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

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.

77 FR 16264 - Manufacturer of Controlled Substances, Notice of Registration; Johnson Matthey Pharmaceutical...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-20

..., Notice of Registration; Johnson Matthey Pharmaceutical Materials Inc. By Notice dated November 18, 2011... Pharmaceutical Materials Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts 01434, made... Matthey Pharmaceutical Materials Inc. to manufacture the listed basic classes of controlled substances is...

Community pharmacists' perceptions about pharmaceutical service of over-the-counter traditional Chinese medicine: a survey study in Harbin of China.

PubMed

Song, Menghuan; Ung, Carolina Oi Lam; Lee, Vivian Wing-Yan; Hu, Yuanjia; Zhao, Jing; Li, Peng; Hu, Hao

2017-01-05

This study aims to investigate community pharmacist's perception on the provision of over-the-counter (OTC) traditional Chinese medicine (TCM) pharmaceutical services; focusing on the areas of their attitude, general practice, perceived barriers and suggested improvements. Questionnaire survey targeting community pharmacists in Harbin of China was applied in this study. Questionnaires were distributed and collected at community pharmacies. Data was analyzed by combining descriptive analysis and Chi-test. 280 valid questionnaires were collected, giving a response rate of 78%. Respondents generally showed positive attitude towards OTC TCM pharmaceutical services. However, they were uncertain about whether such pharmaceutical services should be considered as their primary responsibility. Respondents indicated that they acted proactively to find out all the medicines taken by their patients and to remind consumers of possible OTC TCM adverse reactions. However, they were less keen on recommending or re-directing consumers to suitable OTC TCM. The three main barriers hindering the provision of OTC TCM pharmaceutical service identified in this study were "insufficient professional knowledge" (54.6%), "ambiguity of the professional role of pharmacists" (54.6%) and "lack of scientific evidence of OTC TCM" (45.4%). The three main actions considered most relevant to improving pharmaceutical service of OTC TCM were "formulating or refining legislation to clarify the legal and professional role of pharmacists with respect to TCM" (60.7%), "strengthening training of pharmacists with respect to TCM" (57.9%), and "promoting public awareness of the pharmacist's role" (53.6%). According to the results of Chi-test, respondents' perceptions about the attitude, practice, perceived barriers, and improvement suggestions were significantly different depending on the education levels, certificate types and workloads of western medicine. The community pharmacists in Harbin, China were positive about the provision of OTC TCM pharmaceutical services. However, they were less certain about taking this duty as their primary responsibility. Insufficient knowledge and lack of role definition in the area of OTC TCM were found to be the major factors discouraging the provision of pharmaceutical service on OTC TCM by community pharmacists.

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.

78 FR 19017 - Manufacturer of Controlled Substances; Notice of Application; Johnson Matthey Pharmaceutical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-03-28

... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application; Johnson Matthey Pharmaceutical Materials, Inc. Pursuant to Sec. 1301.33(a), Title... Matthey Pharmaceutical Materials, Inc., Pharmaceutical Service, 25 Patton Road, Devens, Massachusetts...

Measuring Equity in Access to Pharmaceutical Services Using Concentration Curve; Model Development.

PubMed

Davari, Majid; Khorasani, Elahe; Bakhshizade, Zahra; Jafarian Jazi, Marzie; Ghaffari Darab, Mohsen; Maracy, Mohammad Reza

2015-01-01

This paper has two objectives. First, it establishes a model for scoring the access to pharmaceutical services. Second, it develops a model for measuring socioeconomic indicators independent of the time and place of study. These two measures are used for measuring equity in access to pharmaceutical services using concentration curve. We prepared an open-ended questionnaire and distributed it to academic experts to get their ideas to form access indicators and assign score to each indicator based on the pharmaceutical system. An extensive literature review was undertaken for the selection of indicators in order to determine the socioeconomic status (SES) of individuals. Experts' opinions were also considered for scoring these indicators. These indicators were weighted by the Stepwise Adoption of Weights and were used to develop a model for measuring SES independent of the time and place of study. Nine factors were introduced for assessing the access to pharmaceutical services, based on pharmaceutical systems in middle-income countries. Five indicators were selected for determining the SES of individuals. A model for income classification based on poverty line was established. Likewise, a model for scoring home status based on national minimum wage was introduced. In summary, five important findings emerged from this study. These findings may assist researchers in measuring equity in access to pharmaceutical services and also could help them to apply a model for determining SES independent of the time and place of study. These also could provide a good opportunity for researchers to compare the results of various studies in a reasonable way; particularly in middle-income countries.

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2014 CFR

2014-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2011 CFR

2011-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2013 CFR

2013-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

42 CFR 88.16 - Reimbursement for medically necessary treatment, outpatient prescription pharmaceuticals...

Code of Federal Regulations, 2012 CFR

2012-10-01

..., outpatient prescription pharmaceuticals, monitoring, initial health evaluations, and travel expenses. 88.16... for medically necessary treatment, outpatient prescription pharmaceuticals, monitoring, initial health... pharmaceuticals. (1) The costs of providing medically necessary treatment or services for a WTC-related health...

[Present Status of Displaying Pharmaceutical Products for Sale on Flea Market Applications for Smartphones and the Responses to Illicit Selling by Service Providers].

PubMed

Kishimoto, Keiko; Takeuchi, Tomoe; Fukushima, Noriko

2017-12-01

 In Japan, a pharmacy or drug store license is required for selling pharmaceutical products. However, civilians without a pharmacy or drug store license are displaying pharmaceutical products for sale on a flea market application, which is illegal dealing. This study discussed the modality for implementing countermeasures for the illicit selling of pharmaceutical products. We extracted pharmaceutical products displayed for sale on three flea market applications (Mercari, Rakuma, Fril) on one day. One hundred and eighty-one pharmaceutical products were displayed (49 on Mercari, 86 on Rakuma, and 46 on Fril). There were 6.1% (11/181) domestically prescribed drugs, 69.1% (125/181) domestic OTC drugs, 23.8% (43/181) foreign-made prescribed drugs, and 1.1% (2/181) foreign-made OTC drugs. The seller could display the product for sale without confirming whether it is prohibited. We alerted the service providers of this illicit selling at flea markets at three different instances. The pharmaceutical product displays were deleted by the service providers at a rate of 55.1% (27/49) for Mercari and 51.2% (44/86) for Rakuma. The average number of drugs that were displayed for sale by each seller was 1.4 and the average number of total products that were displayed for sale by each seller was 100. The seller could have unintentionally displayed the pharmaceutical products for sale, without the knowledge that it is illegal. The service providers of flea market applications should create mechanisms to alert the sellers that displaying pharmaceutical products for sale is an illicit act and regulate these violations.

Dispensing doctor practices and community pharmacies: exploring the quality of pharmaceutical services.

PubMed

Weiss, Marjorie C; Grey, Elisabeth; Harris, Michael; Rodham, Karen

2016-01-01

This research sought (a) to investigate the similarities and differences in how pharmaceutical services are provided by community pharmacies (CPs) and dispensing doctor practices (DPs) and (b) to identify the issues relevant to determining the quality of pharmaceutical services in these settings. UK pharmaceutical services, including dispensing prescriptions and public health advice, can be provided from both (CP) and, in rural areas, (DP). While there is much similarity between CPs and DPs in the types of services provided, there is also the potential for variation in service quality across settings. A postal questionnaire of DPs and CPs in South West England was conducted to provide a descriptive overview of pharmaceutical services across the settings. A subsection of questionnaire respondent sites were selected to take part in case studies, which involved documentary analyses, observation and staff interviews. Survey response was 39% for CPs (52/134) and 48% (31/64) for DPs. There were three CP and four DP case study sites, with 17 staff interviews. More pharmacies than practices were open at the weekend and they had more staff trained above NVQ level 2. Both doctors and pharmacists saw themselves as medicines experts, as being accessible and having good relationships with patients. Workplace practices and organisational ethos varied both within and across settings, with good practice observed in both. Overall, CPs and DPs have much in common. Workplace culture and an evidence-based approach to checking prescriptions and error reporting need to be considered in future assessments of service quality.

Characterization of the institutionalization of pharmaceutical services in Brazilian primary health care.

PubMed

Souza, Gisélia Santana; Costa, Ediná Alves; Barros, Rafael Damasceno de; Pereira, Marcelo Tavares; Barreto, Joslene Lacerda; Guerra, Augusto Afonso; Acurcio, Francisco de Assis; Guibu, Ione Aquemi; Álvares, Juliana; Costa, Karen Sarmento; Karnikowski, Margô Gomes de Oliveira; Soeiro, Orlando Mario; Leite, Silvana Nair

2017-11-13

To characterize the current stage of the institutionalization of pharmaceutical services in Brazilian cities. This study is part 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), a cross-sectional, exploratory, and evaluative study composed by an information survey in a representative sample of cities, stratified by Brazilian regions. We interviewed municipal secretaries of health, responsible for pharmaceutical services, and pharmacists responsible for the dispensing of medicines. The variables selected from the interviews were grouped into five dimensions that defined three stages of pharmaceutical services institutionalization: incipient (0%-34.0%), partial (35.0%-69.0%), and advanced (70.0%-100%), estimated based on the interviewees' answers. Frequencies were estimated with 95% confidence intervals. For the statistical association analysis, the Chi-square test was applied, with significance level of p<0.05. Our results show a partial and heterogeneous process of institutionalization of pharmaceutical services in Brazil, and an advanced stage in formal structures, such as the municipal health plans and the existence of a standardized list of medicines. The analysed variables in the "organization, structure, and financing" dimension configured stages that range from partial to advanced. The management presented partial institutionalization, positively showing the existence of computerized system, but also disparate results regarding the autonomy in the management of financial resources. Indispensable items related to the structure expressed disparities between the regions, with statistically significant differences. The study showed a partial and heterogeneous process of institutionalization of pharmaceutical services in Brazilian cities, showing regional disparities. Variables related to the normative aspects of institutionalization were positively highlighted in all dimensions; however, it is necessary to conduct new studies to evaluate the institutionalization of pharmaceutical services' finalistic activities.

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

75 FR 54232 - Proposed Collection; Comment Request for Report of Covered Pharmaceutical Manufacturers and...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-09-03

... Report of Covered Pharmaceutical Manufacturers and Importers (Form-8947) AGENCY: Internal Revenue Service...)). Currently, the IRS is soliciting comments concerning Form-8947, Report of Covered Pharmaceutical...: Title: Report of Covered Pharmaceutical Manufacturers and Importers. OMB Number: 1545-XXXX. Form Number...

78 FR 46373 - Manufacturer of Controlled Substances; Notice of Registration; Johnson Matthey Pharmaceutical...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-31

...; Notice of Registration; Johnson Matthey Pharmaceutical Materials, Inc. By Notice dated March 20, 2013, and published in the Federal Register on March 28, 2013, 78 FR 19017, Johnson Matthey Pharmaceutical Materials, Inc., Pharmaceutical Services, 25 Patton Road, Devens, Massachusetts 01434, made application by...

An evaluation of governance capacity of the specialized component of pharmaceutical services in Brazil.

PubMed

Rover, Marina Raijche Mattozo; Peláez, Claudia Marcela Vargas; Faraco, Emília Baierle; Farias, Mareni Rocha; Leite, Silvana Nair

2017-08-01

This paper presents application of an indicator protocol to assessment of current levels of governance capacity of the Specialized Component of Pharmaceutical Services (CEAF) in a state of the South of Brazil. We chose the theoretical referential of 'governance capacity' proposed by Carlos Matus, which reflects in the concepts of management capacity and pharmaceutical service management, due to the perception of a need to overcome the fragmentation and technicist reductionism that we believe has been imposed on the area of pharmaceutical services. Data was collected using the protocol in 74 municipal or state units. The results of the analysis indicate that the currently existing governance capacity needs improvement in all three dimensions that were evaluated, principally in relation to the aspects that seek sustainability of the governance. The model and the protocol used indicate a way forward for governance of pharmaceutical service by proposing a change from the technicist-logistical focus to an emphasis on strategic and political actions, or ones which foster greater participation and autonomy. With these results in hand, it will be possible to develop strategies for improvement of access to medicines in the SUS, in the sense that the CEAF becomes able to guarantee integrality of medicines treatments.

Characterization of the institutionalization of pharmaceutical services in Brazilian primary health care

PubMed Central

Souza, Gisélia Santana; Costa, Ediná Alves; de Barros, Rafael Damasceno; Pereira, Marcelo Tavares; Barreto, Joslene Lacerda; Guerra, Augusto Afonso; Acurcio, Francisco de Assis; Guibu, Ione Aquemi; Álvares, Juliana; Costa, Karen Sarmento; Karnikowski, Margô Gomes de Oliveira; Soeiro, Orlando Mario; Leite, Silvana Nair

2017-01-01

ABSTRACT OBJECTIVE To characterize the current stage of the institutionalization of pharmaceutical services in Brazilian cities. METHODS This study is part 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), a cross-sectional, exploratory, and evaluative study composed by an information survey in a representative sample of cities, stratified by Brazilian regions. We interviewed municipal secretaries of health, responsible for pharmaceutical services, and pharmacists responsible for the dispensing of medicines. The variables selected from the interviews were grouped into five dimensions that defined three stages of pharmaceutical services institutionalization: incipient (0%-34.0%), partial (35.0%-69.0%), and advanced (70.0%-100%), estimated based on the interviewees’ answers. Frequencies were estimated with 95% confidence intervals. For the statistical association analysis, the Chi-square test was applied, with significance level of p<0.05. RESULTS Our results show a partial and heterogeneous process of institutionalization of pharmaceutical services in Brazil, and an advanced stage in formal structures, such as the municipal health plans and the existence of a standardized list of medicines. The analysed variables in the “organization, structure, and financing” dimension configured stages that range from partial to advanced. The management presented partial institutionalization, positively showing the existence of computerized system, but also disparate results regarding the autonomy in the management of financial resources. Indispensable items related to the structure expressed disparities between the regions, with statistically significant differences. CONCLUSION The study showed a partial and heterogeneous process of institutionalization of pharmaceutical services in Brazilian cities, showing regional disparities. Variables related to the normative aspects of institutionalization were positively highlighted in all dimensions; however, it is necessary to conduct new studies to evaluate the institutionalization of pharmaceutical services’ finalistic activities. PMID:29160459

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.

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.

[The development and operation of a package inserts service system for electronic medical records].

PubMed

Yamada, Hidetoshi; Nishimura, Sachiho; Shimamori, Yoshimitsu; Sato, Seiji; Hayase, Yukitoshi

2003-03-01

To promote the appropriate use of pharmaceuticals and to prevent side effects, physicians need package inserts on medicinal drugs as soon as possible. A medicinal drug information service system was established for electronic medical records to speed up and increase the efficiency of package insert communications within a medical institution. Development of this system facilitates access to package inserts by, for example, physicians. The time required to maintain files of package inserts was shortened, and the efficiency of the drug information service increased. As a source of package inserts for this system, package inserts using a standard generalized markup language (SGML) form were used, which are accessible to the public on the homepage of the Organization for Pharmaceutical Safety and Research (OPSR). This study found that a delay occurred in communicating revised package inserts from pharmaceutical companies to the OPSR. Therefore a pharmaceutical department page was set up as part of the homepage of the medical institution for electronic medical records to shorten the delay in the revision of package inserts posted on the medicinal drug information service homepage of the OPSR. The usefulness of this package insert service system for electronic medical records is clear. For more effective use of this system based on the OPSR homepage pharmaceutical companies have been requested to provide quicker updating of package inserts.

A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey.

PubMed

Van Campen, Luann E; Allen, Albert J; Watson, Susan B; Therasse, Donald G

2015-04-03

Background : Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods : Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results : Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions : Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues.

A Pharmaceutical Bioethics Consultation Service: Six-Year Descriptive Characteristics and Results of a Feedback Survey

PubMed Central

Van Campen, Luann E.; Allen, Albert J.; Watson, Susan B.; Therasse, Donald G.

2015-01-01

Background: Bioethics consultations are conducted in varied settings, including hospitals, universities, and other research institutions, but there is sparse information about bioethics consultations conducted in corporate settings such as pharmaceutical companies. The purpose of this article is to describe a bioethics consultation service at a pharmaceutical company, to report characteristics of consultations completed by the service over a 6-year period, and to share results of a consultation feedback survey. Methods: Data on the descriptive characteristics of bioethics consultations were collected from 2008 to 2013 and analyzed in Excel 2007. Categorical data were analyzed via the pivot table function, and time-based variables were analyzed via formulas. The feedback survey was administered to consultation requesters from 2009 to 2012 and also analyzed in Excel 2007. Results: Over the 6-year period, 189 bioethics consultations were conducted. The number of consultations increased from five per year in 2008 to approximately one per week in 2013. During this time, the format of the consultation service was changed from a committee-only approach to a tiered approach (tailored to the needs of the case). The five most frequent topics were informed consent, early termination of a clinical trial, benefits and risks, human biological samples, and patient rights. The feedback survey results suggest the consultation service is well regarded overall and viewed as approachable, helpful, and responsive. Conclusions: Pharmaceutical bioethics consultation is a unique category of bioethics consultation that primarily focuses on pharmaceutical research and development but also touches on aspects of clinical ethics, business ethics, and organizational ethics. Results indicate there is a demand for a tiered bioethics consultation service within this pharmaceutical company and that advice was valued. This company's experience indicates that a bioethics consultation service raises awareness about bioethics, empowers employees to raise bioethical concerns, and helps them reason through challenging issues. PMID:26740962

77 FR 40088 - Rollins College; T.A. Loving Co.; US Ecology Idaho, Inc.; and West Pharmaceutical Services, Inc...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-06

...] Rollins College; T.A. Loving Co.; US Ecology Idaho, Inc.; and West Pharmaceutical Services, Inc... 11481 1910.37(i). T.A. Loving Co V-74-43 04/13/1976 41 FR 15483 1918.66(f)(1)(i). US Ecology Idaho, Inc.... US Ecology Idaho, Inc. The Agency granted Envirosafe Services, Inc. (now US Ecology Idaho, Inc.), a...

Defining pharmaceutical systems strengthening: concepts to enable measurement

PubMed Central

Hafner, Tamara; Lee, David; Aboagye-Nyame, Francis

2017-01-01

Abstract Pharmaceutical products are indispensable for improving health outcomes. An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information. This work adds clarity to the concept of pharmaceutical systems and their strengthening by proposing holistic definitions on the basis of systems thinking. It provides a practical starting point for measuring the progress of pharmaceutical systems strengthening. PMID:28025324

[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.

Civic Engagement as Risk Management and Public Relations: What the Pharmaceutical Industry Can Teach Us about Service-Learning

ERIC Educational Resources Information Center

Scott, J. Blake

2009-01-01

The pharmaceutical industry's corporate responsibility reports illustrate how the liberal rhetoric of civic engagement can be reappropriated to serve the market-driven aims of risk management and public relations. Tracing the ideologic linkage of corporate responsibility and service-learning versions of civic engagement, and contextualizing…

77 FR 42746 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-20

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

75 FR 10488 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

77 FR 1696 - Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2012-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting AGENCY: Food and... of Committee: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. General...

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.

Entry of new pharmacies in the deregulated Norwegian pharmaceuticals market--consequences for costs and availability.

PubMed

Rudholm, Niklas

2008-08-01

The objective of this study is to analyze the impact of the new regulation concerning entry of pharmacies into the Norwegian pharmaceuticals market in 2001 on cost and availability of pharmaceutical products. In order to study costs, a translog cost function is estimated using data from the annual reports of a sample of Norwegian pharmacies before and after the deregulation of the market. Linear regression models for the number of pharmacies in each region in Norway are also estimated. The results show that the costs of the individual pharmacies have not decreased as a consequence of the deregulation of the Norwegian pharmaceuticals market. The deregulation of the market did, however, increase the availability to pharmacy services substantially. Increased availability of pharmacy services can be achieved by deregulating pharmaceutical markets as in Norway, but at the expense of increased costs for the pharmacies.

Improving the Service with the Servqual Method

NASA Astrophysics Data System (ADS)

Midor, Katarzyna; Kučera, Marian

2018-03-01

At the time when economy is growing, there is strong competition in the market, and customers have increasingly higher expectations as regards quality of service and products. Under such conditions, organizations need to improve. One of the areas of improvement for an organization is to research the level of customer satisfaction. The article presents results of customer satisfaction surveys conducted by the Servqual method in a pharmaceutical service company. Use of this method allowed to improve the services provided by that pharmaceutical wholesaler, identify areas that need to be improved as soon as possible in order to improve the level of service provided.

Global marketing of cholesterol-lowering drugs as therapy.

PubMed

Elimimian, Jonathan U; Gilmore, James M; Singletary, Tony J

2006-01-01

Pharmaceutical marketing services (PMS) are a key component of pharmaceutical companies' marketing strategies in that they create links between the pharmaceutical company and the physician. They are is also a link between physician and patients locally and globally. PMS discussed in this paper provide various services from tangible to intangible products in order to increase the physicians and pharmacists prescribing activities of their treatment modalities. Given the high cost of recruiting, training, and supporting PMS global marketing efforts, it is important for PMS channels to understand the significance of pharmaceutical multinational companies to ascribe to prescription drug services provided in Thailand. This created the unique marketing environment for the pharmaceutical companies. This study examines whether there is a gap in the existing cholesterol-lowering medication prescribed by physicians in Thailand and the newly introduced brand to the U.S. market. The degree of the new product adoption is analyzed through physician prescription frequency and records. Results of the study indicate there is significant improvement in the health conditions of the users of the new cholesterol medication among Thailand patients. Physicians in Thailand were, however, faced with competing brands in the market due to aggressiveness of advertising and promotion by multinational pharmaceutical marketing and manufacturers Associations. Perceived value and benefit to users were significant outcome of the study. More diagnostic and prescriptive research is recommended to cover Southeast Asia and other parts of the developing countries.

Defining pharmaceutical systems strengthening: concepts to enable measurement.

PubMed

Hafner, Tamara; Walkowiak, Helena; Lee, David; Aboagye-Nyame, Francis

2017-05-01

Pharmaceutical products are indispensable for improving health outcomes. An extensive body of work on access to and use of medicines has resulted in an assortment of tools measuring various elements of pharmaceutical systems. Until now however, there has been little attempt to conceptualize a pharmaceutical system as an entity and define its strengthening in a way that allows for measuring systems strengthening. The narrow focus of available tools limits their value in ascertaining which interventions result in stronger, more resilient systems. We sought to address this shortcoming by revisiting the current definitions, frameworks and assessment tools related to pharmaceutical systems. We conducted a comprehensive literature review and consulted with select pharmaceutical experts. On the basis of our review, we propose that a pharmaceutical system consists of all structures, people, resources, processes, and their interactions within the broader health system that aim to ensure equitable and timely access to safe, effective, quality pharmaceutical products and related services that promote their appropriate and cost-effective use to improve health outcomes. We further propose that pharmaceutical systems strengthening is the process of identifying and implementing strategies and actions that achieve coordinated and sustainable improvements in the critical components of a pharmaceutical system to make it more responsive and resilient and to enhance its performance for achieving better health outcomes. Finally, we established that, in addition to system performance and resilience, seven components of the pharmaceutical system are critical for measuring pharmaceutical systems strengthening: pharmaceutical products and related services; policy, laws and governance; regulatory systems; innovation, research and development, manufacturing, and trade; financing; human resources; and information. This work adds clarity to the concept of pharmaceutical systems and their strengthening by proposing holistic definitions on the basis of systems thinking. It provides a practical starting point for measuring the progress of pharmaceutical systems strengthening. © The Author 2016. Published by Oxford University Press in association with The London School of Hygiene and Tropical Medicine.

77 FR 60124 - Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-D-1010] Draft Guidance for Industry on Initial Completeness Assessments for Type II Active Pharmaceutical... certain drug master files, namely, Type II active pharmaceutical ingredient (API) drug master files (DMFs...

[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.

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.

75 FR 42455 - Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 27 New Drug Applications and 58...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-07-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0318... NDA 6-008 Mesantoin (mephenytoin) Tablets Novartis Pharmaceuticals Corp., One Health Plaza, East... Endo Pharmaceuticals NDA 17-255 MPI DTPA Chelate multidose (kit for Medi-Physics, Inc., d/b/a GE...

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.

[Pharmaceutical logistic in turnover of pharmaceutical products of Azerbaijan].

PubMed

Dzhalilova, K I

2009-11-01

Development of pharmaceutical logistic system model promotes optimal strategy for pharmaceutical functioning. The goal of such systems is organization of pharmaceutical product's turnover in required quantity and assortment, at preset time and place, at a highest possible degree of consumption readiness with minimal expenses and qualitative service. Organization of the optimal turnover chain in the region is offered to start from approximate classification of medicaments by logistic characteristics. Supplier selection was performed by evaluation of timeliness of delivery, quality of delivered products (according to the minimum acceptable level of quality) and time-keeping of time spending for orders delivery.

Growth of near-infrared spectroscopy in pharmaceutical and medical sciences

NASA Astrophysics Data System (ADS)

Ciurczak, Emil W.

2002-06-01

Near-IR Spectroscopy (NIRS) is used extensively in the health services industries: medical research, pharmaceutical production, and bioprocessing. NIRS Is rugged, simple to operate, flexible, and relatively inexpensive. It may be used to monitor the progress biochemical reactions. It is used to control mixing, blending, drying, and coating in pharmaceutical production and is used for imaging and chemical determinations in living 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.

Biopharma CRO industry in China: landscape and opportunities.

PubMed

Xia, Christine; Gautam, Ajay

2015-07-01

The pharmaceutical industry has responded to the declining research and development (R&D) productivity over the past decade by decreasing its cost base and outsourcing parts of drug research, with China increasingly being the preferred destination for such outsourced work. For this Focus article, we collected and analyzed data for 66 China-based nonclinical contract research organizations (CROs); approximately 60% of the companies were localized in the Yangtze River Delta cluster and another 20% within the Beijing cluster. Almost 25% of the companies offered services in discovery biology, the single largest service offering in the data set, with another 20% offering preclinical research (toxicology, pharmacology, and animal models) and approximately 15% offering pharmaceutical development. The biologics and pharmaceutical development services represent key future growth areas, with CROs showing an increasing appetite for risk-sharing partnerships. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Pharmaceutical reform in South Korea and the lessons it provides.

PubMed

Kim, Hak-Ju; Ruger, Jennifer Prah

2008-01-01

Through implementation of its 2000 pharmaceutical reform, the South Korean government expected to reduce the cost of medications and improve service levels, medical appropriateness of care, and drug effectiveness. However, despite the reform's lofty goals, unintended consequences have distorted the supply of medical services and spending. These consequences have included increasing the use of uninsured services, prescribing high-price drugs, and a growing market share for multinational drug companies. Further reforms are needed to reduce the measure's adverse effects. This paper examines the Korean mandatory prescription system and offers an analysis of Korea's reforms.

[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.

Restructuring the Production of Medicines: An Investigation on the Pharmaceutical Sector in China and the Role of Mergers and Acquisitions

PubMed Central

Barbieri, Elisa; Huang, Manli; Pi, Shenglei; Tassinari, Mattia

2017-01-01

In places like China, an ageing population coupled with changes in living standards and increases in disposable income, imply a shift of the demand for health-related goods and services which is likely to affect the whole organization of the industries that supply such goods and services at the global level. One of the industries most likely to be affected is the pharmaceutical sector. In the early 2000s China was already the second largest global producer of pharmaceutical ingredients. The pharmaceutical sector has become one of the most important industries promoted by the Chinese government and Five-Year Plan of China’s Strategic Emerging Sectors, mergers and acquisition (M&A) activity has been the key strategy to restructure the sector and increase its competitiveness. This paper firstly provides an updated picture of the evolution of M&As in the pharmaceutical sector, compared to other sectors, in China in the period 2005–2013. Secondly, we develop a composite indicator to measure the industrial performance of all Chinese industrial sectors over time, which allows us to assess the performance of the pharmaceutical industry compared to that of other sectors of the Chinese economy. Finally, we develop and estimate an empirical model that tests the relationship between the number of M&A in a sector and its performance, with a particular focus on the pharmaceutical case. The results offer some initial evidence of positive effects from the process of restructuring of the pharmaceutical sector in China. PMID:28981463

Restructuring the Production of Medicines: An Investigation on the Pharmaceutical Sector in China and the Role of Mergers and Acquisitions.

PubMed

Barbieri, Elisa; Huang, Manli; Pi, Shenglei; Tassinari, Mattia

2017-10-05

In places like China, an ageing population coupled with changes in living standards and increases in disposable income, imply a shift of the demand for health-related goods and services which is likely to affect the whole organization of the industries that supply such goods and services at the global level. One of the industries most likely to be affected is the pharmaceutical sector. In the early 2000s China was already the second largest global producer of pharmaceutical ingredients. The pharmaceutical sector has become one of the most important industries promoted by the Chinese government and Five-Year Plan of China's Strategic Emerging Sectors, mergers and acquisition (M&A) activity has been the key strategy to restructure the sector and increase its competitiveness. This paper firstly provides an updated picture of the evolution of M&As in the pharmaceutical sector, compared to other sectors, in China in the period 2005-2013. Secondly, we develop a composite indicator to measure the industrial performance of all Chinese industrial sectors over time, which allows us to assess the performance of the pharmaceutical industry compared to that of other sectors of the Chinese economy. Finally, we develop and estimate an empirical model that tests the relationship between the number of M&A in a sector and its performance, with a particular focus on the pharmaceutical case. The results offer some initial evidence of positive effects from the process of restructuring of the pharmaceutical sector in China.

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.

Pharmaceutical industry exposure in our hospitals: the final frontier.

PubMed

Dean, Jessica; Loh, Erwin; Coleman, Justin J

2016-01-18

Despite recent changes in attitudes, most hospitals continue to experience pharmaceutical industry presence. Pharmaceutical industry presence may be necessary and beneficial in the context of sponsorship of clinical trials with appropriate governance. Doctors continue to hold positive attitudes towards market-oriented activities of the pharmaceutical and medical device industries. Despite evidence to the contrary, doctors believe they are able to effectively manage pharmaceutical sales representative interactions such that their own prescribing is not adversely impacted. Doctors also share a belief that small gifts and benefits are harmless. There may be significant financial burden associated with divestment of such sponsorship by hospitals. Change requires education and effective policies to manage pharmaceutical industry relationships and conflicts of interest. We discuss case studies involving students and public hospital doctors to show that divestment is possible without significant financial detriment. Health services need to be proactive in transitioning financial and cultural reliance on pharmaceutical industry sponsorship to other potentially less harmful sources.

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).

Pharmaceutical services in a Mexican pain relief and palliative care institute

PubMed Central

Escutia Gutiérrez, Raymundo; Cortéz Álvarez, César R.; Álvarez Álvarez, Rosa M.; Flores Hernández, Jorge LV.; Gutiérrez Godínez, Jéssica; López Y López, José G.

Neither the purchase nor the distribution of pharmaceuticals in hospitals and community pharmacies in Mexico is under the care of pharmacists. Some are under control of physicians. This report presents the results of the implementation of somef pharmaceutical services for the Jalisco Pain Relief, and Palliative Care Institute (Palia Institute), under the direction of the Secretary of Health, Government of Jalisco. The services implemented were drug distribution system, Drug Information Service, Pharmacovigilance Program, and home pharmacotherapy follow-up pilot program for patients with advanced illness, with the ultimate using the appropriate medication. The drug distribution system included dispensing of opioid pain medications, antidepressants, anticonvulsants, NSAIDs, anxiolytic drugs, steroid drugs, laxatives, and anti-emetics. The frequently used drugs were morphine sulfate (62%), amitriptyline (6.4%), and dextropropoxyphene (5.8%). The Drug Information Service answered 114 consultations, mainly asked by a physician (71%) concerned with adverse drug reactions and contraindications (21%). The pharmacovigilance program identified 146 suspected adverse drug reactions and classified them reasonably as possible (27%), probable (69%), and certain (4%). These were attributed mainly to pregabalin and tramadol. The home pharmacotherapy follow-up pilot program cared patients with different cancer diagnoses and drug-related problems (DRP), which were identified and classified (according to second Granada Consensus) for pharmaceutical intervention as DRP 1 (5%), DRP 2 (10%), DRP 3 (14%), DRP 4 (19%), DRP 5 (24%), or DRP 6 (28%). This report provides information concerning the accurate use of medication and, above all, an opportunity for Mexican pharmacists to become an part of health teams seeking to resolve drug-related problems. PMID:25170355

Activities of the Federal Interagency Workgroup on ...

EPA Pesticide Factsheets

In 2012, four federal agencies signed a Memorandum of Understanding (MOU) establishing a formal mechanism to improve and sustain federal coordination and collaboration on issues related to pharmaceuticals in water. The MOU is in response to the Government Accountability Office recommendation in its August 2011 report “Action Needed to Sustain Agencies’ Collaboration on Pharmaceuticals in Drinking Water.” The signatories are the US Environmental Protection Agency (EPA), US Department of Agriculture/Agricultural Research Service (USDA), US Department of Health and Human Services/Food and Drug Administration (FDA), and US Department of Interior/Geological Survey (USGS). As a result of this agreement, an interagency workgroup (EPA, USGS, FDA, USDA, Army Public Health Center (Provisional), National Toxicology Program, National Oceanic and Atmospheric Administration, and Center for Disease Control and Prevention) was formed to address issues related to the occurrence of pharmaceuticals in water. This Workgroup provides a forum for the exchange of information on pharmaceuticals in the environment, supports coordination of joint studies on pharmaceuticals in the environment, and facilitates interagency consultation on implications of research and analyses derived from shared information. The Workgroup is currently developing a product that will summarize ongoing federal efforts in this area and describe the process for monitoring, evaluating, and reporting to the

75 FR 69585 - New Animal Drugs; Change of Sponsor; Sulfadiazine and Pyrimethamine Suspension

Federal Register 2010, 2011, 2012, 2013, 2014

2010-11-15

... pyrimethamine oral suspension from Animal Health Pharmaceuticals, LLC, to Pegasus Laboratories, Inc. DATES: This... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 510 and 520...-8300, e-mail: [email protected] . SUPPLEMENTARY INFORMATION: Animal Health Pharmaceuticals, LLC...

21 CFR 26.7 - Participation in the equivalence assessment and determination.

Code of Federal Regulations, 2010 CFR

2010-04-01

... determination. 26.7 Section 26.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE... EUROPEAN COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.7...

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

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.

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

PubMed

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

2016-12-01

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. RESUMO O artigo apresenta o processo de construção da Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamento a partir de uma concepção integradora da Assistência Farmacêutica, Ciência, Tecnologia e Inovação. Inicia-se contextualizando a saúde e o desenvolvimento no País e apresenta elementos da Política Nacional de Ciência Tecnologia e Inovação em Saúde no Brasil e da Política Nacional de Assistência Farmacêutica. Ao apresentar as diretrizes das Políticas Farmacêuticas, destaca-se a carência de dados de abrangência nacional. A presente pesquisa, encomendada pelo Ministério da Saúde, foi estruturada em dois componentes: inquérito domiciliar e avaliação dos serviços de assistência farmacêutica na atenção básica. As perspectivas dos resultados representam, além do incremento das políticas públicas farmacêuticas e de saúde pública, resultados de ações governamentais voltadas ao desenvolvimento do complexo econômico-industrial da saúde, visando a melhoria das condições de saúde da população brasileira.

Cloud computing in pharmaceutical R&D: business risks and mitigations.

PubMed

Geiger, Karl

2010-05-01

Cloud computing provides information processing power and business services, delivering these services over the Internet from centrally hosted locations. Major technology corporations aim to supply these services to every sector of the economy. Deploying business processes 'in the cloud' requires special attention to the regulatory and business risks assumed when running on both hardware and software that are outside the direct control of a company. The identification of risks at the correct service level allows a good mitigation strategy to be selected. The pharmaceutical industry can take advantage of existing risk management strategies that have already been tested in the finance and electronic commerce sectors. In this review, the business risks associated with the use of cloud computing are discussed, and mitigations achieved through knowledge from securing services for electronic commerce and from good IT practice are highlighted.

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.…

The reality of task shifting in medicines management- a case study from Tanzania.

PubMed

Wiedenmayer, Karin A; Kapologwe, Ntuli; Charles, James; Chilunda, Fiona; Mapunjo, Siana

2015-01-01

Tanzania suffers a severe shortage of pharmaceutical staff. This negatively affects the provision of pharmaceutical services and access to medicines, particularly in rural areas. Task shifting has been proposed as a way to mitigate the impact of health worker shortfalls.The aim of this study was to understand the context and extent of task shifting in pharmaceutical management in Dodoma Region, Tanzania. We explored 1) the number of trained pharmaceutical staff as compared to clinical cadres managing medicines, 2) the national establishment for staffing levels, 3) job descriptions, 4) supply management training conducted and 5) availability of medicines and adherence to Good Storage Practice. A cross-sectional study was conducted in 270 public health facilities in 2011. A pre-tested questionnaire was administered to the person in charge of the facility to collect data on staff employed and their respective pharmaceutical tasks. Availability of 26 tracer medicines and adherence to Good Storage Practice guidelines was surveyed by direct observation. The national establishments for pharmaceutical staffing levels and job descriptions of facility cadres were analysed. While required staffing levels in 1999 were 50, the region employed a total of only 14 pharmaceutical staff in 2011. Job descriptions revealed that, next to pharmaceutical staff, only nurses were required to provide dispensing services and adherence counselling. In 95.5% of studied health facilities medicines management was done by non-pharmaceutically trained cadres, predominantly medical attendants. The first training on supply management was provided in 2005 with no refresher training thereafter. Mean availability of tracer medicines was 53%, while 56% of health facilities fully met criteria of Good Storage Practice. Task shifting is a reality in the pharmaceutical sector in Tanzania and it occurs mainly as a coping mechanism rather than a formal response to the workforce crisis. In Dodoma Region, pharmacy-related tasks and supply management have informally been shifted to clinical staff without policy guidance, explicit job descriptions, and without the necessary support through training. Implicit task shifting should be recognized and formalized. Job orientation, training and operational procedures may be useful to support non-pharmaceutical health workers to effectively manage medicine supply.

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.

Pharmaceutical care in smoking cessation

PubMed Central

Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

2015-01-01

As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients’ access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre–post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy’s smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation. PMID:25678779

Pharmaceutical care in smoking cessation.

PubMed

Marín Armero, Alicia; Calleja Hernandez, Miguel A; Perez-Vicente, Sabina; Martinez-Martinez, Fernando

2015-01-01

As a determining factor in various diseases and the leading known cause of preventable mortality and morbidity, tobacco use is the number one public health problem in developed countries. Facing this health problem requires authorities and health professionals to promote, via specific programs, health campaigns that improve patients' access to smoking cessation services. Pharmaceutical care has a number of specific characteristics that enable the pharmacist, as a health professional, to play an active role in dealing with smoking and deliver positive smoking cessation interventions. The objectives of the study were to assess the efficacy of a smoking cessation campaign carried out at a pharmaceutical care center and to evaluate the effects of pharmaceutical care on patients who decide to try to stop smoking. The methodology was an open, analytical, pre-post intervention, quasi-experimental clinical study performed with one patient cohort. The results of the study were that the promotional campaign for the smoking cessation program increased the number of patients from one to 22, and after 12 months into the study, 43.48% of the total number of patients achieved total smoking cessation. We can conclude that advertising of a smoking cessation program in a pharmacy increases the number of patients who use the pharmacy's smoking cessation services, and pharmaceutical care is an effective means of achieving smoking cessation.

Pharmaceutical advertising revenue and physician organizations: how much is too much?

PubMed Central

Glassman, P A; Hunter-Hayes, J; Nakamura, T

1999-01-01

OBJECTIVE: To determine if revenue generated from pharmaceutical advertisements in medical journals creates potential financial conflicts of interest for nonprofit physician organizations that own those journals. DESIGN: Convenience sample of six professional medical societies and their respective journals. Calculation of pharmaceutical advertising revenue generated by these journals for their respective professional medical societies. METHODS: Random selection of each journal for one month per quarter in calendar year 1996 and tabulation per edition of the average number of pharmaceutical advertising pages for each journal. OUTCOME MEASURES: Published advertising rates were used to estimate pharmaceutical advertising revenue for calendar year 1996 and compared with each organization's gross revenue and membership dues and assessments, based on Internal Revenue Service documents for the last available fiscal year (1995). RESULTS: Estimated pharmaceutical advertising revenue ranged from $715,000 to $18,630,000. Five organizations raised more than 10% of their gross income (range 2% to 30%) from a single journal's pharmaceutical advertising. Four organizations raised as much or more from pharmaceutical advertising as from members (range 17% to 790%). CONCLUSIONS: Potential financial conflicts of interest arising from pharmaceutical advertisements in medical journals may be substantial. The impact on professional societies' financial independence and behavior is unknown. PMID:10578674

Pharmaceutical advertising revenue and physician organizations: how much is too much?

PubMed

Glassman, P A; Hunter-Hayes, J; Nakamura, T

1999-10-01

To determine if revenue generated from pharmaceutical advertisements in medical journals creates potential financial conflicts of interest for nonprofit physician organizations that own those journals. Convenience sample of six professional medical societies and their respective journals. Calculation of pharmaceutical advertising revenue generated by these journals for their respective professional medical societies. Random selection of each journal for one month per quarter in calendar year 1996 and tabulation per edition of the average number of pharmaceutical advertising pages for each journal. Published advertising rates were used to estimate pharmaceutical advertising revenue for calendar year 1996 and compared with each organization's gross revenue and membership dues and assessments, based on Internal Revenue Service documents for the last available fiscal year (1995). Estimated pharmaceutical advertising revenue ranged from $715,000 to $18,630,000. Five organizations raised more than 10% of their gross income (range 2% to 30%) from a single journal's pharmaceutical advertising. Four organizations raised as much or more from pharmaceutical advertising as from members (range 17% to 790%). Potential financial conflicts of interest arising from pharmaceutical advertisements in medical journals may be substantial. The impact on professional societies' financial independence and behavior is unknown.

Issues around household pharmaceutical waste disposal through community pharmacies in Croatia.

PubMed

Jonjić, Danijela; Vitale, Ksenija

2014-06-01

Croatian regulations mandate pharmacies to receive unused medicines from households. Pharmacies are considered as producers and holders of pharmaceutical waste and are obliged to finance this service. Model where pharmacies are responsible for financing disposal of unused medicines without reimbursement is not common in Europe. Present service was not tested before implementation. To investigate the elements of the pharmaceutical waste disposal service provided by pharmacies, and to gain insight into the factors that might influence the effectiveness of the service. Setting All pharmacies in the city of Zagreb. Each pharmacy was asked to weigh the collected waste from the public during a period of 30 days, between June 1st and July 10th of 2011, absent from any media advertisement and answer a specifically designed questionnaire that was exploring possible connections between the amount of collected waste, type of pharmacy ownership, discretion while disposing, location of the container, appropriate labeling and to compare the amount of collected waste between neighborhoods. Quantity of collected unused medicines from the public. Of 210 pharmacies, 91 participated completing the questionnaire (43 % response rate). The total amount of collected waste was 505 kg. Pharmacies owned by the city of Zagreb had higher response rate (74 %) than privately owned pharmacies (36 %), and collected significantly higher amount of waste. Anonymity when disposing influenced collected quantity, while labelling and location of the container did not. There were differences in the amount of collected waste between neighborhoods due to the demographic characteristics and number of pharmacies per capita. The effectiveness of the pharmacy service of collecting unused medicines in Croatia shows a number of weaknesses. The amount of collected medicines is below the European average. Functioning of the service seems to be negatively influenced by the type of pharmacy ownership, distribution of pharmacies and lack of anonymity when disposing unused medicines. Additionally, type of ownership is connected with financial burden for pharmacies. Governmental bodies should examine current legislation regulating pharmaceutical waste disposal, particularly financial responsibility for providing the service, in order to increase pharmacies' compliance. Advertising of the service may increase awareness of the importance of proper disposal of unused medicines.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

PubMed

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

Computerized Drug Information Services

ERIC Educational Resources Information Center

And Others; Smith, Daniel R.

1972-01-01

To compare computerized services in chemistry, pharmacology, toxicology, and clinical medicine of pharmaceutical interest, equivalent profiles were run on magnetic tape files of CA-Condensates," CBAC," Excerpta Medica," MEDLARS" and Ringdoc." The results are tabulated for overlap of services, relative speed of citing references, and unique…

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.

Pharmaceutical services for endemic situations in the Brazilian Amazon: organization of services and prescribing practices for Plasmodium vivax and Plasmodium falciparum non-complicated malaria in high-risk municipalities

PubMed Central

2011-01-01

Background In spite of the fact that pharmaceutical services are an essential component of all malaria programmes, quality of these services has been little explored in the literature. This study presents the first results of the application of an evaluation model of pharmaceutical services in high-risk municipalities of the Amazon region, focusing on indicators regarding organization of services and prescribing according to national guidelines. Methods A theoretical framework of pharmaceutical services for non-complicated malaria was built based on the Rapid Evaluation Method (WHO). The framework included organization of services and prescribing, among other activities. The study was carried out in 15 primary health facilities in six high-risk municipalities of the Brazilian Amazon. Malaria individuals ≥ 15 years old were approached and data was collected using specific instruments. Data was checked by independent reviewers and fed to a data bank through double-entry. Descriptive variables were analyzed. Results A copy of the official treatment guideline was found in 80% of the facilities; 67% presented an environment for receiving and prescribing patients. Re-supply of stocks followed a different timeline; no facilities adhered to forecasting methods for stock management. No shortages or expired anti-malarials were observed, but overstock was a common finding. On 86.7% of facilities, the average of good storage practices was 48%. Time between diagnosis and treatment was zero days. Of 601 patients interviewed, 453 were diagnosed for Plasmodium vivax; of these, 99.3% received indications for the first-line scheme. Different therapeutic schemes were given to Plasmodium falciparum patients. Twenty-eight (4.6%) out of 601 were prescribed regimens not listed in the national guideline. Only 5.7% individuals received a prescription or a written instruction of any kind. Conclusions The results show that while diagnostic procedure is well established and functioning in the Brazilian malaria programme, prescribing is still an activity that is actually not performed. The absence of physicians and poor integration between malaria services and primary health services make for the lack of a prescription or written instruction for malaria patients throughout the Brazilian Amazon. This fact may lead to a great number of problems in rational use and in adherence to medication. PMID:22050832

Impacts of international sanctions on Iranian pharmaceutical market

PubMed Central

2013-01-01

Iran in recent decade faced several regional and international sanctions in foreign trade, financial and banking services. Iran national pharmaceutical industry has always played a major role in providing medicines to the Iranian patients. However, following the sanctions it has faced profound difficulties for importing of both finished products and pharmaceutical raw materials. Although medicines are exempted from sanctions, due to restriction on money transaction and proper insurance Iranian pharmaceutical companies have to pay cash in advance for imports of medicines and raw materials or to secure offshore funds at very high risks. Current situation in Iran pharmaceutical market confirms that the sanctions against Iran are affecting ordinary citizens and national health sector which resulted to reduction of availability of lifesaving medicines in the local market and has caused increasing pain and suffering for Iranian patients. PMID:23902642

Ethics in the marketing of medical services.

PubMed

Latham, Stephen R

2004-09-01

This paper deals with the ethics of marketing medical services by physicians, medical groups, hospitals and other mainstream medical caregivers in the United States. It does not deal with pharmaceutical marketing, since that raises a number of special issues, some of them legal and some having to do with the unique culture of pharmaceutical marketing, which really ought to be dealt with separately. Nor does it touch on the little-explored field of marketing alternative and complementary medicine. It begins with a general description of what is included in "the marketing process." It then briefly tours some of the difficulties faced by those who would market medical services ethically, and ends with some comments on the relevance of professionalism to ethical marketing.

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…

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.

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.

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.

Pharmaceutical penetration of new drug and pharmaceutical market structure in Taiwan: hospital-level prescription of thiazolidinediones for diabetes.

PubMed

Tsai, Yi-Wen; Wen, Yu-Wen; Huang, Weng-Foung; Kuo, Ken N; Chen, Pei-Fen; Shih, Hsin-Wei; Lee, Yue-Chune

2010-06-01

This study used Taiwan's National Health Insurance claim database (years 2000-2005) to examine how thiazolidinediones (TZD), a new class of drugs for diabetes, penetrated into Taiwan's hospitals, and its association with the concentration of all diabetes drugs at the hospital level. We collected 72 monthly summaries of diabetes prescriptions from all hospitals in Taiwan. Hospital-level pharmaceutical concentration was measured by penetration of TZD, defined as monthly market share of TZD in each hospital. Concentration of diabetes drugs was measured by Herfindahl-Hirschman indices. We found a negative association (coefficient = -0.3610) between TZD penetration and concentration of diabetes drug but a positive association between penetration of TZD and the volume of prescribed diabetes drugs (coefficient = 0.4088). In conclusion, hospital characteristics and volume of services determined the concentration of pharmaceuticals at the institution level, reflecting the heterogeneous competition between pharmaceutical companies within each hospital. Institution-level pharmaceutical concentration influences the adoption and penetration of new drugs.

WHO Expert Committee on Specifications for Pharmaceutical Preparations.

PubMed

2011-01-01

The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use: procedure for adoption of International Chemical Reference Substances; WHO good practices for pharmaceutical microbiology laboratories; good manufacturing practices: main principles for pharmaceutical products; good manufacturing practices for blood establishments (jointly with the Expert Committee on Biological Standardization); guidelines on good manufacturing practices for heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms; good manufacturing practices for sterile pharmaceutical products; guidelines on transfer of technology in pharmaceutical manufacturing; good pharmacy practice: standards for quality of pharmacy services (joint FIP/WHO); model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (jointly with the Expert Committee on Biological Standardization); procedure for prequalification of pharmaceutical products; guide on submission of documentation for prequalification of innovator finished pharmaceutical products approved by stringent regulatory authorities; prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies; guidelines for preparing a laboratory information file; guidelines for drafting a site master file; guidelines on submission of documentation for a multisource (generic) finished product: general format: preparation of product dossiers in common technical document format.

[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.

77 FR 16042 - Agency Information Collection Activities: Proposed Collection: Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-19

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency... States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and... sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the...

76 FR 17420 - Proposed Data Collections Submitted for Public Comment and Recommendations

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-29

... services; and the types of medical, dental, mental health, and pharmaceutical services provided to inmates. NSPH will collect data on intake physical and mental health assessments practices for inmates... deliver medical and mental health services, NCHS in partnership with the Bureau of Justice Statistics (BJS...

Extended possibilities of pharmaceuticals delivery to patients using dematerialized prescriptions.

PubMed

Urbański, Andrzej P

2004-01-01

This paper considers the requirement for e-commerce enabled delivery of pharmaceutical prescriptions. First, currently available solutions are critically reviewed and an ideal solution is specified and then the concept of the proposed solution--Dematerialized Prescription (DP), is outlined. Next, the information flows required to enable such a service are considered. The paper then considers a number of possible services which could be made available with DP to deliver medicals to patients. Finally, a proposed solution, which enables physician to fill dematerialized prescriptions online using inexpensive mobile Internet devices is presented in detail, the advantages of such a model are summarized and future research directions are suggested.

Adoption and Diffusion of Evidence-Based Addiction Medications in Substance Abuse Treatment

PubMed Central

Heinrich, Carolyn J; Cummings, Grant R

2014-01-01

ObjectiveTo examine the roles of facility-and state-level factors in treatment facilities’ adoption and diffusion of pharmaceutical agents used in addiction treatment. Data SourcesSecondary data from the National Survey of Substance Abuse Treatment Services (N-SSATS), Substance Abuse and Mental Health Services Administration (SAMHSA), Centers for Medicare and Medicaid Services, Alcohol Policy Information System, and Kaiser Family Foundation. Study DesignWe estimate ordered logit and multinomial logit models to examine the relationship of state and treatment facility characteristics to the adoption and diffusion of three pharmaceutical agents over 4 years when each was at a different stage of adoption or diffusion. Data CollectionN-SSATS data with facility codes, obtained directly from SAMHSA, were linked by state identifiers to the other publicly available, secondary data. Principal FindingsThe analysis confirms the importance of awareness and exposure to the adoption behavior of others, dissemination of information about the feasibility and effectiveness of innovations, geographical clustering, and licensing and accreditation in legitimizing facilities’ adoption and continued use of pharmacotherapies in addiction treatment. ConclusionsPolicy and administrative levers exist to increase the availability of pharmaceutical technologies and their continued use by substance abuse treatment facilities. PMID:23855719

[Pharmacist's interventions on outpatient prescriptions in a university hospital drugs sales service].

PubMed

Chappuy, M; Garcia, S; Uhres, A-C; Janoly-Dumenil, A; Dessault, J; Chamouard, V; Bréant, V; Leboucher, G; Pivot, C; Carpentier, I

2015-07-01

For public health reasons, some drugs are only available in hospital drugs sales service. This activity takes place in a specific risk context of organization, patients and/or drugs. A systematic prescription analysis by pharmacist contributes to securise treatment dispensed. The aim of this paper is to present the main drugs problems in the analysis of outpatient prescriptions and pharmaceutical interventions in three units of hospital drugs sales service belong to university hospital. Throughout the year 2013, drug problems detected were recorded prospectively and systematically. Of the 22,279 prescriptions analyzed, 247 pharmaceutical interventions (1.1%) were detected including 27.6% of problems concerning the dosages, 15.4% the unconformity, 6.9% contraindications. Regarding ATC drugs classes, we found 43.7% for anti-infectives and 17.4% for antineoplatics. The overall acceptance rate is 81.8%. These results show the importance of the analysis of outpatient prescriptions before dispensing and the need to have all prescriptions, clinical and biological elements and to develop interprofessionality. The implementation of a platform for dematerialized data exchanges between professionals, including data from the pharmaceutical patient record should contribute to improving drug management of the patient. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

[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.

Delivery of pharmaceutical services at ward level in a teaching hospital.

PubMed

Schellack, N; Martins, V; Botha, N; Meyer, J C

2009-03-01

Poor management of pharmaceuticals could lead to wastage of financial resources and poor services in the public sector. The main aim of the study was to investigate the quality of pharmaceutical services at ward level in a teaching hospital. The design of the study was descriptive. Three data collection instruments were designed and pilot-tested prior to the actual data collection. Two structured questionnaires were used to interview the sister-in-charge of each ward and the stock and drug controller at the pharmacy. A checklist for the management of pharmaceuticals was completed for each ward. Descriptive statistics were used to describe and summarise the data. Sisters-in-charge of 30 wards and the stock and drug controller at the pharmacy participated in the study. The relationship with the pharmacy was perceived to be average by 54% (n = 30) of the sisters-in-charge of the wards. Communication with the pharmacy was mainly by telephone and 57% of the sisters-in-charge mentioned that they experienced difficulties in conveying messages to the pharmacy. Ten of the wards received regular ward visits by a pharmacist. Expiry dates were checked by all wards but at different intervals. The majority of the wards (90%) used patient cards, which refer to prescription charts, for stock control and ordering from the pharmacy. Fridge temperatures were checked and charted on a daily basis by 30% of the wards. Written standard operating procedures (SOPs) were used by the pharmacy for issuing ward stock. Although 83% of the wards indicated that they used SOPs, evidence of written SOPs was not available. The results indicated that the management of pharmaceutical services at ward level could be improved. Implementation of appropriate communication systems will enhance cooperation between the pharmacy and the wards. A uniform ward stock control system, either by computer or stock cards, should be introduced. Regular ward visits by a pharmacist to oversee ward stock management are recommended. Standard operating procedures for use in the wards should be developed and implemented.

Tackling corruption in the pharmaceutical systems worldwide with courage and conviction.

PubMed

Cohen, J C; Mrazek, M; Hawkins, L

2007-03-01

Poor drug access continues to be one of the main global health problems. Global inequalities in access to pharmaceuticals are caused by a number of variables including poverty, high drug prices, poor health infrastructure, and fraud and corruption--the latter being the subject of this article. There is growing recognition among policy makers that corruption in the pharmaceutical system can waste valuable resources allocated to pharmaceutical products and services. This, in turn, denies those most in need from life-saving or life-enhancing medicines. As a result, international organizations, including the World Health Organization and the World Bank are beginning to address the issue of corruption in the health sector broadly and the pharmaceutical system specifically. This is encouraging news for improving drug access for the global poor who are most harmed by corruption as they tend to purchase less expensive drugs from unqualified or illegal drug sellers selling counterfeit or sub-standard drugs. In our paper, we illuminate what are the core issues that relate to corruption in the pharmaceutical sector. We argue that corruption in the pharmaceutical system can be detrimental to a country's ability to improve the health of its population. Moreover, unless policy makers deal with the issue of corruption, funding allocated to the pharmaceutical system to treat health conditions may simply be wasted and the inequality between rich and poor in access to health and pharmaceutical products will be aggravated.

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.

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.

The nature of outsourced preclinical research--the example of chemical synthesis.

PubMed

Festel, Gunter W

2013-09-01

The possibility to buy standardized external services or even new and innovative methods within drug discovery has increased dramatically during the last decades. Service providers are able to provide timely and efficient solutions to any given problem within preclinical research. The outsourcing behavior depends on the specific company type. Generally, the outsourcing level of emerging pharmaceutical and biotechnology companies is much higher than established companies due to low or missing internal resources. Whereas the "make-or-buy" decisions of large and fully integrated pharmaceutical companies are mainly competency driven, those of mid-size and small pharmaceutical, as well as biotech companies show a specific combination of cost/capacity and competency. The three different cooperation models "price competition", "project selection," and "strategic partnership" were identified. For all types of companies, the cooperation model of "strategic partnership" offers access to high-level expertise while reducing fixed costs and complexity. This was shown using chemical synthesis as an example but is also true for other areas of preclinical research.

Description and analysis of hospital pharmacies in Madagascar.

PubMed

Ratsimbazafimahefa, H R; Sadeghipour, F; Trouiller, P; Pannatier, A; Allenet, B

2018-05-01

Madagascar's health care system has operated without formal hospital pharmacies for more than two decades. The gradual integration of pharmacists in public hospitals since 2012 will allow the structuring of this field. This study was conducted to characterize the current situation regarding all aspects relating to the general functioning of hospital pharmacies and the services provided. This qualitative research used semi-structured interviews. Interviewees' perceptions about the general organization and functioning of hospital pharmacies and details on services provided were collected. The 16 interviewees were Ministry of Health staff members involved in hospital pharmacy, hospital directors, medical staff members and hospital pharmacy managers. Interviews were recorded, translated into French if conducted in Malagasy, and fully transcribed. Verbatim transcripts were coded according to the themes of hospital pharmacy and topical content analysis was performed. The principal issue perceived by interviewees was the heterogeneity of the system in terms of technical and financing management, with a main impact on the restocking of pharmaceutical products. The drug supply chain is not under control: no internal procedure has been established for the selection of pharmaceutical products, the quantification of needs is complex, stock management is difficult to supervise, a standard prescription protocol is lacking, dispensing is performed by unqualified staff, no pharmaceutical preparation is manufactured in the hospitals and administration occurs without pharmaceutical support. Progressive structuring of efficient hospital pharmacy services using the Basel statements for the future of hospital pharmacy is urgently needed to improve health care in Madagascar. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

[Pharmacist perception of the use of analgesics and their practice on mild-moderate pain. DOLOR-OFF survey].

PubMed

Arrebola, Cristobal; García-Delgado, Pilar; Labrador Barba, Elena; Orera Peña, Maria Luisa; Martínez-Martínez, Fernando

2016-01-01

To examine the use of analgesics, from the perspective of the pharmacist community, and pharmaceutical practice in mild-moderate pain. A cross-sectional, observational study was performed between April and September 2013. 696 community pharmacies in 20 Spanish provinces. Community pharmacists with a minimum professional experience of one year. Characterisation of the demand for analgesics, analgesic users, and pharmaceutical intervention for mild-moderate pain from the perspective of the pharmaceutical community. The main reason why a patient with mild-moderate pain visits a pharmacy is to receive a drug with prescription (45.5%), and the most common condition is headache (35.2%). Ibuprofen and paracetamol are the most commonly used drugs for mild-moderate pain. More than one-third (38.9%) of pharmacists follow a protocol for counselling. A correlation was found between the pharmacist's professional experience and the application of counselling process (Fisher P<.05). Some 87.8% of pharmacists checked two indicators from the dispensing service, and only 1.3% did not check any. Referral to a physician was made by 14.8% of pharmacists, with the main reason being the detection of alarm indicators. Protocols need to be designed and adapted to the characteristics of the 3 profiles identified, in order to increase the efficiency of pharmaceutical services in mild-moderate pain relief. Practical and specific training in pain are required to implement services to ensure the correct and systemic use of analgesics and positive clinical outcomes. Copyright © 2016. Publicado por Elsevier España, S.L.U.

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.

Monopolistic structures and industrial analysis in Spain: the case of the pharmaceutical industry.

PubMed

Lobo, F

1979-01-01

This article seeks to illustrate the monopolistic structure of the Spanish pharmaceutical industry, focusing on its many dimensions. The basic conditions of technology and demand, product differentiation, effect of advertising, and barriers to entry are considered, as is financial and economic concentration. Although economic conditions are emphasized, the ways they affect public and private health, the quality of health services, and health education are also highlighted.

Cost containment through pharmaceutical procurement: a Caribbean case study.

PubMed

Huff-Rousselle, M; Burnett, F

1996-01-01

This article discusses the potential for health sector cost containment in developing countries through improved pharmaceutical procurement. By describing the specific example of the Eastern Caribbean Drug Service (ECDS), which provides a pooled procurement service to nine ministries of health in the small island nations of the Caribbean, it examines the elements of the procurement operation that allowed ECDS to reduce unit costs for pharmaceuticals by over 50 per cent during its first procurement cycle. The analysis of ECDS considers: (1) political will, institutional alliances, and the creation of a public sector monopsony; (2) pooling demand; (3) restricted international tendering and the pharmaceutical industry; (4) estimating demand and supplier guarantees; (5) reducing variety and increasing volume through standardizing pack sizes, dosage forms and strengths; (6) generic bidding and therapeutic alternative bidding; (7) mode of transport from foreign suppliers; (8) financing mechanisms, including choice of currency, foreign exchange, and terms of payment; (9) market conditions and crafting and enforcing supplier contracts; and, (10) the adjudication process, including consideration of suppliers' past performance, precision requirements in the manufacturing process, number of products awarded to suppliers, and issues of judgment. The authors consider the relevance of this agency's experience to other developing countries by providing a blueprint that can be adopted or modified to suit other situations.

Determinants of Chronic Respiratory Symptoms among Pharmaceutical Factory Workers

PubMed Central

Enquselassie, Fikre; Tefera, Yifokire; Gizaw, Muluken; Wakuma, Samson; Woldemariam, Messay

2018-01-01

Background Chronic respiratory symptoms including chronic cough, chronic phlegm, wheezing, shortness of breath, and chest pain are manifestations of respiratory problems which are mainly evolved as a result of occupational exposures. This study aims to assess determinants of chronic respiratory symptoms among pharmaceutical factory workers. Methods A case control study was carried out among 453 pharmaceutical factory workers with 151 cases and 302 controls. Data was collected using pretested and structured questionnaire. The data was analyzed using descriptive statistics and bivariate and multivariate analysis. Result Previous history of chronic respiratory diseases (AOR = 3.36, 95% CI = 1.85–6.12), family history of chronic respiratory diseases (AOR = 2.55, 95% CI = 1.51–4.32), previous dusty working environment (AOR = 2.26, 95% CI = 1.07–4.78), ever smoking (AOR = 3.66, 95% CI = 1.05–12.72), and service years (AOR = 1.86, 95% CI = 1.16–2.99) showed statistically significant association with chronic respiratory symptoms. Conclusion Previous history of respiratory diseases, family history of chronic respiratory diseases, previous dusty working environment, smoking, and service years were determinants of chronic respiratory symptoms. Public health endeavors to prevent the burden of chronic respiratory symptoms among pharmaceutical factory workers should target the reduction of adverse workplace exposures and discouragement of smoking. PMID:29666655

A need for the standardization of the pharmaceutical sector in Libya

PubMed Central

Mustafa, Asma Abubakr; Kowalski, Stefan Robert

2010-01-01

Medicines are health technologies that can translate into tangible benefits for numerous acute as well as chronic health conditions. A nation's pharmaceutical sector needs to be appropriately structured and managed in order to ensure a safe, effective and quality supply of medicines to society. The process of medicines management involves the sequential management of five critical activity areas; namely; registration, selection, procurement, distribution and use. Formalized and standardized management of all five critical activity areas positively influences the availability, quality and affordability of medicines and ultimately increases the reliability and quality of the national healthcare system. Aim The aim of this review is to examine the current structure and operation of medicines management (i.e. the pharmaceutical sector) in Libya. Conclusion In the Libyan healthcare system all five critical activity areas are compromised. Restructuring of the pharmaceutical sector in Libya is required in order to provide and sustain sound pharmaceutical services for Libyan society and improve the national public health outcomes. PMID:21483563

[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.

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

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.

Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study.

PubMed

Salazar-Ospina, Andrea; Amariles, Pedro; Hincapié-García, Jaime A; González-Avendaño, Sebastián; Benjumea, Dora M; Faus, Maria José; Rodriguez, Luis F

2017-01-01

Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I. To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up. This study is based on the EMDADER-TAB trial, which was an RCT designed to compare pharmaceutical care with the usual care given to outpatients with BD-I in a psychiatric clinic. The main outcome was the use of health care services, using Kaplan-Meier methods and Cox regression. The trial protocol was registered in ClinicalTrials.gov (Identifier NCT01750255). 92 patients were included in the EMDADER-TAB study: 43 pharmaceutical care patients (intervention group) and 49 usual care patients (control group). At baseline, no significant differences in demographic and clinical characteristics were found across the 2 groups. After 1 year of follow-up, the risk of hospitalizations and emergencies was higher for the control group than for the intervention group (HR = 9.03, P = 0.042; HR = 3.38, P = 0.034, respectively); however, the risk of unscheduled outpatient visits was higher for the intervention group (HR = 4.18, P = 0.028). There was no "placebo" treatment, and patients in the control group might have produced positive outcomes and reduced the magnitude of differences compared with the intervention group. Compared with usual care, pharmaceutical care significantly reduced hospitalizations and emergency service consultations by outpatients with BD-I. This study received funding from the Universidad de Antioquia, Committee for Development Research and Sustainability Program, CODI, (2013-2014 and 2014-2015). Humax Pharmaceutical provided support for the initial development of the EMDADER-TAB trial without commercial interest in the outcomes derived from the trial. Salazar-Ospina reports grants from Credito Beca Francisco José de Caldas Scholarship for Doctoral Programs (528), which also contributed to the support of this study. González-Avendaño is an employee of Humax Pharmaceutical. The other authors have nothing to disclose. Study concept and design were contributed by Benjumea, Faus, and Rodriguez, along with Salazar-Ospina and Amariles. Salazar-Ospina took the lead in data collection, assisted by González-Avendaño, and data interpretation was performed by Salazar-Ospina, Hincapié-García, and González-Avendaño. The manuscript was written primarily by Salazar-Ospina, with assistance from Amariles and González-Avendaño, and revised by all the authors.

Why Become Pharmacy Compounding Accreditation Board Accredited?

PubMed

Dillon, L Rad

2016-01-01

The Pharmacy Compounding Accreditation Board's goal is to assist pharmacies to obtain formal recognition of their status as a high-quality and fully compliant provider of pharmaceuticals and patient services. This article provides a brief outline of the application process, the survey preparation, points of information about the actual survey, and suggestions on how to remain in compliance with Pharmacy Compounding Accreditation Board's standards. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

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.

Building intentions with the Theory of Planned Behaviour: the mediating role of knowledge and expectations in implementing new pharmaceutical services in Malaysia.

PubMed

Tan, Christine L; Gan, Vincent B; Saleem, Fahad; Hassali, Mohamed A

2016-01-01

Pharmacy value added services (PVAS) was introduced as a matter of public health policy by Malaysia's Ministry of Health to improve health outcomes through public healthcare services. For example, drive through pharmacy services is a major policy implementation of the Ministry. However, adoption rates are low and therefore hampering the achievement of national health policy goals. Our objective is to explore the key determinants and mediators of successful implementation of new public pharmaceutical services by investigating the cognitive perspectives of patients' intentions to adopt with the Theory of Planned Behavior as the theoretical framework. A two phase mixed methodology involving first a qualitative exploration and the second a quantitative phase was conducted in public health facilities in Negeri Sembilan, Malaysia. Multiple regression and mediation analysis were performed. Subjective norms, perceived behavioural control, knowledge and expectations are found to be significant predictors of intentions to adopt PVAS. Knowledge and expectations are found to exert significant indirect effects on intentions. Overall, we suggest that patient knowledge be enhanced through appropriate channels and expectations of service quality be met to increase intentions.

Ecological Exposure Research: Water

EPA Pesticide Factsheets

Overview of ecological exposure water research, including invasive species, Functional Process Zones (FPZs), biomarkers, pharmaceuticals in water, headwater streams, DNA barcoding, wetland ecosystem services, and sediment remediation.

Keeping the doctor in the loop: Ayurvedic pharmaceuticals in Kerala.

PubMed

Kudlu, Chithprabha

2016-12-01

Ethnographic inquiry into Ayurvedic commodification in Kerala revealed the prevalence of a distinct regional pharmaceutical market dominated by physician-manufacturers, oriented towards supplying classical medicines to Ayurvedic doctors. This stands in sharp contrast to mainstream Ayurveda that is observed to have undergone biomedicalization and pharmaceuticalization. This paper argues that Kerala's classical-medicine-centric pharmaceutical market constitutes an alternative modernity because it provided Kerala Ayurveda with a different route to modernization impervious to the biomedical regime, as well as endowing it with the institutional power to safeguard its regional identity. Although physician-entrepreneurs are its key architects, it is sustained by value regimes shaped by a unique regional medico-cultural milieu. Even when industrially produced, classical medicines remain embedded within Ayurveda's socio-technical network; unlike proprietary drugs sold as individual product-identities through non-Ayurvedic channels, they travel together as a pharmacopeia, distributed through exclusive doctor-mediated agencies. This clinic-centric distribution format is best conceptualized as an open-source business model as it made low-margin generics viable by packaging them with therapies and services. Besides ensuring better access and affordability, it provided resistance to pharmaceuticalization and intellectual property concentration. By keeping the doctor in the loop, it prevented medicines from degenerating into de-contextualized commodities; the service component of Ayurveda therein preserved went on become the unique selling point in the health-tourism market. The tourism-inspired proliferation of Brand Kerala eventually triggered a paradigm shift in mainstream Ayurveda - shifting focus from 'pharmaceuticals' to 'services' and from 'illness' to 'wellness'. Furthermore, interacting with hybrid Ayurvedas in transnational markets, Kerala Ayurveda co-produces new alterities countervailing the structurally dominant biomedical paradigm.

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

The Early Patient-Oriented Care Program as an Educational Tool and Service.

ERIC Educational Resources Information Center

Grabe, Darren W.; Bailie, George R.; Manley, Harold J.; Yeaw, Barbara F.

1998-01-01

The Early Patient-Oriented Care Program provides early clinical education for pharmacy students and clinical services for patients. Six students were assigned to visit 12-15 hemodialysis patients monthly under preceptor supervision. Topics covered include approach to patient, medical information retrieval, pharmaceutical care philosophy,…

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...

About Being Pure and Natural: Understandings of Pre-Service Primary Teachers

ERIC Educational Resources Information Center

Lake, David

2005-01-01

In an investigation of 149 pre-service primary teachers' understanding of the terms "pure" and "natural," the participants were asked to provide definitions of the two words, and classify various substances including drugs of abuse, pharmaceuticals, nutriceuticals, and household substances as either natural or not natural, and…

An Inventory and Safety Stock Analysis of Air Force Medical Service Pharmaceuticals

DTIC Science & Technology

2015-03-26

Adam D. Reiman , PhD Member AFIT-ENS-MS-15-M-133 iv Abstract A significant challenge facing the Air Force Medical Service (AFMS...sincere gratitude to my research committee, Dr. William Cunningham and Lt Col Adam Reiman for their guidance and support throughout the research

What do pharmaceutical industry professionals in Europe believe about involving patients and the public in research and development of medicines? A qualitative interview study.

PubMed

Parsons, Suzanne; Starling, Bella; Mullan-Jensen, Christine; Tham, Su-Gwan; Warner, Kay; Wever, Kim

2016-01-07

To explore European-based pharmaceutical industry professionals' beliefs about patient and public involvement (PPI) in medicines research and development (R&D). Pharmaceutical companies in the UK, Poland and Spain. 21 pharmaceutical industry professionals, four based in the UK, five with pan-European roles, four based in Spain and eight based in Poland. Qualitative interview study (telephone and face-to-face, semistructured interviews). All interviews were audio taped, translated (where appropriate) and transcribed for analysis using the Framework approach. 21 pharmaceutical industry professionals participated. Key themes were: beliefs about (1) whether patients and the public should be involved in medicines R&D; (2) the barriers and facilitators to PPI in medicines R&D and (3) how the current relationships between the pharmaceutical industry, patient organisations and patients influence PPI in medicines R&D. Although interviewees appeared positive about PPI, many were uncertain about when, how and which patients to involve. Patients and the public's lack of knowledge and interest in medicines R&D, and the pharmaceutical industry's lack of knowledge, interest and receptivity to PPI were believed to be key challenges to increasing PPI. Interviewees also believed that relationships between the pharmaceutical industry, patient organisations, patients and the public needed to change to facilitate PPI in medicines R&D. Existing pharmaceutical industry codes of practice and negative media reporting of the pharmaceutical industry were also seen as negative influences on these relationships. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

[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.

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.

Public health in community pharmacy: a systematic review of pharmacist and consumer views.

PubMed

Eades, Claire E; Ferguson, Jill S; O'Carroll, Ronan E

2011-07-21

The increasing involvement of pharmacists in public health will require changes in the behaviour of both pharmacists and the general public. A great deal of research has shown that attitudes and beliefs are important determinants of behaviour. This review aims to examine the beliefs and attitudes of pharmacists and consumers towards pharmaceutical public health in order to inform how best to support and improve this service. Five electronic databases were searched for articles published in English between 2001 and 2010. Titles and abstracts were screened by one researcher according to the inclusion criteria. Papers were included if they assessed pharmacy staff or consumer attitudes towards pharmaceutical public health. Full papers identified for inclusion were assessed by a second researcher and data were extracted by one researcher. From the 5628 papers identified, 63 studies in 67 papers were included. Pharmacy staff: Most pharmacists viewed public health services as important and part of their role but secondary to medicine related roles. Pharmacists' confidence in providing public health services was on the whole average to low. Time was consistently identified as a barrier to providing public health services. Lack of an adequate counselling space, lack of demand and expectation of a negative reaction from customers were also reported by some pharmacists as barriers. A need for further training was identified in relation to a number of public health services. Consumers: Most pharmacy users had never been offered public health services by their pharmacist and did not expect to be offered. Consumers viewed pharmacists as appropriate providers of public health advice but had mixed views on the pharmacists' ability to do this. Satisfaction was found to be high in those that had experienced pharmaceutical public health There has been little change in customer and pharmacist attitudes since reviews conducted nearly 10 years previously. In order to improve the public health services provided in community pharmacy, training must aim to increase pharmacists' confidence in providing these services. Confident, well trained pharmacists should be able to offer public health service more proactively which is likely to have a positive impact on customer attitudes and health.

Public health in community pharmacy: A systematic review of pharmacist and consumer views

PubMed Central

2011-01-01

Background The increasing involvement of pharmacists in public health will require changes in the behaviour of both pharmacists and the general public. A great deal of research has shown that attitudes and beliefs are important determinants of behaviour. This review aims to examine the beliefs and attitudes of pharmacists and consumers towards pharmaceutical public health in order to inform how best to support and improve this service. Methods Five electronic databases were searched for articles published in English between 2001 and 2010. Titles and abstracts were screened by one researcher according to the inclusion criteria. Papers were included if they assessed pharmacy staff or consumer attitudes towards pharmaceutical public health. Full papers identified for inclusion were assessed by a second researcher and data were extracted by one researcher. Results From the 5628 papers identified, 63 studies in 67 papers were included. Pharmacy staff: Most pharmacists viewed public health services as important and part of their role but secondary to medicine related roles. Pharmacists' confidence in providing public health services was on the whole average to low. Time was consistently identified as a barrier to providing public health services. Lack of an adequate counselling space, lack of demand and expectation of a negative reaction from customers were also reported by some pharmacists as barriers. A need for further training was identified in relation to a number of public health services. Consumers: Most pharmacy users had never been offered public health services by their pharmacist and did not expect to be offered. Consumers viewed pharmacists as appropriate providers of public health advice but had mixed views on the pharmacists' ability to do this. Satisfaction was found to be high in those that had experienced pharmaceutical public health Conclusions There has been little change in customer and pharmacist attitudes since reviews conducted nearly 10 years previously. In order to improve the public health services provided in community pharmacy, training must aim to increase pharmacists' confidence in providing these services. Confident, well trained pharmacists should be able to offer public health service more proactively which is likely to have a positive impact on customer attitudes and health. PMID:21777456

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

Economic evaluation of the Programs Rede Farmácia de Minas do SUS versus Farmácia Popular do Brasil.

PubMed

Garcia, Marina Morgado; Guerra, Augusto Afonso; Acúrcio, Francisco de Assis

2017-01-01

We conducted an economic assessment of the Pharmaceutical Assistance - Rede Farmácia de Minas Gerais-RFMG and Farmácia Popular do Brasil-FPB to ascertain which of the two models stands out as the most efficient. To do this, a model, which consisted of a study of incurred costs in both programs, up to the dispensing of medicine to citizens, was developed. The uncertainties of the proposed model were tested using the Monte Carlo method. If the entire population initially estimated in the RFMG were attended in the FPB, there would be an additional cost of R$ 139,324,050.19. The sensitivity analysis appeared to be favorable to the RFMG. A total of 10000 simulations were carried out, resulting in a median value of R$ 114,053,709.99 for the RFMG and R$ 254,106,120.65 for the FPB. The current National Drug Policy emphasizes the need to strengthen pharmaceutical services beyond the mere acquisition and delivery of pharmaceutical products. The public healthcare service model, consistent with the principles and guidelines of the SUS, seems to be more appropriate in ensuring complete and universal quality healthcare services to the citizens. The economic study conducted reinforces this fact, as it appears to be a more efficient alternative of the direct use of resources in the public health network.

Six sigma tools in integrating internal operations of a retail pharmacy: a case study.

PubMed

Kumar, Sameer; Kwong, Anthony M

2011-01-01

This study was initiated to integrate information and enterprise-wide healthcare delivery system issues specifically within an inpatient retail pharmacy operation in a U.S. community hospital. Six Sigma tools were used to examine the effects to an inpatient retail pharmacy service process. Some of the tools used include service blueprints, cause-effect diagram, gap analysis derived from customer and employee surveys, mistake proofing was applied in various business situations and results were analyzed to identify and propose process improvements and integration. The research indicates that the Six Sigma tools in this discussion are very applicable and quite effective in helping to streamline and integrate the pharmacy process flow. Additionally, gap analysis derived from two different surveys was used to estimate the primary areas of focus to increase customer and employee satisfaction. The results of this analysis were useful in initiating discussions of how to effectively narrow these service gaps. This retail pharmaceutical service study serves as a framework for the process that should occur for successful process improvement tool evaluation and implementation. Pharmaceutical Service operations in the U.S. that use this integration framework must tailor it to their individual situations to maximize their chances for success.

Pharmacy workforce to prevent and manage non-communicable diseases in developing nations: The case of Nepal.

PubMed

Khanal, Saval; Nissen, Lisa; Veerman, Lennert; Hollingworth, Samantha

2016-01-01

Non-communicable diseases (NCDs, e.g. cardiovascular diseases, cancer, chronic respiratory diseases and diabetes mellitus) are the main causes of mortality and morbidity in developing countries, including Nepal. Nearly half of the deaths in Nepal are caused by NCDs. Nepal lacks adequate human resources to prevent and manage NCDs, but the skills and expertise of pharmacists in Nepal are underused. There is evidence from many countries that pharmacists can contribute substantially to the prevention and management NCD. We aim to describe the opportunities and challenges for pharmacists to prevent and manage NCDs in Nepal. Pharmacists can contribute by screening and monitoring NCDs; counseling on lifestyle; providing medication therapy management services; promoting public health; and providing other pharmaceutical services. Challenges to the implementation of some of these activities in the current context include inadequate training of pharmacists in NCD prevention and management, the cost of pharmaceutical services to patients and government, and the existing health care service delivery model. There is a need for health services research to determine how pharmacists can be best used to prevent and manage NCDs in Nepal. Copyright © 2015 Elsevier Inc. All rights reserved.

75 FR 6335 - Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Inclusion of...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-09

... DEPARTMENT OF DEFENSE Office of the Secretary [DoD-2008-HA-0029; 0720-AB22] 32 CFR Part 199 Civilian Health and Medical Program of the Uniformed Services (CHAMPUS)/TRICARE: Inclusion of TRICARE Retail Pharmacy Program in Federal Procurement of Pharmaceuticals AGENCY: Office of the Secretary...

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…

Healthcare professionals' perceptions related to the provision of clinical pharmacy services in the public health sector of Mexico: a case study.

PubMed

Díaz de León-Castañeda, Christian; Gutiérrez-Godínez, Jéssica; Colado-Velázquez, Juventino Iii; Toledano-Jaimes, Cairo

2018-04-22

In Mexico, the Modelo Nacional de Farmacia Hospitalaria (MNFH, or National Hospital Pharmacy Model), published in 2009, mainly aims to promote the provision of clinical pharmacy services in private and public hospitals. However, there is little scientific documentation about the quality of these services. To explore healthcare professionals' perceptions related to the quality of clinical pharmacy services provision. A case-study based on a qualitative approach was performed at the pharmaceutical services unit at a public hospital located in Mexico City, which operates under the administrative control of the Ministry of Health. Donabedian's conceptual model was adapted to explore health care professionals' perceptions of the quality of clinical pharmacy services provision. Semi-structured interviews were carried out with pharmacists, physicians and nurses and then transcribed and analyzed via discourse analysis and codification techniques, using the software package Atlas. ti. Limitations in pharmaceutical human resources were identified as the main factor affecting coverage and quality in clinical pharmacy services provision. However, the development in pharmacy staff of technical competences and skills for clinical pharmacy service provision were recognized. Significant improvements in the rational use of medicines were associated with clinical pharmacy services provision. The perception analysis performed in this study suggested that it is necessary to increase pharmacy staff in order to improve interprofessional relationships and the quality of clinical pharmacy services provision. Copyright © 2018 Elsevier Inc. All rights reserved.

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.

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.

Marketing to the consumer: perspectives from the pharmaceutical industry.

PubMed

David, C

2001-01-01

Individualized health management is one of the most exciting challenges facing health care marketing today. Greater access to health information has empowered consumers to take more control of their health needs, creating a whole new landscape for marketers, manufacturers, and service providers. Customization is the key to creating marketing campaigns that successfully target today's health-conscious consumers. Drawing on individualized market intelligence and available genetic information, pharmaceutical companies are learning to tailor products to meet the needs of this growing market.

Medicine and pharmacy--facts and myths about the development of an innovative pharmaceutical industry in Poland.

PubMed

Kubiak, Włodzimierz

2005-01-01

Innovation is fundamental to the pharmaceutical industry and a key to improvements in healthcare. Its effectiveness depends on huge, constant investments in research. This innovative industry directly affects the course of studies in healthcare and medicine. Its efforts translate directly into the length and quality of our lives. For several years now, the progress underway in pharmaceutical industry has produced measurable benefits. Doctors have new pharmaceuticals at their disposal, including many types of antibiotics and anti-viral drugs, vaccines and a wide range of drugs which save lives or make them more comfortable. In the near future, ever more efficient cures for neoplastic, rheumatic, neurological, psychic, metabolic, circulatory or respiratory diseases can be expected. Innovation is necessary. The human population is ageing, and the task of an innovative pharmaceutical industry is to keep it in a good condition. The use of innovative drugs can translate directly into lowering the costs of illness. A continuous reduction in spending on healthcare has been observed. The costs of inventing an innovative drug are enormous though (US dollar 800 million), and studies on a new drug last between 10 and 13 years. An essential element in recovering the incurred costs and ensuring funds needed for new research is protection by patent. Innovative pharmaceutical companies in Poland are committed to increasing the competitiveness and sustaining the development of not only the market, but also the entire pharmaceutical sector. It is a group of companies of crucial importance to the Polish healthcare system, as it influences improvement in the quality of medical services. Through their investments and spending on research and development, innovative companies accelerate economic growth. In Poland, the innovative pharmaceutical industry is represented by the Association of Pharmaceutical Companies Representatives in Poland (SPFFwP).

Drug policy in China. Transformations, current status and future prospects.

PubMed

Liu, X; Li, S

1997-07-01

The pharmaceutical sector in China developed rapidly with the implementation of the market-oriented economic reforms, which began at the end of the 1970s. From 1980 to 1988 the production of drugs quadrupled, subsequently increasing at an annual rate of 20%, and consumption of drugs correspondingly increased. The increase in drug production was largely a result of the increase in the number of pharmaceutical companies, particularly the number of private joint ventures, of which there were none in 1980 and 1900 in 1994, accounting for 37% of the total number of pharmaceutical companies. With the transformation of the Chinese pharmaceutical market, some new problems have appeared. The low efficiency of pharmaceutical companies, poor-quality drugs, unfair competition and misuse of drugs have been of great concern to the Chinese government. Some countermeasures have been taken, but the problems remain. Increases in the age of the Chinese population, increases in income and changes in disease patterns, together with membership of the World Trade Organization will promote the development of the pharmaceutical market. However, health-insurance reform, an essential drug list, the separation of drugs from services, and controls on the increases in hospital revenue will reduce the demand for drugs. Pharmaceutical companies in China face both opportunities and challenges. The trend in development of the pharmaceutical market depends on the outcome of the interaction between the factors that increase, and those that decrease, the demand for drugs. While the general trend is towards an increase in the demand for drugs and the expansion of the pharmaceutical market, downward fluctuation is inevitable if effective health reforms of cost control are introduced nationwide.

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21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2013 CFR

2013-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2012 CFR

2012-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2011 CFR

2011-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2010 CFR

2010-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

21 CFR 211.52 - Washing and toilet facilities.

Code of Federal Regulations, 2014 CFR

2014-04-01

...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities... cold water, soap or detergent, air driers or single-service towels, and clean toilet facilities easily...

Measurement of patient satisfaction with community pharmacy services: a review.

PubMed

Naik Panvelkar, Pradnya; Saini, Bandana; Armour, Carol

2009-10-01

The aim of this review is to conduct an in-depth analysis of the available literature in order to identify and evaluate studies measuring patient satisfaction with pharmacy services delivered by pharmacists in a community setting. An extensive literature search was conducted in five databases (Medline, Scopus, Embase, Psychinfo, International Pharmaceutical Abstracts) using the search terms "patient/client/consumer satisfaction" AND "community pharmacy/pharmacies" AND "pharmacy service/pharmaceutical services/pharmacy program/intervention/intervention studies". Only those articles where the main focus was measuring patient satisfaction with services delivered in community pharmacies were included in the review. Patient satisfaction was explored with three different levels of pharmacy services -- general services, intervention services and cognitive services. Twenty-four articles measuring patient satisfaction with community pharmacy services were retrieved. Of these, eleven measured patient satisfaction with general services, six measured satisfaction with intervention services and seven measured satisfaction with cognitive services. The majority of studies reviewed had adopted and measured satisfaction as a multidimensional construct. None of the studies reviewed tested any theoretical models of satisfaction. Further a lack of consistent instruments measuring patient satisfaction was observed, with most of the reviewed studies using self developed, non-validated or ad hoc instruments with items from various previously published papers. The review also observed high levels of patient satisfaction with pharmacy services be they general, intervention or cognitive services. This review found that patient satisfaction has been measured within the community pharmacy context to a certain degree. Further research is needed to develop and test instruments based on theoretical frameworks, to test satisfaction pre and post hoc and in well designed randomized controlled trials and to measure changes in satisfaction over time. Novel approaches involving an understanding of expectations and preferences of patients and matching these to the services provided also need to be explored.

21 CFR 26.67 - Suspension of listed conformity assessment bodies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

21 CFR 26.68 - Withdrawal of listed conformity assessment bodies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

National Survey on Access, Use and Promotion of Rational Use of Medicines: methods

PubMed Central

Álvares, Juliana; Alves, Maria Cecilia Goi Porto; Escuder, Maria Mercedes Loureiro; Almeida, Alessandra Maciel; Izidoro, Jans Bastos; Guerra, Augusto Afonso; Costa, Karen Sarmento; Costa, Ediná Alves; Guibu, Ione Aquemi; Soeiro, Orlando Mario; Leite, Silvana Nair; Karnikowski, Margô Gomes de Oliveira; Acurcio, Francisco de Assis

2017-01-01

ABSTRACT The Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos –Serviços (PNAUM – National Survey on Access, Use and Promotion of Rational Use of Medicines – Services) aimed to characterize the organization of pharmaceutical services in the Primary Health Care of the Brazilian Unified Health System (SUS). PNAUM – Services is a cross-sectional and evaluative study, with planned sample of 600 cities, held between 2014 and 2015, composed of a remote phase, with telephone interviews with health managers. Of these 600 cities, 300 were selected for a survey on health services. We selected the 27 capitals, the 0.5% largest cities of each region, and the remaining cities were drawn. The estimate of the representative national sample size considered three levels: cities, medicine dispensing services, and patients. The interviews were carried out with a structured questionnaire specific for: municipal secretaries of health, professionals responsible for pharmaceutical services in the city, professionals responsible for the dispensing of medicines, physicians, and patients. The secondary data were obtained in official databases, in the latest update date. PNAUM – Services was the first nationwide research aimed at the assessment and acquisition of national and regional indicators on access to medicines, as well as use and rational use, from the perspective of various social subjects. PMID:29160446

The regional drug information service: a factor in health care?

PubMed Central

Leach, F N

1978-01-01

Most regional health authorities throughout the United Kingdom have established drug information units to provide health service staff with a wide range of information about drugs and drug use. The units, which are staffed by drug information pharmacists, provide their service mainly by answering inquiries, although some disseminate information more positively through lectures and bulletins. An analysis of inquiries received by regional information units during 1976 showed that most were submitted by hospital doctors or pharmacists; comparatively few were received from general practitioners. Topics of inquiry included adverse effects of drugs, source of supply and identification, current treatment, dosage, route, precautions, and pharmaceutical problems such as stability or formulation of drug preparations. A more detailed analysis of the inquiries received by the North-western Regional Drug Information Service at Manchester over three years showed that the number of inquiries gradually increased and that more were received from general practitioners after a programme of lectures had been introduced to tell them about the service. The North-western service also received more requests from hospital pharmacists than other units, though many originated from clinicians. The regional drug information units consulted widely with clinical and other specialists in answering questions, but about a quarter of all inquiries were pharmaceutical, relating to stability and incompatibility. A multidisciplinary approach therefore seems necessary to provide a comprehensive and advisory drug information service. PMID:630339

Maintenance of Clinical Expertise and Clinical Research by the Clinical Professors at Gifu Pharmaceutical University.

PubMed

Tachi, Tomoya; Noguchi, Yoshihiro; Teramachi, Hitomi

2017-01-01

The clinical professors at Gifu Pharmaceutical University (GPU) provide pharmaceutical services at GPU Pharmacy, Gifu University Hospital, and Gifu Municipal Hospital to keep their clinical skills up-to-date; they also perform clinical research in collaboration with many clinical institutes. The Laboratory of Clinical Pharmacy is part of the Department of Pharmacy Practice and Science, to which the clinical professors belong, and is composed of three clinical professors (a professor, an associate professor, and an assistant professor). The professor administers the GPU Pharmacy as its director, while the associate professor and assistant professor provide pharmaceutical services to patients at Gifu Municipal Hospital, and also provide practical training for students in the GPU Pharmacy. Collectively, they have performed research on such topics as medication education for students, clinical communication education, and analysis of clinical big data. They have also conducted research in collaboration with clinical institutes, hospitals, and pharmacies. Here, we introduce the collaborative research between the Laboratory of Clinical Pharmacy and Gifu Municipal Hospital. These studies include "Risk factors contributing to urinary protein expression resulting from bevacizumab combination chemotherapy", "Hyponatremia and hypokalemia as risk factors for falls", "Economic evaluation of adjustments of levofloxacin dosage by dispensing pharmacists for patients with renal dysfunction", and "Effect of patient education upon discharge for use of a medication notebook on purchasing over-the-counter drugs and health foods". In this symposium, we would like to demonstrate one model of the association and collaborative research between these clinical professors and clinical institutes.

Medicines as a Service

PubMed Central

Mattke, Soeren; Klautzer, Lisa; Mengistu, Tewodaj

2012-01-01

Abstract The past decade has not been kind to large pharmaceutical companies. Their share prices have been lagging the market after many years of outperforming it. Many had to undergo painful restructuring and workforce reductions because their traditional blockbuster model is becoming extinct. More and more top-selling drugs are being replaced by cheap generics, and developing new drugs is more difficult because fewer opportunities exist and more-costly research and development (R&D) productivity has declined. Although this diagnosis is not disputed, the best course of treatment is not clear. Companies have tried to stop the bleeding with the help of mergers and reorganizations and infused new blood by acquiring biotech companies or their innovative products or by diversifying into products other than prescription drugs. In this article, the authors propose that the pharmaceutical industry can reconfigure its considerable resources to develop innovative and meaningful business models that are based on services that improve access and adherence to prescription drugs for chronic conditions. They argue that such innovation beyond drug development is consistent with the core capabilities of large pharmaceutical companies and has the potential to achieve profit levels similar to those of its traditional models. Their argument is based on the fact that, although effective medicines for most chronic conditions exist, access and adherence to medicines is far from what would be needed to achieve full treatment efficacy. Therefore, value can be created by getting and keeping more patients on their drugs, and innovative business models would allow pharmaceutical companies to capture that value. PMID:28083254

Competition among pharmacies and the typology of services delivered: The Portuguese case.

PubMed

Martins, Lurdes; Queirós, Sónia

2015-05-01

To analyze the impact of individual and market characteristics (such as competition) on the typology of services delivered by a community pharmacy after a recent Portuguese pro-competitive regulatory change. In this paper, market concentration indices are used to identify market competition groups in the sample. These competition groups are then described with regard to the typology of services on offer by pharmacies within the group. Finally, a system of structural equations is estimated to verify if the decision of a pharmacy to offer or not to offer each of the studied pharmaceutical services is affected by local market regulated competition. In some cases, pharmacies belonging to different competition groups do not present significant differences in terms of the typology of services on offer, but according to our regressions, it seems that vaccines and medicines administration services, pharmaceutical care programmes and medicines management programmes are more likely to be offered in pharmacies located in higher competitive markets. These are also urban areas, in which there is already easy access to products sold in pharmacies, and to health services in general. Access to additional pharmacy services may in some cases increase as market competition increases. Thus, pro-competitive regulatory measures may have led to an asymmetric distribution of pharmacy services across the country, favouring more competitive urban marketplaces. If policy-makers are interested in a more symmetrical distribution of pharmacies services all over the country, they are recommended to take action to ensure equitable access to these services. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

21 CFR 26.10 - Regulatory authorities not listed as currently equivalent.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

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.

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

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.

Social and economic value of Portuguese community pharmacies in health care.

PubMed

Félix, Jorge; Ferreira, Diana; Afonso-Silva, Marta; Gomes, Marta Vargas; Ferreira, César; Vandewalle, Björn; Marques, Sara; Mota, Melina; Costa, Suzete; Cary, Maria; Teixeira, Inês; Paulino, Ema; Macedo, Bruno; Barbosa, Carlos Maurício

2017-08-29

Community pharmacies are major contributors to health care systems across the world. Several studies have been conducted to evaluate community pharmacies services in health care. The purpose of this study was to estimate the social and economic benefits of current and potential future community pharmacies services provided by pharmacists in health care in Portugal. The social and economic value of community pharmacies services was estimated through a decision-model. Model inputs included effectiveness data, quality of life (QoL) and health resource consumption, obtained though literature review and adapted to Portuguese reality by an expert panel. The estimated economic value was the result of non-remunerated pharmaceutical services plus health resource consumption potentially avoided. Social and economic value of community pharmacies services derives from the comparison of two scenarios: "with service" versus "without service". It is estimated that current community pharmacies services in Portugal provide a gain in QoL of 8.3% and an economic value of 879.6 million euros (M€), including 342.1 M€ in non-remunerated pharmaceutical services and 448.1 M€ in avoided expense with health resource consumption. Potential future community pharmacies services may provide an additional increase of 6.9% in QoL and be associated with an economic value of 144.8 M€: 120.3 M€ in non-remunerated services and 24.5 M€ in potential savings with health resource consumption. Community pharmacies services provide considerable benefit in QoL and economic value. An increase range of services including a greater integration in primary and secondary care, among other transversal services, may add further social and economic value to the society.

[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.

Social inequalities and pharmaceutical cost sharing in Italian regions.

PubMed

Terraneo, Marco; Sarti, Simone; Tognetti Bordogna, Mara

2014-01-01

In recent years, Italian citizens have increasingly been asked to share pharmaceutical costs, but at the same time, households' medicines expenditure has decreased. Cost-sharing policies have to be assessed not just in terms of limitation of moral hazard and revenue to the state, but also for equal opportunities for citizen users accessing health services. The aim of this article is to analyze how Italian co-payment policies ("ticket") on medicines may affect pharmaceutical expenditure of households, considering territorial and social groups variation. We reviewed the per capita private spending on medicines of Italian regions, separating pharmaceutical outlay and "ticket." Across the period 2001-2010 we found that the overall per capita private spending on medicines remained substantially stable, although medicine expenditure decreases while the "ticket" increases. When cost sharing rises, out-of-pocket spending on medicines by poorer families seems to remain unchanged; however, poorer families seem to reduce their pharmaceutical expenditure. Our analysis suggests that applying co-payment in Italy is partly successful, in terms of greater revenue to the health system, but in the last few years, cost-sharing increases would seem to have rebounded negatively on more vulnerable families, due to the economic crisis.

Attention to 'details': etiquette and the pharmaceutical salesman in postwar American.

PubMed

Greene, Jeremy A

2004-04-01

This paper provides a sketch of the emerging role of the pharmaceutical salesman, or 'detail man', in the growth years of the American post-World War II pharmaceutical industry. Using training manuals, trade literature, in-house company newsletters, memoirs, and a variety of other published sources, the paper follows the delicate tactics employed by salesmen and their managers in their attempts to recast drug salesmanship as a 'professional service' fulfilling vital functions within medical education. As they worked to legitimate their presence in the nation's hospitals and clinics, particular emphasis was given to precise management of the etiquette of doctor-salesman interaction. Ultimately, the techniques employed by mid-century salesmen and their managers were to prove successful in generating a widespread acceptance of the industry representative within the clinical spaces of hospital and clinic. Indeed, many of the practices of market research and market strategy employed across the pharmaceutical industry today have their origins in the practices of the individual detail man. Exploration of the postwar pharmaceutical salesman as an overlooked historical 'type' provides significant insights into the intersection of medicine and the consumer marketplace during the later 20th century.

21 CFR 26.47 - Role and composition of the Joint Sectoral Committee.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE...

Clients’ perception and satisfaction toward service provided by pharmacy professionals at a teaching hospital in Ethiopia

PubMed Central

Teshome Kefale, Adane; Hagos Atsebah, Gebru; Ayele Mega, Teshale

2016-01-01

Background Evaluation of client’s perception and satisfaction with pharmacy services is important to identify specific areas of the service that need improvement in achieving high-quality pharmacy services. It also helps to detect the gaps in the current pharmaceutical services provision. Objective To assess clients’ perception and satisfaction toward service provided by pharmacy professionals at Mizan-Tepi University Teaching Hospital. Methods A cross-sectional study design was employed from March 8 to 24, 2016. A semistructured questionnaire was used to assess clients’ perception and satisfaction toward service provided by pharmacy professionals. The data collected were entered into Epi data 3.1, cleaned, and transported into and analyzed using SPSS version 20. Logistic regression was employed to determine associated factors, and statistical significance was considered at p-value <0.05. Results Among 384 respondents, 53.1% were male. Of the total participants, 63.8% had good perception and 36.2% had poor perception toward pharmacy services. With regard to satisfaction, 52.6% of the respondents were satisfied and 47.4% were unsatisfied by the pharmaceutical services. Sociodemographic variables such as educational level (p=0.000), occupation (p=0.031), payment for service (p=0.002), and reasons the respondents seek service (p=0.001) showed statistically significant association with the level of perception. Clients’ satisfaction was found to be significantly associated with educational level (p=0.002) and reason for seeking service (p=0.016). Conclusion and recommendation This study showed that the overall mean perception and satisfaction of clients in Mizan-Tepi University Teaching Hospital was low, even though it was above the mean level of perception and satisfaction. Action has to be taken to improve the perception and satisfaction of clients with the services provided in the pharmacy section. PMID:29354544

Clients' perception and satisfaction toward service provided by pharmacy professionals at a teaching hospital in Ethiopia.

PubMed

Teshome Kefale, Adane; Hagos Atsebah, Gebru; Ayele Mega, Teshale

2016-01-01

Evaluation of client's perception and satisfaction with pharmacy services is important to identify specific areas of the service that need improvement in achieving high-quality pharmacy services. It also helps to detect the gaps in the current pharmaceutical services provision. To assess clients' perception and satisfaction toward service provided by pharmacy professionals at Mizan-Tepi University Teaching Hospital. A cross-sectional study design was employed from March 8 to 24, 2016. A semistructured questionnaire was used to assess clients' perception and satisfaction toward service provided by pharmacy professionals. The data collected were entered into Epi data 3.1, cleaned, and transported into and analyzed using SPSS version 20. Logistic regression was employed to determine associated factors, and statistical significance was considered at p -value <0.05. Among 384 respondents, 53.1% were male. Of the total participants, 63.8% had good perception and 36.2% had poor perception toward pharmacy services. With regard to satisfaction, 52.6% of the respondents were satisfied and 47.4% were unsatisfied by the pharmaceutical services. Sociodemographic variables such as educational level ( p =0.000), occupation ( p =0.031), payment for service ( p =0.002), and reasons the respondents seek service ( p =0.001) showed statistically significant association with the level of perception. Clients' satisfaction was found to be significantly associated with educational level ( p =0.002) and reason for seeking service ( p =0.016). This study showed that the overall mean perception and satisfaction of clients in Mizan-Tepi University Teaching Hospital was low, even though it was above the mean level of perception and satisfaction. Action has to be taken to improve the perception and satisfaction of clients with the services provided in the pharmacy section.

Time trends and determinants of pharmaceutical expenditure in China (1990-2009).

PubMed

Shi, Lizheng; Yang, Heidi Y; Cheng, Gang; Meng, Qingyue

2014-03-01

Pharmaceutical policy reform is currently one of the primary areas of health reform in China. The national pharmaceutical policy of China has multiple objectives: to develop the domestic pharmaceutical industry and encourage innovation, to control escalation of total pharmaceutical expenditures (TPE) which constitute a substantial component of total health expenditures (THE), and to ensure access to essential medicines for poor and uninsured patients. The current pharmaceutical system has been criticized for its high costs, questionable prescribing practices, and poor regulation of drug quality. This study aims to examine the time trends and influential factors of TPE in China. Data from the 2010 China National Health Accounts Report and the 2010 China Health Statistics Year Book were used in the analysis. Time trends of TPE as a share of THE (TPE/THE), of gross domestic product [GDP] (TPE/GDP), and the relationship between TPE/THE and GDP were examined. The growth of TPE was examined after adjusting for health care utilization and GDP. The determinants of the TPE/THE and the TPE/GDP between 1990 and 2009 were investigated by two time-series regression models including the amount of prescriptions dispensed (using proxy variables of health utilization), the price indices of medical services, and the price indices of pharmaceuticals during that time period. Descriptive analyses showed that TPE and THE grew consistently during the years 1990-2009. The ratio of the THE/GDP increased more rapidly in recent years than the TPE/GDP. Furthermore, outpatient pharmaceutical expenditures (PEs) per visit and hospital PEs per admission grew throughout the study period. The amount of outpatient visits did not show a significant growth pattern during the 1990s, despite rapid GDP growth during that period. The time-series models showed that the TPE/THE was negatively associated with GDP during the same year (p = 0.039), as well as the medical consumer price index [CPI] (p = 0.021). The TPE/GDP was influenced by the price index of prescriptions (p < 0.001) and the amount of health services utilization, including inpatient admissions (p = 0.012) and outpatient visits (p = 0.003). The cost escalations in PEs and health expenditures were concurrent with GDP growth. TPE has been the major source of financial burden for patients. Even though the rapid growth in China's economy may ameliorate the overall TPE burden, control of PEs is still a key for successful health system reform.

[Adaptation possibility of chosen aspects of pharmaceutical marketing for realization of promotion in health care].

PubMed

Syrycki, Marek

2002-01-01

Reform of health service in Poland introduced reliable economic bill and elements of competition among its subjects as well. It created a new situation both for doctors and managers of health service. Need of search for rules and ways of competition exists at present among institutions of health care. Certain solutions can be modelled on the example of pharmaceutical companies already present on the market. As an example of such activities, which they can be applied directly in this new situation may serve so called personal sale and related to it case of institutions the best direct contact between the next but more controversial form of marketing activities worth spreading. The use of direct marketing and advertisements carries most problems with itself. This latter should be easier to accept when it selects an important social aim.

Association between hospital size and quality improvement for pharmaceutical services.

PubMed

Nau, David P; Garber, Mathew C; Lipowski, Earlene E; Stevenson, James G

2004-01-15

The relationship between hospital size and quality improvement (QI) for pharmaceutical services was studied. A questionnaire on QI was sent to hospital pharmacy directors in Michigan and Florida in 2002. The questionnaire included items on QI lead-team composition, QI tools, QI training, and QI culture. Usable responses were received from 162 (57%) of 282 pharmacy directors. Pharmacy QI lead teams were present in 57% of institutions, with larger teams in large hospitals (> or = 300 patients). Only two QI tools were used by a majority of hospitals: root-cause analysis (62%) and flow charts (66%). Small hospitals (< 50 patients) were less likely than medium-sized hospitals (50-299 patients) and large hospitals to use several QI tools, including control charts, cause-and-effect diagrams, root-cause analysis, flow charts, and histograms. Large hospitals were more likely than small and medium-sized hospitals to use root-cause analysis and control charts. There was no relationship between hospital size and the frequency with which physician or patient satisfaction with pharmaceutical services was measured. There were no differences in QI training or QI culture across hospital size categories. A survey suggested that a majority of hospital pharmacies in Michigan and Florida have begun to adopt QI techniques but that most are not using rigorous QI tools. Pharmacies in large hospitals had more QI lead-team members and were more likely to use certain QI tools, but there was no relationship between hospital size and satisfaction measurements, QI training, or QI culture.

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.

Use of medicinal plants and pharmaceuticals by indigenous communities in the Bolivian Andes and Amazon.

PubMed

Vandebroek, Ina; Calewaert, Jan-Bart; De jonckheere, Stijn; Sanca, Sabino; Semo, Lucio; Van Damme, Patrick; Van Puyvelde, Luc; De Kimpe, Norbert

2004-04-01

To investigate, by means of household surveys, the use of medicinal plants and pharmaceuticals in Apillapampa, a large Andean community of Quechua peasants, and in six small communities of Yuracaré-Trinitario "slash-and-burn" cultivators of the National Park Isiboro-Secure (the NPIS) in the Bolivian Amazon. A total of 12% of households in Apillapampa and nearly all households in the NPIS were interviewed about their use of medicinal plants and pharmaceuticals for treating illnesses. Informants were also asked to name any medicinal plants they knew. In spite of the presence of a primary health care service (PHC) with medical doctor in Apillapampa, an equal number of informants used medicinal plants and pharmaceuticals. In the NPIS, the prevalent use of medicinal plants or pharmaceuticals in any community depended on the distance of the community from the nearest village and from a PHC with medical doctor (r = 0.85 and r = -0.96; both P = 0.05. The NPIS communities' knowledge of plants expressed as the average number of medicinal plants mentioned correlated positively and negatively with distance from the nearest village and use of pharmaceuticals, respectively (r= 0.95, P < 0.005 and r = -0.90, P < 0.05, respectively). The cultural importance of traditional medicine and the physical isolation of communities, both in general and from PHCs, are factors that influence the use of and knowledge about medicinal plants.

[The "pharmaceutical chain", important asset of health safety in France. Synthesis of the session].

PubMed

Santini, C

2008-01-01

The National Academy of Pharmacy underlines the importance of health safety guarantees, provided by the "pharmaceutical chain" that bring the medicine until his user (from manufacturers to dispensing pharmacists), chain of which the security of each link is controlled and guaranteed by pharmacists. The first of the safety rules lies in the very fast availability of the medicine for the patients, in every respect of the national territory, due to an efficient system of pharmaceutical distribution and to a tightened network of pharmaceutical dispensaries (that constitutes a network of expertises especially to the service of patients and public health). All along the chain, also exists a same concern to guarantee and to preserve the pharmaceutical quality of the medicines. An essential element of the health safety is the right usage of the medicine, to which contribute: information associated with the marketing of the medicine, the very important role of the dispensing pharmacist as such sanitary adviser and therapeutic education teacher, the intervention of the hospital dispensary in clinical pharmacy, the "Pharmaceutical File" under setting up, pharmacovigilance, traceability of medicines ... Pharmacists, responsible at the level of the different steps of the chain, get appropriate skills, carry out themselves their duties and are responsible in front of the National Board of Pharmacists, and their common professional knowledge reinforces the cohesion and the robustness of the chain. Facing the serious issue of counterfeiting of medicines, the pharmaceutical chain constitutes an important line of defence against the entry of counterfeited drugs into commercial channels. The academy of Pharmacy warns against all evolution that would consist to break, even partially, of the mandatory and continuous pharmaceutical control.

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.

Provision of pharmaceutical care services in North Carolina: a 1999 survey.

PubMed

McDermott, June H; Christensen, Dale B

2002-01-01

To describe the extent of and factors associated with the provision of pharmaceutical care services (PCS) and value-added pharmaceutical services (PS) by pharmacists in North Carolina, the physical changes made in pharmacies to accommodate these services, the nature and extent of prior consent or collaborative practice arrangements between North Carolina pharmacists and prescribers, and the frequency of reimbursement for PCS. Descriptive study based on a mail survey. Pharmacist-managers at each of the 2,048 licensed pharmacy sites in North Carolina; a list of licensed pharmacies provided by the North Carolina Board of Pharmacy was used as the sampling frame. Pharmacists' reports of PCS and pharmacy demographics. Response rate was 40%. More than 30% of respondents provided PCS at their site, although only 20% met our more stringent definition of PCS (i.e., ensuring appropriate pharmacotherapy, ensuring patient understanding and adherence, and monitoring and reporting patient outcomes). Services were more frequently offered by university-affiliated (35%) or independent (32%) pharmacies. The median number of patients receiving PCS across all sites was 10 per week. Diabetes was the most common health problem for which PCS were offered. Three variables-weekly prescription volume (positive correlation); number of staff pharmacists with advanced training, specifically fellowship training; and medical clinic/health maintenance organization setting-were significant predictors of the numbers of patients provided PCS. Independent community pharmacies were most likely to have private counseling areas and to bill for and receive payment for PCS. In North Carolina, a substantial number of pharmacists provided PCS in 1999 or planned to do so in the near future. However, the number of patients receiving PCS was relatively low. Practice setting, pharmacist education level, and prescription volume were weakly predictive of the number of patients receiving PCS. Pharmacists commonly used prior consent arrangements with physicians in their practices, but primarily to facilitate generic substitution. Relatively few pharmacists billed for PS or PCS.

Technical issues and conservation conditions of medicines in the primary health care of the Brazilian Unified Health System

PubMed Central

Costa, Ediná Alves; Araújo, Patrícia Sodré; Pereira, Marcelo Tavares; Souto, Ana Cristina; Souza, Gisélia Santana; 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 characterize the technical issues and conditions of medicines conservation in Primary Health Care of Brazilian regions, responsible for pharmacy/dispensing unit profile; environmental, storage, and dose fractioning conditions; inventory control and waste management; fire and electrical failure safety items; transportation problems; advertising regulation; and pharmacovigilance. METHODS This article is part of the Pesquisa Nacional sobre Acesso, Utilização e Promoção do Uso Racional de Medicamentos – Serviços (National Survey on Access, Use and Promotion of Rational Use of Medicines – Services)–, a cross-sectional and exploratory study, of evaluative nature, consisting of an information survey within a representative sample of municipalities, stratified by Brazilian regions, which constitute the study domains, and a sample of Primary Health Care services. Pharmaceutical services (PS) were directly observed with photographic record and face-to-face interviews with those responsible for the dispensing of medicines and over the telephone with those responsible for pharmaceutical services. Data were processed with the SPSS® software version 21. RESULTS The investigated dimensions showed relevant deficiencies and inequalities between the regions, generally more favorable in the Southeast and Midwest regions and weaker in the Northeast and North regions. We verified non-compliance with technical requirements and conditions essential to the conservation of medicines, which may interfere with the maintenance of stability and, thus, on their quality, efficacy, and safety. The regulation of advertising/promotion of medicines is still incipient and there is some progress in the structuring of mechanisms regarding pharmacovigilance. CONCLUSIONS The sanitary situation of medicines in Brazilian Primary Health Care is alarming due to the violation of the specific sanitary legislation for dispensing establishments and due to a wide range of requirements essential to the conservation of medicines. We observed a disconnection between the efforts made in the Brazilian Unified Health System to promote access to medicines for all population and the organization and qualification of pharmaceutical services. PMID:29160452

Hazardous Waste Cleanup: Schering Corporation in Union, New Jersey

EPA Pesticide Factsheets

Schering Corporation is located at 1011 Morris Avenue, Union, New Jersey. Schering Corporation owns this facility, which conducts research and development along with some manufacturing of new pharmaceutical product lines. Support services include

42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

Code of Federal Regulations, 2010 CFR

2010-10-01

... biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the... physicians or registered nurses. (3) Orders given orally for drugs and biologicals must be followed by a...

42 CFR 416.48 - Condition for coverage-Pharmaceutical services.

Code of Federal Regulations, 2011 CFR

2011-10-01

... biologicals in a safe and effective manner, in accordance with accepted professional practice, and under the... physicians or registered nurses. (3) Orders given orally for drugs and biologicals must be followed by a...

75 FR 63509 - Notice of Determinations Regarding Eligibility To Apply for Worker Adjustment Assistance

Federal Register 2010, 2011, 2012, 2013, 2014

2010-10-15

.... Products LLC. 74,606 Watson Laboratories, Inc., Carmel, NY September 3, 2009. Watson Pharmaceuticals...--Enterprise Services), Virtual Workers Across the United States. 74,343 JohnsonDiversey Santa Cruz, CA...

Surface-Water to Groundwater Transport of Pharmaceuticals in a Wastewater-Impacted Stream in the U.S.

NASA Astrophysics Data System (ADS)

Bradley, P. M.; Barber, L. B.; Duris, J. W.; Foreman, W. T.; Furlong, E. T.; Hubbard, L. E.; Hutchinson, K. J.; Keefe, S. H.; Kolpin, D. W.

2014-12-01

Wastewater pharmaceutical contamination of shallow groundwater is a substantial concern in effluent-dominated streams, due to aqueous mobility and designed bioactivity of pharmaceuticals and due to effluent-driven hydraulic gradients. Improved understanding of the environmental fate and transport of wastewater-derived pharmaceuticals is essential for effective protection of vital aquatic ecosystem services, environmental health, and drinking-water supplies. Substantial longitudinal (downstream) transport of pharmaceutical contaminants has been documented in effluent-impacted streams. The comparative lack of information on vertical and lateral transport (infiltration) of wastewater contaminants from surface-water to hyporheic and shallow groundwater compartments is a critical scientific data gap, given the potential for contamination of groundwater supplies in effluent-impacted systems. Growing dependencies on bank filtration and artificial recharge applications for release of wastewater to the environment and for pretreatment of poor-quality surface-water for drinking water emphasize the critical need to better understand the exchange of wastewater contaminants, like pharmaceuticals, between surface-water and groundwater compartments. The potential transport of effluent-derived pharmaceutical contaminants from surface-water to hyporheic-water and shallow groundwater compartments was examined in a wastewater-treatment-facility (WWTF) impacted stream in Ankeny, Iowa under effluent-dominated (71-99% of downstream flow) conditions. Strong hydraulic gradients and hydrologic connectivity were evident between surface-water and shallow-groundwater compartments in the vicinity of the WWTF outfall. Carbamazepine, sulfamethoxazole, and immunologically-related compounds were detected in groundwater 10-20 meters from the stream bank. Direct aqueous-injection HPLC-MS/MS revealed high percentage detections of pharmaceuticals (110 total analytes) in surface-water and groundwater samples. The results demonstrate the importance of effluent discharge as a driver of local hydrologic conditions in an effluent-impacted stream and thus as a fundamental control on surface-water to groundwater transport of effluent-derived pharmaceutical contaminants.

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).

76 FR 51916 - Procurement of Commodities and Services Financed by USAID

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-19

... such patent. (22 U.S.C. 2356). In addition, USAID shall not finance non-contraceptive pharmaceuticals.... Contraceptives may be financed in accordance with the procedures in ADS 310. Subpart C--Conditions Governing the...

The Pistoia Alliance Controlled Substance Compliance Service Project: from start to finish.

PubMed

Taylor, Daniel; Bowden, Stuart G; Knorr, Reinhard; Wilson, Derek R; Proudfoot, John; Dunlop, Anne E

2015-02-01

Pharmaceutical companies and other life science R&D organizations routinely work with controlled substances, and must have adequate controls in place to meet the legislative requirements of the countries in which they operate. Controlled substances include a range of narcotics and psychotropic drugs, which are covered by increasingly complex legislation as legislators attempt to keep up with a rapidly changing environment. This legislation must be interpreted and transformed from legal wording into chemical structures to be used effectively. Over the past year a working party of pharmaceutical and technology companies has come together under the umbrella of the Pistoia Alliance to define a Controlled Substance Compliance Service. We describe the benefits of bringing together this group of experts to solve the pre-competitive issue of controlled substance management. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

Pharmacists' views on the development of asthma pharmaceutical care model in Indonesia: A needs analysis study.

PubMed

Widayati, Aris; Virginia, Dita Maria; Setiawan, Christianus Heru; Fenty, Fenty; Donowati, Maria Wisnu; Christasani, Putu Dyana; Hartayu, Titien Siwi; Suhadi, Rita; Saini, Bandana; Armour, Carol

2018-01-30

Over recent years the pharmacy profession in Indonesia has adopted a stance of pharmaceutical care to expand their scope of practice. Asthma management presents a key opportunity for pharmacists to test expanded roles in health service provision. There is however no exploratory work on the willingness, experience or future practice needs of Indonesian pharmacists in the realm of specialised asthma service provision. The objectives of this study were to explore Indonesian pharmacists' experiences, perspectives, and needs regarding the provision of pharmaceutical care for asthma patients in Indonesia. The study utilised conventional qualitative content analyses with two stages, i.e.: deductive analyses and inductive concept development. Data were collected using Focus Group Discussion (FGD) Method. FGDs were conducted using a topic guide and by facilitators trained in FGD conduct. FGDs were audio-recorded and transcribed verbatim prior to analysis. A maximum variation sampling methods targeted pharmacist across various settings of practice within Yogyakarta Indonesia. Nine focus groups with 103 pharmacist participants were conducted, with an average of 11 participants in each group. Inductively derived concepts that emerged included: willingness to adopt asthma service provision roles, pragmatism in recognising essential barriers/facilitators in adopting such roles, reflections regarding practice gaps and barriers to interprofessional collaboration mainly in relation to doctors. Inductive data analysis indicated clear differences in responses between hospital and non-hospital pharmacists. Key barriers to service provision included lack of training, lack of supportive professional frameworks, time and lack of reimbursement channels for services. Participants urged for a visionary leadership to facilitate pharmacists' role expansion into health services provision in Indonesia. Indonesian pharmacists were willing to adopt change and reported universally recognised barriers and facilitators to changing roles, especially in the provision of asthma care. Given this universality of pharmacists expressions, it may be suggested that the experience of researchers and academics who have expended time and effort in developing and implementing asthma care models in other countries should be, to some extent, transplanted to regions where pharmacy organisations are now considering adopting roles additional to medicines supply. Copyright © 2018 Elsevier Inc. All rights reserved.

Relationship between use of general practice and healthcare costs at the end of life: a data linkage study in New South Wales, Australia.

PubMed

Tran, Bich; Falster, Michael O; Girosi, Federico; Jorm, Louisa

2016-01-07

This analysis investigated the relationships between healthcare expenditures in the last 6 months of life and use of general practitioner (GP) services in the preceding 12-month period among older residents of New South Wales, Australia. Questionnaire data (2006-2009) for more than 260,000 people aged 45 years and over were linked to individual hospital and death records and cost data. For 14,819 participants who died during follow-up, generalised linear mixed models were used to explore the relationships between costs of hospital, emergency department (ED) and Medicare-funded outpatient and pharmaceutical services in the last 6 months of life, and quintile of GP use in the 18-7 months before death. Analyses were adjusted for age at death, sex, educational level, language, private health insurance, household income, self-reported health status, functional limitation, psychological distress, number of comorbidities and geographic clustering. Almost 85% of decedents had at least one hospitalisation in the last 6 months, and the mean (median) of total cost for each person in this period was $A20,453 (14,835). There was no significant difference in the hospital cost, including cost for preventable hospitalisations in the last 6 months of life, across quintiles of GP use in the 18-7 months before death. Participants in the lowest quintile of GP use incurred more ED costs, but ED costs were similar across the other quintiles of GP use. Costs for Medicare-funded outpatient services and pharmaceuticals increased steeply according to quintile of GP use. In the Australian setting, there was no association between use of GP services in the 18-7 months before death and hospital costs in the last 6 months, but there was significant association with higher costs for outpatient services and pharmaceuticals. However, there was some indication that limited GP access might be associated with increased ED use at end of life. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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.

Comparing pharmaceutical pricing and reimbursement policies in Croatia to the European Union Member States.

PubMed

Vogler, Sabine; Habl, Claudia; Bogut, Martina; Voncina, Luka

2011-04-15

To perform a comparative analysis of the pharmaceutical pricing and reimbursement systems in Croatia and the 27 European Union (EU) Member States. Knowledge about the pharmaceutical systems in Croatia and the 27 EU Member States was acquired by literature review and primary research with stakeholders. Pharmaceutical prices are controlled at all levels in Croatia, which is also the case in 21 EU Member States. Like many EU countries, Croatia also applies external price referencing, i.e., compares prices with other countries. While the wholesale remuneration by a statutorily regulated linear mark-up is applied in Croatia and in several EU countries, the pharmacy compensation for dispensing reimbursable medicines in the form of a flat rate service fee in Croatia is rare among EU countries, which usually apply a linear or regressive pharmacy mark-up scheme. Like in most EU countries, the Croatian Social Insurance reimburses specific medicines at 100%, whereas patients are charged co-payments for other reimbursable medicines. Criteria for reimbursement include the medicine's importance from the public health perspective, its therapeutic value, and relative effectiveness. In Croatia and in many EU Member States, reimbursement is based on a reference price system. The Croatian pharmaceutical system is similar to those in the EU Member States. Key policies, like external price referencing and reference price systems, which have increasingly been introduced in EU countries are also applied in Croatia and serve the same purpose: to ensure access to medicines while containing public pharmaceutical expenditure.

[Italian physician's needs for medical information. Retrospective analysis of the medical information service provided by Novartis Pharma to clinicians].

PubMed

Speroni, Elisabetta; Poggi, Susanna; Vinaccia, Vincenza

2013-10-01

The physician's need for medical information updates has been studied extensively in recent years but the point of view of the pharmaceutical industry on this need has rarely been considered. This paper reports the results of a retrospective analysis of the medical information service provided to Italian physicians by an important pharmaceutical company, Novartis Pharma, from 2004 to 2012. The results confirm clinicians' appreciation of a service that gives them access to tailored scientific documentation and the number of requests made to the network of medical representatives has been rising steadily, peaking whenever new drugs become available to physicians. The analysis confirms what -other international studies have ascertained, that most queries are about how to use the drugs and what their properties are. The results highlight some differences between different medical specialties: for example, proportionally, neurologists seem to be the most curious. This, as well as other interesting snippets, is worth further exploration. Despite its limits in terms of representativeness, what comes out of the study is the existence of an real unmet need for information by healthcare institutions and that the support offered by the pharmaceutical industry could be invaluable; its role could go well beyond that of a mere supplier to National Healthcare Systems, to that of being recognised as an active partner the process of ensuring balanced and evidence-based information. At the same time, closer appraisal of clinicians' needs could help the pharma industries to improve their communication and educational strategies in presenting their latest clinical research and their own products.

42 CFR 419.2 - Basis of payment.

Code of Federal Regulations, 2010 CFR

2010-10-01

...; (4) Anesthesia, certain drugs, biologicals, and other pharmaceuticals; medical and surgical supplies... dislocations; (5) Supplies and equipment for administering and monitoring anesthesia or sedation; (6... § 415.160. (5) The reasonable costs of anesthesia services furnished to hospital outpatients by...

42 CFR 419.2 - Basis of payment.

Code of Federal Regulations, 2011 CFR

2011-10-01

...; (4) Anesthesia, certain drugs, biologicals, and other pharmaceuticals; medical and surgical supplies... dislocations; (5) Supplies and equipment for administering and monitoring anesthesia or sedation; (6... § 415.160. (5) The reasonable costs of anesthesia services furnished to hospital outpatients by...

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

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.

Nurse prescribers' interactions with and perceptions of pharmaceutical sales representatives.

PubMed

Clauson, Kevin A; Khanfar, Nile M; Polen, Hyla H; Gibson, Florencetta

2009-01-01

The aim of our study was to investigate the perceptions of pharmaceutical sales representatives by nurse prescribers. Nurses with advanced training have earned prescriptive authority in North America, Europe and other parts of the world. These nurses are being increasingly targeted by pharmaceutical sales representatives. There is a paucity of data regarding nurses' perceptions of pharmaceutical sales representatives. Survey. A convenience sample of nurse prescribers was recruited to complete an Internet questionnaire about their interactions with and perceptions of sales representatives. The data were collected over one month ending in January 2007. There were 39 survey items ranging from perception-based items assessed by Likert-type scale to open-ended queries. Descriptive statistics were used to summarise the results. Ninety-two nurses completed this survey, which demonstrated good internal consistency yielding a Cronbach's alpha coefficient of 0.83. Positive perceptions of pharmaceutical representatives included: explaining their products clearly (80.4%) and knowledge about their medications (88.0%). Negative aspects included: lack of consideration of nurses' time (50%) and failure to equally discuss medication strengths and weaknesses (21.8%). Perhaps the most alarming finding was that 35.9% of respondents indicated that sales representatives suggested paybacks for promoting their drugs. Nurses with prescriptive authority generally perceive interactions with pharmaceutical sales representatives as positive. However, they also have concerns about the nature and methods of some of their activities. Nations that have nurses with prescribing authority can benefit from observing both the mis-steps and the positive inroads that have already been made by the profession in the USA and other countries. Appropriate use of pharmaceutical sales representatives' services may enhance the ability of nurse prescribers to deliver optimal nursing care. Methods, such as counter-detailing may be necessary to maintain an evidence-based approach as the controlling factor.

Sex, gender, and pharmaceutical politics: From drug development to marketing.

PubMed

Fisher, Jill A; Ronald, Lorna M

2010-08-01

Biological sex differences and sociocultural gender norms affect the provision of health care products and services, but there has been little explicit analysis of the impact of sex differences and gender norms on the regulation of pharmaceutical development and marketing. This article provides an overview of the regulation of pharmaceuticals and examines the ways that regulatory agencies account for sex and gender in their review of scientific data and marketing materials. The primary focus is on the US context, but information is also included about regulatory models in Europe, Canada, and Japan for comparative purposes. Specific examples show how sex differences and gender norms influence scientific and policy decisions about pharmaceuticals. The United States and Canada were found to be the only countries that have explicit requirements to include women in clinical trials and to perform sex-based subgroup analysis on study results. The potential influence of politics on regulatory decisions may have led to an uneven application of standards, as seen through the examples of mifepristone (for abortion) and sildenafil citrate (for erectile dysfunction). Three detailed case studies illustrate the importance of considering sex and gender in pharmaceutical development and marketing: Phase I clinical trials; human papillomavirus quadrivalent vaccine; and tegaserod, a drug for irritable bowel syndrome. Sex and gender play important roles in pharmaceutical regulation, from the design of clinical trials and the approval of new drugs to advertising and postmarketing surveillance. However, regulatory agencies pay insufficient attention to both biological sex differences and sociocultural gender norms. This disregard perpetuates inequalities by ignoring drug safety problems that predominate in women and by allowing misleading drug marketing that reinforces gender stereotypes. Recommendations have been made to improve the regulation of pharmaceuticals in regard to sex and gender. Copyright © 2010 Excerpta Medica Inc. All rights reserved.

Growth of the Asian health-care market: global implications for the pharmaceutical industry.

PubMed

Epstein, Richard J

2007-10-01

The global economy is being transformed by an explosion of information unleashed by the internet, the digital revolution, communications and increased international mobility. This transformation is manifesting in many ways, including rapid development of countries such as China, commoditization of public services, mobilization of workforces, shifting of market control from suppliers to consumers, interlinked rises in product demand and customer expectations, and problems regulating international business competition. As Asia is home to half of the world's population, and offers both a large relatively low-cost workforce in some countries and a potentially huge retail market, this region could be central to the future of the global economy. Like other industries, the pharmaceutical industry faces a new array of Asia-specific opportunities and challenges. Success in meeting these challenges will go to those pharmaceutical companies that best understand the unique strengths and constraints of Asia's diverse cultures, talents and markets.

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

Patient-centered care as value-added service by compounding pharmacists.

PubMed

McPherson, Timothy B; Fontane, Patrick E; Day, Jonathan R

2013-01-01

The term "value-added" is widely used to describe business and professional services that complement a product or service or that differentiate it from competing products and services. The objective of this study was to determine compounding pharmacists' self-perceptions of the value-added services they provide. A web-based survey method was used. Respondents' perceptions of their most important value-added service frequently fell into one of two categories: (1) enhanced pharmacist contribution to developing and implementing patient therapeutic plans and (2) providing customized medications of high pharmaceutical quality. The results were consistent with a hybrid community clinical practice model for compounding pharmacists wherein personalization of the professional relationship is the value-added characteristic.

The Search for Quality by Management in Service-Related Industry Today

DTIC Science & Technology

1988-09-05

service delivery. Rossy, Gerard L. ’The Executive’s Role in Ethics: The View from Business and Industry.* Healthcare Executive 2 (September/October...to study and compare: h-spitality, pharmaceutical, and healthcare . The hospitality industry was identified due to the dependence upon the consumer. If...only regulatory requirements, but a social obligation. The healthcare industry was chosen due to the need for quality, the increased competition, and

Costs of paying higher prices for equivalent effects on the Pharmaceutical Benefits Scheme.

PubMed

Karnon, Jonathan; Edney, Laura; Sorich, Michael

2017-03-01

Objective The aims of the present study were to illustrate and discuss the effects of the non-maintenance of equivalent prices when the comparators of pharmaceuticals listed on the Pharmaceutical Benefits Schedule (PBS) on a cost-minimisation basis come off-patent and are subject to statutory price reductions, as well as further potential price reductions because of the effects of price disclosure. Methods Service use, benefits paid, and price data were analysed for a selected sample of pharmaceuticals recommended for listing on a cost-minimisation basis between 2008 and 2011, and their comparators, to estimate the cost savings to the PBS of maintaining equivalent prices. Results Potential cost savings for 12 pharmaceuticals, including alternative compounds and combination products across nine therapeutic groups, ranged from A$570000 to A$40million to April 2015. Potential savings increased significantly following recent amendments to the price disclosure process. Conclusions Potential savings from maintaining equivalent prices for all pharmaceuticals listed on the PBS on a cost-minimisation basis could be over A$500million per year. Actions to reduce these costs can be taken within existing policy frameworks, but legislative and political barriers may need to be addressed to minimise these costs, which are incurred by the taxpayer for no additional benefit. What is known about the topic? Pharmaceuticals listed on the PBS must provide value for money. Many pharmaceuticals achieve this by demonstrating equal effectiveness to an already listed pharmaceutical and requesting the same price as this comparator; that is, listing on a cost-minimisation basis. When the comparator moves off-patent, the price of the still-patented pharmaceutical is protected, whereas the off-patent drug is subject to price disclosure and often steep price reductions. What does this paper add? This paper adds to recent evidence on the costs to government of paying different prices for two or more pharmaceuticals that are equally effective. Between 2008 and 2011, the direct comparators for 68 pharmaceuticals listed on a cost-minimisation basis have moved onto the price disclosure list. Across 12 of these listings, the potential cost savings in the 10 months to April 2015 were A$73million. What are the implications for practitioners? The PBS costs the Australian government over A$9 billion per year. Annual savings over A$500million per year could be achieved by maintaining cost-minimisation across equally effective pharmaceuticals. This would improve the efficiency of the PBS at no risk to patients. Legislation is required to remove the existing F1 and F2 categorisation of listed pharmaceuticals, but the proposed changes would remove the need for therapeutic group premiums and simplify the pricing of PBS items.

"Lookalike" Drugs. Specialized Information Service.

ERIC Educational Resources Information Center

Do It Now Foundation, Phoenix, AZ.

The document presents a collection of articles about "lookalike drugs." Article 1 presents readers with a look at "peashooters" (lookalike drugs which are usually replicas of pharmaceutical amphetamines, but increasingly used to describe simulations of cocaine and prescription downers). Lookalikes, although usually legal, are…

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.

Costs of Public Pharmaceutical Services in Rio de Janeiro Compared to Farmácia Popular Program

PubMed Central

da Silva, Rondineli Mendes; Caetano, Rosângela

2016-01-01

ABSTRACT OBJECTIVE To analyze the costs of public pharmaceutical services compared to Farmácia Popular Program (Popular Pharmacy Program). METHODS Comparison between prices paid by Aqui Tem Farmácia Popular Program (Farmácia Popular is available here) with the full costs of medicine provision by the Municipal Health Department of Rio de Janeiro. The comparison comprised 25 medicines supplied by both the municipal pharmaceutical service and Aqui Tem Farmácia Popular Program. Calculating the cost per pharmaceutical unit of each medicine included expenditure by Municipal Health Department of Rio de Janeiro with procurement (price), logistics, and local dispensation. The reference price of medicines paid by Aqui Tem Farmácia Popular was taken from the Brazilian Ministry of Health standard in force in 2012. Comparisons included full reference price; reference price minus 10.0% copayment by users; and maximum reference paid by the Ministry of Health (minus copayment and taxes). Simulations were carried out of the differences between the costs of Municipal Health Department of Rio de Janeiro with the common medicines and those potentially incurred based on the reference price of Aqui Tem Farmácia Popular. RESULTS The Municipal Health Department of Rio de Janeiro spent R$28,526,526.57 with 25 medicines of the common list in 2012; 58.7% accounted for direct procurement costs. The estimated costs of the Health Department were generally lower than the reference prices of the Aqui Tem Farmácia Popular Program for 20 medicines, regardless of reference prices. The potential costs incurred by Health Department if expenditure of its consumption pattern were based on the reference prices of Aqui Tem Farmácia Popular would be R$124,170,777.76, considering the best scenario of payment by the Brazilian Ministry of Health (90.0% of the reference price, minus taxes). CONCLUSIONS The difference in costs between public provision by Municipal Health Department of Rio de Janeiro and Farmácia Popular Program indicates that some reference prices could be reviewed aiming at their reduction. PMID:28099664

Pharmaceutical care in Brazil’s primary health care

PubMed Central

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

2017-01-01

ABSTRACT OBJECTIVE To characterize the activities of clinical nature developed by pharmacists in basic health units and their participation in educational activities aiming at health promotion. METHODS This article 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), a cross-sectional and exploratory study, of evaluative nature, consisting of a survey of information in a representative sample of cities, stratified by the Brazilian regions that constitute domains of study, and a subsample of primary health care services. The interviewed pharmacists (n=285) were responsible for the delivery of medicines and were interviewed in person with the use of a script. The characterization of the activities of clinical nature was based on information from pharmacists who declared to perform them, and on participation in educational activities aiming at health promotion, according to information from all pharmacists. The results are presented in frequency and their 95% confidence intervals. RESULTS From the interviewed subjects, 21.3% said they perform activities of clinical nature. Of these, more than 80% considered them very important; the majority does not dispose of specific places to perform them, which hinders privacy and confidentiality in these activities. The main denominations were “pharmaceutical guidance” and “pharmaceutical care.” The registration of activities is mainly made in the users’ medical records, computerized system, and in a specific document filed at the pharmacy, impairing the circulation of information among professionals. Most pharmacists performed these activities mainly along with physicians and nurses; 24.7% rarely participated in meetings with the health team, and 19.7% have never participated. CONCLUSIONS Activities of clinical nature performed by pharmacists in Brazil are still incipient. The difficulties found point out to the professionals’ improvisation and effort. The small participation in educational activities of health promotion indicates little integration of pharmacists with the health team and of pharmaceutical services with other health actions. PMID:29160454

Caveat oncologist: clinical findings and consequences of distributing counterfeit erythropoietin in the United States.

PubMed

Qureshi, Zaina P; Norris, Leann; Sartor, Oliver; McKoy, June M; Armstrong, John; Raisch, Dennis W; Garg, Vishvas; Stafkey-Mailey, Dana; Bennett, Charles Lee

2012-03-01

Counterfeit pharmaceuticals pose risks domestically. Because of their cost, cancer pharmaceuticals are vulnerable. We review findings from a domestic counterfeiting episode involving erythropoietin and outline anticounterfeiting recommendations for policy makers, patients, and health care professionals. Information was obtained on patients who received counterfeit erythropoietin, its distribution, and criminal investigations into counterfeiting networks. Interview sources included a physician, an attorney, employees of the Florida Department of Health and Human Services and the US Food and Drug Administration's (FDA) Office of Criminal Investigation, manufacturers, and wholesalers. Other sources included the book "Dangerous Doses," LexisNexis (search terms "counterfeit" and "erythropoietin") and the FDA database. Counterfeit product consisted of 2,000 U vials with counterfeit labels denoting 40,000 U. The counterfeiters, in collaboration with a Miami pharmacy, purchased 110,000 erythropoietin 2,000 U vials and affixed counterfeit labels to each vial. Products were then sold via the pharmaceutical "gray market" to wholesalers, then pharmacy chains. Investigations by Florida government officials implicated 17 persons, all of whom were found guilty of trafficking in counterfeit pharmaceuticals. Despite the large size of the operation, the FDA received reports of only 12 patients who had received counterfeit erythropoietin and detailed information for only two individuals. A 17-year-old liver transplant recipient and a 61-year-old patient with breast cancer experienced loss of efficacy after receiving counterfeit erythropoietin. Wider use of FDA anticounterfeit initiatives, limiting pharmaceutical suppliers to reputable distributors, and educating providers and patients about signs of counterfeit drugs can improve the safety of cancer pharmaceuticals.

Comparing pharmaceutical pricing and reimbursement policies in Croatia to the European Union Member States

PubMed Central

Vogler, Sabine; Habl, Claudia; Bogut, Martina; Vončina, Luka

2011-01-01

Aim To perform a comparative analysis of the pharmaceutical pricing and reimbursement systems in Croatia and the 27 European Union (EU) Member States. Methods Knowledge about the pharmaceutical systems in Croatia and the 27 EU Member States was acquired by literature review and primary research with stakeholders. Results Pharmaceutical prices are controlled at all levels in Croatia, which is also the case in 21 EU Member States. Like many EU countries, Croatia also applies external price referencing, ie, compares prices with other countries. While the wholesale remuneration by a statutorily regulated linear mark-up is applied in Croatia and in several EU countries, the pharmacy compensation for dispensing reimbursable medicines in the form of a flat rate service fee in Croatia is rare among EU countries, which usually apply a linear or regressive pharmacy mark-up scheme. Like in most EU countries, the Croatian Social Insurance reimburses specific medicines at 100%, whereas patients are charged co-payments for other reimbursable medicines. Criteria for reimbursement include the medicine’s importance from the public health perspective, its therapeutic value, and relative effectiveness. In Croatia and in many EU Member States, reimbursement is based on a reference price system. Conclusion The Croatian pharmaceutical system is similar to those in the EU Member States. Key policies, like external price referencing and reference price systems, which have increasingly been introduced in EU countries are also applied in Croatia and serve the same purpose: to ensure access to medicines while containing public pharmaceutical expenditure. PMID:21495202

The rational use of drugs and WHO.

PubMed

1985-01-01

On November 25-29, 1985, the World Health Organization held a Conference in Nairobi of Experts on the Rational Use of Drugs. In the early 1980s, both the International Federation of Pharmaceutical Manufacturers Association (IFPMA) and Health Action International (HAI) had developed codes of pharmaceutical marketing practices in order to come to terms with the malpractices in this field. A more comprehensive approach was needed, however. Prime responsibility for rational drug use must rest with the member governments, operating through national regulatory authorities and assisted in their work by guidelines on minimum requirements for national drug regulation prepared by WHO. The Dag Hammarskjold Foundation organized a seminar on Another Development in Pharmaceuticals as an independent contribution to the international debate on this global issue. The seminar emphasized that development should be need-oriented, self-reliant, and based on structural transformations. Governments view the pharmaceutical crisis as 1 facet of the more general problem of spiralling health costs which put an intolerable burden on already overstretched welfare services. The pharmaceutical industry sees the crisis largely in terms of excessively restrictive regulations which stifle innovation of products. Some doctors and pharmacists feel that increased regulatory measures will erode their rights to prescribe and to control the supply and information to patients. On the other hand, some clinical pharmacologists and administrators express concern about excessive, irrational and uneconomic prescribing and its effects on public health. Consumer groups define the problem in terms of an overbearing and greedy business community. The general public fail to understand the effects of pharmaceuticals.

Pharmaceutical consumption and cost in patients with dementia: A longitudinal study by the Registry of Dementias of Girona (ReDeGi) in Catalonia (Spain).

PubMed

Turró-Garriga, O; Calvó-Perxas, L; Albaladejo, R; Alsina, E; Cuy, J M; Llinàs-Reglà, J; Roig, A M; Serena, J; Vallmajó, N; Viñas, M; López-Pousa, S; Vilalta-Franch, J; Garre-Olmo, J

2015-01-01

Drug spending increases exponentially from the age of 65-70 years, and dementia is one of the diseases significantly contributing to this increase. Our aim was to describe pharmaceutical consumption and cost in patients with dementia, using the Anatomical Therapeutic Chemical (ATC) classification system. We also assessed the evolution of costs and consumption, and the variables associated to this evolution during three years. Three years prospective cohort study using data from the ReDeGi and the Health Region of Girona (HRG) Pharmacy Unit database from the Public Catalan Healthcare Service (PCHS). Frequency of consumption and costs of ATC categories of drugs were calculated. Sample of 869 patients with dementia, most of them with a diagnosis of degenerative dementia (72.6%), and in a mild stage of the disease (68.2%). Central nervous system (CNS) drugs had the highest consumption rate (97.2%), followed by metabolic system drugs (80.1%), and cardiovascular system drugs (75.4%). Total pharmaceutical cost was of 2124.8 € per patient/year (standard deviation (SD)=1018.5 €), and spending on CNS drugs was 55.5% of the total cost. After 36 months, pharmaceutical cost increased in 694.9 € (SD=1741.9), which was associated with dementia severity and institutionalization at baseline. Pharmaceutical consumption and costs are high in patients with dementia, and they increase with time, showing an association with baseline dementia severity and institutionalization. CNS drugs are the pharmaceuticals with highest prescription rates and associated costs. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

75 FR 18837 - Findings of Research Misconduct

Federal Register 2010, 2011, 2012, 2013, 2014

2010-04-13

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct... Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following... Boris Cheskis, Ph.D., former senior scientist, Discovery Research, Women's Health, Wyeth Pharmaceuticals...

21 CFR 26.76 - Confidentiality.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Confidentiality. 26.76 Section 26.76 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

Pharmacoeconomic Analysis in Saudi Arabia: An Overdue Agenda Item for Action

PubMed Central

Al-Jazairi, Abdulrazaq S.; Al-Qadheeb, Nada S.; Ajlan, Aziza

2011-01-01

Pharmacoeconomics is a branch of health economics related to the most economical and efficient use of pharmaceuticals. Pharmacoeconomic research identifies, measures and compares the costs and outcomes (clinical, economic and humanistic) of pharmaceutical products and services. Pharmacoeconomic evaluation can play a significant role in the efficient allocation of resources in healthcare systems with constrained budgets. Countries are trying to control the rising costs of health care in their aging population. They are all asking the same question: Is the new drug good value for money; and if so, what is the society willing to pay for it? This article reviews the importance of, and the need for, adaptation of pharmacoeconomic analysis to the conditions in Saudi Arabia. It will shed some light on the important steps for converting the concept into practice, including the need for identifying the willing-to-pay (WTP) or the threshold cutoff, the existence of a real cost for each utility, the nonexistence of an pharmacoeconomic advisory forum, pharmaceutical budget allocation, and the impact of pharmaceutical marketing. It will also provide recommendations for easing any challenges that might jeopardize the conduct of such analysis in Saudi Arabia. PMID:21808106

High-Cost Users of Prescription Drugs: A Population-Based Analysis from British Columbia, Canada.

PubMed

Weymann, Deirdre; Smolina, Kate; Gladstone, Emilie J; Morgan, Steven G

2017-04-01

To examine variation in pharmaceutical spending and patient characteristics across prescription drug user groups. British Columbia's population-based linked administrative health and sociodemographic databases (N = 3,460,763). We classified individuals into empirically derived prescription drug user groups based on pharmaceutical spending patterns outside hospitals from 2007 to 2011. We examined variation in patient characteristics, mortality, and health services usage and applied hierarchical clustering to determine patterns of concurrent drug use identifying high-cost patients. Approximately 1 in 20 British Columbians had persistently high prescription costs for 5 consecutive years, accounting for 42 percent of 2011 province-wide pharmaceutical spending. Less than 1 percent of the population experienced discrete episodes of high prescription costs; an additional 2.8 percent transitioned to or from high-cost episodes of unknown duration. Persistent high-cost users were more likely to concurrently use multiple chronic medications; episodic and transitory users spent more on specialized medicines, including outpatient cancer drugs. Cluster analyses revealed heterogeneity in concurrent medicine use within high-cost groups. Whether low, moderate, or high, costs of prescription drugs for most individuals are persistent over time. Policies controlling high-cost use should focus on reducing polypharmacy and encouraging price competition in drug classes used by ordinary and high-cost users alike. © 2016 The Authors. Health Services Research published by Wiley Periodicals, Inc. on behalf of Health Research and Educational Trust.

Use of a service evaluation and lean thinking transformation to redesign an NHS 111 refer to community Pharmacy for Emergency Repeat Medication Supply Service (PERMSS)

PubMed Central

Nazar, Hamde; Nazar, Zachariah; Simpson, Jill; Yeung, Andre; Whittlesea, Cate

2016-01-01

Objectives To demonstrate the contribution of community pharmacy from NHS 111 referrals out of hours (OOH) for emergency supply repeat medication requests via presentation of service activity, community pharmacist feedback and lean thinking transformation. Design Descriptive service evaluation using routine service activity data over the pilot period; survey of community pharmacists, and service redesign through lean thinking transformation. Setting North East of England NHS 111 provider and accredited community pharmacies across the North East of England. Participants Patients calling the North East of England NHS 111 provider during OOH with emergency repeat medication supply requests. Interventions NHS 111 referral to community pharmacies for assessment and if appropriate, supply of emergency repeat medication. Main outcome measures Number of emergency repeat medication supply referrals, completion rates, reasons for rejections, time of request, reason for access, medication(s), pharmaceutical advice and services provided. Secondary outcomes were community pharmacist feedback and lean thinking transformation of the patient pathway. Results NHS 111 referred 1468 patients to 114 community pharmacies (15/12/2014–7/4/2015). Most patients presented on Saturdays, with increased activity over national holidays. Community pharmacists completed 951 (64.8%) referrals providing 2297 medications; 412 were high risk. The most common reason for rejecting referrals was no medication in stock. Community pharmacists were positive about the provision of this service. The lean thinking transformation reduced the number of non-added value steps, waits and bottlenecks in the patient pathway. Conclusions NHS 111 can redirect callers OOH from urgent and emergency care services to community pharmacy for management of emergency repeat medication supply. Existing IT and community pharmacy regulations allowed patients to receive a medication supply and pharmaceutical advice. Community pharmacists supported integration into the NHS OOH services. Adopting lean thinking provided a structured framework to evaluate and redesign the service with the aim to improve effectiveness and efficiency. PMID:27566629

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false General requirements. 211.160 Section 211.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false General requirements. 211.160 Section 211.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.160 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false General requirements. 211.160 Section 211.160 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.160...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.25 - Personnel qualifications.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Personnel qualifications. 211.25 Section 211.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and Personnel § 211...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.65 - Equipment construction.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment construction. 211.65 Section 211.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.65 Equipment...

21 CFR 211.137 - Expiration dating.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Expiration dating. 211.137 Section 211.137 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.115 - Reprocessing.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Reprocessing. 211.115 Section 211.115 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls § 211.115...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 211.142 - Warehousing procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Warehousing procedures. 211.142 Section 211.142 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

21 CFR 211.125 - Labeling issuance.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Labeling issuance. 211.125 Section 211.125 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.44 - Lighting.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Lighting. 211.44 Section 211.44 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.44...

21 CFR 211.105 - Equipment identification.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment identification. 211.105 Section 211.105 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

21 CFR 211.68 - Automatic, mechanical, and electronic equipment.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS... satisfactorily, may be used in the manufacture, processing, packing, and holding of a drug product. If such... designed to assure proper performance. Written records of those calibration checks and inspections shall be...

21 CFR 26.13 - Transmission of postapproval inspection reports.

Code of Federal Regulations, 2010 CFR

2010-04-01

... SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Transmission of postapproval inspection reports...

21 CFR 211.3 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Definitions. 211.3 Section 211.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.3 Definitions...

21 CFR 211.167 - Special testing requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Special testing requirements. 211.167 Section 211.167 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls...

21 CFR 26.49 - Regulatory cooperation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory cooperation. 26.49 Section 26.49 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.21 - Safeguard clause.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Safeguard clause. 26.21 Section 26.21 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.18 - Regulatory collaboration.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.16 - Suspension.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Suspension. 26.16 Section 26.16 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.77 - Fees.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Fees. 26.77 Section 26.77 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.73 - Joint Committee.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Joint Committee. 26.73 Section 26.73 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.60 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Definitions. 26.60 Section 26.60 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.79 - Territorial application.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Territorial application. 26.79 Section 26.79 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.65 - Designating authorities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Designating authorities. 26.65 Section 26.65 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.3 - Scope.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Scope. 26.3 Section 26.3 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.34 - Regulatory authorities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Regulatory authorities. 26.34 Section 26.34 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.64 - Transitional arrangements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Transitional arrangements. 26.64 Section 26.64 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.48 - Harmonization.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Harmonization. 26.48 Section 26.48 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.62 - General obligations.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General obligations. 26.62 Section 26.62 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.0 - General.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General. 26.0 Section 26.0 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...

21 CFR 26.81 - Final provisions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Final provisions. 26.81 Section 26.81 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.18 - Regulatory collaboration.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Regulatory collaboration. 26.18 Section 26.18 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL... Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.18 Regulatory collaboration...

Clinical Pharmacokinetic Service and Research--Present Status and Future Goals at SUNY-Buffalo

ERIC Educational Resources Information Center

Koup, Jeffrey R.

1976-01-01

Two Clinical Pharmacokinetics Laboratories at Buffalo are described: one at the Millard Fillmore Hospital and the other at the Buffalo Children's Hospital. Their research efforts are reviewed and their scientific contributions to clinical therapeutics and pharmaceutical research are noted. (LBH)

21 CFR 211.176 - Penicillin contamination.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Penicillin contamination. 211.176 Section 211.176 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.176...

21 CFR 211.48 - Plumbing.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Plumbing. 211.48 Section 211.48 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.48...

21 CFR 211.80 - General requirements.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false General requirements. 211.80 Section 211.80 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.28 - Personnel responsibilities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Personnel responsibilities. 211.28 Section 211.28 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and Personnel § 211...

21 CFR 211.56 - Sanitation.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Sanitation. 211.56 Section 211.56 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.56...

A medical consultation service on Facebook: descriptive analysis of questions answered.

PubMed

Helve, Otto

2014-09-04

Social media is used increasingly by the general public to access health information. However, a lack of models for health information distribution limits the presence of publicly funded services on social media sites. The goal of the study was to present a model for delivering child health information to parents through a social media site. A Facebook site was launched for 11 months based on a question-and-answer service produced by a pediatrician and open to Facebook users over 18 years old. If the answer did not include a further referral to a health care service provider, the question was considered comprehensively answered. The site was funded by a pharmaceutical company, and it included an advertisement of a pharmaceutical product for children's fever and pain. During the study, 768 questions were submitted: an average of 69.8 (SD 31.7) per month. There were 245,533 independent Facebook users on the site, with an average of 727.0 (SD 2280.6) per day. Infections were the most common theme in questions (355/768, 46.2%). Questions were more likely to be comprehensively answered if they were related to infections (279/355, 78.6%) than questions related to non-infectious symptoms (265/423, 64.2%, P=.003). On this site aimed at parents of small children, personalized answers were an effective way of delivering information. The service is likely to have reduced the need for further contacts with a health care service provider in more than half of the cases. The site could serve as a model for publicly funded health information distribution.

The impact of the internet on community pharmacy practice: a comparison of a Delphi panel's forecast with emerging trends.

PubMed

Holmes, Erin R; Tipton, David J; Desselle, Shane P

2002-01-01

The purpose of this study was to forecast the impact of Internet pharmacy commerce on various stakeholders. A panel of experts assembled from a list of academicians in the social and administrative pharmaceutical sciences participated in a three-iteration Delphi procedure. Feedback from the aggregate responses of the panel was used to construct questionnaires employed in subsequent iterations of the Delphi. The panel converged to form a consensus upon a variety of issues. They forecasted the attainment of a 10-15% share in the market of prescription and over-the-counter pharmaceuticals through on-line purchases, the formation of strategic alliances among stakeholders in the drug distribution process, a shift in marketing strategies by brick-and-mortar stores, an increase in the prevalence of niching among pharmacy service providers and a subsequent growth in the implementation of cognitive services throughout the industry. With few exceptions, the forecast produced by the Delphi panel appears to be coming to fruition.

Comparison of patients' expectations and experiences at traditional pharmacies and pharmacies offering enhanced advanced pharmacy practice experiences.

PubMed

Kassam, Rosemin; Collins, John B; Berkowitz, Jonathan

2010-06-15

To compare patients' expectations and experiences at pharmacies offering traditional APPE learning opportunities with those offering enhanced APPEs that incorporate pharmaceutical care activities. A survey of anchored measures of patient satisfaction was conducted in 2 groups of APPE- affiliated community pharmacies: those participating in an enhanced APPE model versus those participating in the traditional model. The enhanced intervention included preceptor training, a comprehensive student orientation, and an extended experience at a single pharmacy rather than the traditional 2 x 4-week experience at different pharmacies. While patient expectations were similar in both traditional and enhanced APPE pharmacies, patients in enhanced pharmacies reported significantly higher in-store satisfaction and fewer service gaps. Additionally, satisfaction was significantly higher for patients who had received any form of consultation, from either pharmacist or students, than those reporting no consultations. Including provision of pharmaceutical care services as part of APPEs resulted in direct and measurable improvements in patient satisfaction.

Pharmaceutical Services in Primary Health Care: are pharmacists and users on the same page?

PubMed

Luz, Tatiana Chama Borges; Costa, Maria Emília Silva de Souza; Portes, Daniela Santana; Santos, Lucas Barbi Costa E; Sousa, Samuel Rodrigues Almeida E; Luiza, Vera Lucia

2017-08-01

This study investigated structural and organizational characteristics of the Pharmaceutical Services based on Primary Health Care (PHCPS) from the viewpoints of users and pharmacists. A mixed method design was applied, combining one-to-one semi-structured interviews with four pharmacists in charge of five public dispensing facilities and 69 users, with a secondary database analysis. Data were collected from February to August 2014 in Divinópolis, a municipality in Minas Gerais State. PHCPS were similar in terms of general activities performed and staff profile and background. While users were concerned about medicines' availability and improvements related to the PHCPS' conveniences and personnel, pharmacists pointed out problems regarding infrastructure to storage. Despite most users had low information on how to use their medicines, no pharmacists declared to participate in medicines dispensing activities. There was a low match between users and pharmacists viewpoints and advantages for concentrate medicines dispensing in a smaller number of facilities were not clear.

Customers' perceptions of and satisfaction with medicine retail outlet services in Addis Ababa, Ethiopia: a cross-sectional study.

PubMed

Gebregeorgise, Dawit T; Mohammed, Tofik A; Redi, Zebiba S; Sporrong, Sofia Kälvemark

2018-06-01

The aim of this study was to assess customers' perceptions of and satisfaction with MRO services in Addis Ababa and to explore factors associated with their satisfaction and reasons for visits. A cross-sectional survey was conducted among customers selected from 28 MROs in Addis Ababa, using multi-stage sampling techniques. Simple descriptive statistics and multivariable logistic regression at 95% confidence interval were used for the analysis. Of 396 respondents, 324 (81.8%) visited MROs to purchase prescription medicines. A majority (338/396; 85.4%) of them perceived that pharmacists and druggists (pharmacy professionals) play a major role in healthcare delivery. A third (140/396; 35.4%) of the respondents agreed with the statement that pharmacy professionals are more concerned about patient care than about their business. Regarding reasons for visiting, being married was positively associated with buying over-the-counter, higher educational status was linked with more satisfaction. Overall, 56.8% (225/396) of the respondents reported that they were satisfied with the service provided by MROs. Customers of MROs had mixed perceptions of and satisfaction with the current service. Marital status and age were associated with the reason for visiting, while the educational level was associated with the level of satisfaction. The overall positive perceptions and satisfaction about MROs should be taken as an opportunity to promote and improve pharmaceutical services rendered in MROs, to ensure that the public is receiving maximum benefit. © 2017 Royal Pharmaceutical Society.

Implementation of a comprehensive pharmaceutical care program for an underserved population.

PubMed

Mascardo, Lisa A; Spading, Kimberly A; Abramowitz, Paul W

2012-07-15

The implementation of a prescription benefit program for low-income patients emphasizing clinical pharmacist services and strict formulary control is described, with a review of program expenditures and cost avoidance. In 2006, University of Iowa Hospitals and Clinics (UIHC) launched a program to provide a limited prescription benefit to indigent patients under the IowaCare Medicaid demonstration waiver. Sudden dramatic growth in IowaCare enrollment, combined with sharp budget cuts, forced UIHC pharmacy leaders to implement creative cost-control strategies: (1) the establishment of an ambulatory care clinic staffed by a clinical pharmacy specialist, (2) increased reliance on an almost exclusively generic formulary, (3) collaboration with social services staff to help secure medication assistance for patients requiring brand-name drugs, (4) optimized purchasing through the federal 340B Drug Pricing Program, and (5) the imposition of medication copayments and mailing fees for prescription refills. Now in its seventh year, the UIHC pharmacy program has expanded indigent patients' access to pharmaceutical care services while reducing their use of hospital and emergency room services and lowering program medication costs by an estimated 50% (from $2.6 million in fiscal year 2009 to $1.3 million in fiscal year 2010). The UIHC ambulatory care pharmacy implemented a prescription program in collaboration with social service workers to address the medication needs of the state's low-income and uninsured patients in a fiscally responsible manner by managing purchasing contracts, revising a generic formulary, implementing copayments and mailing fees, and reviewing medication profiles.

Wireless access to a pharmaceutical database: a demonstrator for data driven Wireless Application Protocol (WAP) applications in medical information processing.

PubMed

Schacht Hansen, M; Dørup, J

2001-01-01

The Wireless Application Protocol technology implemented in newer mobile phones has built-in facilities for handling much of the information processing needed in clinical work. To test a practical approach we ported a relational database of the Danish pharmaceutical catalogue to Wireless Application Protocol using open source freeware at all steps. We used Apache 1.3 web software on a Linux server. Data containing the Danish pharmaceutical catalogue were imported from an ASCII file into a MySQL 3.22.32 database using a Practical Extraction and Report Language script for easy update of the database. Data were distributed in 35 interrelated tables. Each pharmaceutical brand name was given its own card with links to general information about the drug, active substances, contraindications etc. Access was available through 1) browsing therapeutic groups and 2) searching for a brand name. The database interface was programmed in the server-side scripting language PHP3. A free, open source Wireless Application Protocol gateway to a pharmaceutical catalogue was established to allow dial-in access independent of commercial Wireless Application Protocol service providers. The application was tested on the Nokia 7110 and Ericsson R320s cellular phones. We have demonstrated that Wireless Application Protocol-based access to a dynamic clinical database can be established using open source freeware. The project opens perspectives for a further integration of Wireless Application Protocol phone functions in clinical information processing: Global System for Mobile communication telephony for bilateral communication, asynchronous unilateral communication via e-mail and Short Message Service, built-in calculator, calendar, personal organizer, phone number catalogue and Dictaphone function via answering machine technology. An independent Wireless Application Protocol gateway may be placed within hospital firewalls, which may be an advantage with respect to security. However, if Wireless Application Protocol phones are to become effective tools for physicians, special attention must be paid to the limitations of the devices. Input tools of Wireless Application Protocol phones should be improved, for instance by increased use of speech control.

Wireless access to a pharmaceutical database: A demonstrator for data driven Wireless Application Protocol applications in medical information processing

PubMed Central

Hansen, Michael Schacht

2001-01-01

Background The Wireless Application Protocol technology implemented in newer mobile phones has built-in facilities for handling much of the information processing needed in clinical work. Objectives To test a practical approach we ported a relational database of the Danish pharmaceutical catalogue to Wireless Application Protocol using open source freeware at all steps. Methods We used Apache 1.3 web software on a Linux server. Data containing the Danish pharmaceutical catalogue were imported from an ASCII file into a MySQL 3.22.32 database using a Practical Extraction and Report Language script for easy update of the database. Data were distributed in 35 interrelated tables. Each pharmaceutical brand name was given its own card with links to general information about the drug, active substances, contraindications etc. Access was available through 1) browsing therapeutic groups and 2) searching for a brand name. The database interface was programmed in the server-side scripting language PHP3. Results A free, open source Wireless Application Protocol gateway to a pharmaceutical catalogue was established to allow dial-in access independent of commercial Wireless Application Protocol service providers. The application was tested on the Nokia 7110 and Ericsson R320s cellular phones. Conclusions We have demonstrated that Wireless Application Protocol-based access to a dynamic clinical database can be established using open source freeware. The project opens perspectives for a further integration of Wireless Application Protocol phone functions in clinical information processing: Global System for Mobile communication telephony for bilateral communication, asynchronous unilateral communication via e-mail and Short Message Service, built-in calculator, calendar, personal organizer, phone number catalogue and Dictaphone function via answering machine technology. An independent Wireless Application Protocol gateway may be placed within hospital firewalls, which may be an advantage with respect to security. However, if Wireless Application Protocol phones are to become effective tools for physicians, special attention must be paid to the limitations of the devices. Input tools of Wireless Application Protocol phones should be improved, for instance by increased use of speech control. PMID:11720946

Developing a Business Plan for Critical Care Pharmacy Services

PubMed Central

Erstad, Brian L.; Mann, Henry J.; Weber, Robert J.

2016-01-01

Critical care medicine has grown from a small group of physicians participating in patient care rounds in surgical and medical intensive care units (ICUs) to a highly technical, interdisciplinary team. Pharmacy's growth in the area of critical care is as exponential. Today's ICU requires a comprehensive pharmaceutical service that includes both operational and clinical services to meet patient medication needs. This article provides the elements for a business plan to justify critical care pharmacy services by describing the pertinent background and benefit of ICU pharmacy services, detailing a current assessment of ICU pharmacy services, listing the essential ICU pharmacy services, describing service metrics, and delineating an appropriate timeline for implementing an ICU pharmacy service. The structure and approach of this business plan can be applied to a variety of pharmacy services. By following the format and information listed in this article, the pharmacy director can move closer to developing patient-centered pharmacy services for ICU patients. PMID:27928193

Developing a Business Plan for Critical Care Pharmacy Services.

PubMed

Erstad, Brian L; Mann, Henry J; Weber, Robert J

2016-11-01

Critical care medicine has grown from a small group of physicians participating in patient care rounds in surgical and medical intensive care units (ICUs) to a highly technical, interdisciplinary team. Pharmacy's growth in the area of critical care is as exponential. Today's ICU requires a comprehensive pharmaceutical service that includes both operational and clinical services to meet patient medication needs. This article provides the elements for a business plan to justify critical care pharmacy services by describing the pertinent background and benefit of ICU pharmacy services, detailing a current assessment of ICU pharmacy services, listing the essential ICU pharmacy services, describing service metrics, and delineating an appropriate timeline for implementing an ICU pharmacy service. The structure and approach of this business plan can be applied to a variety of pharmacy services. By following the format and information listed in this article, the pharmacy director can move closer to developing patient-centered pharmacy services for ICU patients.

Human resource management in patient-centered pharmaceutical care.

PubMed

White, S J

1994-04-01

Patient-centered care may have the pharmacists and technicians reporting either directly or in a matrix to other than pharmacy administration. The pharmacy administrative people will need to be both effective leaders and managers utilizing excellent human resource management skills. Significant creativity and innovation will be needed for transition from departmental-based services to patient care team services. Changes in the traditional methods of recruiting, interviewing, hiring, training, developing, inspiring, evaluating, and disciplining are required in this new environment.

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

21 CFR 211.111 - Time limitations on production.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Time limitations on production. 211.111 Section 211.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.198 - Complaint files.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.198 - Complaint files.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

21 CFR 211.180 - General requirements.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false General requirements. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

21 CFR 211.198 - Complaint files.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.111 - Time limitations on production.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Time limitations on production. 211.111 Section 211.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...

21 CFR 211.180 - General requirements.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false General requirements. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

21 CFR 211.170 - Reserve samples.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Reserve samples. 211.170 Section 211.170 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory Controls § 211.170 Reserve...

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

21 CFR 211.180 - General requirements.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false General requirements. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.180 - General requirements.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false General requirements. 211.180 Section 211.180 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.180...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.134 - Drug product inspection.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product inspection. 211.134 Section 211.134 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and Labeling Control...

21 CFR 211.198 - Complaint files.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.194 - Laboratory records.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Laboratory records. 211.194 Section 211.194 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.194...

21 CFR 211.111 - Time limitations on production.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Time limitations on production. 211.111 Section 211.111 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...

21 CFR 211.103 - Calculation of yield.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Calculation of yield. 211.103 Section 211.103 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.198 - Complaint files.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Complaint files. 211.198 Section 211.198 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.198 Complaint...

21 CFR 211.165 - Testing and release for distribution.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Testing and release for distribution. 211.165 Section 211.165 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Laboratory...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 211.208 - Drug product salvaging.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Drug product salvaging. 211.208 Section 211.208 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

21 CFR 26.36 - Listing of CAB's.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Listing of CAB's. 26.36 Section 26.36 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.71 - Exchange of information.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Exchange of information. 26.71 Section 26.71 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.70 - Conformity assessment bodies.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Conformity assessment bodies. 26.70 Section 26.70 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.8 - Other transition activities.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Other transition activities. 26.8 Section 26.8 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.72 - Sectoral contact points.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Sectoral contact points. 26.72 Section 26.72 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 211.204 - Returned drug products.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Returned drug products. 211.204 Section 211.204 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Returned and Salvaged Drug...

Introduction to Validation of Analytical Methods: Potentiometric Determination of CO[subscript 2

ERIC Educational Resources Information Center

Hipólito-Nájera, A. Ricardo; Moya-Hernandez, M. Rosario; Gomez-Balderas, Rodolfo; Rojas-Hernandez, Alberto; Romero-Romo, Mario

2017-01-01

Validation of analytical methods is a fundamental subject for chemical analysts working in chemical industries. These methods are also relevant for pharmaceutical enterprises, biotechnology firms, analytical service laboratories, government departments, and regulatory agencies. Therefore, for undergraduate students enrolled in majors in the field…

Cooperation Between Schools of Pharmacy and Dentistry: A Survey of Educational Involvement

ERIC Educational Resources Information Center

Oksas, Richard M.

1978-01-01

To meet the needs of dental patients for pharmaceutical services, dental schools have upgraded their emphasis in teaching pharmacology and the professional associations have developed liaison between each other. This survey examines the nature and extent of pharmacy colleges' involvement with dentistry. (LBH)

21 CFR 211.113 - Control of microbiological contamination.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Control of microbiological contamination. 211.113 Section 211.113 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and...

21 CFR 211.42 - Design and construction features.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Design and construction features. 211.42 Section 211.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities...

Caveat Oncologist: Clinical Findings and Consequences of Distributing Counterfeit Erythropoietin in the United States

PubMed Central

Qureshi, Zaina P.; Norris, LeAnn; Sartor, Oliver; McKoy, June M.; Armstrong, John; Raisch, Dennis W.; Garg, Vishvas; Stafkey-Mailey, Dana; Bennett, Charles Lee

2012-01-01

Purpose: Counterfeit pharmaceuticals pose risks domestically. Because of their cost, cancer pharmaceuticals are vulnerable. We review findings from a domestic counterfeiting episode involving erythropoietin and outline anticounterfeiting recommendations for policy makers, patients, and health care professionals. Materials and Methods: Information was obtained on patients who received counterfeit erythropoietin, its distribution, and criminal investigations into counterfeiting networks. Interview sources included a physician, an attorney, employees of the Florida Department of Health and Human Services and the US Food and Drug Administration's (FDA) Office of Criminal Investigation, manufacturers, and wholesalers. Other sources included the book “Dangerous Doses,” LexisNexis (search terms “counterfeit” and “erythropoietin”) and the FDA database. Results: Counterfeit product consisted of 2,000 U vials with counterfeit labels denoting 40,000 U. The counterfeiters, in collaboration with a Miami pharmacy, purchased 110,000 erythropoietin 2,000 U vials and affixed counterfeit labels to each vial. Products were then sold via the pharmaceutical “gray market” to wholesalers, then pharmacy chains. Investigations by Florida government officials implicated 17 persons, all of whom were found guilty of trafficking in counterfeit pharmaceuticals. Despite the large size of the operation, the FDA received reports of only 12 patients who had received counterfeit erythropoietin and detailed information for only two individuals. A 17-year-old liver transplant recipient and a 61-year-old patient with breast cancer experienced loss of efficacy after receiving counterfeit erythropoietin. Conclusion: Wider use of FDA anticounterfeit initiatives, limiting pharmaceutical suppliers to reputable distributors, and educating providers and patients about signs of counterfeit drugs can improve the safety of cancer pharmaceuticals. PMID:23077434

Kitchen chemistry: A scoping review of the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions.

PubMed

Van Hout, Marie Claire

2014-01-01

Misuse of pharmaceuticals is of increasing drug policy and public health concern. A scoping review was conducted on the diversionary use of pharmaceuticals for non-medicinal use and home production of drug solutions. The research question was broad: What is known from the existing literature about the diversion of pharmaceuticals for non-medicinal use and for home production of drug solutions? The scoping process centred on the systematic selection, collection, and summarization of extant knowledge within this broad thematic remit. One hundred and thirty-four records were grouped into discrete thematic categories namely: non medicinal use and tampering with pharmaceuticals, oral misuse of codeine cough syrups, homemade drug solutions, and home-produced drug-related harms in the narrative review design. Forms of abuse of codeine cough syrup include mixtures with alcohol or soft drinks ('Purple Drank'), with kratom leaves ('Kratom cocktails'), or chemically altered to extract dextromorphan ('Lemon Drop'). Production of homemade opiates ('Cheornaya', 'Kolyosa', Himiya', 'Braun', 'Krokodil'), methamphetamine ('Vint', 'Pervitin'), methcathinone ('Jeff'), and cathinone ('Boltushka') are described. Displacement patterns between the non-medical use of pharmaceuticals, commercial, and homemade drugs appear dependent on availability of opiates, prescribing practices, supervision of substitution drug dosing, availability of cheap ingredients, policing, and awareness of harms. Adverse health and social consequences relate to the use of unknown and contaminated (end) substances, injecting practices, redosing, medical complications, and death. The review highlights a public health imperative requiring a multidisciplinary approach to quantify potential impact and required integrated policy responses incorporating international regulation, enforcement, health surveillance and service delivery. Copyright © 2014 John Wiley & Sons, Ltd.

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.

Direct‐to‐consumer advertising of pharmaceuticals: developed countries experiences and Turkey

PubMed Central

Semin, Semih; Aras, Şahbal; Guldal, Dilek

2006-01-01

Abstract While several major problems concerning drugs occur in the world, the attempts to direct‐to‐consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives’ work efficiency; drug reimbursement restrictions; and the escalating role of the Internet in the consumer market. Some of the main disadvantages of the DTCA are: increasing drug expenditures, unnecessary drug consumption and adverse effect risks. Even though the influence of pharmaceuticals on health services and the economy hold the same importance in the developed and developing countries, its negative consequences have increased by encompassing developing countries in its grip. Therefore, in this review, using Turkey as an example, the situation of direct‐to‐consumer advertisements in developing countries is analysed in relation with developed countries. PMID:17324191

Can a medical need clause help manage the growing costs of prescription drugs in the EU?

PubMed

Brooks, Eleanor; Geyer, Robert

2016-04-01

Innovation in the development of new drugs has to balance the needs of health actors and administrators, the pharmaceutical industry and patients. Differing perspectives on what constitutes an innovation, where research and development should be directed and how new drugs should be evaluated and priced cause ongoing tensions within the regulatory framework. In the current climate, where Europe's health systems face rising demand for health services and increasingly restricted resources, the efficiency of pharmaceutical regulation and drug development is under even greater scrutiny. How can regulation foster innovation and industry growth while also serving the public health needs of society, and what is the EU's role in pursuing this objective? Drawing on a provision which formerly existed in Norwegian pharmaceutical legislation, this article explores the potential of a medical need clause (MNC) in addressing these issues. In restricting market authorisations to those drugs that offer an added therapeutic value, might a MNC foster innovation and spending efficiency in Europe's health systems?

Drug policy and administration affecting quality of life of the poor in Thailand.

PubMed

Prutipinyo, Chardsumon; Sirichotiratana, Nithat

2011-09-01

This study aims to analyze drug policy and administration affecting quality of life of the poor in Thailand. Review of official reports and related documents, for the past 10 years (from 2000-2010). By imposing compulsory licensing, the Thai government maintains negotiating power over the price of pharmaceutical products with the patent holders of the original drugs. This gives an opportunity for relevant government agencies to produce or import patented drugs. At present, there are many problems and obstacles. The findings show that developing countries need to strengthen their negotiating power so that the pharmaceutical manufacturers cannot take advantage through mechanisms provided for such as compulsory licensing and provisions for flexibility in Trade-Related Intellectual Property Rights (TRIPS) agreement. Furthermore, these countries must support and empower the local pharmaceutical manufacturers to produce generic drugs. Developing countries should ensure that their populations have confidence in universal coverage service and medical systems regarding the quality of generic drugs.

Direct-to-consumer advertising of pharmaceuticals: developed countries experiences and Turkey.

PubMed

Semin, Semih; Aras, Sahbal; Guldal, Dilek

2007-03-01

While several major problems concerning drugs occur in the world, the attempts to direct-to-consumer advertising (DTCA) has gained a considerable impetus lately in both developed and developing countries. DTCA has increasingly become an appealing advertising alternative for the pharmaceutical industry as drug companies have come to wrestle with such problems as the expansion of the drug market; the decline of the medical representatives' work efficiency; drug reimbursement restrictions; and the escalating role of the Internet in the consumer market. Some of the main disadvantages of the DTCA are: increasing drug expenditures, unnecessary drug consumption and adverse effect risks. Even though the influence of pharmaceuticals on health services and the economy hold the same importance in the developed and developing countries, its negative consequences have increased by encompassing developing countries in its grip. Therefore, in this review, using Turkey as an example, the situation of direct-to-consumer advertisements in developing countries is analysed in relation with developed countries.

Factors associated with the diffusion rate of innovations: a pilot study from the perspective of the Brazilian Unified National Health System.

PubMed

Schneiders, Roberto Eduardo; Ronsoni, Ricardo de March; Sarti, Flávia Mori; Nita, Marcelo Eidi; Bastos, Ediane de Assis; Zimmermann, Ivan Ricardo; Ferreira, Fernando Fagundes

2016-10-10

Budget Impact Analyses require a set of essential information on health technology innovation, including expected rates of adoption. There is an absence of studies investigating trends, magnitude of budgetary effects and determinants of diffusion rates for health technology innovations worldwide during the last decades. The present study proposes a pilot assessment on main determinants influencing diffusion rates of pharmaceutical innovations within the Brazilian Unified National Health System (SUS). Data from the Brazilian Health Informatics Department (DATASUS) was gathered to establish the main determinants of diffusion rates of health technology innovations in Brazil, specifically referring to pharmaceutical innovations incorporated in the Brazilian Program for Specialized Pharmaceutical Services (CEAF) at SUS. Information was retrieved on DATASUS relating to patients who had used one of the medicines incorporated into CEAF at least three years prior to the beginning of the study (2015) for treatment of each health condition available. Thus, data from patients adopting 10 different medicines were analyzed in the study. Results from the zero-one inflated beta model showed a higher influence on diffusion rates of pharmaceutical innovations due to: number of pharmaceutical competitors for treatment of the same disease available at CEAF (negative); medicine used in combination with other medication (positive); and innovative medicine within the SUS (positive). Further research on diffusion rates of health technology innovations is required, including wider scope of diseases and medications, potential confusion factors and other variables that may influence rates of adoption in different health systems.

OntoGene web services for biomedical text mining.

PubMed

Rinaldi, Fabio; Clematide, Simon; Marques, Hernani; Ellendorff, Tilia; Romacker, Martin; Rodriguez-Esteban, Raul

2014-01-01

Text mining services are rapidly becoming a crucial component of various knowledge management pipelines, for example in the process of database curation, or for exploration and enrichment of biomedical data within the pharmaceutical industry. Traditional architectures, based on monolithic applications, do not offer sufficient flexibility for a wide range of use case scenarios, and therefore open architectures, as provided by web services, are attracting increased interest. We present an approach towards providing advanced text mining capabilities through web services, using a recently proposed standard for textual data interchange (BioC). The web services leverage a state-of-the-art platform for text mining (OntoGene) which has been tested in several community-organized evaluation challenges,with top ranked results in several of them.

OntoGene web services for biomedical text mining

PubMed Central

2014-01-01

Text mining services are rapidly becoming a crucial component of various knowledge management pipelines, for example in the process of database curation, or for exploration and enrichment of biomedical data within the pharmaceutical industry. Traditional architectures, based on monolithic applications, do not offer sufficient flexibility for a wide range of use case scenarios, and therefore open architectures, as provided by web services, are attracting increased interest. We present an approach towards providing advanced text mining capabilities through web services, using a recently proposed standard for textual data interchange (BioC). The web services leverage a state-of-the-art platform for text mining (OntoGene) which has been tested in several community-organized evaluation challenges, with top ranked results in several of them. PMID:25472638

Principles of economics crucial to pharmacy students' understanding of the prescription drug market.

PubMed

Rattinger, Gail B; Jain, Rahul; Ju, Jing; Mullins, C Daniel

2008-06-15

Many pharmacy schools have increased the amount of economics coursework to which pharmacy students are exposed in their prepharmacy and pharmacy curriculums. Students obtain competencies aimed at understanding the basic concepts of microeconomic theory, such as supply and demand. However, pharmacy students often have trouble applying these principles to real world pharmaceuticals or healthcare markets. Our objective is to make economics more relevant for pharmacy students. Specifically, we detail and provide pharmacy-relevant examples of the effects of monopoly power, barriers to marketplace entry, regulatory environment, third party insurance, information asymmetry and unanticipated changes in the marketplace on the supply and demand for pharmaceuticals and healthcare services.

Principles of Economics Crucial to Pharmacy Students' Understanding of the Prescription Drug Market

PubMed Central

Jain, Rahul; Ju, Jing; Mullins, C. Daniel

2008-01-01

Many pharmacy schools have increased the amount of economics coursework to which pharmacy students are exposed in their prepharmacy and pharmacy curriculums. Students obtain competencies aimed at understanding the basic concepts of microeconomic theory, such as supply and demand. However, pharmacy students often have trouble applying these principles to real world pharmaceuticals or healthcare markets. Our objective is to make economics more relevant for pharmacy students. Specifically, we detail and provide pharmacy-relevant examples of the effects of monopoly power, barriers to marketplace entry, regulatory environment, third party insurance, information asymmetry and unanticipated changes in the marketplace on the supply and demand for pharmaceuticals and healthcare services. PMID:18698403

Prices and availability of pharmaceuticals: evidence from nine countries.

PubMed

Danzon, Patricia M; Furukawa, Michael F

2003-01-01

This study compares average price levels for pharmaceuticals in eight countries--Canada, Chile, France, Germany, Italy, Japan, Mexico, and the United Kingdom--relative to the United States. Our most comprehensive indexes, adjusted for U.S. manufacturer discounts, show Japan's prices to be higher than U.S. prices, and other countries' prices ranging from 6 percent to 33 percent lower than U.S. prices. The decline of the Canadian dollar and rise of the U.K. pound contribute to the finding of lower Canadian prices and higher U.K. prices in 1999 than in 1992. Our findings suggest that U.S.-foreign price differentials are roughly in line with income and smaller for drugs than for other medical services.

The Politics of Access to Expensive Drugs: INESSS and the Innovative Pharmaceutical Industry

PubMed Central

Hughes, David

2012-01-01

The innovative pharmaceutical industry employs thousands of people in Quebec and so has the ability to exert strong political pressure; the public statements of Sanofi-Aventis concerning the provincial reimbursement of certain expensive drugs are an example. “Maintaining a dynamic biopharmaceutical industry” is one of four main axes of the drug policy of Quebec's ministry of health. However, this role of government should not take precedence over the efficient and equitable management of health resources. We defend the legitimate and responsible choice of the Institut national d'excellence en santé et en services sociaux du Québec (INESSS) to require an acceptable cost-effectiveness ratio from expensive new drugs. PMID:23634161

[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.

Quality information for quality use of medicines; 2nd International Conference, Kazan, 15-16 October 2010.

PubMed

Ziganshina, Lilia E; Menkes, David B; Herxheimer, Andrew

2011-01-01

Kazan hosted Russia's first international conference on medicines that was entirely independent of the pharmaceutical industry, attracting 414 participants from 9 countries and 20 regions of the Russian Federation. The meeting was greeted and endorsed by world leaders in pharmaceutical information, policy and regulation. Delegates discussed the professional and social problems arising from unethical drug promotion, including compromised evidence from clinical trials and consequent impairments in health service delivery. The Conference adopted a resolution prioritizing policy development and health system needs, notably including the development of clinical pharmacology. A website documents conference materials and provides an interface for future collaboration: http://evidenceupdate-tatarstan.ru/confer.

Pharmaceutical companies and their drugs on social media: a content analysis of drug information on popular social media sites.

PubMed

Tyrawski, Jennifer; DeAndrea, David C

2015-06-01

Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies' social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers who interacted with pharmaceutical companies through commenting (23.9%, 177/740). For the drug-specific analysis, we found that the majority of search results contained drug product claims (69.4%, 482/695); more claims mentioned only benefits (44.8%, 216/482) relative to only risks (27.2%, 131/482). Additionally, approximately 25% (150/603) of posts on Twitter and YouTube were presented as personal testimonials. A considerable percentage of content on Facebook contained advertisements for illegal online pharmacies (17%, 16/92). Pharmaceutical companies avoid making drug product claims on their social media accounts but frequently post content that is consistent with FDA definitions for help-seeking DTCA. Thousands of people often view content posted by pharmaceutical companies on social media; users also share company postings making both direct and indirect influence possible. Finally, people are likely to be exposed to drug product claims and information about illegal pharmacies when searching for information about popular pharmaceutical drugs on social media.

Pharmaceutical Companies and Their Drugs on Social Media: A Content Analysis of Drug Information on Popular Social Media Sites

PubMed Central

2015-01-01

Background Many concerns have been raised about pharmaceutical companies marketing their drugs directly to consumers on social media. This form of direct-to-consumer advertising (DTCA) can be interactive and, because it is largely unmonitored, the benefits of pharmaceutical treatment could easily be overemphasized compared to the risks. Additionally, nonexpert consumers can share their own drug product testimonials on social media and illegal online pharmacies can market their services on popular social media sites. There is great potential for the public to be exposed to misleading or dangerous information about pharmaceutical drugs on social media. Objective Our central aim was to examine how pharmaceutical companies use social media to interact with the general public and market their drugs. We also sought to analyze the nature of information that appears in search results for widely used pharmaceutical drugs in the United States on Facebook, Twitter, and YouTube with a particular emphasis on the presence of illegal pharmacies. Methods Content analyses were performed on (1) social media content on the Facebook, Twitter, and YouTube accounts of the top 15 pharmaceutical companies in the world and (2) the content that appears when searching on Facebook, Twitter, and YouTube for the top 20 pharmaceutical drugs purchased in the United States. Notably, for the company-specific analysis, we examined the presence of information similar to various forms of DTCA, the audience reach of company postings, and the quantity and quality of company-consumer interaction. For the drug-specific analysis, we documented the presence of illegal pharmacies, personal testimonials, and drug efficacy claims. Results From the company-specific analysis, we found information similar to help-seeking DTCA in 40.7% (301/740) of pharmaceutical companies’ social media posts. Drug product claims were present in only 1.6% (12/740) of posts. Overall, there was a substantial amount of consumers who interacted with pharmaceutical companies through commenting (23.9%, 177/740). For the drug-specific analysis, we found that the majority of search results contained drug product claims (69.4%, 482/695); more claims mentioned only benefits (44.8%, 216/482) relative to only risks (27.2%, 131/482). Additionally, approximately 25% (150/603) of posts on Twitter and YouTube were presented as personal testimonials. A considerable percentage of content on Facebook contained advertisements for illegal online pharmacies (17%, 16/92). Conclusions Pharmaceutical companies avoid making drug product claims on their social media accounts but frequently post content that is consistent with FDA definitions for help-seeking DTCA. Thousands of people often view content posted by pharmaceutical companies on social media; users also share company postings making both direct and indirect influence possible. Finally, people are likely to be exposed to drug product claims and information about illegal pharmacies when searching for information about popular pharmaceutical drugs on social media. PMID:26032738

21 CFR 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2011 CFR

2011-04-01

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21 CFR 211.1 - Scope.

Code of Federal Regulations, 2013 CFR

2013-04-01

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21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2010 CFR

2010-04-01

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21 CFR 211.1 - Scope.

Code of Federal Regulations, 2011 CFR

2011-04-01

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21 CFR 211.50 - Sewage and refuse.

Code of Federal Regulations, 2011 CFR

2011-04-01

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21 CFR 211.89 - Rejected components, drug product containers, and closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

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21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2012 CFR

2012-04-01

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21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2014 CFR

2014-04-01

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21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2014 CFR

2014-04-01

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21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2014 CFR

2014-04-01

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21 CFR 211.89 - Rejected components, drug product containers, and closures.

Code of Federal Regulations, 2012 CFR

2012-04-01

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21 CFR 211.89 - Rejected components, drug product containers, and closures.

Code of Federal Regulations, 2013 CFR

2013-04-01

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21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2010 CFR

2010-04-01

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21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Equipment cleaning and use log. 211.182 Section 211.182 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2012 CFR

2012-04-01

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21 CFR 211.89 - Rejected components, drug product containers, and closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

21 CFR 211.1 - Scope.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. (a) The regulations in...

21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

21 CFR 211.50 - Sewage and refuse.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Sewage and refuse. 211.50 Section 211.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.50 Sewage...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

21 CFR 211.1 - Scope.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Scope. 211.1 Section 211.1 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS General Provisions § 211.1 Scope. (a) The regulations in...

21 CFR 211.122 - Materials examination and usage criteria.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Materials examination and usage criteria. 211.122 Section 211.122 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Packaging and...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 211.22 - Responsibilities of quality control unit.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Responsibilities of quality control unit. 211.22 Section 211.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Organization and...

21 CFR 211.89 - Rejected components, drug product containers, and closures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Rejected components, drug product containers, and closures. 211.89 Section 211.89 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.50 - Sewage and refuse.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Sewage and refuse. 211.50 Section 211.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.50 Sewage...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

21 CFR 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Equipment cleaning and use log. 211.182 Section 211.182 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and...

21 CFR 211.50 - Sewage and refuse.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Sewage and refuse. 211.50 Section 211.50 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Buildings and Facilities § 211.50 Sewage...

21 CFR 211.101 - Charge-in of components.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Charge-in of components. 211.101 Section 211.101 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Production and Process Controls...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

21 CFR 211.182 - Equipment cleaning and use log.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Equipment cleaning and use log. 211.182 Section 211.182 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and...

21 CFR 211.192 - Production record review.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Production record review. 211.192 Section 211.192 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Records and Reports § 211.192...

Prescription Program Provides Significant Savings

ERIC Educational Resources Information Center

Rowan, James M.

2010-01-01

Most school districts today are looking for ways to save money without decreasing services to its staff. Retired pharmacist Tim Sylvester, a lifelong resident of Alpena Public Schools in Alpena, Michigan, presented the district with a pharmaceuticals plan that would save the district money without raising employee co-pays for prescriptions. The…

42 CFR 482.25 - Condition of participation: Pharmaceutical services.

Code of Federal Regulations, 2013 CFR

2013-10-01

... registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible... principles. (1) A full-time, part-time, or consulting pharmacist must be responsible for developing... under the supervision of a pharmacist and performed consistent with State and Federal laws. (2)(i) All...

42 CFR 482.25 - Condition of participation: Pharmaceutical services.

Code of Federal Regulations, 2014 CFR

2014-10-01

... registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible... principles. (1) A full-time, part-time, or consulting pharmacist must be responsible for developing... under the supervision of a pharmacist and performed consistent with State and Federal laws. (2)(i) All...

42 CFR 482.25 - Condition of participation: Pharmaceutical services.

Code of Federal Regulations, 2012 CFR

2012-10-01

... registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible... principles. (1) A full-time, part-time, or consulting pharmacist must be responsible for developing... under the supervision of a pharmacist and performed consistent with State and Federal laws. (2)(i) All...

42 CFR 482.25 - Condition of participation: Pharmaceutical services.

Code of Federal Regulations, 2010 CFR

2010-10-01

... registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible... principles. (1) A full-time, part-time, or consulting pharmacist must be responsible for developing... under the supervision of a pharmacist and performed consistent with State and Federal laws. (2)(i) All...

42 CFR 482.25 - Condition of participation: Pharmaceutical services.

Code of Federal Regulations, 2011 CFR

2011-10-01

... registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible... principles. (1) A full-time, part-time, or consulting pharmacist must be responsible for developing... under the supervision of a pharmacist and performed consistent with State and Federal laws. (2)(i) All...

78 FR 69441 - Wheatland Pharmacy; Decision and Order

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-19

... Order proposed the denial of Applicant's pending application for a DEA Certificate of Registration as a... adjudication in 1991 following Ms. Clark's guilty plea to a felony charge of Theft of Service in the District... the Pharmacy Buying Association (PBA), a pharmaceutical distributing company, that Applicant ordered 1...

21 CFR 26.5 - Length of transition period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Length of transition period. 26.5 Section 26.5 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.61 - Purpose of this part.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Purpose of this part. 26.61 Section 26.61 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.11 - Start of operational period.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Start of operational period. 26.11 Section 26.11 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 26.63 - General coverage of this part.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 1 2010-04-01 2010-04-01 false General coverage of this part. 26.63 Section 26.63 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 4 2014-04-01 2014-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 4 2012-04-01 2012-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 4 2013-04-01 2013-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.150 - Distribution procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Distribution procedures. 211.150 Section 211.150 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Holding and Distribution § 211.150 Distribution procedures. Written...

21 CFR 211.46 - Ventilation, air filtration, air heating and cooling.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Ventilation, air filtration, air heating and cooling. 211.46 Section 211.46 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS...

21 CFR 211.94 - Drug product containers and closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drug product containers and closures. 211.94 Section 211.94 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of...

76 FR 60052 - Agency Information Collection Activities; Submission for Office of Management and Budget Review...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-28

... Request; Current Good Manufacturing Practice Regulations for Finished Pharmaceuticals AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0362...

76 FR 14024 - Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-03-15

... appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals... implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...

21 CFR 211.67 - Equipment cleaning and maintenance.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Equipment cleaning and maintenance. 211.67 Section 211.67 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Equipment § 211.67...

21 CFR 26.4 - Product coverage.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Product coverage. 26.4 Section 26.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL MUTUAL RECOGNITION OF... Provisions for Pharmaceutical Good Manufacturing Practices § 26.4 Product coverage. (a) The provisions of...

76 FR 20690 - Preparation for International Conference on Harmonization Steering Committee and Expert Working...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-13

..., the European Free Trade Area and the World Health Organization. The ICH process has achieved... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002... Associations; the Japanese Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical Manufactures...

9 CFR 325.19 - Provisions inapplicable to specimens for laboratory examination, etc., or to naturally inedible...

Code of Federal Regulations, 2011 CFR

2011-01-01

... Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND... preparing pharmaceutical, organotherapeutic, or technical products and not used for human food, as described..., research, or other nonhuman food purposes, when authorized by the Administrator, and under conditions...

9 CFR 325.19 - Provisions inapplicable to specimens for laboratory examination, etc., or to naturally inedible...

Code of Federal Regulations, 2010 CFR

2010-01-01

... Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE AGENCY ORGANIZATION AND... preparing pharmaceutical, organotherapeutic, or technical products and not used for human food, as described..., research, or other nonhuman food purposes, when authorized by the Administrator, and under conditions...

Informational Environments: Organizational Contexts of Online Information Use.

ERIC Educational Resources Information Center

Lamb, Roberta; King, John Leslie; Kling, Rob

2003-01-01

Examines sustained use and non-use of online services within organizations using an open-systems view that overcomes limitations of traditional approaches that led to over-estimates of use. Focuses on the informational environments of firms in three industries: law, real estate, and biotech/pharmaceuticals; and discusses insights from an intranets…

Pharmaceutical policy reform in Canada: lessons from history.

PubMed

Boothe, Katherine

2018-07-01

Canada is the only country with a broad public health system that does not include universal, nationwide coverage for pharmaceuticals. This omission causes real hardship to those Canadians who are not well-served by the existing patchwork of limited provincial plans and private insurance. It also represents significant forgone benefits in terms of governments' ability to negotiate drug prices, make expensive new drugs available to patients on an equitable basis, and provide integrated health services regardless of therapy type or location. This paper examines Canada's historical failure to adopt universal pharmaceutical insurance on a national basis, with particular emphasis on the role of public and elite ideas about its supposed lack of affordability. This legacy provides novel lessons about the barriers to reform and potential methods for overcoming them. The paper argues that reform is most likely to be successful if it explicitly addresses entrenched ideas about pharmacare's affordability and its place in the health system. Reform is also more likely to achieve universal coverage if it is radical, addressing various components of an effective pharmaceutical program simultaneously. In this case, an incremental approach is likely to fail because it will not allow governments to contain costs and realize the social benefits that come along with a universal program, and because it means forgoing the current promising conditions for achieving real change.

Effects of a consumer driven health plan on pharmaceutical spending and utilization.

PubMed

Parente, Stephen T; Feldman, Roger; Chen, Song

2008-10-01

To compare pharmaceutical spending and utilization in a consumer driven health plan (CDHP) with a three-tier pharmacy benefit design, and to examine whether the CDHP creates incentives to reduce pharmaceutical spending and utilization for chronically ill patients, generic or brand name drugs, and mail-order drugs. Retrospective insurance claims analysis from a large employer that introduced a CDHP in 2001 in addition to a point of service (POS) plan and a preferred provider organization (PPO), both of which used a three-tier pharmacy benefit. Difference-in-differences regression models were estimated for drug spending and utilization. Control variables included the employee's income, age, and gender, number of covered lives per contract, election of flexible spending account, health status, concurrent health shock, cohort, and time trend. Results. CDHP pharmaceutical expenditures were lower than those in the POS cohort in 1 year without differences in the use of brand name drugs. We find limited evidence of less drug consumption by CDHP enrollees with chronic illnesses, and some evidence of less generic drug use and more mail-order drug use among CDHP members. The CDHP is cost-neutral or cost-saving to both the employer and the employee compared with three-tier benefits with no differences in brand name drug use. © Health Research and Educational Trust.

A Medical Consultation Service on Facebook: Descriptive Analysis of Questions Answered

PubMed Central

2014-01-01

Background Social media is used increasingly by the general public to access health information. However, a lack of models for health information distribution limits the presence of publicly funded services on social media sites. Objective The goal of the study was to present a model for delivering child health information to parents through a social media site. Methods A Facebook site was launched for 11 months based on a question-and-answer service produced by a pediatrician and open to Facebook users over 18 years old. If the answer did not include a further referral to a health care service provider, the question was considered comprehensively answered. The site was funded by a pharmaceutical company, and it included an advertisement of a pharmaceutical product for children’s fever and pain. Results During the study, 768 questions were submitted: an average of 69.8 (SD 31.7) per month. There were 245,533 independent Facebook users on the site, with an average of 727.0 (SD 2280.6) per day. Infections were the most common theme in questions (355/768, 46.2%). Questions were more likely to be comprehensively answered if they were related to infections (279/355, 78.6%) than questions related to non-infectious symptoms (265/423, 64.2%, P=.003). Conclusions On this site aimed at parents of small children, personalized answers were an effective way of delivering information. The service is likely to have reduced the need for further contacts with a health care service provider in more than half of the cases. The site could serve as a model for publicly funded health information distribution. PMID:25189182

Stretching the Boundaries: Tanzanian Pharmacy Workers’ Views and Experiences of Providing STI Services for Men Who Have Sex with Men

PubMed Central

Larsson, Markus; Odberg Pettersson, Karen; Kashiha, John; Ross, Michael W.; Agardh, Anette

2016-01-01

Objective To explore the views and experiences of providing assistance and treatment of sexually transmitted infections to same-sex practicing male clients among service providers at pharmacies and drugstores in Dar es Salaam, Tanzania. Previous research suggests that sexually transmitted infections are an increasing concern for this population. Due to stigma and discrimination, men who have sex with men face limited access to treatment, which might contribute to increased self-medication. However, limited research has been conducted on the role of the pharmaceutical service provider with regards to this population in sub-Saharan Africa. Method In January 2016, 16 service providers at private pharmacies and drugstores with previous experience of providing services to this population were purposively selected for open-ended face-to-face interviews. The analysis was guided by the grounded theory approach. Results The process that emerged was labelled “Stretching Boundaries for Pharmaceutical Responsibilities”. This reflected informants’ perceptions of themselves as being involved in a transition from having limited engagement in the care of same-sex practicing male clients to becoming regular service-providers to this group. Findings further revealed that the emotional commitment they developed for clients through this process led to a transgression of provider-client boundaries, which undermined objective decision-making when clients lacked prescription. Financial interests also emerged as an underlying motivation for providing incomplete or inaccurate drug dosages. Conclusions Further studies are required to better address incentives related to unregulated sale of drugs. Inter-professional networks between pharmacy and healthcare workers could support the development of targeted treatment for men who have sex with men and other key populations. PMID:27812206

Use of a service evaluation and lean thinking transformation to redesign an NHS 111 refer to community Pharmacy for Emergency Repeat Medication Supply Service (PERMSS).

PubMed

Nazar, Hamde; Nazar, Zachariah; Simpson, Jill; Yeung, Andre; Whittlesea, Cate

2016-08-26

To demonstrate the contribution of community pharmacy from NHS 111 referrals out of hours (OOH) for emergency supply repeat medication requests via presentation of service activity, community pharmacist feedback and lean thinking transformation. Descriptive service evaluation using routine service activity data over the pilot period; survey of community pharmacists, and service redesign through lean thinking transformation. North East of England NHS 111 provider and accredited community pharmacies across the North East of England. Patients calling the North East of England NHS 111 provider during OOH with emergency repeat medication supply requests. NHS 111 referral to community pharmacies for assessment and if appropriate, supply of emergency repeat medication. Number of emergency repeat medication supply referrals, completion rates, reasons for rejections, time of request, reason for access, medication(s), pharmaceutical advice and services provided. Secondary outcomes were community pharmacist feedback and lean thinking transformation of the patient pathway. NHS 111 referred 1468 patients to 114 community pharmacies (15/12/2014-7/4/2015). Most patients presented on Saturdays, with increased activity over national holidays. Community pharmacists completed 951 (64.8%) referrals providing 2297 medications; 412 were high risk. The most common reason for rejecting referrals was no medication in stock. Community pharmacists were positive about the provision of this service. The lean thinking transformation reduced the number of non-added value steps, waits and bottlenecks in the patient pathway. NHS 111 can redirect callers OOH from urgent and emergency care services to community pharmacy for management of emergency repeat medication supply. Existing IT and community pharmacy regulations allowed patients to receive a medication supply and pharmaceutical advice. Community pharmacists supported integration into the NHS OOH services. Adopting lean thinking provided a structured framework to evaluate and redesign the service with the aim to improve effectiveness and efficiency. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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.

Infrastructure of pharmacies of the primary health care in the Brazilian Unified Health System: Analysis of PNAUM - Services data.

PubMed

Leite, Silvana Nair; Manzini, Fernanda; Álvares, Juliana; Guerra, Augusto Afonso; Costa, Ediná Alves; Acurcio, Francisco de Assis; Guibu, Ione Aquemi; Costa, Karen Sarmento; Karnikowski, Margô Gomes de Oliveira; Soeiro, Orlando Mário; Farias, Mareni Rocha

2017-11-13

To characterize the infrastructure of the primary health care pharmacies of the Brazilian Unified Health System, aiming at humanizing the offered services. This is a cross-sectional study, of quantitative approach, from data obtained in the Pesquisa Nacional de 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). Information on 1,175 pharmacies/dispensing units were gathered from direct observation and assessment of dispensing units installations conducted by trained researchers who used a standardized form. The analyzed variables refer to the physical structure of pharmacies or medicine dispensing units of the health units under research. The pharmacy area was greater than 14 m2 in 40.3% of the sampled units, highlighting those from Midwest (56.9%) and Southeast (56.2%) regions and those of Northeast, with only 23.3%. About 80.2% units had waiting rooms with chairs for patients, 31.8% of them had dispensing areas inferior to 5m2, while in 46.2% these areas were superior to 10m2. Bars were found in service counters in 23.8% of health units, thus separating the patient from the professional; 44.1% had internet access. In most units, the area of medicine storage had no refrigerator or freezer for their exclusive storage and 13.7% had a specific room for pharmaceutical consultation. Aiming at achieving care humanization and improving working conditions for professionals, the structuring of the environment of pharmacy services is necessary. This would contribute to the better qualification of pharmacy services, comprising more than medicine delivery. Data on the Northeast region indicated less favorable conditions to the development of adequate dispensing services. Based on the panorama pointed out, we suggest the expansion of stimulus concerning the physical structure of pharmaceutical services, considering regional specificities.

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.

The effect of pre-existing health conditions on the cost of recovery from road traffic injury: insights from data linkage of medicare and compensable injury claims in Victoria, Australia.

PubMed

Hassani-Mahmooei, Behrooz; Berecki-Gisolf, Janneke; Hahn, Youjin; McClure, Roderick J

2016-04-29

Comorbidity is known to affect length of hospital stay and mortality after trauma but less is known about its impact on recovery beyond the immediate post-accident care period. The aim of this study was to investigate the role of pre-existing health conditions in the cost of recovery from road traffic injury using health service use records for 1 year before and after the injury. Individuals who claimed Transport Accident Commission (TAC) compensation for a non-catastrophic injury that occurred between 2010 and 2012 in Victoria, Australia and who provided consent for Pharmaceutical Benefits Scheme (PBS) and Medicare Benefits Schedule (MBS) linkage were included (n = 738) in the analysis. PBS and MBS records dating from 12 months prior to injury were provided by the Department of Human Services (Canberra, Australia). Pre-injury use of health service items and pharmaceuticals were considered to indicate pre-existing health condition. Bayesian Model Averaging techniques were used to identify the items that were most strongly correlated with recovery cost. Multivariate regression models were used to determine the impact of these items on the cost of injury recovery in terms of compensated ambulance, hospital, medical, and overall claim cost. Out of the 738 study participants, 688 used at least one medical item (total of 15,625 items) and 427 used at least one pharmaceutical item (total of 9846). The total health service cost of recovery was $10,115,714. The results show that while pre-existing conditions did not have any significant impact on the total cost of recovery, categorical costs were affected: e.g. on average, for every anaesthetic in the year before the accident, hospital cost of recovery increased by 24 % [95 % CI: 13, 36 %] and for each pathological test related to established diabetes, hospital cost increased by $10,407 [5466.78, 15346.28]. For medical costs, each anaesthetic led to $258 higher cost [174.16, 341.16] and every prescription of drugs used in diabetes increased the cost by 8 % [5, 11 %]. Services related to pre-existing conditions, mainly chronic and surgery-related, are likely to increase certain components of cost of recovery after road traffic trauma but pre-existing physical health has little impact on the overall recovery costs.

Factors affecting the implementation of clinical pharmacy services in China.

PubMed

Penm, Jonathan; Moles, Rebekah; Wang, Holly; Li, Yan; Chaar, Betty

2014-03-01

New policies in China have recently led to the implementation of clinical pharmacy services in hospitals. We explored the views of hospital administrators, pharmacy directors, clinical pharmacists, and dispensing pharmacists about the factors affecting clinical pharmacy services in China, using the framework approach and organizational theory. We conducted 30 interviews with 130 participants at 29 hospitals (both secondary and tertiary) in Beijing, Zhengzhou, Luoyang, and Shanghai. We found that the barriers to and facilitators of implementation of clinical pharmacy services slotted into the environment and participant dimensions of Scott's adapted version of Leavitt's organizational model. External support from government was perceived as crucial to promoting pharmacy services. It is proposed that the internationally recognized Basel Statements of the International Pharmaceutical Federation also provide a strong foundation for guiding China in implementing clinical pharmacy services.

Pharmacy in transition: A work sampling study of community pharmacists using smartphone technology.

PubMed

van de Pol, Jeroen M; Geljon, Jurjen G; Belitser, Svetlana V; Frederix, Geert W J; Hövels, Anke M; Bouvy, Marcel L

2018-03-09

The nature of community pharmacy is changing, shifting from the preparation and distribution of medicines to the provision of cognitive pharmaceutical services (CPS); however, often the provision of traditional services leaves little time for innovative services. This study investigated the time community pharmacists spend on the tasks and activities of daily practice and to what extent they are able to implement CPS-related services in daily practice. Self-reporting work sampling was used to register the activities of community pharmacists. A smartphone application, designed specifically for this purpose, alerted participants to register their current activity five times per working day for 6 weeks. Participants also completed an online survey about baseline characteristics. Ninety-one Dutch community pharmacists provided work-sampling data (7848 registered activities). Overall, 51.5% of their time was spent on professional activities, 35.4% on semi-professional activities, and 13.1% on non-professional activities. The proportion of time devoted to CPS decreased during the workweek, whereas the time spent on traditional task increased. This study shows it is feasible to collect work-sampling data using smartphone technology. Community pharmacists spent almost half of their time on semi-professional and non-professional activities, activities that could be delegated to other staff members. In practice, the transition to CPS is hampered by competing traditional tasks, which prevents community pharmacists from profiling themselves as pharmaceutical experts in daily practice. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

Code of Federal Regulations, 2013 CFR

2013-07-01

... are met and the promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of... promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of Pharmacy Services, or...-related supplies must be forwarded to the VISN Pharmacist Executive or VISN Formulary Committee. All...

Monetary Value of a Prescription Assistance Program Service in a Rural Family Medicine Clinic

ERIC Educational Resources Information Center

Whitley, Heather P.

2011-01-01

Purpose: To quantify the monetary value of medications provided to rural Alabamians through provision of pharmaceutical manufacturer-sponsored prescription assistance programs (PAPs) provided by a clinical pharmacist in a private Black Belt family medicine clinic during 2007 and 2008. Methods: Patients struggling to afford prescription medications…

38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

Code of Federal Regulations, 2014 CFR

2014-07-01

... are met and the promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of... promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of Pharmacy Services, or...-related supplies must be forwarded to the VISN Pharmacist Executive or VISN Formulary Committee. All...

38 CFR 1.220 - On-site activities by pharmaceutical company representatives at VA medical facilities.

Code of Federal Regulations, 2012 CFR

2012-07-01

... are met and the promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of... promotion is specifically permitted by the VISN Pharmacist Executive, or Chief of Pharmacy Services, or...-related supplies must be forwarded to the VISN Pharmacist Executive or VISN Formulary Committee. All...

An Integrated Model of Knowledge Acquisition and Innovation: Examining the Mediation Effects of Knowledge Integration and Knowledge Application

ERIC Educational Resources Information Center

Dahiyat, Samer E.

2015-01-01

The aim of this research is to empirically investigate the relationships among the three vital knowledge management processes of acquisition, integration and application, and their effects on organisational innovation in the pharmaceutical manufacturing industry in Jordan; a knowledge-intensive business service (KIBS) sector. Structural equation…

76 FR 75551 - Draft Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-02

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA... Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD...

78 FR 24754 - Guidance for Industry on Regulatory Classification of Pharmaceutical Co-Crystals; Availability

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-26

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0800... and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is... this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and...

21 CFR 26.12 - Nature of recognition of inspection reports.

Code of Federal Regulations, 2013 CFR

2013-04-01

... 21 Food and Drugs 1 2013-04-01 2013-04-01 false Nature of recognition of inspection reports. 26.12 Section 26.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.12 Nature of...

21 CFR 26.12 - Nature of recognition of inspection reports.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 1 2011-04-01 2011-04-01 false Nature of recognition of inspection reports. 26.12 Section 26.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.12 Nature of...

21 CFR 26.12 - Nature of recognition of inspection reports.

Code of Federal Regulations, 2014 CFR

2014-04-01

... 21 Food and Drugs 1 2014-04-01 2014-04-01 false Nature of recognition of inspection reports. 26.12 Section 26.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.12 Nature of...

21 CFR 26.12 - Nature of recognition of inspection reports.

Code of Federal Regulations, 2012 CFR

2012-04-01

... 21 Food and Drugs 1 2012-04-01 2012-04-01 false Nature of recognition of inspection reports. 26.12 Section 26.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL... COMMUNITY Specific Sector Provisions for Pharmaceutical Good Manufacturing Practices § 26.12 Nature of...

MalWebID-Autodetection and Identification of Malicious Web Hosts Through Live Traffic Analysis

DTIC Science & Technology

2013-03-01

blogs, video services, and popular social media sites. In December 2000, there were near 361 million Internet users and by the end of December 2012...site (i.e., Porn , Rx/Pharmaceutical, illegal activity, etc.) – propagate or contain viruses, spyware, or other harmful programs, participate in spamming

Information as An Important Production Factor.

ERIC Educational Resources Information Center

Ljungberg, Sixten

This paper focuses on the importance of information and documentation (I&D) as one of the essential production factors in pharmaceutical industrial activities. The need for and use of I&D services depends far more on such factors as product profile, decision making processes within the organization, and ownership than on the size of the…

Patients Perception of Community Pharmacist in Bosnia and Herzegovina

PubMed Central

Catic, Tarik; Jusufovic, Fatima Insanic; Tabakovic, Vedad

2013-01-01

Community pharmacists play a significant role in patient/disease management and perception by patients is increasingly important. A self-administered questionnaire was developed consisted of sociodemographic part and 15 questions. Patients have a positive overall perception of community pharmacists that is comparable to most studies in Europe. Community pharmacists’ beyond dispensing drugs play a significant role in patient and disease management. This role of the pharmacist is performed through pharmaceutical care. Patient’s opinion is increasingly considered to be a useful component in the determination of care outcomes and consumer satisfaction is an integral component of the quality of primary health care. For the purpose of this study we developed self-administered questionnaire consisted of sociodemographic part, and 15 questions. Survey has been conducted in 10 pharmacies. Results are presented in tables and figures and descriptive statistics has been used. We found that patients in Bosnia and Herzegovina have a positive overall perception of community pharmacists and of the services offered from community pharmacies that is comparable to most studies in Europe, but there is still room for improvement of relationships and pharmaceutical services. PMID:24167438

Pricing, profits and pharmacoeconomics--for whose benefit?

PubMed

Adams, J R; Ali, S; Bennett, C L

2001-03-01

In today's troubled healthcare climate, it is not uncommon to run across headlines like: 'Health insurance premiums increasing by 10 percent to 30 percent across the country.' This particular New York Times article went on to explain that this premium price hike, the third consecutive double digit increase in 3 years, is driven largely by escalating pharmaceutical costs. The pharmaceutical industry has largely been vilified in the media and in the recent presidential debates, for fueling healthcare inflation and setting what many perceive to be 'unfair' prices in light of the profit margins on their life-saving products. A report released by the Congressional Research Service found that after tax, profits for the pharmaceutical industry averaged 17% of sales, compared with 5% for all other industries. The White House has added its voice to the popular discontent with notices such as this one reported in the New York Times: 'There is a rising tide politically in this country of strong antagonism against the pharmaceutical industry on the dimension of prices. (Without expanded access to insurance) price controls are an inevitable outcome.' Although the prospect of price control remains dubious in America's entrenched laissez-faire economy, David Kessler, former head of the FDA and the Dean of the Yale School of Medicine, described the situation as a 'powder keg,' stating 'the current system is simply not sustainable'. Although there does not appear to be an immediate solution to this escalating crisis, this editorial will examine pharmaceutical pricing, industry profits and the role of pharmacoeconomic analyses amidst the chaos.

Prescription preferences in antipsychotics and attitude towards the pharmaceutical industry in Belgium.

PubMed

Cleymans, Stijn; Morrens, Manuel; Bervoets, Chris

2017-06-01

The number of antipsychotic prescriptions are increasing rapidly worldwide, a trend which is mainly driven by the steep rise in second-generation antipsychotic (SGA) prescriptions. However, the success of SGA, compared with the older first-generation antipsychotics (FGAs), cannot be explained by evidence. Several studies concluded on equal efficacy of FGA and SGA on positive, negative and cognitive symptoms of schizophrenia. Next to that, the influence of the pharmaceutical industry on prescription behaviour has drawn considerable interest. Therefore, the relationship between antipsychotic prescription patterns and exposure to information directly provided by pharmaceutical companies was studied. A cross-sectional online survey, addressing psychiatrists, general practitioners (GPs) and trainees in Flanders, was carried out. Respondents were questioned about their prescription behaviour, opinion about efficacy of SGA versus FGA and the nature and frequency of their contact with the pharmaceutical industry. Using Spearman's rank correlations and χ 2 tests, the relationship between different variables and group differences were examined. Psychiatrists, GPs and trainees in Flanders clearly favour olanzapine and risperidone, followed by quetiapine and aripiprazole above all other agents. This behaviour is supported by the conviction that SGAs have superior efficacy and a more benign side effect profile, compared with FGA. Frequent contact with drug representatives is correlated with a preference of SGA over FGA. 41% of the respondents acknowledge to be influenced by the pharmaceutical industry, which is more than that previously reported. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Pharmaceutical counseling: Between evidence-based medicine and profits.

PubMed

Egorova, S N; Akhmetova, T

2015-01-01

The number of pharmacies, which produce drug formulations locally, has recently considerably reduced in Russia. Pharmacies mainly operate as retailers of industrially manufactured drugs.Pharmaceutical consultation of customers at pharmacies aimed at responsible self-medication is the most popular and accessible feature of pharmaceutical care. In Russia there is a significant list of medicines approved for sale in pharmacies on a non-prescription basis that is specified in the product label. In this regard, the role of pharmacists in public health in Russia increases. Pharmacist, working directly with population, is an important figure for the rational use of medicines. This type of work requires high level of professional training and appropriate ethics. To explore the current status of pharmaceutical counseling in Russia. Situation analysis, surveys of pharmacists. Our experience in the system of postgraduate professional education, the results of the survey of pharmacists, and the long-term dialogue with pharmacists allowed us to identify several unresolved issues in the work of a pharmacist selling non-prescription drugs.Lack of differentiation in the functions of a pharmacist with a higher education and pharmaceutical technologist: In production/industrial pharmacy technicians are engaged in manufacturing of pharmaceutical formulations. However, due to the loss of production functions technologists had to move away from production laboratories of apothecaries to the sales area. Currently, the apothecary's assignment to receive prescriptions and dispense medications can be fulfilled by either a pharmacist or a pharmaceutical technician. It significantly discerns the pharmacy from the medical organization with clearly delineated functions of doctors and nurses. Russian regulations should consider the level of education required for high-quality pharmaceutical counseling.Contradiction between the pharmacist's special functions and trade procedure with the lack of pharmaceutical counseling standards: Article 1.1 "Code of Ethics of the pharmaceutical worker of Russia" states: "The main task of the professional activity of the pharmaceutical worker - protection of human health", Article 1.3 states that a pharmaceutical worker must take professional decisions solely in the interests of a patient [1]. However, the pharmacy is a trade organization, thus as a retailer the pharmacy is directly interested in making profits and increasing sales of pharmaceutical products, including non-prescription medicines. Moreover, while the clinical medicine is monitored for unjustified prescribing and measures are being taken to prevent polypharmacy, for a pharmacist the growing sales of over-the-counter drugs, active promotion of dietary supplements, homeopathic medicines, medical devices, and, consequently, an increase of financial indicators (particularly "average purchase size") - all are characteristics of success [2].Rational use of over-the-counter medicines requires introduction of pharmaceutical counseling standards (pharmaceutical care) according to symptoms - major reasons to visit a pharmacy as part of responsible self-medication (cold, sore throat, headache, diarrhea, etc.). Standards of pharmaceutical counseling should be objective, reliable and up-to-date and contain recommendations for the rational use of over-the-counter drugs as well as indications requiring treatment to the doctor. Standardization of pharmaceutical counseling in terms of Evidence-based Pharmacy would enhance the efficiency, safety and cost-effectiveness of over-the-counter medicines.Currently, the lack of clinical component in the higher pharmaceutical education and the lack of approved standards of pharmaceutical counseling lead to the introduction of cross-selling technologies (which are broadly applied in other areas of trade, for example, the offer of a boot-polish during the sale of shoes) to the pharmaceutical practice [2, 3]. However, drugs belong to a special group of products, proper selection of which requires special education, and the consumer is not always able to evaluate the quality of the recommendations. Marketing cross-selling recommendations are aimed at promotion of the over-the-counter medicines for customers buying prescription drugs. For example, business coaches recommend the pharmacists to make additional offers: with the purchase of physician-prescribed antibiotics - offer of vitamins, with prescribed nonsteroidal anti-inflammatory drugs - commercially available ointment with non-steroidal topical formulation ("to enhance the effect") and others. These recommendations do not agree with evidence-based medicine and lead to inefficient use of over-the-counter drugs and unjustified financial expenses. Thus, to ensure the rational use of medicines permitted for free (non-prescription) dispensing at the pharmacies, pharmaceutical information needs standardization on the basis of evidence-based medicine as well as standardization of the pharmaceutical counseling service. The development of practical recommendations on the rational use of over-the counter medicines by doctors and pharmacists with further adoption at the state level, the recommendation of most secure, efficient and cost-effective over-the-counter medications during pharmaceutical counseling in pharmacies will contribute to the restoration and preservation of public health.

How can a policy foster local pharmaceutical production and still protect public health? Lessons from the health-industry complex in Brazil.

PubMed

da Fonseca, Elize Massard

2018-04-01

The global health community is increasingly advocating for the local production of pharmaceuticals in developing countries as a way to promote technology transfer, capacity building and improve access to medicines. However, efforts to advance drug manufacturing in these countries revive an old dilemma of fostering technological development versus granting access to social services, such as healthcare. This paper explores the case of Brazil, a country that has developed large-scale health-inspired industrial policies, but is, yet, little understood. Brazil's experience suggests that progressive healthcare bureaucrats can create innovative practices for technology and knowledge transfers. It also demonstrates that highly competitive pharmaceutical firms can collaborate with each other, if a government provides them the right incentives. Reforming regulatory policies is crucial for guaranteeing high-quality products in developing countries, but governments must play a crucial role in supporting local firms to adapt to these regulations. These findings send a strong message to global health policymakers and practitioners on the conditions to create a suitable environment for local production of medical products.

[Medication-related oculogyric crises: a description of four cases and a review of the literature].

PubMed

Darling, A; Poo, P; Perez-Duenas, B; Campistol, J

2013-02-01

Oculogyric crises are considered to be a form of focal dystonia and can be observed as reactions to pharmaceuticals. The signs and symptoms may be confused with epileptic crises. To describe the clinical features and progress of patients with pharmaceutical-related oculogyric crises and to carry out a review of the topic. We conducted a retrospective, descriptive study of four patients evaluated in the neurology service due to oculogyric crises. The patients had been diagnosed with an associated conduct disorder requiring treatment with antipsychotic drugs. The episodes of oculogyric crises did not correlate with the findings in the electroencephalogram. They responded well to the reduction in dosage or to withdrawal of the apparent causing agent. The clinical picture does not present only in patients treated with antipsychotics but is also linked with other pharmaceuticals that are frequently used in daily paediatric practice. When oculogyric crises are the reason for visiting, differential diagnoses must be taken into account in order to avoid unnecessary studies and to carry out an appropriate therapeutic management.

Free Medicines Thanks to Retirement: Impact of Coinsurance Exemption on Pharmaceutical Expenditures and Hospitalization Offsets in a national health service.

PubMed

Puig-Junoy, Jaume; García-Gómez, Pilar; Casado-Marín, David

2016-06-01

This paper examines the impact of coinsurance exemption for prescription medicines applied to elderly individuals in Spain after retirement. We use a rich administrative dataset that links pharmaceutical consumption and hospital discharge records for the full population aged 58 to 65 years in January 2004 covered by the public insurer in a Spanish region, and we follow them until December 2006. We use a difference-in-differences strategy and exploit the eligibility age for Social Security to control for the endogeneity of the retirement decision. Our results show that this uniform exemption increases the consumption of prescription medicines on average by 17.5%, total pharmaceutical expenditure by 25% and the costs borne by the insurer by 60.4%, without evidence of any offset effect in the form of lower short term probability of hospitalization. The impact is concentrated among consumers of medicines for acute and other non-chronic diseases whose previous coinsurance rate was 30% to 40%. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

[The pharmaceutical industry and the sustainability of healthcare systems in developed countries and in Latin America].

PubMed

Iñesta, Antonio; Oteo, Luis Angel

2011-06-01

The global economic crisis and its impact on public finances in most developed countries are giving rise to cost-containment policies in healthcare systems. Prevailing legislation on medication requires the safety, quality, and efficacy of these products. A few countries include efficiency criteria, primarily for new medication that they wish to include in public financing. The appropriate use of generic and "biosimilar medication" is very important for maintaining the financial equilibrium of the Health Services. The problem in Latin America is that not all multisource products are bioequivalent and not all countries have the resources to conduct bioequivalence studies in vivo. The European Medicines Agency in 2005 adopted guidelines on "biosimilar medicines" and thirteen of them were subsequently approved for general release. Benchmarking of this model by other countries would be important. The influence of the pharmaceutical industry on political and administrative areas is enormous and control is necessary. The pharmaceutical companies claim that they act with corporate social responsibility, therefore, they must ensure this responsibility toward society.

Industry's efforts: devices and pharmaceuticals.

PubMed

Sanders, C A

1995-11-01

The pharmaceutical industry has been irreversibly affected by the changes occurring in healthcare. Despite the obvious contributions of pharmaceuticals to human health, our customers are demanding that we help the patient and contribute to value, whether it be in terms of cost, clinical outcomes, or quality of life. We are learning to balance the variables to ensure that cost plus quality equals value in the marketplace in three ways: by focusing on the needs of the customers and demonstrating value through outcomes research, by maintaining an emphasis on innovation, and by taking an active role in the public arena to direct the course of our future. Outcomes research proves the value of what we do. Economic data will have to be correlated with clinical data. In addition to standard clinical and economic parameters, we must also provide quality of life data. Collaboration between the academic and the practicing community produces a win-win situation for both parties. Industry and practitioners are bonded together ineluctably in the service of the patient. Working together we can shape our future and the future of our patients.

[The role of biotechnology in pharmaceutical drug design].

PubMed

Gaisser, Sibylle; Nusser, Michael

2010-01-01

Biotechnological methods have become an important tool in pharmaceutical drug research and development. Today approximately 15 % of drug revenues are derived from biopharmaceuticals. The most relevant indications are oncology, metabolic disorders and disorders of the musculoskeletal system. For the future it can be expected that the relevance of biopharmaceuticals will further increase. Currently, the share of substances in preclinical testing that rely on biotechnology is more than 25 % of all substances in preclinical testing. Products for the treatment of cancer, metabolic disorders and infectious diseases are most important. New therapeutic approaches such as RNA interference only play a minor role in current commercial drug research and development with 1.5 % of all biological preclinical substances. Investments in sustainable high technology such as biotechnology are of vital importance for a highly developed country like Germany because of its lack of raw materials. Biotechnology helps the pharmaceutical industry to develop new products, new processes, methods and services and to improve existing ones. Thus, international competitiveness can be strengthened, new jobs can be created and existing jobs preserved.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

PubMed

Obreli-Neto, Paulo Roque; Marusic, Srecko; Guidoni, Camilo Molino; Baldoni, André de Oliveira; Renovato, Rogério Dias; Pilger, Diogo; Cuman, Roberto Kenji Nakamura; Pereira, Leonardo Régis Leira

2015-01-01

Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

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.

A Mobile Service Robot for Life Science Laboratories

NASA Astrophysics Data System (ADS)

Schulenburg, Erik; Elkmann, Norbert; Fritzsche, Markus; Teutsch, Christian

In this paper we presents a project that is developing a mobile service robot to assist users in biological and pharmaceutical laboratories by executing routine jobs such as filling and transporting microplates. A preliminary overview of the design of the mobile platform with a robotic arm is provided. Safety aspects are one focus of the project since the robot and humans will share a common environment. Hence, several safety sensors such as laser scanners, thermographie components and artificial skin are employed. These are described along with the approaches to object recognition.

Intervention research to enhance community pharmacists' cognitive services: a systematic review.

PubMed

Patwardhan, Pallavi D; Amin, Mohamed E; Chewning, Betty A

2014-01-01

Positive impact of community pharmacists' cognitive pharmaceutical services (CPS) is well documented. However, community pharmacists have been slow to expand CPS roles. This systematic review explores how community pharmacy intervention research can help inform efforts to expand cognitive pharmaceutical service delivery. To: 1) identify community pharmacy CPS intervention studies that report data on pharmacist behaviors, either as a final study outcome itself or as a fidelity measure in patient outcome studies, and 2) describe the state of this research to help frame future research agendas. Empirical articles examining improvement or expansion of community pharmacist cognitive services published through December 2010 were searched using various search engines, bibliography searches and authors' libraries. Studies were included if they: 1) reported findings on pharmacist behaviors during cognitive service delivery, 2) employed a minimum of pre-post design or two study arms for pharmacists/pharmacies, and 3) were in community-based pharmacies. A total of 50 studies evaluated impact of community pharmacy based CPS delivery; however, only 21 included a pharmacist behavior outcome measure as a final outcome or as a fidelity measure. The majority (14 out of 21) of studies used a randomized controlled trial design. Nearly half (10 of 21) addressed asthma or tobacco cessation. Limited details were provided about interventions to prepare pharmacists for CPS delivery. The most frequent measures of pharmacist behavior were patient surveys and observation of pharmacists' behavior by secret shoppers; electronic data sets were rarely used. There is a need for well-designed intervention research that evaluates how interventions impact on pharmacist cognitive service behavior. Positive findings from this review reinforce that planned interventions have the potential to improve and expand pharmacist cognitive service delivery; however, more detail is needed in study publications for this potential to be fully realized. Copyright © 2014 Elsevier Inc. All rights reserved.

[Design and validation of a satisfaction survey with pharmaceutical care received in hospital pharmacyconsultation].

PubMed

Monje-Agudo, Patricia; Borrego-Izquierdo, Yolanda; Robustillo-Cortés, Ma de Las Aguas; Jiménez-Galán, Rocio; Almeida-González, Carmen V; Morillo-Verdugo, Ramón A

2015-05-01

To design and to validate a questionnaire to assess satisfaction with pharmaceutical care (PC) received at the hospital pharmacy. Multicentric study in five andalusian hospital in January 2013. A bibliography search was performed in PUBMED; MESH term; pharmaceutical services, patients satisfaction and questionnaire. Next, the questionnaire was produced by Delphi methodology with ten items and with the following variables; demographics, socials, pharrmacologicals and clinics which the patient was asked for the consequences of the PC in his treatment and illness and for the acceptance with the received service. The patient could answer between one= very insufficient and five= excellent. Before the validation phase questionnaire, a pilot phase was carried out. Descriptive analysis, Cronbach's alpha coefficient and intraclass correlation coefficient (ICC) were performed in both phases. Data analysis was conducted using the SPSS statistical software package release 20.0. In the pilot phase were included 21 questionnaires and 154 of them in validation phase (response index of 100%). In the last phase, 62% (N=96) of patients were men. More than 50% of patients answered "excelent" in all items of questionnaire in both phases. The Cronbach's alpha coefficient and ICC were 0.921 and 0.915 (95%IC: 0.847-0.961) and 0.916 and 0,910 (95%IC: 0.886-0.931) in pilot and validation phases, respectively. A high reliability instrument was designed and validated to evaluate the patient satisfaction with PC received at hospital pharmacy. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Public-private partnerships for health: their main targets, their diversity, and their future directions.

PubMed Central

Widdus, R.

2001-01-01

The global burden of disease, especially the part attributable to infectious diseases, disproportionately affects populations in developing countries. Inadequate access to pharmaceuticals plays a role in perpetuating this disparity. Drugs and vaccines may not be accessible because of weak distribution infrastructures or because development of the desired products has been neglected. This situation can be tackled with push interventions to lower the costs and risks of product development for industry, with pull interventions providing economic and market incentives, and with the creation of infrastructures allowing products to be put into use. If appropriately motivated, pharmaceutical companies can bring to partnerships expertise in product development, production process development, manufacturing, marketing, and distribution--all of which are lacking in the public sector. A large variety of public-private partnerships, combining the skills and resources of a wide range of collaborators, have arisen for product development, disease control through product donation and distribution, or the general strengthening or coordination of health services. Administratively, such partnerships may either involve affiliation with international organizations, i.e. they are essentially public-sector programmes with private-sector participation, or they may be legally independent not-for-profit bodies. These partnerships should be regarded as social experiments; they show promise but are not a panacea. New ventures should be built on need, appropriateness, and lessons on good practice learnt from experience. Suggestions are made for public, private, and joint activities that could help to improve the access of poor populations to the pharmaceuticals and health services they need. PMID:11545327

Emerging trends in contract research industry in India.

PubMed

Drabu, Sushma; Gupta, Alka; Bhadauria, Anupama

2010-09-01

A Contract Research Organization (CRO) is a service organization that provides support to the pharmaceutical industry and offers a wide range of "outsourced" pharmaceutical research services to aid in R&D process and is thus an essential tool for undertaking clinical trials in the present scenario when high stakes are involved in the drug discovery process. This industry also offers a safe option of investment as the industry is largely recession-proof, with a significant upscale growth. Presently India occupies a very small pie of the global market share in the Clinical Trials Industry but it is estimated to conduct nearly 5% of global clinical trials by 2012. The global CRO industry valued $18 bn in 2008 and the market is expected to grow at an annual rate of 14% between 2009 and 13. Top multinational pharmaceuticals companies are venturing into the Indian business, in collaboration with the Indian Drug Companies. According to a recent study by Mckinsey & Company, the Indian Clinical Research Industry can attract $1.5 bn of revenue from US and EU by 2010. Such an increase in outsourcing from the western countries has led the global pharma companies and Indian entrepreneurs to set up Contract Research Organizations (CROs) in India. To bring this into realization and fulfil the market demand, while simultaneously aiding in improving the country's economical standards and market position, joint and well-coordinated efforts on part of the government, industry, and working professionals are needed in terms of regulatory affairs, audits, transparency in work affairs, garnering patient confidence, and pharmacovigilance. Copyright 2010 Elsevier Inc. All rights reserved.

Paediatric clinical research from the perspective of hospital pharmacists from France and Canada.

PubMed

Guérin, Aurélie; Tanguay, Cynthia; Lebel, Denis; Prot-Labarthe, Sonia; Bourdon, Olivier; Bussières, Jean-François

2014-12-01

To compare pharmacy support for paediatric research services in France and Canada and to describe the perception of pharmacists and rank the paediatric clinical research issues. This was a cross-sectional descriptive study. All paediatric hospitals from Canada and the main hospitals from France were contacted. A survey was conducted from May-September 2012. Descriptive statistics were performed. Results from 11 paediatric hospitals in Canada (11/12, 92%) and 11 (11/18, 61%) in France were obtained. There was a similar number of ongoing paediatric clinical trials per hospital in France versus Canada (38 (10-81) versus 20 (4-178)). A lower number of pharmacists per hospital was observed in France (17 (11.5-35) versus 45 (18.9-76.8)), but a similar number of pharmacists were assigned to clinical trials (1.5 (1-3) versus 1.9 (0.2-17.4)). Institutional protocols represented the majority of paediatric clinical trials in France (61% (14-100) versus 25% (0-100)). Similar pharmacy support services were offered, but the majority of French respondents also offered help for institutional protocol development (91 versus 50% P = 0.063). The main issues associated with paediatric clinical research were absence of financial interest from the pharmaceutical industry, prohibitive cost versus profit ratio, small patient cohorts and the non-availability of the appropriate drug formulations. Difficulties related to pharmaceutical compounding were identified as the main hindrance to paediatric clinical research; particular attention should be paid to these details when setting up a paediatric trial. © 2014 Royal Pharmaceutical Society.

Impact of sanctions on procurement of medicine and medical devices in Iran; a technical response.

PubMed

Hosseini, Seyed Alireza

2013-12-01

Following recent sanctions on foreign trade, financial and banking services, Iran has faced major difficulties for importing medicines (both finished products and pharmaceutical raw materials) and medical devices. Problems with money transfer have made it extremely lengthy in time to import medicine and medical devices and these have negatively affected access to and affordability of medicines. Quality of pharmaceuticals and treatment of patients have also been affected due to changing the sources of imported medicines and raw materials for locally produced pharmaceuticals. Several interventions have been employed during the past few months in Iran to overcome the effects imposed by recent sanctions and drug shortages have been managed to some extent with attempts made by Iran Food and Drug Organization (IRI FDO). As recommended by the experts, a specific Society for Worldwide Interbank Financial Telecommunication line should be allocated for transferring money for medicines and medical devices and certain financial institutions are assigned for this purpose. It is also suggested that defining a white list of Iranian pharmaceuticals and medical device companies together with their foreign counterparts would facilitate this process. It appears that, in a public health prospective, ordinary people and patients are hurt and paying the cost for current sanctions. It remains the responsibility of the public health and international communities to separate public health from politics and to ease the pain of public from sanctions.

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.

Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products.

PubMed

Desai, Kashappa Goud; Obayashi, Hirokazu; Colandene, James D; Nesta, Douglas P

2018-03-28

Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies due to differences in language and culture. This article summarizes key Japan-specific regulatory aspects/requirements/expectations applicable to new drug development, approval, and postapproval phases. Formulation excipients should meet Japan compendial requirements with respect to the type of excipient, excipient grade, and excipient concentration. Preclinical safety assessments needed to support clinical phases I, II, and III development are summarized. Japanese regulatory authorities have taken appropriate steps to consider foreign clinical data, thereby enabling accelerated drug development and approval in Japan. Other important topics summarized in this article include: Japan new drug application-specific bracketing strategies for critical and noncritical aspects of the manufacturing process, regulatory requirements related to stability studies, release specifications and testing methods, standard processes involved in pre and postapproval inspections, management of postapproval changes, and Japan regulatory authority's consultation services available to global pharmaceutical companies. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

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.

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.

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.

A risk-based approach to scheduling audits.

PubMed

Rönninger, Stephan; Holmes, Malcolm

2009-01-01

The manufacture and supply of pharmaceutical products can be a very complex operation. Companies may purchase a wide variety of materials, from active pharmaceutical ingredients to packaging materials, from "in company" suppliers or from third parties. They may also purchase or contract a number of services such as analysis, data management, audit, among others. It is very important that these materials and services are of the requisite quality in order that patient safety and company reputation are adequately protected. Such quality requirements are ongoing throughout the product life cycle. In recent years, assurance of quality has been derived via audit of the supplier or service provider and by using periodic audits, for example, annually or at least once every 5 years. In the past, companies may have used an audit only for what they considered to be "key" materials or services and used testing on receipt, for example, as their quality assurance measure for "less important" supplies. Such approaches changed as a result of pressure from both internal sources and regulators to the time-driven audit for all suppliers and service providers. Companies recognised that eventually they would be responsible for the quality of the supplied product or service and audit, although providing only a "snapshot in time" seemed a convenient way of demonstrating that they were meeting their obligations. Problems, however, still occur with the supplied product or service and will usually be more frequent from certain suppliers. Additionally, some third-party suppliers will no longer accept routine audits from individual companies, as the overall audit load can exceed one external audit per working day. Consequently a different model is needed for assessing supplier quality. This paper presents a risk-based approach to creating an audit plan and for scheduling the frequency and depth of such audits. The approach is based on the principles and process of the Quality Risk Management guideline (ICH Q9) of the International Conference on Harmonisation (ICH). It proposes that if regulatory conditions allow, it may be possible to remove the need to conduct audits on the sole basis of time elapsed since the last audit, or at least to increase the time interval between such audits without compromising either patient safety or company reputation. The proposal is equally applicable to both large and small companies. Small companies may find it particularly useful in cases where they use a supplier that may have a monopoly position or that serves many other pharmaceutical companies. In such circumstances the supplier may be reluctant or even refuse to accept audits from some individual companies because of their low purchasing levels. A similar approach could be proposed for regulatory authorities for the scheduling of regulatory inspections.

Drug rationing in the UK National Health Service. Current status and future prospects.

PubMed

Walley, T; Haycox, A; Barton, S

1997-09-01

There are major problems in attempting to ration drug use in the UK. These include the large indigenous pharmaceutical industry, the nature of funding of drugs within the National Health Service (NHS) and the political sensitivities of rationing. Rationing of services within the NHS has therefore usually been implicit rather than explicit, and there is little public debate about rationing of health services. In relation to drug therapy, prescribing in primary care technically can only be rationed by encouraging the general practitioner (GP) to contain his or her own costs-effectively moving the difficult decision to the GP. Direct incentives to the GP, in the form of incentive payments or by fundholding seem to have some success in containing costs, largely by simple generic substitution. There are established systems in hospitals to control the costs of drugs, including formularies and drug management committees. Hospitals commonly try to transfer drug costs to the GP budget. While in part this is clinically appropriate, it can lead to tensions. Health authorities and GP fundholders now include prescribing, particularly at this interface, in their contracts with hospitals. Economic evaluations currently play little part in aiding decisions about choice of drug. These decisions tend to be dominated by the need for short term cost containment in the UK. Recent reforms of the NHS have moved responsibility for the rationing of services to the local authorities or purchasers; this might in time create an additional, local hurdle for pharmaceutical companies trying to market new drugs. A proposal to introduce a national limited formulary in which drugs will be selected partly on the basis of an economic evaluation seems impractical, although similar ideas might be further developed.

Use of health care services and pharmaceutical agents in coeliac disease: a prospective nationwide study

PubMed Central

2012-01-01

Background Approximately 1% of the population suffer from coeliac disease. However, the disease is heavily underdiagnosed. Unexplained symptoms may lead to incremented medical consultations and productivity losses. The aim here was to estimate the possible concealed burden of untreated coeliac disease and the effects of a gluten-free diet. Methods A nationwide cohort of 700 newly detected adult coeliac patients were prospectively evaluated. Health care service use and sickness absence from work during the year before diagnosis were compared with those in the general population; the data obtained from an earlier study. Additionally, the effect of one year on dietary treatment on the aforementioned parameters and on consumption of pharmaceutical agents was assessed. Results Untreated coeliac patients used primary health care services more frequently than the general population. On a gluten-free diet, visits to primary care decreased significantly from a mean 3.6 to 2.3. The consumption of medicines for dyspepsia (from 3.7 to 2.4 pills/month) and painkillers (6.8-5.5 pills/month) and the number of antibiotic courses (0.6-0.5 prescriptions/year) was reduced. There were no changes in hospitalizations, outpatient visits to secondary and tertiary care, use of other medical services, or sickness absence, but the consumption of nutritional supplements increased on treatment. Conclusions Coeliac disease was associated with excessive health care service use and consumption of drugs before diagnosis. Dietary treatment resulted in a diminished burden to the health care system and lower use of on-demand medicines and antibiotic treatment. The results support an augmented diagnostic approach to reduce underdiagnosis of coeliac disease. Trial registration ClinicalTrials.gov NCT01145287 PMID:23016889

Use of health care services and pharmaceutical agents in coeliac disease: a prospective nationwide study.

PubMed

Ukkola, Anniina; Kurppa, Kalle; Collin, Pekka; Huhtala, Heini; Forma, Leena; Kekkonen, Leila; Mäki, Markku; Kaukinen, Katri

2012-09-27

Approximately 1% of the population suffer from coeliac disease. However, the disease is heavily underdiagnosed. Unexplained symptoms may lead to incremented medical consultations and productivity losses. The aim here was to estimate the possible concealed burden of untreated coeliac disease and the effects of a gluten-free diet. A nationwide cohort of 700 newly detected adult coeliac patients were prospectively evaluated. Health care service use and sickness absence from work during the year before diagnosis were compared with those in the general population; the data obtained from an earlier study. Additionally, the effect of one year on dietary treatment on the aforementioned parameters and on consumption of pharmaceutical agents was assessed. Untreated coeliac patients used primary health care services more frequently than the general population. On a gluten-free diet, visits to primary care decreased significantly from a mean 3.6 to 2.3. The consumption of medicines for dyspepsia (from 3.7 to 2.4 pills/month) and painkillers (6.8-5.5 pills/month) and the number of antibiotic courses (0.6-0.5 prescriptions/year) was reduced. There were no changes in hospitalizations, outpatient visits to secondary and tertiary care, use of other medical services, or sickness absence, but the consumption of nutritional supplements increased on treatment. Coeliac disease was associated with excessive health care service use and consumption of drugs before diagnosis. Dietary treatment resulted in a diminished burden to the health care system and lower use of on-demand medicines and antibiotic treatment. The results support an augmented diagnostic approach to reduce underdiagnosis of coeliac disease. ClinicalTrials.gov NCT01145287.

75 FR 3471 - International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-D-0470... Human Clinical Trials and Marketing Authorization for Pharmaceuticals; Availability AGENCY: Food and... the availability of a guidance entitled ``M3(R2) Nonclinical Safety Studies for the Conduct of Human...

42 CFR 482.41 - Condition of participation: Physical environment.

Code of Federal Regulations, 2011 CFR

2011-10-01

... pharmaceutical, food preparation, and other appropriate areas. [51 FR 22042, June 17, 1986, as amended at 53 FR... rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and.... 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information...

42 CFR 482.41 - Condition of participation: Physical environment.

Code of Federal Regulations, 2012 CFR

2012-10-01

... pharmaceutical, food preparation, and other appropriate areas. [51 FR 22042, June 17, 1986, as amended at 53 FR... rooms, and stairwells. In all other areas not serviced by the emergency supply source, battery lamps and.... 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information...

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...

21 CFR 211.86 - Use of approved components, drug product containers, and closures.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Use of approved components, drug product containers, and closures. 211.86 Section 211.86 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS Control of Components and Drug...