pharmacies, including traditional chains, mass merchandisers, and supermarkets, comprise more than 50% of community pharmacies in the US. Dispensing of drugs remains the primary focus, yet the incidence of patients being counseled on medications appears to be increasing. More than 25% of independent community pharmacy owners report providing some patient clinical care services, such as medication counseling and chronic disease management. Most insurance programs pay pharmacists only for dispensing services, yet there are a growing number of public and private initiatives that reimburse pharmacists for cognitive services. Clinical care opportunities exist in the new Medicare prescription drug benefit plan, as it requires medication therapy management services for specific enrollees. The private market approach to healthcare delivery in the US, including pharmacy services, precludes national and statewide strategies to change the basic business model. To date, most pharmacies remain focused on dispensing prescriptions. With lower dispensing fees and higher operating costs, community pharmacies are focused on increasing productivity and efficiency through technology and technicians. Pharmacists remain challenged to establish the value of their nondispensing-related pharmaceutical care services in the private sector. As the cost of suboptimal drug therapy becomes more evident, medication therapy management may become a required pharmacy benefit in private drug insurance plans. Pharmacy school curricula, as well as national and state pharmacy associations, continually work to train and promote community pharmacists for these roles. Practice research is driven primarily by interested academics and, to a lesser degree, by pharmacy associations. Efficient dispensing of prescriptions is the primary focus of community pharmacies in the US. Some well designed practice-based research has been conducted, but there is no national research agenda or infrastructure. Reimbursement for cognitive services remains an infrequent, but growing, activity.

Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and development.

PubMed

Bodrogi, József; Kaló, Zoltán

2010-04-01

The importance of evidence-based health policy is widely acknowledged among health care professionals, patients and politicians. Health care resources available for medical procedures, including pharmaceuticals, are limited all over the world. Economic evaluations help to alleviate the burden of scarce resources by improving the allocative efficiency of health care financing. Reimbursement of new medicines is subject to their cost-effectiveness and affordability in more and more countries. There are three major approaches to calculate the cost-effectiveness of new pharmaceuticals. Economic analyses alongside pivotal clinical trials are often inconclusive due to the suboptimal collection of economic data and protocol-driven costs. The major limitation of observational naturalistic economic evaluations is the selection bias and that they can be conducted only after registration and reimbursement. Economic modelling is routinely used to predict the cost-effectiveness of new pharmaceuticals for reimbursement purposes. Accuracy of cost-effectiveness estimates depends on the quality of input variables; validity of surrogate end points; and appropriateness of modelling assumptions, including model structure, time horizon and sophistication of the model to differentiate clinically and economically meaningful outcomes. These economic evaluation methods are not mutually exclusive; in practice, economic analyses often combine data collection alongside clinical trials or observational studies with modelling. The need for pharmacoeconomic evidence has fundamentally changed the strategic imperatives of research and development (R&D). Therefore, professionals in pharmaceutical R&D have to be familiar with the principles of pharmacoeconomics, including the selection of health policy-relevant comparators, analytical techniques, measurement of health gain by quality-adjusted life-years and strategic pricing of pharmaceuticals.

Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and development

PubMed Central

Bodrogi, József; Kaló, Zoltán

2010-01-01

The importance of evidence-based health policy is widely acknowledged among health care professionals, patients and politicians. Health care resources available for medical procedures, including pharmaceuticals, are limited all over the world. Economic evaluations help to alleviate the burden of scarce resources by improving the allocative efficiency of health care financing. Reimbursement of new medicines is subject to their cost-effectiveness and affordability in more and more countries. There are three major approaches to calculate the cost-effectiveness of new pharmaceuticals. Economic analyses alongside pivotal clinical trials are often inconclusive due to the suboptimal collection of economic data and protocol-driven costs. The major limitation of observational naturalistic economic evaluations is the selection bias and that they can be conducted only after registration and reimbursement. Economic modelling is routinely used to predict the cost-effectiveness of new pharmaceuticals for reimbursement purposes. Accuracy of cost-effectiveness estimates depends on the quality of input variables; validity of surrogate end points; and appropriateness of modelling assumptions, including model structure, time horizon and sophistication of the model to differentiate clinically and economically meaningful outcomes. These economic evaluation methods are not mutually exclusive; in practice, economic analyses often combine data collection alongside clinical trials or observational studies with modelling. The need for pharmacoeconomic evidence has fundamentally changed the strategic imperatives of research and development (R&D). Therefore, professionals in pharmaceutical R&D have to be familiar with the principles of pharmacoeconomics, including the selection of health policy-relevant comparators, analytical techniques, measurement of health gain by quality-adjusted life-years and strategic pricing of pharmaceuticals. PMID:20132213

The future of pharmaceutical care in France: a survey of final-year pharmacy students' opinions

PubMed Central

2011-01-01

Background In the last decades, the provision of pharmaceutical care by community pharmacists has developed in OECD countries. These developments involved significant changes in professional practices and organization of primary care. In France, they have recently been encouraged by a new legal framework and favored by an increasing demand for health care (increase in the number of patients with chronic diseases) and reductions in services being offered (reduction in the number of general practitioners and huge regional disparities). Objectives: This study aimed to investigate final-year pharmacy students' opinions on 1/expanding the scope of pharmacists' practices and 2/the potential barriers for the implementation of pharmaceutical care. We discussed these in the light of the experiences of pharmacists in Quebec, and other countries in Europe (United Kingdom and the Netherlands). Methods All final-year students in pharmaceutical studies, preparing to become community pharmacists, at the University Paris-Descartes in Paris during 2010 (n = 146) were recruited. All of them were interviewed by means of a questionnaire describing nine "professional" practices by pharmacists, arranged in four dimensions: (1) screening and chronic disease management, (2) medication surveillance, (3) pharmacy-prescribed medication and (4) participation in health care networks. Respondents were asked (1) how positively they view the extension of their current practices, using a 5 point Likert scale and (2) their perception of potential professional, technical, organizational and/or financial obstacles to developing these practices. Results 143 (97.9%) students completed the questionnaire. Most of practices studied received a greater than 80% approval rating, although only a third of respondents were in favor of the sales of over-the-counter (OTC) drugs. The most significant perceived barriers were working time, remuneration and organizational problems, specifically the need to create a physical location for consultations to respect patients' privacy within a pharmacy. Conclusions Despite remaining barriers to cross, this study showed that future French pharmacists were keen to develop their role in patient care, beyond the traditional role of dispensing. However, the willingness of doctors and patients to consent should be investigated and also rigorous studies to support or refute the positive impact of pharmaceutical care on the quality of care should be carried out. PMID:21612642

Education in Medical Biochemistry in Serbia

PubMed Central

2010-01-01

Medical biochemistry is the usual name for clinical biochemistry or clinical chemistry in Serbia. Medical biochemistry laboratories and medical biochemists as a profession are part of Health Care System and are regulated through: the Health Care Law and rules issued by the Chamber of Medical Biochemists of Serbia. The first continuous and organized education for Medical Biochemists in Serbia dates from 1945, when Department of Medical Biochemistry was established at Pharmaceutical Faculty in Belgrade. In 1987 at the same Faculty a five years undergraduate branch was established, educating Medical Biochemists under a special program. Since 2006 the new five year undergraduate (according to Bologna Declaration) and postgraduate program of four-year specialization according to EC4 European Syllabus for Post-Graduate Training in Clinical Chemistry and Laboratory Medicine has been established. The Ministry of Education and Ministry of Public Health accredits the programs. There are four requirements for practicing medical biochemistry in the Health Care System: University Diploma of the Faculty of Pharmacy (Medical Biochemistry), successful completion of the profession exam at the Ministry of Health after completion of one additional year of obligatory practical training in medical laboratories, membership in the Serbian Chamber of Medical Biochemists and licence for skilled work issued by Serbian Chamber of Medical Biochemists. PMID:27683360

ENVIRONMENTAL STEWARDSHIP OF PHARMACEUTICALS - THE GREEN PHARMACY

EPA Science Inventory

The occurrence of pharmaceuticals and personal care products (PPCPS) as environmental pollutants is a multifaceted issue whose scope continues to become better delineated since the escalation of conceited attention beginning in the 1980s. PPCPs typically occur as trace environme...

PharmEcovigilance and the Environmental Footprint of Pharmaceuticals

EPA Science Inventory

The prescribing and usage of medications have ramifications extending far beyond conventional medical care. The healthcare industry has an environmental footprint because the active ingredients from pharmaceuticals enter the environment as pollutants by a variety of routes, prima...

PHARMACEUTICALS IN THE ENVIRONMENT: SOURCES AND THEIR MANAGEMENT

EPA Science Inventory

An issue that began to receive more attention by environmental scientists in the late 1990s was the conveyancy of pharmaceuticals in the environment by way of their use in human and veterinary medical practices and personal care

Cost-effectiveness analysis of pharmaceutical care for hypertensive patients from the perspective of the public health system in Brazil.

PubMed

Cazarim, Maurílio de Souza; Pereira, Leonardo Régis Leira

2018-01-01

Only 20% of patients with systemic arterial hypertension (SAH) have blood pressure within recommended parameters. SAH has been the main risk factor for morbidity and mortality of cardiovascular diseases, which affects the burden of the Public Health System (PHS). Some studies have shown the effectiveness of Pharmaceutical Care (PC) in the care of hypertensive patients. To perform a cost-effectiveness analysis to compare SAH treatment with PC management and conventional treatment for hypertensive patients offered by the PHS. A cost-effectiveness study nested to a quasi-experimental study was conducted, in which 104 hypertensive patients were followed up in a PC program. Blood pressure control was considered as the outcome for the economic analysis and the costs were direct and non-direct medical costs. PC was dominant for two years in the post-PC period compared with the pre-PC year. The mean cost effectiveness ratio (CER) for the CERPre-PC, CERPC, and CERPost-PC periods were: US$ 364.65, US$ 415.39, and US$ 231.14 respectively. The incremental cost effectiveness ratio (ICER) analysis presented ICER of US$ 478.41 in the PC period and US$ 42.95 in the post PC period. Monte Carlo sensitivity analysis presented mean ICERPC and ICERPost-PC equal to US$ 605.09 and US$ 128.03, reaching US$ 1,725.00 and US$ 740.00 respectively. Even for the highest ICER, the values were below the cost effectiveness threshold, which means that PC was a cost effective strategy for the care of hypertensive patients in the PHS.

Role of the pharmacist in parenteral nutrition therapy: challenges and opportunities to implement pharmaceutical care in Kuwait

PubMed Central

2015-01-01

Background: Pharmacists can provide beneficial pharmaceutical care services to patients receiving Parenteral Nutrition (PN) therapy by working within Nutrition Support Teams (NSTs). Objective: This study was designed to explore pharmacists’ role in PN therapy in hospitals of Kuwait, sources of PN-related information, opinions on NSTs, perceptions about the barriers to pharmaceutical care implementation and views on how to enhance their practices. Methods: Data were collected via face-to-face semi-structured interviews with the senior Total Parenteral Nutrition (TPN) pharmacists at all the hospitals which provide TPN preparation services (six governmental hospitals and one private hospital) in Kuwait. Descriptive statistics were used to describe pharmacists’ demographic details and practice site characteristics. The interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis. Results: The pharmacists mainly performed technical tasks such as TPN compounding with minimal role in providing direct patient care. They used multiple different sources of TPN-related information to guide their practice. They reported positive and negative experiences with physicians depending on their practice environment. None of the hospitals had a functional NST. However, pharmacists expressed preference to work within NSTs due to the potential benefits of enhanced communication and knowledge exchange among practitioners and to improve service. Pharmacists perceived several barriers to providing pharmaceutical care including lack of reliable sources of TPN-related information, lack of a standard operating procedure for TPN across hospitals, insufficient staff, time constraints and poor communication between TPN pharmacists. To overcome these barriers, they recommended fostering pharmacists’ education on TPN, establishing national standards for TPN practices, provision of pharmacy staff, development of NSTs, enhancing TPN pharmacists’ communication and conducting TPN-research research. Conclusion: TPN pharmacists in Kuwait are confined to performing TPN manufacturing processes. There are promising avenues for future development of their role in patient care. This can be achieved by overcoming the barriers to pharmaceutical care practice and providing pharmacists with educational opportunities to equip them with the clinical competencies needed to practise as nutrition support pharmacists with patient-centred roles. PMID:27382419

Role of the pharmacist in parenteral nutrition therapy: challenges and opportunities to implement pharmaceutical care in Kuwait.

PubMed

Katoue, Maram G; Al-Taweel, Dalal

2016-01-01

Pharmacists can provide beneficial pharmaceutical care services to patients receiving Parenteral Nutrition (PN) therapy by working within Nutrition Support Teams (NSTs). This study was designed to explore pharmacists' role in PN therapy in hospitals of Kuwait, sources of PN-related information, opinions on NSTs, perceptions about the barriers to pharmaceutical care implementation and views on how to enhance their practices. Data were collected via face-to-face semi-structured interviews with the senior Total Parenteral Nutrition (TPN) pharmacists at all the hospitals which provide TPN preparation services (six governmental hospitals and one private hospital) in Kuwait. Descriptive statistics were used to describe pharmacists' demographic details and practice site characteristics. The interviews were audio-recorded, transcribed verbatim and analysed using thematic analysis. The pharmacists mainly performed technical tasks such as TPN compounding with minimal role in providing direct patient care. They used multiple different sources of TPN-related information to guide their practice. They reported positive and negative experiences with physicians depending on their practice environment. None of the hospitals had a functional NST. However, pharmacists expressed preference to work within NSTs due to the potential benefits of enhanced communication and knowledge exchange among practitioners and to improve service. Pharmacists perceived several barriers to providing pharmaceutical care including lack of reliable sources of TPN-related information, lack of a standard operating procedure for TPN across hospitals, insufficient staff, time constraints and poor communication between TPN pharmacists. To overcome these barriers, they recommended fostering pharmacists' education on TPN, establishing national standards for TPN practices, provision of pharmacy staff, development of NSTs, enhancing TPN pharmacists' communication and conducting TPN-research research. TPN pharmacists in Kuwait are confined to performing TPN manufacturing processes. There are promising avenues for future development of their role in patient care. This can be achieved by overcoming the barriers to pharmaceutical care practice and providing pharmacists with educational opportunities to equip them with the clinical competencies needed to practise as nutrition support pharmacists with patient-centred roles.

[Pharmaceutical care for patients of the third age in pharmacy organizations as a significant aspect of social gerontology].

PubMed

Krivosheev, S A; Kartashova, O V; Tikhonova, U A; Zakharova, O V

2017-01-01

There are questions in the article that study mutual relations of patients of elderly and senile age with pharmaceutical experts. It was revealed that pharmacy organizations are an important element in the life of patients of the third age and noted the high role of the pharmaceutical specialist in their social environment. The article shows the need to focus on the psychosomatic features of elderly patients with proper pharmaceutical counseling and professional communication. It was noted that interaction of patients of the third age with pharmaceutical specialists and their confidence in them has high importance.

A New Approach to Health Services and Pharmacy in Cuba.

PubMed

Sánchez, Alina M

2015-12-01

In December 17, 2014, U.S. President Barack Obama surprised the world by announcing his intention to enter into negotiations aimed at reestablishing diplomatic relations with Cuba. Since then, expectations and interest regarding the health system of that country have increased. This report focuses on the Cuban health and pharmacy systems from a practical and educational standpoint. Pharmaceutical services, strengths, opportunities, and challenges are described. Cuba's new trends toward patient-centered care are analyzed to provide insights for developing pharmaceutical care practice and implementing policies suitable for practice in all health care settings. © 2015 Pharmacotherapy Publications, Inc.

Changing tides: Adaptive monitoring, assessment, and management of pharmaceutical hazards in the environment through time.

PubMed

Gaw, Sally; Brooks, Bryan W

2016-04-01

Pharmaceuticals are ubiquitous contaminants in aquatic ecosystems. Adaptive monitoring, assessment, and management programs will be required to reduce the environmental hazards of pharmaceuticals of concern. Potentially underappreciated factors that drive the environmental dose of pharmaceuticals include regulatory approvals, marketing campaigns, pharmaceutical subsidies and reimbursement schemes, and societal acceptance. Sales data for 5 common antidepressants (duloxetine [Cymbalta], escitalopram [Lexapro], venlafaxine [Effexor], bupropion [Wellbutrin], and sertraline [Zoloft]) in the United States from 2004 to 2008 were modeled to explore how environmental hazards in aquatic ecosystems changed after patents were obtained or expired. Therapeutic hazard ratios for Effexor and Lexapro did not exceed 1; however, the therapeutic hazard ratio for Zoloft declined whereas the therapeutic hazard ratio for Cymbalta increased as a function of patent protection and sale patterns. These changes in therapeutic hazard ratios highlight the importance of considering current and future drivers of pharmaceutical use when prioritizing pharmaceuticals for water quality monitoring programs. When urban systems receiving discharges of environmental contaminants are examined, water quality efforts should identify, prioritize, and select target analytes presently in commerce for effluent monitoring and surveillance. © 2015 SETAC.

Health care expenditures among Asian American subgroups.

PubMed

Chen, Jie; Vargas-Bustamante, Arturo; Ortega, Alexander N

2013-06-01

Using two nationally representative data sets, this study examined health care expenditure disparities between Caucasians and different Asian American subgroups. Multivariate analyses demonstrate that Asian Americans, as a group, have significantly lower total expenditures compared with Caucasians. Results also point to considerable heterogeneities in health care spending within Asian American subgroups. Findings suggest that language assistance programs would be effective in reducing disparities among Caucasians and Asian American subgroups with the exception of Indians and Filipinos, who tend to be more proficient in English. Results also indicate that citizenship and nativity were major factors associated with expenditure disparities. Socioeconomic status, however, could not explain expenditure disparities. Results also show that Asian Americans have lower physician and pharmaceutical costs but not emergency department or hospital expenditures. These findings suggest the need for culturally competent policies specific to Asian American subgroups and the necessity to encourage cost-effective treatments among Asian Americans.

Health Care Expenditures Among Asian American Subgroups

PubMed Central

Chen, Jie; Vargas-Bustamante, Arturo; Ortega, Alexander N.

2014-01-01

Using two nationally representative data sets, this study examined health care expenditure disparities between Caucasians and different Asian American subgroups. Multivariate analyses demonstrate that Asian Americans, as a group, have significantly lower total expenditures compared with Caucasians. Results also point to considerable heterogeneities in health care spending within Asian American subgroups. Findings suggest that language assistance programs would be effective in reducing disparities among Caucasians and Asian American subgroups with the exception of Indians and Filipinos, who tend to be more proficient in English. Results also indicate that citizenship and nativity were major factors associated with expenditure disparities. Socioeconomic status, however, could not explain expenditure disparities. Results also show that Asian Americans have lower physician and pharmaceutical costs but not emergency department or hospital expenditures. These findings suggest the need for culturally competent policies specific to Asian American subgroups and the necessity to encourage cost-effective treatments among Asian Americans. PMID:23223329

The U.S. Health Care Crisis Five Years After Passage of the Affordable Care Act: A Data Snapshot.

PubMed

Hellander, Ida

2015-01-01

Despite passage of the Affordable Care Act in 2010, the U.S. health care crisis continues. While coverage has been expanded, the reform will leave 27 million people uninsured in 2024, according to the Congressional Budget Office. Much of the new coverage is of low actuarial value with high cost-sharing requirements, creating barriers to access. Choice of physician is restricted to narrow networks of providers. Recent measures of uninsurance, underinsurance, access to care, and health care costs are given. Changes in Medicare, particularly privatization and the rise of specialty drug tiers that limit access to medically necessary medications, are reviewed. Data on a new wave of consolidation among hospitals, medical groups, insurers, and drug companies are presented. The rise of ultra-high-price drugs, such as Solvadi, is raising pharmaceutical costs, particularly in Medicaid, the program for low-income Americans. International health comparisons continue to show the United States performing poorly in relation to other countries. Recent polling data are presented, showing support for more fundamental reform. © The Author(s) 2015.

[The planning of resource support of secondary medical care in hospital].

PubMed

Kungurov, N V; Zil'berberg, N V

2010-01-01

The Ural Institute of dermatovenerology and immunopathology developed and implemented the software concerning the personalized total recording of medical services and pharmaceuticals. The Institute also presents such software as listing of medical services, software module of calculation of financial costs of implementing full standards of secondary medical care in case of chronic dermatopathy, reference book of standards of direct specific costs on laboratory and physiotherapy services, reference book of pharmaceuticals, testing systems and consumables. The unified information system of management recording is a good technique to substantiate the costs of the implementation of standards of medical care, including high-tech care with taking into account the results of total calculation of provided medical services.

[Economics of health care in Mali].

PubMed

Coulibaly, S O; Keita, M

1996-01-01

From the results obtained regarding the financing of health care in Mali, we emphasize two important points. First, there is a lack of criteria for the distribution of finding in the health care sector, resulting in a waste of resources. Secondly, there is an absence of adequate pharmaceutical policies. The field studies led in 1987 provided the following observations. The rate of occupation of the beds is very low. Also, the numerous new investments are not yet put into service because of the lack of necessary equipment of qualified personnel. In addition, this does not consider the excessive investments occurring in certain localities where neither the rate of frequentation nor the economic conditions will ever allow the use of the capacity created. Among the possible solutions for the crisis of health care funding in Mali, the following should be priority: first, to fight against the complete lack of organization of the activities at the health care centers; secondly, to fight against the waste and misappropriation of money resulting from the behavior of the medical and paramedical personnel: and thirdly, to clarify the management of the resources coming from the charges for each service. The pharmaceutical policies adopted and implemented in recent years Largely contributed to, first, the creation of competition between essential generic medications and nongeneric medications that can be replaced, and then, the destruction of the public network of drug distribution. These conditions considerably limited the distribution of essential medications; yet, this is the only manner of reducing the pharmaceutical expenses and accordingly, allowing more funding for other medical services. As the distribution network is disorganized, the only alternative for the population to obtain the medications at the lowest price was to create centers of purchasing and distribution and to multiply the number of retailers of essential medications. Extensive work has been conducted in the health care sector in Mali, accompanied by concrete proposals allowing for improved functioning of the system. However, despite these improvements, these conclusions are rarely considered by the health policy makers. This is because behind the financial aspects of health services, there is an important political stake. Also, the governments of many countries, including Mali, had to resort to adjustment programs that reduce their maneuverability of economic policies in general, and of health care policies in particular. The sponsors "give" large sums of financial aid to the health care sector, but are not interested in the results. The promotion of the health care sector requires a courageous political will. In contrast, microeconomic studies allowed the creation of the first community health centers in Mali. These examples, now followed in many village throughout Mali, constitute the hope of the health care sector.

Recommendations for safety planning, data collection, evaluation and reporting during drug, biologic and vaccine development: a report of the safety planning, evaluation, and reporting team.

PubMed

Crowe, Brenda J; Xia, H Amy; Berlin, Jesse A; Watson, Douglas J; Shi, Hongliang; Lin, Stephen L; Kuebler, Juergen; Schriver, Robert C; Santanello, Nancy C; Rochester, George; Porter, Jane B; Oster, Manfred; Mehrotra, Devan V; Li, Zhengqing; King, Eileen C; Harpur, Ernest S; Hall, David B

2009-10-01

The Safety Planning, Evaluation and Reporting Team (SPERT) was formed in 2006 by the Pharmaceutical Research and Manufacturers of America. SPERT's goal was to propose a pharmaceutical industry standard for safety planning, data collection, evaluation, and reporting, beginning with planning first-in-human studies and continuing through the planning of the post-product-approval period. SPERT's recommendations are based on our review of relevant literature and on consensus reached in our discussions. An important recommendation is that sponsors create a Program Safety Analysis Plan early in development. We also give recommendations for the planning of repeated, cumulative meta-analyses of the safety data obtained from the studies conducted within the development program. These include clear definitions of adverse events of special interest and standardization of many aspects of data collection and study design. We describe a 3-tier system for signal detection and analysis of adverse events and highlight proposals for reducing "false positive" safety findings. We recommend that sponsors review the aggregated safety data on a regular and ongoing basis throughout the development program, rather than waiting until the time of submission. We recognize that there may be other valid approaches. The proactive approach we advocate has the potential to benefit patients and health care providers by providing more comprehensive safety information at the time of new product marketing and beyond.

Quality of pharmaceutical care at the pharmacy counter: patients' experiences versus video observation.

PubMed

Koster, Ellen S; Blom, Lyda; Overbeeke, Marloes R; Philbert, Daphne; Vervloet, Marcia; Koopman, Laura; van Dijk, Liset

2016-01-01

Consumer Quality Index questionnaires are used to assess quality of care from patients' experiences. To provide insight into the agreement about quality of pharmaceutical care, measured both by a patient questionnaire and video observations. Pharmaceutical encounters in four pharmacies were video-recorded. Patients completed a questionnaire based upon the Consumer Quality Index Pharmaceutical Care after the encounter containing questions about patients' experiences regarding information provision, medication counseling, and pharmacy staff's communication style. An observation protocol was used to code the recorded encounters. Agreement between video observation and patients' experiences was calculated. In total, 109 encounters were included for analysis. For the domains "medication counseling" and "communication style", agreement between patients' experiences and observations was very high (>90%). Less agreement (45%) was found for "information provision", which was rated more positive by patients compared to the observations, especially for the topic, encouragement of patients' questioning behavior. A questionnaire is useful to assess the quality of medication counseling and pharmacy staff's communication style, but might be less suitable to evaluate information provision and pharmacy staff's encouragement of patients' questioning behavior. Although patients may believe that they have received all necessary information to use their new medicine, some information on specific instructions was not addressed during the encounter. When using questionnaires to get insight into information provision, observations of encounters are very informative to validate the patient questionnaires and make necessary adjustments.

How pharmacist-patient communication determines pharmacy loyalty? Modeling relevant factors.

PubMed

Patrícia Antunes, Liliana; Gomes, João José; Cavaco, Afonso Miguel

2015-01-01

Portuguese community pharmacies provide pharmaceutical services, such as therapeutic outcomes follow-up, supplemented by relevant point-of-care testing that require continuity of provision to be effective. To identify factors of technical and communication nature that during a patient interview contribute to patients' loyalty. A cross-sectional descriptive study, with a purposive sample of community pharmacies providing pharmaceutical care, was conducted. Patient interviews were taped and transcribed verbatim. Duration, segments and utterances were identified and time stamped, using a previously validated coding scheme. To identify predictors of loyalty, logistic regression analyses were performed. From 59 interviews, participants' average age was 65.7 years and 42 (71.2%) were female; 45 (76.3%) interviews were classified as outcomes measurements and 14 (23.7%) as pharmaceutical consultations, with 33.2% of the patients booking a following appointment. The significant items to explain loyalty were associated with lifestyle and psychosocial exchange, age of the patient, and the presence of all interview segments (i.e. a complete consultation). Contrary to common professional beliefs and practice orientation it would appear that pharmacists' technical skills are not the essential factors that promote patients' loyalty needed for continuity of care, at least in the same extent as the social and lifestyle-related content of the exchange. Pharmaceutical care education should focus on relational skills as much as on medication-related competencies. Copyright © 2015 Elsevier Inc. All rights reserved.

An ecological perspective on medical care: environmental, occupational, and public health impacts of medical supply and pharmaceutical chains.

PubMed

Vatovec, Christine; Senier, Laura; Bell, Michael

2013-09-01

Healthcare organizations are increasingly examining the impacts of their facilities and operations on the natural environment, their workers, and the broader community, but the ecological impacts of specific healthcare services provided within these institutions have not been assessed. This paper provides a qualitative assessment of healthcare practices that takes into account the life-cycle impacts of a variety of materials used in typical medical care. We conducted an ethnographic study of three medical inpatient units: a conventional cancer ward, palliative care unit, and a hospice center. Participant observations (73 participants) of healthcare and support staff including physicians, nurses, housekeepers, and administrators were made to inventory materials and document practices used in patient care. Semi-structured interviews provided insight into common practices. We identified three major domains that highlight the cumulative environmental, occupational health, and public health impacts of medical supplies and pharmaceuticals used at our research sites: (1) medical supply procurement; (2) generation, handling, and disposal of medical waste; and (3) pharmaceutical handling and disposal. Impacts discovered through ethnographic inquiry included occupational exposures to chemotherapy and infectious waste, and public health exposures to pharmaceutical waste. This study provides new insight into the environmental, occupational, and public health impacts resulting from medical practices. In many cases, the lack of clear guidance and regulations regarding environmental impacts contributed to elevated harms to the natural environment, workers, and the broader community.

76 FR 9028 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-16

... pharmaceutical companies interested in participating in this program to contact CDER. DATES: Pharmaceutical companies may submit proposed agendas to the Agency by April 18, 2011. FOR FURTHER INFORMATION CONTACT: Beth...-Miller (see DATES and FOR FURTHER INFORMATION CONTACT). Dated: February 9, 2011. Leslie Kux, Acting...

77 FR 10538 - Training Program for Regulatory Project Managers; Information Available to Industry

Federal Register 2010, 2011, 2012, 2013, 2014

2012-02-22

... pharmaceutical companies interested in participating in this program to contact CDER. DATES: Pharmaceutical companies may submit proposed agendas to the Agency by April 23, 2012. FOR FURTHER INFORMATION CONTACT: Dan... DATES and FOR FURTHER INFORMATION CONTACT). Dated: February 14, 2012. Leslie Kux, Acting Assistant...

Medication therapy management: its relationship to patient counseling, disease management, and pharmaceutical care.

PubMed

McGivney, Melissa Somma; Meyer, Susan M; Duncan-Hewitt, Wendy; Hall, Deanne L; Goode, Jean-Venable R; Smith, Randall B

2007-01-01

To delineate the relationship, including similarities and differences, between medication therapy management (MTM) and contemporary pharmacist-provided services, including patient counseling, disease management, and pharmaceutical care, to facilitate the continued evolution of commonly used language and a standard of practice across geographic areas and practice environments. Incorporation of MTM services into the array of Medicare-funded services affords an opportunity for pharmacists to develop direct patient care services in the community. Defining the role of MTM within the scope of pharmacist-provided patient care activities, including patient counseling, disease management, and all currently provided pharmacy services is essential to the delineation of a viable and sustainable practice model for pharmacists. The definitions of each of these services are offered, as well as comparisons and contrasts of the individual services. In addition to Medicare-eligible patients, MTM services are appropriate for anyone with medication-related needs. MTM is offered as an all-encompassing model that incorporates the philosophy of pharmaceutical care, techniques of patient counseling, and disease management in an environment that facilitates the direct collaboration of patients, pharmacists, and other health professionals. Defining the role of MTM within the current patient care models, including patient counseling, disease management, and all who provide pharmacy services, is essential in delineating a viable and sustainable practice model for pharmacists.

An Elective Pharmaceutical Care Course to Prepare Students for an Advanced Pharmacy Practice Experience in Kenya

PubMed Central

Miller, Monica L.; Ogallo, William; Pastakia, Sonak D.

2013-01-01

Objective. To develop a prerequisite elective course to prepare students for an advanced pharmacy practice experience (APPE) in Kenya. Design. The course addressed Kenyan culture, travel preparation, patient care, and disease-state management. Instructional formats used were small-group discussions and lectures, including some Web-based presentations by Kenyan pharmacists on disease states commonly treated in Kenya. Cultural activities include instruction in conversational and medical Kiswahili and reading of a novel related to global health programs. Assessment. Student performance was assessed using written care plans, quizzes, reflection papers, a formulary management exercise, and pre- and post-course assessments. Student feedback on course evaluations indicated that the course was well received and students felt prepared for the APPE. Conclusion. This course offered a unique opportunity for students to learn about pharmacy practice in global health and to apply previously acquired skills in a resource-constrained international setting. It prepares students to actively participate in clinical care activities during an international APPE. PMID:23610478

A population-based analysis of incentive payments to primary care physicians for the care of patients with complex disease

PubMed Central

Lavergne, M. Ruth; Law, Michael R.; Peterson, Sandra; Garrison, Scott; Hurley, Jeremiah; Cheng, Lucy; McGrail, Kimberlyn

2016-01-01

Background: In 2007, the province of British Columbia implemented incentive payments to primary care physicians for the provision of comprehensive, continuous, guideline-informed care for patients with 2 or more chronic conditions. We examined the impact of this program on primary care access and continuity, rates of hospital admission and costs. Methods: We analyzed all BC patients who qualified for the incentive based on their diagnostic profile. We tracked primary care contacts and continuity, hospital admissions (total, via the emergency department and for targeted conditions), and cost of physician services, hospital care and pharmaceuticals, for 24 months before and 24 months after the intervention. Results: Of 155 754 eligible patients, 63.7% had at least 1 incentive payment billed. Incentive payments had no impact on primary care contacts (change in contacts per patient per month: 0.016, 95% confidence interval [CI] −0.047 to 0.078) or continuity of care (mean monthly change: 0.012, 95% CI −0.001 to 0.024) and were associated with increased total rates of hospital admission (change in hospital admissions per 1000 patients per month: 1.46, 95% CI 0.04 to 2.89), relative to preintervention trends. Annual costs per patient did not decline (mean change: $455.81, 95% CI −$2.44 to $914.08). Interpretation: British Columbia’s $240-million investment in this program improved compensation for physicians doing the important work of caring for complex patients, but did not appear to improve primary care access or continuity, or constrain resource use elsewhere in the health care system. Policymakers should consider other strategies to improve care for this patient population. PMID:27527484

Incorporating Natural Products, Pharmaceutical Drugs, Self-Care and Digital/Mobile Health Technologies into Molecular-Behavioral Combination Therapies for Chronic Diseases.

PubMed

Bulaj, Grzegorz; Ahern, Margaret M; Kuhn, Alexis; Judkins, Zachary S; Bowen, Randy C; Chen, Yizhe

2016-01-01

Merging pharmaceutical and digital (mobile health, mHealth) ingredients to create new therapies for chronic diseases offers unique opportunities for natural products such as omega-3 polyunsaturated fatty acids (n-3 PUFA), curcumin, resveratrol, theanine, or α-lipoic acid. These compounds, when combined with pharmaceutical drugs, show improved efficacy and safety in preclinical and clinical studies of epilepsy, neuropathic pain, osteoarthritis, depression, schizophrenia, diabetes and cancer. Their additional clinical benefits include reducing levels of TNFα and other inflammatory cytokines. We describe how pleiotropic natural products can be developed as bioactive incentives within the network pharmacology together with pharmaceutical drugs and self-care interventions. Since approximately 50% of chronically-ill patients do not take pharmaceutical drugs as prescribed, psychobehavioral incentives may appeal to patients at risk for medication non-adherence. For epilepsy, the incentive-based network therapy comprises anticonvulsant drugs, antiseizure natural products (n-3 PUFA, curcumin or/and resveratrol) coupled with disease-specific behavioral interventions delivered by mobile medical apps. The add-on combination of antiseizure natural products and mHealth supports patient empowerment and intrinsic motivation by having a choice in self-care behaviors. The incentivized therapies offer opportunities: (1) to improve clinical efficacy and safety of existing drugs, (2) to catalyze patient-centered, disease self-management and behavior-changing habits, also improving health-related quality-of-life after reaching remission, and (3) merging copyrighted mHealth software with natural products, thus establishing an intellectual property protection of medical treatments comprising the natural products existing in public domain and currently promoted as dietary supplements. Taken together, clinical research on synergies between existing drugs and pleiotropic natural products, and their integration with self-care, music and mHealth, expands precision/personalized medicine strategies for chronic diseases via pharmacological-behavioral combination therapies.

Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in Argentina.

PubMed

Mills, Katherine T; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A; He, Jiang

2014-08-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This article summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure [BP], health education for medication adherence and lifestyle modification) conducted by community health workers and a mobile health intervention. The primary outcome is net change in systolic BP from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic BP, BP control and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries.

Comprehensive Approach for Hypertension Control in Low-income Populations: Rationale and Study Design for the Hypertension Control Program in Argentina (HCPIA)

PubMed Central

Mills, Katherine T.; Rubinstein, Adolfo; Irazola, Vilma; Chen, Jing; Beratarrechea, Andrea; Poggio, Rosana; Dolan, Jacquelyn; Augustovski, Federico; Shi, Lizheng; Krousel-Wood, Marie; Bazzano, Lydia A.; He, Jiang

2014-01-01

Although the efficacy and effectiveness of lifestyle modifications and antihypertensive pharmaceutical treatment for the prevention and control of hypertension and concomitant cardiovascular disease have been demonstrated in randomized controlled trials, this scientific knowledge has not been fully applied in the general population, especially in low-income communities. This paper summarizes interventions to improve hypertension management and describes the rationale and study design for a cluster randomized trial testing whether a comprehensive intervention program within a national public primary care system will improve hypertension control among uninsured hypertensive men and women and their families. We will recruit 1,890 adults from 18 clinics within a public primary care network in Argentina. Clinic patients with uncontrolled hypertension, their spouses and hypertensive family members will be enrolled. The comprehensive intervention program targets the primary care system through health care provider education, a home-based intervention among patients and their families (home delivery of antihypertensive medication, self-monitoring of blood pressure, health education for medication adherence and lifestyle modification) conducted by community health workers, and a mobile health intervention. The primary outcome is net change in systolic blood pressure from baseline to month 18 between intervention and control groups among hypertensive study participants. The secondary outcomes are net change in diastolic blood pressure, blood pressure control, and cost-effectiveness of the intervention. This study will generate urgently needed data on effective, practical, and sustainable intervention programs aimed at controlling hypertension and concomitant cardiovascular disease in underserved populations in low- and middle-income countries. PMID:24978148

Pharmaceutical care issues identified by pharmacists in patients with diabetes, hypertension or hyperlipidaemia in primary care settings.

PubMed

Chua, Siew Siang; Kok, Li Ching; Yusof, Faridah Aryani Md; Tang, Guang Hui; Lee, Shaun Wen Huey; Efendie, Benny; Paraidathathu, Thomas

2012-11-12

The roles of pharmacists have evolved from product oriented, dispensing of medications to more patient-focused services such as the provision of pharmaceutical care. Such pharmacy service is also becoming more widely practised in Malaysia but is not well documented. Therefore, this study is warranted to fill this information gap by identifying the types of pharmaceutical care issues (PCIs) encountered by primary care patients with diabetes mellitus, hypertension or hyperlipidaemia in Malaysia. This study was part of a large controlled trial that evaluated the outcomes of multiprofessional collaboration which involved medical general practitioners, pharmacists, dietitians and nurses in managing diabetes mellitus, hypertension and hyperlipidaemia in primary care settings. A total of 477 patients were recruited by 44 general practitioners in the Klang Valley. These patients were counselled by the various healthcare professionals and followed-up for 6 months. Of the 477 participants, 53.7% had at least one PCI, with a total of 706 PCIs. These included drug-use problems (33.3%), insufficient awareness and knowledge about disease condition and medication (20.4%), adverse drug reactions (15.6%), therapeutic failure (13.9%), drug-choice problems (9.5%) and dosing problems (3.4%). Non-adherence to medications topped the list of drug-use problems, followed by incorrect administration of medications. More than half of the PCIs (52%) were classified as probably clinically insignificant, 38.9% with minimal clinical significance, 8.9% as definitely clinically significant and could cause patient harm while one issue (0.2%) was classified as life threatening. The main causes of PCIs were deterioration of disease state which led to failure of therapy, and also presentation of new symptoms or indications. Of the 338 PCIs where changes were recommended by the pharmacist, 87.3% were carried out as recommended. This study demonstrates the importance of pharmacists working in collaboration with other healthcare providers especially the medical doctors in identifying and resolving pharmaceutical care issues to provide optimal care for patients with chronic diseases.

Pharmaceutical care for patients with COPD in Belgium and views on protocol implementation.

PubMed

Tommelein, Eline; Tollenaere, Kathleen; Mehuys, Els; Boussery, Koen

2014-08-01

A protocol-based pharmaceutical care program (the PHARMACOP-protocol) focusing on patient counselling during prescription filling has shown to be effective in patients with chronic obstructive pulmonary disease (COPD). However, implementation of this protocol in daily practice has not yet been studied. To describe current implementation level of the items included in the PHARMACOP-protocol in Belgian community pharmacies and to evaluate pharmacists' perspectives on the implementation of this protocol in daily practice. A cross-sectional study was conducted from April to June 2012, in randomly selected community pharmacies in Flanders. Pharmacists were questionned using structured interviews. 125 pharmacies were contacted and 80 managing pharmacists (64 %) participated. In >70 % of pharmacies, 4/7 protocol items for first prescriptions and 3/5 protocol items for follow-up prescriptions were already routinely implemented. For first and follow-up prescriptions, respectively 39 (49 %) and 34 pharmacists (43 %) stated they would need to spend at least 5 min extra to offer optimal patient counselling. Most mentioned barriers preventing protocol implementation included lack of time (80 %), no integration in pharmacy software (61 %) and too much administrative burden (58 %). Approximately 50 % of the PHARMACOP-protocol items are currently routinely provided in Belgian community pharmacies. Nearly all interviewed pharmacists are willing to implement the protocol fully or partially in daily practice.

PHARMACEUTICALS IN THE ENVIRONMENT: OVERVIEW OF SIGNIFICANCE, CONCERNS, AND SOLUTIONS

EPA Science Inventory

Pharmaceuticals and personal care products (PPCPs) comprise large, diverse arrays of chemicals that can occur in the environment as unregulated pollutants. They originate largely from the combined activities and actions of multitudes of individuals as well as from veterinary and ...

Specialty pharmaceuticals care management in an integrated health care delivery system with electronic health records.

PubMed

Monroe, C Douglas; Chin, Karen Y

2013-05-01

The specialty pharmaceuticals market is expanding more rapidly than the traditional pharmaceuticals market. Specialty pharmacy operations have evolved to deliver selected medications and associated clinical services. The growing role of specialty drugs requires new approaches to managing the use of these drugs. The focus, expectations, and emphasis in specialty drug management in an integrated health care delivery system such as Kaiser Permanente (KP) can vary as compared with more conventional health care systems. The KP Specialty Pharmacy (KP-SP) serves KP members across the United States. This descriptive account addresses the impetus for specialty drug management within KP, the use of tools such as an electronic health record (EHR) system and process management software, the KP-SP approach for specialty pharmacy services, and the emphasis on quality measurement of services provided. Kaiser Permanente's integrated system enables KP-SP pharmacists to coordinate the provision of specialty drugs while monitoring laboratory values, physician visits, and most other relevant elements of the patient's therapy. Process management software facilitates the counseling of patients, promotion of adherence, and interventions to resolve clinical, logistic, or pharmacy benefit issues. The integrated EHR affords KP-SP pharmacists advantages for care management that should become available to more health care systems with broadened adoption of EHRs. The KP-SP experience may help to establish models for clinical pharmacy services as health care systems and information systems become more integrated.

Workforce in the pharmaceutical services of the primary health care of SUS, Brazil

PubMed Central

Carvalho, Marselle Nobre; Álvares, Juliana; Costa, Karen Sarmento; Guerra, Augusto Afonso; Acurcio, Francisco de Assis; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Karnikowski, Margô Gomes de Oliveira; Leite, Silvana Nair

2017-01-01

ABSTRACT OBJECTIVE To characterize the workforce in the pharmaceutical services in the primary care of the Brazilian Unified Health System (SUS). METHODS This is a cross-sectional and quantitative study, with data from the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços, 2015 (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services, 2015). For the analysis, we considered the data stratification into geographical regions. We analyzed the data on workers in the municipal pharmaceutical services management and in the medicine dispensing units, according to the country’s regions. For the statistical association analysis, we carried out a Pearson correlation test for the categorical variables. RESULTS We analyzed 1,175 pharmacies/dispensing units, 507 phone interviews (495 pharmaceutical services coordinators), and 1,139 professionals responsible for medicine delivery. The workforce in pharmaceutical services was mostly constituted by women, aged from 18 to 39 years, with higher education (90.7% in coordination and 45.5% in dispensing units), having permanent employment bonds (public tender), being for more than one year in the position or duty, and with weekly work hours above 30h, working both in municipal management and in medicine dispensing units. We observed regional differences in the workforce composition in dispensing units, with higher percentage of pharmacists in the Southeast and Midwest regions. CONCLUSIONS The professionalization of municipal management posts in primary health care is an achievement in the organization of the workforce in pharmaceutical services. However, significant deficiencies exist in the workforce composition in medicine dispensing units, which may compromise the medicine use quality and its results in population health. PMID:29160455

Pharmaceutical Biotechnology: A New Graduate Course at the University of Florida College of Pharmacy.

ERIC Educational Resources Information Center

Schreier, Hans; And Others

1990-01-01

The University of Florida's efforts to include aspects of genetically engineered drugs into undergraduate teaching and develop a graduate program focusing on the pharmaceutical aspects of technology are outlined, including constituent contributions, attendance, and evaluation. The program's current status and plans for a lab course are discussed.…

Pharmaceutical industry research and cost savings in community-acquired pneumonia.

PubMed

Kessler, Lori A; Waterer, Grant W; Barca, Robin; Wunderink, Richard G

2002-09-01

To provide financial justification for continuing pharmaceutical research in an environment that has met with increasing resistance from insurance carriers to paying for the care of patients enrolled in research studies. Matched case-control study of patients enrolled into inpatient community-acquired pneumonia (CAP) pharmaceutical research protocols. Case patients were enrolled into a CAP pharmaceutical research trial. Control patients were obtained from a prospective cohort study of CAP. Cases were matched to controls on the basis of age, sex, pneumonia severity index (PSI) grade, and comorbid illnesses as measured by the PSI and Acute Physiologic and Chronic Health Evaluation II (APACHE II) scoring systems. Financial data were obtained from hospital billing records. Twenty-five cases were identified and matched to appropriate controls. There was no statistically significant difference in mean PSI and APACHE II scores between cases and controls. There was a significant reduction in the total charges for hospital care of patients enrolled into a pharmaceutical industry trial ($6267 vs $9979; P = .03). As expected, the most dramatic reduction was in pharmacy charges ($642 vs $1797; P = .002), but there were trends toward lower charges in all cost subgroups. Interestingly, there was also a strong trend toward reduced length of hospital stay associated with enrollment in a pharmaceutical trial (4.5 vs 6.0 days; P = .06). Enrollment in a pharmaceutical research protocol results in significant cost savings in patients admitted to the hospital with CAP and may lead to earlier hospital discharge.

Making an impact: an adventure into international pharmacy.

PubMed

Hitch, William; Ransom, Matthew

2009-01-01

To support a medical team, organized by Shoulder to Shoulder, with pharmacy services in an effort to expand ongoing health care to a rural community in Honduras. Pharmacy services in a temporary medical clinic in a schoolhouse in Colomarigua, a small mountain village in Honduras. Pharmacy services and medical care to address acute care needs of the people of Colomarigua, Honduras, during a week-long clinic. Interpreters assisted with patient counseling. Medication labels with pictures that connected doses to mealtimes increased patient understanding and the potential for medications to be dosed correctly. Fill lines were drawn on delivery devices for pediatric suspensions. An effort was made to avoid polypharmacy by communicating with physicians about the different prescriptions that were being prescribed in each household. Not applicable. Not applicable. We created a temporary clinic with a pharmacy and provided medical care to more than 600 children and adults in the surrounding regions. The medical team identified need for a feeding program, and local Shoulder to Shoulder teams began activities to support the community's development. Education programs were initiated to allow promising local children access to higher education. Challenges to providing optimal pharmaceutical care included language barriers, space and flow of the pharmacy, and a limited formulary. Benefits included gaining a whole new perspective on pharmacotherapy, health, and the importance of service to those in need whether abroad or at home.

Private-sector research ethics: marketing or good conflicts management? The 2005 John J. Conley Lecture on Medical Ethics.

PubMed

Dresser, Rebecca

2006-01-01

Pharmaceutical companies are major sponsors of biomedical research. Most scholars and policymakers focus their attention on government and academic oversight activities, however. In this article, I consider the role of pharmaceutical companies' internal ethics statements in guiding decisions about corporate research and development (R&D). I review materials from drug company websites and contributions from the business and medical ethics literature that address ethical responsibilities of businesses in general and pharmaceutical companies in particular. I discuss positive and negative uses of pharmaceutical companies' ethics materials and describe shortcomings in the companies' existing ethics programs. To guide employees and reassure outsiders, companies must add rigor, independence, and transparency to their R&D ethics programs.

PHARMACEUTICALS IN THE ENVIRONMENT: OVERVIEW OF SIGNIFICANCE, CONCERNS AND SOLUTIONS

EPA Science Inventory

Pharmaceuticals and personal care products (PPCPs) comprise a large and diverse array of unregulated pollutants that can occur in the environment from the combined activities and actions of multitudes of individuals as well as from veterinary and agricultural use
(http://epa....

Quality indicators for pharmaceutical care: a comprehensive set with national scores for Dutch community pharmacies.

PubMed

Teichert, Martina; Schoenmakers, Tim; Kylstra, Nico; Mosk, Berend; Bouvy, Marcel L; van de Vaart, Frans; De Smet, Peter A G M; Wensing, Michel

2016-08-01

Background The quality of pharmaceutical care in community pharmacies in the Netherlands has been assessed annually since 2008. The initial set has been further developed with pharmacists and patient organizations, the healthcare inspectorate, the government and health insurance companies. The set over 2012 was the first set of quality indicators for community pharmacies which was validated and supported by all major stakeholders. The aims of this study were to describe the validated set of quality indicators for community pharmacies and to report their scores over 2012. In subanalyses the score development over 5 years was described for those indicators, that have been surveyed before and remained unchanged. Methods Community pharmacists in the Netherlands were invited in 2013 to provide information for the set of 2012. Quality indicators were mapped by categories relevant for pharmaceutical care and defined for structures, processes and dispensing outcomes. Scores for categorically-measured quality indicators were presented as the percentage of pharmacies reporting the presence of a quality aspect. For numerical quality indicators, the mean of all reported scores was expressed. In subanalyses for those indicators that had been questioned previously, scores were collected from earlier measurements for pharmacies providing their scores in 2012. Multilevel analysis was used to assess the consistency of scores within one pharmacy over time by the intra-class correlation coefficient (ICC). Results For the set in 2012, 1739 Dutch community pharmacies (88 % of the total) provided information for 66 quality indicators in 10 categories. Indicator scores on the presence of quality structures showed relatively high quality levels. Scores for processes and dispensing outcomes were lower. Subanalyses showed that overall indicators scores improved within pharmacies, but this development differed between pharmacies. Conclusions A set of validated quality indicators provided insight into the quality of pharmaceutical care in the Netherlands. The quality of pharmaceutical care improved over time. As of 2012 quality structures were present in at least 80 % of the community pharmacies. Variation in scores on care processes and outcomes between individual pharmacies and over time can initiate future research to better understand and facilitate quality improvement in community pharmacies.

[Implementation of bedside training and advanced objective structured clinical examination (OSCE) trial to learn and confirm about pharmacy clinical skills].

PubMed

Tokunaga, Jin; Takamura, Norito; Ogata, Kenji; Setoguchi, Nao; Sato, Keizo

2013-01-01

Bedside training for fourth-year students, as well as seminars in hospital pharmacy (vital sign seminars) for fifth-year students at the Department of Pharmacy of Kyushu University of Health and Welfare have been implemented using patient training models and various patient simulators. The introduction of simulation-based pharmaceutical education, where no patients are present, promotes visually, aurally, and tactilely simulated learning regarding the evaluation of vital signs and implementation of physical assessment when disease symptoms are present or adverse effects occur. A patient simulator also promotes the creation of training programs for emergency and critical care, with which basic as well as advanced life support can be practiced. In addition, an advanced objective structured clinical examination (OSCE) trial has been implemented to evaluate skills regarding vital signs and physical assessments. Pharmacists are required to examine vital signs and conduct physical assessment from a pharmaceutical point of view. The introduction of these pharmacy clinical skills will improve the efficacy of drugs, work for the prevention or early detection of adverse effects, and promote the appropriate use of drugs. It is considered that simulation-based pharmaceutical education is essential to understand physical assessment, and such education will ideally be applied and developed according to on-site practices.

A guide to understanding and implementing risk evaluation and mitigation strategies in organ transplantation.

PubMed

Gabardi, Steven; Tichy, Eric M

2013-03-01

To review the components of the Congressional mandate for risk evaluation and mitigation strategies (REMS) managed by the Food and Drug Administration and assess their impact on health care providers practicing within the organ transplant arena. A non-date-limited search of MEDLINE and EMBASE (January 2007-June 2012) was conducted by using the following search terms: risk evaluation and mitigation strategies, REMS, and organ transplant, including a query of the individual organs. Information from the Federal Register and the Food and Drug Administration was also evaluated. REMS are strategies implemented to manage known or potential risks associated with medications and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product. Elements of REMS programs may consist of 3 levels: a medication guide, communication plan, and elements to assure safe use. A medication guide is used to help prevent serious adverse events, aid in patients' decision making, and enhance medication adherence. Communication plans help educate health care providers and encourage adherence with REMS. The elements to assure safe use is a restrictive process implemented when it is deemed necessary to ensure safe access for patients to products with known serious risks. In transplant medicine, REMS currently exist for belatacept (medication guide and communication plan) and the mycophenolic acid derivatives (medication guide and elements to assure safe use). REMS are another step in the evolution of the development and marketing of pharmaceutical agents. Use of REMS in solid-organ transplant is becoming common. Transplant clinicians must provide required patient education and become involved with other aspects of REMS implementation to reduce the serious risks of pharmaceuticals and to improve patients' outcomes.

Understanding risk evaluation and mitigation strategies in organ transplantation.

PubMed

Gabardi, Steven

2011-07-01

The United States Food and Drug Administration (FDA) Amendments Act of 2007 mandated that Risk Evaluation and Mitigation Strategies (REMS) be required of manufacturers. These REMS are strategies implemented to manage known or potential risks associated with drugs and to ensure ongoing pharmacovigilance throughout the life of a pharmaceutical product, including once the product becomes available as generic. The elements of an individual REMS program consist of three levels: medication guide or patient package insert, communication plan, and elements to assure safe use (ETASU). A medication guide or patient package insert is used to help prevent serious adverse events, aid in patient decision making, and enhance drug adherence. Communication plans are used to educate health care providers and to encourage their compliance with REMS. The ETASU is a restrictive process that is implemented when it is deemed necessary to ensure that patients have safe access to products with known serious risks that would otherwise be unavailable. To review the components of REMS and specifically assess their impact on health care providers practicing within the organ transplantation arena, a literature search of the MEDLINE database (January 2007-December 2010) was performed, and published materials from the FDA and its Web site were also reviewed. In transplantation, REMS programs exist for both everolimus (medication guide and communication plan) and sirolimus (medication guide). The FDA has stated that all mycophenolic acid derivatives will be subject to a proposed REMS that has not yet been approved; however, both branded mycophenolic acid agents already have approved medication guides. The REMS are a permanent fixture in the development and marketing of pharmaceutical agents, and their further implementation in solid organ transplantation is inevitable. Transplantation providers should take a proactive role in patient education and implementation of REMS within the therapeutic area. It is imperative for health care providers to realize that the ultimate goals of REMS are to reduce the potential for serious risks and to make outcomes from the treatment of disease more predictable.

Ethics and the pharmaceutical industry.

PubMed

Green, Stephen

2008-06-01

Relationships between the pharmaceutical industry and the medical profession enhance the potential for physicians to become involved in conflicts of interest. Whether or not these rise to a level that violates standards of medical ethics depends on the degree to which they detract from the quality of health care and its cost, the objectivity of research, and the profession's integrity. This paper explores those issues from two perspectives--the micro-level of the medical profession and the macro-level of society. Practices and policies that affect varied aspects of the interaction between the pharmaceutical industry and the medical profession--such as education, research and marketing--are discussed. The reader is asked to reflect on the ethics of issues raised; the author offers suggestions for mitigating conflicts of interest and, in turn, the potential for unethical medical care.

76 FR 44956 - Solicitation for a Cooperative Agreement; Correctional Health Care Executive Curriculum Development

Federal Register 2010, 2011, 2012, 2013, 2014

2011-07-27

...; Correctional Health Care Executive Curriculum Development AGENCY: U.S. Department of Justice, National... competency- based correctional health care executive curriculum to train two-person teams comprised of a..., pharmaceutical, radiographic, infection control, long-term care, restorative therapy, health information...

Quality of pharmaceutical care at the pharmacy counter: patients’ experiences versus video observation

PubMed Central

Koster, Ellen S; Blom, Lyda; Overbeeke, Marloes R; Philbert, Daphne; Vervloet, Marcia; Koopman, Laura; van Dijk, Liset

2016-01-01

Introduction Consumer Quality Index questionnaires are used to assess quality of care from patients’ experiences. Objective To provide insight into the agreement about quality of pharmaceutical care, measured both by a patient questionnaire and video observations. Methods Pharmaceutical encounters in four pharmacies were video-recorded. Patients completed a questionnaire based upon the Consumer Quality Index Pharmaceutical Care after the encounter containing questions about patients’ experiences regarding information provision, medication counseling, and pharmacy staff’s communication style. An observation protocol was used to code the recorded encounters. Agreement between video observation and patients’ experiences was calculated. Results In total, 109 encounters were included for analysis. For the domains “medication counseling” and “communication style”, agreement between patients’ experiences and observations was very high (>90%). Less agreement (45%) was found for “information provision”, which was rated more positive by patients compared to the observations, especially for the topic, encouragement of patients’ questioning behavior. Conclusion A questionnaire is useful to assess the quality of medication counseling and pharmacy staff’s communication style, but might be less suitable to evaluate information provision and pharmacy staff’s encouragement of patients’ questioning behavior. Although patients may believe that they have received all necessary information to use their new medicine, some information on specific instructions was not addressed during the encounter. When using questionnaires to get insight into information provision, observations of encounters are very informative to validate the patient questionnaires and make necessary adjustments. PMID:27042025

Strengthening pharmaceutical systems for palliative care services in resource limited settings: piloting a mHealth application across a rural and urban setting in Uganda.

PubMed

Namisango, Eve; Ntege, Chris; Luyirika, Emmanuel B K; Kiyange, Fatia; Allsop, Matthew J

2016-02-19

Medicine availability is improving in sub-Saharan Africa for palliative care services. There is a need to develop strong and sustainable pharmaceutical systems to enhance the proper management of palliative care medicines, some of which are controlled. One approach to addressing these needs is the use of mobile technology to support data capture, storage and retrieval. Utilizing mobile technology in healthcare (mHealth) has recently been highlighted as an approach to enhancing palliative care services but development is at an early stage. An electronic application was implemented as part of palliative care services at two settings in Uganda; a rural hospital and an urban hospice. Measures of the completeness of data capture, time efficiency of activities and medicines stock and waste management were taken pre- and post-implementation to identify changes to practice arising from the introduction of the application. Improvements in all measures were identified at both sites. The application supported the registration and management of 455 patients and a total of 565 consultations. Improvements in both time efficiency and medicines management were noted. Time taken to collect and report pharmaceuticals data was reduced from 7 days to 30 min and 10 days to 1 h at the urban hospice and rural hospital respectively. Stock expiration reduced from 3 to 0.5% at the urban hospice and from 58 to 0% at the rural hospital. Additional observations relating to the use of the application across the two sites are reported. A mHealth approach adopted in this study was shown to improve existing processes for patient record management, pharmacy forecasting and supply planning, procurement, and distribution of essential health commodities for palliative care services. An important next step will be to identify where and how such mHealth approaches can be implemented more widely to improve pharmaceutical systems for palliative care services in resource limited settings.

Psychiatric Training Program Engagement with the Pharmaceutical Industry: An Educational Issue, Not Strictly an Ethical One

ERIC Educational Resources Information Center

Mohl, Paul C.

2005-01-01

OBJECTIVE: To analyze the educational and ethical issues involved in interactions between departments of psychiatry and the pharmaceutical industry. METHODS: The author analyzes the history of attitudes toward pharmaceutical companies, various conflicting ethical principles that apply, and areas of confluence and conflict of interest between…

[Effect of Environmental Factors on the Ecotoxicity of Pharmaceuticals and Personal Care Products].

PubMed

Sugihara, Kazumi

2018-01-01

　In recent years, pharmaceuticals and personal care products (PPCPs) have emerged as significant pollutants of aquatic environments and have been detected at levels in the range of ng/L to μg/L. The source of PPCPs is humans and livestock that have been administered pharmaceuticals and subsequently excreted them via urine and feces. Unlike agricultural chemicals, the environmental dynamics of PPCPs is not examined and they would undergo structural transformation by environmental factors, e.g., sunlight, microorganisms and treatments in sewage treatment plants (STPs). Processing at STPs can remove various PPCPs; however, they are not removed completely and some persist in the effluents. In this study, we examined the degradation of 9 pharmaceuticals (acetaminophen, amiodarone, dapsone, dexamethasone, indomethacin, raloxifene, phenytoin, naproxen, and sulindac) by sunlight or UV, and investigated the ecotoxicological variation of degradation products. Sunlight (UVA and UVB) degraded most pharmaceuticals, except acetaminophen and phenytoin. Similar results were obtained with UVB and UVA. All the pharmaceuticals were photodegraded by UVC, which is used for sterilization in STPs. Ecotoxicity assay using the luminescent bacteria test (ISO11348) indicated that UVC irradiation increased the toxicity of acetaminophen and phenytoin significantly. The photodegraded product of acetaminophen was identified as 1-(2-amino-5-hydroxyphenyl)ethanone and that of phenytoin as benzophenone, and the authentic compounds showed high toxicity. Photodegraded products of PPCPs are a concern in ecotoxicology.

An explanatory model for state Medicaid per capita prescription drug expenditures.

PubMed

Roy, Sanjoy; Madhavan, S Suresh

2012-01-01

Rising prescription drug expenditure is a growing concern for publicly funded drug benefit programs like Medicaid. To be able to contain drug expenditures in Medicaid, it is important that cause(s) for such increases are identified. This study attempts to establish an explanatory model for Medicaid prescription drugs expenditure based on the impacts of key influencers/predictors identified using a comprehensive framework of drug utilization. A modified Andersen's behavior model of health services utilization is employed to identify potential determinants of pharmaceutical expenditures in state Medicaid programs. Level of federal matching funds, access to primary care, severity of diseases, unemployment, and education levels were found to be key influencers of Medicaid prescription drug expenditure. Increases in all, except education levels, were found to result in increases in drug expenditures. Findings from this study could better inform intervention policies and cost-containment strategies for state Medicaid drug benefit programs.

Asynchronous Training in Pharmaceutical Manufacturing: A Model for University and Industrial Collaboration

ERIC Educational Resources Information Center

Elliot, Norbert; Haggerty, Blake; Foster, Mary; Spak, Gale

2008-01-01

The present study documents the results of a 17-month program to train Cardinal Health Pharmaceutical Technology Services (PTS) employees in an innovative model that combines investigative and writing techniques. Designed to address the Code of Federal Regulations (CFR) for the United States Food and Drug Administration (FDA), the program is a…

Farmácia Popular Program: pharmaceutical market analysis of antihypertensive acting on the renin-angiotensin system medicines.

PubMed

Silva, Rondineli Mendes da; Chaves, Gabriela Costa; Chaves, Luisa Arueira; Campos, Mônica Rodrigues; Luiza, Vera Lucia; Bertoldi, Andréa Dâmaso; Ross-Degnan, Dennis; Emmerick, Isabel Cristina Martins

2017-08-01

This paper aims to analyse changes in the retail pharmaceutical market following policy changes in the Farmácia Popular Program (FP), a medicines subsidy program in Brazil. The retrospective longitudinal analyses focus on therapeutic class of agents acting on the renin-angiotensin system. Data obtained from QuintilesIMS (formerly IMS Health) included private retail pharmacy sales volume (pharmaceutical units) and sales values from 2002 to 2013. Analyses evaluated changes in market share following key FP policy changes. The therapeutic class was selected due to its relevance to hypertension treatment. Market share was analysed by therapeutic sub-classes and by individual company. Losartan as a single product accounted for the highest market share among angiotensin II antagonists. National companies had higher sales volume during the study period, while multinational companies had higher sales value. Changes in pharmaceutical market share coincided with the inclusion of specific products in the list of medicines covered by FP and with increases in or exemption from patient copayment.

A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran.

PubMed

Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Ebadifard Azar, Farbod; Nabilo, Bahram; Abolghasem Gorji, Hassan; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

2015-04-23

Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world's greatest businesses. The aim of this study was to analyze Iran's comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran's trade in this field. To identify Iran's comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran's intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran's Customs Administration, Iran's pharmaceutical Statistics, World Bank and International Trade Center. The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world's total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran's pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran's intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade.

[Globalization and its impact on pharmacy services in the Slovak Republic].

PubMed

Malovecká, Ivona; Minarovič, Igor; Mináriková, Daniela; Lehocká, Lubica; Snopková, Miroslava; Foltán, Viliam

2014-02-01

Public pharmacies are excellent medical facilities having the largest number of contacts with patients. They are the facilities of the first and last contact with the health care system for the patient. Public pharmacies are unique and easily accessible places in the health care system with a high proficiency in the provision of pharmaceutical care and highly qualified medical staff. The aim of this paper was to determine geographical-demographic situation, the legal form of the ownership of public pharmacies, and the owner share of pharmacists on the capital of public pharmacies in Slovakia. The number on of providers of pharmaceutical care depends on the population at the level of regions, districts, towns and villages with differing tightness of binding. The most common legal form of the provider of pharmaceutical care in Slovakia in public pharmacies were limited companies with 73.6% share, a sole proprietor - pharmacist had 23.9%, and public limited companies had 1.3%. In the branches of public pharmacies the limited companies had 73.4% share, a sole proprietor - pharmacist had 26%, public limited companies had 1%. The owner share of the pharmacist on the capital in public pharmacies was 50.4%, and in the branches of public pharmacies it was 66%, owned by a sole proprietor or limited company.

High resource utilization in liver transplantation-how strongly differ costs between the care sectors and what are the main cost drivers?: a retrospective study.

PubMed

Harries, Lena; Schrem, Harald; Stahmeyer, Jona T; Krauth, Christian; Amelung, Volker E

2017-06-01

To control treatment pathways of transplant patients across healthcare sectors, a profound knowledge of the underlying cost structure is necessary. The aim of this study was to analyze the resource utilization of patients undergoing liver transplantation. Data on resource utilization for 182 liver-transplanted patients was investigated retrospectively. The observational period started with the entry on the waiting list and ended up to 3 years after transplantation. Median treatment cost was 144 424€. During waiting time, median costs amounted to 9466€; 72% of costs were attributed to inpatient care, 3% to outpatient care, and 26% to pharmaceuticals. During the first year after transplantation, median costs of 105 566€ were calculated; 83% were allocated for inpatient and 1% outpatient care, 14% for drugs, and 1% for rehabilitative care. During follow-up after the first year of transplantation, median costs amounted to 20 115€; 75% of these were caused by pharmaceuticals, 21% by inpatient, 4% by outpatient, and <1% by rehabilitative services. Subgroup analyses (e.g., for labMELD scores) were done. Costs incurred by inpatient care and pharmaceuticals are the dominating cost factors. These findings encourage a debate on challenges and improvements for cost-efficient clinical management between different healthcare sectors. © 2017 Steunstichting ESOT.

Investigating Research Gaps of Pharmaceutical take back Events: An Analysis of take back Program Participants' Socioeconomic, Demographic, and Geographic Characteristics and the Public Health Benefits of take back Programs

NASA Astrophysics Data System (ADS)

Stoddard, K. I.; Hodge, V.; Maxey, G.; Tiwari, C.; Cready, C.; Huggett, D. B.

2017-06-01

Research continues to show that pharmaceutical environmental contamination causes adverse effects to aquatic life. There are also public health risks associated with pharmaceuticals because in-home reserves of medications provide opportunities for accidental poisoning and intentional medication abuse. Pharmaceutical take back programs have been seen as a potential remedy for these issues; however, a thorough review of past programs indicates limited research has been conducted on take back programs. Furthermore, there are significant gaps in take back program research. To address these gaps and ultimately determine if take back programs could improve public health, research was conducted in conjunction with the take back program Denton drug disposal days held in Denton, Texas. Socioeconomic, demographic, and geographic characteristics of Denton drug disposal days participants were investigated using surveys and Geographic Information Systems. Potential impacts of the Denton drug disposal days program on public health were determined by comparing data from Denton drug disposal days events with data supplied by the North Texas Poison Center. Results suggest that Denton drug disposal days events may have prevented accidental poisonings or intentional abuse, however only qualitative comparisons support this statement and there was insufficient empirical evidence to support the conclusion that Denton drug disposal days events were exclusively responsible for public health improvements. An interesting finding was that there was a definitive travel threshold that influenced participation in Denton drug disposal days events. Overall, this study fills some geographic, socioeconomic, and demographic data gaps of take back programs and proposes methods to analyze and improve participation in future take back programs. These methods could also be applied to improve participation in other local environmentally-focused programs such as household hazardous collection events.

Investigating Research Gaps of Pharmaceutical take back Events: An Analysis of take back Program Participants' Socioeconomic, Demographic, and Geographic Characteristics and the Public Health Benefits of take back Programs.

PubMed

Stoddard, K I; Hodge, V; Maxey, G; Tiwari, C; Cready, C; Huggett, D B

2017-06-01

Research continues to show that pharmaceutical environmental contamination causes adverse effects to aquatic life. There are also public health risks associated with pharmaceuticals because in-home reserves of medications provide opportunities for accidental poisoning and intentional medication abuse. Pharmaceutical take back programs have been seen as a potential remedy for these issues; however, a thorough review of past programs indicates limited research has been conducted on take back programs. Furthermore, there are significant gaps in take back program research. To address these gaps and ultimately determine if take back programs could improve public health, research was conducted in conjunction with the take back program Denton drug disposal days held in Denton, Texas. Socioeconomic, demographic, and geographic characteristics of Denton drug disposal days participants were investigated using surveys and Geographic Information Systems. Potential impacts of the Denton drug disposal days program on public health were determined by comparing data from Denton drug disposal days events with data supplied by the North Texas Poison Center. Results suggest that Denton drug disposal days events may have prevented accidental poisonings or intentional abuse, however only qualitative comparisons support this statement and there was insufficient empirical evidence to support the conclusion that Denton drug disposal days events were exclusively responsible for public health improvements. An interesting finding was that there was a definitive travel threshold that influenced participation in Denton drug disposal days events. Overall, this study fills some geographic, socioeconomic, and demographic data gaps of take back programs and proposes methods to analyze and improve participation in future take back programs. These methods could also be applied to improve participation in other local environmentally-focused programs such as household hazardous collection events.

Pharmaceutical Technology Clerkship: A Professional Elective Course at the University of Kentucky

ERIC Educational Resources Information Center

Im, Sophann; DeLuca, Patrick P.

1978-01-01

Three objectives are described: (1) teach methods for applying the principles of pharmaceutical technology to institutional services involving drug safety, efficacy, and administration; (2) develop student skills in drug-delivery systems within hospitals; and (3) encourage technology application within a clinical setting for better patient care.…

Environmental stewardship practices of veterinary professionals and educators related to use and disposal of pharmaceuticals and personal care products.

PubMed

Lam, Jennifer; Chan, Samuel S; Conway, Flaxen D L; Stone, David

2018-03-01

OBJECTIVE To document the environmental stewardship practices (decisions and actions regarding use and disposal) of pet and human pharmaceuticals and personal care products (PPCPs) among pet-owning veterinary-care professionals (practicing veterinarians, veterinary students, and veterinary technicians and trainees) and environmental educators. DESIGN Internet-based cross-sectional survey. SAMPLE 191 pet owners (103 veterinary-care professionals and 88 environmental educators). PROCEDURES Study participants were recruited by means of a 2-part internet survey distributed to veterinary-care professional and environmental educator networks of individuals residing in Washington state, Oregon, and southern California. Survey questions addressed motivators for environmental stewardship practices (ie, decisions and actions regarding use and disposal of pet and human PPCPs). RESULTS Data were collected from 191 respondents; the response rate for individuals who self-selected to opt in was 78% (191/246). Of the 191 respondents, 42 (22%) stored pet pharmaceuticals indefinitely. The most common disposal method was the garbage (88/191 [46%]). Veterinary-care professionals counseled clients infrequently regarding environmental stewardship practices for PPCPs. Fifty-five percent (105/191) of all respondents preferred more environmentally friendly and clinically effective PPCPs. CONCLUSIONS AND CLINICAL RELEVANCE Results of the present survey emphasized the urgent need for improved educational resources to minimize environmental contamination from improper disposal of PPCPs. Environmental and economic motivations among pet owners in the veterinary-care and education professions indicate further opportunities for outreach and institutional support.

Intelligent MONitoring System for antiviral pharmacotherapy in patients with chronic hepatitis C (SiMON-VC).

PubMed

Margusino-Framiñán, Luis; Cid-Silva, Purificación; Mena-de-Cea, Álvaro; Sanclaudio-Luhía, Ana Isabel; Castro-Castro, José Antonio; Vázquez-González, Guillermo; Martín-Herranz, Isabel

2017-01-01

Two out of six strategic axes of pharmaceutical care in our hospital are quality and safety of care, and the incorporation of information technologies. Based on this, an information system was developed in the outpatient setting for pharmaceutical care of patients with chronic hepatitis C, SiMON-VC, which would improve the quality and safety of their pharmacotherapy. The objective of this paper is to describe requirements, structure and features of Si- MON-VC. Requirements demanded were that the information system would enter automatically all critical data from electronic clinical records at each of the visits to the Outpatient Pharmacy Unit, allowing the generation of events and alerts, documenting the pharmaceutical care provided, and allowing the use of data for research purposes. In order to meet these requirements, 5 sections were structured for each patient in SiMON-VC: Main Record, Events, Notes, Monitoring Graphs and Tables, and Follow-up. Each section presents a number of tabs with those coded data needed to monitor patients in the outpatient unit. The system automatically generates alerts for assisted prescription validation, efficacy and safety of using antivirals for the treatment of this disease. It features a completely versatile Indicator Control Panel, where temporary monitoring standards and alerts can be set. It allows the generation of reports, and their export to the electronic clinical record. It also allows data to be exported to the usual operating systems, through Big Data and Business Intelligence. Summing up, we can state that SiMON-VC improves the quality of pharmaceutical care provided in the outpatient pharmacy unit to patients with chronic hepatitis C, increasing the safety of antiviral therapy. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Developing the Care in Pharmaceutical Care.

ERIC Educational Resources Information Center

Fjortoft, Nancy F.; Zgarrick, David P.

The purpose of this study was to assess the level of caring ability of a sample of pharmacy students and assess the relationship between selected predictor variables and pharmacy students' caring ability. Caring was viewed as the ability to assume responsibility for the protection and welfare of another without being perfunctory or begrudging.…

A Medical Outreach Elective Course

PubMed Central

Storer, Amanda; Caldwell, David; Smith, Jennifer

2013-01-01

Objective. To design and implement a Medical Outreach Experience elective course and assess its impact on students’ level of confidence in organizing future medical outreach trips, providing population-specific pharmaceutical care, and achieving learning outcomes. Design. A 2-credit hour elective course was designed for second- and third-year pharmacy students. The course was structured to include 3 sections over 1 semester, a 10-week training and preparation phase, followed by a weeklong international outreach experience and post-outreach reflection. Assessment. Student achievement of curricular outcomes was measured using in-class activities, readings, reflections, and longitudinal projects, as well as performance during the outreach trip. Results from pre- and post-course surveys demonstrated significant improvement in student-rated confidence in several components of outreach trip organization and provision of pharmaceutical care. Conclusions. Students completing the course exhibited increased confidence in their abilities to organize and practice on a medical outreach trip. All students met the learning outcomes of the course, which included providing comprehensive patient-specific pharmaceutical care, communicating effectively, promoting health improvement and self-care, thinking critically, and appropriately managing and using resources of the healthcare system. Students agreed that the elective course was a valuable addition to the curriculum. PMID:23716746

[Function and structure of the Federal Joint Committee and the Institute for Quality and Efficiency in Health Care in consideration of patient involvement].

PubMed

Mühlbauer, V; Teupen, S

2014-01-01

The Federal Joint Committee and the Institute for Quality and Efficiency in Health Care have become important players in the German health care system, not only since the benefit assessment of pharmaceuticals and the Act on the Reform of the Market for Medicinal Products (AMNOG) were established. However, the manifold tasks and duties these institutions have besides the benefit assessment of pharmaceuticals is less known, just as the role the patient's representatives play. The function and structure of the Federal Joint Committee and the Institute for Quality and Efficiency in Health Care as well as their collaboration in consideration of patient involvement will be explained in this article. © Georg Thieme Verlag KG Stuttgart · New York.

The role of health technology assessment on pharmaceutical reimbursement in selected middle-income countries.

PubMed

Oortwijn, Wija; Mathijssen, Judith; Banta, David

2010-05-01

Middle-income countries are often referred to as developing or emerging economies and face multiple challenges of severe financial stresses in their health care sectors, and high disease burden. The objective of this study is to provide an overview of how health technology assessment (HTA) is used and organized in selected middle-income countries and its role in the process of pharmaceutical coverage. We selected middle-income countries where HTA activities are evident: Argentina, Brazil, China, Colombia, Israel, Mexico, Philippines, Korea, Taiwan, Thailand, and Turkey. We collected and reviewed relevant information to describe the health care and reimbursement systems and how HTA relates to coverage decision-making of pharmaceuticals. This was supplemented by information from a structured survey among professionals working in public and private health insurance, industry, regulatory authorities, ministries of health, academic units or HTA. All countries require market authorization for pharmaceuticals to be sold and most countries have a national plan defining which pharmaceuticals can be reimbursed. However, the use of HTA in reimbursement decisions is still in its early stages with varying levels of HTA guidance implementation. The study provides evidence of the development of HTA in coverage decision-making in middle-income countries. Increased health care spending and the resulting access to modern technology give a strong impetus to HTA. However, HTA is developing with uneven speed in middle-income countries and many countries are building on the organisational and methodological experience from established HTA agencies. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

Brightening up: the effect of the Physician Payment Sunshine Act on existing regulation of pharmaceutical marketing.

PubMed

Gorlach, Igor; Pham-Kanter, Genevieve

2013-01-01

With the passage of the Physician Payment Sunshine Act as part of the federal health care reform law, pharmaceutical manufacturers are now required to disclose a wide range of payments made by manufacturers to physicians. We review current state regulation of pharmaceutical marketing and consider how the federal sunshine provision will affect existing marketing regulation. We analyze the legal and practical implications of the Physician Payment Sunshine Act. © 2013 American Society of Law, Medicine & Ethics, Inc.

Pharmaceutical new product development: the increasing role of in-licensing.

PubMed

Edwards, Nancy V

2008-12-01

Many pharmaceutical companies are facing a pipeline gap because of the increasing economic burden and uncertainty associated with internal research and development programs designed to develop new pharmaceutical products. To fill this pipeline gap, pharmaceutical companies are increasingly relying on in-licensing opportunities. New business development identifies new pharmaceuticals that satisfy unmet needs and are a good strategic fit for the company, completes valuation models and forecasts, evaluates the ability of the company to develop and launch products, and pursues in-licensing agreements for pharmaceuticals that cannot be developed internally on a timely basis. These agreements involve the transfer of access rights for patents, trademarks, or similar intellectual property from an outside company in exchange for payments. Despite the risks, in-licensing is increasingly becoming the preferred method for pharmaceutical companies with pipeline gaps to bring new pharmaceuticals to the clinician.

Cooperative research and development opportunities with the National Cancer Institute

NASA Technical Reports Server (NTRS)

Sybert, Kathleen

1991-01-01

The Office of Technology Development (OTD) of the National Cancer Institute (NCI) is responsible for negotiating Cooperative Research and Development Agreements (CRADAs), whereby the knowledge resulting from NCI investigators' government-sponsored research is developed in collaboration with universities and/or industry into new products of importance for the diagnosis and treatment of cancer and acquired immunodeficiency syndrome (AIDS). The NCI has recently executed a unique 'clinical trials' CRADA and is developing a model agreement based upon it for the development and commercialization of products for the diagnosis and treatment of cancer and AIDS. NCI drug screening, preclinical testing, clinical trials, and AIDS program capabilities form the basis for this new technology development/technology transfer vehicle. NCI's extensive drug screening program and 'designer foods' program serve as potential sources of investigational new drugs (INDs) and cancer preventatives. Collaborations between NCI and pharmaceutical companies having the facilities, experience, and expertise necessary to develop INDs into approved drugs available to the public are being encouraged where the companies have proprietary rights to INDs, or where NCI has proprietary rights to INDs and invites companies to respond to a collaborator announcement published in the Federal Register. The joint efforts of the NCI and the chosen collaborator are designed to generate the data necessary to obtain pharmaceutic regulatory approval from the Food and Drug Administration (FDA) to market the drugs developed, and thereby make them available to health care providers for the diagnosis and treatment of cancer and AIDS.

Nonimaging detectors in drug development and approval.

PubMed

Wagner, H N

2001-07-01

Regulatory applications for imaging biomarkers will expand in proportion to the validation of specific parameters as they apply to individual questions in the management of disease. This validation is likely to be applicable only to a particular class of drug or a single mechanism of action. Awareness among the world's regulatory authorities of the potential for these emerging technologies is high, but so is the cost to the sponsor (including the logistics of including images in a dossier), and therefore the pharmaceutical industry must evaluate carefully the potential benefit of each technology for its drug development programs, just as the authorities must consider carefully the extent to which the method is valid for the use to which the applicant has put it. For well-characterized tracer systems, it may be possible to design inexpensive cameras that make rapid assessments.

Comprehension by older people of medication information with or without supplementary pharmaceutical pictograms.

PubMed

Ng, Annie W Y; Chan, Alan H S; Ho, Vincy W S

2017-01-01

This study examined the benefits of pharmaceutical pictograms for improving comprehension of medication information for older people. Fifty Hong Kong Chinese older people completed a medical information comprehension task for five drugs. Participants in the control group were presented with text labels while those in the experimental group were given the text labels plus supplementary pharmaceutical pictograms, and then all reported their understanding of the medication information conveyed. Lower educated older people had poorer understanding of medication information. The addition of pharmaceutical pictograms significantly improved the comprehension of medication information for older people. The majority of older people tested with pictograms favored adding pictograms to text and thought the pictograms were useful for conveying medical information rather than using written text alone. The findings suggested that pharmaceutical and health care professionals should include pharmaceutical pictograms on labels to better convey instructions on medication to older people. Copyright © 2016 Elsevier Ltd. All rights reserved.

Individual capacity-building approaches in a global pharmaceutical systems strengthening program: a selected review.

PubMed

Konduri, Niranjan; Rauscher, Megan; Wang, Shiou-Chu Judy; Malpica-Llanos, Tanya

2017-01-01

Medicines use related challenges such as inadequate adherence, high levels of antimicrobial resistance and preventable adverse drug reactions have underscored the need to incorporate pharmaceutical services to help achieve desired treatment outcomes, and protect patients from inappropriate use of medicines. This situation is further constrained by insufficient numbers of pharmaceutical personnel and inappropriate skill mix. Studies have addressed individual capacity building approaches of logistics, supply chain or disease specific interventions but few have documented those involving such pharmacy assistants/professionals, or health workers/professionals charged with improving access and provision of pharmaceutical services. We examined how different training modalities have been employed and adapted to meet country-specific context and needs by a global pharmaceutical systems strengthening program in collaboration with a country's Ministry of Health and local stakeholders. Structured, content analysis of training approaches from twelve selected countries and a survey among conveniently selected trainees in Bangladesh and Ethiopia. Case-based learning, practice and feedback, and repetitive interventions such as post-training action plan, supportive supervision and mentoring approaches are effective, evidence-based training techniques. In Ethiopia and Bangladesh, over 94% of respondents indicated that they have improved or developed skills or competencies as a result of the program's training activities. Supportive supervision structures and mentorship have been institutionalized with appropriate management structures. National authorities have been sensitized to secure funding from domestic resources or from the global fund grants for post-training follow-up initiatives. The Pharmaceutical Leadership Development Program is an effective, case-based training modality that motivates staff to develop quality-improvement interventions and solve specific challenges. Peer-to-peer learning mechanisms than traditional didactic methods was a preferred intervention among high level government officials both within country and between countries. Interventions must involve local institutions in the design and delivery of content for both pre-service and in-service training as well as web-based methods where feasible. Such efforts would meet the changing demand in the pharmaceutical system, and promote the ownership of the human capacity development interventions. The cost-effective partnership with universities demonstrate that competency based pre-service training will prepare the future pharmaceutical workforce with a critical foundation of knowledge and skills required to meet the growing demand for patient-centered pharmaceutical services in resource-constrained countries.

Hypnosis: Adjunct Therapy for Cancer Pain Management

PubMed Central

Kravits, Kathy

2013-01-01

Pain is a symptom associated with prolonged recovery from illness and procedures, decreased quality of life, and increased health-care costs. While there have been advances in the management of cancer pain, there is a need for therapeutic strategies that complement pharmaceutical management without significantly contributing to the side-effect profile of these agents. Hypnosis provides a safe and efficacious supplement to pharmaceutical management of cancer pain. One barrier to the regular use of hypnosis is health-care providers’ lack of current knowledge of the efficacy and safety of hypnosis. Advanced practitioners who are well-informed about hypnosis have an opportunity to increase the treatment options for patients who are suffering with cancer pain by suggesting to the health-care team that hypnosis be incorporated into the plan of care. Integration of hypnosis into the standard of care will benefit patients, caregivers, and survivors by reducing pain and the suffering associated with it. PMID:25031986

A Study of Comparative Advantage and Intra-Industry Trade in the Pharmaceutical Industry of Iran

PubMed Central

Yusefzadeh, Hassan; Rezapour, Aziz; Lotfi, Farhad; Azar, Farbod Ebadifard; Nabilo, Bahram; Gorji, Hassan Abolghasem; Hadian, Mohammad; Shahidisadeghi, Niusha; Karami, Atiyeh

2015-01-01

Background: Drug costs in Iran accounts for about 30% of the total health care expenditure. Moreover, pharmaceutical business lies among the world’s greatest businesses. The aim of this study was to analyze Iran’s comparative advantage and intra-industry trade in pharmaceuticals so that suitable policies can be developed and implemented in order to boost Iran’s trade in this field. Methods: To identify Iran’s comparative advantage in pharmaceuticals, trade specialization, export propensity, import penetration and Balassa and Vollrath indexes were calculated and the results were compared with other pharmaceutical exporting countries. The extent and growth of Iran’s intra-industry trade in pharmaceuticals were measured and evaluated using the Grubel-Lloyd and Menon-Dixon indexes. The required data was obtained from Iran’s Customs Administration, Iran’s pharmaceutical Statistics, World Bank and International Trade Center. Results: The results showed that among pharmaceutical exporting countries, Iran has a high level of comparative disadvantage in pharmaceutical products because it holds a small share in world’s total pharmaceutical exports. Also, the low extent of bilateral intra-industry trade between Iran and its trading partners in pharmaceuticals shows the trading model of Iran’s pharmaceutical industry is mostly inter-industry trade rather than intra-industry trade. In addition, the growth of Iran’s intra-industry trade in pharmaceuticals is due to its shares of imports from pharmaceutical exporting countries to Iran and exports from Iran to its neighboring countries. Conclusions: The results of the analysis can play a valuable role in helping pharmaceutical companies and policy makers to boost pharmaceutical trade. PMID:26153184

The flipped classroom: a course redesign to foster learning and engagement in a health professions school.

PubMed

McLaughlin, Jacqueline E; Roth, Mary T; Glatt, Dylan M; Gharkholonarehe, Nastaran; Davidson, Christopher A; Griffin, LaToya M; Esserman, Denise A; Mumper, Russell J

2014-02-01

Recent calls for educational reform highlight ongoing concerns about the ability of current curricula to equip aspiring health care professionals with the skills for success. Whereas a wide range of proposed solutions attempt to address apparent deficiencies in current educational models, a growing body of literature consistently points to the need to rethink the traditional in-class, lecture-based course model. One such proposal is the flipped classroom, in which content is offloaded for students to learn on their own, and class time is dedicated to engaging students in student-centered learning activities, like problem-based learning and inquiry-oriented strategies. In 2012, the authors flipped a required first-year pharmaceutics course at the University of North Carolina Eshelman School of Pharmacy. They offloaded all lectures to self-paced online videos and used class time to engage students in active learning exercises. In this article, the authors describe the philosophy and methodology used to redesign the Basic Pharmaceutics II course and outline the research they conducted to investigate the resulting outcomes. This article is intended to serve as a guide to instructors and educational programs seeking to develop, implement, and evaluate innovative and practical strategies to transform students' learning experience. As class attendance, students' learning, and the perceived value of this model all increased following participation in the flipped classroom, the authors conclude that this approach warrants careful consideration as educators aim to enhance learning, improve outcomes, and fully equip students to address 21st-century health care needs.

"Dualities of interest": the inter-organizational relationships between disease-specific nonprofits and the pharmaceutical industry.

PubMed

Paluzzi, Joan E

2012-01-01

Health care and biomedical research environments in the United States are largely characterized by strategic relational practices conducted beyond the public gaze. The very nature of health care has been widely reconceptualized from a response to physical/biological imperatives regulated by health promotion and the epidemiological distribution of diseases to profit/market imperatives regulated by "product/brand" promotion and market dynamics. At critical decision points throughout the system, we find the multinational pharmaceutical industry wielding the influence that its wealth and power have bought. This study contributes to the growing body of work that seeks to illuminate the relationships between the pharmaceutical industry and the various entities that constitute the U.S. health and research systems. Through the use of case studies, it examines the relationships between the multinational pharmaceutical industry and the large disease-specific public and professional nonprofit organizations. It explores several questions, including: Is the concept of what constitutes a conflict of interest being purposefully manipulated? Is the public benevolence afforded to nonprofits extended to their corporate partners in ways that preclude critical oversight of relational dynamics? And are public donations, solicited by and given in good faith to these organizations, inevitably serving the economic interests and profits of donor pharmaceutical companies?

Oncology drugs in the crosshairs of pharmaceutical crime.

PubMed

Venhuis, Bastiaan J; Oostlander, Angela E; Giorgio, Domenico Di; Mosimann, Ruth; du Plessis, Ines

2018-04-01

Oncology drugs clearly have become a target for pharmaceutical crime. In 2016, falsified oncology drugs ranked fifth in the most commonly falsified drug category among the reports received by the Pharmaceutical Security Institute. Although the prevalence of illicit oncology drugs in the legal supply chains appears to be small, these drugs are difficult to detect, particularly in clinical practice. Forthcoming countermeasures to detect illicit drugs in high-income countries include compulsory antitampering devices and product verification technology for a risk-based selection of medicines. Health-care professionals must implement these new procedures into their workflow and remain vigilant about those medicines that are not selected. Although countermeasures should firmly tighten supply chain security, there are concerns about how quickly pharmaceutical crime will adapt to these protections. Because patients and health-care professionals have shown a lenient attitude towards purchasing medicines from unreliable sources, measures against the highly accessible illegal medicine supply chain remain necessary. To improve detectability in clinical practice, reporting of ineffectiveness and unusual drug effects as adverse events or adverse drug reactions is essential. Copyright © 2018 Elsevier Ltd. All rights reserved.

National Medicines Policy in retrospective: a review of (almost) 20 years of implementation.

PubMed

Vasconcelos, Daniela Moulin Maciel de; Chaves, Gabriela Costa; Azeredo, Thiago Botelho; Silva, Rondineli Mendes da

2017-08-01

Pharmaceutical services and the formulation of a medicines policy are SUS areas ensured by the organic health care law 8,080/90. Thus, after a widely participative process, involving stakeholders, the National Medicines Policy (NMP) was approved in 1998 by Ordinance 3,916.The NMP presents directives and priorities, aligned with organic health care law, which should guide the federal, states and municipals entities actions to achieve the policy goals. Considering almost 20 years of the NMP, this paper took stock discussed some of the directives in light of the SUS principles. It was not the objective to provide an exhaustive review of all the activities performed during this period. The authors tried to get close to those that have brought advances and dilemmas, with potential risk of regression. Efforts to implement an ambitious agenda applied to pharmaceutical services were identified. This agenda tried to deal with different challenges like the dynamics of the pharmaceutical market and the operation of pharmaceutical services to guarantee the supply of medicines aligned with principles and directives of SUS.

Incorporating Natural Products, Pharmaceutical Drugs, Self-Care and Digital/Mobile Health Technologies into Molecular-Behavioral Combination Therapies for Chronic Diseases

PubMed Central

Bulaj, Grzegorz; Ahern, Margaret M.; Kuhn, Alexis; Judkins, Zachary S.; Bowen, Randy C.; Chen, Yizhe

2016-01-01

Merging pharmaceutical and digital (mobile health, mHealth) ingredients to create new therapies for chronic diseases offers unique opportunities for natural products such as omega-3 polyunsaturated fatty acids (n-3 PUFA), curcumin, resveratrol, theanine, or α-lipoic acid. These compounds, when combined with pharmaceutical drugs, show improved efficacy and safety in preclinical and clinical studies of epilepsy, neuropathic pain, osteoarthritis, depression, schizophrenia, diabetes and cancer. Their additional clinical benefits include reducing levels of TNFα and other inflammatory cytokines. We describe how pleiotropic natural products can be developed as bioactive incentives within the network pharmacology together with pharmaceutical drugs and self-care interventions. Since approximately 50% of chronically-ill patients do not take pharmaceutical drugs as prescribed, psychobehavioral incentives may appeal to patients at risk for medication non-adherence. For epilepsy, the incentive-based network therapy comprises anticonvulsant drugs, antiseizure natural products (n-3 PUFA, curcumin or/and resveratrol) coupled with disease-specific behavioral interventions delivered by mobile medical apps. The add-on combination of antiseizure natural products and mHealth supports patient empowerment and intrinsic motivation by having a choice in self-care behaviors. The incentivized therapies offer opportunities: (1) to improve clinical efficacy and safety of existing drugs, (2) to catalyze patient-centered, disease self-management and behavior-changing habits, also improving health-related quality-of-life after reaching remission, and (3) merging copyrighted mHealth software with natural products, thus establishing an intellectual property protection of medical treatments comprising the natural products existing in public domain and currently promoted as dietary supplements. Taken together, clinical research on synergies between existing drugs and pleiotropic natural products, and their integration with self-care, music and mHealth, expands precision/personalized medicine strategies for chronic diseases via pharmacological-behavioral combination therapies. PMID:27262323

Blood pressure kiosks for medication therapy management programs: business opportunity for pharmacists.

PubMed

Houle, Sherilyn K D; Chuck, Anderson W; Tsuyuki, Ross T

2012-01-01

To develop an economic model based on the use of pharmacy-based blood pressure kiosks for case finding of remunerable medication therapy management (MTM) opportunities. Descriptive, exploratory, nonexperimental study. Ontario, Canada, between January 2010 and September 2011. More than 7.5 million blood pressure kiosk readings were taken from 341 pharmacies. A model was developed to estimate revenues achievable by using blood pressure kiosks for 1 month to identify a cohort of patients with blood pressure of 130/80 mm Hg or more and caring for those patients during 1 year. Revenue generated from MTM programs. Pharmacies could generate an average of $12,270 (range $4,523-24,420) annually in revenue from billing for MTM services. Blood pressure kiosks can be used to identify patients with elevated blood pressure who may benefit from reimbursable pharmacist cognitive services. Revenue can be reinvested to purchase automated dispensing technology or offset pharmacy technician costs to free pharmacists to provide pharmaceutical care. Improved patient outcomes, increased patient loyalty, and improved adherence are additional potential benefits.

[Effectiveness of Team-Based Learning (TBL) as a new teaching approach for pharmaceutical care education].

PubMed

Suno, Manabu; Yoshida, Toshiko; Koyama, Toshihiro; Zamami, Yoshito; Miyoshi, Tomoko; Mizushima, Takaaki; Tanimoto, Mitsune

2013-01-01

The concept of Team-Based Learning (TBL) was developed in the late 1970s by Larry Michaelsen, who wanted students to enjoy the benefits of small group learning within large classes in the business school environment. In contrast to problem-based learning (PBL), which is student centered, TBL is typically instructor centered. Recently, TBL is being used as a teaching method in over 60 health science professional schools in the US and other countries. In the present study, the impact of adopting TBL in teaching pharmaceutical care practices to students was evaluated. Students were required to answer a set of multiple-choice questions individually in individual readiness assessment test (IRAT) before the TBL sessions to assess their level of preparation. The same set of questions was then reattempted by the group readiness assessment test (GRAT) during TBL. Comparing the scores obtained in the GRAT and IRAT before the first TBL session, the scores from the GRAT were always higher than those of the IRAT, indicating that TBL has encouraged active learning. In addition, students were surveyed about their level of satisfaction with TBL and written comments about TBL were solicited. The results of the questionnaire showed that 87.3±9.3% of the students were satisfied. Moreover, no student commented that TBL was in any way inferior to the PBL. Implementation of a TBL approach was successfully integrated into the pharmaceutical care education course. In order to further improve the usefulness of TBL in teaching pharmaceutical care, a hybrid teaching approach that also comprises PBL and a lecture-based course is desirable.

Effectiveness of pharmaceutical care at discharge in the emergency department: study protocol of a randomized controlled trial.

PubMed

Kuhmmer, Regina; Lima, Karine Margarites; Ribeiro, Rodrigo Antonini; Hammes, Luciano Serpa; Bastos, Gisele Alsina Nader; Cotta de Souza, Maria Claudia Schardosim; Polanczyk, Carisi Anne; Soares Rollin, Guilherme Alcides Flores; Caon, Suhelen; Guterres, Cátia Moreira; Araújo Leite, Leni Everson; Delabary, Tássia Scholante; Falavigna, Maicon

2015-02-25

Patient education on pharmacological therapy may increase medication adherence and decrease hospitalizations. Our aim is to evaluate the effectiveness of pharmaceutical care at emergency department discharge in patients with hypertension and/or diabetes. This is a randomized controlled trial. Participants will be recruited from a public emergency department at Restinga district in Porto Alegre, southern Brazil. A total of 380 patients will be randomly assigned into 2 groups at the moment of emergency department discharge after receiving medical orientations: an intervention group, consisting of a structured individual counseling session by a pharmacist in addition to written orientations, or a control group, consisting only of written information about the disease. Outcomes will be assessed in an ambulatory visit 2 months after the randomization. The primary outcome is the proportion of patients with high medication adherence assessed using the Morisky-Green Test and the Brief Medication Questionnaire. The secondary outcomes are reduction of blood pressure, glycated hemoglobin, fasting plasma glucose, quality of life and number of visits to the emergency department. Pharmaceutical care interventions have shown to be feasible and effective in increasing medication adherence in both hospital outpatient and community pharmacy settings. However, there have been no previous assessments of the effectiveness of pharmacy care interventions initiated in patients discharged from emergency departments. Our hypothesis is that pharmaceutical counseling is also effective in this population. ClinicalTrials.gov registration number: NCT01978925 (11 November 2013) and Brazilian Registry of Clinical Trials U1111-1149-8922 (5 November 2013).

Curriculum Recommendations of the AACP-PSSC Task Force on Caring for the Underserved

PubMed Central

Roche, Victoria F.; Assemi, Mitra; Conry, John M.; Shane-McWhorter, Laura; Sorensen, Todd D.

2008-01-01

A task force was convened by the American Association of Colleges of Pharmacy (AACP) and the Pharmaceutical Services Support Center (PSSC) and charged with the development of a curriculum framework to guide pharmacy programs in educating students on caring for the underserved. Utilizing a literature-based model, the task force constructed a framework that delineated evidence-based practice, clinical prevention and health promotion, health systems and policy, and community aspects of practice. Specific learning outcomes tailored to underserved populations were crafted and linked to resources readily available to the academy. The AACP-PSSC curriculum framework was shared with the academy in 2007. Schools and Colleges are urged to share experiences with implementation so that the impact of the tool can be evaluated. The task force recommends that the AACP Institutional Research Advisory Committee be involved in gathering assessment data. Implementation of the curriculum framework can help the academy fulfill the professional mandate to proactively provide the highest quality care to all, including underserved populations. PMID:18698398

Ultrafiltration for acute decompensated heart failure: cost, reimbursement, and financial impact.

PubMed

Ross, Edward A; Bellamy, Frank B; Hawig, Scott; Kazory, Amir

2011-05-01

In addition to the proposed pathophysiologic mechanisms whereby ultrafiltration (UF) can be advantageous over diuretics in the treatment of heart failure, there can also be financial and resource-utilization reasons for pursuing this extracorporeal strategy. In those cases in which the clinical outcomes would be equivalent, however, the decision whether to pursue UF will depend greatly on the anticipated hospitalization length of stay (LOS), the patient population's pay or mix, the needs and costs for high-acuity (eg, intensive care unit) care, and widely varying expenses for the equipment and disposable supplies. From a fiscal perspective, the financial viability of UF programs revolves around how improvements in LOS, resource utilization, and readmissions relate to the typical diagnosis-driven (eg, diagnosis-related group) reimbursement. We analyzed the impact of these various factors so as to better understand how the intensity (and expense) of pharmaceutical and extracorporeal therapies impacts a single admission, as well as to serve as the basis for developing strategies for optimizing long-term care. 2011 Wiley Periodicals, Inc.

Integrated Formulation, Testing and Analysis Program for Trans Sodium Crocetinate (TSC)

DTIC Science & Technology

2006-05-05

Report February 1, 2006 - April 30, 2006 David G. Kalergis, Principal Investigator Diffusion Pharmaceuticals, LLC 2020 Avon...WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Diffusion Pharmaceuticals, LLC 2020 Avon Court #4 Charlottesville, VA 22902 8...currently supporting Diffusion Pharmaceuticals LLC, Charlottesville, VA in development of TSC for clinical testing. An important step is the development

Pharmaceutical lobbying in Brazil: a missing topic in the public health research agenda.

PubMed

Paumgartten, Francisco José Roma

2016-12-22

In the US, where registration of lobbyists is mandatory, the pharmaceutical industry and private health-care providers spend huge amounts of money seeking to influence health policies and government decisions. In Brazil, where lobbying lacks transparency, there is virtually no data on drug industry expenditure to persuade legislators and government officials of their viewpoints and to influence decision-making according to commercial interests. Since 1990, however, the Associação da Indústria Farmacêutica de Pesquisa (Interfarma - Pharmaceutical Research Industry Association), Brazilian counterpart of the Pharmaceutical Research and Manufacturers of America (PhRMA), main lobbying organization of the US pharmaceutical industry, has played a major role in the advocacy of interests of major drug companies. The main goals of Interfarma lobbying activities are: shortening the average time taken by the Brazilian regulatory agency (ANVISA) to approve marketing authorization for a new drug; making the criteria for incorporation of new drugs into SUS (Brazilian Unified Health System) more flexible and speeding up technology incorporation; changing the Country's ethical clearance system and the ethical requirements for clinical trials to meet the need of the innovative drug industry, and establishing a National Policy for Rare Diseases that allows a prompt incorporation of orphan drugs into SUS. Although lobbying affects community health and well-being, this topic is not in the public health research agenda. The impacts of pharmaceutical lobbying on health policies and health-care costs are of great importance for SUS and deserve to be investigated.

Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research.

PubMed

Newcombe, J P; Kerridge, I H

2007-01-01

Conflicts of interest arising from pharmaceutical industry sponsorship of clinical research have the potential to bias research outcomes and ultimately prejudice patient care. It is unknown how Australian Human Research Ethics Committees (HREC) assess and manage such conflicts of interest. We aimed to gain an understanding of how HREC approach the problem of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. We conducted a survey of HREC chairpersons in New South Wales. HREC vary widely in their approaches to conflicts of interest, including in their use of National Health and Medical Research Council guidelines, which were often misinterpreted or overlooked. Many committees rely primarily on researchers disclosing potential conflicts of interest, whereas a majority of HREC use disclosure to research participants as the primary tool for preventing and managing conflicts of interest. Almost no HREC place limitations on researcher relationships with pharmaceutical companies. These findings suggest reluctance on the part of HREC to regulate many potential conflicts of interest between researchers and pharmaceutical sponsors, which may arise from uncertainty regarding the meaning or significance of conflicts of interest in research, from ambiguity surrounding the role of HREC in assessing and managing conflicts of interest in research or from misinterpretation or ignorance of current National Health and Medical Research Council guidelines. Further review of policies and practices in this important area may prove beneficial in safeguarding clinical research and patient care while promoting continuing constructive engagement with the pharmaceutical industry.

Pharmaceuticals and Personal Care Products in the Environment: What Are the Big Questions?

PubMed Central

Rudd, Murray A.; Brooks, Bryan W.; Caldwell, Daniel J.; Choi, Kyungho; Hickmann, Silke; Innes, Elizabeth; Ostapyk, Kim; Staveley, Jane P.; Verslycke, Tim; Ankley, Gerald T.; Beazley, Karen F.; Belanger, Scott E.; Berninger, Jason P.; Carriquiriborde, Pedro; Coors, Anja; DeLeo, Paul C.; Dyer, Scott D.; Ericson, Jon F.; Gagné, François; Giesy, John P.; Gouin, Todd; Hallstrom, Lars; Karlsson, Maja V.; Larsson, D. G. Joakim; Lazorchak, James M.; Mastrocco, Frank; McLaughlin, Alison; McMaster, Mark E.; Meyerhoff, Roger D.; Moore, Roberta; Parrott, Joanne L.; Snape, Jason R.; Murray-Smith, Richard; Servos, Mark R.; Sibley, Paul K.; Straub, Jürg Oliver; Szabo, Nora D.; Topp, Edward; Tetreault, Gerald R.; Trudeau, Vance L.; Van Der Kraak, Glen

2012-01-01

Background: Over the past 10–15 years, a substantial amount of work has been done by the scientific, regulatory, and business communities to elucidate the effects and risks of pharmaceuticals and personal care products (PPCPs) in the environment. Objective: This review was undertaken to identify key outstanding issues regarding the effects of PPCPs on human and ecological health in order to ensure that future resources will be focused on the most important areas. Data sources: To better understand and manage the risks of PPCPs in the environment, we used the “key question” approach to identify the principle issues that need to be addressed. Initially, questions were solicited from academic, government, and business communities around the world. A list of 101 questions was then discussed at an international expert workshop, and a top-20 list was developed. Following the workshop, workshop attendees ranked the 20 questions by importance. Data synthesis: The top 20 priority questions fell into seven categories: a) prioritization of substances for assessment, b) pathways of exposure, c) bioavailability and uptake, d) effects characterization, e) risk and relative risk, f ) antibiotic resistance, and g) risk management. Conclusions: A large body of information is now available on PPCPs in the environment. This exercise prioritized the most critical questions to aid in development of future research programs on the topic. PMID:22647657

pdb-care (PDB carbohydrate residue check): a program to support annotation of complex carbohydrate structures in PDB files.

PubMed

Lütteke, Thomas; von der Lieth, Claus-W

2004-06-04

Carbohydrates are involved in a variety of fundamental biological processes and pathological situations. They therefore have a large pharmaceutical and diagnostic potential. Knowledge of the 3D structure of glycans is a prerequisite for a complete understanding of their biological functions. The largest source of biomolecular 3D structures is the Protein Data Bank. However, about 30% of all 1663 PDB entries (version September 2003) containing carbohydrates comprise errors in glycan description. Unfortunately, no software is currently available which aligns the 3D information with the reported assignments. It is the aim of this work to fill this gap. The pdb-care program http://www.glycosciences.de/tools/pdb-care/ is able to identify and assign carbohydrate structures using only atom types and their 3D atom coordinates given in PDB-files. Looking up a translation table where systematic names and the respective PDB residue codes are listed, both assignments are compared and inconsistencies are reported. Additionally, the reliability of reported and calculated connectivities for molecules listed within the HETATOM records is checked and unusual values are reported. Frequent use of pdb-care will help to improve the quality of carbohydrate data contained in the PDB. Automatic assignment of carbohydrate structures contained in PDB entries will enable the cross-linking of glycobiology resources with genomic and proteomic data collections.

Changes in Equity in Out-of-pocket Payments during the Period of Health Care Reforms: Evidence from Hungary

PubMed Central

2012-01-01

Background At the beginning of 2007, health care reforms were implemented in Hungary in order to decrease public expenditure on health care. Reforms involved the increase of co-payments for pharmaceuticals and the introduction of co-payments for health care services. Objective The objective of this paper is to examine the progressivity of household expenditure on health care during the reform period, separately for expenditures on pharmaceuticals and medical devices, as well as for formal and informal patient payments for health care services. Methods We use data on household expenditure from the Household Budget Survey carried out by the Central Statistical Office of Hungary. We present household expenditure as a percentage of household income across different income quintiles and calculate Kakwani indexes as a measure of progressivity for a four years period (2005–2008): before, during and after the implementation of the health care reforms. Results We find that out-of-pocket payments on health care are highly regressive in Hungary with a Kakwani index of −0.22. In particular, households from the lowest income quintile spend an about three times larger share of their income on out-of-pocket payments (6–7 %) compared to households in the highest income quintile (2 %). Expenditures on pharmaceuticals and medical devices are the most regressive types of expenditure (Kakwani index −0.23/-0.24), and at the same time they represent a major part of the total household expenditure on health care (78–85 %). Informal payments are also regressive while expenditures on formal payments for services are the most proportional to income. We find that expenditures on formal payments became regressive after the introduction of user fees (Kakwani index −0.1). At the same time, we observe that expenditures on informal payments became less regressive during the reform period (Kakwani index increases from −0.20/-0.18 to −0.12.) Conclusions More attention should be paid on the protection of low-income social groups when increasing or introducing co-payments especially for pharmaceuticals but also for services. Also, it is important to eliminate the practice of informal payments in order to improve equity in health care financing. PMID:22828250

U.S. News Media Coverage of Pharmaceutical Pollution in the Aquatic Environment: A Content Analysis of the Problems and Solutions Presented by Actors.

PubMed

Blair, Benjamin; Zimny-Schmitt, Daniel; Rudd, Murray A

2017-08-01

Pharmaceutical pollution in the aquatic environment is an issue of concern that has attracted attention by the news media. Understanding the factors that contribute to media framing of pharmaceutical pollution may lead to a better understanding of the management and governance of this issue, including why these pollutants are generally unregulated at this time. This study conducted a content analysis of 405 newspaper articles (81 had substantive information on the topic) from 2007 to 2014, using the search terms "water" and "pharmaceuticals" in the Chicago Tribune, Denver Post, Los Angeles Times, New York Daily News, New York Times, USA Today, Wall Street Journal, and Washington Post. We sought to analyze the factors that contributed to the news media presentation of pharmaceutical pollution in the United States, including the presentation of the risks/safety and solutions by various actors. We found that the primary issues in the news media were uncertainty regarding public health and harm to the environment. The primary solutions recommended within the news media were implementing additional water treatment technologies, taking unused pharmaceuticals to predetermined sites for disposal (take-back programs), and trash disposal of unused pharmaceuticals. Water utilities and scientists presented improved water treatment technology, government actors presented take-back programs, and pharmaceutical representatives, while sparsely involved in the news media, presented trash disposal as their primary solutions. To advance the understanding of the management of pharmaceutical pollution, this article offers further insight into the debate and potential solutions within the news media presentation of this complex scientific topic.

U.S. News Media Coverage of Pharmaceutical Pollution in the Aquatic Environment: A Content Analysis of the Problems and Solutions Presented by Actors

NASA Astrophysics Data System (ADS)

Blair, Benjamin; Zimny-Schmitt, Daniel; Rudd, Murray A.

2017-08-01

Pharmaceutical pollution in the aquatic environment is an issue of concern that has attracted attention by the news media. Understanding the factors that contribute to media framing of pharmaceutical pollution may lead to a better understanding of the management and governance of this issue, including why these pollutants are generally unregulated at this time. This study conducted a content analysis of 405 newspaper articles (81 had substantive information on the topic) from 2007 to 2014, using the search terms "water" and "pharmaceuticals" in the Chicago Tribune, Denver Post, Los Angeles Times, New York Daily News, New York Times, USA Today, Wall Street Journal, and Washington Post. We sought to analyze the factors that contributed to the news media presentation of pharmaceutical pollution in the United States, including the presentation of the risks/safety and solutions by various actors. We found that the primary issues in the news media were uncertainty regarding public health and harm to the environment. The primary solutions recommended within the news media were implementing additional water treatment technologies, taking unused pharmaceuticals to predetermined sites for disposal (take-back programs), and trash disposal of unused pharmaceuticals. Water utilities and scientists presented improved water treatment technology, government actors presented take-back programs, and pharmaceutical representatives, while sparsely involved in the news media, presented trash disposal as their primary solutions. To advance the understanding of the management of pharmaceutical pollution, this article offers further insight into the debate and potential solutions within the news media presentation of this complex scientific topic.

How does the pharmaceutical industry influence prescription? A qualitative study of provider payment incentives and drug remunerations in hospitals in Shanghai.

PubMed

Yang, Wei

2016-10-01

Over-prescription has become one major problem in China's health care sector. Incorporating interview data from hospitals in Shanghai, this paper provided empirical evidence on how the process of over-prescription was carried out in day-to-day clinical settings, and demonstrates various mechanisms that allow over-prescription to continue vigorously in the context of the Chinese health care system. In particular, this study identified four levels of incentives that over-prescription was carried out: hospital, medical department, doctors and pharmaceutical companies. Due to the insufficient funding from the government and rising operational costs, hospitals had to rely on the sales of drugs and provision of medical services to survive. This funding pressure then transferred to specific revenue targets for medical departments. A combination of incentives, including drug remunerations, bonus system, low pay and high workloads motivated over-prescription at doctor level. At pharmaceutical company level, high profits of pharmaceuticals products as well as lack of emphasis on efficacy of drugs led to under-table payments and illicit drug remunerations. The study argued that the way that the Chinese health care system operates was based on the profit-seeking principle rather than on fulfilling its social functions, and called for a systematic reform of provider incentives to eradicating the problem of over-prescription.

Self Managing Heart Failure in Remote Australia - Translating Concepts into Clinical Practice

PubMed Central

Iyngkaran, Pupalan; Toukhsati, Samia R.; Harris, Melanie; Connors, Christine; Kangaharan, Nadarajan; Ilton, Marcus; Nagel, Tricia; Moser, Debra K.; Battersby, Malcolm

2016-01-01

Congestive heart failure (CHF) is an ambulatory health care condition characterized by episodes of decompensation and is usually without cure. It is a leading cause for morbidity and mortality and the lead cause for hospital admissions in older patients in the developed world. The long-term requirement for medical care and pharmaceuticals contributes to significant health care costs. CHF management follows a hierarchy from physician prescription to allied health, predominately nurse-led, delivery of care. Health services are easier to access in urban compared to rural settings. The differentials for more specialized services could be even greater. Remote Australia is thus faced with unique challenges in delivering CHF best practice. Chronic disease self-management programs (CDSMP) were designed to increase patient participation in their health and alleviate stress on health systems. There have been CDSMP successes with some diseases, although challenges still exist for CHF. These challenges are amplified in remote Australia due to geographic and demographic factors, increased burden of disease, and higher incidence of comorbidities. In this review we explore CDSMP for CHF and the challenges for our region. PMID:27397492

A Pharmaceutical Industry Elective Course on Practice Experience Selection and Fellowship Pursuit by Pharmacy Students

PubMed Central

Blustein, Leona; Morel, Diane; Davis, Lisa

2014-01-01

Objective. To design and implement 2 pharmaceutical industry elective courses and assess their impact on students’ selection of advanced pharmacy practice experiences (APPEs) and pursuit of pharmaceutical industry fellowships. Methods. Two 2-credit-hour elective courses that explored careers within the prescription and nonprescription pharmaceutical drug industries were offered for second- and third-year pharmacy students in a doctor of pharmacy (PharmD) degree program. Results. The impact of the courses on pharmacy students’ pursuit of a pharmaceutical industry fellowship was evaluated based on responses to annual graduating students’ exit surveys. A greater percentage (17.9%) of students who had taken a pharmaceutical industry elective course pursued a pharmaceutical industry fellowship compared to all PharmD graduates (4.8%). Of the students who enrolled in pharmaceutical industry APPEs, 31% had taken 1 of the 2 elective courses. Conclusion. Exposure to a pharmaceutical industry elective course within a college or school of pharmacy curriculum may increase students’ interest in pursuing pharmaceutical industry fellowships and enrolling in pharmaceutical industry APPEs. PMID:25147398

Development of a taxonomy for pharmaceutical interventions in HIV+ patients based on the CMO model.

PubMed

Morillo Verdugo, Ramón; Villarreal Arevalo, Andrea Lisbeth; Alvarez De Sotomayor, Maria; Robustillo Cortes, Maria de Las Aguas

2016-11-01

To agree on a proposal for pharmaceutical interventions and establish their classification taxonomy according to the CMO-Pharmaceutical Care Model (Capacity-Motivation- Opportunity). A study conducted between March and May, 2016. Two phases of development were defined. A literature review was initially conducted. Then, the DELPHI-Rand-UCLA methodology was used in order to reach a consensus about those interventions selected, and to define the taxonomy. Fifteen (15) experts, specialists in Pharmaceutical Care for HIV+ patients, were selected. This selection was explicitly conducted, following a protocol in order to avoid any bias. An initial proposal was developed according to the interventions extracted from Phase 1. These were tentatively classified according to the CMO Model, in a category based on their design and utility. Three issues were raised from the initial question: Do you agree with the proposed classification? If not, there was an option to re-categorize. Additionally, they were asked about the importance, priority and impact to achieve pharmacotherapeutic objectives that they would assign to it. Interventions were classified according to the degree of agreement. Once a consensus was reached, the final taxonomy was established. Eighteen (18) articles were finally considered. The initial proposal included 20 pharmaceutical interventions with the following classification: seven in Capacity, eight in Motivation, and five in Opportunity. Those interventions considered to have greater importance and priority were: Review and Validation, Safety, and Adherence. The interventions with the greatest impact were: Review and Validation, Coordination, Adherence, and Motivation. On the other hand, the lowest scores for importance were for: Planning and Social Coordination; and in terms of impact: Social Coordination. The taxonomy reached by consensus will allow to classify pharmaceutical interventions with the new model, and therefore to conduct an improved research and patient care. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

High-risk population health management--achieving improved patient outcomes and near-term financial results.

PubMed

Lynch, J P; Forman, S A; Graff, S; Gunby, M C

2000-07-01

A managed care organization sought to achieve efficiencies in care delivery and cost savings by anticipating and better caring for its frail and least stable members. Time sequence case study of program intervention across an entire managed care population in its first year compared with the prior baseline year. Key attributes of the intervention included predictive registries of at-risk members based on existing data, relentless focus on the high-risk group, an integrated clinical and psychosocial approach to assessments and are planning, a reengineered care management process, secured Internet applications enabling rapid implementation and broad connectivity, and population-based outcomes metrics derived from widely used measures of resource utilization and functional status. Concentrating on the highest-risk group, which averaged just 1.1% prevalence in the total membership, yielded bottom line results. When the year before program implementation (July 1997 through June 1998) was compared with the subsequent year, the total population's annualized commercial admission rate was reduced 5.3%, and seniors' was reduced 3.0%. A claims-paid analysis exclusively of the highest-risk group revealed that their efficiencies and savings overwhelmingly contributed to the membershipwide effect. This subgroup's costs dropped 35.7% from preprogram levels of $2590 per member per month (excluding pharmaceuticals). During the same time, patient-derived cross-sectional functional status rose 12.5%. A sharply focused, Internet-deployed case management strategy achieved economic and functional status results on a population basis and produced systemwide savings in its first year of implementation.

Experts Foresee a Major Shift From Inpatient to Ambulatory Care.

PubMed

Beans, Bruce E

2016-04-01

An American Society of Health-System Pharmacists Research and Education Foundation report predicts trends in health care delivery and financing, drug development and therapeutics, pharmaceutical marketplace, pharmacy workforce, and more.

[Involvement of medical representatives in team medical care].

PubMed

Hirotsu, Misaki; Sohma, Michiro; Takagi, Hidehiko

2009-04-01

In recent years, chemotherapies have been further advanced because of successive launch of new drugs, introduction of molecular targeting, etc., and the concept of so-called Team Medical Care ,the idea of sharing interdisciplinary expertise for collaborative treatment, has steadily penetrated in the Japanese medical society. Dr. Naoto Ueno is a medical oncologist at US MD Anderson Cancer Center, the birthplace of the Team Medical Care. He has advocated the concept of ABC of Team Oncology by positioning pharmaceutical companies as Team C. Under such team practice, we believe that medical representatives of a pharmaceutical company should also play a role as a member of the Team Medical Care by providing appropriate drug use information to healthcare professionals, supporting post-marketing surveillance of treated patients, facilitating drug information sharing among healthcare professionals at medical institutions, etc.

More people than ever before are receiving behavioral health care in the United States, but gaps and challenges remain.

PubMed

Mechanic, David

2014-08-01

The high prevalence of mental illness and substance abuse disorders and their significant impact on disability, mortality, and other chronic diseases have encouraged new initiatives in mental health policy including important provisions of the Affordable Care Act and changes in Medicaid. This article examines the development and status of the behavioral health services system, gaps in access to and quality of care, and the challenges to implementing aspirations for improved behavioral and related medical services. Although many more people than ever before are receiving behavioral health services in the United States-predominantly pharmaceutical treatments-care is poorly allocated and rarely meets evidence-based standards, particularly in the primary care sector. Ideologies, finances, and pharmaceutical marketing have shaped the provision of services more than treatment advances or guidance from a growing evidence base. Among the many challenges to overcome are organizational and financial realignments and improved training of primary care physicians and the behavioral health workforce. Project HOPE—The People-to-People Health Foundation, Inc.

Diabetes Care as an Active Learning Model of Postgraduate Education and Training for Pharmaceutical Care.

ERIC Educational Resources Information Center

Koda-Kimble, Mary Anne; Batz, Forrest R.

1994-01-01

In a University of California continuing pharmacy education course in diabetes care, practicing pharmacists lived as patients with diabetes for two days and role-played in small groups. One year later, participants reported making changes in their diabetes care-related practice, suggesting its effectiveness in improving practitioners' skill…

[Implementation of the program of "Collaborative Development of Advanced Practical Education to Train Pharmacists in Leadership" under the joint operation of the pharmaceutical departments in fourteen national universities].

PubMed

Hirata, Kazumasa; Tamura, Satoru; Kobayashi, Motomasa

2012-01-01

"Collaborative Development of Advanced Practical Education Program to Train Pharmacists with Leadership" applied jointly by the pharmaceutical departments of fourteen national universities was selected to receive the special expenditure support of Ministry of Education, Culture, Sports, Science and Technology for fiscal year 2010 under "the Training of Highly Skillful Professionals and Improvement of the Quality of the Function of Professional Education". This project is to promote the collaborative development of the educational program which will make it possible to further advance and substantiate the education of pharmacists in the six year course of the pharmaceutical department for the ultimate purpose to introduce pharmacists with leadership who can play an active role and fill in a leadership position in a wide range of responsibilities into the society which, more and more, has come to expect pharmacy to take the initiative in acting against health hazards caused by infections, foods and environmental pollution as well as to meet the diversification of healthcare. To be more specific, this project is to try and evaluate the following programs repeatedly based on the plan-do-check-act (PDCA) cycle: 1) Practical medical and pharmaceutical education program; 2) Program concerning research on long term themes and advanced education; 3) Program concerning training and education of SPs (standardized patients or simulated patients) and PBL (problem-based learning) tutorial education; and 4) Program concerning the method of evaluation of education. Through this repeated trial and evaluation, this project ultimately seeks to construct a highly effective practical educational program which integrates each university's achievements and educational attempts rich in originality.

AMCP Partnership Forum: Advancing Value-Based Contracting.

PubMed

2017-11-01

During the past decade, payment models for the delivery of health care have undergone a dramatic shift from focusing on volume to focusing on value. This shift began with the Affordable Care Act and was reinforced by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), which increased the emphasis on payment for delivery of quality care. Today, value-based care is a primary strategy for improving patient care while managing costs. This shift in payment models is expanding beyond the delivery of health care services to encompass models of compensation between payers and biopharmaceutical manufacturers. Value-based contracts (VBCs) have emerged as a mechanism that payers may use to better align their contracting structures with broader changes in the health care system. While pharmaceuticals represent a small share of total health care spending, it is one of the fastest-growing segments of the health care marketplace, and the increasing costs of pharmaceuticals necessitate more flexibility to contract in new ways based on the value of these products. Although not all products or services are appropriate for these types of contracts, VBCs could be a part of the solution to address increasing drug prices and overall drug spending. VBCs encompass a variety of different contracting strategies for biopharmaceutical products that do not base payment rates on volume. These contracts instead may include payment on the achievement of specific goals in a predetermined patient population and offer innovative solutions for quantifying and rewarding positive outcomes or otherwise reducing payer risk associated with pharmaceutical costs. To engage national stakeholders in a discussion of current practices, barriers, and potential benefits of VBCs, the Academy of Managed Care Pharmacy (AMCP) convened a Partnership Forum on Advancing Value-Based Contracting in Arlington, Virginia, on June 20-21, 2017. The goals of the VBC forum were as follows: (a) agree to a definition of a VBC for facilitating discussion with key policy makers and regulators; (b) determine strategies for advancing the development and utilization of performance benchmarks; (c) identify best practices in evaluating, implementing, and monitoring VBCs; and (d) develop action plans to mitigate legal and regulatory barriers to VBCs. More than 30 national and regional health care leaders representing health plans, integrated delivery systems, pharmacy benefit managers, employers, data and analytics companies, and biopharmaceutical companies participated. Speakers, panelists, and stakeholders attended the forum and explored the current environment for VBCs, identified challenges to the expansion of VBCs, offered potential solutions to those challenges, and developed an action plan for addressing selected challenges. The forum recommendations will be used by AMCP to establish a coalition of organizations to seek broader acceptance of VBCs in the marketplace and by policymakers. The recommendations will also help AMCP provide tools and resources to stakeholders in managing VBCs. This Partnership Forum was supported by Amgen, Bristol-Myers Squibb, Eli Lilly, Merck, the National Pharmaceutical Council, Novo Nordisk, Premier, the Pharmaceutical Research and Manufacturers of America, RxAnte, Takeda, and Xcenda.

Patients’ perception of pharmaceutical services available in a community pharmacy among patients living in a rural area of the United Kingdom

PubMed Central

2016-01-01

Objective: Patients’ opinion about prevalence of pharmaceutical services available in a community pharmacy among patients living in a rural area of the United Kingdom. The secondary objective was to identify appropriate action(s) to enhance patients’ awareness of pharmaceutical services in rural areas. Methods: A self-administered, anonymous questionnaire was distributed to patients visiting a community pharmacy in Eye, Suffolk, United Kingdom between July and August, 2015. The main inclusion criterion was living in a rural area. Comparisons were performed using chi-square tests and logistic regression. Results: The study included 103 respondents: 70 women (69.0%) and 33 men (32.0%), aged 16–85 years. Most respondents declared the primary tasks of a community pharmacy were dispensing medicines (86.4% of respondents) and repeat dispensing (72.8% of respondents). Additionally, 23.3% of respondents treated minor ailments at the pharmacy, including bacterial/viral infections, minor injuries, stomach problems, and allergies. The Medicines Use Review service was the only advanced service used in this pharmacy (12.6% of respondents), primarily by men. Younger patients were more familiar with the term of pharmaceutical care (p<0.05; OR=0.33). Conclusions: Only a few pharmaceutical services are utilized by people living in rural areas in the UK, namely prescription dispensing, repeat dispensing, and sale of medications that support self-care for minor ailments. We found an overall poor awareness of the expanded variety of pharmaceutical services encouraged by the community pharmacy contract introduced in the UK in 2005. Therefore, politicians, pharmacists, and pharmacy experts should actively promote these advanced pharmaceutical services in rural areas. PMID:27785163

[Pharmacogenetics--implications for health management and health care economics].

PubMed

Weihrauch, Thomas R

2002-07-15

Pharmacogenetics, which is principally concerned with drug efficacy and safety, will change the way future health care is practiced. The growing understanding of the genetic basis for drug response and use of this knowledge to predict the response of an individual patient offer new opportunities to meet the changing needs of health care systems and the demands placed upon them. For the individual patient, overall quality of life should be higher as physicians will be able to select the most effective and safest treatments for them. However, the cost of patient evaluation will need to be weighed against the additional therapeutic benefit and savings made by avoidance of unnecessary and inadequate drug use and adverse drug responses. Getting the right medicine at the right dose to the patient first time and avoidance of "try and see" prescribing also have the potential to reduce costs due a reduction in number of visits to the physician required to obtain satisfactory treatment. Application of pharmacogenetics to drug development has the potential to streamline the drug development process. Disease and therapy differentiation may lead to stratification of patient groups, and it is possible that the fragmented indications will not represent commercially attractive markets to the pharmaceutical industry with current marketing paradigms. However, the ability to target patients more accurately may represent considerable commercial value within a given market sector. Changes in health care policy and structure will be needed so that short-term budget constraints are not allowed to take precedence over mid- to long-term benefits. In order to realize the potential of pharmacogenetics, tailored communication/education programs for the key stakeholders--patients and patient groups, health care professionals, regulators, health care industry (biotechnology, pharmaceutical and diagnostic companies), health care payers, governments, and academia--will be necessary. Pharmacogenetics is likely to be introduced according to need, clinical validity and value, with resources first being directed at diseases for which it is vital to prescribe the right drug at the right dose from the outset, e.g. in cancer.

The argument for pharmaceutical policy.

PubMed

Traulsen, Janine Morgall; Almarsdóttir, Anna Birna

2005-02-01

Pharmaceutical policy is a global concern. It has become a hot political topic in most countries--developed as well as developing--and can be found on the agenda of international organizations such as WHO, OECD, EU, WTO and even the World Bank. Pharmaceutical policy affects everyone in the world of pharmacy and it is therefore imperative that it be understood, discussed and debated within the pharmacy profession and included in the curriculum of schools of pharmacy. This, the first article in a series, argues for the importance of the academic discipline of pharmaceutical policy analysis and the involvement of pharmacists in this endeavour. The aim of the authors is to stimulate an informed and critical appreciation of this field. The authors begin with an introduction to the field of pharmaceutical policy, introducing several important concepts and current trends including: medicines regulation; how pharmaceutical policy is made; pharmaceutical policy as a dynamic process; and the new public health as a global issue. The article ends with a short description of the remaining five articles in the series which will deal with important aspects of pharmaceutical policy. The topics include: economic pressures on health care systems; drug utilization from the clinical viewpoint (rational use of medicines); the impact of pharmaceutical policy on patients and the patient impact on pharmaceutical policy; the professional perspective; and finally the last article which deals with studying and evaluating pharmaceutical policy.

Identifying new persistent and bioaccumulative organics among chemicals in commerce II: pharmaceuticals.

PubMed

Howard, Philip H; Muir, Derek C G

2011-08-15

The goal of this study was to identify commercial pharmaceuticals that might be persistent and bioaccumulative (P&B) and that were not being considered in current wastewater and aquatic environmental measurement programs. We developed a database of 3193 pharmaceuticals from two U.S. Food and Drug Administration (FDA) databases and some lists of top ranked or selling drugs. Of the 3193 pharmaceuticals, 275 pharmaceuticals have been found in the environment and 399 pharmaceuticals were, based upon production volumes, designated as high production volume (HPV) pharmaceuticals. All pharmaceuticals that had reported chemical structures were evaluated for potential bioaccumulation (B) or persistence (P) using quantitative structure property relationships (QSPR) or scientific judgment. Of the 275 drugs detected in the environment, 92 were rated as potentially bioaccumulative, 121 were rated as potentially persistent, and 99 were HPV pharmaceuticals. After removing the 275 pharmaceuticals previously detected in the environment, 58 HPV compounds were identified that were both P&B and 48 were identified as P only. Of the non-HPV compounds, 364 pharmaceuticals were identified that were P&B. This study has yielded some interesting and probable P&B pharmaceuticals that should be considered for further study.

[Implementation of a remote oncology-monitoring program for cancer patients in outpatient care unit: A major challenge for the different actors].

PubMed

Peyrilles, Elodie; Lepage-Seydoux, Coralie; Sejean, Karine; Bonan, Brigitte

2018-04-01

The development of outpatient departments requires health professionals to reorganize practices for a better patient monitoring and a better patient care pathway. To evaluate, using indicators, the impact of an oncology-monitoring program on activity and organizational fluidity in a Cytotoxic Preparation Unit and clinical departments. Method the clinical and biological data are collected between two injections by calling the patient two days prior chemotherapy is performed by a specialist nurse of an outsourced medical call center. After medical and pharmaceutical validation, early preparations (D-1) for expensive and non-expensive molecules are performed. The program is started in February 2016. After 3 months, 382 patients were included into the program. Twenty-three patients on average are called per day related to 1162 completed clinical questionnaires (87%). Among the files, 47% are complete at D-2 (biological and clinical data). The early preparation rate of expensive drugs, zero before the program for financial reasons, has reached 40% at 3 months. The destroyed preparation rate because of non-administration decreased from 5 to 2%. Preliminary results show a significant patient compliance, feasibility of early preparation of expensive and non-expensive chemotherapy. These are preliminary results of a one-year study. They will be completed by an evaluation of patients' and health professionals' satisfaction, evaluation of length of stay, optimization of operations for clinical departments and CPU. The D-2 biological data collection must be improved. A strong doctor/pharmacist collaboration is essential for better patient care pathway. Copyright © 2018 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

An ethical framework for pharmacy management: balancing autonomy and other principles.

PubMed

Glassman, Peter A; Schneider, Paul L; Good, Chester B

2014-04-01

Decisions to control pharmaceutical costs can cause conflicts as to what medications are covered. Such conflicts have ethical implications, however implicit, and given this fact, an ethical framework can help address them. In the following commentary, we discuss the more traditional, individual-level ethical considerations likely familiar to most clinicians. We, then, discuss population-level ethical constructs that clinicians may not as readily embrace. We also present a hypothetical cancer-care case to illustrate how imbalances in ethical foci between individual- and population-level constructs may lead to conflicts among health care actors and promote shifts in pharmaceutical decision making away from providers and toward payers, paradoxically reducing provider autonomy and hence patient autonomy. Finally, we propose a more comprehensive ethical framework to help converge individual, payer, and societal interests when making pharmaceutical use decisions. Pharmacists play a crucial role as pharmacy benefits managers and should be familiar with individual- and population-based ethical constructs.

The Development of the Croatian Competency Framework for Pharmacists.

PubMed

Mucalo, Iva; Hadžiabdić, Maja Ortner; Govorčinović, Tihana; Šarić, Martina; Bruno, Andreia; Bates, Ian

2016-10-25

Objective. To adjust and validate the Global Competency Framework (GbCF) to be relevant for Croatian community and hospital pharmacists. Methods. A descriptive study was conducted in three steps: translation, consensus development, and validation by an expert panel and public consultation. Panel members were representatives from community pharmacies, hospital pharmacies, regulatory and professional bodies, academia, and industry. Results. The adapted framework consists of 96 behavioral statements organized in four clusters: Pharmaceutical Public Health, Pharmaceutical Care, Organization and Management, and Personal and Professional Competencies. When mapped against the 100 statements listed in the GbCF, 27 matched, 39 were revised, 30 were introduced, and 24 were excluded from the original framework. Conclusions. The adaptation and validation proved that GbCF is adaptable to local needs, the Croatian Competency Framework that emerged from it being an example. Key amendments were made within Organization and Management and Pharmaceutical Care clusters, demonstrating that these issues can be country specific.

Randomized controlled trial of clinical pharmacy management of patients with type 2 diabetes in an outpatient diabetes clinic in Jordan.

PubMed

Jarab, Anan Sadeq; Alqudah, Salam Ghazi; Mukattash, Tareq Lewis; Shattat, Ghassan; Al-Qirim, Tariq

2012-09-01

Glycemic goals (hemoglobin A1c < 7%) are often not achieved in patients with type 2 diabetes despite the availability of many effective treatments and the documented benefits of glycemic control in the reduction of long-term microvascular and macrovascular complications. Several studies have established the important positive effects of pharmacist-led management on achieving glycemic control and other clinical outcomes in patients with diabetes. Diabetes prevalence and mortality are increasing rapidly in Jordan. Nevertheless, clinical pharmacists in Jordan do not typically provide pharmaceutical care; instead, the principal responsibilities of pharmacists in Jordan are dispensing and marketing of medical products to physicians. To assess the primary clinical outcome of glycemic control (A1c) and secondary outcomes, including blood pressure, lipid values, self-reported medication adherence, and self-care activities for patients with type 2 diabetes in an outpatient diabetes clinic randomly assigned to either usual care or a pharmacist-led pharmaceutical care intervention program. Patients with type 2 diabetes attending an outpatient diabetes clinic of a large teaching hospital were recruited over a 4-month period from January through April 2011 and randomly assigned to intervention and usual care groups using the Minim software technique. The intervention group at baseline received face-to-face objective-directed education from a clinical pharmacist about type 2 diabetes, prescription medications, and necessary lifestyle changes, followed by 8 weekly telephone follow-up calls to discuss and review the prescribed treatment plan and to resolve any patient concerns. The primary outcome measure was glycemic control (A1c), and secondary measures included systolic and diastolic blood pressure, complete lipid profile (i.e., total cholesterol, low-density lipoprotein cholesterol [LDL-C], high-density lipoprotein cholesterol [HDL-C], serum triglycerides), and self-reported medication adherence (4-item Morisky Scale) and self-care activities (Summary of Diabetes Self-Care Activities questionnaire). Data were collected at baseline and at 6 months follow-up. Changes from baseline to follow-up were calculated for biomarker values, and between-group differences in the change amounts were tested using the t test for independent samples. A P value of < 0.05 was considered statistically significant. A total of 77 of 85 patients (90.6%) randomly assigned to the intervention group and 79 of 86 patients (91.9%) assigned to usual care had baseline and 6-month follow-up values. Compared with baseline values, patients in the intervention group had a mean reduction of 0.8% in A1c versus a mean increase of 0.1% from baseline in the usual care group (P = 0.019). The intervention group compared with the usual care group had small but statistically significant improvements in the secondary measures of fasting blood glucose, systolic and diastolic blood pressure, total cholesterol, LDL-C, serum triglycerides, self-reported medication adherence, and self-care activities. Between-group differences in changes in the secondary measures of HDL-C and body mass index were not significant. Patients with type 2 diabetes who received pharmacist-led pharmaceutical care in an outpatient diabetes clinic experienced reduction in A1c at 6 months compared with essentially no change in the usual care group. Six of 8 secondary biomarkers were improved in the intervention group compared with usual care. Copyright © 2012, Academy of Managed Care Pharmacy. All rights reserved.

Marketing the use of the space environment for the processing of biological and pharmaceutical materials

NASA Technical Reports Server (NTRS)

1984-01-01

The perceptions of U.S. biotechnology and pharmaceutical companies concerning the potential use of the space environment for the processing of biological substances was examined. Physical phenomena that may be important in space-base processing of biological materials are identified and discussed in the context of past and current experiment programs. The capabilities of NASA to support future research and development, and to engage in cooperative risk sharing programs with industry are discussed. Meetings were held with several biotechnology and pharmaceutical companies to provide data for an analysis of the attitudes and perceptions of these industries toward the use of the space environment. Recommendations are made for actions that might be taken by NASA to facilitate the marketing of the use of the space environment, and in particular the Space Shuttle, to the biotechnology and pharmaceutical industries.

[Translational/regulatory science researches of NIHS for regenerative medicine and cellular therapy products].

PubMed

Sato, Yoji

2014-01-01

In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the revisions to the Pharmaceutical Affairs Act, which was also renamed as the Therapeutic Products Act (TPA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the TPA, a product derived from processing cells is categorized as a subgroup of "regenerative medicine, cellular therapy and gene therapy products" (RCGPs), products distinct from pharmaceuticals and medical devices, allowing RCGPs to obtain a conditional and time- limited marketing authorization much earlier than that under the conventional system. To foster not only RCGPs, but also innovative pharmaceuticals and medical devices, the Ministry of Health, Labour and Welfare recently launched Translational Research Program for Innovative Pharmaceuticals, Medical Devices and RCGPs. This mini-review introduces contributions of the National Institute of Health Sciences (NIHS) to research projects on RCGPs in the Program.

Occurrence and distribution of selected pharmaceuticals and personal care products in aquatic environments: a comparative study of regions in China with different urbanization levels.

PubMed

Chen, Hong; Li, Xiaojuan; Zhu, Saichang

2012-07-01

We analyzed and compared the distributions of 13 target pharmaceuticals in different water samples from the Hangzhou metropolitan area and Linan County, Southeast China. Sampling was conducted in five hospitals, two wastewater treatment plants (WWTPs), and Qiantang River. Samples were concentrated by solid-phase extraction and PPCP concentrations were determined by UPLC-MS/MS. Trimethoprim, erythromycin A dihydrate, norfloxacin, ofloxacin, diclofenac sodium, and atenolol were the most frequently detected pharmaceuticals in hospital effluents. Most of the pharmaceutical concentrations in hospital effluents were higher than those in the WWTP influents. Although both WWTPs adopt the anaerobic-aerobic-anoxic treatment process, the removal rates for pharmaceuticals, such as trimethoprim and diclofenac sodium, were completely different. Meanwhile, erythromycin A dihydrate, ofloxacin, penicillin-G, cephalexin, cefazolin, ibuprofen, and diclofenac sodium were detected in Qiantang River. These results indicate that hospitals are more concentrated sources of pharmaceuticals than WWTPs, and the WWTPs are not the only route of entry of pharmaceuticals into aquatic environments in these two regions.

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2012 CFR

2012-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2014 CFR

2014-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2013 CFR

2013-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

38 CFR 62.33 - Supportive service: Assistance in obtaining and coordinating other public benefits.

Code of Federal Regulations, 2011 CFR

2011-07-01

... pharmaceuticals, supplies, equipment, devices, appliances, and assistive technology. (b) Daily living services...) Child care, which includes the: (1) Referral of a participant, as appropriate, to an eligible child care provider that provides child care with sufficient hours of operation and serves appropriate ages, as needed...

[Toward a new model of pharmacy management comprehensive care of patients with chronic kidney disease].

PubMed

Muros-Ortega, M; Ramos, R; Molina, M

2014-07-01

The treatment of chronic kidney disease represents 2.5% of the National Healthcare System budget. Given the panorama of economic crisis, actions aimed at containing the costs in this kind of pathologies should be implemented. Centralization of the management of the medications used for the treatment of chronic kidney disease and its complications aims at reducing the pharmaceutical expenditure. The new contracts of public healthcare administrations with companies of dialysis centers establish a single price by which the contractor takes care of the integral management of the patients, including the dialysis therapy and pharmacological treatment. Drug management at dialysis centers will be handled by specialized pharmacists by means of the creation of pharmacy departments or drug warehouse. these measures aim at improving healthcare of the patient in hemodialysis program, with health benefits at a lower healthcare cost. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

The role of the pharmaceutical animal health industry in post-marketing surveillance of resistance.

PubMed

Lens, S

1993-06-01

The pharmaceutical animal health industry must be committed to the total life cycle of products, i.e. during both the pre- and post-marketing period. Support of antibacterial agents during the postmarketing period is not restricted to maintaining a well-established distribution and promotion system. Care has to be taken continuously to maintain and/or improve the quality, safety (for user, target animal and environment) and clinical efficacy. The pharmaceutical industry contributes to this by: 1. Introducing antibacterials in different animal species for the most effective disease condition only and by ensuring the veterinary profession is informed about relevant findings on: a. the mechanism of action; b. pharmacodynamic properties; c. pharmacokinetic properties (plasma, target tissue); d. clinical efficacy data and in vitro sensitivity data; e. valid species-specific MIC breakpoints; f. precise dose and treatment regime. 2. Updating on a regular basis on: a. new findings on the mechanism of action (in vitro and in vivo); b. the optimal use program in the light of changes in animal husbandry, farm management and epidemiology on national and international level; c. adjustment of species-specific MIC breakpoints when necessary. 3. Providing continuous information in collaboration with animal health laboratories about: a. clinical field surveillance for efficacy (national, international); b. in vitro sensitivity/resistance surveillance (national, international); c. use of in vitro data to support prediction of in vivo efficacy. Surveillance of resistance, in vitro, is therefore part of a package of information needed on a routine basis by the pharmaceutical industry to allow the best possible use of antibacterials and to minimize induction of resistance.(ABSTRACT TRUNCATED AT 250 WORDS)

Uptake and Accumulation of Pharmaceuticals in Lettuce Under Surface and Overhead Irrigations

NASA Astrophysics Data System (ADS)

Bhalsod, G.; Chuang, Y. H.; Jeon, S.; Gui, W.; Li, H.; Guber, A.; Zhang, W.

2015-12-01

Pharmaceuticals and personal care products are being widely detected in wastewater and surface waters. As fresh water becomes scarcer, interests in using reclaimed water for crop irrigation is intensified. Since reclaimed waters often carry trace levels of pharmaceuticals, accumulation of pharmaceuticals in food crops could increase the risk of human exposure. This study aims to investigate uptake and accumulations of pharmaceuticals in greenhouse-grown lettuce under contrasting irrigation practices (i.e., overhead and surface irrigations). Lettuce was irrigated with water spiked with 11 commonly used pharmaceuticals (acetaminophen, caffeine, carbamazepine, sulfadiazine, sulfamethoxazole, carbadox, trimethoprim, lincomycin hydrochloride, oxytetracycline hydrochloride, monensin sodium, and tylosin). Weekly sampling of lettuce roots, shoots, and soils were continued for 5 weeks, and the samples were freeze dried, extracted for pharmaceuticals and analyzed by LC-MS/MS. Preliminary results indicate that higher concentrations of pharmaceuticals were found in overhead irrigated lettuce compared to surface irrigated lettuce. For carbamezapine, sulfadiazine, trimethoprim, oxytetracycline, and monensin sodium, their concentrations generally increased in lettuce shoots in the overhead treatment over time. However, acetaminophen was found at higher concentrations in both shoots and roots, indicating that acetaminophen can be easily transported in the plant system. This study provides insight on developing better strategies for using reclaimed water for crop irrigations, while minimizing the potential risks of pharmaceutical contamination of vegetables.

Curbing the costly trend: exploring the need for a progressive approach to the management of specialty pharmaceuticals under the medical benefit.

PubMed

Jacobs, Michael S; Johnson, Kjel A

2012-07-01

Specialty injectables and protein-based biologic therapies represent the fastest growing segment of the drug trend for many plan sponsors. Coupled with the decline in spending on traditional pharmaceuticals and so-called blockbuster drugs coming off patent, the upward trend of specialty drug spending continues at an unprecedented rate, precipitating a shift in the focus of payers who manage prescription drugs. To characterize the current and future specialty drug spending and describe contemporary trends among payers for managing cost and quality in this segment, as well as to elucidate the shortcomings of the current efforts and to explore a comprehensive approach for addressing the cost and quality concerns directly associated with specialty injectables and protein-based biologics through interrelated management interventions. Although a notable decrease in spending on traditional pharmaceuticals was realized in 2010, disproportionate increases in specialty drug utilization and cost per unit fueled the continuing growth of the injectable and biologic markets. Each course of these therapies can cost in the tens of thousands of dollars, and this upward trend of specialty spending represents an escalation of an already significant spending for payers, employers, and members. Beyond the high cost and growing utilization of specialty pharmaceuticals, current management efforts have been met with variable degrees of success and have often proved challenging and, in some cases, even counterproductive. Common interventions used by payers nationwide for addressing specialty drug spending trend include specialty drug formularies, provider reimbursement strategies, distribution channel management, benefit design modifications, utilization management, and operational and administrative improvements such as postclaim edits. Although often overlooked, appropriate implementation of these tactics, and the extent to which they are integrated with overall drug benefit management, are key to the success of the pharmaceutical management program. Conventional specialty pharmaceutical management initiatives offer promise in various areas, but incentives for the best protocols may be misaligned when they are applied individually. Conversely, a comprehensive approach that integrates effective components of the specialty pharmaceutical management interventions can improve the quality of care and control costs associated with these agents, with significant specialty drug management expertise and access to benchmarking data serving as the foundation for appropriate decision-making.

[Having trouble with pressure ulcers care?].

PubMed

Mizuno, Masako; Noda, Yasuhiro; Nohara, Yoko; Fujii, Keiko; Sato, Noriko; Renda, Akiyoshi; Yuasa, Takashi; Muramatsu, Shuichi; Furuta, Katsunori

2004-12-01

Since 1997, we, the community pharmacists, have established this society, Aichi Prefecture Society for the Study of Pressure Ulcers Care, in order to furnish drug information about pressure ulcers care. Moist atmosphere is required for the healing of pressure ulcers. The moist environment that could be regulated depends on the physicochemical property of ointment bases. Therefore, ointment should reasonably be chosen to adjust the moisture. Since 2000, we have been committed to providing pharmacists, who work on home care, with a booklet to instruct how to choose ointments for pressure ulcers treatment. In 2002, when the Aichi pharmaceutical association held a training conference held at various hospitals using the booklet as a teaching material, hospital pharmacists cooperated by making a field study trip to observe pressure ulcers treatments. Nowadays researchers at pharmaceutical colleges have also cooperated in studying the efficacy and economical effect of the method of blending different ointments to improve the healing process of pressure ulcers.

Ovation Pharmaceuticals, Inc.

PubMed

Deutsch, Barry

2002-11-01

Ovation Pharmaceuticals, Inc. is a privately held specialty pharmaceutical company that focuses on products in central nervous system (CNS) disorders, oncology and other therapeutic areas where a small number of specialized physicians treat patients. Ovation serves unmet medical needs by acquiring underpromoted branded pharmaceutical products and promising late-stage development products no longer being actively promoted or developed by larger companies. Ovation supports acquired products through active sales and marketing activities and a clinical development program focused on new formulations, new indications and other product improvements. In April 2002, Ovation received a US$150 million commitment in private equity financing, believed to be the largest private equity investment received to date by an early-stage specialty pharmaceutical firm. Ovation used a portion of those funds to purchase its first two products from a major pharmaceutical company in August 2002.

The Belgian commitment to pharmaceutical quality: a model policy to improve quality assurance of medicines available through humanitarian and development programs.

PubMed

Ravinetto, Raffaella; Roosen, Tim; Dujardin, Catherine

2018-01-01

Today, a combination of globalization of pharmaceutical production, lack of regulatory harmonization, and weakness of Medicines Regulatory Authorities, creates the "perfect conditions" for poor-quality medicine to circulate in the global market and to penetrate the less-regulated countries. Medicines regulation is the responsibility of the national regulatory authorities in the recipient country, but in the poorer countries, in practice, the responsibility of supply of quality-assured medicines is often taken by Non-Governmental Organizations and other implementers. But with some notable exceptions, many donors lack a pharmaceutical procurement policy with adequate quality requirements; and many implementers lack the skills and expertise needed to orient themselves in the complex web of global pharmaceutical supply. Thus, patients served by humanitarian or development programs may remain exposed to the risk of poor-quality medicines. When public money is used to purchase medicines for medical programs to be carried out overseas, adequate policies should be in place to assure that the same quality requirements are set that would be required for medicines marketed in the "donor" country. We will describe here a policy recently adopted in Belgium, i.e. the "Commitment to Quality Assurance for Pharmaceutical Products", signed in October 2017 by the Vice Prime Minister and Minister for Development Cooperation and 19 Belgian implementing agencies. By signing the new policy, the counterparts committed to ensure quality of medicines in the programs funded by Belgium's Official Development Assistance, and to build quality-assurance capacity in the recipient countries. Implementers are requested to integrate in their financing applications a section for pharmaceutical quality assurance, with a justified budget. They are also invited to consider how costs could be rationalized and mutualized by aligning the strengths of the various implementers. This model policy has the potential to be considered for adoption by other donors, to help to reduce the current multiple standards in pharmaceutical quality, and to contribute to protect vulnerable communities from the plague of poor-quality medicines. The online version of this article (10.1186/s40545-018-0136-z) contains an additional file, which is available to authorized users.

[Current Status of Community Pharmacies: Expectations as a Health Information Hub, the Enforcement of Revised Pharmaceutical and Medical Device Act, and a New Role as Stakeholders].

PubMed

Saito, Mitsuo

2016-01-01

According to the "Japan Revitalization Strategy" established in June 2013, "the government will promote better contributions of local pharmacies and pharmacists in encouraging self-medication of citizens by making pharmacies the community-based hub for providing information, giving advice on the proper use of non-prescription drugs, etc. and offering consultation and information service concerning health". In addition, the "Demanded Function and Ideal Form of Pharmacy," published in January 2014, requested a change, from pharmacies that specialized in dispensing medicines to pharmacies that serve as whole healthcare stations, providing pharmaceutical care based on patients' medical history, including the intake of dietary supplements. The medication fee was revised in April 2014 to enhance family pharmacy services and the management of pharmaceutical care. At that time, blood testing at a registered pharmacy was officially allowed under strict regulation. Revision of the "Pharmacist Law" in June 2014 included a request to pharmacists to provide pharmaceutical advice in addition to information. For the mitigation of drug-induced tragedies, the "Pharmaceutical Affairs Law" was amended to the "Pharmaceutical and Medical Device Act (PMD Act)" in November 2014, and proper use of medicines was imposed on healthcare professionals and other stakeholders. Patients were also requested to learn and understand the safety and harmful effects of medicines, and were requested to use medicines appropriately. As mentioned above, the status of pharmacies and pharmacists has dramatically changed in the past 2 years, and such changes over time are required.

Pharmaceuticals in drinking water: local analysis of the problem and finding a solution through awareness.

PubMed

Leal, Julie Ehret; Thompson, Amy N; Brzezinski, Walter A

2010-01-01

To evaluate public awareness of pharmaceuticals in drinking water and to develop educational efforts to promote awareness in our community. A review of the literature was conducted to gain a full perspective of the current issue. Questionnaires, interviews, and website feedback were used to assess awareness of the problem and the most commonly used medication disposal methods. In addition, educational flyers were created to disseminate information to the public. The questionnaires were completed by a total of 96 respondents. Of respondents employed in health care, 72% had previous knowledge of pharmaceutical medications being found in our local (Charleston, SC) water supply, and of respondents not employed in health care, 54% had previous knowledge. For those with previous knowledge, 7% disposed of medications in the toilet or sink, 38% used the trash, and 36% used multiple methods. Of respondents indicating no previous knowledge, 3% disposed of medications in the toilet or sink, 35% used the trash, and 42% used multiple methods. Public awareness of pharmaceuticals in drinking water and educational efforts focusing on proper disposal of medications are essential in helping to reduce drinking water contamination.

Development and clinical application of an evidence-based pharmaceutical care service algorithm in acute coronary syndrome.

PubMed

Kang, J E; Yu, J M; Choi, J H; Chung, I-M; Pyun, W B; Kim, S A; Lee, E K; Han, N Y; Yoon, J-H; Oh, J M; Rhie, S J

2018-06-01

Drug therapies are critical for preventing secondary complications in acute coronary syndrome (ACS). The purpose of this study was to develop and apply a pharmaceutical care service (PCS) algorithm for ACS and confirm that it is applicable through a prospective clinical trial. The ACS-PCS algorithm was developed according to extant evidence-based treatment and pharmaceutical care guidelines. Quality assurance was conducted through two methods: literature comparison and expert panel evaluation. The literature comparison was used to compare the content of the algorithm with the referenced guidelines. Expert evaluations were conducted by nine experts for 75 questionnaire items. A trial was conducted to confirm its effectiveness. Seventy-nine patients were assigned to either the pharmacist-included multidisciplinary team care (MTC) group or the usual care (UC) group. The endpoints of the trial were the prescription rate of two important drugs, readmission, emergency room (ER) visit and mortality. The main frame of the algorithm was structured with three tasks: medication reconciliation, medication optimization and transition of care. The contents and context of the algorithm were compliant with class I recommendations and the main service items from the evidence-based guidelines. Opinions from the expert panel were mostly positive. There were significant differences in beta-blocker prescription rates in the overall period (P = .013) and ER visits (four cases, 9.76%, P = .016) in the MTC group compared to the UC group, respectively. We developed a PCS algorithm for ACS based on the contents of evidence-based drug therapy and the core concept of pharmacist services. © 2018 John Wiley & Sons Ltd.

A Study of Attitude and Knowledge of the Psychiatry Resident Doctors toward Clinician–Pharmaceutical Industry Interaction

PubMed Central

Balhara, Yatan Pal Singh; Mathur, Shachi; Anand, Nikhilesh

2012-01-01

Background: Pharmaceutical industry and clinicians are the two important stakeholders in the modern-day health care. However, concerns have been expressed about the lack of congruence between the goals of these two. Aims: The current study aimed at exploring the knowledge and attitude of the psychiatry resident doctors toward the clinician–pharmaceutical industry interaction and also at exploring the knowledge of the residents about the new Medical Council of India guidelines on this issue. Materials and Methods: The survey was conducted among psychiatry residents. Descriptive statistics with frequency distribution was carried out by using SPSS version 17.0. Results: It had a good response rate of around 90%. The survey reveals the knowledge and attitude of the psychiatry residents toward the psychiatrist–pharmaceutical industry interaction. Conclusions: The survey provides understanding in knowledge and attitude of the psychiatry residents towards the psychiatrist-pharmaceutical industry interaction. PMID:22661810

Pharmaceutical marketing research and the prescribing physician.

PubMed

Greene, Jeremy A

2007-05-15

Surveillance of physicians' prescribing patterns and the accumulation and sale of these data for pharmaceutical marketing are currently the subjects of legislation in several states and action by state and national medical associations. Contrary to common perception, the growth of the health care information organization industry has not been limited to the past decade but has been building slowly over the past 50 years, beginning in the 1940s when growth in the prescription drug market fueled industry interest in understanding and influencing prescribing patterns. The development of this surveillance system was not simply imposed on the medical profession by the pharmaceutical industry but was developed through the interactions of pharmaceutical salesmen, pharmaceutical marketers, academic researchers, individual physicians, and physician organizations. Examination of the role of physicians and physician organizations in the development of prescriber profiling is directly relevant to the contemporary policy debate surrounding this issue.

Health Care Spending on Diabetes in the U.S., 1996-2013.

PubMed

Squires, Ellen; Duber, Herbert; Campbell, Madeline; Cao, Jackie; Chapin, Abigail; Horst, Cody; Li, Zhiyin; Matyasz, Taylor; Reynolds, Alex; Hirsch, Irl B; Dieleman, Joseph L

2018-05-10

Health care spending on diabetes in the U.S. has increased dramatically over the past several decades. This research describes health care spending on diabetes to quantify how that spending has changed from 1996 to 2013 and to determine what drivers are increasing spending. Spending estimates were extracted from the Institute for Health Metrics and Evaluation's Disease Expenditure 2013 database. Estimates were produced for each year from 1996 to 2013 for each of 38 age and sex groups and six types of care. Data on disease burden were extracted from the Global Burden of Disease 2016 study. We analyzed the drivers of spending by measuring the impact of population growth and aging and changes in diabetes prevalence, service utilization, and spending per encounter. Spending on diabetes in the U.S. increased from $37 billion (95% uncertainty interval $32-$42 billion) in 1996 to $101 billion ($97-$107 billion) in 2013. The greatest amount of health care spending on diabetes in 2013 occurred in prescribed retail pharmaceuticals (57.6% [53.8-62.1%] of spending growth) followed by ambulatory care (23.5% [21.7-25.7%]). Between 1996 and 2013, pharmaceutical spending increased by 327.0% (222.9-456.6%). This increase can be attributed to changes in demography, increased disease prevalence, increased service utilization, and, especially, increases in spending per encounter, which increased pharmaceutical spending by 144.0% (87.3-197.3%) between 1996 and 2013. Health care spending on diabetes in the U.S. has increased, and spending per encounter has been the biggest driver. This information can help policymakers who are attempting to control future spending on diabetes. © 2018 by the American Diabetes Association.

Estimated cost savings associated with the transfer of office-administered specialty pharmaceuticals to a specialty pharmacy provider in a Medical Injectable Drug program.

PubMed

Baldini, Christopher G; Culley, Eric J

2011-01-01

A large managed care organization (MCO) in western Pennsylvania initiated a Medical Injectable Drug (MID) program in 2002 that transferred a specific subset of specialty drugs from physician reimbursement under the traditional "buy-and-bill" model in the medical benefit to MCO purchase from a specialty pharmacy provider (SPP) that supplied physician offices with the MIDs. The MID program was initiated with 4 drugs in 2002 (palivizumab and 3 hyaluronate products/derivatives) growing to more than 50 drugs by 2007-2008. To (a) describe the MID program as a method to manage the cost and delivery of this subset of specialty drugs, and (b) estimate the MID program cost savings in 2007 and 2008 in an MCO with approximately 4.6 million members. Cost savings generated by the MID program were calculated by comparing the total actual expenditure (plan cost plus member cost) on medications included in the MID program for calendar years 2007 and 2008 with the total estimated expenditure that would have been paid to physicians during the same time period for the same medication if reimbursement had been made using HCPCS (J code) billing under the physician "buy-and-bill" reimbursement rates. For the approximately 50 drugs in the MID program in 2007 and 2008, the drug cost savings in 2007 were estimated to be $15.5 million (18.2%) or $290 per claim ($0.28 per member per month [PMPM]) and about $13 million (12.7%) or $201 per claim ($0.23 PMPM) in 2008. Although 28% of MID claims continued to be billed by physicians using J codes in 2007 and 22% in 2008, all claims for MIDs were limited to the SPP reimbursement rates. This MID program was associated with health plan cost savings of approximately $28.5 million over 2 years, achieved by the transfer of about 50 physician-administered injectable pharmaceuticals from reimbursement to physicians to reimbursement to a single SPP and payment of physician claims for MIDs at the SPP reimbursement rates.

Roles and Educational Effects of Clinical Case Studies in Home Medical Care.

PubMed

Ohsawa, Tomoji; Shimazoe, Takao

2017-01-01

Due to the progression of aging in Japan, pharmacists need to participate in home medical care. To enable pharmacists with no previous experience to participate in home medical care of patients with various diseases in the home environment, it is necessary to adopt an approach of training them in advance. It is thought useful for such clinical training to include patient case studies, which may facilitate the training of pharmacists for home medical care through simulated experience. "The working group to create home clinical cases for education" was launched by a group of university faculty, who have educational knowledge, and trained pharmacists who work with the patients at home. The home care cases were compiled by the university faculty members and the home care practice pharmacists. Working pharmacists and students at pharmaceutical college studied the same case studies of home medical care, and their self-evaluations were compared. They showed that the students rated themselves higher than the pharmacists. One of the reasons was the systematic education of the case studies. The clinical case studies are a good educational tool to promote home care medicine in pharmacies and university pharmaceutical colleges.

[Pharmaceutical Assistance in Mental Health: a diagnosis of Psychosocial Care Centers].

PubMed

Silva, Sarah Nascimento; Lima, Marina Guimarães

2017-06-01

The study evaluated the conditions of Pharmaceutical Assistance (PA) in Psychosocial Care Centers (CAPS) through a cross-sectional study in 15 CAPS located in the Médio Paraopeba region of the State of Minas Gerais. Data collection was conducted through direct observation of CAPS and interviews with pharmacists and managers of PA. The instruments were based on indicators proposed by the WHO, technical documents for the organization of PA, from legislation and recommendations seeking pharmaceutical Best Practices. There were 13 dispensing units, nine of them within the CAPS. The services presented updated lists of essential medicines with high availability of the main drugs used in mental health treatment. All of the cities participated in an inter-municipal consortium for the purchase of medicines. The complete identification of drugs was present in only seven services and all had failings in traceability of medicines dispensed. In the CAPS there is only one pharmacist during part of the operating period. The need for greater participation of the pharmacist was observed in the control and standardization of the activities of CAPS and especially in care activities comprising the benchmark team in Mental Health.

Investigating sources of pharmaceutical pollution: Survey of over-the-counter and prescription medication purchasing, use, and disposal practices among university students.

PubMed

Vatovec, Christine; Van Wagoner, Emily; Evans, Corey

2017-08-01

Pharmaceutical pollution in surface waters poses a range of risks to public health and aquatic ecosystems. Consumers contribute to pharmaceutical pollution via use and disposal of medications, though data on such behaviors is limited. This paper investigates the purchasing, use, and disposal practices among a population that has been researched only minimally to date, yet will determine pharmaceutical pollution for decades to come: young adults represented by a university student population. We employed an online, 21-question survey to examine behaviors related to pharmaceuticals among students at the University of Vermont (n = 358). Results indicate that the majority of respondents had purchased medications in the previous 12 months (94%), and had leftover drugs (61%). Contrary to previous studies of older populations, only a small proportion of students had disposed of drugs (18%); municipal trash was the primary route of drug disposal (25%), and very few students disposed drugs via flushing (1%). Less than a quarter of students were aware of drug take-back programs (24%), and only 4% had ever used take-back services. These findings indicate that the university student population may be storing a large volume of unused drugs that will require future disposal. Increasing awareness of, access to, and participation in pro-environment pharmaceutical behaviors, such as purchasing over-the-counter medication in smaller quantities and utilizing drug take-back programs, could minimize future pharmaceutical pollution from this population. Copyright © 2017 Elsevier Ltd. All rights reserved.

Chemical hazards in health care: high hazard, high risk, but low protection.

PubMed

McDiarmid, Melissa A

2006-09-01

It is counter-intuitive that the healthcare industry, whose mission is the care of the sick, is itself a "high-hazard" industry for the workers it employs. Possessing every hazard class, with chemical agents in the form of pharmaceuticals, sterilants, and germicidals in frequent use, this industry sector consistently demonstrates poor injury and illness statistics, among the highest in the United States, and in the European Union (EU), 34% higher than the average work-related accident rate. In both the United States and the EU, about 10% of all workers are employed in the healthcare sector, and in developing countries as well, forecasts for the increasing need of healthcare workers (HCW) suggests a large population at potential risk of health harm. The explosion of technology growth in the healthcare sector, most obvious in pharmaceutical applications, has not been accompanied by a stepped up safety program in hospitals. Where there is hazard recognition, the remedies are often voluntary, and often poorly enforced. The wrong assumption that this industry would police itself, given its presumed knowledge base, has also been found wanting. The healthcare industry is also a significant waste generator threatening the natural environment with chemical and infectious waste and products of incineration. The ILO has recommended that occupational health goals for industrial nations focus on the hazards of new technology of which pharma and biopharma products are the leaders. This unchecked growth cannot continue without a parallel commitment to the health and safety of workers encountering these "high tech" hazards. Simple strategies to improve the present state include: (a) recognizing healthcare as a "high-hazard" employment sector; (b) fortifying voluntary safety guidelines to the level of enforceable regulation; (c) "potent" inspections; (d) treating hazardous pharmaceuticals like the chemical toxicants they are; and (e) protecting HCWs at least as well as workers in other high-hazard sectors.

The impact of pharmaceutical direct advertising: opportunities and obstructions.

PubMed

Pinto, M B; Pinto, J K; Barber, J C

1998-01-01

The recent dramatic increase in direct-to-consumer advertising of prescription drugs has important implications for the pharmaceutical industry, physicians, and patients. One goal of direct advertising is to increase patient awareness of specific brands of medications while hoping to promote a greater frequency in office visits, presumably to specifically request these medicines. This paper will examine some of the benefits as well as drawbacks of the new, direct-to-customer pharmaceutical advertising, suggesting that in an era increasingly defined by the demands of managed care, such direct advertising may prove to have limited long-term effects.

Roles for Educational Psychologists in Pharmaceutical Education.

ERIC Educational Resources Information Center

Speedie, Stuart M.

Functions of educational specialists, including educational psychologists, in the field of pharmaceutical education are discussed. The functions considered range from a general educational consultant to evaluator of an innovative program. Requirements for functioning effectively within a pharmacy school are also examined. The compensation…

Daily baseline skin care in the prevention, treatment, and supportive care of skin toxicity in oncology patients: recommendations from a multinational expert panel

PubMed Central

Bensadoun, René-Jean; Humbert, Phillipe; Krutman, Jean; Luger, Thomas; Triller, Raoul; Rougier, André; Seite, Sophie; Dreno, Brigitte

2013-01-01

Skin reactions due to radiotherapy and chemotherapy are a significant problem for an important number of cancer patients. While effective for treating cancer, they disturb cutaneous barrier function, causing a reaction soon after initiation of treatment that impacts patient quality of life. Managing these symptoms with cosmetics and nonpharmaceutical skin care products for camouflage or personal hygiene may be important for increasing patient self-esteem. However, inappropriate product choice or use could worsen side effects. Although recommendations exist for the pharmaceutical treatment of skin reactions, there are no recommendations for the choice or use of dermatologic skin care products for oncology patients. The present guidelines were developed by a board of European experts in dermatology and oncology to provide cancer care professionals with guidance for the appropriate use of non-pharmaceutical, dermocosmetic skin care management of cutaneous toxicities associated with radiotherapy and systemic chemotherapy, including epidermal growth factor inhibitors and monoclonal antibodies. The experts hope that these recommendations will improve the management of cutaneous side effects and hence quality of life for oncology patients. PMID:24353440

A Student Orientation Program to Build a Community of Learners

PubMed Central

Santanello, Cathy R.; Gupchup, Gireesh V.

2007-01-01

Objectives To describe and evaluate a new student orientation program designed to lay the foundations for a community of learners. Design A weeklong orientation program structured as the first week of an 18-week fall semester was held for the first-professional year class. Each of the activities supported program objectives and developed elements of a community of learners. Assessment Students' reflective portfolios, daily evaluations and final program evaluations provided evidence of development of a community of learners. Positive student observations included the use of technology, a discussion of the curriculum and experiential education, the use of reflective portfolios, and presentations from pharmacy practitioners. Students also appreciated becoming acquainted with the faculty, staff, and their peers in a non-threatening atmosphere. Some of the aspects rated as least helpful were the learning styles exercise, library tour, history of pharmacy session, and the overall length of the orientation. Summary A model for a new student orientation program that builds the foundations for the development of a community of learning, which is vital to preparing students to provide pharmaceutical care in interdisciplinary teams and become critical thinkers, was successfully established. This model could be implemented at other schools of pharmacy. PMID:17429513

A review of intensive care nurse staffing practices overseas: what lessons for Australia?

PubMed

Clarke, T; Mackinnon, E; England, K; Burr, G; Fowler, S; Fairservice, L

1999-09-01

In view of market-driven health-care policies and the move to greater efficiencies within the health-care system, the cost of nursing care is being increasingly scrutinised. Different overseas practices are commonly cited as justification for changing practices within Australia. This study is based on a review of the literature on intensive care nurse staffing requirements in Australasia; specifically, New South Wales, the United States (US) and, to a lesser extent, Europe. It was found that looking to the US for cost-cutting strategies in intensive care units (ICUs) is based on a false premise: that we are comparing like with like. ICUs in the US have a different historical trajectory and culture, service wider constituencies, have technicians and unregistered personnel providing nursing care and do not provide demonstrably better outcomes or significant cost savings. Research indicates that continuous nursing care by trained professionals provides the best outcomes. If costs must be cut, technology, pharmaceuticals and laboratory tests should be targeted. Further, a greater commitment to the development of a 'progressive patient care' model in hospital planning is required, in order to establish or consolidate an intermediate level of nursing care between the ward and the ICU. Programs aiming to improve and continuously monitor patient care, such as adverse event monitoring, the prevention of unplanned extubation and facilitation of early extubation, should be instituted, as these have been shown to not only reduce ICU costs but also improve patient outcomes.

[Opinion of primary care physicians from Ourense on various features of the pharmaceutical prescription].

PubMed

Díaz Grávalos, G J; Palmeiro Fernández, G; Núnñez Masid, E; Casado Górriz, I

2001-01-01

To learn the opinion of the primary care Physicians of Ourense (Spain) with respect to certain aspects of their prescription of medicines, such as their awareness of the price of drugs, the induced prescribing perceived, their relationship with the pharmaceutical industry and their opinions concerning possible measures for reducing the expenditure on medicines. In this transversal descriptive study, all of the primary care physicians in the province of Ourense (243) were surveyed by means of a previously-approved questionnaire sent to them by post. The questionnaire included demographic characteristics of the physicians, the influence of cost when prescribing medicines, their estimate of the price of 15 drugs routinely prescribed and their opinion on different aspects relating to induced prescription, the pharmaceutical industry and different strategies in order to curtail the expenditure on medicines. In order to analyze the results, the chi 2 and Student's t tests and an analysis of the variance were used, together with the Spearman correlation coefficient with alpha = 0.05. The level of participation of the physicians surveyed was 42.8% (104). The average daily duration of visits by pharmaceutical company representatives was 13.6 minutes, with new specialities being the topic of greatest interest. Close to 27% admitted to having participated in clinical testing sponsored by the industry. 23% considered the price to be a priority when prescribing. Induced prescription accounted for 39.7% of the total. The majority of physicians chose co-payment as the means for reducing expenditure on medicines. In the estimate of prices, the overall percentage of error was 45.7%, underestimating the more expensive medicines and overestimating the less expensive. There is a significant lack of awareness of the price of drugs among the primary care physicians. Most of the physicians do not feel that the price of a drug should be a priority when prescribing medicines. There is a high percentage of induced prescription perceived. With regard to the expenditure on pharmaceuticals, the majority of those surveyed feel that financial measures, specifically co-payment, are the most effective in order to curtail rising costs.

Evaluation of a Teaching Assistant Program for Third-Year Pharmacy Students.

PubMed

Bradley, Courtney L; Khanova, Julia; Scolaro, Kelly L

2016-11-25

Objectives. To determine if a teaching assistant (TA) program for third-year pharmacy students (PY3s) improves confidence in teaching abilities. Additionally, 3 assessment methods (faculty, student, and TA self-evaluations) were compared for similarities and correlations. Methods. An application and interview process was used to select 21 pharmacy students to serve as TAs for the Pharmaceutical Care Laboratory course for 2 semesters. Participants' self-perceived confidence in teaching abilities was assessed at the start, midpoint, and conclusion of the program. The relationships between the scores were analyzed using 3 assessment methods. Results. All 21 TAs agreed to participate in the study and completed the 2 teaching semesters. The TAs confidence in overall teaching abilities increased significantly (80.7 vs 91.4, p <0.001). There was a significant difference between the three assessment scores in the fall ( p =0.027) and spring ( p <0.001) semesters. However, no correlation was found among the assessment scores. Conclusions. The TA program was effective in improving confidence in teaching abilities. The lack of correlation among the assessment methods highlights the importance of various forms of feedback.

Free access to hypertension and diabetes medicines among the elderly: a reality yet to be constructed.

PubMed

Paniz, Vera Maria Vieira; Fassa, Anaclaudia Gastal; Facchini, Luiz Augusto; Piccini, Roberto Xavier; Tomasi, Elaine; Thumé, Elaine; da Silveira, Denise Silva; Rodrigues, Maria Aparecida; Domingues, Marlos Rodrigues; Bertoldi, Andréa Dâmaso

2010-06-01

The study evaluated free access to hypertension and diabetes medicines and the reasons reported for lack of access. The sample included 4,003 elderly people living in Primary Care Unit coverage areas from 41 Southern and Northeastern Brazilian cities. Free access was higher in the Northeast (62.4%). The strategy of the Family Health Program (Programa Saúde da Família - PSF) was more effective in providing access than the traditional model, with higher results in the Northeast (61.2%) than in the South (39.6%). Around 20% of medicines included in the Hypertension and Diabetes Program and 26% of those included in the National Essential Medicines List (RENAME) were paid out of pocket. In the Northeast, 25% of insulin and 32% of oral antidiabetics were paid out of pocket. Unavailability in the public sector and a lack of money determined the lack of access. Although the PSF, Hypertension and Diabetes Program and RENAME expanded free access, supplies were insufficient. A greater connection between programs and a clear definition of responsibilities can improve medicine acquisition process, increasing the effectiveness of pharmaceutical assistance.

Management considerations to implementing pharmaceutical care.

PubMed

Wichman, K; Hales, B; O'Brodovich, M; Paton, T; Wielenga, J

1993-12-01

Progressing towards the goal of PC requires a fundamental change to pharmacy practice. Strong leadership and management skills will be needed to facilitate this change. Even with enthusiastic and capable staff, implementation of the PC model will require considerable effort. Changes to the department's mission statement and organizational structure will be required. From this beginning, an action plan for the department can be developed. This plan includes the training of individuals and/or recruiting the necessary personnel. An ongoing education program, as well as determining the value of your service, is required. With successful implementation the PC model will lead to the acceptance of the pharmacist's role as the person responsible for identifying, preventing, and resolving drug-related problems.

The removal of pharmaceuticals, personal care products, endocrine disruptors and illicit drugs during wastewater treatment and its impact on the quality of receiving waters.

PubMed

Kasprzyk-Hordern, Barbara; Dinsdale, Richard M; Guwy, Alan J

2009-02-01

A 5-month monitoring program was undertaken in South Wales in the UK to determine the fate of 55 pharmaceuticals, personal care products, endocrine disruptors and illicit drugs (PPCPs) in two contrasting wastewater plants utilising two different wastewater treatment technologies: activated sludge and trickling filter beds. The impact of treated wastewater effluent on the quality of receiving waters was also assessed. PPCPs were found to be present at high loads reaching 10kgday(-1) in the raw sewage. Concentrations of PPCPs in raw sewage were found to correlate with their usage/consumption patterns in Wales and their metabolism. The efficiency of the removal of PPCPs was found to be strongly dependent on the technology implemented in the wastewater treatment plant (WWTP). In general, the WWTP utilising trickling filter beds resulted in, on average, less than 70% removal of all 55 PPCPs studied, while the WWTP utilising activated sludge treatment gave a much higher removal efficiency of over 85%. The monitoring programme revealed that treated wastewater effluents were the main contributors to PPCPs concentrations (up to 3kg of PPCPsday(-1)) in the rivers studied. Bearing in mind that in the cases examined here the WWTP effluents were also major contributors to rivers' flows (dilution factor for the studied rivers did not exceed 23 times) the effect of WWTP effluent on the quality of river water is significant and cannot be underestimated.

[Clinical pharmacist influence at hospital to prevent overdosed prescription of acetaminophen].

PubMed

Viguier, F; Roessle, C; Zerhouni, L; Rouleau, A; Benmelouka, C; Chevallier, A; Chast, F; Conort, O

2016-11-01

The recommended daily dose of acetaminophen is limited to 60mg/kg/day with a maximum of 3g daily dose in adults weighing less than 50kg or in patients undergoing certain risk factors. This study aimed at assessing the fulfillment of those recommendations and the possible impact on the liver dysfunction at supra-therapeutic doses of acetaminophen. This study was performed one day in 9 services. Patients characteristics, acetaminophen dose, daily dose administered, physiopathological aspects, markers of liver damage were collected. Among 542 prescriptions analyzed, 343 of them contained acetaminophen. The median age of patients studied was 81 years and one third weighed less than 50kg. The main risk factor of supra-therapeutic prescriptions was the lack of dose acetaminophen based on weight with 14% patients concerned and this risk raised at 17% when the pathophysiological conditions were included. The presence of pharmacists in medicals departments was more effective than the use of informatics programs limiting the dose systematically to 3g/day, or a distant pharmaceutical validation from care services to reduce the risk of acetaminophen overdose. According to the statement of administrations, only 4 of 49 patients received doses above 60mg/kg/day with a low impact on liver function tests. The continuous presence in pharmaceutical care services was the most effective measure to ensure effective implementation of acetaminophen recommendations. Copyright © 2016 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Pharmaceutical technology management--profitable business avenue.

PubMed

Puthli, Shivanand P

2010-01-01

Growing research expenditure, regulatory framework and generic erosion have forced pharmaceutical companies globally to resort to pharmaceutical technology management (PTM). Indeed, the pharmaceutical industry has witnessed the impact of innovative drug delivery and device technologies and their influence on business. PTM has given a new business insight with greater profits and enhancement of product franchise. Promising breakthrough technologies have not been able to reach a commercial platform largely owing to lack of capital at the preliminary stages of the product development program. Intellectual property plays a considerable role in protecting innovative technologies. Joint ventures and strategic alliances also become important for commercializing a new technology. The synergy of PTM with options of in-licensing is expected to infuse newer opportunities to the pharmaceutical business.

Learning through the Community Service.

PubMed

Duzel, Goran; Kristo, Tina; Parcina, Marijo; Simunović, Vladimir J

2003-02-01

To present a model of teaching general practice to medical students as a part of care for refugees in Mostar, Bosnia and Herzegovina. With an international support, 33 medical students (from the third study year on) participated in a total of 51 field visits to 4 refugee camps near Mostar, Bosnia and Herzegovina, over a period of two years. Some students made more than 30 visits. Together with residents in family medicine at the Mostar University Hospital, the students performed physical examinations and small interventions, and distributed packs of different pharmaceutical agents to refugees. At the end of the project, participants were surveyed to assess the benefits of the program. Thirty out of 33 participating students responded to the survey. Fourteen students said that "the opportunity to do something, however small, for the people" was the main benefit from the project, whereas 5 thought that meeting "a real patient" early in their medical studies was very beneficial. The students assisted in 1,302 physical examinations, an average of 25-/+8 examinations per visit. The most requested physical examination was blood pressure measurement (52%), followed by chest auscultation (24%) and psychological counseling (16%). They also helped with a total of 320 minor procedures, an average of 6-/+2 per visit. Among the procedures, wound care and dressing were most common (63.4%), followed by nursing care procedures (20%) and minor surgical procedures (suture removal, abscess drainage, and bed sores debridement) in 6.9% of the cases. The students helped distribute 1,917 packs of pharmaceuticals: analgesics (52.5%), antihypertensive drugs (16.1%), antidiabetics (11.2%), cardiovascular drugs (10.9%), vitamins (5.6%), and dermatological remedies (3.6%). During the first two years of the project, we achieved three objectives. Residents in family medicine had a chance to practice and gain experience as group leaders, health promoters, and teachers. Medical students were exposed to a demanding outpatient environment early in their medical training. Refugees in three camps received health care and attention they needed so much.

Drug Information Residency Rotation with Pharmaceutical Industry.

ERIC Educational Resources Information Center

Cramer, Richard L.

1986-01-01

Program objectives of a drug information rotation at the Upjohn Company include improving communication between the pharmaceutical industry and hospital pharmacy/academia, exposing the resident to the challenges the industry encounters, improving proficiency in drug information practice, and providing insight into the working relationships of…

A unique degree program for pre-pharmacy education: An undergraduate degree in pharmaceutical sciences.

PubMed

Jafari, Mahtab

2018-02-01

Within the coming decade, the demand for well-trained pharmacists is expected to only increase, especially with the aging of the United States (US) population. To help fill this growing demand, the University of California, Irvine (UCI) aims to offer a unique pre-pharmacy degree program and has developed a Bachelor of Science (BS) degree in Pharmaceutical Sciences to help achieve this goal. In this commentary, we share our experience with our curriculum and highlight its features in an effort to encourage other institutions to enhance the learning experience of their pre-pharmacy students. The efforts of the UCI Department of Pharmaceutical Sciences has resulted in UCI being consistently ranked as one of the top feeder institutions by the Pharmacy College Application Service (PharmCAS) in recent years. The UCI Pharmaceutical Sciences Bachelor of Science offers a unique pre-pharmacy educational experience in an effort to better prepare undergraduates for the rigors of the doctorate of pharmacy curriculum. Copyright © 2017. Published by Elsevier Inc.

Academia-industry collaboration in continuing medical education: description of two approaches.

PubMed

Katz, Harvey P; Goldfinger, Stephen E; Fletcher, Suzanne W

2002-01-01

Although concerns have been raised about industry support of continuing medical education (CME), there are few published reports of academia-industry collaboration in the field. We describe and evaluate Pri-Med, a CME experience for primary care clinicians developed jointly by the Harvard Medical School (HMS) and M/C Communications. Since 1995, 19 Pri-Med conferences have been held in four cities, drawing more than 100,000 primary care clinicians. The educational core of each Pri-Med conference is a 3-day Harvard course, "Current Clinical Issues in Primary Care." Course content is determined by a faculty committee independent of any commercial influence. Revenues from multiple industry sources flow through M/C Communications to the medical school as an educational grant to support primary care education. Pri-Med also offers separate pharmaceutical company-funded symposia. Comparing the two educational approaches during four conferences, 221 HMS talks and 103 symposia were presented. The HMS course covered a wide range with 133 topics; the symposia focused on 30 topics, most of which were linked to recently approved new therapeutic products manufactured by the funders. Both the course and the symposia were highly rated by attendees. When CME presentations for primary care physicians receive direct support from industry, the range of offered topics is narrower than when programs are developed independently of such support. There appear to be no differences in the perceived quality of presentations delivered with and without such support. Our experience suggests that a firewall between program planners and providers of financial support will result in a broader array of educational subjects relevant to the field of primary care.

Pharmaceuticals, political money, and public policy: a theoretical and empirical agenda.

PubMed

Jorgensen, Paul D

2013-01-01

Why, when confronted with policy alternatives that could improve patient care, public health, and the economy, does Congress neglect those goals and tailor legislation to suit the interests of pharmaceutical corporations? In brief, for generations, the pharmaceutical industry has convinced legislators to define policy problems in ways that protect its profit margin. It reinforces this framework by selectively providing information and by targeting campaign contributions to influential legislators and allies. In this way, the industry displaces the public's voice in developing pharmaceutical policy. Unless citizens mobilize to confront the political power of pharmaceutical firms, objectionable industry practices and public policy will not change. Yet we need to refine this analysis. I propose a research agenda to uncover pharmaceutical influence. It develops the theory of dependence corruption to explain how the pharmaceutical industry is able to deflect the broader interests of the general public. It includes empirical studies of lobbying and campaign finance to uncover the means drug firms use to: (1) shape the policy framework adopted and information used to analyze policy; (2) subsidize the work of political allies; and (3) influence congressional voting. © 2013 American Society of Law, Medicine & Ethics, Inc.

Unhealthy marketing of pharmaceutical products: An international public health concern.

PubMed

Mulinari, Shai

2016-05-01

I consider the current state of pharmaceutical marketing vis-à-vis ethical and legal standards and advocate measures to improve it. There is abundant evidence of unethical or illicit marketing. It fuels growing concerns about undue corporate influence over pharmaceutical research, education, and consumption. The most extensive evidence of industry transgressions comes from the United States (US), where whistle-blowers are encouraged by financial rewards to help uncover illicit marketing and fraud. Outside the US increasing evidence of transgressions exists. Recently I have observed a range of new measures to align pharmaceutical marketing practices with ethical and legal standards. In the interest of public health, I highlight the need for additional and more profound reforms to ensure that information about medicines supports quality and resource-efficient care.

Marketing concepts for pharmaceutical service development.

PubMed

Grauer, D W

1981-02-01

Marketing concepts as a mechanism to help pharmacy develop, communicate, and sell future pharmaceutical services to consumers are discussed. Pharmacy as a profession must define itself broadly to take advantage of future growth opportunities. These growth opportunities will be realized from unmet health-care needs and changing consumer life style trends and values. New services must therefore be oriented toward consumers (i.e., patients, health professionals, and third-party agencies) to gain acceptance. Dispensing and drug-knowledge-distribution pharmaceutical services are reviewed by a product life cycle analysis of sales profits versus time. A marketing mix for new pharmaceutical services is developed consisting of service, price, distribution, and promotion strategies. Marketing can encompass those key elements necessary to meet the organizational goals of pharmacy and provide a systematic, disciplined approach for presenting a new service to consumers.

Pharmaceutical concentrations in screened municipal wastewaters in Victoria, British Columbia: A comparison with prescription rates and predicted concentrations.

PubMed

Saunders, Leslie J; Mazumder, Asit; Lowe, Christopher J

2016-04-01

Pharmaceuticals and personal care products (PPCPs) are emerging chemicals of concern detected in surface waters globally. Recent reviews advocate that PPCP occurrence, fate, and exposure need to be better predicted and characterized. The use of pharmaceutical prescription rates to estimate PPCP concentrations in the environment has been suggested. Concentrations of 7 pharmaceuticals (acetylsalicylic acid, diclofenac, fenoprofen, gemfibrozil, ibuprofen, ketoprofen, and naproxen) were measured in municipal wastewater using gas chromatography/ion trap-tandem mass spectroscopy (GC/IT-MS/MS). Subregional pharmaceutical prescription data were investigated to determine whether they could predict measured effluent concentrations (MECs) in wastewaters. Predicted effluent concentrations (PECs) for 5 of the 7 pharmaceuticals were within 2-fold agreement of the MECs when the fraction of parent pharmaceutical excreted was not considered. When the fraction of parent pharmaceutical excreted was considered, the respective PECs decreased, and most were within an order of magnitude of the MECs. Regression relationships of monthly PECs versus MECs were statistically significant (p < 0.05) but weak (R(2) = 0.18-0.56) for all pharmaceuticals except ketoprofen. This suggests high variability in the data and may be the result of factors influencing MECs such as the analytical methods used, wastewater sampling frequency, and methodology. The PECs were based solely on prescription rates and did not account for inputs of pharmaceuticals that had a significant over-the-counter component or were from other sources (e.g., hospitals). © 2015 SETAC.

Applying Multi-Criteria Decision Analysis (MCDA) Simple Scoring as an Evidence-based HTA Methodology for Evaluating Off-Patent Pharmaceuticals (OPPs) in Emerging Markets.

PubMed

Brixner, Diana; Maniadakis, Nikos; Kaló, Zoltán; Hu, Shanlian; Shen, Jie; Wijaya, Kalman

2017-09-01

Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population's health. In addition, many health care systems lack the resources or expertise to evaluate such products, and current assessment methods can be complex and difficult to adapt to a health system's needs. Multicriteria decision analysis (MCDA) simple scoring is an evidence-based health technology assessment methodology for evaluating OPPs, especially in emerging countries in which resources are limited but decision makers still must balance affordability with factors such as drug safety, level interchangeability, manufacturing site and active pharmaceutical ingredient quality, supply track record, and real-life outcomes. MCDA simple scoring can be applied to pharmaceutical pricing, reimbursement, formulary listing, and drug procurement. In November 2015, a workshop was held at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in Milan to refine and prioritize criteria that can be used in MCDA simple scoring for OPPs, resulting in an example MCDA process and 22 prioritized criteria that health care systems in emerging countries can easily adapt to their own decision-making processes. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

Irradiation treatment of pharmaceutical and personal care products (PPCPs) in water and wastewater: An overview

NASA Astrophysics Data System (ADS)

Wang, Jianlong; Chu, Libing

2016-08-01

Pharmaceutical and personal care products (PPCPs), especially the pharmaceutically active compounds (PhACs) such as antibiotics and hormones have attracted great concerns worldwide for their persistence and potential threat to ecosystem and public health. This paper presents an overview on the ionizing irradiation-induced degradation of PPCPs in aqueous solution. Parameters that affect PPCPs degradation, such as the absorbed dose, solution pH, dose rate, water matrices and the presence of some inorganic ions and humic acid are evaluated. The mechanism and pathways of radiolytic degradation of PPCPs are reviewed. In many cases, PPCPs such as antibiotics and X-ray contrast agent could be removed completely by radiation, but a higher absorbed dose was needed for their mineralization and toxicity reduction. The combination of ionizing irradiation with other methods such as H2O2, ozonation and TiO2 nanoparticles could improve the degradation efficacy and reduce the cost. Ionizing irradiation is a promising alternative for degradation of PPCPs in aqueous solution.

Antibiotic, Pharmaceutical, and Wastewater-Compound Data for Michigan, 1998-2005

USGS Publications Warehouse

Haack, Sheridan Kidd

2010-01-01

Beginning in the late 1990's, the U.S. Geological Survey began to develop analytical methods to detect, at concentrations less than 1 microgram per liter (ug/L), emerging water contaminants such as pharmaceuticals, personal-care chemicals, and a variety of other chemicals associated with various human and animal sources. During 1998-2005, the U.S. Geological Survey analyzed the following Michigan water samples: 41 samples for antibiotic compounds, 28 samples for pharmaceutical compounds, 46 unfiltered samples for wastewater compounds (dissolved and suspended compounds), and 113 filtered samples for wastewater compounds (dissolved constituents only). The purpose of this report is to summarize the status of emerging contaminants in Michigan waters based on data from several different project-specific sample-collection efforts in Michigan during an 8-year period. During the course of the 8-year sampling effort, antibiotics were determined at 20 surface-water sites and 2 groundwater sites, pharmaceuticals were determined at 11 surface-water sites, wastewater compounds in unfiltered water were determined at 31 surface-water sites, and wastewater compounds in filtered water were determined at 40 surface-water and 4 groundwater sites. Some sites were visited only once, but others were visited multiple times. A variety of quality-assurance samples also were collected. This report describes the analytical methods used, describes the variations in analytical methods and reporting levels during the 8-year period, and summarizes all data using current (2009) reporting criteria. Very few chemicals were detected at concentrations greater than current laboratory reporting levels, which currently vary from a low of 0.005 ug/L for some antibiotics to 5 ug/L for some wastewater compounds. Nevertheless, 10 of 51 chemicals in the antibiotics analysis, 9 of 14 chemicals in the pharmaceuticals analysis, 34 of 67 chemicals in the unfiltered-wastewater analysis, and 56 of 62 chemicals in the filtered-wastewater analysis were detected. Antibiotics were detected at 7 of 20 tested surface-water sites, but none were detected in 2 groundwater samples. Pharmaceuticals were detected at 7 of 11 surface-water sites. Wastewater compounds were detected at 25 of 31 sites for which unfiltered water samples were analyzed and at least once at all 40 surface-water sites and all 4 groundwater sites for which filtered water samples were analyzed. Overall, the chemicals detected most frequently in Michigan waters were similar to those reported frequently in other studies nationwide. Patterns of chemical detections were site specific and appear to be related to local sources, overall land use, and hydrologic conditions at the time of sampling. Field-blank results provide important information for the design of future sampling programs in Michigan and demonstrate the need for careful field-study design. Field-replicate results indicated substantial confidence regarding the presence or absence of the many chemicals tested. Overall, data reported herein indicate that a wide array of antibiotic, pharmaceutical, and organic wastewater compounds occur in Michigan waters. Patterns of occurrence, with respect to hydrologic, land use, and source variables, generally appear to be similar for Michigan as for other sampled waters across the United States. The data reported herein can serve as a basis for future studies in Michigan.

Application of Emerging Pharmaceutical Technologies for Therapeutic Challenges of Space Exploration Missions

NASA Technical Reports Server (NTRS)

Putcha, Lakshmi

2011-01-01

An important requirement of therapeutics for extended duration exploration missions beyond low Earth orbit will be the development of pharmaceutical technologies suitable for sustained and preventive health care in remote and adverse environmental conditions. Availability of sustained, stable and targeted delivery pharmaceuticals for preventive health of major organ systems including gastrointestinal, hepato-renal, musculo-skeletal and immune function are essential to offset adverse effects of space environment beyond low Earth orbit. Specifically, medical needs may include multi-drug combinations for hormone replacement, radiation protection, immune enhancement and organ function restoration. Additionally, extended stability of pharmaceuticals dispensed in space must be also considered in future drug development. Emerging technologies that can deliver stable and multi-therapy pharmaceutical preparations and delivery systems include nanotechnology based drug delivery platforms, targeted-delivery systems in non-oral and non-parenteral formulation matrices. Synthetic nanomaterials designed with molecular precision offer defined structures, electronics, and chemistries to be efficient drug carriers with clear advantages over conventional materials of drug delivery matricies. Nano-carrier materials like the bottle brush polymers may be suitable for systemic delivery of drug cocktails while Superparamagnetic Iron Oxide Nanoparticles or (SPIONS) have great potential to serve as carriers for targeted drug delivery to a specific site. These and other emerging concepts of drug delivery and extended shelf-life technologies will be reviewed in light of their application to address health-care challenges of exploration missions. Innovations in alternate treatments for sustained immune enhancement and infection control will be also discussed.

Using information technology for an improved pharmaceutical care delivery in developing countries. Study case: Benin.

PubMed

Edoh, Thierry Oscar; Teege, Gunnar

2011-10-01

One of the problems in health care in developing countries is the bad accessibility of medicine in pharmacies for patients. Since this is mainly due to a lack of organization and information, it should be possible to improve the situation by introducing information and communication technology. However, for several reasons, standard solutions are not applicable here. In this paper, we describe a case study in Benin, a West African developing country. We identify the problem and the existing obstacles for applying standard ECommerce solutions. We develop an adapted system approach and describe a practical test which has shown that the approach has the potential of actually improving the pharmaceutical care delivery. Finally, we consider the security aspects of the system and propose an organizational solution for some specific security problems.

Setting up chronic disease programs: perspectives from Aboriginal Australia.

PubMed

Hoy, Wendy E; Kondalsamy-Chennakesavan, S; Smith, J; Sharma, S; Davey, R; Gokel, G

2006-01-01

To share some perspectives on setting up programs to improve management of hypertension, renal disease, and diabetes in high-risk populations, derived from experience in remote Australian Aboriginal settings. Regular integrated checks for chronic disease and their risk factors and appropriate treatment are essential elements of regular adult health care. Programs should be run by local health workers, following algorithms for testing and treatment, with back up from nurses. Constant evaluation is essential. COMPONENTS: Theses include testing, treatment, education for individuals and communities, skills and career development for staff, ongoing evaluation, program modification, and advocacy. Target groups, elements, and frequency of testing, as well as the reagents and treatment modalities must be designed for local circumstances, which include disease burden and impact, competing priorities, and available resources. Pilot surveys or record reviews can define target groups and conditions. Opportunistic testing will suffice if people are seen with some regularity for other conditions; otherwise, systematic screening is needed, preferably embedded in primary care streams. The chief goal of treatment is to lower blood pressure, and if the patient is diabetic, to control hyperglycemia. Many people will need multiple drugs for many years. Challenges include lack of resources, competing demands of acute care, the burden of treatment when disease rates are high, problems with information systems, and in our setting, health worker absenteeism. Businesses, altruistic organizations, and pharmaceutical and biotechnology companies might fund feasibility studies. Where governments or insurance companies already support health services, they must ultimately commit to chronic disease services over the long- term. Effective advocacy requires the presentation of an integrated view of chronic disease and a single cross-disciplinary program for its containment. Arguments based on preserving the economic base of societies by preventing or delaying premature death will carry most weight, as will the costs of dialysis avoided in countries that already support open-access programs.

Professional Trends in American Optometry.

ERIC Educational Resources Information Center

Haffner, Alden N.

1991-01-01

A review of optometry's twentieth-century history looks at curriculum standardization and recognition of the doctorate in Optometry, federal legislation, public health movement, optometry in universities, use of pharmaceuticals, the primary care concept, Optometry in group health care, growth of professional publications, and entry into health…

Impact of the introduction of a specialist critical care pharmacist on the level of pharmaceutical care provided to the critical care unit.

PubMed

Richter, Anja; Bates, Ian; Thacker, Meera; Jani, Yogini; O'Farrell, Bryan; Edwards, Caroline; Taylor, Helen; Shulman, Rob

2016-08-01

To evaluate the impact of a dedicated specialist critical care pharmacist service on patient care at a UK critical care unit (CCU). Pharmacist intervention data was collected in two phases. Phase 1 was with the provision of a non-specialist pharmacist chart review service and Phase 2 was after the introduction of a specialist dedicated pharmacy service. Two CCUs with established critical care pharmacist services were used as controls. The impact of pharmacist interventions on optimising drug therapy or preventing harm from medication errors was rated on a 4-point scale. There was an increase in the mean daily rate of pharmacist interventions after the introduction of the specialist critical care pharmacist (5.45 versus 2.69 per day, P < 0.0005). The critical care pharmacist intervened on more medication errors preventing potential harm and optimised more medications. There was no significant change to intervention rates at the control sites. Across all study sites the majority of pharmacist interventions were graded to have at least moderate impact on patient care. The introduction of a specialist critical care pharmacist resulted in an increased rate of pharmacist interventions compared to a non-specialist pharmacist service thus improving the quality of patient care. © 2016 The Authors. IJPP © 2016 Royal Pharmaceutical Society.

The ethics of the medical-pharmaceutical relationship.

PubMed

Vashi, Neelam A; Latkowski, Jo-Ann M

2012-01-01

Physician interaction with the pharmaceutical industry raises many ethical concerns. This relationship is complex, owing to a pluralism of beliefs held by physicians, patients, and third parties. As a result, determining whether physicians fulfill their responsibilities to both the professional and public communities is an arduous endeavor. In an effort to clarify the situation and provide transparency to this complex relationship, medical and pharmaceutical organizations have enacted their own respective codes and guidelines. Even with adherence to these guidelines, questions remain regarding the codependent relationship that interweaves the pharmaceutical industry with the medical community. Owing to the ever-changing landscape enmeshing product development, scientific advancement, corporate realities and patient care, the proper choice for physicians is rarely obvious; however, to operate to the highest standards, those in the medical community must be candid about relations with the pharmaceutical industry and transparent in their financial interests. Further undertakings should focus not on the eradication of physician-pharmaceutical interaction, but instead on the education of physicians about industry marketing strategies and the delineation of boundaries of these interactions to benefit not the individual physician, but our patients. Copyright © 2012. Published by Elsevier Inc.

Incentives and pharmaceutical reimbursement reforms in Spain.

PubMed

Puig-Junoy, Jaume

2004-02-01

The aim of this paper is to assess whether cost containment has been affected by recent pharmaceutical reimbursement reforms that have been introduced in the Spanish health care system over the period 1996-2002, under the conservative Popular Party Government. Four main reimbursement policies can be observed in the Spanish pharmaceutical market after 1996, each of them largely unintegrated with the other three. First, a second supplementary negative list of excluded pharmaceutical products was introduced in 1998. Second, a reference pricing (RP) system was introduced in December 2000, with annual updating and enlargement. Third, the pharmacies' payment system has moved from the traditional set margin on the consumer price to a margin that varies according to the consumer price of the product, the generic status of the product, and the volume of sales by pharmacies. And fourth, general agreements between the government and the industry have been reached with cost containment objectives. In the final section of this paper, we present an overall assessment of the impact of these pharmaceutical reimbursement policies on the behaviour of the agents in the pharmaceutical market.

Pharmaceutical cocrystals, salts and polymorphs: Advanced characterization techniques.

PubMed

Pindelska, Edyta; Sokal, Agnieszka; Kolodziejski, Waclaw

2017-08-01

The main goal of a novel drug development is to obtain it with optimal physiochemical, pharmaceutical and biological properties. Pharmaceutical companies and scientists modify active pharmaceutical ingredients (APIs), which often are cocrystals, salts or carefully selected polymorphs, to improve the properties of a parent drug. To find the best form of a drug, various advanced characterization methods should be used. In this review, we have described such analytical methods, dedicated to solid drug forms. Thus, diffraction, spectroscopic, thermal and also pharmaceutical characterization methods are discussed. They all are necessary to study a solid API in its intrinsic complexity from bulk down to the molecular level, gain information on its structure, properties, purity and possible transformations, and make the characterization efficient, comprehensive and complete. Furthermore, these methods can be used to monitor and investigate physical processes, involved in the drug development, in situ and in real time. The main aim of this paper is to gather information on the current advancements in the analytical methods and highlight their pharmaceutical relevance. Copyright © 2017 Elsevier B.V. All rights reserved.

77 FR 12997 - Drug and Drug-Related Supply Promotion by Pharmaceutical Company Representatives at VA Facilities

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-05

... reduce or eliminate any potential for disruption in the patient care environment, manage activities and... activities that VA staff would otherwise perform during duty hours, including patient care and other... important that VA be able to limit the effects of such promotion on patient care. Again, we make no changes...

Self-care Improvement After a Pharmaceutical Intervention in Elderly Type 2 Diabetic Patients.

PubMed

Nascimentoa, Tania; Braz, Nídia; Gomes, Eurico; Fernandez-Arche, Angeles; De La Puerta, Rocio

2015-01-01

Diabetes mellitus involves long-term complications that affect diabetic patients' quality of life. The best way to prevent these complications is that patients achieve good metabolic control. In order to reach this goal, patients are requested to acquire daily behaviours (self-care). Such behaviours are sometimes hard to adhere, because they require changes in habits acquired over time. The aim of the present study is to evaluate the improvement on self-care after a pharmaceutical intervention on home regime patients. We performed a controlled experimental comparative study with a follow up of 6 months, on 87 patients, randomized in control group (n=43) and intervention group (n=44). We accessed sociodemographic and clinical data (glycaemic profile), as well as adherence to drug therapy and self-assessed care (before/after). In the intervention group, mean age was 74.2±5.4 years, and the median time of T2DM diagnosis was 14.7±8.5 years. At the end of study, the decrease in fasting blood glucose was higher in the intervention group patients than that observed in the control group (50.2mg/dL), with statistically significant difference (p<0.05), as well as the decrease verified in HbA1c. In self-care adherence, alterations in the levels of adherence of the general nutrition and physical exercise dimensions became evident, with an increase in the number of days of adherence. On medication adherence statistically significant alterations (p<0.05) were also recorded. We can conclude that an individualized pharmaceutical intervention can improve self-care behaviours, as well as medication adherence, contributing to better metabolic control.

National trends in prescription drug expenditures and projections for 2014.

PubMed

Schumock, Glen T; Li, Edward C; Suda, Katie J; Matusiak, Linda M; Hunkler, Robert J; Vermeulen, Lee C; Hoffman, James M

2014-03-15

An analysis of trends in U.S. pharmaceutical spending is presented, including projections for drug expenditures in nonfederal hospital and clinic settings in 2014. Trends in pharmaceutical expenditures and developments likely to influence future spending, including new drug approvals and patent expirations, were analyzed using data from the IMS Health National Sales Perspectives database. Projections were based on a combination of quantitative and qualitative analyses and expert opinion. Total prescription sales for the 12 months ending September 2013 were approximately $326 billion, 0.7% lower than sales during the previous 12 months; pharmaceutical spending by clinics and nonfederal hospitals grew by 4.5% and 1.8%, respectively. Vaccines were among the products driving large sales increases in clinic settings, with alteplase and pegfilgrastim topping the list of fast-growing drugs by hospital expenditures. Few new drug approvals anticipated in 2014 are expected to result in major expenditures by hospitals and clinics. Expansion of access to health care and other changes related to the Patient Protection and Affordable Care Act, as well as continued improvement in the U.S. economy, may drive growth in pharmaceutical spending over the next 12-24 months. Growth in U.S. prescription drug expenditures is expected to rebound in 2014, with a projected 3-5% increase in total drug expenditures across all settings this year, including a 5-7% increase in clinic spending and a 1-3% increase in hospital spending. Health-system pharmacy leaders should carefully examine local drug-utilization patterns to determine their respective organization's anticipated spending in 2014.

Navigating through the maze of pricing and affordability of branded pharmaceuticals in the midst of the financial crisis: a comparative study among five European recession countries, from a Cyprus perspective.

PubMed

Petrou, Panagiotis; Talias, Michael A

2016-01-01

Financial recession mandated the introduction of harsh austerity measures. Health, and particularly pharmaceuticals, constitute a significant part of public expenditure and as such they have been subject to significant budget reduction and stringent policies. As a consequence of these measures, an increasing percentage of patients resort to private sector for acquisition of their prescribed pharmaceuticals, due to exclusion of public health care beneficiary status, reduction of breadth of national formularies, delays in reimbursement and excessive waiting times. Affordability for pharmaceuticals in the private sector is of paramount importance since household disposable income plummets and more people are prone to impoverishment. This is critical for branded products, whose active substance and trademark are under patent protection, since no alternative options exist while their monopoly status imply that their prices are high. The impact on affordability regarding access of patient to necessary pharmaceutical care has not been documented in developed countries. A laspeyer index was constructed to compare prices of branded pharmaceuticals and assess affordability, by adjusting price index with Gross Domestic Product Purchase Power Parity per capita. Laspeyer index compares prices based on weights, which in our study are the corresponding sales of products in Cyprus. Moreover, we define the percentage of population that will face catastrophic pharmaceutical expenditure after acquisition of one product from eight major and common therapeutic categories. We used data from five European recession countries: Italy, Portugal, Spain, Greece and Cyprus, for 48 products which were selected based on sales. Cyprus displays the highest prices for pharmaceuticals. By adjusting for Gross Domestic Product Purchase Power Parity per capita, affordability is worst for Cyprus and Portugal. As more patients have to resort to private sector for provision of adequate and timely healthcare, health agencies must reassess affordability of medicines and minimise catastrophic expenditure impact. Health agencies should primarily try to enhance efficiency of the system and reduce waste, instead of resorting to blunt budget reduction, which can demonstrate unpredictable consequences in public health.

The Supply of Pharmaceuticals in Humanitarian Assistance Missions: Implications for Military Operations

DTIC Science & Technology

2011-08-01

essential medicines list ( EML ), which provides information The Supply of Pharmaceuticals in Humanitarian Assistance Missions: Implications for...Health Organization (WHO) introduced the concept of the EML to encourage health systems at the country level to focus on a limited number of carefully...be used as a global standard to guide country authorities develop their own national EMLs . 5 In many developing countries, national formularies

Conflicts of interest between physicians and the pharmaceutical industry and special interest groups.

PubMed

Schetky, Diane H

2008-01-01

Health care in the United States is a tangled web of competing interest groups beneath which ethical conflicts of interest flourish. Physicians, professional organizations, and academic medical centers must continually evaluate their relationships with the pharmaceutical industry as they relate to personal, professional, and institutional ethical values. This article explores the relevant pressing ethical issues and proposals for changing course and managing these potentially troublesome relationships.

Global prevention, funding, accountability debated in fight against HIV / AIDS.

PubMed

1999-10-18

World leaders, physicians, economists, governmental health organizations, and pharmaceutical manufacturers attended the Third International Conference on Healthcare Resource Allocation for HIV/AIDS and Other Life-threatening Illnesses in Vienna, Austria. The conference participants discussed the economic, ethical, and human rights issues underlying health care resource allocation. Some highlights of the meeting included: the prevention strategies in fighting AIDS virus; the use of high medical ethical standards; the affordability and accessibility of essential therapies; the economic aspects affecting the medical assistance mechanisms; the need to improve the pharmaceutical industry; the need to improve HIV/AIDS care access in developing countries; promoting the development of HIV/AIDS vaccines; and developing rapid diagnosis of HIV.

Pharmaceutical preparations. A review of drugs commonly used during the neonatal period.

PubMed

Faucher, M A; Jackson, G

1992-01-01

Certified nurse-midwives, whose responsibility includes care of the newborn in the first days of life, should be well versed in the commonly used pharmaceutical preparations in the neonatal period. This article reviews therapeutic uses and the pharmacodynamics of vitamin K, as well as the neonatal eye preparations for prophylaxis of infections (silver nitrate, tetracycline, and erythromycin ophthalmic ointments). Preparations used in caring for the umbilical cord, as well as the commonly prescribed antibiotics ampicillin and gentamicin, are discussed. The narcotic antagonist naloxone is also reviewed, along with commonly used medications for colic and thrush. The etiology and clinical conditions that require the application of these medications are considered.

The growing impact of pediatric pharmaceutical poisoning.

PubMed

Bond, G Randall; Woodward, Randall W; Ho, Mona

2012-02-01

To understand which medications, under which circumstances, are responsible for the noted increase in pediatric medication poisonings, resource use, and morbidity. Patient records from 2001-2008 were obtained from the National Poison Data System of the American Association of Poison Control Centers for children aged ≤5 years evaluated in a health care facility following exposure to a potentially toxic dose of a pharmaceutical agent. Pharmaceutical agents were classified as over-the-counter or prescription and by functional category. Exposures were classified as child self-ingested the medication or as therapeutic error. For the 8-year period, emergency visits, admissions, significant injuries, and trends in these events were calculated for each substance category. We evaluated 453 559 children for ingestion of a single pharmaceutical product. Child self-exposure was responsible for 95% of visits. Child self-exposure to prescription products dominated the health care impact with 248 023 of the visits (55%), 41 847 admissions (76%), and 18 191 significant injuries (71%). The greatest resource use and morbidity followed self-ingestion of prescription products, particularly opioids, sedative-hypnotics, and cardiovascular agents. Prevention efforts have proved to be inadequate in the face of rising availability of prescription medications, particularly more dangerous medications. Copyright © 2012 Mosby, Inc. All rights reserved.

A cross-sectional investigation of acceptance of health information technology: A nationwide survey of community pharmacists in Turkey.

PubMed

Sezgin, Emre; Özkan-Yıldırım, Sevgi

Health information technologies have become vital to health care services. In that regard, successful use of information technologies in pharmaceutical services is important to manage, control and maintain pharmaceutical transactions, which increase the quality of health care delivery. This study aimed to identify influencing factors on pharmacists' acceptance of pharmaceutical service systems. A cross-sectional study was conducted employing a research model based on technology acceptance theories. A parsimonious model was developed, and a self-reported questionnaire was distributed online. Community pharmacists participated voluntarily via the website of Turkish Pharmacists' Association. The data was analyzed employing Structural Equation Modeling. From 77 out of 81 cities of Turkey, 2169 community pharmacists participated to the survey with 43% response rate. Perceived usefulness, perceived ease of use, system factors and perceived behavioral control explained 47% of total variance in pharmacists' intention to use the pharmaceutical technology. The findings of the research provided insight about relations of influencing factors and practical implications regarding perceived behaviors and system use. Future researchers would benefit from the study design and findings. The study is also valuable for being the first nationwide study conducted on pharmacists about user attitudes toward a technology. Copyright © 2015 Elsevier Inc. All rights reserved.

[Hypernatremia caused by treatment with GHB obtained via a doctor's prescription].

PubMed

Rood, I M; Seijger, C G W; van Waarde, J A; de Maat, M M R; Verhave, J C; Blans, M J

In the last few years, gamma hydroxybutyric acid (GHB) has been used increasingly as a party drug; this has led to a marked increase in the number of requests for professional help with the treatment of GHB addiction. Pharmaceutical GHB (sodium oxybate, the sodium-salt of GHB), registered for cataplexia in narcolepsy patients, is used off-label to treat the withdrawal symptoms associated with GHB addiction. Pharmaceutical GHB has a high sodium load. In this report we present the cases of two patients who developed symptomatic hypernatremia following treatment with pharmaceutical GHB and who thereafter needed intensive care for the severe withdrawal symptoms that they experienced.

Confronting AIDS. Directions for Public Health, Health Care, and Research.

ERIC Educational Resources Information Center

Institute of Medicine (NAS), Washington, DC.

This book is addressed to anyone involved with or affected by the Acquired Immune Deficiency Syndrome (AIDS) epidemic, including legislators, researchers, health care personnel, insurance providers, educators, health officials, executives in the pharmaceutical industry, blood bank administrators, and other concerned individuals. The following…

[JSPS-NRCT Core university program on natural medicine in pharmaceutical sciences].

PubMed

Saiki, Ikuo; Yamazaki, Mikako; Matsumoto, Kinzo

2009-04-01

The Core University Program provides a framework for international cooperative research in specifically designated fields and topics, centering around a core university in Japan and its counterpart university in other countries. In this program, individual scientists in the affiliated countries carry out cooperative research projects with sharply focused topics and explicitly delineated goals under leadership of the core universities. The Core University Program which we introduce here has been renewed since 2001 under the support of both the Japan Society for the Promotion of Science (JSPS) and the National Research Council of Thailand (NRCT). Our program aims to conduct cooperative researches particularly focusing on Natural Medicine in the field of Pharmaceutical Sciences. Institute of Natural Medicine at University of Toyama (Japan), Faculty of Pharmaceutical Sciences at Chulalongkorn University (Thailand), and Chulabhorn Research Institute (Thailand) have been taking part in this JSPS-NRCT Core University Program as core universities. The Program is also supported by the 20 institution members in both countries. This program is running the five research subject under a key word of natural medicine which are related to i) age-related diseases, ii) allergy and cancer, iii) hepatitis and infectious diseases, iv) structure, synthesis, and bioactivity of natural medicines, and v) molecular biology of Thai medicinal plant components and database assembling of Thai medicinal plants. The program also encourages university members to strengthen related research activities, to share advanced academic and scientific knowledge on natural medicines.

Pharmaceuticals in the environment--exposure, effects and risks to humans and ecosystems: what we think we know, and what we need to know

EPA Science Inventory

U.S., European and Korean environmental monitoring and research programs have confirmed the occurrence of low levels of pharmaceuticals in stream waters, in soils and streambed sediments, in ground water, in estuaries, and in drinking water.

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2012 CFR

2012-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2011 CFR

2011-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - Pharmacy benefits program.

Code of Federal Regulations, 2013 CFR

2013-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

32 CFR 199.21 - TRICARE Pharmacy Benefits Program.

Code of Federal Regulations, 2014 CFR

2014-07-01

... limited to: (1) Approval of a new pharmaceutical agent by the U.S. Food and Drug Administration; (2) Approval of a new indication for an existing pharmaceutical agent; (3) Changes in the clinical use of... the new formulary management process, the processes established by this section shall apply. (h...

The counter and consultation room work explored in the Netherlands.

PubMed

Mobach, Mark P

2008-08-01

To determine the frequency and nature of conversations at the counter and of private consultations at three Dutch community pharmacies. In a purposive and convenience sample of three Dutch community pharmacies two work categories were investigated: counter work and consultation room work with self-reporting tally. The study took 6 weeks: 2 weeks at each pharmacy. The number of care related conversations and consultations emerging in the counter work and consultation room work. About 43% of all counter conversations consisted of the provision of pharmaceutical information and 72% of the consultations in the separate consultation room dealt with care related activities. However, only 18 consultations were held in this latter room: 0.4% of all reported conversations. The proportion of care related work at the counter and in the consultation room did have significant substance. There are however serious possibilities to change pharmaceutical care for the better. It is suggested that standard procedures at the counter may help increasing care related work. The presence of a separate consultation room may increase the number of consultations held in private, when combined with raising patient awareness of its existence.

Practicing Research Ethics: Private-Sector Physicians & Pharmaceutical Clinical Trials

PubMed Central

2008-01-01

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first upon historical studies of physicians as investigators and then upon 12 months of qualitative fieldwork in the South Western US, this paper analyzes the shifting, contextualized ethics that shape physicians’ relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities. PMID:18353515

Practicing research ethics: private-sector physicians & pharmaceutical clinical trials.

PubMed

Fisher, Jill A

2008-06-01

This paper focuses on constructions of research ethics by primary care physicians in the USA as they engage in contract research for the pharmaceutical industry. Drawing first on historical studies of physicians as investigators and then on 12 months of qualitative fieldwork in the Southwestern US, this paper analyzes the shifting, contextualized ethics that shape physicians' relationships with patients/subjects and pharmaceutical companies. Just as physicians followed professional codes of ethics prior to the codification of acceptable research conduct in the 1980s, physicians today continue to develop tacit systems of research ethics. This paper argues that private-sector physicians primarily conceptualize their ethical conduct in relation to the pharmaceutical companies hiring them, not to human subjects they enroll in clinical trials. This is not to say that these physicians do not follow the formal U.S. regulation to protect human subjects, but rather that their financial relationships with the pharmaceutical industry have a greater influence on their identities as researchers and on their constructions of their ethical responsibilities.

Fate and Uptake of Pharmaceuticals in Soil–Plant Systems

PubMed Central

2014-01-01

Pharmaceuticals have been detected in the soil environment where there is the potential for uptake into crops. This study explored the fate and uptake of pharmaceuticals (carbamazepine, diclofenac, fluoxetine, propranolol, sulfamethazine) and a personal care product (triclosan) in soil–plant systems using radish (Raphanus sativus) and ryegrass (Lolium perenne). Five of the six chemicals were detected in plant tissue. Carbamazepine was taken up to the greatest extent in both the radish (52 μg/g) and ryegrass (33 μg/g), whereas sulfamethazine uptake was below the limit of quantitation (LOQ) (<0.01 μg/g). In the soil, concentrations of diclofenac and sulfamethazine dropped below the LOQ after 7 days. However, all pharmaceuticals were still detectable in the pore water at the end of the experiment. The results demonstrate the ability of plant species to accumulate pharmaceuticals from soils with uptake apparently specific to both plant species and chemical. Results can be partly explained by the hydrophobicity and extent of ionization of each chemical in the soil. PMID:24405013

[New distribution forms for pharmaceuticals--a logistic perspective].

PubMed

Grund, J; Vartdal, T E

1998-11-10

Pharmaceuticals are an important input in health care. As a complement to other modes of treatment and as a substitute for hospitalisation, they affect the health of individuals and populations. Enormous public financial resources are spent on pharmaceuticals, and halting the growth in expenditures is a political objective. Factors with room for improvement include drug use efficiency, cost-efficient prescription, purchasing prices and distribution. High distribution costs affect prices and, thus, the assessment of product cost vs. utility. Changes in the distribution system may be important, for three reasons: First, increased capital costs call for higher efficiency. Second, increased competition requires improved logistics. And third, information technology has opened up for new supply chain solutions. Direct sales solutions are being considered, and were discussed in a Norwegian public report on the matter, but no final conclusion has been reached. This article discusses changes in the supply of pharmaceuticals and the development of the market. Alternative supply chains are outlined, including what role the postal service may play in a deregulated pharmaceutical market.

Development and Assessment of a Medication Safety Measurement Program in a Long-Term Care Pharmacy.

PubMed

Hertig, John B; Hultgren, Kyle E; Parks, Scott; Rondinelli, Rick

2016-02-01

Medication errors continue to be a major issue in the health care system, including in long-term care facilities. While many hospitals and health systems have developed methods to identify, track, and prevent these errors, long-term care facilities historically have not invested in these error-prevention strategies. The objective of this study was two-fold: 1) to develop a set of medication-safety process measures for dispensing in a long-term care pharmacy, and 2) to analyze the data from those measures to determine the relative safety of the process. The study was conducted at In Touch Pharmaceuticals in Valparaiso, Indiana. To assess the safety of the medication-use system, each step was documented using a comprehensive flowchart (process flow map) tool. Once completed and validated, the flowchart was used to complete a "failure modes and effects analysis" (FMEA) identifying ways a process may fail. Operational gaps found during FMEA were used to identify points of measurement. The research identified a set of eight measures as potential areas of failure; data were then collected on each one of these. More than 133,000 medication doses (opportunities for errors) were included in the study during the research time frame (April 1, 2014, and ended on June 4, 2014). Overall, there was an approximate order-entry error rate of 15.26%, with intravenous errors at 0.37%. A total of 21 errors migrated through the entire medication-use system. These 21 errors in 133,000 opportunities resulted in a final check error rate of 0.015%. A comprehensive medication-safety measurement program was designed and assessed. This study demonstrated the ability to detect medication errors in a long-term pharmacy setting, thereby making process improvements measureable. Future, larger, multi-site studies should be completed to test this measurement program.

Barriers to Universal Prescribing of Antiretroviral Therapy by HIV Care Providers in the United States, 2013–2014

PubMed Central

Weiser, John; Brooks, John T.; Skarbinski, Jacek; West, Brady T.; Duke, Christopher C.; Gremel, Garrett W.; Beer, Linda

2017-01-01

Introduction HIV treatment guidelines recommend initiating antiretroviral therapy (ART) regardless of CD4 cell (CD4) count, barring contraindications or barriers to treatment. An estimated 6% of persons receiving HIV care in 2013 were not prescribed ART. We examined reasons for this gap in the care continuum. Methods During 2013–2014, we surveyed a probability sample of HIV care providers, of whom 1234 returned surveys (64.0% adjusted response rate). We estimated percentages of providers who followed guidelines and their characteristics, and who deferred ART prescribing for any reason. Results Barring contraindications, 71.2% of providers initiated ART regardless of CD4 count. Providers less likely to initiate had caseloads ≤20 vs. >200 patients [adjusted prevalence ratios (aPR) 0.69, 95% confidence interval (CI): 0.47 to 1.02, P = 0.03], practiced at non–Ryan White HIV/AIDS Program-funded facilities (aPR 0.85, 95% CI: 0.74 to 0.98, P = 0.02), or reported pharmaceutical assistance programs provided insufficient medication to meet patients’ needs (aPR 0.79, 95% CI: 0.65 to 0.98, P = 0.02). In all, 17.0% never deferred prescribing ART, 69.6% deferred for 1%–10% of patients, and 13.3% deferred for >10%. Among providers who had deferred ART, 59.4% cited patient refusal as a reason in >50% of cases, 31.1% reported adherence concerns because of mental health disorders or substance abuse, and 21.4% reported adherence concerns because of social problems, eg, homelessness, as factors in >50% of cases when deferring ART. Conclusions An estimated 29% of HIV care providers had not adopted recommendations to initiate ART regardless of CD4 count, barring contraindications, or barriers to treatment. Low-volume providers and those at non–Ryan White HIV/AIDS Program-funded facilities were less likely to follow this guideline. Among all providers, leading reasons for deferring ART included patient refusal and adherence concerns. PMID:28002186

Design of the POINT study: Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT).

PubMed

Hazen, Ankie C M; Sloeserwij, Vivianne M; Zwart, Dorien L M; de Bont, Antoinette A; Bouvy, Marcel L; de Gier, Johan J; de Wit, Niek J; Leendertse, Anne J

2015-07-02

In the Netherlands, 5.6 % of acute hospital admissions are medication-related. Almost half of these admissions are potentially preventable. Reviewing medication in patients at risk in primary care might prevent these hospital admissions. At present, implementation of medication reviews in primary care is suboptimal: pharmacists lack access to patient information, pharmacists are short of clinical knowledge and skills, and working processes of pharmacists (focus on dispensing) and general practitioners (focus on clinical practice) match poorly. Integration of the pharmacist in the primary health care team might improve pharmaceutical care outcomes. The aim of this study is to evaluate the effect of integration of a non-dispensing pharmacist in general practice on the safety of pharmacotherapy in the Netherlands. The POINT study is a non-randomised controlled intervention study with pre-post comparison in an integrated primary care setting. We compare three different models of pharmaceutical care provision in primary care: 1) a non-dispensing pharmacist as an integral member of a primary care team, 2) a pharmacist in a community pharmacy with a predefined training in performing medication reviews and 3) a pharmacist in a community pharmacy (care as usual). In all models, GPs remain accountable for individual medication prescription. In the first model, ten non-dispensing clinical pharmacists are posted in ten primary care practices (including 5 - 10 000 patients each) for a period of 15 months. These non-dispensing pharmacists perform patient consultations, including medication reviews, and share responsibility for the pharmaceutical care provided in the practice. The two other groups consist of ten primary care practices with collaborating pharmacists. The main outcome measurement is the number of medication-related hospital admissions during follow-up. Secondary outcome measurements are potential medication errors, drug burden index and costs. Parallel to this study, a qualitative study is conducted to evaluate the feasibility of introducing a NDP in general practice. As the POINT study is a large-scale intervention study, it should provide evidence as to whether integration of a non-dispensing clinical pharmacist in primary care will result in safer pharmacotherapy. The qualitative study also generates knowledge on the optimal implementation of this model in primary care. Results are expected in 2016. NTR4389 , The Netherlands National Trial Register, 07-01-2014.

Curriculum Mapping of the Master's Program in Pharmacy in Slovenia with the PHAR-QA Competency Framework.

PubMed

Gmeiner, Tanja; Horvat, Nejc; Kos, Mitja; Obreza, Aleš; Vovk, Tomaž; Grabnar, Iztok; Božič, Borut

2017-05-02

This article presents the results of mapping the Slovenian pharmacy curriculum to evaluate the adequacy of the recently developed and validated European Pharmacy Competences Framework (EPCF). The mapping was carried out and evaluated progressively by seven members of the teaching staff at the University of Ljubljana's Faculty of Pharmacy. Consensus was achieved by using a two-round modified Delphi technique to evaluate the coverage of competences in the current curriculum. The preliminary results of the curriculum mapping showed that all of the competences as defined by the EPCF are covered in Ljubljana's academic program. However, because most EPCF competences cover healthcare-oriented pharmacy practice, a lack of competences was observed for the drug development and production perspectives. Both of these perspectives are important because a pharmacist is (or should be) responsible for the entire process, from the development and production of medicines to pharmaceutical care in contact with patients. Nevertheless, Ljubljana's graduates are employed in both of these pharmaceutical professions in comparable proportions. The Delphi study revealed that the majority of differences in scoring arise from different perspectives on the pharmacy profession (e.g., community, hospital, industrial, etc.). Nevertheless, it can be concluded that curriculum mapping using the EPCF is very useful for evaluating and recognizing weak and strong points of the curriculum. However, the competences of the framework should address various fields of the pharmacist's profession in a more balanced way.

Curriculum Mapping of the Master’s Program in Pharmacy in Slovenia with the PHAR-QA Competency Framework

PubMed Central

Gmeiner, Tanja; Horvat, Nejc; Kos, Mitja; Obreza, Aleš; Vovk, Tomaž; Grabnar, Iztok; Božič, Borut

2017-01-01

This article presents the results of mapping the Slovenian pharmacy curriculum to evaluate the adequacy of the recently developed and validated European Pharmacy Competences Framework (EPCF). The mapping was carried out and evaluated progressively by seven members of the teaching staff at the University of Ljubljana’s Faculty of Pharmacy. Consensus was achieved by using a two-round modified Delphi technique to evaluate the coverage of competences in the current curriculum. The preliminary results of the curriculum mapping showed that all of the competences as defined by the EPCF are covered in Ljubljana’s academic program. However, because most EPCF competences cover healthcare-oriented pharmacy practice, a lack of competences was observed for the drug development and production perspectives. Both of these perspectives are important because a pharmacist is (or should be) responsible for the entire process, from the development and production of medicines to pharmaceutical care in contact with patients. Nevertheless, Ljubljana’s graduates are employed in both of these pharmaceutical professions in comparable proportions. The Delphi study revealed that the majority of differences in scoring arise from different perspectives on the pharmacy profession (e.g., community, hospital, industrial, etc.). Nevertheless, it can be concluded that curriculum mapping using the EPCF is very useful for evaluating and recognizing weak and strong points of the curriculum. However, the competences of the framework should address various fields of the pharmacist’s profession in a more balanced way. PMID:28970436

Cost Sharing, Health Care Expenditures, and Utilization: An International Comparison.

PubMed

Perkowski, Patryk; Rodberg, Leonard

2016-01-01

Health systems implement cost sharing to help reduce health care expenditure and utilization by discouraging the use of unnecessary health care services. We examine cost sharing in 28 countries in the Organisation for Economic Co-operation and Development from 1999 through 2009 in the areas of medical care, hospital care, and pharmaceuticals. We investigate associations between cost sharing, health care expenditures, and health care utilization and find no significant association between cost sharing and health care expenditures or utilization in these countries. © The Author(s) 2015.

Pharmaceutical policies in Canada: another example of federal-provincial discord

PubMed Central

Anis, A H

2000-01-01

Pharmaceutical policy in Canada is set at both the federal and provincial levels of government. The federal government is responsible for intellectual property rights of manufacturers (patents) and the initial approval and labelling of prescription drugs and for ensuring overall market competitiveness. The provincial government has responsibility and jurisdiction over the funding of all health care services, including pharmaceuticals. Various interactions between the pharmaceutical industry, the federal and provincial governments and consumers have shaped the current landscape for prescription drugs in Canada. One key failing of the system is that the federal government is almost completely insulated from the impact of its policies because, although it regulates drug prices, it does not buy any drugs. In contrast, provincial governments have no jurisdiction over market competitiveness or pricing, yet end up paying for most of the drug expenditures incurred. PMID:10701389

Institutional framework for integrated Pharmaceutical Benefits Management: results from a systematic review

PubMed Central

Hermanowski, Tomasz Roman; Drozdowska, Aleksandra Krystyna; Kowalczyk, Marta

2015-01-01

Objectives In this paper, we emphasised that effective management of health plans beneficiaries access to reimbursed medicines requires proper institutional set-up. The main objective was to identify and recommend an institutional framework of integrated pharmaceutical care providing effective, safe and equitable access to medicines. Method The institutional framework of drug policy was derived on the basis of publications obtained by systematic reviews. A comparative analysis concerning adaptation of coordinated pharmaceutical care services in the USA, the UK, Poland, Italy, Denmark and Germany was performed. Results While most European Union Member States promote the implementation of selected e-Health tools, like e-Prescribing, these efforts do not necessarily implement an integrated package. There is no single agent who would manage an insured patients’ access to medicines and health care in a coordinated manner, thereby increasing the efficiency and safety of drug policy. More attention should be paid by European Union Member States as to how to integrate various e-Health tools to enhance benefits to both individuals and societies. One solution could be to implement an integrated “pharmacy benefit management” model, which is well established in the USA and Canada and provides an integrated package of cost-containment methods, implemented within a transparent institutional framework and powered by strong motivation of the agent. PMID:26528099

Evolving trade policy and the Trans-Pacific Partnership Agreement: does it threaten Vietnam's access to medicine and its progress towards scaling up HIV prevention, treatment and care?

PubMed

Linh, Nguyen Nhat; Huong, Nguyen Thanh; Thuy, Hua Thanh

2015-01-01

The Trans-Pacific Partnership Agreement (TPP) has undergone 18 rounds of secretive negotiation between the USA and 11 Asia-Pacific countries. Aiming at a free trade area, this multilateral trade proposal covers all aspects of commercial relations among the countries involved. Despite some anticipated positive impacts in trade, specific articles in this proposal's intellectual property and transparency chapters might negatively impact access to medicine, in general, and to antiretroviral (ARV) drugs, in particular, in Vietnam. Drawing on a desk review and qualitative in-depth interviews with 20 key informants from government, academia, hospitals and civil society, we analyse various provisions of the proposal being negotiated leaked after the 14th round of negotiations in September 2012. Findings suggest that the TPP could lead to increased monopoly protection and could limit technological advancements within the local pharmaceutical manufacturing industry, resulting in higher medicine prices in Vietnam. This outcome would have a significant impact on Vietnam's ability to achieve goals for HIV prevention, treatment and care, and create barriers to universal health-care coverage. This research provides unique evidence for Vietnam to advocate for more equitable pharmaceutical provisions in and to raise awareness of the implications of the TPP among the pharmaceutical stakeholder community in Vietnam.

A qualitative assessment of a community pharmacy cognitive pharmaceutical services program, using a work system approach.

PubMed

Chui, Michelle A; Mott, David A; Maxwell, Leigh

2012-01-01

Although lack of time, trained personnel, and reimbursement have been identified as barriers to pharmacists providing cognitive pharmaceutical services (CPS) in community pharmacies, the underlying contributing factors of these barriers have not been explored. One approach to better understand barriers and facilitators to providing CPS is to use a work system approach to examine different components of a work system and how the components may impact care processes. The goals of this study were to identify and describe pharmacy work system characteristics that pharmacists identified and changed to provide CPS in a demonstration program. A qualitative approach was used for data collection. A purposive sample of 8 pharmacists at 6 community pharmacies participating in a demonstration program was selected to be interviewed. Each semistructured interview was audio recorded and transcribed, and the text was analyzed in a descriptive and interpretive manner by 3 analysts. Themes were identified in the text and aligned with 1 of 5 components of the Systems Engineering Initiative for Patient Safety (SEIPS) work system model (organization, tasks, tools/technology, people, and environment). A total of 21 themes were identified from the interviews, and 7 themes were identified across all 6 interviews. The organization component of the SEIPS model contained the most (n=10) themes. Numerous factors within a pharmacy work system appear important to enable pharmacists to provide CPS. Leadership and foresight by the organization to implement processes (communication, coordination, planning, etc.) to facilitate providing CPS was a key finding across the interviews. Expanding technician responsibilities was reported to be essential for successfully implementing CPS. To be successful in providing CPS, pharmacists must be cognizant of the different components of the pharmacy work system and how these components influence providing CPS. Copyright © 2012 Elsevier Inc. All rights reserved.

A qualitative assessment of a community pharmacy cognitive pharmaceutical services program, using a work system approach

PubMed Central

Chui, Michelle A.; Mott, David A.; Maxwell, Leigh

2012-01-01

Background Although lack of time, trained personnel, and reimbursement have been identified as barriers to pharmacists providing cognitive pharmaceutical services (CPS) in community pharmacies, the underlying contributing factors of these barriers have not been explored. One approach to better understand barriers and facilitators to providing CPS is to use a work system approach to examine different components of a work system and how the components may impact care processes. Objectives The goals of this study were to identify and describe pharmacy work system characteristics that pharmacists identified and changed to provide CPS in a demonstration program. Methods A qualitative approach was used for data collection. A purposive sample of 8 pharmacists at 6 community pharmacies participating in a demonstration program was selected to be interviewed. Each semistructured interview was audio recorded and transcribed, and the text was analyzed in a descriptive and interpretive manner by 3 analysts. Themes were identified in the text and aligned with 1 of 5 components of the Systems Engineering Initiative for Patient Safety (SEIPS) work system model (organization, tasks, tools/technology, people, and environment). Results A total of 21 themes were identified from the interviews, and 7 themes were identified across all 6 interviews. The organization component of the SEIPS model contained the most (n = 10) themes. Numerous factors within a pharmacy work system appear important to enable pharmacists to provide CPS. Leadership and foresight by the organization to implement processes (communication, coordination, planning, etc.) to facilitate providing CPS was a key finding across the interviews. Expanding technician responsibilities was reported to be essential for successfully implementing CPS. Conclusions To be successful in providing CPS, pharmacists must be cognizant of the different components of the pharmacy work system and how these components influence providing CPS. PMID:21824822

Genomics and proteomics: the next generation of health care.

PubMed

Sica, Joanne M

2002-12-01

Biotechnology research will dramatically impact health care, and the pharmaceutical industry in particular, in the coming decade. Health outcomes may be improved in a cost-effective manner through the ability to selectively prescribe medications; safer, more effective treatment may reduce long-term health care costs. As genetic testing becomes the standard of care, new challenges will surface around how genetic information will be used or misused, and how and where health care dollars are spent.

PPCPS IN THE ENVIRONMENT: FUTURE RESEARCH - BEGINNING WITH THE END ALWAYS IN MIND

EPA Science Inventory

Pharmaceuticals and personal care products (PPCPs) are an extraordinarily diverse group of chemicals used in veterinary medicine, agricultural practice, and human health and cosmetic care. The various sources and origins of PPCPs as pollutants in the environment are depicted in a...

[Regulation, innovation, and improvement of health care. The pharmaceutical sector].

PubMed

López-Casasnovas, Guillem

2008-01-01

The paper comments on present and future scenarios for the pharmaceutical sector in Spain, framed a highly regulated system. So far the drug industry has evolved under the short term public financial constraints for additional health care spending and the long term efforts to innovate. This has not proved to offer a stable setting for the relationship between the industry and Health Authorities. The author offers from the economic analysis and a subjective appraisal from his experience some recommendations for regulatory changes in order to better align the incentives of the parts for improving the health system as a whole. The basic point is that 'consumption levels' (quantities) and not (unit costs) are the main challenge to tackle today in our Public Health Care system, and for this the decentralisation of financial responsibility is not in itself 'the' problem but it may well be a part of the solution.

Concentrations of hormones, pharmaceuticals and other micropollutants in groundwater affected by septic systems in New England and New York.

PubMed

Phillips, P J; Schubert, C; Argue, D; Fisher, I; Furlong, E T; Foreman, W; Gray, J; Chalmers, A

2015-04-15

Septic-system discharges can be an important source of micropollutants (including pharmaceuticals and endocrine active compounds) to adjacent groundwater and surface water systems. Groundwater samples were collected from well networks tapping glacial till in New England (NE) and sandy surficial aquifer New York (NY) during one sampling round in 2011. The NE network assesses the effect of a single large septic system that receives discharge from an extended health care facility for the elderly. The NY network assesses the effect of many small septic systems used seasonally on a densely populated portion of Fire Island. The data collected from these two networks indicate that hydrogeologic and demographic factors affect micropollutant concentrations in these systems. The highest micropollutant concentrations from the NE network were present in samples collected from below the leach beds and in a well downgradient of the leach beds. Total concentrations for personal care/domestic use compounds, pharmaceutical compounds and plasticizer compounds generally ranged from 1 to over 20 μg/L in the NE network samples. High tris(2-butoxyethyl phosphate) plasticizer concentrations in wells beneath and downgradient of the leach beds (>20 μg/L) may reflect the presence of this compound in cleaning agents at the extended health-care facility. The highest micropollutant concentrations for the NY network were present in the shoreline wells and reflect groundwater that is most affected by septic system discharges. One of the shoreline wells had personal care/domestic use, pharmaceutical, and plasticizer concentrations ranging from 0.4 to 5.7 μg/L. Estradiol equivalency quotient concentrations were also highest in a shoreline well sample (3.1 ng/L). Most micropollutant concentrations increase with increasing specific conductance and total nitrogen concentrations for shoreline well samples. These findings suggest that septic systems serving institutional settings and densely populated areas in coastal settings may be locally important sources of micropollutants to adjacent aquifer and marine systems. Published by Elsevier B.V.

The barriers to patient-driven treatment in mental health: why patients may choose to follow their own path.

PubMed

Greenall, Paul

2006-01-01

The paper aims to explore the barriers that currently exist to patient-driven treatment within the field of mental health care and reform. This study represents action learning research using grounded theory to explore a possible causal basis for recidivism related to non-compliance with medication. Interviews addressed concerns from the literature around perceived barriers to patient-driven treatment evidenced by non-compliance with medically recommended pharmaceutical treatment. Results were correlated to look for emergent themes that were used to form the basis for subsequent interview questions. An analysis of the resulting emergent themes illustrated the importance of participatory treatment and coaching rather than medically applied paternalistic care, which is seen as encouraging learned helplessness on the part of patients. Similar helplessness was also revealed in clinicians themselves. Patients' awareness of their own needs and demands for more services place clients and the caregivers at odds over appropriate care in an environment of limited resources. The research was limited to only a small number of interviewees in one institution, all of whom were closely associated with mental illness in various capacities. The grounded theory nature of the research does, however, provide a framework for more research in other institutions to test and further explore some of the findings. The study demonstrated a reinforcement of Maslow's theory of needs hierarchy. The study illustrated a step-wise approach to treatment to decrease the rate of failure and recidivism in mental health care. The provision of a stable living environment was viewed as instrumental in improving patients' compliance with pharmaceutical treatment. An action plan was therefore created to initiate the support of a transitional/emergency house by various community groups in partnership with pharmaceutical manufacturing companies. Recidivism in mental health-created by non-compliance in pharmaceutical treatment, is a major issue in Canada's health care system. This study brings to the forefront issues from a number of perspectives in order to form a course of action in response to its findings.

A first screening and risk assessment of pharmaceuticals and additives in personal care products in waste water, sludge, recipient water and sediment from Faroe Islands, Iceland and Greenland.

PubMed

Huber, Sandra; Remberger, Mikael; Kaj, Lennart; Schlabach, Martin; Jörundsdóttir, Hrönn Ó; Vester, Jette; Arnórsson, Mímir; Mortensen, Inge; Schwartson, Richard; Dam, Maria

2016-08-15

A screening of a broad range of pharmaceuticals and additives in personal care products (PPCPs) in sub-arctic locations of the Faroe Islands (FO), Iceland (IS) and Greenland (GL) was conducted. In total 36 pharmaceuticals including some metabolites, and seven additives in personal care products were investigated in influent and effluent waters as well as sludge of waste water treatment plants (WWTPs) and in water and sediment of recipients. Concentrations and distribution patterns for PPCPs discharged via sewage lines (SLs) to the marine environment were assessed. Of the 36 pharmaceuticals or metabolites analysed 33 were found close to or above the limit of detection (LOD) in all or a part of the samples. All of the seven investigated additives in personal care products were detected above the LOD. Some of the analysed PPCPs occurred in every or almost every sample. Among these were diclofenac, ibuprofen, lidocaine, naproxen, metformin, citalopram, venlafaxine, amiloride, furosemide, metoprolol, sodium dodecyl sulphate (SDS) and cetrimonium salt (ATAC-C16). Additionally, the study encompasses ecotoxicological risk assessment of 2/3 of the analysed PPCPs in recipient and diluted effluent waters. For candesartan only a small margin to levels with inacceptable risks was observed in diluted effluent waters at two locations (FO). Chronical risks for aquatic organisms staying and/or living around WWTP effluent pipe-outlets were indicated for 17β-estradiol and estriol in the three countries. Additives in PCPs were found to pose the largest risk to the aquatic environment. The surfactants CAPB and ATAC-C16 were found in concentrations resulting in risk factors up to 375 for CAPB and 165 for ATAC-C16 in recipients for diluted effluents from Iggia, Nuuk (GL) and Torshavn (FO) respectively. These results demonstrates a potentially high ecological risk stemming from discharge of surfactants as used in household and industrial detergents as well as additives in personal care products. Copyright © 2016 Elsevier B.V. All rights reserved.

Does government subsidy for costs of medical and pharmaceutical services result in higher service utilization by older widowed women in Australia?

PubMed

Tooth, Leigh R; Hockey, Richard; Treloar, Susan; McClintock, Christine; Dobson, Annette

2012-06-27

In Australia, Medicare, the national health insurance system which includes the Medical Benefits Scheme (MBS) and Pharmaceutical Benefits Scheme (PBS), provides partial coverage for most medical services and pharmaceuticals. For war widows, the Department of Veterans' Affairs (DVA) covers almost the entire cost of their health care. The objective of this study was to test whether war widows have higher usage of medical services and pharmaceuticals. Data were from 730 women aged 70-84 years (mostly World War II widows) participating in the Australian Longitudinal Study on Women's Health who consented to data linkage to Medicare Australia. The main outcome measures were PBS costs, claims, co-payments and scripts presented, and MBS total costs, claims and gap payments for medical services in 2005. There was no difference between the war widows and similarly aged widows in the Australian population without DVA support on use of medical services. While war widows had more pharmaceutical prescriptions filled they generated equivalent total costs, number of claims and co-payments for pharmaceuticals than widows without DVA support. Older war widows are not using more medical services and pharmaceuticals than other older Australian women despite having financial incentives to do so.

[A pilot study of the professional ethical thinking of Quebec hospital pharmacists and pharmacy students].

PubMed

Guérin, A; Bussières, J-F

2017-01-01

The main objective was to assess the position of Quebec pharmaceutical community about pharmaceutical ethics statements. The second objective was to compare the level of agreement of pharmacy students and hospitals pharmacists. Survey conducted one day given in 2012 and 2013 for students in 2013 and from 29/08/2014 to 02/09/2014 for pharmacists. A questionnaire of eight themes and 43 statements was developed: training and education (5 questions), clinical research (7) advertising and marketing (5) evaluation (5) dispensing medication (4), pharmaceutical care (9) economic aspect (6) and code of ethics (2). A Likert scale with four choices was used to measure the level of agreement. The primary outcome was the difference between the level of agreement of pharmacy students and hospital pharmacists. The Chi 2  test was used. A total of 347 students and 398 pharmacists responded to the survey. There was a statistically significant difference regarding the level of agreement with 28 statements on 43. The differences focused on eight themes of the questionnaire, or training and education (3/5 significantly different questions), clinical research (2/7), advertising and marketing (2/5), Evaluation (4/5) dispensing medication (4/4), pharmaceutical care (5/9), economic aspect (6/6) and ethics (2/2). This study shows that there is a difference between pharmacists and pharmacy students about pharmaceutical ethics statements. Copyright © 2016 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

Illicit drugs and pharmaceuticals in the environment--forensic applications of environmental data, Part 2: Pharmaceuticals as chemical markers of faecal water contamination.

PubMed

Kasprzyk-Hordern, Barbara; Dinsdale, Richard M; Guwy, Alan J

2009-06-01

This manuscript is part two of a two-part study aiming to provide a better understanding and application of environmental data not only for environmental aims but also to meet forensic objectives. In this paper pharmaceuticals were investigated as potential chemical indicators of water contamination with sewage. The monitoring program carried out in Wales revealed that some pharmaceuticals are particularly persistent and/or ubiquitous in contaminated river water and therefore might be considered as potential conservative or labile wastewater indicators. In particular, these include some anti-inflammatory/analgesics, antiepileptics, beta-blockers, some H2-receptor antagonists and antibacterial drugs.

AMCP Partnership Forum: Improving Quality, Value, and Outcomes with Patient-Reported Outcomes.

PubMed

2018-03-01

Patient-reported outcomes (PROs), which provide a direct measure of a patient's health status or treatment preferences, represent a key component of the shift toward patient-centered health care. PROs can measure the state of a patient's disease-specific and overall health throughout the care continuum, enabling them to have a variety of uses for key health care stakeholders. Currently, PROs are used in drug development, aligning patient and clinician goals in care, quality-of-care measures, and coverage and reimbursement decisions. While there have been significant strides by key health care stakeholders to further the development and use of PROs, there are a number of challenges limiting more widespread use. In light of these current challenges and the potential for PROs to improve health care quality and value, on October 19, 2017, the Academy of Managed Care Pharmacy convened a forum of key stakeholders representing patients, payers, providers, government, and pharmaceutical companies to discuss and identify solutions to the current challenges and barriers to further use of PROs. These discussions informed the development of participants' ideal future state in which PROs maximize the goals of all health care stakeholders and the actionable steps required to make the future state a reality. While stakeholders shared unique perspectives throughout the forum, they had consensus on 2 overarching issues: the importance of PROs in defining value, improving patient care, and implementing value-based payment models and the need for strong organizational and operational systems to achieve optimal adoption and use. Participants identified several key challenges in PRO use and adoption: achieving a representative patient population, inclusion of PRO data in medication labels, the necessity for both standardized and customizable PROs, and operational and organizational barriers to collecting and analyzing PROs. To overcome these challenges, participants recommended that manufacturers should engage key stakeholders early and throughout the drug development process to ensure the most valid and representative PROs and patient populations will be included. To streamline the PRO collection process, participants suggested engaging pharmacists and other providers who may have more frequent interaction with patients. Participants also recommended that PRO collection and analysis should use common technology platforms, streamline components of clinician care to reduce workflow, and be integrated with claims data to provider payers a better understanding of patient health in real time. Finally, additional work should be done to develop patient-reported outcome measures that contain relevant measures for all healthcare stakeholders. While significant challenges remain in PRO development and adoption, participants agreed that greater use can only be achieved through collaboration and patient-centered care. The AMCP Partnership Forum titled "Improving Quality, Value, and Outcomes with Patient-Reported Outcomes" and the development of this proceedings report were supported by Amgen, Boehringer Ingelheim Pharmaceuticals, Genentech, GlaxoSmithKline, Novartis Pharmaceuticals, Novo Nordisk, Precision for Value, Premier, Sanofi, Takeda Pharmaceuticals USA, and Xcenda.

Pharmaceutical company sponsored disease management programs: an alternative for tax-exempt MCOs and hospitals.

PubMed

Jedrey, Christopher M; Chaurette, Katherine A; Winn, Lara Beth

2002-01-01

On April 25, 2002, the Internal Revenue Service finalized the proposed Corporate Sponsorship regulations. The changes made in the final regulations pertain to the proposed $79 ceiling on disregarded benefits, the 2 percent threshold for disregarded benefits, the scope of disregarded benefits, Web site hyperlinks, the inclusion of certain electronic publications in the definition of periodicals, the valuation date for substantial return benefits, and the scope of use or acknowledgement. The proposed regulations were discussed in the Winter 2002 issue of Managed Care Quarterly in an article titled the same as this one. This article is based on the final IRS regulations and therefore supersedes the original article published in the Winter 2002 issue.

Approaches to education of pharmaceutical biotechnology in faculties of pharmacy.

PubMed

Calis, S; Oner, F; Kas, S; Hincal, A A

2001-06-01

Pharmaceutical biotechnology is developing rapidly both in academic institutions and in the biopharmaceutical industry. For this reason, FIP Special Interest Group of Pharmaceutical Biotechnology decided to develop a questionnaire concerning pharmaceutical biotechnology education. After preliminary studies were completed, questionnaires were sent to the leading scientists in academia and research directors or senior managers of various Pharmaceutical Biotechnology Companies in order to gather their views about how to create a satisfactory program. The objectives of this study were as follows: -To review all of the graduate and undergraduate courses which are presently available worldwide on pharmaceutical biotechnology in Faculties of Pharmacy. -To review all of the text books, references and scientific sources available worldwide in the area of pharmaceutical biotechnology. When replying to the questionnaires, the respondents were asked to consider the present status of pharmaceutical biotechnology education in academia and future learning needs in collaboration with the biotechnology industry. The data from various pharmacy faculties and biotechnology industry representatives from Asia, Europe and America were evaluated and the outcome of the survey showed that educational efforts in training qualified staff in the rapidly growing field of pharmaceutical biotechnology is promising. Part of the results of this questionnaire study have already been presented at the 57th International Congress of FIP Vancouver, Canada in 1997.

Syrian pharmacy students' intentions and attitudes toward postgraduate education.

PubMed

El-Hammadi, Mazen

2012-10-12

To investigate Syrian pharmacy students' intentions and attitudes toward postgraduate study, and to determine and evaluate the factors that influence their preferences. A questionnaire was developed and used to collect data from final-year bachelor of pharmacy (BPharm) students at Damascus University. Of the 265 students who responded to the survey, approximately 50% intended to work, 25% intended to pursue further study, and 25% were undecided. Personal fulfillment was the factor that most influenced students' intentions concerning future education. Men were more concerned over their financial future, while women's intentions were more influenced by scientific issues. The 3 most preferred pharmaceutical areas of further study were biochemistry and laboratory diagnosis, pharmaceutics and pharmaceutical industry, and clinical pharmacy. More students favored pursuing graduate school abroad rather than in Syria. The majority of those who intended to enroll in local graduate programs were interested in academic programs while less than a fifth favored residency programs. The graduate programs in Syria do not appear to satisfy pharmacy students' ambitions or have the capacity to accommodate the growing demand associated with the rapid increase in the number of pharmacy graduates in the country. Consequently, a majority of students prefer to pursue postgraduate study abroad.

Epilepsy in Sweden: health care costs and loss of productivity--a register-based approach.

PubMed

Bolin, Kristian; Lundgren, Anders; Berggren, Fredrik; Källén, Kristina

2012-12-01

The objective was to estimate health care costs and productivity losses due to epilepsy in Sweden and to compare these estimates to previously published estimates. Register data on health care utilisation, pharmaceutical sales, permanent disability and mortality were used to calculate health care costs and costs that accrue due to productivity losses. By linkage of register information, we were able to distinguish pharmaceuticals prescribed against epilepsy from prescriptions that were prompted by other indications. The estimated total cost of epilepsy in Sweden in 2009 was 441 million, which corresponds to an annual per-patient cost of 8,275. Health care accounted for about 16% of the estimated total cost, and drug costs accounted for about 7% of the total cost. The estimated health care cost corresponded to about 0.2% of the total health care cost in Sweden in 2009. Indirect costs were estimated at 370 million, 84% of which was due to sickness absenteeism. Costs resulting from epilepsy-attributable premature deaths or permanent disability to work accounted for about 1% of the total indirect cost in Sweden in 2009. The per-patient cost of epilepsy is substantial. Thus, even though the prevalence of the illness is relatively small, the aggregated cost that epilepsy incurs on society is significant.

[Drug utilization and pharmaceutical cost-containment in germany-perspectives 1 year after enactment of the GMG].

PubMed

Schlander, Michael

2005-06-15

After 3 decades of health care cost containment in Germany, enactment of the most recent reform (Health Insurance Modernization Act, GMG) marks a watershed insofar as, apparently, the potential has been largely exhausted for further savings in pharmaceutical spending. Yet the new drugs segment maintains its role as a growth driver, owing to the continuing shift from older to new, and frequently more expensive, products. This observation holds true even after introducing phase 2 reference pricing, covering so-called me too products. Health economic analyses would be required to better differentiate pharmaceutical products based on their incremental cost-effectiveness ratio. However, the opportunity was missed with the GMG to introduce formal health-economic evaluations and thus overcome the counterproductive silo mentality associated with traditional German component management. International experience from Australia, Canada, and the United Kingdom suggests that economic evaluations, while informing rational reimbursement decisions, may in fact contribute to increasing pharmaceutical expenditures. Further tightening of pharmaceutical component management in Germany may result in increasing inefficiencies due to underuse of effective products; furthermore, it appears conceivable that ("second order") dynamic inefficiencies and, hence, social costs might be the consequence of reduced pharmaceutical research and development expenditures.

Pharmaceuticals released from senior residences: occurrence and risk evaluation.

PubMed

Lacorte, Silvia; Luis, Silvia; Gómez-Canela, Cristian; Sala-Comorera, Teresa; Courtier, Audrey; Roig, Benoit; Oliveira-Brett, Ana Maria; Joannis-Cassan, Claire; Aragonés, Juan Ignacio; Poggio, Lucia; Noguer, Thierry; Lima, Luisa; Barata, Carlos; Calas-Blanchard, Carole

2018-03-01

One of the main pursuits, yet most difficult, in monitoring studies is to identify the sources of environmental pollution. In this study, we have identified health-care facilities from south European countries as an important source of pharmaceuticals in the environment. We have estimated that compounds consumed in by the elderly and released from effluents of senior residences can reach river waters at a concentration higher than 0.01 μg/L, which is the European Medicines Agency (EMA) threshold for risk evaluation of pharmaceuticals in surface waters. This study has been based on five health institutions in Portugal, Spain, and France, with 52 to 130 beds. We have compiled the pharmaceuticals dispensed on a daily base and calculated the consumption rates. From 54.9 to 1801 g of pharmaceuticals are consumed daily, with laxatives, analgesics, antiepileptics, antibiotics, and antidiabetic agents being the main drug families administered. According to excretion rates, dilution in the sewerage system, and elimination in wastewater treatment plants, macrogol, metformin, paracetamol, acetylcysteine, amoxicillin, and gabapentin, among others, are expected to reach river waters. Finally, we discuss the risk management actions related to the discharge of pharmaceuticals from senior residences to surface waters.

Quality of claims and references found in Australian pharmacy journal advertisements.

PubMed

Mandoh, Mona; Curtain, Colin Michael

2017-10-01

To evaluate the quality of pharmaceutical advertisement claims and supporting references in Australian pharmacy journals that target community pharmacists. All full-page advertisements for a medicinal product, found in two Australian pharmacy journals from the year 2012 to 2015 were included. Advertisement claims and references were evaluated by claim type (unambiguous to immeasurable) and level of evidence (strong to irrelevant) in supporting references. Two hundred and ninety distinct advertisements and 598 claims were identified, with a median of 2 claims per advertisement. Twenty-seven percent of claims were unambiguous, 40% were vague, 16% were emotive/immeasurable and 17% were non-clinical or other marketing claims. Half of all claims were referenced. Although 68% of unambiguous claims were referenced, 63% of those were supported by studies that were funded directly or indirectly by pharmaceutical companies. Only 13% of claims were supported with strong or moderate independent evidence. Pharmaceutical advertisements continue to present vague and emotive claims with little independent supporting evidence. Pharmacists need to be aware of these limitations when providing patient care. Increased awareness of this issue among pharmaceutical companies, Australian pharmaceutical journal publishers, regulators and pharmacists will assist in promoting optimised healthcare outcomes for the Australian public. © 2016 Royal Pharmaceutical Society.

Safer injections following a new national medicine policy in the public sector, Burkina Faso 1995 – 2000

PubMed Central

Logez, Sophie; Hutin, Yvan; Somda, Paul; Thuault, Jérôme; Holloway, Kathleen

2005-01-01

Background The common failure of health systems to ensure adequate and sufficient supplies of injection devices may have a negative impact on injection safety. We conducted an assessment in April 2001 to determine to which extent an increase in safe injection practices between 1995 and 2000 was related to the increased access to injection devices because of a new essential medicine policy in Burkina Faso. Methods We reviewed outcomes of the new medicine policy implemented in1995. In April 2001, a retrospective programme review assessed the situation between 1995 and 2000. We visited 52 health care facilities where injections had been observed during a 2000 injection safety assessment and their adjacent operational public pharmaceutical depots. Data collection included structured observations of available injection devices and an estimation of the proportion of prescriptions including at least one injection. We interviewed wholesaler managers at national and regional levels on supply of injection devices to public health facilities. Results Fifty of 52 (96%) health care facilities were equipped with a pharmaceutical depot selling syringes and needles, 37 (74%) of which had been established between 1995 and 2000. Of 50 pharmaceutical depots, 96% had single-use 5 ml syringes available. At all facilities, patients were buying syringes and needles out of the depot for their injections prescribed at the dispensary. While injection devices were available in greater quantities, the proportion of prescriptions including at least one injection remained stable between 1995 (26.5 %) and 2000 (23.8 %). Conclusion The implementation of pharmaceutical depots next to public health care facilities increased geographical access to essential medicines and basic supplies, among which syringes and needles, contributing substantially to safer injection practices in the absence of increased use of therapeutic injections. PMID:16364178

Looking at CER from the pharmaceutical industry perspective.

PubMed

Dubois, Robert W

2012-05-01

Comparative effectiveness research (CER) is increasing as an element of health care reform in the United States. By comparing drugs against other drugs or other therapies instead of just to placebo, CER has the potential to improve decisions about the appropriate treatment for patients. But the growth of CER also brings an array of questions and decisions for purchasers and policy makers that will not be easy to answer and which require significant dialogue to fully understand and address. To describe some of the impact, both positive and negative, that comparative effectiveness research (CER) may have on the pharmaceutical industry. As CER data proliferate, questions are being raised about who can access the data, who can discuss it, and in what forums. Regulations place different communication restrictions on the pharmaceutical industry than on other health care stakeholders, which creates a potential inequality. Another CER consideration will be the tendency to apply average results to individuals, even if not every individual experiences the average result. Policy makers should implement CER findings carefully with a goal toward accommodating flexibility. A final impact to consider is whether greater expectations for CER will have a negative or positive effect on incentives for drug innovation. In some cases, CER may increase development costs or decrease market size. In other cases, better targeting of trial populations could result in lower development costs. The rising expectations and growth in CER raise questions about information access, communication restrictions, flexible implementation policies, and incentives for innovation. Members of the pharmaceutical industry should be cognizant of the questions and should be participating in dialogues now to pave the way for future solutions.

The Use of Molecular Modeling Programs in Medicinal Chemistry Instruction.

ERIC Educational Resources Information Center

Harrold, Marc W.

1992-01-01

This paper describes and evaluates the use of a molecular modeling computer program (Alchemy II) in a pharmaceutical education program. Provided are the hardware requirements and basic program features as well as several examples of how this program and its features have been applied in the classroom. (GLR)

[Methods for assessing the potential health risks of traces of pharmaceuticals in drinking water].

PubMed

Kozísek, Frantisek; Jeligová, Hana

2012-01-01

Increasing consumption of pharmaceuticals leads also to higher release of its non-metabolized residues into environment, mostly hydrosphere. Some of these substances may reach also processed drinking water. Although it is found in traces, it causes public concern as it can represent a non-targeted and unwanted medication. Toxicologists and public health authorities are appealed to assess potential health risks carefully and to communicate the risk adequately to public. As health risks assessment of environmental exposure to pharmaceuticals is a new field of expertise, its methodology has not been unified and standardized yet, but several different procedures have been proposed and used. The paper provides overview of these methods.

76 FR 62813 - Pilot Program To Evaluate Proposed Proprietary Name Submissions; Public Meeting on Pilot Program...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-11

...] Pilot Program To Evaluate Proposed Proprietary Name Submissions; Public Meeting on Pilot Program Results... voluntary pilot program that enabled participating pharmaceutical firms to evaluate proposed proprietary... public meeting at the end of fiscal year 2011 to discuss the results of the pilot program, but the Agency...

Emerging contaminants (pharmaceuticals, personal care products, a food additive and pesticides) in waters of Sydney estuary, Australia.

PubMed

Birch, G F; Drage, D S; Thompson, K; Eaglesham, G; Mueller, J F

2015-08-15

The current investigation of marine water from 30 sites adjacent to stormwater outlets across the entire Sydney estuary is the first such research in Australia. The number of analytes detected were: 8/59 pharmaceutical compounds (codeine, paracetamol, tramadol, venlafaxine, propranolol, fluoxetine, iopromide and carbamazepine), 7/38 of the pesticides (2,4-dichlorophenoxyacetic acid (2,4-D), 3,4-dichloroaniline, carbaryl, diuron, 2-methyl-4-chlorophenoxyacetic acid (MCPA), mecoprop and simazine) and 0/3 of the personal care products (PCPs) analysed. An artificial sweetener (acesulfame) was detected, however none of the nine antibiotics analysed were identified. Sewage water is not discharged to this estuary, except infrequently as overflow during high-precipitation events. The presence of acesulfame (a recognised marker of domestic wastewater) and pharmaceuticals in water from all parts of the estuary after a dry period, suggests sewage water is leaking into the stormwater system in this catchment. The pesticides are applied to the environment and were discharged via stormwater to the estuary. Copyright © 2015 Elsevier Ltd. All rights reserved.

Methods for handling uncertainty within pharmaceutical funding decisions

NASA Astrophysics Data System (ADS)

Stevenson, Matt; Tappenden, Paul; Squires, Hazel

2014-01-01

This article provides a position statement regarding decision making under uncertainty within the economic evaluation of pharmaceuticals, with a particular focus upon the National Institute for Health and Clinical Excellence context within England and Wales. This area is of importance as funding agencies have a finite budget from which to purchase a selection of competing health care interventions. The objective function generally used is that of maximising societal health with an explicit acknowledgement that there will be opportunity costs associated with purchasing a particular intervention. Three components of uncertainty are discussed within a pharmaceutical funding perspective: methodological uncertainty, parameter uncertainty and structural uncertainty, alongside a discussion of challenges that are particularly pertinent to health economic evaluation. The discipline has focused primarily on handling methodological and parameter uncertainty and a clear reference case has been developed for consistency across evaluations. However, uncertainties still remain. Less attention has been given to methods for handling structural uncertainty. The lack of adequate methods to explicitly incorporate this aspect of model development may result in the true uncertainty surrounding health care investment decisions being underestimated. Research in this area is ongoing as we review.

Occurrence, removal and risk assessment of pharmaceutical and personal care products (PPCPs) in an advanced drinking water treatment plant (ADWTP) around Taihu Lake in China.

PubMed

Lin, Tao; Yu, Shilin; Chen, Wei

2016-06-01

The occurrence and removal of 39 selected pharmaceutical and personal care products (PPCPs) were investigated in an advanced drinking water treatment plant (ADWTP) around Taihu Lake. Fourteen of 39 targeted pharmaceuticals were detected in the raw water. After a series of purification processes, only indomethacin, caffeine and sulfamethoxazole were found in effluent, albeit at concentrations less than 2 ng L(-1). The results of principal component analysis suggested that three main purification processes, oxidation, coagulation combined with sedimentation and filtration combined with bio-degradation, influenced the removal performance of PPCPs. The ecotoxicological and human health risk assessment confirmed that drugs detected in effluent posed no potential toxicity and also suggested that two PPCPs (roxithromycin and sulfamethoxazole), especially sulfamethoxazole, should be seriously considered as candidates for regulatory monitoring and prioritization. Finally, the correlation between removal efficiency and risk quotient indicated that uniform removal efficiency for all PPCPs may not reflect an equal risk control in the ADWTP. Copyright © 2016 Elsevier Ltd. All rights reserved.

Nonconsensual clinical trials: a foreseeable risk of offshoring under global corporatism.

PubMed

Spielman, Bethany

2015-03-01

This paper explores the connection of offshoring and outsourcing to nonconsensual global pharmaceutical trials in low-income countries. After discussing reasons why the topic of nonconsensual offshored clinical trials may be overlooked in bioethics literature, I suggest that when pharmaceutical corporations offshore clinical trials today, nonconsensual experiments are often foreseeable and not simply the result of aberrant ethical conduct by a few individuals. Offshoring of clinical trials is structured so that experiments can be presented as health care in a unique form of outsourcing from the host country to pharmaceutical corporations. Bioethicists' assessments of the risks and potential benefits of offshore corporate pharmaceutical trials should therefore systematically include not only the hoped for benefits and the risks of the experimental drug but also the risk that subjects will not have consented, as well as the broader international consequences of nonconsensual experimentation.

The Effect of Capital Structure on the Profitability of Pharmaceutical Companies The Case of Iran

PubMed Central

Mohammadzadeh, Mehdi; Rahimi, Farimah; Rahimi, Forough; Aarabi, Seyed Mohammad; Salamzadeh, Jamshid

2013-01-01

Funding combination is the most important issue for the companies while they know the amount of required capital. Companies should be careful regarding the appliance of financial providing methods compatible with the investment strategy of company and profitability. This study seeks to examine the relationship between the capital structure and the profitability of pharmaceutical companies in Iran. For this purpose, top 30 Iranian pharmaceutical companies defined as study samples and their financial data were gathered for the period of 2001-2010. In this study, the net margin profit and debts to asset ratio were used as indicators of profitability and capital structure, respectively and sales growth was used as a control variable. Results showed that there was significant negative relationship between the profitability and the capital structure which means that the pharmaceutical companies have established a Pecking Order Theory and the internal financing has led to more profitability. PMID:24250664

The effect of capital structure on the profitability of pharmaceutical companies the case of iran.

PubMed

Mohammadzadeh, Mehdi; Rahimi, Farimah; Rahimi, Forough; Aarabi, Seyed Mohammad; Salamzadeh, Jamshid

2013-01-01

Funding combination is the most important issue for the companies while they know the amount of required capital. Companies should be careful regarding the appliance of financial providing methods compatible with the investment strategy of company and profitability. This study seeks to examine the relationship between the capital structure and the profitability of pharmaceutical companies in Iran. For this purpose, top 30 Iranian pharmaceutical companies defined as study samples and their financial data were gathered for the period of 2001-2010. In this study, the net margin profit and debts to asset ratio were used as indicators of profitability and capital structure, respectively and sales growth was used as a control variable. Results showed that there was significant negative relationship between the profitability and the capital structure which means that the pharmaceutical companies have established a Pecking Order Theory and the internal financing has led to more profitability.

A Review of Clinical Trial Endpoints of Patients with Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension and How They Relate to Patient Outcomes in the United States.

PubMed

Divers, Christine; Platt, David; Wang, Edward; Lin, Jay; Lingohr-Smith, Melissa; Mathai, Stephen C

2017-01-01

Pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) are subgroups of pulmonary hypertension and are considered rare diseases. Understanding how endpoints of clinical trials (and patient registry studies) of patients with PAH and CTEPH are associated with patient outcomes is important in order to address the concerns of patients, health care providers, decision makers, and payers. The purpose of this review was to examine how endpoints used in clinical trials and patient registry studies are associated with outcomes of patients with PAH and CTEPH. A PubMed literature search was conducted to retrieve published studies, including randomized phase III clinical trials and observational studies, from years 2000 to May 2015 that evaluated the associations between change in 6-minute walking distance (6MWD), 6MWD thresholds, change in World Health Organization functional class (WHO-FC), and time to clinical worsening with outcomes of patients with PAH and CTEPH. Based on this review of published literature, a reduction in 6MWD as a criterion for PAH worsening, a deterioration in WHO-FC, and delay in the time to clinical worsening are clinically meaningful trial endpoints and are associated with outcomes of patients with PAH and CTEPH. Utilization and standardization of these endpoints will be useful for comparing interventions of clinical trials and therapies. Hospitalizations are frequent among patients with PAH and CTEPH, and total health care costs are high. From a U.S. payer perspective, clinical worsening is an important composite endpoint in that it includes hospitalization, which can be transformed into a preventative cost value associated with efficacious treatment of patients with PAH and CTEPH. In view of the greater number of medications available to treat PAH, the introduction of the first approved therapy to treat CTEPH, and the increasing use of combination pharmacotherapy, reliable prognostic markers of treatment responsiveness are important to help guide appropriate management. As new clinical trials and observational studies are conducted, it will be important to maintain universal endpoints so that health care providers, decision makers, and payers can better understand the value of targeted pharmacotherapies and combination therapies for the treatment of patients with PAH and CTEPH. Sponsorship for this review and article processing charges were funded by Bayer HealthCare Pharmaceuticals. Divers and Platt are employees of Bayer HealthCare Pharmaceuticals. Wang is an employee of Bayer HealthCare Pharmaceuticals and owns stock in the company. Lin and Lingohr-Smith are employees of Novosys Health, which received research funds from Bayer HealthCare Pharmaceuticals in connection with conducting this review and developing this manuscript. Mathai is a consultant to Bayer HealthCare Pharmaceuticals and also reports consulting fees from Actelion and Gilead. Study concept and design were contributed by Divers, Platt, Lin, and Mathai. Lin and Lingohr-Smith collected the data, and data interpretation was performed by Divers, Platt, Wang, and Matthai. The manuscript was written primarily by Lingohr-Smith, with assistance from the other authors, and revised by Divers, Platt, Wang, and Mathai.

Asserting the primacy of health over patent rights: a comparative study of the processes that led to the use of compulsory licensing in Thailand and Brazil.

PubMed

Rosenberg, Stephanie T

2014-08-01

Since the 1970s, the United States has adopted a trade policy agenda that has forced countries to trade away flexible patent provisions for access to US markets. While pharmaceutical companies have argued that the recognition of patent rights is essential for recovering investments in research and development of pharmaceuticals and incentivizing future innovation, the lack of competition has had damaging consequences for public health, as companies tend to set the prices of treatments beyond the reach of consumers and government programs. Thailand and Brazil are bound by law to provide universal access to anti-retroviral treatment (ART) to People Living with HIV/AIDS (PLWHA). This has been made possible in part due to the universal health care systems in each country and the countries' local technical and industrial capacities that provide the government with affordable generic medicines. The introduction of stronger intellectual property protection laws however, has limited possibilities for procuring generic medicines and inflated the cost of treatment. Between 2006-2008, Thailand and Brazil used compulsory licensing to authorize generic competition against the consent of the pharmaceutical companies in order to guarantee the right to health and ensure the viability of government health budgets. This paper will demonstrate how the interaction between individual / collective action and structural and institutional elements in Thailand and Brazil produced propitious conditions for each country to assert the primacy of health over patent rights. © 2014 John Wiley & Sons Ltd.

Catalytic photodegradation of pharmaceuticals - homogeneous and heterogeneous photocatalysis.

PubMed

Klementova, S; Kahoun, D; Doubkova, L; Frejlachova, K; Dusakova, M; Zlamal, M

2017-01-18

Photocatalytic degradation of pharmaceuticals (hydrocortisone, estradiol, and verapamil) and personal care product additives (parabens-methyl, ethyl, and propyl derivatives) was investigated in the homogeneous phase (with ferric ions as the catalyst) and on TiO 2 . Ferric ions in concentrations corresponding to concentrations in natural water bodies were shown to be a significant accelerator of the degradation in homogeneous reaction mixtures. In heterogeneous photocatalytic reactions on TiO 2 , lower reaction rates, but mineralisation to higher extents, were observed.

PHARMACEUTICALS AND PERSONAL CARE PRODUCTS ...

EPA Pesticide Factsheets

Modern sanitary practices result in large volumes of human waste, as well as domestic and industrial sewage, being collected and treated at common collection points, wastewater treatment plants (WWTP). In recognition of the growing use of sewage sludges as a fertilizers and as soilamendments, and the scarcity of current data regarding the chemical constituents in sewage sludges, the United States National Research Council (NRC) in 2002 produced a report on sewage sludges. Among the NRC's recommendations was the need for investigating the occurrence of pharmaceuticals and personal care products (PPCPs) in sewage sludges. PPCPsare a diverse array of non-regulated contaminants that had not been studied in previous sewage sludges surveys but which are likely to be present. The focus of this paper will be to review the current analytical methodologies available for investigating whether pharmaceuticals are present in WWTP-produced sewage sludges, to summarize current regulatory practices regarding sewage sludges, and to report on the presence of pharmaceuticals in sewage sludges. The research focused on in the subtasks is the development and application of state-of the-art technologies to meet the needs of the public, Office of Water, and ORD in the area of Water Quality. Located In the subtasks are the various research projects being performed in support of this Task and more in-depth coverage of each project. Briefly, each project's objective is stated below.Subta

A survey of parabens in commercial pharmaceuticals from China and its implications for human exposure.

PubMed

Ma, Wan-Li; Zhao, Xue; Lin, Zhong-Yang; Mohammed, Mohammed O A; Zhang, Zi-Feng; Liu, Li-Yan; Song, Wei-Wei; Li, Yi-Fan

2016-10-01

Parabens are widely used as antimicrobial preservatives during pharmaceutical production. However, little information is available regarding the occurrence of parabens in commercial pharmaceuticals and their implications for human exposure. In this study, six commonly used parabens were analyzed by ultra-performance liquid chromatography-tandem mass spectrometry with 100 commercial pharmaceuticals collected from China. Almost all of the pharmaceutical samples contained at least one kind of parabens with the detection frequency of 97%. The concentrations of Σ6parabens (sum of the six parabens) ranged from below MDL to 1256ng/g, with mean and median values of 94.8 and 119ng/g, respectively. Methyl paraben (MeP), ethyl paraben (EtP) and propyl paraben (PrP) were the predominant compounds. Significant positive correlation was observed between concentrations of MeP and PrP, indicating their co-applications in pharmaceuticals. Levels of Σ6parabens varied in different categories of pharmaceuticals and increased with their shelf lives. Based on the measured concentrations and daily ingestion rates of pharmaceuticals, the estimated daily intake (EDI) of parabens was calculated. The median values of EDIpharmaceutical for male adults, female adults and children were 4.05, 4.75 and 9.73ng/kg-bw/day, respectively, which were three orders of magnitude lower than those from foodstuffs and personal care products (PCPs). It was firstly reported that the total exposure dose was 0.326mg/kg-bw/day via foodstuffs, PCPs, and pharmaceuticals for Chinese female adults. Copyright © 2016 Elsevier Ltd. All rights reserved.

Risks to health care workers from nano-enabled medical products.

PubMed

Murashov, Vladimir; Howard, John

2015-01-01

Nanotechnology is rapidly expanding into the health care industry. However, occupational safety and health risks of nano-enabled medical products have not been thoroughly assessed. This manuscript highlights occupational risk mitigation practices for nano-enabled medical products throughout their life cycle for all major workplace settings including (1) medical research laboratories, (2) pharmaceutical manufacturing facilities, (3) clinical dispensing pharmacies, (4) health care delivery facilities, (5) home health care, (6) health care support, and (7) medical waste management. It further identifies critical research needs for ensuring worker protection in the health care industry.

An Empirical Review of Major Legislation Affecting Drug Development: Past Experiences, Effects, and Unintended Consequences

PubMed Central

Kesselheim, Aaron S

2011-01-01

Context: With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market. Methods: This report provides an historical perspective on proposals for encouraging drug research. Four legislative programs have been primarily designed to offer market exclusivity to promote public health goals in the pharmaceutical or biomedical sciences: the Bayh-Dole Act of 1980, the Orphan Drug Act of 1983, the Hatch-Waxman Act of 1984, and the pediatric exclusivity provisions of the FDA Modernization Act of 1997. I reviewed quantitative and qualitative studies that reported on the outcomes from these programs and evaluated the quality of evidence generated. Findings: All four legislative programs generally have been regarded as successful, although such conclusions are largely based on straightforward descriptive reports rather than on more rigorous comparative data or analyses that sufficiently account for confounding. Overall, solid data demonstrate that market exclusivity incentives can attract interest from parties involved in drug development. However, using market exclusivity to promote innovation in the pharmaceutical market can be prone to misuse, leading to improper gains. In addition, important collateral effects have emerged with substantial negative public health implications. Conclusions: Using market exclusivity to promote pharmaceutical innovation can lead to positive outcomes, but the practice is also characterized by waste and collateral effects. Certain practices, such as mechanisms for reevaluation and closer ties of incentives programs to public health outcomes, can help address these problems. PMID:21933276

An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences.

PubMed

Kesselheim, Aaron S

2011-09-01

With the development of transformative drugs at a low point, numerous commentators have recommended new legislation that uses supplementary market exclusivity as an incentive to promote innovation in the pharmaceutical market. This report provides an historical perspective on proposals for encouraging drug research. Four legislative programs have been primarily designed to offer market exclusivity to promote public health goals in the pharmaceutical or biomedical sciences: the Bayh-Dole Act of 1980, the Orphan Drug Act of 1983, the Hatch-Waxman Act of 1984, and the pediatric exclusivity provisions of the FDA Modernization Act of 1997. I reviewed quantitative and qualitative studies that reported on the outcomes from these programs and evaluated the quality of evidence generated. All four legislative programs generally have been regarded as successful, although such conclusions are largely based on straightforward descriptive reports rather than on more rigorous comparative data or analyses that sufficiently account for confounding. Overall, solid data demonstrate that market exclusivity incentives can attract interest from parties involved in drug development. However, using market exclusivity to promote innovation in the pharmaceutical market can be prone to misuse, leading to improper gains. In addition, important collateral effects have emerged with substantial negative public health implications. Using market exclusivity to promote pharmaceutical innovation can lead to positive outcomes, but the practice is also characterized by waste and collateral effects. Certain practices, such as mechanisms for reevaluation and closer ties of incentives programs to public health outcomes, can help address these problems. © 2011 Milbank Memorial Fund. Published by Wiley Periodicals Inc.

Taking Pharmaceutical Innovation to the Masses.

PubMed

Burcham, Philip C

2017-07-13

General levels of "pharmaceuticals literacy" are not high in contemporary societies. To address this educational need, in 2012 the University of Western Australia introduced an innovative multidisciplinary course for undergraduates within any degree program entitled PHAR1101: Drugs that Changed the World . Now ranking among the largest courses at the institution, PHAR1101 enrollments will likely approach 1000 students in 2017.

Are regional hospital pharmacies prepared for public health emergencies?

PubMed

Hsu, Edbert B; Casani, Julie A; Romanosky, Al; Millin, Michael G; Singleton, Christa M; Donohue, John; Feroli, E Robert; Rubin, Melvin; Subbarao, Italo; Whyne, Dianne M; Snodgrass, Thomas D; Kelen, Gabor D

2006-01-01

In the event of a major chemical, biological, radiological, nuclear, or explosive (CBRNE) attack or a natural disaster, large quantities of pharmaceuticals and medical supplies may be required with little or no warning. Pharmaceutical surge capacity for immediate response, before Strategic National Stockpile (SNS) supplies become available, remains a significant gap in emergency preparedness. To date, limited attempts have been made to assess collective regional hospital pharmaceutical response capabilities. In this project, we characterized the level of hospital pharmaceutical response preparedness in a major metropolitan region. The Johns Hopkins Office of Critical Event Preparedness and Response (CEPAR) convened a collaborative partnership to assess hospital pharmaceutical response capabilities. A survey was developed to characterize pharmaceutical response preparedness to CBRNE threats. All 22 acute care hospitals in the Maryland region were sent pharmaceutical response surveys, and responses were received from 86% (19/22). Within the past year, 84% (16/19) of hospitals had implemented an exercise with pharmacy participation. More than half of the hospitals expect to receive assistance from the SNS in 48 hours or less. Seventy-four percent (14/19) of the hospitals reported an additional dedicated reserve supply for biological events, 74% (14/19) for chemical events, and 58% (11/19) for radiological events. Many hospitals in this metropolitan region have taken important steps toward enhancing pharmaceutical preparedness. However, hospitals generally remain underprepared for CBRNE threats and collectively have limited supplies of antibiotics to provide prophylaxis or treatment for hospital staff, their families, and patients in the event of a significant biological incident.

Out-of-pocket expenditures for pharmaceuticals: lessons from the Austrian household budget survey.

PubMed

Sanwald, Alice; Theurl, Engelbert

2017-05-01

Paying pharmaceuticals out of pocket is an important source of financing pharmaceutical consumption. Only limited empirical knowledge is available on the determinants of these expenditures. In this article we analyze which characteristics of private households influence out-of-pocket pharmaceutical expenditure (OOPPE) in Austria. We use cross-sectional information on OOPPE and household characteristics provided by the Austrian household budget survey 2009/10. We split pharmaceutical expenditures into the two components prescription fees and over-the-counter (OTC) expenditures. To adjust for the specific characteristics of the data, we compare different econometric approaches: a two-part model, hurdle model, generalized linear model and zero-inflated negative binomial regression model. The finally selected econometric approaches give a quite consistent picture. The probability of expenditures of both types is strongly influenced by the household structure. It increases with age, doctoral visits and the presence of a female householder. The education level and income only increase the probability of OTC pharmaceuticals. The level of OTC expenditures remains widely unexplained while the household structure and age influence the expenditures for prescription fees. Insurance characteristics of private households, either private or public, play a minor role in explaining the expenditure levels in all specifications. This refers to a homogeneous and comprehensive provision of pharmaceuticals in the public part of the Austrian health care system. The article gives useful insights into the determinants of pharmaceutical expenditures of private households and supplements the previous research that focuses on the individual level.

Financing of Pharmaceutical Services in the municipal management of the Brazilian Unified Health System

PubMed Central

Faleiros, Daniel Resende; Acurcio, Francisco de Assis; Álvares, Juliana; do Nascimento, Renata Cristina Rezende Macedo; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Leite, Silvana Nair; Karnikowski, Margô Gomes de Oliveira; Costa, Karen Sarmento; Guerra, Augusto Afonso

2017-01-01

ABSTRACT OBJECTIVE To discuss factors related to the financing of the Basic Component of Pharmaceutical Services within the municipal management of the Brazilian Unified Health System. METHODS The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil – Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) is a cross-sectional, exploratory, and evaluative study that performed an information survey in a representative sample, stratified by Brazilian regions It considered different study populations in the sampling plan, which represent primary health care services in the cities. Data were collected in 2015 by two methods: in person, by applying direct observation scripts and interviews with users, physicians, and professionals responsible for the dispensing of medicines in primary care services; by telephone interviews with municipal health managers and municipal professionals responsible for Pharmaceutical Services. The results were extracted from the questionnaires applied by telephone. RESULTS Of the sample of 600 eligible cities, we collected 369 interviews (61.5%) with secretaries and 507 (84.5%) with pharmaceutical services managers. 70.8% of the cities have a computerized management system; and 11.9% have qualification/training of professionals. More than half (51.3%) of the cities received funds for the structuring of pharmaceutical services, and almost 60% of these cities performed this type of spending. In 35.4% of cases, municipal secretaries of health said that they use resources of medicines from the Componente Básico da Assistência Farmacêutica (CBAF – Basic Component of Pharmaceutical Services) to cover demands of other medicines, but only 9.7% believed that these funds were sufficient to cover the demands. The existence of a permanent bidding committee exclusively for acquiring medicines was reported in 40.0% of the cities. CONCLUSIONS We found serious deficiencies in the public financing of medicines, as well as little concern about the formality in the use of public resources, expenses that meet individual demands to the detriment of the community, insufficient resources allocated to the Basic Component of Pharmaceutical Services, and exhaustion of the financing model. PMID:29160447

Financing of Pharmaceutical Services in the municipal management of the Brazilian Unified Health System.

PubMed

Faleiros, Daniel Resende; Acurcio, Francisco de Assis; Álvares, Juliana; Nascimento, Renata Cristina Rezende Macedo do; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Leite, Silvana Nair; Karnikowski, Margô Gomes de Oliveira; Costa, Karen Sarmento; Guerra, Augusto Afonso

2017-11-13

To discuss factors related to the financing of the Basic Component of Pharmaceutical Services within the municipal management of the Brazilian Unified Health System. The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos no Brasil - Serviços (PNAUM - National Survey on Access, Use and Promotion of Rational Use of Medicines - Services) is a cross-sectional, exploratory, and evaluative study that performed an information survey in a representative sample, stratified by Brazilian regions It considered different study populations in the sampling plan, which represent primary health care services in the cities. Data were collected in 2015 by two methods: in person, by applying direct observation scripts and interviews with users, physicians, and professionals responsible for the dispensing of medicines in primary care services; by telephone interviews with municipal health managers and municipal professionals responsible for Pharmaceutical Services. The results were extracted from the questionnaires applied by telephone. Of the sample of 600 eligible cities, we collected 369 interviews (61.5%) with secretaries and 507 (84.5%) with pharmaceutical services managers. 70.8% of the cities have a computerized management system; and 11.9% have qualification/training of professionals. More than half (51.3%) of the cities received funds for the structuring of pharmaceutical services, and almost 60% of these cities performed this type of spending. In 35.4% of cases, municipal secretaries of health said that they use resources of medicines from the Componente Básico da Assistência Farmacêutica (CBAF - Basic Component of Pharmaceutical Services) to cover demands of other medicines, but only 9.7% believed that these funds were sufficient to cover the demands. The existence of a permanent bidding committee exclusively for acquiring medicines was reported in 40.0% of the cities. We found serious deficiencies in the public financing of medicines, as well as little concern about the formality in the use of public resources, expenses that meet individual demands to the detriment of the community, insufficient resources allocated to the Basic Component of Pharmaceutical Services, and exhaustion of the financing model.

Controversy and consensus on a clinical pharmacist in primary care in the Netherlands.

PubMed

Hazen, Ankie C M; Wal, Aletta W van der; Sloeserwij, Vivianne M; Zwart, Dorien L M; Gier, Johan J de; Wit, Niek J de; Leendertse, Anne J; Bouvy, Marcel L; Bont, Antoinette A de

2016-10-01

Background Controversy about the introduction of a non-dispensing pharmacist in primary care practice hampers implementation. Objective The aim of this study is to systematically map the debate on this new role for pharmacists amongst all stakeholders to uncover and understand the controversy and consensus. Primary health care in the Netherlands. Method Q methodology. 163 participants rank-ordered statements on issues concerning the integration of a non-dispensing pharmacist in primary care practice. Stakeholder perspectives on the role of the non-dispensing pharmacist and pharmaceutical care in primary care. Results This study identified the consensus on various features of the non-dispensing pharmacist role as well as the financial, organisational and collaborative aspects of integrating a non-dispensing pharmacist in primary care practice. Q factor analysis revealed four perspectives: "the independent community pharmacist", "the independent clinical pharmacist", "the dependent clinical pharmacist" and "the medication therapy management specialist". These four perspectives show controversies to do with the level of professional independency of the non-dispensing pharmacist and the level of innovation of task performance. Conclusion Despite the fact that introducing new professional roles in healthcare can lead to controversy, the results of this Q study show the potential of a non-dispensing pharmacist as a pharmaceutical care provider and the willingness for interprofessional collaboration. The results from the POINT intervention study in the Netherlands will be an important next step in resolving current controversies.

75 FR 4408 - Notice of Public Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-27

..., pharmaceutical companies, health care delivery organizations, agricultural producers, consumer groups, and other...: January 20, 2010. Tanja Popovic, Chief Science Officer, Centers for Disease Control and Prevention. [FR...

The relative risk and its distribution of endocrine disrupting chemicals, pharmaceuticals and personal care products to freshwater organisms in the Bohai Rim, China.

PubMed

Zhang, Meng; Shi, Yajuan; Lu, Yonglong; Johnson, Andrew C; Sarvajayakesavalu, Suriyanarayanan; Liu, Zhaoyang; Su, Chao; Zhang, Yueqing; Juergens, Monika D; Jin, Xiaowei

2017-07-15

In this study, the risks to aquatic organisms posed by 12 commonly detected pharmaceuticals and personal care products (PPCPs) and endocrine disrupting chemicals (EDCs) that are extensively used in Bohai coastal region of China were examined. These were linear alkylbenzene sulfonate (LAS), nonylphenol (NP), diethylhexyl phthalate (DEHP), norfloxacin (NOR), sulfamethoxazole (SMX), erythromycin (ERY), bisphenol A (BPA), ofloxacin (OFL), carbamazepine (CBZ), naproxen (NPX), atenolol (ATL) and metoprolol (MET). Their relative risk was ranked based on the proximity between the medians of the reported effect concentrations and measured river or lake water concentrations. The surfactants (LAS) and endocrine disrupting chemicals NP (a breakdown product of the surfactant nonylphenol polyethoxylate) and DEHP (a plasticizer) were identified as posing the greatest risk from this range of chemicals. LAS had a hundred-fold higher risk than any of the pharmaceuticals. The highest risk ranked pharmaceuticals were all antibiotics. Zinc (Zn) and mercury (Hg) were added to the comparison as representative heavy metals. Zn posed a risk higher than all the organics. The risk posed by Hg was less than the surfactants but greater than the selected pharmaceuticals. Whereas LAS and DEHP could cause harmful effects to all the wildlife groups, NP and BPA posed the greatest risk to fish. Antibiotics showed the highest risk to algae. Spatial and temporal distributions of PPCPs and EDCs were conducted for risk identification, source analysis and seasonal change exploration. Municipal sewage effluent linked to urban areas was considered to be the major source of pharmaceuticals. With regard to seasonal influence the risk posed by LAS to the aquatic organisms was significantly affected by wet and dry seasonal change. The dilution effects were the common feature of LAS and ERY risks. The difference in LAS and ERY risk patterns along the rivers was mainly affected by the elimination process. Copyright © 2017 Elsevier B.V. All rights reserved.

A prototype for evidence-based pharmaceutical opinions to promote physician-pharmacist communication around deprescribing

PubMed Central

Tannenbaum, Cara

2018-01-01

Context: Interprofessional communication is an effective mechanism for reducing inappropriate prescriptions among older adults. Physicians’ views about which elements are essential for pharmacists to include in an evidence-based pharmaceutical opinion for deprescribing remain unknown. Objective: To develop a prototype for an evidence-based pharmaceutical opinion that promotes physician-pharmacist communication around deprescribing. Methods: A standardized template for an evidence-based pharmaceutical opinion was developed with input from a convenience sample of 32 primary care physicians and 61 primary care pharmacists, recruited from conferences and community settings in Montreal, Canada. Participants were asked to comment on the need for clarifying treatment goals, including personalized patient data and biomarkers, highlighting evidence about drug harms, listing the credibility and source of the recommendations, providing therapeutic alternatives and formalizing official documentation of decision making. The content and format of the prototype underwent revision by community physicians and pharmacists until consensus was reached on a final recommended template. Results: The majority of physicians (84%-97%) requested that the source of the deprescribing recommendations be cited, that alternative management options be provided and that the information be tailored to the patient. Sixteen percent of physicians expressed concern about the information in the opinions being too dense. Pharmacists also questioned the length of the opinion and asked that additional space be provided for the physician’s response. A statement was added making the opinion a valid prescription upon receipt of a signature from physicians. Compared to a nonstandardized opinion, the majority of pharmacists believed the template was easier to use, more evidence based, more time efficient and more likely to lead to deprescribing. Conclusion: Physicians and pharmacists endorsed a standardized template that promotes interprofessional communication for deprescribing (available at https://www.deprescribingnetwork.ca/pharmaceutical-opinions). The outcome of the D-Prescribe trial will determine the effectiveness of these evidence-based pharmaceutical opinions on deprescribing processes and outcomes. Can Pharm J (Ott) 2018;151:xx-xx. PMID:29531631

Access to Cancer Therapeutics in Low- and Middle-Income Countries.

PubMed

Ruff, Paul; Al-Sukhun, Sana; Blanchard, Charmaine; Shulman, Lawrence N

2016-01-01

Cancer is rapidly becoming a major health care problem, especially in developing countries, where 60% of the world's total new cases are diagnosed. The success of new antineoplastic medicines and modern radiation devices to cure a good proportion of patients with cancer and to alleviate the suffering of many more has been achieved at a dramatic cost. Therefore, it has become mandatory for health care authorities and pharmaceutical companies to cooperate to use and develop resources in an efficient manner to improve health care delivery to patients with cancer worldwide. Regulatory harmonization is an important key to overcome delays in the approval process, whether for antineoplastic and pain control medicines or for essential medical devices. More emphasis on the significant role of opiates in pain control among patients with cancer is needed to overcome the ingrained belief in their potential for addiction. The World Health Organization (WHO) serves an important role in guiding priorities for health care and efficiently allocating resources by providing essential medicine lists (EMLs) and device lists. However, the financial challenge for access to health care is multi-tiered and requires collaboration between key stakeholders including pharmaceutical industry, local national health authorities, WHO, and other nonprofit, patient-oriented organizations.

Allied against reform: pharmaceutical industry-academic physician relations in the United States, 1945-1970.

PubMed

Tobbell, Dominique A

2008-01-01

During the 1960s, the drug industry was the subject of two congressional investigations into its business practices and pricing policies, and in 1962, passage of the Drug Amendments mandated greater Food and Drug Administration authority over pharmaceutical development. In this article, I examine the industry's efforts to circumvent these political challenges by drawing on its longstanding relationship with academic physicians and the American Medical Association. Using the medical profession's shared concern about expanding government oversight over therapeutic practice, the industry called on academic physicians to join forces with it and establish an expert advisory body to guide government officials on pharmaceutical policy. Drawing on research in the archives of the University of Pennsylvania and the National Academy of Sciences and a careful reading of the trade and biomedical literature and congressional documents, I argue that by positioning themselves as pharmaceutical experts, the members of this industry-academic alliance gave industry a seat at the policy table and enabled it to challenge the efforts of pharmaceutical reformers to further increase the government's role in drug development.

A Case Study: Introducing a New Benefit Plan on Campus

ERIC Educational Resources Information Center

Gustin, Karen; Bursic, Paul

2004-01-01

Many higher education institutions are strapped by benefit compensation costs for medical and pharmaceutical insurance, and there are few budget dollars left over for other health benefits, such as dental and eye care. Cornell University faced this dilemma and found voluntary dental and eye care plans to be an excellent solution. This article…

Treatment of gestational diabetes mellitus: glyburide compared to subcutaneous insulin therapy and associated perinatal outcomes.

PubMed

Cheng, Yvonne W; Chung, Judith H; Block-Kurbisch, Ingrid; Inturrisi, Maribeth; Caughey, Aaron B

2012-04-01

To examine perinatal outcomes in women with gestational diabetes mellitus treated with glyburide compared to insulin injections. This is a retrospective cohort study of women diagnosed with gestational diabetes mellitus (GDM) who required pharmaceutical therapy and were enrolled in the Sweet Success California Diabetes and Pregnancy Program between 2001 and 2004, a California state-wide program. Women managed with glyburide were compared to women treated with insulin injections. Perinatal outcomes were compared using chi-square test and multivariable logistic regression models; statistical significance was indicated by p < 0.05 and 95% confidence intervals (CI). Among the 10,682 women with GDM who required medical therapy and met study criteria, 2073 (19.4%) received glyburide and 8609 (80.6%) received subcutaneous insulin injections. Compared to insulin therapy and controlling for confounders, oral hypoglycemic treatment was associated with increased risk of birthweight >4000 g (aOR = 1.29; 95% CI [1.03-1.64]), and admission to the intensive care nursery (aOR = 1.46 [1.07-2.00]). Neonates born to women with gestational diabetes managed on glyburide, and were more likely to be macrosomic and to be admitted to the intensive care unit compared to those treated with insulin injections. These findings should be examined in a large, prospective trial.

Influence of seasonal climate differences on the pharmaceutical, hormone and personal care product removal efficiency of a drinking water treatment plant.

PubMed

Azzouz, Abdelmonaim; Ballesteros, Evaristo

2013-11-01

The potential presence of pharmaceuticals, hormones and personal care products in drinking water supplies has raised concerned over the efficiency with which these substances are removed by water treatment processes. In this work, we analyzed samples of raw, unprocessed water collected in different periods and found them to contain higher levels of these contaminants in the colder periods (viz. 12-314 ng L(-1) in autumn and winter as compared to 8-127 ng L(-1) in spring and summer) as a result of their biodegradation being favoured by high temperatures and solar irradiance. We also assessed the efficiency with which these contaminants are removed from drinking water by a water treatment plant operating in south-eastern Spain. Preoxidation with potassium permanganate and chloramination with sodium hypochlorite in the presence of highly concentrated ammonia were found to be the treatment steps most markedly contributing to the removal of pharmaceuticals, hormones and personal care products from drinking water (especially in the warmer periods, where these contaminants were completely removed from the water). By contrast, water treated in the colder periods (autumn and winter) still contained small amounts of ibuprofen and carbamazepine (0.09-0.5 ng L(-1)) which, however, accounted for less than 0.2% of their original concentrations in the water prior to treatment. Copyright © 2013 Elsevier Ltd. All rights reserved.

Core competencies for pharmaceutical physicians and drug development scientists

PubMed Central

Silva, Honorio; Stonier, Peter; Buhler, Fritz; Deslypere, Jean-Paul; Criscuolo, Domenico; Nell, Gerfried; Massud, Joao; Geary, Stewart; Schenk, Johanna; Kerpel-Fronius, Sandor; Koski, Greg; Clemens, Norbert; Klingmann, Ingrid; Kesselring, Gustavo; van Olden, Rudolf; Dubois, Dominique

2013-01-01

Professional groups, such as IFAPP (International Federation of Pharmaceutical Physicians and Pharmaceutical Medicine), are expected to produce the defined core competencies to orient the discipline and the academic programs for the development of future competent professionals and to advance the profession. On the other hand, PharmaTrain, an Innovative Medicines Initiative project, has become the largest public-private partnership in biomedicine in the European Continent and aims to provide postgraduate courses that are designed to meet the needs of professionals working in medicines development. A working group was formed within IFAPP including representatives from PharmaTrain, academic institutions and national member associations, with special interest and experience on Quality Improvement through education. The objectives were: to define a set of core competencies for pharmaceutical physicians and drug development scientists, to be summarized in a Statement of Competence and to benchmark and align these identified core competencies with the Learning Outcomes (LO) of the PharmaTrain Base Course. The objectives were successfully achieved. Seven domains and 60 core competencies were identified and aligned accordingly. The effective implementation of training programs using the competencies or the PharmaTrain LO anywhere in the world may transform the drug development process to an efficient and integrated process for better and safer medicines. The PharmaTrain Base Course might provide the cognitive framework to achieve the desired Statement of Competence for Pharmaceutical Physicians and Drug Development Scientists worldwide. PMID:23986704

Interactions with the pharmaceutical industry: a survey of family medicine residents in Ontario.

PubMed Central

Sergeant, M D; Hodgetts, P G; Godwin, M; Walker, D M; McHenry, P

1996-01-01

OBJECTIVE: To determine the attitudes, knowledge and practices of family medicine residents relating to the pharmaceutical industry and to assess the effectiveness of existing guidelines on appropriate interactions with the pharmaceutical industry. DESIGN: Survey by mailed questionnaire. SETTING: Ontario. PARTICIPANTS: All 262 second-year family medicine residents in Ontario (seven centres); 226 (86.3%) responded. RESULTS: Fifty-two (23.0%) of the residents who responded stated that they had read the CMA policy statement on appropriate interactions between physicians and the pharmaceutical industry. A total of 124 (54.9%) stated that they would attend a private dinner paid for by a pharmaceutical representative; the proportion was not significantly reduced among those who had read the CMA guidelines, which prohibit the acceptance of personal gifts. In all, 186 (82.3%) reported that they would like the opportunity to interact with pharmaceutical representatives in an educational setting, even though several programs now discourage these interactions. Approximately three quarters (172/226 [76.1%]) of the residents indicated that they plan to see pharmaceutical representatives in their future practice. Residents at Centre 2 were significantly more critical of the pharmaceutical industry than those from the other centres. Overall, being aware of, and familiar with, departmental policy or CMA policy on interactions with the pharmaceutical industry did not affect the residents' attitudes or intended future practices. CONCLUSION: The presence of guidelines concerning physicians' interactions with the pharmaceutical industry does not appear to have a significant impact on family medicine residents in Ontario. PMID:8911290

Pharmaceuticals Exposed to the Space Environment: Problems and Prospects

NASA Technical Reports Server (NTRS)

Jaworske, Donald A.; Myers, Jerry G.

2016-01-01

The NASA Human Research Program (HRP) Health Countermeasures Element maintains ongoing efforts to inform detailed risks, gaps, and further questions associated with the use of pharmaceuticals in space. Most recently, the Pharmacology Risk Report, released in 2010, illustrates the problems associated with maintaining pharmaceutical efficacy. Since the report, one key publication includes evaluation of pharmaceutical products stored on the International Space Station (ISS). This study shows that selected pharmaceuticals on ISS have a shorter shelf-life in space than corresponding terrestrial controls. The HRP Human Research Roadmap for planetary exploration identifies the risk of ineffective or toxic medications due to long-term storage during missions to Mars. The roadmap also identifies the need to understand and predict how pharmaceuticals will behave when exposed to radiation for long durations. Terrestrial studies of returned samples offer a start for predictive modeling. This paper shows that pharmaceuticals returned to Earth for post-flight analyses are amenable to a Weibull distribution analysis in order to support probabilistic risk assessment modeling. The paper also considers the prospect of passive payloads of key pharmaceuticals on sample return missions outside of Earth's magnetic field to gather additional statistics. Ongoing work in radiation chemistry suggests possible mitigation strategies where future work could be done at cryogenic temperatures to explore methods for preserving the strength of pharmaceuticals in the space radiation environment, perhaps one day leading to an architecture where pharmaceuticals are cached on the Martian surface and preserved cryogenically.