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Sample records for management drug study

  1. Collaborative Behavioral Management for Drug-Involved Parolees: Rationale and Design of the Step'n Out Study

    ERIC Educational Resources Information Center

    Friedmann, Peter D.; Katz, Elizabeth C.; Rhodes, Anne G.; Taxman, Faye S.; O'Connell, Daniel J.; Frisman, Linda K.; Burdon, William M.; Fletcher, Bennett W.; Litt, Mark D.; Clarke, Jennifer; Martin, Steven S.

    2008-01-01

    This article describes the rationale, study design, and implementation for the Step'n Out study of the Criminal Justice Drug Abuse Treatment Studies. Step'n Out tests the relative effectiveness of collaborative behavioral management of drug-involved parolees. Collaborative behavioral management integrates the roles of parole officers and treatment…

  2. Collaborative Drug Therapy Management: Case Studies of Three Community-Based Models of Care

    PubMed Central

    Snyder, Margie E.; Earl, Tara R.; Greenberg, Michael; Heisler, Holly; Revels, Michelle; Matson-Koffman, Dyann

    2015-01-01

    Collaborative drug therapy management agreements are a strategy for expanding the role of pharmacists in team-based care with other providers. However, these agreements have not been widely implemented. This study describes the features of existing provider–pharmacist collaborative drug therapy management practices and identifies the facilitators and barriers to implementing such services in community settings. We conducted in-depth, qualitative interviews in 2012 in a federally qualified health center, an independent pharmacy, and a retail pharmacy chain. Facilitators included 1) ensuring pharmacists were adequately trained; 2) obtaining stakeholder (eg, physician) buy-in; and 3) leveraging academic partners. Barriers included 1) lack of pharmacist compensation; 2) hesitation among providers to trust pharmacists; 3) lack of time and resources; and 4) existing informal collaborations that resulted in reduced interest in formal agreements. The models described in this study could be used to strengthen clinical–community linkages through team-based care, particularly for chronic disease prevention and management. PMID:25811494

  3. Management of postoperative pain in abdominal surgery in Spain. A multicentre drug utilization study

    PubMed Central

    Vallano, Antonio; Aguilera, Cristina; Arnau, Josep Maria; Baños, Josep-Eladi; Laporte, Joan-Ramon

    1999-01-01

    Participating centres: Hospital Universitario San Juan, Alicante: Maria Jesús Olaso, Javier Agulló, Clara Faura. Hospital Torrecárdenas, Almería: Carmen Fernández Sánchez, Miguel Lorenzo Campos, Juan Manuel Rodríguez Alonso. Hospital Quirúrgic Adriano, Barcelona: Carmen Alerany Pardo, Paquita Alvarez González, Teresa Martín Benito. Hospital Universitari del Mar-IMIM, Barcelona: Magí Farré, Maite Terán. Corporació Sanitària Parc Taulí, Sabadell: Montserrat Cañellas, Sergio Zavala, Josep Planell. Hospital Universitari de la Santa Creu i Sant Pau: Gonzalo Calvo, Rosa Morros, Silvia Mateo. Hospital General Vall d’Hebron, Barcelona: Carmen Bosch, María José Martínez. Hospital Universitario Virgen de la Victoria, Málaga: Maribel Lucena, José Antonio González, Gabriel Carranque. Hospital Clínico Universitario San Carlos, Madrid: Emilio Vargas, Amparo Gil López-Oliva, Míriam García Mateos. Hospital Universitario Marqués de Valdecilla, Santander: Mario González, Antonio Cuadrado. Hospital Universitario Virgen de la Macarena, Sevilla: Juan Antonio Durán, Pilar Máyquez, María Isabel Serrano. Hospital Universitario Virgen del Rocío, Sevilla: Jaume Torelló, Juan Ramón Castillo, María de las Nieves Merino. Aims Postoperative pain is common in hospital-admitted patients. Its management is determined by different therapeutic traditions and by the attitudes of health professionals in each hospital. The aim of this study was to describe the patterns of prescription and administration of analgesic drugs used for postoperative pain after abdominal surgery in Spanish hospitals, to know the prevalence and the severity of postoperative pain, and to determine the extent of variability in the management of postoperative pain among the participating centres. Methods The study was a multicentre descriptive cross-sectional drug utilization study in 12 Spanish hospitals. The subjects were an unselected sample of consecutive patients undergoing abdominal

  4. Medical Management of Drug-Resistant Tuberculosis

    PubMed Central

    2015-01-01

    Drug-resistant tuberculosis (TB) is still a major threat worldwide. However, recent scientific advances in diagnostic and therapeutic tools have improved the management of drug-resistant TB. The development of rapid molecular testing methods allows for the early detection of drug resistance and prompt initiation of an appropriate treatment. In addition, there has been growing supportive evidence for shorter treatment regimens in multidrug-resistant TB; and for the first time in over 50 years, new anti-TB drugs have been developed. The World Health Organization has recently revised their guidelines, primarily based on evidence from a meta-analysis of individual patient data (n=9,153) derived from 32 observational studies, and outlined the recommended combination and correct use of available anti-TB drugs. This review summarizes the updated guidelines with a focus on the medical management of drug-resistant TB. PMID:26175768

  5. Clinical Management of HIV Drug Resistance

    PubMed Central

    Cortez, Karoll J.; Maldarelli, Frank

    2011-01-01

    Combination antiretroviral therapy for HIV-1 infection has resulted in profound reductions in viremia and is associated with marked improvements in morbidity and mortality. Therapy is not curative, however, and prolonged therapy is complicated by drug toxicity and the emergence of drug resistance. Management of clinical drug resistance requires in depth evaluation, and includes extensive history, physical examination and laboratory studies. Appropriate use of resistance testing provides valuable information useful in constructing regimens for treatment-experienced individuals with viremia during therapy. This review outlines the emergence of drug resistance in vivo, and describes clinical evaluation and therapeutic options of the individual with rebound viremia during therapy. PMID:21994737

  6. A Prospective Study of Tuberculosis Drug Susceptibility in Sabah, Malaysia, and an Algorithm for Management of Isoniazid Resistance

    PubMed Central

    Rashid Ali, Muhammad Redzwan S.; Parameswaran, Uma; William, Timothy; Bird, Elspeth; Wilkes, Christopher S.; Lee, Wai Khew; Yeo, Tsin Wen; Anstey, Nicholas M.; Ralph, Anna P.

    2015-01-01

    Introduction. The burden of tuberculosis is high in eastern Malaysia, and rates of Mycobacterium tuberculosis drug resistance are poorly defined. Our objectives were to determine M. tuberculosis susceptibility and document management after receipt of susceptibility results. Methods. Prospective study of adult outpatients with smear-positive pulmonary tuberculosis (PTB) in Sabah, Malaysia. Additionally, hospital clinicians accessed the reference laboratory for clinical purposes during the study. Results. 176 outpatients were enrolled; 173 provided sputum samples. Mycobacterial culture yielded M. tuberculosis in 159 (91.9%) and nontuberculous Mycobacterium (NTM) in three (1.7%). Among outpatients there were no instances of multidrug resistant M. tuberculosis (MDR-TB). Seven people (4.5%) had isoniazid resistance (INH-R); all were switched to an appropriate second-line regimen for varying durations (4.5–9 months). Median delay to commencement of the second-line regimen was 13 weeks. Among 15 inpatients with suspected TB, 2 had multidrug resistant TB (one extensively drug resistant), 2 had INH-R, and 4 had NTM. Conclusions. Current community rates of MDR-TB in Sabah are low. However, INH-resistance poses challenges, and NTM is an important differential diagnosis in this setting, where smear microscopy is the usual diagnostic modality. To address INH-R management issues in our setting, we propose an algorithm for the treatment of isoniazid-resistant PTB. PMID:25838829

  7. Age- and Sex-related Prevalence and Drug Utilization Pattern in the Management of Type 2 Diabetes Mellitus and its Comorbidity with Cardiovascular Diseases: A Comparative Study.

    PubMed

    Das, S; Haroled Peter, P L; Bhavani, M Lakshmi; Naresh, P; Ramana, M V

    2015-01-01

    A cross-sectional study of 250 cases of type 2 diabetes management was conducted in a governmental tertiary care hospital of urban south India to determine the comparative prevalence of type 2 diabetes and its comorbidity with cardiovascular diseases in diabetic population, core drug use indicators and drug utilization pattern in the management of diabetics entirely and with cardiovascular diseases. Highest prevalent age group for type 2 diabetes/cardiovascular diseases (greater incidence in female than male) was 51-60 years. The 62.8% prevalence of cardiovascular diseases in the diabetic population ascertained in the study could provide an evidence-based rationale for the World Health Organization guidelines for the management of hypertension in type 2 diabetics. Incidence of polypharmacy (6.06, the mean number of total drug products prescribed); 59.26% of encounters prescribed antibiotics; 17.6 and 18.5 min of average consultation and dispensing time, respectively; 100% of drugs actually dispensed and adequately labeled; 81.26% of patients having knowledge of correct dosage and average drug cost of Indian Rupees 145.54 per prescription were the core drug use indicators found mainly. Moreover, drugs prescribed from the Essential Drug List were more than 90% and thereby indicated the drug use in this set-up quite rational. Around 71.09% of cardiovascular agents prescribed by generic name revealed the cost effective medical care. Among the agents in type 2 diabetes management, Actrapid(®) (35.43%) was the highest. Among the cardiovascular agents prescribed, lasix (19.37%) was the highest. Cardiovascular agents prescribed orally by 76.48% signified the good prescription habit indicating the improved patients' adherence to the treatment. The present study emphasizes the need of early detection of hypertension as a preliminary diagnostic parameter of cardiovascular diseases in diabetics and appropriate management through concomitant therapy of cardiovascular drugs to

  8. Age- and Sex-related Prevalence and Drug Utilization Pattern in the Management of Type 2 Diabetes Mellitus and its Comorbidity with Cardiovascular Diseases: A Comparative Study.

    PubMed

    Das, S; Haroled Peter, P L; Bhavani, M Lakshmi; Naresh, P; Ramana, M V

    2015-01-01

    A cross-sectional study of 250 cases of type 2 diabetes management was conducted in a governmental tertiary care hospital of urban south India to determine the comparative prevalence of type 2 diabetes and its comorbidity with cardiovascular diseases in diabetic population, core drug use indicators and drug utilization pattern in the management of diabetics entirely and with cardiovascular diseases. Highest prevalent age group for type 2 diabetes/cardiovascular diseases (greater incidence in female than male) was 51-60 years. The 62.8% prevalence of cardiovascular diseases in the diabetic population ascertained in the study could provide an evidence-based rationale for the World Health Organization guidelines for the management of hypertension in type 2 diabetics. Incidence of polypharmacy (6.06, the mean number of total drug products prescribed); 59.26% of encounters prescribed antibiotics; 17.6 and 18.5 min of average consultation and dispensing time, respectively; 100% of drugs actually dispensed and adequately labeled; 81.26% of patients having knowledge of correct dosage and average drug cost of Indian Rupees 145.54 per prescription were the core drug use indicators found mainly. Moreover, drugs prescribed from the Essential Drug List were more than 90% and thereby indicated the drug use in this set-up quite rational. Around 71.09% of cardiovascular agents prescribed by generic name revealed the cost effective medical care. Among the agents in type 2 diabetes management, Actrapid(®) (35.43%) was the highest. Among the cardiovascular agents prescribed, lasix (19.37%) was the highest. Cardiovascular agents prescribed orally by 76.48% signified the good prescription habit indicating the improved patients' adherence to the treatment. The present study emphasizes the need of early detection of hypertension as a preliminary diagnostic parameter of cardiovascular diseases in diabetics and appropriate management through concomitant therapy of cardiovascular drugs to

  9. Drug-Induced Itch Management.

    PubMed

    Ebata, Toshiya

    2016-01-01

    Drugs may cause itching as a concomitant symptom of drug-induced skin reactions or in the form of pruritus without skin lesions. Drug-induced itch is defined as generalized itching without skin lesions, caused by a drug. Itching associated with drug-induced cholestasis is among the common dermatologic adverse events (dAEs) that induce itching. Some drugs such as opioids, antimalarials, and hydroxyethyl starch are known to induce itching without skin lesions. The clinical features and underlying proposed mechanisms of itching caused by these drugs have been specifically investigated. The recent application of targeted anticancer drugs has increased the survival rate of cancer patients. These new agents cause significant dAEs such as acneiform rashes, dry skin, hand-foot syndrome, paronychia, and itching. Itching is a common side effect of epidermal growth factor receptor inhibitors. Though not life-threatening, these dAEs have a negative impact on a patient's quality of life, leading to dose reduction and possibly less effective cancer therapy. It is important to provide an effective supportive antipruritic treatment without interruption of the administration of these drugs. This chapter concludes by describing basic measures to be taken for diagnosis and treatment of drug-induced itch. The principle of treatment is discontinuation of suspected causative drugs in general except for anticancer medications. In case itching lasts long after drug withdrawal or the causative drug cannot be stopped, vigorous symptomatic antipruritic treatment and specific therapies for different types of drug-induced itch should be undertaken. PMID:27578085

  10. Iowa Case Management for Rural Drug Abuse

    ERIC Educational Resources Information Center

    Hall, James A.; Vaughan Sarrazin, Mary S.; Huber, Diane L.; Vaughn, Thomas; Block, Robert I.; Reedy, Amanda R.; Jang, MiJin

    2009-01-01

    Objective: The purpose of this research was to evaluate the effectiveness of a comprehensive, strengths-based model of case management for clients in drug abuse treatment. Method: 503 volunteers from residential or intensive outpatient treatment were randomly assigned to one of three conditions of Iowa Case Management (ICM) plus treatment as usual…

  11. Case management in a DUI lab: effect on drugs reported.

    PubMed

    Tiscione, Nicholas B; Shan, Xiaoqin; Yeatman, Dustin Tate

    2014-10-01

    An evaluation of an internal laboratory decision to implement a protocol for limiting drug testing based on ethanol concentration in laboratory analysis for driving under the influence (DUI) cases is presented. The described case management strategy is supported by known impairment of ethanol at relatively high concentrations, difficulty assigning a level of contributing impairment from drugs in the presence of high ethanol levels and the likelihood that the drug results may be suppressed at trial. Although the results of this study reinforce the assertion that such protocols lead to the under reporting of drugs in DUI cases, for the majority of cases, 95% in this study, the drug analysis results were not significant and did not warrant the time and resources needed for the additional blood drug testing. Furthermore, the study demonstrated that a high drug positivity rate does not necessarily mean that those drug results are legally or pharmacologically meaningful. Additional research should be conducted with quantitative drug results and casework impact of blood drug screen protocols as previous studies only report drug positivity rates and not whether the drug results would be meaningful to the case. PMID:25217546

  12. Deprivation, clubs and drugs: results of a UK regional population-based cross-sectional study of weight management strategies

    PubMed Central

    2014-01-01

    Background Despite rising levels of obesity in England, little is known about slimming club and weight loss drug (medication) use or users. In order to inform future commissioning, we report the prevalence of various weight management strategies and examine the associations between slimming club and medication use and age, gender, deprivation and body mass index. Methods A population based cross-sectional survey of 26,113 adults was conducted in South Yorkshire using a self-completed health questionnaire. Participants were asked whether they had ever used the following interventions to manage their weight: increasing exercise, healthy eating, controlling portion size, slimming club, over the counter weight loss medication, or meal replacements. Factors associated with slimming club and weight-loss medication use were explored using logistic regression. Results Over half of the sample was either overweight (36.6%) or obese (19.6%). Obesity was more common in the most deprived areas compared to the least deprived (26.3% vs. 12.0%). Healthy eating (49.0%), controlling portion size (43.4%), and increasing exercise (43.0%) were the most commonly reported weight management strategies. Less common strategies were attending a slimming club (17.2%), meal replacements (3.4%) and weight-loss medication (3.2%). Adjusting for BMI, age, deprivation and long standing health conditions, women were significantly more likely to report ever using a slimming club (adjusted OR = 18.63, 95% CI = 16.52–21.00) and more likely to report ever using over the counter weight-loss medications (AOR = 3.73, 95% CI = 3.10-4.48), while respondents from the most deprived areas were less likely to report using slimming clubs (AOR = 0.60, 95% CI = 0.53-0.68), and more likely to reporting using weight loss medications (AOR =1.38, 95% CI = 1.05-1.82). Conclusion A large proportion of individuals report having used weight management strategies. Slimming clubs and over-the-counter weight loss medication

  13. Iowa Case Management for Rural Drug Abuse.

    PubMed

    Hall, James A; Sarrazin, Mary S Vaughan; Huber, Diane L; Vaughn, Thomas; Block, Robert I; Reedy, Amanda R; Jang, Mijin

    2009-07-01

    OBJECTIVE: The purpose of this research was to evaluate the effectiveness of a comprehensive, strengths-based model of case management for clients in drug abuse treatment. METHOD: 503 volunteers from residential or intensive outpatient treatment were randomly assigned to one of three conditions of Iowa Case Management (ICM) plus treatment as usual (TAU), or to a fourth condition of TAU only. All were assessed at intake and followed at 3, 6, and 12 months. RESULTS: Clients in all four conditions significantly decreased substance use by 3 months after intake and maintained most gains over time. However, the addition of ICM to TAU did not improve substance use outcomes. CONCLUSION: Overall, the addition of case management did not significantly improve drug treatment as hypothesized by both researchers and clinicians. Some results were mixed, possibly due to the heterogeneous sample, wide range of case management activities, or difficulty retaining participants over time.

  14. Iowa Case Management for Rural Drug Abuse

    PubMed Central

    Hall, James A.; Sarrazin, Mary S. Vaughan; Huber, Diane L.; Vaughn, Thomas; Block, Robert I.; Reedy, Amanda R.; Jang, MiJin

    2011-01-01

    Objective The purpose of this research was to evaluate the effectiveness of a comprehensive, strengths-based model of case management for clients in drug abuse treatment. Method 503 volunteers from residential or intensive outpatient treatment were randomly assigned to one of three conditions of Iowa Case Management (ICM) plus treatment as usual (TAU), or to a fourth condition of TAU only. All were assessed at intake and followed at 3, 6, and 12 months. Results Clients in all four conditions significantly decreased substance use by 3 months after intake and maintained most gains over time. However, the addition of ICM to TAU did not improve substance use outcomes. Conclusion Overall, the addition of case management did not significantly improve drug treatment as hypothesized by both researchers and clinicians. Some results were mixed, possibly due to the heterogeneous sample, wide range of case management activities, or difficulty retaining participants over time. PMID:22065018

  15. Management of psychotropic drugs during pregnancy.

    PubMed

    Chisolm, Margaret S; Payne, Jennifer L

    2016-01-01

    Psychiatric conditions (including substance misuse disorders) are serious, potentially life threatening illnesses that can be successfully treated by psychotropic drugs, even during pregnancy. Because few rigorously designed prospective studies have examined the safety of these drugs during pregnancy, the default clinical recommendation has been to discontinue them, especially during the first trimester. However, in the past decade, as more evidence has accumulated, it seems that most psychotropic drugs are relatively safe to use in pregnancy and that not using them when indicated for serious psychiatric illness poses a greater risk to both mother and child, including tragic outcomes like suicide and infanticide. This review presents an up to date and careful examination of the most rigorous scientific studies on the effects of psychotropic drugs in pregnancy. The lack of evidence in several areas means that definite conclusions cannot be made about the risks and benefits of all psychotropic drug use in pregnancy. PMID:26791406

  16. A Pilot Comparative Study of the Clarity and Assessability of the Drug Management Standards of Accreditation Canada and the US Joint Commission

    PubMed Central

    Alemanni, Jordane; Brisseau, Lionel; Lebel, Denis; Vaillancourt, Régis; Rocheleau, Louis; Bussières, Jean-François

    2011-01-01

    Background: There are few data comparing the drug management standards of the US and Canadian agencies that accredit health care institutions. Objective: To evaluate the clarity and assessability of criteria in the drug management standards adopted by Accreditation Canada and the Joint Commission (United States). Methods: A pilot study was conducted to compare the clarity and assessability of the criteria listed in the 2 standards. Criteria that were common to the 2008 versions of the Canadian and US drug management standards were identified. A panel of 12 health care professionals was assembled to independently rate the clarity (i.e., clear or unclear) and the assessability (i.e., assessable or not assessable) of each statement, using a validated comparative grid. Results: In total, there were 143 Canadian standards and 103 US standards. Sixty-two (43%) of the 143 Canadian criteria could be directly paired with a US criterion, whereas 70 (68%) of the 103 US criteria could be paired with one or more Canadian criteria. Six of the US criteria were paired with more than one Canadian criterion, and 12 of the Canadian criteria could be paired with more than one US criterion. Four of the 22 themes in the Canadian standards had no equivalent criteria in the US standards. Panel members from the pharmaceutical practice group evaluated the clarity and assessability of the Canadian criteria more severely than panel members from the nursing practice group: 86% versus 95% of individual ratings were deemed “clear” by these two groups, respectively (p < 0.001) and 64% versus 88% of individual ratings were deemed “assessable” (p < 0.001). There were no criteria that were considered unclear or unassessable by all of the panel members. Conclusions: Few data are available on drug management standards and their impact on health care. A better understanding of these standards, as well as comparisons of Canadian standards with those of other countries, might help in determining

  17. [Terbinafine : Relevant drug interactions and their management].

    PubMed

    Dürrbeck, A; Nenoff, P

    2016-09-01

    The allylamine terbinafine is the probably most frequently prescribed systemic antifungal agent in Germany for the treatment of dermatomycoses and onychomycoses. According to the German drug law, terbinafine is approved for patients who are 18 years and older; however, this antifungal agent is increasingly used off-label for treatment of onychomycoses and tinea capitis in children. Terbinafine is associated with only a few interactions with other drugs, which is why terbinafine can generally be used without problems in older and multimorbid patients. Nevertheless, some potential interactions of terbinafine with certain drug substances are known, including substances of the group of antidepressants/antipsychotics and some cardiovascular drugs. Decisive for the relevance of interactions is-along with the therapeutic index of the substrate and the possible alternative degradation pathways-the genetically determined type of metabolism. When combining terbinafine with tricyclic antidepressants or selective serotonin reuptake inhibitors and serotonin/noradrenalin reuptake inhibitors, the clinical response and potential side effects must be monitored. Problematic is the use of terbinafine with simultaneous treatment with tamoxifen. The administration of potent CYP2D6 inhibitors leads to a diminished efficacy of tamoxifen because one of its most important active metabolites-endoxifen-is not sufficiently available. Therefore, combination of tamoxifen and terbinafine should be avoided. In conclusion, the number of substances which are able to cause clinically relevant interactions in case of simultaneously administration with terbinafine is clear and should be manageable in the dermatological office with adequate monitoring. PMID:27474731

  18. Human aspects of the management of drug discovery knowledge.

    PubMed

    Davenport, Thomas H; Peitsch, Manuel C

    2005-01-01

    A well-defined strategy for knowledge management is a key success factor of any knowledge-intensive industry. This applies particularly well to pharmaceutical drug discovery, which is one of the most knowledge-intensive processes. The subject has only rarely been studied in the context of pharmaceutical firms and we can only extrapolate a limited number of findings from other industries. Here, we look at five key human aspects of knowledge management (social networks and communities of practice, the roles of professional knowledge managers, the behaviors and processes of knowledge workers, management strategies and tactics and the role of the external work environment) and how they apply to the drug discovery process.: PMID:24981937

  19. Deliberating Tarceva: A case study of how British NHS managers decide whether to purchase a high-cost drug in the shadow of NICE guidance.

    PubMed

    Hughes, David; Doheny, Shane

    2011-11-01

    This paper examines audio-recorded data from meetings in which NHS managers decide whether to fund high-cost drugs for individual patients. It investigates the work of a Welsh individual patient commissioning (IPC) panel responsible for sanctioning the purchase of 'un-commissioned' treatments for exceptional cases. The case study presented highlights the changing rationales used for approving or denying a cancer drug, Tarceva, during a period when NICE first suggested it was not cost effective, but then changed its position in a final technology appraisal recommending use when the cost did not exceed that of an alternative product. Our data show how decisions taken in the shadow of NICE guidance remain complex and subject to local discretion. Guidance that takes time to prepare, is released in stages, and relates to particular disease stages, must be interpreted in the context of particular cases. The case-based IPC panel discourse stands in tension with the standardised population-based recommendations in guidance. Panel members, who based their decisions on the central notions of 'efficacy' and 'exceptionality', often struggled to apply NICE information on cost-effectiveness to their deliberations on efficacy (clinical effectiveness). The case study suggests that the complex nature of decision making makes standardization of outcomes very difficult to achieve, so that local professional judgement is likely to remain central to health care rationing at this level. PMID:22000765

  20. Experimental study and evaluation of radioprotective drugs

    NASA Technical Reports Server (NTRS)

    Smith, D. E.; Thomson, J. F.

    1968-01-01

    Experimental study evaluates radioprotective drugs administered before exposure either orally or intravenously. Specifically studied are the sources of radiation, choice of radiation dose, choice of animals, administration of drugs, the toxicity of protective agents and types of protective drug.

  1. Prioritizing the human genome: knowledge management for drug discovery.

    PubMed

    Golden, James B

    2003-05-01

    This review covers recent methods to create a manageable subset of drug targets for development by prioritizing novel genes from the Human Genome Project. The ability to organize genomic data into a distinct set of drug discovery assets can be viewed as a form of knowledge management. While bioinformatics systems have been built to manage genomics-based data, the central theme in creating any bioinformatics infrastructure should be organization-specific knowledge management. PMID:12833662

  2. Increased Access to Care and Appropriateness of Treatment at Private Sector Drug Shops with Integrated Management of Malaria, Pneumonia and Diarrhoea: A Quasi-Experimental Study in Uganda

    PubMed Central

    Awor, Phyllis; Wamani, Henry; Tylleskar, Thorkild; Jagoe, George; Peterson, Stefan

    2014-01-01

    Introduction Drug shops are a major source of care for children in low income countries but they provide sub-standard care. We assessed the feasibility and effect on quality of care of introducing diagnostics and pre-packaged paediatric-dosage drugs for malaria, pneumonia and diarrhoea at drug shops in Uganda. Methods We adopted and implemented the integrated community case management (iCCM) intervention within registered drug shops. Attendants were trained to perform malaria rapid diagnostic tests (RDTs) in each fever case and count respiratory rate in each case of cough with fast/difficult breathing, before dispensing recommended treatment. Using a quasi-experimental design in one intervention and one non-intervention district, we conducted before and after exit interviews for drug seller practices and household surveys for treatment-seeking practices in May–June 2011 and May–June 2012. Survey adjusted generalized linear models and difference-in-difference analysis was used. Results 3759 (1604 before/2155 after) household interviews and 943 (163 before/780 after) exit interviews were conducted with caretakers of children under-5. At baseline, no child at a drug shop received any diagnostic testing before treatment in both districts. After the intervention, while no child in the non-intervention district received a diagnostic test, 87.7% (95% CI 79.0–96.4) of children with fever at the intervention district drug shops had a parasitological diagnosis of malaria, prior to treatment. The prevalence ratios of the effect of the intervention on treatment of cough and fast breathing with amoxicillin and diarrhoea with ORS/zinc at the drug shop were 2.8 (2.0–3.9), and 12.8 (4.2–38.6) respectively. From the household survey, the prevalence ratio of the intervention effect on use of RDTs was 3.2 (1.9–5.4); Artemisinin Combination Therapy for malaria was 0.74 (0.65–0.84), and ORS/zinc for diarrhoea was 2.3 (1.2–4.7). Conclusion iCCM can be utilized to improve

  3. Management of type 2 diabetes and its prescription drug cost before and during the economic crisis in Greece: an observational study

    PubMed Central

    2014-01-01

    Background The aim of the present study is to examine the clinical indices related to cardiovascular risk management of Greek patients with type 2 diabetes, before and after the major economic crisis that emerged in the country. Methods In this retrospective database study, the medical records of patients with type 2 diabetes treated at three diabetes outpatient centers of the national health system during 2006 and 2012 were examined. Only patients with at least six months of follow-up prior to the recorded examination were included. The prescription cost was calculated in Euros per patient-year (€PY). Results A total of 1953 medical records (938 from 2006 and 1015 from 2012) were included. There were no significant differences in adjusted HbA1c, systolic blood pressure and HDL-C, while significant reductions were observed in LDL-C and triglycerides. In 2012, a higher proportion of patients were prescribed glucose-lowering, lipid-lowering and antihypertensive medications. Almost 4 out of 10 patients were prescribed the new incretin-based medications, while the use of older drugs, except for metformin, decreased. A significant increase in the adjusted glucose-lowering prescription cost (612.4 [586.5-638.2] €PY vs 390.7 [363.5-418.0]; p < 0.001) and total prescription cost (1306.7 [1264.6-1348.7] €PY vs 1122.3[1078.1-1166.5]; p < 0.001) was observed. The cost of antihypertensive prescriptions declined, while no difference was observed for lipid-lowering and antiplatelet agents. Conclusions During the economic crisis, the cardiovascular risk indices of Greek patients with type 2 diabetes being followed in public outpatient diabetes clinics did not deteriorate and in the case of lipid profile improved. However, the total prescription cost increased, mainly due to the higher cost of glucose-lowering prescriptions. PMID:24593679

  4. [Quality management systems in drugs regulatory authorities: social impact].

    PubMed

    Frías-Ferreiro, G; Ysa-Sánchez, A M; García-Gutiérrez, B; García-García, V

    2010-01-01

    The aim of this paper is to illustrate the social impact of drugs regulatory authorities' procedures, viewed from the perspective of the implementation of a quality management system. A review of drug regulations and their influence on quality and health systems is described.

  5. Designer drugs 2015: assessment and management.

    PubMed

    Weaver, Michael F; Hopper, John A; Gunderson, Erik W

    2015-03-25

    Recent designer drugs, also known as "legal highs," include substituted cathinones (e.g., mephedrone, methylone, and methylenedioxypyrovalerone, often referred to as "bath salts"); synthetic cannabinoids (SCs; e.g., Spice); and synthetic hallucinogens (25I-NBOMe, or N-bomb). Compound availability has evolved rapidly to evade legal regulation and detection by routine drug testing. Young adults are the primary users, but trends are changing rapidly; use has become popular among members of the military. Acute toxicity is common and often manifests with a constellation of psychiatric and medical effects, which may be severe (e.g., anxiety, agitation, psychosis, and tachycardia), and multiple deaths have been reported with each of these types of designer drugs. Clinicians should keep designer drugs in mind when evaluating substance use in young adults or in anyone presenting with acute neuropsychiatric complaints. Treatment of acute intoxication involves supportive care targeting manifesting signs and symptoms. Long-term treatment of designer drug use disorder can be challenging and is complicated by a lack of evidence to guide treatment.

  6. Collaborative drug therapy management and its application to pharmaceutical compounding.

    PubMed

    Anderson, Derick

    2007-01-01

    Patient care within the US healthcare system is changing constantly, as are the roles of healthcare practitioners, including pharmacists. For over 30 years, pharmacists have promoted the concept of clinical pharmacy, which places pharmacists in a central role in patient medication management. The goal is to allow the pharmacist to become a vital part of treatment planning by individualizing patients' therapeutic regimens. The Collaborative Drug Therapy Management agreement is a step toward that goal. The combination of drug therapy management and compounding pharmacy can be powerful in meeting patients' specific needs. PMID:23974486

  7. [Study methods of drugs in Alzheimer disease].

    PubMed

    Dubois, B; Stehlé, B; Lehner, J P; Derouesné, C; Bourin, M; Lamour, Y; Blin, O; Jourdain, G; Alperovitch, A

    1996-01-01

    The availability of new drugs for Alzheimer's disease, with different pharmacological profiles, leads to a redefinition the relevant methodology for developing drugs in this indication, including the inclusion/exclusion criteria, the duration of the studies, and therefore, the relevant guidelines. This was the purpose of the Giens Round-table devoted to the new methodology for drug development in Alzheimer disease.

  8. Health concerns and management of select veterinary drug residues.

    PubMed

    Baynes, Ronald E; Dedonder, Keith; Kissell, Lindsey; Mzyk, Danielle; Marmulak, Tara; Smith, Geof; Tell, Lisa; Gehring, Ronette; Davis, Jennifer; Riviere, Jim E

    2016-02-01

    The aim of this manuscript is to review the potential adverse health effects in humans if exposed to residues of selected veterinary drugs used in food-producing animals. Our other objectives are to briefly inform the reader of why many of these drugs are or were approved for use in livestock production and how drug residues can be mitigated for these drugs. The selected drugs include several antimicrobials, beta agonists, and phenylbutazone. The antimicrobials continue to be of regulatory concern not only because of their acute adverse effects but also because their use as growth promoters have been linked to antimicrobial resistance. Furthermore, nitroimidazoles and arsenicals are no longer approved for use in food animals in most jurisdictions. In recent years, the risk assessment and risk management of beta agonists, have been the focus of national and international agencies and this manuscript attempts to review the pharmacology of these drugs and regulatory challenges. Several of the drugs selected for this review can cause noncancer effects (e.g., penicillins) and others are potential carcinogens (e.g., nitroimidazoles). This review also focuses on how regulatory and independent organizations manage the risk of these veterinary drugs based on data from human health risk assessments.

  9. Management Development Study.

    ERIC Educational Resources Information Center

    Department of Transportation, Washington, DC.

    This document reports on a management development study within the Department of Transportation (DOT). The aim of the study was to develop a systematic approach to management development for military and civilian personnel. A variety of methods was used to gather data including having DOT staff members gather the information to be passed on to the…

  10. The implications of urine drug testing in pain management.

    PubMed

    Vadivelu, Nalini; Chen, Isabel L; Kodumudi, Vijay; Ortigosa, Esperanza; Gudin, Maria Teresa

    2010-07-01

    In the treatment of pain management, physicians employ a variety of drugs, ranging from low-impact to highly potent, and to maximize patient health, urine toxicology analyses can significantly improve the delivery of pain treatment. Drugs such as opioids that are used for pain management are peculiar in that they provide effective pain relief and have a high risk of addiction. The use of illicit drugs in the general population has been on the rise; however, self-reporting and close monitoring of patient behavior are insufficient means to detect drug abuse and confirm compliance. Therefore, in order to create more effective drug treatment plans, physicians must understand and account for the implications of patient drug use history. Urine toxicology analysis is an important tool for pain physicians because it is more sensitive than most alternative blood tests, more efficient and cost-effective. Urine testing in addition to improving patient pain management also has forensic and legal implications. There are however limitations to urine toxicology methods as they can produce false-positive and false-negative results and are prone to human error and sample contamination There is also a need for more specific and rapid urine drug testing. Healthcare professionals should therefore be familiar with the limitations of various urine drug testing methods, and possess skills necessary to properly interpret these results. This review suggests that the overall benefits incurred by both the patient's short-term and long-term health support the routine integration of urine toxicology analysis in routine clinical care. In addition to improving health care and patient health, it has a strong potential to improve patient-physician relationships and protects the interest of involved healthcare practitioners.

  11. Identification and management of prescription drug abuse in pregnancy.

    PubMed

    Worley, Julie

    2014-01-01

    Prescription drug abuse is a growing problem in the United States and many other countries. Estimates of prescription drug abuse rates during pregnancy range from 5% to 20%. The primary prescription drugs designated as controlled drugs with abuse potential in pregnancy are opiates prescribed for pain, benzodiazepines prescribed for anxiety, and stimulants prescribed for attention-deficit/hyperactivity disorder. Prescription drugs are obtained for abuse through diversion methods, such as purchasing them from others or by doctor shopping. The use of prescription drugs puts both the mother and the fetus at high risk during pregnancy. Identification of women who are abusing prescription drugs is important so that treatment can be ensured. It is crucial for healthcare professionals to use a multidisciplinary approach and be supportive and maintain a good rapport with pregnant women who abuse prescription drugs. Management includes inpatient hospitalization for detoxification and withdrawal symptoms, and in the case of opiate abuse, opiate maintenance is recommended for pregnant women for the duration of their pregnancy to reduce relapse rates and improve maternal and fetal outcomes. Other recommendations include referral for support groups and supportive housing. PMID:25062521

  12. Identification and management of prescription drug abuse in pregnancy.

    PubMed

    Worley, Julie

    2014-01-01

    Prescription drug abuse is a growing problem in the United States and many other countries. Estimates of prescription drug abuse rates during pregnancy range from 5% to 20%. The primary prescription drugs designated as controlled drugs with abuse potential in pregnancy are opiates prescribed for pain, benzodiazepines prescribed for anxiety, and stimulants prescribed for attention-deficit/hyperactivity disorder. Prescription drugs are obtained for abuse through diversion methods, such as purchasing them from others or by doctor shopping. The use of prescription drugs puts both the mother and the fetus at high risk during pregnancy. Identification of women who are abusing prescription drugs is important so that treatment can be ensured. It is crucial for healthcare professionals to use a multidisciplinary approach and be supportive and maintain a good rapport with pregnant women who abuse prescription drugs. Management includes inpatient hospitalization for detoxification and withdrawal symptoms, and in the case of opiate abuse, opiate maintenance is recommended for pregnant women for the duration of their pregnancy to reduce relapse rates and improve maternal and fetal outcomes. Other recommendations include referral for support groups and supportive housing.

  13. The Global Drug Facility: a unique, holistic and pioneering approach to drug procurement and management

    PubMed Central

    Ryan, Timothy

    2007-01-01

    Abstract In January 2006, the Stop TB Partnership launched the Global Plan to Stop TB 2006–2015, which describes the actions and resources needed to reduce tuberculosis (TB) incidence, prevalence and deaths. A fundamental aim of the Global Plan is to expand equitable access to affordable high-quality anti-tuberculous drugs and diagnostics. A principal tool developed by the Stop TB Partnership to achieve this is the Global Drug Facility (GDF). This paper demonstrates the GDF’s unique, holistic and pioneering approach to drug procurement and management by analysing its key achievements. One of these has been to provide 9 million patient-treatments to 78 countries in its first 6 years of operation. The GDF recognized that the incentives provided by free or affordable anti-tuberculosis drugs are not sufficient to induce governments to improve their programmes’ standards and coverage, nor does the provision of free or affordable drugs guarantee that there is broad access to, and use of, drug treatment in cases where procurement systems are weak, regulatory hurdles exist or there are unreliable distribution and storage systems. Thus, the paper also illustrates how the GDF has contributed towards making sustained improvements in the capacity of countries worldwide to properly manage their anti-TB drugs. This paper also assesses some of the limitations, shortcomings and risks associated with the model. The paper concludes by examining the GDF’s key plans and strategies for the future, and the challenges associated with implementation. PMID:17639218

  14. 77 FR 65000 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-24

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... (REMS) with Elements to Assure Safe Use (ETASU) before CDER's Drug Safety and Risk Management...

  15. 77 FR 75176 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-19

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice..., 2012, Drug Safety and Risk Management Advisory Committee meeting due to unanticipated weather conditions caused by Hurricane Sandy. Name of Committee: Drug Safety and Risk Management Advisory...

  16. 77 FR 34051 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-08

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm....

  17. Clinical features and management of intoxication due to hallucinogenic drugs.

    PubMed

    Leikin, J B; Krantz, A J; Zell-Kanter, M; Barkin, R L; Hryhorczuk, D O

    1989-01-01

    Hallucinogenic drugs are unique in that they produce the desired hallucinogenic effects at what are considered non-toxic doses. The hallucinogenic drugs can be categorised into 4 basic groups: indole alkaloid derivatives, piperidine derivatives, phenylethylamines and the cannabinols. The drugs reviewed include lysergic acid diethylamide (LSD), phencyclidine (PCP), cocaine, amphetamines, opiates, marijuana, psilocybin, mescaline, and 'designer drugs.' Particularly noteworthy is that each hallucinogen produces characteristic behavioural effects which are related to its serotonergic, dopaminergic or adrenergic activity. Cocaine produces simple hallucinations, PCP can produce complex hallucinations analogous to a paranoid psychosis, while LSD produces a combination of hallucinations, pseudohallucinations and illusions. Dose relationships with changes in the quality of the hallucinatory experience have been described with amphetamines and, to some extent, LSD. Flashbacks have been described with LSD and alcohol. Management of the intoxicated patient is dependent on the specific behavioural manifestation elicited by the drug. The principles involve differentiating the patient's symptoms from organic (medical or toxicological) and psychiatric aetiologies and identifying the symptom complex associated with the particular drug. Panic reactions may require treatment with a benzodiazepine or haloperidol. Patients with LSD psychosis may require an antipsychotic. Patients exhibiting prolonged drug-induced psychosis may require a variety of treatments including ECT, lithium and l-5-hydroxytryptophan.

  18. [Pain management with herbal antirheumatic drugs].

    PubMed

    Chrubasik, Sigrun; Pollak, S

    2002-01-01

    Herbal antirheumatics are indicated in painful inflammatory and degenerative rheumatic diseases. Their mechanism of action is broader than that of synthetic antirheumatics. Particular preparations from Devils's Claw with 50 to 100 mg of harpagoside in the daily dosage as well as a particular willow bark extract with 120 to 240 mg salicin in the daily dosage proved efficacy in a number of clinical studies including confirmatory ones. Exploratory studies indicate that these herbal antirheumatics were not inferior to the selective COX-2 inhibitor rofecoxib when treating acute exacerbations of chronic low back pain. For the proprietary nettle root extract IDS23 promising in vitro/in vivo results indicate an anti-inflammatory effect, however there are only 2 open uncontrolled clinical studies available and the proof of efficacy is still missing. Safety data in order to recommend use during pregnancy and lactation are only available for the herbal combination product Phytodolor prepared from aspen, ash and goldenrod. In principle, blackcurrent leaf with not less than 1.5% flavonoids may be an appropriate antirheumatic. Likewise, the seed oils of blackcurrent, evening primrose and borage offering at least 1 to 3 g gammalinolenic acid/day are recommendable. In case superiority versus placebo has been established, proprietary herbal antirheumatics should be administered before the conventional analgesics due to the lower incidence of adverse events. PMID:12017748

  19. An Oral Contraceptive Drug Interaction Study

    ERIC Educational Resources Information Center

    Bradstreet, Thomas E.; Panebianco, Deborah L.

    2004-01-01

    This article focuses on a two treatment, two period, two treatment sequence crossover drug interaction study of a new drug and a standard oral contraceptive therapy. Both normal theory and distribution-free statistical analyses are provided along with a notable amount of graphical insight into the dataset. For one of the variables, the decision on…

  20. Drug sample management in University of Montreal family medicine teaching units

    PubMed Central

    Lussier, Marie-Thérèse; Vanier, Marie-Claude; Authier, Marie; Diallo, Fatoumata Binta; Gagnon, Justin

    2015-01-01

    Abstract Objective To describe the management and distribution of drug samples in family medicine teaching units (FMUs). Design Cross-sectional descriptive study. Setting All 16 FMUs affiliated with the Department of Family Medicine and Emergency Medicine at the University of Montreal in Quebec. Participants Health care professionals (physicians, residents, pharmacists, and nurses) who manage (n = 22) and dispense (n = 294) drug samples in the FMUs. Methods Data were collected between February and March 2013 using 2 self-administered questionnaires completed by health care professionals who manage or dispense drug samples. The data were subjected to descriptive and bivariate analyses. Results The participation rate was 100.0% for staff who manage drug samples and 72.5% for those who dispense them. Of the 16 participating FMUs, 12 have drug sample cabinets. Eight of the FMUs have a written institutional policy governing the management of drug samples. Of the 76.2% of respondents who said they distributed samples, more than half did not know whether their institution had a policy. In 7 of 12 FMUs with drug sample cabinets, access to samples is not restricted to those authorized to prescribe medications. Cabinets are most often managed by nurses (9 of 12 FMUs). Only 4 of 12 FMUs take regular inventory of cabinet contents. The main reasons cited for dispensing samples were to help a patient financially and to test for tolerance and efficacy when initiating or modifying a treatment for a patient. Three-quarters (78.2%) of dispensers reported that sometimes they were unable to find the drug they wanted in the cabinet; half of those consequently gave patients drugs that were not their first choice. More than half the dispensers reported they never or only occasionally referred patients to their community pharmacists. Conclusion A portrait of drug sample management and dispensation in the academic FMUs emerged from this study. This study provides insight into current

  1. Monitoring Adverse Drug Reactions: A Preliminary Study

    PubMed Central

    Reynolds, J. L.

    1981-01-01

    The feasibility of family physicians functioning as monitors of adverse drug reactions (ADR) was examined over one month in ten practices. This was done as a preliminary trial, before attempting to use the 200 family physicians of the National Reporting System of the College of Family Physicians of Canada to monitor ADRs on a national basis. Both of these trials were designed to examine the feasibility of family physicians acting as prospective monitors of ADRs in newly marketed drugs and to identify a drug group suitable for monitoring. This study examined the detection of ADRs, prescribing and practice profiles. No firm conclusion could be reached as to the value of family doctors monitoring ADRs. This study supports the evidence that older patients receive more drugs and are at even greater risk of an ADR. Antibiotics, cardiovascular, anti-inflammatory or antidepressant drugs are suggested as those most suitable for prospective monitoring in a family practice setting. PMID:21289786

  2. Role of antiepileptic drugs in the management of eating disorders.

    PubMed

    McElroy, Susan L; Guerdjikova, Anna I; Martens, Brian; Keck, Paul E; Pope, Harrison G; Hudson, James I

    2009-01-01

    Growing evidence suggests that antiepileptic drugs (AEDs) may be useful in managing some eating disorders. In the present paper, we provide a brief overview of eating disorders, the rationale for using AEDs in the treatment of these disorders and review the data supporting the effectiveness of specific AEDs in the treatment of patients with eating disorders. In addition, the potential mechanisms of action of AEDs in these conditions are discussed. Of the available AEDs, topiramate appears to have the broadest spectrum of action as an anti-binge eating, anti-purging and weight loss agent, as demonstrated in two placebo-controlled studies in bulimia nervosa and three placebo-controlled studies in binge-eating disorder (BED) with obesity. Topiramate may also have beneficial effects in night-eating syndrome and sleep-related eating disorder, but controlled trials in these conditions are needed. The results of one small controlled study suggest that zonisamide may have efficacy in BED with obesity. However, both topiramate and zonisamide are associated with adverse effect profiles that may limit their use in patients with eating disorders. Phenytoin may be effective in some patients with compulsive binge eating, particularly if co-morbid EEG abnormalities are present, but available data are too varied to allow definitive conclusions to be made. Carbamazepine and valproate may be effective in treating patients with bulimia nervosa or anorexia nervosa when they are used to treat an associated psychiatric (e.g. mood) or neurological (e.g. seizure) disorder; otherwise, both agents, particularly valproate, are associated with weight gain. In conclusion, AEDs have an emerging role in the management of some eating disorders.

  3. Why Hospital Pharmacists Have Failed to Manage Antimalarial Drugs Stock-Outs in Pakistan? A Qualitative Insight

    PubMed Central

    Hassali, Mohamed Azmi Ahmad; Shafie, Asrul Akmal; Hussain, Azhar

    2013-01-01

    Purpose. This study aimed to explore the perceptions of hospital pharmacists towards drug management and reasons underlying stock-outs of antimalarial drugs in Pakistan. Methods. A qualitative study was designed to explore the perceptions of hospital pharmacists regarding drug management and irrational use of antimalarial drugs in two major cities of Pakistan, namely, Islamabad (national capital) and Rawalpindi (twin city). Semistructured interviews were conducted with 16 hospital pharmacists using indepth interview guides at a place and time convenient for the respondents. Interviews, which were audiotaped and transcribed verbatim, were evaluated by thematic content analysis and by other authors' analysis. Results. Most of the respondents were of the view that financial constraints, inappropriate drug management, and inadequate funding were the factors contributing toward the problem of antimalarial drug stock-outs in healthcare facilities of Pakistan. The pharmacists anticipated that prescribing by nonproprietary names, training of health professionals, accepted role of hospital pharmacist in drug management, implementation of essential drug list and standard treatment guidelines for malaria in the healthcare system can minimize the problem of drug stock outs in healthcare system of Pakistan. Conclusion. The current study showed that all the respondents in the two cities agreed that hospital pharmacist has failed to play an effective role in efficient management of anti-malarial drugs stock-outs. PMID:24223321

  4. The VACS Index Accurately Predicts Mortality and Treatment Response among Multi-Drug Resistant HIV Infected Patients Participating in the Options in Management with Antiretrovirals (OPTIMA) Study

    PubMed Central

    Brown, Sheldon T.; Tate, Janet P.; Kyriakides, Tassos C.; Kirkwood, Katherine A.; Holodniy, Mark; Goulet, Joseph L.; Angus, Brian J.; Cameron, D. William; Justice, Amy C.

    2014-01-01

    Objectives The VACS Index is highly predictive of all-cause mortality among HIV infected individuals within the first few years of combination antiretroviral therapy (cART). However, its accuracy among highly treatment experienced individuals and its responsiveness to treatment interventions have yet to be evaluated. We compared the accuracy and responsiveness of the VACS Index with a Restricted Index of age and traditional HIV biomarkers among patients enrolled in the OPTIMA study. Methods Using data from 324/339 (96%) patients in OPTIMA, we evaluated associations between indices and mortality using Kaplan-Meier estimates, proportional hazards models, Harrel’s C-statistic and net reclassification improvement (NRI). We also determined the association between study interventions and risk scores over time, and change in score and mortality. Results Both the Restricted Index (c = 0.70) and VACS Index (c = 0.74) predicted mortality from baseline, but discrimination was improved with the VACS Index (NRI = 23%). Change in score from baseline to 48 weeks was more strongly associated with survival for the VACS Index than the Restricted Index with respective hazard ratios of 0.26 (95% CI 0.14–0.49) and 0.39(95% CI 0.22–0.70) among the 25% most improved scores, and 2.08 (95% CI 1.27–3.38) and 1.51 (95%CI 0.90–2.53) for the 25% least improved scores. Conclusions The VACS Index predicts all-cause mortality more accurately among multi-drug resistant, treatment experienced individuals and is more responsive to changes in risk associated with treatment intervention than an index restricted to age and HIV biomarkers. The VACS Index holds promise as an intermediate outcome for intervention research. PMID:24667813

  5. Thermodynamic Studies for Drug Design and Screening

    PubMed Central

    Garbett, Nichola C.; Chaires, Jonathan B.

    2012-01-01

    Introduction A key part of drug design and development is the optimization of molecular interactions between an engineered drug candidate and its binding target. Thermodynamic characterization provides information about the balance of energetic forces driving binding interactions and is essential for understanding and optimizing molecular interactions. Areas covered This review discusses the information that can be obtained from thermodynamic measurements and how this can be applied to the drug development process. Current approaches for the measurement and optimization of thermodynamic parameters are presented, specifically higher throughput and calorimetric methods. Relevant literature for this review was identified in part by bibliographic searches for the period 2004 – 2011 using the Science Citation Index and PUBMED and the keywords listed below. Expert opinion The most effective drug design and development platform comes from an integrated process utilizing all available information from structural, thermodynamic and biological studies. Continuing evolution in our understanding of the energetic basis of molecular interactions and advances in thermodynamic methods for widespread application are essential to realize the goal of thermodynamically-driven drug design. Comprehensive thermodynamic evaluation is vital early in the drug development process to speed drug development towards an optimal energetic interaction profile while retaining good pharmacological properties. Practical thermodynamic approaches, such as enthalpic optimization, thermodynamic optimization plots and the enthalpic efficiency index, have now matured to provide proven utility in design process. Improved throughput in calorimetric methods remains essential for even greater integration of thermodynamics into drug design. PMID:22458502

  6. Therapeutic drug monitoring: A patient management tool for precision medicine.

    PubMed

    Jang, S H; Yan, Z; Lazor, J A

    2016-02-01

    The precision medicine initiative is designed to better understand the causes of disease, to develop target therapies, and to identify patients that would benefit from treatment. Prescribing the right dose, which is not always the same to all patients, is needed for a successful outcome. The purpose of this commentary is to discuss the role of dose individualization based on therapeutic drug monitoring as a clinical patient management tool in the application of precision medicine.

  7. 75 FR 23782 - Drug Safety and Risk Management Advisory Committee; Notice of Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... HUMAN SERVICES Food and Drug Administration Drug Safety and Risk Management Advisory Committee; Notice... be open to the public. Name of Committee: Drug Safety and Risk Management Advisory Committee. General... risks of dextromethorphan use as a cough suppressant in prescription and nonprescription drug...

  8. A theoretical examination of the relative importance of evolution management and drug development for managing resistance.

    PubMed

    McClure, Nathan S; Day, Troy

    2014-12-22

    Drug resistance is a serious public health problem that threatens to thwart our ability to treat many infectious diseases. Repeatedly, the introduction of new drugs has been followed by the evolution of resistance. In principle, there are two complementary ways to address this problem: (i) enhancing drug development and (ii) slowing the evolution of drug resistance through evolutionary management. Although these two strategies are not mutually exclusive, it is nevertheless worthwhile considering whether one might be inherently more effective than the other. We present a simple mathematical model that explores how interventions aimed at these two approaches affect the availability of effective drugs. Our results identify an interesting feature of evolution management that, all else equal, tends to make it more effective than enhancing drug development. Thus, although enhancing drug development will necessarily be a central part of addressing the problem of resistance, our results lend support to the idea that evolution management is probably a very significant component of the solution as well.

  9. A theoretical examination of the relative importance of evolution management and drug development for managing resistance

    PubMed Central

    McClure, Nathan S.; Day, Troy

    2014-01-01

    Drug resistance is a serious public health problem that threatens to thwart our ability to treat many infectious diseases. Repeatedly, the introduction of new drugs has been followed by the evolution of resistance. In principle, there are two complementary ways to address this problem: (i) enhancing drug development and (ii) slowing the evolution of drug resistance through evolutionary management. Although these two strategies are not mutually exclusive, it is nevertheless worthwhile considering whether one might be inherently more effective than the other. We present a simple mathematical model that explores how interventions aimed at these two approaches affect the availability of effective drugs. Our results identify an interesting feature of evolution management that, all else equal, tends to make it more effective than enhancing drug development. Thus, although enhancing drug development will necessarily be a central part of addressing the problem of resistance, our results lend support to the idea that evolution management is probably a very significant component of the solution as well. PMID:25377456

  10. Vaccine and Drug Ontology Studies (VDOS 2014).

    PubMed

    Tao, Cui; He, Yongqun; Arabandi, Sivaram

    2016-01-01

    The "Vaccine and Drug Ontology Studies" (VDOS) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have been critical to prevent and treat human and animal diseases. Work in both (drugs and vaccines) areas is closely related - from preclinical research and development to manufacturing, clinical trials, government approval and regulation, and post-licensure usage surveillance and monitoring. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs - extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, developing new models such as the Vaccine Ontology (VO) and Ontology of Adverse Events (OAE), vernacular medical terminologies such as the Consumer Health Vocabulary (CHV). The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The five full-length papers included in this 2014 thematic issue focus on two main themes: (i) General vaccine/drug-related ontology development and exploration, and (ii) Interaction and network-related ontology studies.

  11. Management of drug interactions with beta-blockers: continuing education has a short-term impact

    PubMed Central

    Driesen, Annelies; Simoens, Steven; Laekeman, Gert

    There is a lack of clear guidelines regarding the management of drug-drug interactions. Objective To assess the impact of an educational intervention on the management of drug interactions with beta-blockers. Methods The study had a controlled before-and-after design. The intervention group (n=10 pharmacies) received a continuing education course and guidelines on the management of drug interactions with beta-blockers. The control group (n=10 pharmacies) received no intervention. Pharmacy students and staff of internship pharmacies participated in this study. Before and after the intervention, students registered interactions with beta-blockers during two weeks. Information was obtained on drug information of the beta-blocker and the interacting drug, patient’s demographics, and the mode of transaction. Results A total number of 288 interactions were detected during both study periods. Most beta-blockers causing an interaction were prescribed for hypertension, and interacted with hypoglycemic agents, NSAIDs, or beta2-agonists. Pharmacists’ intervention rate was low (14% in the pre-test compared to 39% in the post-test), but increased significantly in the post-test in the intervention group. Reasons for overriding the interaction included limited clinical relevance, refill prescriptions, not being aware of the interaction, and communication problems with the prescriber. Conclusion An interactive continuing education course, during which practice-oriented guidelines were offered, affected pharmacists’ short-term behavior at the counter in dealing with interactions of beta-blockers. Continuing education plays a role in raising pharmacists’ awareness and responsibility towards the detection and management of drug interactions in the pharmacy. PMID:25214902

  12. Drug nanocarrier, the future of atopic diseases: Advanced drug delivery systems and smart management of disease.

    PubMed

    Shao, Mei; Hussain, Zahid; Thu, Hnin Ei; Khan, Shahzeb; Katas, Haliza; Ahmed, Tarek A; Tripathy, Minaketan; Leng, Jing; Qin, Hua-Li; Bukhari, Syed Nasir Abbas

    2016-11-01

    Atopic dermatitis (AD) is a chronically relapsing skin inflammatory disorder characterized by perivascular infiltration of immunoglobulin-E (IgE), T-lymphocytes and mast cells. The key pathophysiological factors causing this disease are immunological disorders and the compromised epidermal barrier integrity. Pruritus, intense itching, psychological stress, deprived physical and mental performance and sleep disturbance are the hallmark features of this dermatological complication. Preventive interventions which include educational programs, avoidance of allergens, exclusive care towards skin, and the rational selection of therapeutic regimen play key roles in the treatment of dermatosis. In last two decades, it is evident from a plethora of studies that scientific focus is being driven from conventional therapies to the advanced nanocarrier-based regimen for an effective management of AD. These nanocarriers which include polymeric nanoparticles (NPs), hydrogel NPs, liposomes, ethosomes, solid lipid nanoparticles (SLNs) and nanoemulsion, provide efficient roles for the target specific delivery of the therapeutic payload. The success of these targeted therapies is due to their pharmaceutical versatility, longer retention time at the target site, avoiding off-target effects and preventing premature degradation of the incorporated drugs. The present review was therefore aimed to summarise convincing evidence for the therapeutic superiority of advanced nanocarrier-mediated strategies over the conventional therapies used in the treatment of AD.

  13. Drug nanocarrier, the future of atopic diseases: Advanced drug delivery systems and smart management of disease.

    PubMed

    Shao, Mei; Hussain, Zahid; Thu, Hnin Ei; Khan, Shahzeb; Katas, Haliza; Ahmed, Tarek A; Tripathy, Minaketan; Leng, Jing; Qin, Hua-Li; Bukhari, Syed Nasir Abbas

    2016-11-01

    Atopic dermatitis (AD) is a chronically relapsing skin inflammatory disorder characterized by perivascular infiltration of immunoglobulin-E (IgE), T-lymphocytes and mast cells. The key pathophysiological factors causing this disease are immunological disorders and the compromised epidermal barrier integrity. Pruritus, intense itching, psychological stress, deprived physical and mental performance and sleep disturbance are the hallmark features of this dermatological complication. Preventive interventions which include educational programs, avoidance of allergens, exclusive care towards skin, and the rational selection of therapeutic regimen play key roles in the treatment of dermatosis. In last two decades, it is evident from a plethora of studies that scientific focus is being driven from conventional therapies to the advanced nanocarrier-based regimen for an effective management of AD. These nanocarriers which include polymeric nanoparticles (NPs), hydrogel NPs, liposomes, ethosomes, solid lipid nanoparticles (SLNs) and nanoemulsion, provide efficient roles for the target specific delivery of the therapeutic payload. The success of these targeted therapies is due to their pharmaceutical versatility, longer retention time at the target site, avoiding off-target effects and preventing premature degradation of the incorporated drugs. The present review was therefore aimed to summarise convincing evidence for the therapeutic superiority of advanced nanocarrier-mediated strategies over the conventional therapies used in the treatment of AD. PMID:27592075

  14. An Effectiveness Trial of Contingency Management in a Felony Preadjudication Drug Court

    ERIC Educational Resources Information Center

    Marlowe, Douglas B.; Festinger, David S.; Dugosh, Karen L.; Arabia, Patricia L.; Kirby, Kimberly C.

    2008-01-01

    This study evaluated a contingency management (CM) program in a drug court. Gift certificates for compliance were delivered at 4- to 6-week intervals (total value = $390.00). Participants in one condition earned gift certificates that escalated by $5.00 increments. Participants in a second condition began earning higher magnitude gift…

  15. Management of noninfectious posterior uveitis with intravitreal drug therapy

    PubMed Central

    Tan, Hui Yi; Agarwal, Aniruddha; Lee, Cecilia S; Chhablani, Jay; Gupta, Vishali; Khatri, Manoj; Nirmal, Jayabalan; Pavesio, Carlos; Agrawal, Rupesh

    2016-01-01

    Uveitis is an important cause of vision loss worldwide due to its sight-threatening complications, especially cystoid macular edema, as well as choroidal neovascularization, macular ischemia, cataract, and glaucoma. Systemic corticosteroids are the mainstay of therapy for noninfectious posterior uveitis; however, various systemic side effects can occur. Intravitreal medication achieves a therapeutic level in the vitreous while minimizing systemic complications and is thus used as an exciting alternative. Corticosteroids, antivascular endothelial growth factors, immunomodulators such as methotrexate and sirolimus, and nonsteroidal anti-inflammatory drugs are currently available for intravitreal therapy. This article reviews the existing literature for efficacy and safety of these various options for intravitreal drug therapy for the management of noninfectious uveitis (mainly intermediate, posterior, and panuveitis). PMID:27789936

  16. Salivary Secretory Disorders, Inducing Drugs, and Clinical Management

    PubMed Central

    Miranda-Rius, Jaume; Brunet-Llobet, Lluís; Lahor-Soler, Eduard; Farré, Magí

    2015-01-01

    Background: Salivary secretory disorders can be the result of a wide range of factors. Their prevalence and negative effects on the patient's quality of life oblige the clinician to confront the issue. Aim: To review the salivary secretory disorders, inducing drugs and their clinical management. Methods: In this article, a literature search of these dysfunctions was conducted with the assistance of a research librarian in the MEDLINE/PubMed Database. Results: Xerostomia, or dry mouth syndrome, can be caused by medication, systemic diseases such as Sjögren's Syndrome, glandular pathologies, and radiotherapy of the head and neck. Treatment of dry mouth is aimed at both minimizing its symptoms and preventing oral complications with the employment of sialogogues and topical acting substances. Sialorrhea and drooling, are mainly due to medication or neurological systemic disease. There are various therapeutic, pharmacologic, and surgical alternatives for its management. The pharmacology of most of the substances employed for the treatment of salivary disorders is well-known. Nevertheless, in some cases a significant improvement in salivary function has not been observed after their administration. Conclusion: At present, there are numerous frequently prescribed drugs whose unwanted effects include some kind of salivary disorder. In addition, the differing pathologic mechanisms, and the great variety of existing treatments hinder the clinical management of these patients. The authors have designed an algorithm to facilitate the decision making process when physicians, oral surgeons, or dentists face these salivary dysfunctions. PMID:26516310

  17. AIPRC--BIA Management Study: Personnel Management

    ERIC Educational Resources Information Center

    American Indian Journal, 1976

    1976-01-01

    Continuing the American Indian Policy Review Commission's (AIPRC) Bureau of Indian Affairs (BIA) Management Study, this article reviews the divisions of responsibility, Indian preference, recruitment and hiring problems, training, labor relations, and internal communication. (NQ)

  18. [Adaptive clinical study methodologies in drug development].

    PubMed

    Antal, János

    2015-11-29

    The evolution of drug development in human, clinical phase studies triggers the overview of those technologies and procedures which are labelled as adaptive clinical trials. The most relevant procedural and operational aspects will be discussed in this overview from points of view of clinico-methodological aspect.

  19. Mapping lifecycle management activities for blockbuster drugs in Japan based on drug approvals and patent term extensions.

    PubMed

    Yamanaka, Takayuki; Kano, Shingo

    2016-02-01

    Drug lifecycle management (LCM), which entails acquiring drug approvals and patent protections, contributes to maximizing drug discovery investment returns. In a previous survey, a comparative analysis between Japan and the USA indicated that a unique patent term extension system has an important role in Japanese drug LCM. Therefore, in this survey, we focused on drug approvals and patent term extensions, and found that the LCM for blockbuster drugs in Japan can be categorized into three types (drug approval-oriented LCM, patent term extension-oriented LCM, and inactive-type LCM), of which the first two have been implemented recently. Here, we suggest a strategy for selecting a suitable LCM approach among these three types based on the prospects for drug improvements.

  20. Diacerein: A potential therapeutic drug for the management of experimental periodontitis in rats

    PubMed Central

    Zaki, Basma Mostafa; Mahmoud, Enji Ahmed; Aly, Azza Ahmed

    2015-01-01

    Introduction: Knowledge about the pathogenic process in the progression of periodontal disease indicates that the central cause of periodontal disease is the loss of a healthy balance between microbial virulence factors and the host’s inflammatory response. The aim of this study was to evaluate the potential effectiveness of diacerein as an anti-inflammatory drug in the management of experimental periodontitis in rats. Methods: The study included 60 albino rats that were divided into two groups. Periodontitis was induced in both groups. The drug group received systemic administration of diacerein, and the control group received a placebo. IL-1ß was measured two weeks after the induction of periodontitis and before the administration of the drug (baseline measurement), and it was measured again at the end of two and end of four weeks after scaling and root planning and diacerein administration. Results: The results indicated that there was a significant decrease in IL-1ß level in both groups. For the control group, there were significant decreases of the IL-1ß values from the baseline to two weeks and also from the baseline to four weeks, with p-values of 0.0001 for both comparisons. The same results were obtained for the drug group. Conclusion: It was concluded that it is likely that diacerein may play a therapeutic role as a potent anti-inflammatory drug in the management of periodontitis. PMID:26435830

  1. Performance of online drug information databases as clinical decision support tools in infectious disease medication management.

    PubMed

    Polen, Hyla H; Zapantis, Antonia; Clauson, Kevin A; Clauson, Kevin Alan; Jebrock, Jennifer; Paris, Mark

    2008-01-01

    Infectious disease (ID) medication management is complex and clinical decision support tools (CDSTs) can provide valuable assistance. This study evaluated scope and completeness of ID drug information found in online databases by evaluating their ability to answer 147 question/answer pairs. Scope scores produced highest rankings (%) for: Micromedex (82.3), Lexi-Comp/American Hospital Formulary Service (81.0), and Medscape Drug Reference (81.0); lowest includes: Epocrates Online Premium (47.0), Johns Hopkins ABX Guide (45.6), and PEPID PDC (40.8). PMID:18999059

  2. Indicators of Club Management Practices and Biological Measurements of Patrons’ Drug and Alcohol Use

    PubMed Central

    Byrnes, Hilary F.; Miller, Brenda A.; Johnson, Mark B.; Voas, Robert B.

    2015-01-01

    Background Electronic Music Dance Events in nightclubs attract patrons with heavy alcohol/drug use. Public health concerns are raised from risks related to these behaviors. Practices associated with increased risk in these club settings need to be identified. Objectives The relationship between club management practices and biological measures of patrons’ alcohol/drug use is examined. Methods Observational data from 25 events across 6 urban clubs were integrated with survey data (N=738 patrons, 42.8% female) from patrons exiting these events, 2010–2012. Five indicators of club management practices were examined using mixed model regressions: club security, bar crowding, safety signs, serving intoxicated patrons, and isolation. Results Analyses revealed that serving intoxicated patrons and safety signs were related to less substance use. Specifically, serving intoxicated patrons was related to heavy alcohol and drug use at exit, while safety signs were marginally related to less exit drug use. Conclusions/Importance Findings indicate observable measures in nightclubs provide important indicators for alcohol/drug use, suggesting practices to target. Study strengths include the use of biological measures of substance use on a relatively large scale. Limitations and future directions are discussed. PMID:24832721

  3. Emerging Trends in the Use of Drugs to Manage the Challenging Behaviour of People with Intellectual Disability

    ERIC Educational Resources Information Center

    McGillivray, Jane A.; McCabe, Marita P.

    2006-01-01

    Background: Concerns about the pharmacological management of the behaviour of individuals with intellectual disability have resulted in the development of legislative and procedural controls. Method: This Australian study provided a comparison of 873 reported cases where drugs were administered to manage behaviour in March 2000, with 762 cases…

  4. Therapeutic Management of Familial Hypercholesterolemia: Current and Emerging Drug Therapies.

    PubMed

    Patel, Roshni S; Scopelliti, Emily M; Savelloni, Julie

    2015-12-01

    Familial hypercholesterolemia (FH) is a genetic disorder characterized by significantly elevated low-density lipoprotein cholesterol (LDL-C) concentrations that result from mutations of the LDL receptor, apolipoprotein B (apo B-100), and proprotein convertase subtilisin/kexin type 9 (PCSK9). Early and aggressive treatment can prevent premature atherosclerotic cardiovascular disease in these high-risk patients. Given that the cardiovascular consequences of FH are similar to typical hypercholesterolemia, traditional therapies are utilized to decrease LDL-C levels. Patients with FH should receive statins as first-line treatment; high-potency statins at high doses are often required. Despite the use of statins, additional treatments are often necessary to achieve appropriate LDL-C lowering in this patient population. Novel drug therapies that target the pathophysiologic defects of the condition are continuously emerging. Contemporary therapies including mipomersen (Kynamro, Genzyme), an oligonucleotide inhibitor of apo B-100 synthesis; lomitapide (Juxtapid, Aegerion), a microsomal triglyceride transfer protein inhibitor; and alirocumab (Praluent, Sanofi-Aventis/Regeneron) and evolocumab (Repatha, Amgen), PCSK9 inhibitors, are currently approved by the U.S. Food and Drug Administration for use in FH. This review highlights traditional as well as emerging contemporary therapies with supporting clinical data to evaluate current recommendations and discuss the future direction of FH management.

  5. Therapeutic Management of Familial Hypercholesterolemia: Current and Emerging Drug Therapies.

    PubMed

    Patel, Roshni S; Scopelliti, Emily M; Savelloni, Julie

    2015-12-01

    Familial hypercholesterolemia (FH) is a genetic disorder characterized by significantly elevated low-density lipoprotein cholesterol (LDL-C) concentrations that result from mutations of the LDL receptor, apolipoprotein B (apo B-100), and proprotein convertase subtilisin/kexin type 9 (PCSK9). Early and aggressive treatment can prevent premature atherosclerotic cardiovascular disease in these high-risk patients. Given that the cardiovascular consequences of FH are similar to typical hypercholesterolemia, traditional therapies are utilized to decrease LDL-C levels. Patients with FH should receive statins as first-line treatment; high-potency statins at high doses are often required. Despite the use of statins, additional treatments are often necessary to achieve appropriate LDL-C lowering in this patient population. Novel drug therapies that target the pathophysiologic defects of the condition are continuously emerging. Contemporary therapies including mipomersen (Kynamro, Genzyme), an oligonucleotide inhibitor of apo B-100 synthesis; lomitapide (Juxtapid, Aegerion), a microsomal triglyceride transfer protein inhibitor; and alirocumab (Praluent, Sanofi-Aventis/Regeneron) and evolocumab (Repatha, Amgen), PCSK9 inhibitors, are currently approved by the U.S. Food and Drug Administration for use in FH. This review highlights traditional as well as emerging contemporary therapies with supporting clinical data to evaluate current recommendations and discuss the future direction of FH management. PMID:26684558

  6. Managing drug-resistant epilepsy: challenges and solutions

    PubMed Central

    Dalic, Linda; Cook, Mark J

    2016-01-01

    Despite the development of new antiepileptic drugs (AEDs), ~20%–30% of people with epilepsy remain refractory to treatment and are said to have drug-resistant epilepsy (DRE). This multifaceted condition comprises intractable seizures, neurobiochemical changes, cognitive decline, and psychosocial dysfunction. An ongoing challenge to both researchers and clinicians alike, DRE management is complicated by the heterogeneity among this patient group. The underlying mechanism of DRE is not completely understood. Many hypotheses exist, and relate to both the intrinsic characteristics of the particular epilepsy (associated syndrome/lesion, initial response to AED, and the number and type of seizures prior to diagnosis) and other pharmacological mechanisms of resistance. The four current hypotheses behind pharmacological resistance are the “transporter”, “target”, “network”, and “intrinsic severity” hypotheses, and these are reviewed in this paper. Of equal challenge is managing patients with DRE, and this requires a multidisciplinary approach, involving physicians, surgeons, psychiatrists, neuropsychologists, pharmacists, dietitians, and specialist nurses. Attention to comorbid psychiatric and other diseases is paramount, given the higher prevalence in this cohort and associated poorer health outcomes. Treatment options need to consider the economic burden to the patient and the likelihood of AED compliance and tolerability. Most importantly, higher mortality rates, due to comorbidities, suicide, and sudden death, emphasize the importance of seizure control in reducing this risk. Overall, resective surgery offers the best rates of seizure control. It is not an option for all patients, and there is often a significant delay in referring to epilepsy surgery centers. Optimization of AEDs, identification and treatment of comorbidities, patient education to promote adherence to treatment, and avoidance of triggers should be periodically performed until further

  7. In vitro drug release mechanism and drug loading studies of cubic phase gels.

    PubMed

    Lara, Marilisa G; Bentley, M Vitória L B; Collett, John H

    2005-04-11

    Glyceryl monooleate/water cubic phase systems were investigated as drug delivery systems, using salicylic acid as a model drug. The liquid crystalline phases formed by the glyceryl monooleate (GMO)/water systems were characterized by polarizing microscopy. In vitro drug release studies were performed and the influences of initial water content, swelling and drug loading on the drug release properties were evaluated. Water uptake followed second-order swelling kinetics. In vitro release profiles showed Fickian diffusion control and were independent on the initial water content and drug loading, suggesting GMO cubic phase gels suitability for use as drug delivery system.

  8. Doctoral Women: Managing Emotions, Managing Doctoral Studies

    ERIC Educational Resources Information Center

    Aitchison, Claire; Mowbray, Susan

    2013-01-01

    This paper explores the experiences of women doctoral students and the role of emotion during doctoral candidature. The paper draws on the concept of emotional labour to examine the two sites of emotional investment students experienced and managed during their studies: writing and family relationships. Emotion is perceived by many dominant…

  9. PET IMAGING STUDIES IN DRUG ABUSE RESEARCH.

    SciTech Connect

    Fowler, J.S.; Volkow, N.D.; Ding, Y.S.; Logan, J.; Wang, G.J.

    2001-01-29

    . This will be followed by highlights of PET studies of the acute effects of the psychostimulant drugs cocaine and methylphenidate (ritalin) and studies of the chronic effects of cocaine and of tobacco smoke on the human brain. This chapter concludes with the description of a study which uses brain imaging coupled with a specific pharmacological challenge to address the age-old question of why some people who experiment with drugs become addicted while others do not.

  10. Data base management study

    NASA Technical Reports Server (NTRS)

    1976-01-01

    Data base management techniques and applicable equipment are described. Recommendations which will assist potential NASA data users in selecting and using appropriate data base management tools and techniques are presented. Classes of currently available data processing equipment ranging from basic terminals to large minicomputer systems were surveyed as they apply to the needs of potential SEASAT data users. Cost and capabilities projections for this equipment through 1985 were presented. A test of a typical data base management system was described, as well as the results of this test and recommendations to assist potential users in determining when such a system is appropriate for their needs. The representative system tested was UNIVAC's DMS 1100.

  11. Drug use among inner-city African American women: the process of managing loss.

    PubMed

    Roberts, C A

    1999-09-01

    The grounded theory study described in this article investigated illicit drug use in the lives of 32 drug-using women living in two inner-city neighborhoods of a large metropolitan U.S. city. The underlying purpose was to describe the process of how life situations and events influenced the onset of drug use and changes in drug-using behaviors. Analysis of in-depth interviews revealed several themes. The basic social process, managing loss, was identified. Painful feelings of loss resulted from the separation of someone or something from the lives of participants and included death or desertion of a significant other, loss of child custody, and rejection by a significant other. Emotional, physical, and sexual abuse resulted in a loss of ability to give and receive love and trust in oneself or others. Losses resulted in an escalation of drug use. Findings have implications for interventions to assist women in dealing with drug use, violence in their lives, self-care, and parenting.

  12. Drug use among inner-city African American women: the process of managing loss.

    PubMed

    Roberts, C A

    1999-09-01

    The grounded theory study described in this article investigated illicit drug use in the lives of 32 drug-using women living in two inner-city neighborhoods of a large metropolitan U.S. city. The underlying purpose was to describe the process of how life situations and events influenced the onset of drug use and changes in drug-using behaviors. Analysis of in-depth interviews revealed several themes. The basic social process, managing loss, was identified. Painful feelings of loss resulted from the separation of someone or something from the lives of participants and included death or desertion of a significant other, loss of child custody, and rejection by a significant other. Emotional, physical, and sexual abuse resulted in a loss of ability to give and receive love and trust in oneself or others. Losses resulted in an escalation of drug use. Findings have implications for interventions to assist women in dealing with drug use, violence in their lives, self-care, and parenting. PMID:10558371

  13. Online Availability and Safety of Drugs in Shortage: A Descriptive Study of Internet Vendor Characteristics

    PubMed Central

    Mackey, Tim K

    2012-01-01

    Background Unprecedented drug shortages announced by the US Food and Drug Administration (FDA) have severely affected therapeutic access, patient safety, and public health. With continued shortages, patients may seek drugs online. Objective To assess the prevalence of online marketing for current FDA shortage drugs and potential patient safety risks. Methods We performed a descriptive study of the prevalence of online marketing for shortage drugs—that is, offers for sale of each drug, including characteristics of online drug sellers and intermediary sites marketing these drugs. Results Of the 72 FDA shortage-listed drugs, 68 (94%) were offered for sale online. We found 291 offers for these drugs, the vast majority (n = 207, 71.1%) by online drug sellers selling direct to consumers. Intermediary sites included data aggregators (n = 22, 8%), forum links (n = 23, 8%), and personal page data links (n = 34, 12%), as well as Flickr social media links (n = 5, 2%), all advertising drugs without a prescription. Of the 91 online drug sellers identified, 31 (34%) had more than 1 shortage drug offered for sale, representing most (n = 148, 71%) of all online drug seller sales offers. The majority of these online drug sellers (n = 21, 68%) were on the National Association of Boards of Pharmacy (NABP) Not Recommended Sites list. Finally, for shortage drugs with an online drug seller (n = 58, 85%), 53 (91%) had at least one site on the Not Recommended list and 21 (36%) had only sites on the Not Recommended list. Conclusions FDA shortage drugs are widely marketed over the Internet. Suspect online drug sellers and intermediaries dominate these sales offers. As a critical risk management issue, patients, providers, and policymakers should be extremely cautious in procuring shortage drugs through Internet sourcing. PMID:22321731

  14. Progress in the study of drug nanocrystals.

    PubMed

    Shi, Jing; Guo, Fei; Zheng, Aiping; Zhang, Xiaoyan; Sun, Jianxu

    2015-12-01

    The poor water solubility of many candidate drugs remains a major obstacle to their development and clinical use, especially for oral drug delivery. Nanocrystal technology can improve the solubility and dissolution rates of many poorly water-soluble drugs very effectively, significantly improving their oral bioavailability and decreasing the food effect. For this reason, this technology is becoming a key area of drug delivery research. This review presents much of the recent progress in nanocrystal drug pharmaceuticals, including the characteristics, composition, preparation technology, and clinical applications of these drugs. Finally, the effect of nanocrystal technology on insoluble drugs is quantified and described. PMID:26817271

  15. An effectiveness trial of contingency management in a felony preadjudication drug court.

    PubMed

    Marlowe, Douglas B; Festinger, David S; Dugosh, Karen L; Arabia, Patricia L; Kirby, Kimberly C

    2008-01-01

    This study evaluated a contingency management (CM) program in a drug court. Gift certificates for compliance were delivered at 4- to 6-week intervals (total value = $390.00). Participants in one condition earned gift certificates that escalated by $5.00 increments. Participants in a second condition began earning higher magnitude gift certificates, and the density of reinforcement was gradually decreased. No main effects of CM were detected, which appears to be attributable to a ceiling effect from the intensive contingencies already delivered in the drug court and the low density of reinforcement. Preplanned interaction analyses suggested that participants with more serious criminal backgrounds might have performed better in the CM conditions. This suggests that CM programs may be best suited for more incorrigible drug offenders.

  16. Drug Court Effectiveness: A Matched Cohort Study in the Dane County Drug Treatment Court

    ERIC Educational Resources Information Center

    Brown, Randall

    2011-01-01

    Drug treatment courts (DTCs) are widely viewed as effective diversion programs for drug-involved offenders; however, previous studies frequently used flawed comparison groups. In the current study, the author compared rates of recidivism for drug court participants to rates for a traditionally adjudicated comparison group matched on potentially…

  17. Comprehensive stormwater management study

    SciTech Connect

    Morrison, T. ); Alter, M. ); Wassum, R.H. )

    1994-02-01

    This article examines Tucson, Arizona's approach to stormwater management. The topics of the article include the quantity and quality of stormwater, developing the stormwater master plan, meeting environmental and regulatory constraints. Tucson's comprehensive, watershed by watershed approach to public works planning and stormwater program development is described.

  18. Modelling Simple Experimental Platform for In Vitro Study of Drug Elution from Drug Eluting Stents (DES)

    NASA Astrophysics Data System (ADS)

    Kalachev, L. V.

    2016-06-01

    We present a simple model of experimental setup for in vitro study of drug release from drug eluting stents and drug propagation in artificial tissue samples representing blood vessels. The model is further reduced using the assumption on vastly different characteristic diffusion times in the stent coating and in the artificial tissue. The model is used to derive a relationship between the times at which the measurements have to be taken for two experimental platforms, with corresponding artificial tissue samples made of different materials with different drug diffusion coefficients, to properly compare the drug release characteristics of drug eluting stents.

  19. Evaluation of Probation Case Management (PCM) for Drug-Involved Women Offenders

    ERIC Educational Resources Information Center

    Chan, Monica; Guydish, Joseph; Prem, Rosemary; Jessup, Martha A.; Cervantes, Armando; Bostrom, Alan

    2005-01-01

    Based on availability of case management services, drug-involved women offenders entered either a probation case management (PCM) intervention(n = 65) or standard probation(n = 44). Participants were placed in the case management condition until all slots were filled, then placed in standard probation until case management slots opened.…

  20. [The importance of clinical data management in improvement of drug evaluation].

    PubMed

    Huang, Qin; Wang, Jun

    2015-11-01

    Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment. PMID:26911033

  1. [The importance of clinical data management in improvement of drug evaluation].

    PubMed

    Huang, Qin; Wang, Jun

    2015-11-01

    Although the importance of clinical data is drawing more attention in drug development in China, the clinical data management is not good enough in the clinical trials right now. With the development of internet and progress of information technology, especially with the setup of the state innovation strategy for drug development, it is necessary and urgent to improve the clinical data quality. Good data quality is the primary basis of technical evaluation of drug at the marketing authorization. So Center for Drug Evaluation of CFDA has made some endeavors to enhance data management in the clinical trials in recent years. This article is focused on these aspects of data managment.

  2. Clinical management strategies and implications for parenteral nutrition drug shortages in adult patients.

    PubMed

    Hassig, Tanna B; McKinzie, Brian P; Fortier, Christopher R; Taber, David

    2014-01-01

    Drug shortages affect every aspect of patient care, including and especially, nutrition therapy. The purpose of this review is to discuss current parenteral nutrition-related drug shortages, including causes and duration of the disruptions, and provide recommendations for managing specific nutritional shortages that minimize negative patient care outcomes. A general framework for the management of current and future shortages is presented.

  3. Drug Utilisation Study in a Tertiary Care Center: Recommendations for Improving Hospital Drug Dispensing Policies

    PubMed Central

    Mittal, Niti; Mittal, R.; Singh, I.; Shafiq, Nusrat; Malhotra, S.

    2014-01-01

    Drug therapy accounts for a major portion of health expenditure. A useful strategy for achieving cost efficient healthcare is drug utilisation research as it forms the basis for making amendments in drug policies and helps in rational drug use. The present observational study was conducted to generate data on drug utilization in inpatients of our tertiary care hospital to identify potential targets for improving drug prescribing patterns. Data was collected retrospectively from randomly selected 231 medical records of patients admitted in various wards of the hospital. WHO Anatomical Therapeutic Chemical/Defined Daily Dose methodology was used to assess drug utilisation data and drug prescriptions were analysed by WHO core drug indicators. Antibiotics were prescribed most frequently and also accounted for majority of drug costs. The prescribed daily dose for most of the antibiotics corresponded to defined daily dose reflecting adherence to international recommendations. Brand name prescribing and polypharmacy was very common.78% of the total drugs prescribed were from the National List of Essential Medicines 2003. Restricting the use of newer and costlier antibiotics, branded drugs and number of drugs per prescription could be considered as targets to cut down the cost of drug therapysignificantly. PMID:25284928

  4. Practical considerations and patient selection for intrathecal drug delivery in the management of chronic pain.

    PubMed

    Saulino, Michael; Kim, Philip S; Shaw, Erik

    2014-01-01

    Chronic pain continues to pose substantial and growing challenges for patients, caregivers, health care professionals, and health care systems. By the time a patient with severe refractory pain sees a pain specialist for evaluation and management, that patient has likely tried and failed several nonpharmacologic and pharmacologic approaches to pain treatment. Although relegated to one of the interventions of "last resort", intrathecal drug delivery can be useful for improving pain control, optimizing patient functionality, and minimizing the use of systemic pain medications in appropriately selected patients. Due to its clinical and logistical requirements, however, intrathecal drug delivery may fit poorly into the classic pain clinic/interventional model and may be perceived as a "critical mass" intervention that is feasible only for large practices that have specialized staff and appropriate office resources. Potentially, intrathecal drug delivery may be more readily adopted into larger practices that can commit the necessary staff and resources to support patients' needs through the trialing, initiation, monitoring, maintenance, and troubleshooting phases of this therapy. Currently, two agents - morphine and ziconotide - are approved by the United States Food and Drug Administration for long-term intrathecal delivery. The efficacy and safety profiles of morphine have been assessed in long-term, open-label, and retrospective studies of >400 patients with chronic cancer and noncancer pain types. The efficacy and safety profiles of ziconotide have been assessed in three double-blind, placebo-controlled trials of 457 patients, and safety has been assessed in 1,254 patients overall, with severe chronic cancer, noncancer, and acquired immunodeficiency syndrome pain types. Both agents are highlighted as first-line intrathecal therapy for the management of neuropathic or nociceptive pain. The purpose of this review is to discuss practical considerations for intrathecal

  5. Management systems research study

    NASA Technical Reports Server (NTRS)

    Bruno, A. V.

    1975-01-01

    The development of a Monte Carlo simulation of procurement activities at the NASA Ames Research Center is described. Data cover: simulation of the procurement cycle, construction of a performance evaluation model, examination of employee development, procedures and review of evaluation criteria for divisional and individual performance evaluation. Determination of the influences and apparent impact of contract type and structure and development of a management control system for planning and controlling manpower requirements.

  6. Arthritis Possible Side Effect of Certain Cancer Drugs: Study

    MedlinePlus

    ... Arthritis Possible Side Effect of Certain Cancer Drugs: Study Doctors should weigh the risk-benefit ratio, researcher ... of drugs that boost the immune system," said study author Dr. Laura Cappelli. She is a rheumatologist ...

  7. Present concepts in management of atrial fibrillation: From drug therapy to ablation

    PubMed Central

    Forleo, Giovanni B; Santini, Luca; Romeo, Francesco

    2009-01-01

    Atrial fibrillation (AF) management requires knowledge of its pattern of presentation, underlying conditions, and decisions about restoration and maintenance of sinus rhythm, control of the ventricular rate, and anti-thrombotic therapy. Maintenance of sinus rhythm is a desirable goal in AF patients because the prevention of recurrence may improve cardiac function, relieve symptoms and reduce the likelihood of adverse events. Anti-arrhythmic drug therapy is the first-line treatment for patients with paroxysmal and persistent AF based on current guidelines. However, currently used drugs have limited efficacy and cause cardiac and extracardiac toxicity. Thus, there is a continued need to develop new drugs, device and ablative approaches to rhythm management. Additionally, simpler and safer stroke prevention regimens are needed for AF patients on life-long anticoagulation, including occlusion of the left atrial appendage. The results of the Randomized Evaluation of Long-Term Anticoagulant Therapy study are encouraging in these settings. Knowledge on the pathophysiology of AF is rapidly expanding and identification of focally localized triggers has led to the development of new treatment options for this arrhythmia. Conversely, the clinical decision whether to restore and maintain sinus rhythm or simply control the ventricular rate has remained a matter of intense debate. In the minority of patients in whom AF cannot be adequately managed by pharmacological therapy, the most appropriate type of non-pharmacological therapy must be selected on an individualized basis. Curative treatment of AF with catheter ablation is now a legitimate option for a large number of patients. The evolution of hybrid therapy, in which two or more different strategies are employed in the same patient, may be an effective approach to management of AF. In any case, planning a treatment regimen for AF should include evaluation of the risks inherent in the use of various drugs as well as more

  8. Diuretics: still essential drugs for the management of hypertension.

    PubMed

    Fuchs, Flávio Danni

    2009-06-01

    According to most current international guidelines for hypertension, diuretics are indicated for elderly and black patients, unless they have any of a long list of other preferential indications. These recommendations are mostly based on the results of corporate-sponsored and biased trials, which have unsuccessfully tried to demonstrate the existence of pleiotropic effects of newer agents. Metaregression analyses have shown that the benefits of treatments are directly proportional to the difference in blood pressure between trial arms. New analyses of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) trial demonstrated the superiority of chlorthalidone over other agents in the prevention of end-stage renal disease in diabetics and of cardiovascular events in newer cases of diabetes. Despite this evidence, patients continue to withdraw from effective therapies in recent trials. The use of diuretics has also been challenged by the results of the Avoiding Cardiovascular Events in Combination Therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial, which employed hydrochlorothiazide, a diuretic with lower potency and duration of action than chlorthalidone. Diuretics are still essential drugs for hypertension management, but diuretics with higher potency and duration of action, such as chlorthalidone, should be preferred.

  9. Records management modernization study

    SciTech Connect

    Kadec, S.; Hill, L.G.; Riemer, C.A.

    1989-12-01

    The Department of Veterans Affairs (VA) has a single purpose or mission: to provide benefits to the veterans of the nation. Most of these benefits are provided through its medical and health facilities located around the country: the hospitals, nursing homes, and clinics that give medical examinations and provide long-term care or hospitalization. A second sizeable program managed by the Veterans Benefit Administration (VBA) gives pensions, benefits for disability and education, insurance, and home loans to those veterans eligible under law and specific service conditions. In support of the benefits programs, VA staff in the regional offices (ROs) receive and create a large amount of documentation. This documentation supports the award or disallowance of benefits by providing the information necessary to determine eligibility and the amount of the award. This paperwork, which is necessary to document actions and support the appeals process, creates a huge record-keeping problem for the ROs. 6 tabs.

  10. Seniors' uncertainty management of direct-to-consumer prescription drug advertising usefulness.

    PubMed

    DeLorme, Denise E; Huh, Jisu

    2009-09-01

    This study provides insight into seniors' perceptions of and responses to direct-to-consumer prescription drug advertising (DTCA) usefulness, examines support for DTCA regulation as a type of uncertainty management, and extends and gives empirical voice to previous survey results through methodological triangulation. In-depth interview findings revealed that, for most informants, DTCA usefulness was uncertain and this uncertainty stemmed from 4 sources. The majority had negative responses to DTCA uncertainty and relied on 2 uncertainty-management strategies: information seeking from physicians, and inferences of and support for some government regulation of DTCA. Overall, the findings demonstrate the viability of uncertainty management theory (Brashers, 2001, 2007) for mass-mediated health communication, specifically DTCA. The article concludes with practical implications and research recommendations. PMID:19735027

  11. Combo Drug for Childhood Asthma Appears Safe in Study

    MedlinePlus

    ... news/fullstory_160721.html Combo Drug for Childhood Asthma Appears Safe in Study FDA to review findings, ... 2016 (HealthDay News) -- Lingering safety concerns regarding an asthma drug for children may be put to rest ...

  12. Risk Assessment of Drug Management Process in Women Surgery Department of Qaem Educational Hospital (QEH) Using HFMEA Method (2013)

    PubMed Central

    khani-Jazani, Reza; Molavi-Taleghani, Yasamin; Seyedin, Hesam; Vafaee-Najar, Ali; Ebrahimipour, Hossein; Pourtaleb, Arefeh

    2015-01-01

    Evaluation and improvement of drug management process are essential for patient safety. The present study was performed whit the aim of assessing risk of drug management process in Women Surgery Department of QEH using HFMEA method in 2013. A mixed method was used to analyze failure modes and their effects with HFMEA. To classify failure modes; nursing errors in clinical management model, for classifying factors affecting error; approved model by the UK National Health System, and for determining solutions for improvement; Theory of Inventive Problem Solving, were used. 48 failure modes were identified for 14 sub-process of five steps drug management process. The frequency of failure modes were as follow :35.3% in supplying step, 20.75% in prescription step, 10.4% in preparing step, 22.9% in distribution step and 10.35% in follow up and monitoring step. Seventeen failure modes (35.14%) were considered as non-acceptable risk (hazard score≥ 8) and were transferred to decision tree. Among 51 Influencing factors, the most common reasons for error were related to environmental factors (21.5%), and the less common reasons for error were related to patient factors (4.3%). HFMEA is a useful tool to evaluating, prioritization and analyzing failure modes in drug management process. Revision drug management process based focus-PDCA, assessing adverse drug reactions (ADR), USE patient identification bracelet, holding periodical pharmaceutical conferences to improve personnel knowledge, patient contribution in drug therapy; are performance solutions which were placed in work order. PMID:25901157

  13. 76 FR 63929 - Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-14

    ... HUMAN SERVICES Food and Drug Administration Joint Meeting of the Drug Safety and Risk Management... public. Name of Committees: Drug Safety and Risk Management Advisory Committee and Dermatologic and... (Public Law 110-85) requires FDA to bring, at least annually, one or more drugs with Risk Evaluation...

  14. Drug-induced nail disorders: incidence, management and prognosis.

    PubMed

    Piraccini, B M; Tosti, A

    1999-09-01

    A large number of drugs of different classes, ranging from antibacterials to chemotherapeutic agents to psoralens, can be responsible for the development of nail changes. Drug-induced nail changes usually involve several or all 20 nails and appear in temporal correlation with drug intake. Some nail changes are asymptomatic and only cause cosmetic problems, while others cause pain and discomfort and impair manual activities or deambulation. Drug-induced nail abnormalities are usually transitory and disappear with drug withdrawal, but sometimes persist in time. The pathogenesis of the nail changes is usually a toxic effect of the drug on the different nail constituents, but other mechanisms can be involved. Drugs that are well known to produce nail abnormalities include cancer chemotherapeutic agents, psoralens, retinoids, tetracyclines, antimalarials and zidovudine. Arsenic poisoning is also always associated with nail changes that have medico-legal importance. Some drugs taken during pregnancy may impair nail development of the fetus, and nail hypoplasia or other nail dystrophies will be evident in the newborn.

  15. Evaluation and management of a patient with multiple drug allergies.

    PubMed

    Blumenthal, Kimberly G; Saff, Rebecca R; Banerji, Aleena

    2014-01-01

    Multiple drug allergy syndrome (MDAS) is a clinical diagnosis made in patients with adverse reactions to two or more structurally unrelated drugs with an underlying immune-mediated mechanism causing the reaction. The evaluation of a patient with MDAS begins with a comprehensive drug allergy history and consideration of the underlying immune mechanism for each reaction. Skin testing is a useful diagnostic tool; however, the only validated immediate hypersensitivity skin testing is for penicillin where the antigenic determinants have been identified. Skin testing to most other drugs, although not validated, can be considered using a nonirritating concentration (NIC). In general, skin test positivity using an NIC suggests that the drug should be avoided, but a negative result does not rule out an IgE-mediated allergy. A test dose, also called a drug provocation test, graded oral challenge, or incremental challenge, should be performed when there is a low likelihood of an IgE-mediated mechanism for the reaction. In patients with a recent IgE-mediated hypersensitivity reaction or positive skin testing with no reasonable alternative treatment options, desensitization protocols can be used to allow the patient to safely receive a necessary drug. The evaluation of patients with MDAS is both challenging and time-consuming for the practicing allergist, who must systematically evaluate each reaction to help determine which drugs can be safely used again in the future. The molecular mechanisms and risk factors for this condition remain poorly understood, but research to further understand this condition is ongoing.

  16. Prescription for Drug Abuse Education: Managing the Mood Changers

    ERIC Educational Resources Information Center

    Yolles, Stanley F.

    1971-01-01

    This article emphasizes the need to prepare youth to make decisions about drug use. To do this it is essential to eliminate hypocrisy about the use of marihuana, to "infuse" the curriculum with drug information and to provide students with realistic learning experiences. (Author)

  17. OROS® hydromorphone in chronic pain management: when drug delivery technology matches clinical needs.

    PubMed

    Coluzzi, F; Mattia, C

    2010-12-01

    The osmotic-controlled release oral delivery system (OROS®) is an innovative drug delivery technology that uses osmotic pressure as the driving force to deliver pharmacotherapies in many therapeutic areas. In chronic pain management requiring long-term therapy, pharmaceutical technologies that ensure the controlled release of analgesic medications are imperative. In addition, once-daily formulations ensure better patient compliance to prescribed therapies. Hydromorphone was the first opioid to be formulated as a once-daily preparation using OROS® technology. The purpose of this review is to discuss the application of OROS® technology in the field of chronic pain management and to examine clinical trial results for OROS® Hydromorphone. OROS® hydromorphone ensures the constant delivery of hydromorphone over a 24-hour period, and its pharmacokinetic profile is only minimally affected by food and alcohol. Dose-conversion studies have shown that patients with chronic pain can be easily switched from previous opioid therapies to OROS® hydromorphone without a loss of pain control. These studies support the clinical utility of the 5:1 ratio used for the conversion of oral morphine to oral OROS® hydromorphone. Furthermore, once-daily OROS® hydromorphone has been shown to be effective in patients with chronic cancer and non-cancer pain, and it provides similar pain relief to SR morphine and ER oxycodone. In chronic pain management, OROS® products can result in more stable drug concentrations, reduced dosing frequency and an improved safety profile.

  18. Automated method for study of drug metabolism

    NASA Technical Reports Server (NTRS)

    Furner, R. L.; Feller, D. D.

    1973-01-01

    Commercially available equipment can be modified to provide automated system for assaying drug metabolism by continuous flow-through. System includes steps and devices for mixing drug with enzyme and cofactor in the presence of pure oxygen, dialyzing resulting metabolite against buffer, and determining amount of metabolite by colorimetric method.

  19. Active controlled studies in antibiotic drug development.

    PubMed

    Dane, Aaron

    2011-01-01

    The increasing concern of antibacterial resistance has been well documented, as has the relative lack of antibiotic development. This paradox is in part due to challenges with clinical development of antibiotics. Because of their rapid progression, untreated bacterial infections are associated with significant morbidity and mortality. As a consequence, placebo-controlled studies of new agents are unethical. Rather, pivotal development studies are mostly conducted using non-inferiority designs versus an active comparator. Further, infections because of comparator-resistant isolates must usually be excluded from the trial programme. Unfortunately, the placebo-controlled data classically used in support of non-inferiority designs are largely unavailable for antibiotics. The only available data are from the 1930s and 1940s and their use is associated with significant concerns regarding constancy and assay sensitivity. Extended public debate on this challenge has led to proposed solutions by some in which these concerns are addressed by using very conservative approaches to trial design, endpoints and non-inferiority margins, in some cases leading to potentially impractical studies. To compound this challenge, different Regulatory Authorities seem to be taking different approaches to these key issues. If harmonisation does not occur, antibiotic development will become increasingly challenging, with the risk of further decreases in the amount of antibiotic drug development. However with clarity on Regulatory requirements and an ability to feasibly conduct global development programmes, it should be possible to bring much needed additional antibiotics to patients.

  20. Fabrication of drug eluting implants: study of drug release mechanism from titanium dioxide nanotubes

    NASA Astrophysics Data System (ADS)

    Hamlekhan, Azhang; Sinha-Ray, Suman; Takoudis, Christos; Mathew, Mathew T.; Sukotjo, Cortino; Yarin, Alexander L.; Shokuhfar, Tolou

    2015-06-01

    Formation of titanium dioxide nanotubes (TNTs) on a titanium surface holds great potential for promoting desirable cellular response. However, prolongation of drug release from these nano-reservoirs remains to be a challenge. In our previous work TNTs were successfully loaded with a drug. In this study the effect of TNTs dimensions on prolongation of drug release is quantified aiming at the introduction of a simple novel technique which overcomes complications of previously introduced methods. Different groups of TNTs with different lengths and diameters are fabricated. Samples are loaded with a model drug and rate of drug release over time is monitored. The relation of the drug release rate to the TNT dimensions (diameter, length, aspect ratio and volume) is established. The results show that an increase in any of these parameters increases the duration of the release process. However, the strongest parameter affecting the drug release is the aspect ratio. In fact, TNTs with higher aspect ratios release drug slower. It is revealed that drug release from TNT is a diffusion-limited process. Assuming that diffusion of drug in (Phosphate-Buffered Saline) PBS follows one-dimensional Fick’s law, the theoretical predictions for drug release profile is compatible with our experimental data for release from a single TNT.

  1. Alcohol and Drug Use among "Street" Adolescents: An Exploratory Study.

    ERIC Educational Resources Information Center

    McKirnan, David J.; Johnson, Tina

    Although adolescent alcohol and drug use is decreasing, many teenagers continue to use alcohol and drugs. Studies of adolescent alcohol use typically sample intact high school populations, excluding dropouts and adolescents alienated from straight high school populations. Alcohol and drug use and alcohol related attitudes were measured in 62…

  2. Parent Drug Education: A Participatory Action Research Study into Effective Communication about Drugs between Parents and Unrelated Young People

    ERIC Educational Resources Information Center

    Mallick, Jane

    2007-01-01

    Parent drug education is considered a key aspect of drug prevention. Effective communication acts as protective factor for drug misuse in young people. This study is a Participatory Action Research study of "Drugsbridge", a drug education programme that has an emphasis on facilitating intergenerational communication about drugs between parents and…

  3. Drug abuse in Costa Rica: a review of several studies.

    PubMed

    Alfaro Murillo, E

    1990-01-01

    This article provides a review of drug use surveys conducted by Costa Rica's Institute on Alcoholism and Drug Dependence during the years 1983-1987. These studies dealt with a wide range of subjects--residents of marginal neighborhoods, juvenile male and adult female detainees, and high school students--as well as with the general population. Overall, the studies indicated that the most commonly used illicit drug was marijuana, that the bulk of the drug users (excluding alcohol and tobacco users) were young males, that relevant levels of cocaine use were starting to occur, and that the country's general drug abuse picture poses a problem in need of immediate attention. PMID:2331555

  4. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...) Screening for potential drug therapy problems due to therapeutic duplication. (ii) Age/gender-related... dosage or duration of drug therapy. (vi) Drug-allergy contraindications. (vii) Clinical abuse/misuse....

  5. [Consideration about data management and biostatistics analysis from a FDA's botanical drug approval case].

    PubMed

    Tang, Jian-yuan; Huang, Fang-hua; Zhu, Fei-peng

    2009-11-01

    FDA approved the first botanical drug of non-simplex ingredient on 31st Oct 2006. The new drug's trade name is Veregen 15% Ointment. Veregen succeeded in coming into the market in U.S, which attracts other countries and regions' attention where traditional herbs have been always used. From the viewpoints of data management and biostatistics method, the authors will think and discuss this case well, and hope to promote domestic new drug investigation.

  6. [Post-marketing drug safety-risk management plan(RMP)].

    PubMed

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  7. Non-drug Non-invasive Treatment in the Management of Low Back Pain

    PubMed Central

    Sahu, RL

    2014-01-01

    Background: Low back pain (LBP) is a major medical problem. World-wide, from 60% to 80% of people will have it during their lifetime and 2-5% will have it at any given time. The disease impacts upon activities of daily living ultimately leading to a loss of functional independence and quality of life. Aim: The main purpose of this study was to assess the results of non-drug non-invasive treatment in the management of LBP. Subjects and Methods: This was prospective study conducted in the Department of Orthopedics in M. M. Medical College, Mullana, Ambala, Haryana, India from June 2005 to June 2010. A total of 251 out-patients of LBP with a mean age of 45 years were studied. They were managed with non-invasive treatment and were followed for 24 months. Results: Objective Lumbar Spine Assessments up to the age of 40 years at 2 years were excellent. At 40-60 years of age, it was good to excellent. Over the age of 60 years, it was good. The back pain functional scale were found very good up to the age of 40 years at 2-year follow-up, good to very good between 40 and 60 years and over the age of 60 years it was good. Conclusions: Non-drug non-invasive interventions can reduce pain and improve function in LBP. PMID:25328793

  8. Integration of heterogeneous clinical decision support systems and their knowledge sets: feasibility study with Drug-Drug Interaction alerts.

    PubMed

    Kam, Hye Jin; Kim, Jeong Ah; Cho, InSook; Kim, Yoon; Park, Rae Woong

    2011-01-01

    There exist limitations in both commercial and in-house clinical decision support systems (CDSSs) and issues related to the integration of different knowledge sources and CDSSs. We chose Standard-based Shareable Active Guideline Environment (SAGE) as a new architecture with knowledge integration and a centralized knowledge base which includes authoring/management functions and independent CDSS, and applied it to Drug-Drug Interaction (DDI) CDSS. The aim of this study was to evaluate the feasibility of the newly integrated DDI alerting CDSS into a real world hospital information system involving construction of an integrated CDSS derived from two heterogeneous systems and their knowledge sets. The proposed CDSS was successfully implemented and compensated for the weaknesses of the old CDSS from knowledge integration and management, and its applicability in actual situations was verified. Although the DDI CDSS was constructed as an example case, the new CDS architecture might prove applicable to areas of CDSSs.

  9. Impact of Participatory Design for Drug-Drug Interaction Alerts. A Comparison Study Between Two Interfaces.

    PubMed

    Luna, Daniel; Otero, Carlos; Risk, Marcelo; Stanziola, Enrique; González Bernaldo de Quirós, Fernán

    2016-01-01

    Decision support systems for alert drug-drug interactions have been shown as valid strategy to reduce medical error. Even so the use of these systems has not been as expected, probably due to the lack of a suitable design. This study compares two interfaces, one of them developed using participatory design techniques (based on user centered design processes). This work showed that the use of these techniques improves satisfaction, effectiveness and efficiency in an alert system for drug-drug interactions, a fact that was evident in specific situations such as the decrease of errors to meet the specified task, the time, the workload optimization and users overall satisfaction with the system.

  10. [Research on our hospital inventory management status quo of traditional Chinese medicine drugs and treatment method].

    PubMed

    Zhang, Ying-Nan; Xu, Wen

    2014-03-01

    Under the background of the new medical reform, a large variety of traditional Chinese medicine from complicated sources, Chinese traditional medicine of actor of true and false of the quality directly affect the drug safety and clinical efficacy, but also relate to the social and economic benefits of hospital. Along with the development of the modern management of medical institutions and drug circulation circulation system reform in our country, the hospital drug inventory, supply and management work is an important topic for the pharmaceutical trading. However, there is always contradiction, dispensary need to supple pharmacy, in order to satisfy the demands of hospital patients with normal diagnosis and treatment work. However, if the drug inventory is too much, not only increases the drug monitoring problem, at the same time, but also causes storage costs rise. Therefore, completing scientific and reasonable storage and management becomes urgent problems at present. Wherefore, our country administration of traditional Chinese medicine in 2007 promulgated the "Chinese traditional medicine yinpian management norms in hospital", aims to standardize management of Chinese traditional medicine quality and improve the safety of drugs. The author through looking up information and visiting survey, to understand the currently existing problems, and summarizes the literature inland and abroad in recent years Chinese medicine drug inventory management work experience, in view of status quo of Chinese medicine inventory management in China, put forward the solution. To guarantee TCM pharmacy management more standardized, more standard, to adapt to the new reform of Chinese traditional medicine industry, improve the management level of hospital, defend the hospital's reputation and the patient's interests.

  11. A Study on Drug Safety Monitoring Program in India

    PubMed Central

    Ahmad, A.; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R.; Mohanta, G. P.

    2014-01-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers. PMID:25425751

  12. A study on drug safety monitoring program in India.

    PubMed

    Ahmad, A; Patel, Isha; Sanyal, Sudeepa; Balkrishnan, R; Mohanta, G P

    2014-09-01

    Pharmacovigilance is useful in assuring the safety of medicines and protecting the consumers from their harmful effects. A number of single drugs as well as fixed dose combinations have been banned from manufacturing, marketing and distribution in India. An important issue about the availability of banned drugs over the counter in India is that sufficient adverse drug reactions data about these drugs have not been reported. The most common categories of drugs withdrawn in the last decade were nonsteroidal antiinflammatory drugs (28%), antidiabetics (14.28%), antiobesity (14.28%), antihistamines (14.28%), gastroprokinetic drugs (7.14%), breast cancer and infertility drugs (7.14%), irritable bowel syndrome and constipation drugs (7.14%) and antibiotics (7.14%). Drug withdrawals from market were made mainly due to safety issues involving cardiovascular events (57.14%) and liver damage (14.28%). Majority of drugs have been banned since 3-5 years in other countries but are still available for sale in India. The present study compares the drug safety monitoring systems in the developed countries such as the USA and UK and provides implications for developing a system that can ensure the safety and efficacy of drugs in India. Absence of a gold standard for a drug safety surveillance system, variations in culture and clinical practice across countries makes it difficult for India to completely adopt another country's practices. There should be a multidisciplinary approach towards drug safety that should be implemented throughout the entire duration spanning from drug discovery to usage by consumers.

  13. Use of Serotonergic Drugs in Canada for Gastrointestinal Motility Disorders: Results of a Retrospective Cohort Study

    PubMed Central

    Manji, Farouq; Lam, Jennifer; Taylor, Brian M.

    2016-01-01

    Background. Surgery for GI dysmotility is limited to those with severe refractory disease. Though effective, use of serotonergic promotility drugs has been restricted in Canada due to adverse events. We aimed to investigate utilization of promotility serotonergic drugs in patients under consideration for surgical management. Methods. A retrospective cohort study was conducted using prospectively collected data. The study population included consecutive patients referred to a motility clinic for consideration of bowel resection at a Canadian tertiary hospital (1996–2011). Univariable tests and multivariable logistic regression analyses were used to assess predictors of serotonergic drug use. Results. Of 128 patients, the majority (n = 98, 76.6%) had constipation-dominant symptoms. Only 25% (n = 32) had tried serotonergic promotility drugs. There was no association between use of these drugs and severity of constipation nor was there an association between serotonergic drug use and presence of diffuse dysmotility (all p > 0.05). The majority of patients (n = 97, 75.8%) underwent some type of surgical resection, which was associated with considerable morbidity (n = 13, 13.4%). Conclusions. Surgical management of GI dysmotility results in serious morbidity. Serotonergic promotility drugs may allow patients to avoid surgery but disease severity does not predict use of these drugs. PMID:27313955

  14. Current Situation, Determinants, and Solutions to Drug Shortages in Shaanxi Province, China: A Qualitative Study

    PubMed Central

    Yang, Caijun; Wu, Lina; Cai, Wenfang; Zhu, Wenwen; Shen, Qian; Li, Zongjie; Fang, Yu

    2016-01-01

    Objective Drug shortages were a complex global problem. The aim of this study was to analyze, characterize, and assess the drug shortages, and identify possible solutions in Shaanxi Province, western China. Methods A qualitative methodological approach was conducted during May–June 2015 and December 2015–January 2016. Semi-structured interviews were performed to gather information from representatives of hospital pharmacists, wholesalers, pharmaceutical producers, and local health authorities. Results Thirty participants took part in the study. Eight traditional Chinese medicines and 87 types of biologicals and chemicals were reported to be in short supply. Most were essential medicines. Five main determinants of drug shortages were detected: too low prices, too low market demands, Good Manufacturing Practice (GMP) issues, materials issues, and approval issues for imported drugs. Five different solutions were proposed by the participants: 1) let the market decide the drug price; 2) establish an information platform; 3) establish a reserve system; 4) enhance the communication among the three parties in the supply chain; and 5) improve hospital inventory management. Conclusions Western China was currently experiencing a serious drug shortage. Numerous reasons for the shortage were identified. Most drug shortages in China were currently because of “too low prices.” To solve this problem, all of the stakeholders, especially the government, needed to participate in managing the drug shortages. PMID:27780218

  15. Pharmacogenomic study using bio- and nanobioelectrochemistry: Drug-DNA interaction.

    PubMed

    Hasanzadeh, Mohammad; Shadjou, Nasrin

    2016-04-01

    Small molecules that bind genomic DNA have proven that they can be effective anticancer, antibiotic and antiviral therapeutic agents that affect the well-being of millions of people worldwide. Drug-DNA interaction affects DNA replication and division; causes strand breaks, and mutations. Therefore, the investigation of drug-DNA interaction is needed to understand the mechanism of drug action as well as in designing DNA-targeted drugs. On the other hand, the interaction between DNA and drugs can cause chemical and conformational modifications and, thus, variation of the electrochemical properties of nucleobases. For this purpose, electrochemical methods/biosensors can be used toward detection of drug-DNA interactions. The present paper reviews the drug-DNA interactions, their types and applications of electrochemical techniques used to study interactions between DNA and drugs or small ligand molecules that are potentially of pharmaceutical interest. The results are used to determine drug binding sites and sequence preference, as well as conformational changes due to drug-DNA interactions. Also, the intention of this review is to give an overview of the present state of the drug-DNA interaction cognition. The applications of electrochemical techniques for investigation of drug-DNA interaction were reviewed and we have discussed the type of qualitative or quantitative information that can be obtained from the use of each technique.

  16. Nonsteroidal anti-inflammatory drugs as adjuncts in the management of periodontal diseases and peri-implantitis.

    PubMed

    Salvi, G E; Williams, R C; Offenbacher, S

    1997-01-01

    For the past three decades, prostaglandin E2 and other arachidonic acid metabolites have been recognized as important proinflammatory mediators in bone resorption and various forms of periodontal disease. Nonsteroidal anti-inflammatory drugs are chemical compounds that selectively inhibit the synthesis of metabolites of the cyclooxygenase pathway, thereby blocking the production of prostaglandins, thromboxane, and prostacyclin. Inhibiting prostaglandin E2 synthesis with nonsteroidal anti-inflammatory drugs has been unequivocally shown in both animal and human studies to be of primary therapeutic efficacy. Recent lines of nonsteroidal anti-inflammatory drugs research have focused on the development of daily topical administration forms such as gels, toothpastes, and rinses. Furthermore, new studies have implicated prostaglandin E2 in the peri-implantitis process, opening the possibility to manage failing implants with topical nonsteroidal anti-inflammatory drug delivery systems.

  17. 76 FR 1174 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-07

    ... and other parties in response to various DESI notices covering relevant products. \\3\\ 38 FR 34481 (December 14, 1973). \\4\\ 38 FR 4006 (February 9, 1973) and 37 FR 15022 (July 27, 1972). All drugs covered by... Federal Register on May 25, 1982 (47 FR 22606), FDA revoked the temporary exemption that permitted...

  18. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-03

    ... . SUPPLEMENTARY INFORMATION: I. Background In a notice published in the Federal Register of January 7, 2011 (76 FR..., 1982 (47 FR 22610), FDA revoked the temporary exemption that permitted these drug products, and those... (49 FR 32681) that the Agency was withdrawing approval of NDAs 8-306, 8-604, and 11-265 pertaining...

  19. Nuclear materials management storage study

    SciTech Connect

    Becker, G.W. Jr.

    1994-02-01

    The Office of Weapons and Materials Planning (DP-27) requested the Planning Support Group (PSG) at the Savannah River Site to help coordinate a Departmental complex-wide nuclear materials storage study. This study will support the development of management strategies and plans until Defense Programs` Complex 21 is operational by DOE organizations that have direct interest/concerns about or responsibilities for nuclear material storage. They include the Materials Planning Division (DP-273) of DP-27, the Office of the Deputy Assistant Secretary for Facilities (DP-60), the Office of Weapons Complex Reconfiguration (DP-40), and other program areas, including Environmental Restoration and Waste Management (EM). To facilitate data collection, a questionnaire was developed and issued to nuclear materials custodian sites soliciting information on nuclear materials characteristics, storage plans, issues, etc. Sites were asked to functionally group materials identified in DOE Order 5660.1A (Management of Nuclear Materials) based on common physical and chemical characteristics and common material management strategies and to relate these groupings to Nuclear Materials Management Safeguards and Security (NMMSS) records. A database was constructed using 843 storage records from 70 responding sites. The database and an initial report summarizing storage issues were issued to participating Field Offices and DP-27 for comment. This report presents the background for the Storage Study and an initial, unclassified summary of storage issues and concerns identified by the sites.

  20. Managing la malilla: Exploring drug treatment experiences among injection drug users in Tijuana, Mexico, and their implications for drug law reform

    PubMed Central

    Syvertsen, Jennifer; Pollini, Robin A.; Lozada, Remedios; Vera, Alicia; Rangel, Gudelia; Strathdee, Steffanie A.

    2012-01-01

    Background In August 2009, Mexico reformed its drug laws and decriminalized small quantities of drugs for personal use; offenders caught three times will be mandated to enter drug treatment. However, little is known about the quality or effectiveness of drug treatment programs in Mexico. We examined injection drug users’ (IDUs) experiences in drug treatment in Tijuana, Mexico, with the goal of informing program planning and policy. Methods We examined qualitative and quantitative data from Proyecto El Cuete, a multi-phased research study on HIV risk among IDUs in Tijuana. Phase I consisted of 20 in-depth interviews and Phase II employed respondent-driven sampling to recruit 222 IDUs for a quantitative survey. We also reviewed national drug policy documents, surveillance data, and media reports to situate drug users’ experiences within the broader sociopolitical context. Results Participants in the qualitative study were 50% male with a mean age of 32; most injected heroin (85.0%) and methamphetamine (60.0%). The quantitative sample was 91.4% male with a mean age of 35; 98.2% injected heroin and 83.7% injected heroin and methamphetamine together. The majority of participants reported receiving treatment: residential treatment was most common, followed by methadone; other types of services were infrequently reported. Participants’ perceptions of program acceptability and effectiveness were mixed. Mistreatment emerged as a theme in the qualitative interviews and was reported by 21.6% of Phase II participants, primarily physical (72.0%) and verbal (52.0%) abuse. Conclusions Our results point to the need for political, economic, and social investment in the drug treatment system before offenders are sentenced to treatment under the revised national drug law. Resources are needed to strengthen program quality and ensure accountability. The public health impact of the new legislation that attempts to bring drug treatment to the forefront of national drug policy

  1. Comparison of antineoplastic drug handling policies of hospitals with OSHA guidelines: a pilot study.

    PubMed

    Valanis, B; Driscoll, K; McNeil, V

    1990-04-01

    Hospital antineoplastic drug handling policies of 24 hospitals in eight Southwestern Ohio counties were compared with recommendations of the 1986 Occupational Safety and Health Administration (OSHA) guidelines. Although most study facilities where antineoplastics are handled have policies, content varies and is generally less complete than OSHA guidelines, particularly regarding storing, transporting, and disposing of drugs; managing equipment; informing personnel of risk; and surveillance. Recommendations for personal protection concur more closely with OSHA guidelines than do other content areas. PMID:2316776

  2. Antihypertensive drugs for elderly patients: a cross- sectional study

    PubMed Central

    Lim, Ka Keat; Sivasampu, Sheamini; Khoo, Ee Ming

    2015-01-01

    INTRODUCTION As the population ages, the prevalence of hypertension also increases. Although primary care is usually the patient’s first point of contact for healthcare, little is known about the management of hypertension among elderly patients at the primary care level. This study aimed to determine the antihypertensive prescription trend for elderly patients, the predictors of antihypertensive use and any inappropriate prescribing practices in both public and private primary care settings. METHODS Data on patient demographics, diagnosis, prescription pattern, payment mode and follow-up was extracted from a cross-sectional study involving 122 public primary care clinics and 652 private primary care clinics in Malaysia. Encounters with hypertensive patients aged ≥ 60 years were included. RESULTS A total of 1,017 antihypertensive medications were prescribed – calcium channel blockers (27.1%), beta blockers (25.5%), diuretics (23.3%), angiotensin-converting enzyme inhibitors (14.9%) and angiotensin receptor blockers (6.3%). Out of the 614 patient encounters, 53.1% of the patients were prescribed monotherapy, 31.6% were prescribed dual therapy, 12.2% triple therapy, 2.8% quadruple therapy and 0.3% quintuple therapy. Type of primary care clinic and payment mode were significant predictors for the prescription of combination therapy and fixed-dose combination therapy, respectively. Four types of inappropriate prescriptions were identified. CONCLUSION Calcium channel blockers were the most common antihypertensive drug prescribed and more than half of the elderly patients were on monotherapy. Antihypertensive drug prescription was found to be associated with the type of primary care clinic and the payment mode, suggesting that prescription is influenced by the cost of the drug. PMID:25597751

  3. Core Concepts Involving Adverse Psychotropic Drug Effects: Assessment, Implications, and Management.

    PubMed

    Goldberg, Joseph F; Ernst, Carrie L

    2016-09-01

    Adverse effects from psychiatric drugs can profoundly influence treatment adherence and outcomes. Good care involves addressing adverse effects no differently than any other component of treatment. Knowledge about adverse effect assessment and management fosters a proper context that helps clinicians not sacrifice a drug's potential therapeutic benefits because of greater concerns about its tolerability. This article provides an overview of basic concepts related to the assessment and management of suspected adverse effects from psychotropic drugs. Key points are discussed regarding clinical, pharmacogenetic, pharmacokinetic, and pharmacodynamic risk factors for treatment-emergent adverse effects, alongside recommendations for their systematic assessment. PMID:27514295

  4. Solid state drug-polymer miscibility studies using the model drug ABT-102.

    PubMed

    Jog, Rajan; Gokhale, Rajeev; Burgess, Diane J

    2016-07-25

    Amorphous solid dispersions typically suffer storage stability issues due to: their amorphous nature, high drug loading, uneven drug:stabilizer ratio and plasticization effects as a result of hygroscopic excipients. An extensive solid state miscibility study was conducted to aid in understanding the mechanisms involved in drug/stabilizer interactions. ABT-102 (model drug) and nine different polymers with different molecular weights and viscosities were selected to investigate drug/polymer miscibility. Three different polymer:drug ratios (1:3, 1:1 and 3:1, w/w) were analyzed using: DSC, FTIR and PXRD. Three different techniques were used to prepare the amorphous solid dispersions: serial dilution, solvent evaporation and spray drying. Spray drying was the best method to obtain amorphous solid dispersions. However, under certain conditions amorphous formulations could be obtained using solvent evaporation. Melting point depression was used to calculate interaction parameters and free energy of mixing for the various drug polymer mixtures. The spray dried solid dispersions yielded a negative free energy of mixing which indicated strong drug-polymer miscibility compared to the solvent evaporation and serial dilution method. Soluplus was the best stabilizer compared to PVP and HPMC, which is probably a consequence of strong hydrogen bonding between the two CO moieties of soluplus and the drug NH moieities.

  5. Reasons for illicit drug use in people with schizophrenia: Qualitative study

    PubMed Central

    2010-01-01

    Background Drug misuse is an important clinical problem associated with a poorer outcome in patients who have a diagnosis of schizophrenia. Qualitative studies have rarely been used to elicit reasons for drug use in psychosis, but not in schizophrenia. Methods Seventeen people with a diagnosis of schizophrenia and who had used street drugs were interviewed and asked to describe, in narrative form, their street drug use from their early experiences to the present day. Grounded theory was used to analyse the transcripts. Results We identified five reasons for continuing street drug use. The reasons were: as an 'identity defining vocation', 'to belong to a peer group', due to 'hopelessness', because of 'beliefs about symptoms and how street drugs influence them' and viewing drugs as 'equivalent to taking psychotropic medication'. Street drugs were often used to reduce anxiety aroused by voice hearing. Some participants reported street drugs to focus their attention more on persecutory voices in the hope of outwitting their perceived persecutors. Conclusions It would be clinically useful to examine for the presence of the five factors in patients who have a diagnosis of schizophrenia and use street drugs, as this is likely to help the clinician to tailor management of substance misuse to the individual patient's beliefs. PMID:21092168

  6. Drugs for Pain Management in Shock Wave Lithotripsy

    PubMed Central

    Bach, Christian; Zaman, Faruquz; Kachrilas, Stefanos; Kumar, Priyadarshi; Buchholz, Noor; Masood, Junaid

    2011-01-01

    Objective. With this review, we provide a comprehensive overview of the main aspects and currently used drugs for analgesia in shockwave lithotripsy. Evidence Acquisition. We reviewed current literature, concentrating on newer articles and high-quality reviews in international journals. Results. No standardized protocols for pain control in SWL exist, although it is crucial for treatment outcome. General and spinal anaesthesia show excellent pain control but are only recommended for selected cases. The newer opioids and nonsteroidal anti-inflammatory drugs are able to deliver good analgesia. Interest in inhalation anaesthesia with nitrous oxide, local anaesthesia with deep infiltration of the tissue, and dermal anaesthesia with EMLA or DMSO has recently rekindled, showing good results in terms of pain control and a favourable side effect profile. Tamsulosin and paracetamol are further well-known drugs being currently investigated. Conclusion. Apart from classically used drugs like opioids and NSARs, medicaments like nitrous oxide, paracetamol, DMSA, or refined administration techniques for infiltration anaesthesia show a good effectiveness in pain control for SWL. PMID:22135735

  7. Drugs for pain management in shock wave lithotripsy.

    PubMed

    Bach, Christian; Zaman, Faruquz; Kachrilas, Stefanos; Kumar, Priyadarshi; Buchholz, Noor; Masood, Junaid

    2011-01-01

    Objective. With this review, we provide a comprehensive overview of the main aspects and currently used drugs for analgesia in shockwave lithotripsy. Evidence Acquisition. We reviewed current literature, concentrating on newer articles and high-quality reviews in international journals. Results. No standardized protocols for pain control in SWL exist, although it is crucial for treatment outcome. General and spinal anaesthesia show excellent pain control but are only recommended for selected cases. The newer opioids and nonsteroidal anti-inflammatory drugs are able to deliver good analgesia. Interest in inhalation anaesthesia with nitrous oxide, local anaesthesia with deep infiltration of the tissue, and dermal anaesthesia with EMLA or DMSO has recently rekindled, showing good results in terms of pain control and a favourable side effect profile. Tamsulosin and paracetamol are further well-known drugs being currently investigated. Conclusion. Apart from classically used drugs like opioids and NSARs, medicaments like nitrous oxide, paracetamol, DMSA, or refined administration techniques for infiltration anaesthesia show a good effectiveness in pain control for SWL.

  8. Misuse of "study drugs:" prevalence, consequences, and implications for policy

    PubMed Central

    Sussman, Steve; Pentz, Mary Ann; Spruijt-Metz, Donna; Miller, Toby

    2006-01-01

    Background Non-medical/illegal use of prescription stimulants popularly have been referred to as "study drugs". This paper discusses the current prevalence and consequences of misuse of these drugs and implications of this information for drug policy. Results Study drugs are being misused annually by approximately 4% of older teens and emerging adults. Yet, there are numerous consequences of misuse of prescription stimulants including addiction, negative reactions to high dosages, and medical complications. Policy implications include continuing to limit access to study drugs, finding more safe prescription drug alternatives, interdiction, and public education. Conclusion Much more work is needed on prescription stimulant misuse assessment, identifying the extent of the social and economic costs of misuse, monitoring and reducing access, and developing prevention and cessation education efforts. PMID:16764722

  9. Interdisciplinary management of a patient with a drug-induced gingival hyperplasia

    PubMed Central

    Devanna, Raghu; Asif, K.

    2010-01-01

    Interdisciplinary treatment is becoming an ever-increasing part of modern-day orthodontic practice. This case report details the successful orthodontic-periodontal management of an epileptic patient with a significant drug-induced gingival hyperplasia. The problems that such patient's present are discussed before considering the specific orthodontic techniques employed. Recommendations are made for practitioners managing such cases. PMID:22114410

  10. Interdisciplinary management of a patient with a drug-induced gingival hyperplasia.

    PubMed

    Devanna, Raghu; Asif, K

    2010-07-01

    Interdisciplinary treatment is becoming an ever-increasing part of modern-day orthodontic practice. This case report details the successful orthodontic-periodontal management of an epileptic patient with a significant drug-induced gingival hyperplasia. The problems that such patient's present are discussed before considering the specific orthodontic techniques employed. Recommendations are made for practitioners managing such cases.

  11. Drug Dependence in Pregnancy: Clinical Management of Mother and Child. Services Research Reports and Monograph Series.

    ERIC Educational Resources Information Center

    Finnegan, Loretta P., Ed.

    This resouce manual compiles research findings concerning treatment of pregnant addicts. Major topics covered are: (1) prevalence and classification of psychotropic drug use; (2) pharmacologic effects on mother and infant; (3) clinical management during pregnancy; (4) management of labor, delivery, and the immediate post-partum period; (5)…

  12. Antipsychotic Drug-Induced Somnolence: Incidence, Mechanisms, and Management.

    PubMed

    Fang, Fang; Sun, Hongwei; Wang, Zuowei; Ren, Ming; Calabrese, Joseph R; Gao, Keming

    2016-09-01

    Somnolence is a common side effect of antipsychotics. To assess the incidence of this side effect, we performed a MEDLINE search for randomized, double-blinded, placebo- or active-controlled studies of adult patients treated with antipsychotics for schizophrenia, mania, bipolar depression, or bipolar disorder. We extracted rates of somnolence from original publications and pooled them based on the dose of each antipsychotic in the same psychiatric condition, then estimated the absolute risk increase (ARI) and the number needed to harm (NNH) of an antipsychotic relative to placebo or an active comparator in the same psychiatric condition. According to the ARI in acute schizophrenia, bipolar mania, and bipolar depression, antipsychotics can be classified as high somnolence (clozapine), moderate somnolence (olanzapine, perphenazine, quetiapine, risperidone, ziprasidone), and low somnolence (aripiprazole, asenapine, haloperidol, lurasidone, paliperidone, cariprazine). The risk of somnolence with blonanserin, brexpiprazole, chlorpromazine, iloperidone, sertindole, and zotepine needs further investigation. The rates of somnolence were positively correlated to dose and duration for some antipsychotics, but not for others. Many factors, including antipsychotic per se, the method used to measure somnolence, patient population, study design, and dosing schedule, might affect the incidence of antipsychotic-induced somnolence. The mechanisms of antipsychotic-induced somnolence are likely multifactorial, although the blockade of histamine 1 receptors and α1 receptors may play a major role. The management of antipsychotic-induced somnolence should include sleep hygiene education, choosing an antipsychotic with a lower risk for somnolence, starting at a lower dose with a slower titration based on psychiatric diagnoses, adjusting doses when necessary, and minimizing concurrent somnolence-prone agents. Since most cases of somnolence were mild to moderate, allowing tolerance to

  13. Using Nonexperts for Annotating Pharmacokinetic Drug-Drug Interaction Mentions in Product Labeling: A Feasibility Study

    PubMed Central

    Ning, Yifan; Hernandez, Andres; Horn, John R; Jacobson, Rebecca; Boyce, Richard D

    2016-01-01

    labeling of annotated PDDIs across a broader range of drug product labels. Preannotation of drug mentions may ease the annotation task. However, preannotation of PDDIs, as operationalized in this study, presented the participants with difficulties. Future work should test if these issues can be addressed by the use of better performing NLP and a different approach to presenting the PDDI preannotations to users during the annotation workflow. PMID:27066806

  14. Drug abuse in Nigeria: a review of epidemiological studies.

    PubMed

    Pela, O A; Ebie, J C

    1982-01-01

    This paper reviews the available literature on the epidemiology of drug abuse in Nigeria. Depending on the definition used, substances which are abused include antibiotics, antidiarrhoeals, laxatives, pain-relieving drugs, sedatives, amphetamines and cannabis. This review is, however, limited to studies on substances which alter behaviour or mood. These drugs include cannabis, sedative-hypnotics, amphetamines and alcohol. For some classes of drugs there has been a noticeable shift in patterns of drug abuse, for example, from abuse of methaqualone to barbiturates. The abuse of volatile solvents and other substances has also been noted. The review shows that there is no age limit among drug abusers. Studies on the influence of social class have been contradictory. Factors which indicate a predisposition to initial drug use have been similar to those reported in other cultures. Although the studies agreed on the classes of drugs abused and the changing patterns of drug abuse, there has been no uniform reporting system. This situation is attributed to financial constraints. Large-scale surveys which should incorporate most of the core items in any epidemiological study on substance abuse have been suggested. PMID:6985029

  15. Lymphocyte transformation studies in drug hypersensitivity

    PubMed Central

    Warrington, R.J.; Tse, K.S.

    1979-01-01

    In a group of patients with clinically diagnosed drug hypersensitivity the in vitro lymphocyte response to the suspected drug was assessed by the lymphocyte transformation test. The test gave positive results in all 15 patients with penicillin-induced immediate or accelerated allergic reactions and positive immediate skin-test reactivity to the major or the minor antigenic determinant of penicillin, or both, but in only 3 of the 12 patients with delayed-onset maculopapular rashes induced by penicillin, despite positive immediate reactivity to the skin-test reagents. Lymphocyte stimulation greater than five times the control level was demonstrated for five patients with penicillin-induced erythroderma, Stevens-Johnson syndrome or a serum-sickness-like illness, or with methicillin-induced interstitial nephritis, all of whom had negative reactions to the appropriate skin-test reagents. A low level of stimulation was seen in eight other skin-test-negative patients with possible allergic reactions induced by penicillins. However, in all subjects tested the stimulation was significantly greater than the mean for control subjects. For 9 of 11 patients with isoniazid-induced hepatitis or maculopapular rashes, but for only 8 of 31 patients with eruptions induced by a variety of drugs other than penicillins and isoniazid, significant stimulation occurred in the lymphocyte transformation test. It is concluded that the lymphocyte transformation test is useful in the detection of hypersensitivity to the penicillins (although in IgE-mediated reactions skin testing is clearly preferable) and isoniazid but is of limited value in the demonstration of hypersensitivity to other drugs. PMID:445303

  16. Membrane–drug interactions studied using model membrane systems

    PubMed Central

    Knobloch, Jacqueline; Suhendro, Daniel K.; Zieleniecki, Julius L.; Shapter, Joseph G.; Köper, Ingo

    2015-01-01

    The direct interaction of drugs with the cell membrane is often neglected when drug effects are studied. Systematic investigations are hindered by the complexity of the natural membrane and model membrane systems can offer a useful alternative. Here some examples are reviewed of how model membrane architectures including vesicles, Langmuir monolayers and solid supported membranes can be used to investigate the effects of drug molecules on the membrane structure, and how these interactions can translate into effects on embedded membrane proteins. PMID:26586998

  17. Outage management: A case study

    SciTech Connect

    Haber, S.B.; Barriere, M.T. ); Roberts, K.H. . Walter A. Haas School of Business)

    1992-01-01

    Outage management issues identified from a field study conducted at a two-unit commercial pressurized water reactor (PWR), when one unit was in a refueling outage and the other unit was at full power operation, are the focus of this paper. The study was conduced as part of the US Nuclear Regulatory Commission's (NRC) organizational factors research program, and therefore the issues to be addressed are from an organizational perspective. Topics discussed refer to areas identified by the NRC as critical for safety during shutdown operations, including outage planning and control, personnel stress, and improvements in training and procedures. Specifically, issues in communication, management attention, involvement and oversight, administrative processes, organizational culture, and human resources relevant to each of the areas are highlighted by example from field data collection. Insights regarding future guidance in these areas are presented based upon additional data collection subsequent to the original study.

  18. Outage management: A case study

    SciTech Connect

    Haber, S.B.; Barriere, M.T.; Roberts, K.H.

    1992-09-01

    Outage management issues identified from a field study conducted at a two-unit commercial pressurized water reactor (PWR), when one unit was in a refueling outage and the other unit was at full power operation, are the focus of this paper. The study was conduced as part of the US Nuclear Regulatory Commission`s (NRC) organizational factors research program, and therefore the issues to be addressed are from an organizational perspective. Topics discussed refer to areas identified by the NRC as critical for safety during shutdown operations, including outage planning and control, personnel stress, and improvements in training and procedures. Specifically, issues in communication, management attention, involvement and oversight, administrative processes, organizational culture, and human resources relevant to each of the areas are highlighted by example from field data collection. Insights regarding future guidance in these areas are presented based upon additional data collection subsequent to the original study.

  19. Managing Mental Health Problems in Everyday Life: Drug Treatment Client's Self-Care Strategies

    ERIC Educational Resources Information Center

    Holt, Martin; Treloar, Carla

    2008-01-01

    Little is understood about the self-care activities undertaken by drug treatment clients. Using data from a qualitative study of drug treatment and mental health we identify the self-care practices of drug treatment clients diagnosed with anxiety and depression. Seventy-seven participants were interviewed in four sites across Australia.…

  20. Southern African Treatment Resistance Network (SATuRN) RegaDB HIV drug resistance and clinical management database: supporting patient management, surveillance and research in southern Africa.

    PubMed

    Manasa, Justen; Lessells, Richard; Rossouw, Theresa; Naidu, Kevindra; Van Vuuren, Cloete; Goedhals, Dominique; van Zyl, Gert; Bester, Armand; Skingsley, Andrew; Stott, Katharine; Danaviah, Siva; Chetty, Terusha; Singh, Lavanya; Moodley, Pravi; Iwuji, Collins; McGrath, Nuala; Seebregts, Christopher J; de Oliveira, Tulio

    2014-01-01

    Substantial amounts of data have been generated from patient management and academic exercises designed to better understand the human immunodeficiency virus (HIV) epidemic and design interventions to control it. A number of specialized databases have been designed to manage huge data sets from HIV cohort, vaccine, host genomic and drug resistance studies. Besides databases from cohort studies, most of the online databases contain limited curated data and are thus sequence repositories. HIV drug resistance has been shown to have a great potential to derail the progress made thus far through antiretroviral therapy. Thus, a lot of resources have been invested in generating drug resistance data for patient management and surveillance purposes. Unfortunately, most of the data currently available relate to subtype B even though >60% of the epidemic is caused by HIV-1 subtype C. A consortium of clinicians, scientists, public health experts and policy markers working in southern Africa came together and formed a network, the Southern African Treatment and Resistance Network (SATuRN), with the aim of increasing curated HIV-1 subtype C and tuberculosis drug resistance data. This article describes the HIV-1 data curation process using the SATuRN Rega database. The data curation is a manual and time-consuming process done by clinical, laboratory and data curation specialists. Access to the highly curated data sets is through applications that are reviewed by the SATuRN executive committee. Examples of research outputs from the analysis of the curated data include trends in the level of transmitted drug resistance in South Africa, analysis of the levels of acquired resistance among patients failing therapy and factors associated with the absence of genotypic evidence of drug resistance among patients failing therapy. All these studies have been important for informing first- and second-line therapy. This database is a free password-protected open source database available on

  1. Extensively Drug-Resistant Tuberculosis: Principles of Resistance, Diagnosis, and Management.

    PubMed

    Wilson, John W; Tsukayama, Dean T

    2016-04-01

    Extensively drug-resistant (XDR) tuberculosis (TB) is an unfortunate by-product of mankind's medical and pharmaceutical ingenuity during the past 60 years. Although new drug developments have enabled TB to be more readily curable, inappropriate TB management has led to the emergence of drug-resistant disease. Extensively drug-resistant TB describes Mycobacterium tuberculosis that is collectively resistant to isoniazid, rifampin, a fluoroquinolone, and an injectable agent. It proliferates when established case management and infection control procedures are not followed. Optimized treatment outcomes necessitate time-sensitive diagnoses, along with expanded combinations and prolonged durations of antimicrobial drug therapy. The challenges to public health institutions are immense and most noteworthy in underresourced communities and in patients coinfected with human immunodeficiency virus. A comprehensive and multidisciplinary case management approach is required to optimize outcomes. We review the principles of TB drug resistance and the risk factors, diagnosis, and managerial approaches for extensively drug-resistant TB. Treatment outcomes, cost, and unresolved medical issues are also discussed.

  2. Isothermal Microcalorimetry To Study Drugs against Schistosoma mansoni▿

    PubMed Central

    Manneck, Theresia; Braissant, Olivier; Haggenmüller, Yolanda; Keiser, Jennifer

    2011-01-01

    Alternative antischistosomal drugs are required since praziquantel is virtually the only drug available for treatment and morbidity control of schistosomiasis. Manual microscopic reading is the current “gold standard” to assess the in vitro antischistosomal properties of test drugs; however, it is labor-intensive, subjective, and difficult to standardize. Hence, there is a need to develop novel tools for antischistosomal drug discovery. The in vitro effects of praziquantel, oxamniquine, artesunate, and mefloquine on metabolic activity and parasite motility of Schistosoma mansoni (newly transformed schistosomula [NTS] and 49-day-old adult worms) were studied using isothermal microcalorimetry (IMC). Results were compared to morphological readouts of viability. Results obtained for the four drugs tested with phenotypic evaluation by microscopy and IMC showed a good correlation, but IMC also identified drug effects that were not visible by microscopic evaluation, and IMC precisely determined the onset of action of the test drugs. Similar sensitivities on NTS and adult schistosomes were observed for praziquantel and mefloquine, while slight differences in the drug susceptibilities of the two developmental stages were noted with oxamniquine and artesunate. IMC is a useful tool for antischistosomal drug discovery that should be further validated. In addition, our data support the use of NTS in in vitro antischistosomal drug assays. PMID:21270220

  3. EMPADE Study: Evaluation of Medical Prescriptions and Adverse Drug Events in COPD Patients Admitted to Intensive Care Unit

    PubMed Central

    Khan, M. Amer; Khan, M. Nematullah; Sultan, Ihtisham; Khan, M. Aamer; Ali, S. Amir; Farooqui, Afroze

    2015-01-01

    Introduction Inappropriate drug usage may preclude ideal benefit due to increased medical cost, antimicrobial resistance, adverse effects and mortality. Therefore drug utilization studies have become a plausible means in evaluating the healthcare systems. COPD management usually involves more than one drug which may escalate the risk of ADEs (adverse drug events). Aim The present study was aimed at assessing the current drug practice and ADEs in COPD management in ICU. Materials and Methods A total of 1,044 patients admitted for the treatment of COPD were included in the study. Their prescriptions were recorded for evaluation of drug utilization and patients were counseled for assessing ADEs. Results were evaluated by Chi-square test and percentages. Result All-embracing 15,360 drugs were prescribed at an average of 14.71 drugs per patient, wherein β2-agonists were extensively prescribed agents followed by inhaled-corticosteroids and anti-cholinergics. 372 ADEs were reported in 252 patients, wherein restlessness was the most frequent ADE and theophylline was found to be associated with highest cases of ADEs. Conclusion Practitioners should prescribe least number of drugs to mitigate the likelihood of adverse outcomes in patients due to numerous drugs usage, which may be achieved by following GOLD guidelines. The present work may help in improving the current management of COPD by rectifying the flaws delineated in this article. PMID:26675667

  4. Difficulties in Treatment and Management of Epilepsy and Challenges in New Drug Development

    PubMed Central

    Wahab, Abdul

    2010-01-01

    Epilepsy is a serious neurological disorder that affects around 50 million people worldwide. Almost 30% of epileptic patients suffer from pharmacoresistance, which is associated with social isolation, dependent behaviour, low marriage rates, unemployment, psychological issues and reduced quality of life. Currently available antiepileptic drugs have a limited efficacy, and their negative properties limit their use and cause difficulties in patient management. Antiepileptic drugs can provide only symptomatic relief as these drugs suppress seizures but do not have ability to cure epileptogenesis. The long term use of antiepileptic drugs is limited due to their adverse effects, withdrawal symptoms, deleterious interactions with other drugs and economic burden, especially in developing countries. Furthermore, some of the available antiepileptic drugs may even potentiate certain type of seizures. Several in vivo and in vitro animal models have been proposed and many new antiepileptic drugs have been marketed recently, but large numbers of patients are still pharmacoresistant. This review will highlight the difficulties in treatment and management of epilepsy and the limitations of available antiepileptic drugs and animal seizure models.

  5. Difficulties in Treatment and Management of Epilepsy and Challenges in New Drug Development

    PubMed Central

    Wahab, Abdul

    2010-01-01

    Epilepsy is a serious neurological disorder that affects around 50 million people worldwide. Almost 30% of epileptic patients suffer from pharmacoresistance, which is associated with social isolation, dependent behaviour, low marriage rates, unemployment, psychological issues and reduced quality of life. Currently available antiepileptic drugs have a limited efficacy, and their negative properties limit their use and cause difficulties in patient management. Antiepileptic drugs can provide only symptomatic relief as these drugs suppress seizures but do not have ability to cure epileptogenesis. The long term use of antiepileptic drugs is limited due to their adverse effects, withdrawal symptoms, deleterious interactions with other drugs and economic burden, especially in developing countries. Furthermore, some of the available antiepileptic drugs may even potentiate certain type of seizures. Several in vivo and in vitro animal models have been proposed and many new antiepileptic drugs have been marketed recently, but large numbers of patients are still pharmacoresistant. This review will highlight the difficulties in treatment and management of epilepsy and the limitations of available antiepileptic drugs and animal seizure models. PMID:27713344

  6. Current Drug Managements of Wilson's Disease: From West to East.

    PubMed

    Li, Wen-Jie; Chen, Chen; You, Zhi-Fei; Yang, Ren-Min; Wang, Xiao-Ping

    2016-01-01

    Wilson's disease (WD), also called hepatolenticular degeneration, is an autosomal recessive inheritance disorder of copper metabolism characterized by the multiple mutations in the ATP-ase 7B gene of chromosome 13q. About half of the WD patients have neurological or psychiatric symptoms. As WD is a kind of medicable or nearly curable neurodegenerative disease in the field of medicine, early consideration/examination and without delay/ life-long treatment usually lead to better prognoses. The drugs, also named as anticopper agents, are commonly used in clinics including D-penicillamine, trientine, sodium dimercaptosuccinate, dimercaptosuccinic acid, zinc and tetrathiomolybdate. This provides detailed reviews about these medicines.

  7. Current Drug Managements of Wilson's Disease: From West to East.

    PubMed

    Li, Wen-Jie; Chen, Chen; You, Zhi-Fei; Yang, Ren-Min; Wang, Xiao-Ping

    2016-01-01

    Wilson's disease (WD), also called hepatolenticular degeneration, is an autosomal recessive inheritance disorder of copper metabolism characterized by the multiple mutations in the ATP-ase 7B gene of chromosome 13q. About half of the WD patients have neurological or psychiatric symptoms. As WD is a kind of medicable or nearly curable neurodegenerative disease in the field of medicine, early consideration/examination and without delay/ life-long treatment usually lead to better prognoses. The drugs, also named as anticopper agents, are commonly used in clinics including D-penicillamine, trientine, sodium dimercaptosuccinate, dimercaptosuccinic acid, zinc and tetrathiomolybdate. This provides detailed reviews about these medicines. PMID:26639459

  8. Drug Monitoring Programs Do Curb Overdose Deaths: Study

    MedlinePlus

    ... html Drug Monitoring Programs Do Curb Overdose Deaths: Study Opioid epidemic demands such measures, researcher says To ... deaths from prescription painkillers called opioids, a new study finds. In an effort to curb overdose deaths ...

  9. Drug-drug interaction studies: regulatory guidance and an industry perspective.

    PubMed

    Prueksaritanont, Thomayant; Chu, Xiaoyan; Gibson, Christopher; Cui, Donghui; Yee, Ka Lai; Ballard, Jeanine; Cabalu, Tamara; Hochman, Jerome

    2013-07-01

    Recently, the US Food and Drug Administration and European Medicines Agency have issued new guidance for industry on drug interaction studies, which outline comprehensive recommendations on a broad range of in vitro and in vivo studies to evaluate drug-drug interaction (DDI) potential. This paper aims to provide an overview of these new recommendations and an in-depth scientifically based perspective on issues surrounding some of the recommended approaches in emerging areas, particularly, transporters and complex DDIs. We present a number of theoretical considerations and several case examples to demonstrate complexities in applying (1) the proposed transporter decision trees and associated criteria for studying a broad spectrum of transporters to derive actionable information and (2) the recommended model-based approaches at an early stage of drug development to prospectively predict DDIs involving time-dependent inhibition and mixed inhibition/induction of drug metabolizing enzymes. We hope to convey the need for conducting DDI studies on a case-by-case basis using a holistic scientifically based interrogative approach and to communicate the need for additional research to fill in knowledge gaps in these areas where the science is rapidly evolving to better ensure the safety and efficacy of new therapeutic agents. PMID:23543602

  10. Heat Management Strategy Trade Study

    SciTech Connect

    Nick Soelberg; Steve Priebe; Dirk Gombert; Ted Bauer

    2009-09-01

    This Heat Management Trade Study was performed in 2008-2009 to expand on prior studies in continued efforts to analyze and evaluate options for cost-effectively managing SNF reprocessing wastes. The primary objective was to develop a simplified cost/benefit evaluation for spent nuclear fuel (SNF) reprocessing that combines the characteristics of the waste generated through reprocessing with the impacts of the waste on heating the repository. Under consideration were age of the SNF prior to reprocessing, plutonium and minor actinide (MA) separation from the spent fuel for recycle, fuel value of the recycled Pu and MA, age of the remaining spent fuel waste prior to emplacement in the repository, length of time that active ventilation is employed in the repository, and elemental concentration and heat limits for acceptable glass waste form durability. A secondary objective was to identify and qualitatively analyze remaining issues such as (a) impacts of aging SNF prior to reprocessing on the fuel value of the recovered fissile materials, and (b) impact of reprocessing on the dose risk as developed in the Yucca Mountain Total System Performance Assessment (TSPA). Results of this study can be used to evaluate different options for managing decay heat in waste streams from spent nuclear fuel.

  11. Gastroretentive drug delivery systems for therapeutic management of peptic ulcer.

    PubMed

    Garg, Tarun; Kumar, Animesh; Rath, Goutam; Goyal, Amit K

    2014-01-01

    A peptic ulcer, stomach ulcer, or gastric ulcer, also known as peptic ulcer disease (PUD), is a very common chronic disorder of the stomach which is mainly caused by damage or impairment of the stomach lining. Various factors such as pepsin, gastric acid, H. pylori, NSAIDs, prostaglandins, mucus, bicarbonate, and blood flow to mucosa play an important role in causing peptic ulcers. In this review article, our main focus is on some important gastroretentive drug delivery systems (GRDDS) (floating, bioadhesive, high density, swellable, raft forming, superporous hydrogel, and magnetic systems) which will be helpful in gastroretention of different dosage forms for treatment of peptic ulcer. GRDDS provides a mean for controlled release of compounds that are absorbed by active transport in the upper intestine. It also enables controlled delivery for paracellularly absorbed drugs without a decrease in bioavailability. The above approaches are specific for targeting and leading to a marked improvement in the quality of life for a large number of patients. In the future, it is expected that they will become of growing significance, finally leading to improved efficiencies of various types of pharmacotherapies.

  12. Antiviral Information Management System (AIMS): a prototype for operational innovation in drug development.

    PubMed

    Jadhav, Pravin R; Neal, Lauren; Florian, Jeff; Chen, Ying; Naeger, Lisa; Robertson, Sarah; Soon, Guoxing; Birnkrant, Debra

    2010-09-01

    This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques. PMID:20881217

  13. Antiviral Information Management System (AIMS): a prototype for operational innovation in drug development.

    PubMed

    Jadhav, Pravin R; Neal, Lauren; Florian, Jeff; Chen, Ying; Naeger, Lisa; Robertson, Sarah; Soon, Guoxing; Birnkrant, Debra

    2010-09-01

    This article presents a prototype for an operational innovation in knowledge management (KM). These operational innovations are geared toward managing knowledge efficiently and accessing all available information by embracing advances in bioinformatics and allied fields. The specific components of the proposed KM system are (1) a database to archive hepatitis C virus (HCV) treatment data in a structured format and retrieve information in a query-capable manner and (2) an automated analysis tool to inform trial design elements for HCV drug development. The proposed framework is intended to benefit drug development by increasing efficiency of dose selection and improving the consistency of advice from US Food and Drug Administration (FDA). It is also hoped that the framework will encourage collaboration among FDA, industry, and academic scientists to guide the HCV drug development process using model-based quantitative analysis techniques.

  14. Synthetic cannabinoids to avoid urine drug screens: Implications for contingency management and other treatments for drug dependence.

    PubMed

    Ninnemann, Andrew L; Lechner, William V; Borges, Allison; Lejuez, C W

    2016-12-01

    Contingency management (CM) is an effective treatment for substance use dependence. Within CM, rewards or vouchers promote continued abstinence by acting as alternative reinforcers to substance use. However, CM relies on the use of accurate biochemical verification methods, such as urinalysis, to verify abstinence. Synthetic cannabinoids (SCs) pose a risk for CM treatment because they are not easily detected by common urinalysis techniques. Although SCs pose a risk, there is limited information regarding current rates of SC use within substance dependent populations as well as rates of substance use and psychiatric disorders among those who use SCs in treatment. We discuss emerging research on these topics and potential implications for CM treatments. Findings suggest CM researchers should test for and query SC use among those being treated for cannabis and cocaine use problems as well as among younger populations of substance users. Implications of other novel psychoactive substances for drug treatment and drug urinalysis are also discussed. PMID:27424166

  15. "Addicted to Euphoria": The History, Clinical Presentation, and Management of Party Drug Misuse.

    PubMed

    Bearn, Jenny; O'Brien, Matthew

    2015-01-01

    Eating, drinking, sexual activity, and parenting invoke pleasure, an emotion that promotes repetition of these behaviors, are essential for survival. Euphoria, a feeling or state of intense excitement and happiness, is an amplification of pleasure, aspired to one's essential biological needs that are satisfied. People use party drugs as a shortcut to euphoria. Ecstasy (3,4-methylenedioxymethamphetamine), γ-hydroxybutyric acid, and ketamine fall under the umbrella of the term "party drugs," each with differing neuropharmacological and physiological actions. This chapter seeks to survey the history and epidemiology of party drug use; we will then discuss the pharmacological characteristics of each drug to provide a platform for understanding the difficulties that party drug users encounter through intoxication, harmful use, dependence, and withdrawal and how these should be clinically managed. PMID:26070759

  16. Drugs foresight 2020: a Delphi expert panel study

    PubMed Central

    2014-01-01

    Background Historically substance misuse has been relatively common in western countries, but comparatively few Finns report drug use. The Drugs 2020 study aimed at foreseeing changes in the drug situation in Finland by the year 2020. Methods The Delphi method was used, utilizing drug experts of the EU national network in Finland. Results Marked growth was foreseen in drug use, especially in synthetic designer drugs and misuse of medicinal drugs. Significant increase was also expected in growing cannabis at home. However, the control of drug market was expected to shift more into the hands of organized crime. No consensus was reached on how drug prices will develop in the time period. Drug use is likely to remain punishable although the use and possession of cannabis may be treated less severely. It seems likely that health and social services resources will be directed towards medicinal treatment. Conclusions Foresight can be utilized in preparing for the future; desirable developments can be fostered, and measures can be taken to curb probable but undesirable lines of development. Based on the results of this study, the experts’ view is that it is highly likely that the Finnish society will have to prepare for an increase in the demand for drug-related care, both in terms of content of the care and financing the services. Also, the forecasted increase in the role of legal prescription medicine used as intoxicants will call for efforts not only in changing prescription practices but in border and police control measures, as well. Parallel developments have been foreseen in the UK and Sweden, and it is likely that similar trends will actualize also in other western countries. PMID:24885142

  17. Managing disability benefits as part of treatment for persons with severe mental illness and comorbid drug/alcohol disorders. A comparative study of payee and non-payee participants.

    PubMed

    Ries, R K; Comtois, K A

    1997-01-01

    The objective of this pilot study is to describe the use of a Social Security representative payee program as a clinical intervention integrated into long-term, dual-disorder treatment of severely mentally ill outpatients with comorbid drug/alcohol disorders. Compared with non-payees, patients selected to be payee participants were more likely to be male, have a diagnosis of schizophrenia, have a history of high inpatient utilization, and have higher current ratings of psychiatric symptoms, substance use, and functional disability. Despite these higher severity ratings, which usually predict poor outpatient compliance and higher rate of adverse outcomes, the payee participants attended about twice the number of outpatient service sessions as non-payees and were no more likely to be currently homeless, hospitalized, or incarcerated. The payee intervention is described, and ethical and research issues are discussed.

  18. Adjunct therapy of Ayurvedic medicine with anti tubercular drugs on the therapeutic management of pulmonary tuberculosis

    PubMed Central

    Debnath, P. K.; Chattopadhyay, Jaydeb; Mitra, Achintya; Adhikari, Anjan; Alam, Mirza Samsur; Bandopadhyay, S. K.; Hazra, Jayram

    2012-01-01

    Background: Pulmonary tuberculosis (PTB) is an age old disease described in Vedic Medicine as ‘Yakshma’. Later on, in Ayurveda it earned a prefix and found way into mythology as ‘Rajayakshma’. After the discovery of streptomycin, the therapeutic management of PTB received a major breakthrough. The treatment module changed remarkably with the formulation of newer anti-tubercular drugs (ATD) with appreciable success. Recent resurgence of PTB in developed countries like United States posed a threat to the medical community due to resistant strains. Consequently, WHO looked toward traditional medicine. Literature reveals that Ayurvedic treatment of PTB was in vogue in India before the introduction of ATD with limited success. Records show that 2766 patients of PTB were treated with Ayurvedic drugs in a tertiary care hospital in Kolkata in the year 1933-1947. Objectives: To evaluate the toxicity reduction and early restoration by adjunct therapy of Ayurvedic drugs by increasing the bio-availability of ATDs. Materials and Methods: In the present study, treatment response of 99 patients treated with ATD as an adjunct with Aswagandha (Withania somnifera) and a multi-herbal formulation described in Chikitsa-sthana of Charaka samhita i.e. Chyawanprash were investigated. Hematological profile, sputum bacterial load count, immunoglobulin IgA and IgM, blood sugar, liver function test, serum creatinine were the assessed parameters besides blood isoniazid and pyrazinamide, repeated after 28 days of treatment. Results: The symptoms abated, body weight showed improvement, ESR values were normal, there was appreciable change in IgA and IgM patterns and significantly increased bioavailability of isoniazid and pyrazinamide were recorded. Conclusion: This innovative clinical study coupled with empowered research may turn out to be promising in finding a solution for the treatment of PTB. PMID:23125511

  19. Management of drug-drug interactions: considerations for special populations--focus on opioid use in the elderly and long term care.

    PubMed

    Lynch, Tom

    2011-09-01

    Elderly patients and residents in long term care facilities requiring pain medication often have multiple pharmacologic and physiologic factors that can impact the choice of analgesic. One particular problem with prescribing opioids to the elderly and long term care residents is that opioid safety and efficacy have not been well studied in these populations, and it may be difficult to predict how these patients will respond to opioid treatment. As people age, numerous physiological changes occur, which may affect opioid pharmacokinetics and the potential for drug-drug interactions (DDIs). Long term care residents include the elderly but also include many younger patients who require assistance for a variety of reasons, such as physical or mental disability. Many elderly and long term care patients have cognitive deficits that impede communication about their pain, thus making detection of opioid DDIs more difficult. Knowledge of the patient's medical history and current prescriptions can help guide the pain management team in the selection of treatment, help minimize the risk of DDIs, and provide these patients with the pain relief they require. There are several practice management recommendations for opioid therapy in the elderly and long term care residents, with the goal of optimizing analgesia while avoiding adverse events and drug interactions.

  20. Effects of Smoking Cessation on Illicit Drug Use among Opioid Maintenance Patients: A Pilot Study

    PubMed Central

    Dunn, Kelly E.; Sigmon, Stacey C.; Reimann, Edward; Heil, Sarah H.; Higgins, Stephen T.

    2009-01-01

    Opioid treatment program patients and staff often have concerns that smoking cessation may jeopardize abstinence from illicit drug use. In this study, we evaluated whether smoking abstinence produced with a two-week contingency-management (CM) intervention was associated with relapse to illicit drug use among patients enrolled in opioid maintenance. Opioid-maintenance patients who were stable in treatment and abstinent from illicit drugs were enrolled in a 14-day smoking-cessation study. Participants were dichotomized into Abstainers (> 90% smoking-negative samples, n=12) and Smokers (< 10% smoking-negative samples, n=16). Illicit drug assays included opioids, oxycodone, propoxyphene, cannabis, amphetamines, cocaine and benzodiazepines. There were no differences between the Abstainers and Smokers, with 99% and 96% of samples testing negative for all illicit drugs in each group, respectively. Data from this study provide no evidence that smoking cessation among stable opioid-maintained patients undermines drug abstinence and lend support for programs that encourage smoking cessation during drug abuse treatment. PMID:20401340

  1. Management of HIV/AIDS in older patients–drug/drug interactions and adherence to antiretroviral therapy

    PubMed Central

    Burgess, Mary J; Zeuli, John D; Kasten, Mary J

    2015-01-01

    Patients with human immunodeficiency virus (HIV) are living longer with their disease, as HIV has become a chronic illness managed with combination antiretroviral therapy (cART). This has led to an increasing number of patients greater than 50 years old living successfully with HIV. As the number of older adults with HIV has increased, there are special considerations for the management of HIV. Older adults with HIV must be monitored for drug side effects and toxicities. Their other non-HIV comorbidities should also be considered when choosing a cART regimen. Older adults with HIV have unique issues related to medication compliance. They are more likely than the younger HIV patients to have vision loss, cognitive impairment, and polypharmacy. They may have lower expectations of their overall health status. Depression and financial concerns, especially if they are on a fixed income, may also contribute to noncompliance in the aging HIV population. PMID:26604826

  2. A pharmacokinetic drug-drug interaction study of venlafaxine and indinavir.

    PubMed

    Levin, G M; Nelson, L A; DeVane, C L; Preston, S L; Eisele, G; Carson, S W

    2001-01-01

    Depression is a common occurrence in the human immunodeficiency virus (HIV)-infected population. Complications in treating depressed HIV-infected individuals include the use of multiple medications, additive side effects, and potentially significant drug-drug interactions. Based on the pharmacologic characteristics of venlafaxine and indinavir, we hypothesized that significant pharmacokinetic drug-drug interactions would not occur when these drugs where taken concurrently. Nine healthy adult subjects were given a single 800 mg oral dose of indinavir and serial blood samples were collected for measurement of plasma drug concentrations. Over the next 9 days, venlafaxine was administered at a dosage of 50 mg every 8 hours following a brief titration. A venlafaxine trough plasma concentration and serial concentrations following venlafaxine administration were obtained on day 10. On day 11, venlafaxine and indinavir were administered together and serial blood sampling was repeated. Indinavir had no effect on venlafaxine plasma concentrations but resulted in a 7% decrease in plasma concentrations of O-desmethyl-venlafaxine (ODV)(P = 0.028). This effect is unlikely to be clinically significant. Venlafaxine coadministration resulted in a 28% decrease in the area under the concentration time curve (AUC) of plasma indinavir (P = 0.016) and a 36% decrease in its maximum plasma concentration (Cmax; P = 0.038). As the plasma concentration of protease inhibitors is a critical factor in maintaining efficacy and minimizing the potential for viral resistance, the decrease in both AUC and Cmax of indinavir from coadministration of venlafaxine is of concern. The clinical significance of these results obtained from a small number of healthy volunteers is unknown. Further studies are needed to substantiate or refute this apparent drug-drug interaction. Until such time, venlafaxine should be used cautiously in patients receiving indinavir.

  3. Genetic association studies in drug-induced liver injury.

    PubMed

    Daly, Ann K; Day, Chris P

    2009-11-01

    Genetic studies on drug-induced liver injury (DILI) have proved challenging, both because of their rarity and their difficulty in replicating observed effects. However, significant progress has now been achieved by both candidate-gene and genome-wide association studies. These two approaches are considered in detail, together with examples of DILI due to specific drugs where consistent associations have been reported. Particular consideration is given to associations between antituberculosis drug-related liver injury and the "slow acetylator" genotype for N-acetyltransferase 2, amoxicillin/clavulanate-related liver injury, and the human leukocyte antigen (HLA) class II DRB1*1501 allele and flucloxacillin-related injury and the HLA class I B*5701 allele. Although these associations are drug-specific, the possibility that additional, more general susceptibility genes for DILI exist requires further investigation, ideally by genome-wide association studies involving international collaboration. The possibility of interethnic variation in susceptibility to DILI also requires further study.

  4. [Risk management of QT-prolonging drugs by community pharmacists using a mobile electrocardiograph].

    PubMed

    Shinozaki, Kohki

    2010-11-01

    Prolongation of the QT interval is associated with a high risk of serious arrhythmia, i.e., torsades de pointes (TdP). However, in many cases, the QT-prolonging drug(s) is prescribed without performing a thorough check-up of the patient's condition, especially an electrocardiogram. In addition to patient interview, we used an electrocardiogram obtained with a mobile electrocardiograph (RMH-ECG) in a community pharmacy in order to improve the risk management for QT-prolonging drugs. A comparison of the results obtained using RMH-ECG (modified I) and 12-lead ECG (I) revealed that both corrected QT (QTc) values were almost identical, and the correlation coefficient was 0.96. In one month, 5 of 948 patients who visited our pharmacy and continuously took QT-prolonging drugs had additional risk factors for TdP (advanced age, female, and drug-drug interaction). We monitored the QT interval of one of these patients. She had received erythromycin for 19 months along with other drugs metabolized by a P450 (CYP3A4); benidipine and prednisolone (for over 2 years), and tacrolimus (for 13 weeks). Three RMH-ECG tests at every 2 weeks revealed that QTcs were normal (0.43-0.45 s); therefore, we dispensed drugs without any change in the prescription. Approximately 1 in 1200 individuals has a prolonged QT interval without any subjective symptoms, and the time window of drug-induced TdP is considered to be from several hours to months after taking these drugs. Therefore, we think that an ECG test should be performed in community pharmacies before dispensing QT-prolonging drugs and that the QT interval should be monitored.

  5. Ketorolac: a new parenteral nonsteroidal anti-inflammatory drug for postoperative pain management.

    PubMed

    Lassen, K; Epstein-Stiles, M; Olsson, G L

    1992-08-01

    Providing adequate pain control with minimal side effects in inpatient and ambulatory settings is a continuous challenge to the PACU nurse. Ketorolac tromethamine (Toradol, Syntex, Palo Alto, CA) is a new parenteral nonsteroidal anti-inflammatory drug (NSAID) approved for use in the United States. Ketorolac is useful in the management of short term, moderate to severe postoperative pain. It is used by itself or as an adjunct to traditional opioid analgesics. Ketorolac, like other NSAIDs, has analgesic, anti-inflammatory, and antipyretic properties. Unlike morphine or meperidine, ketorolac does not bind to opioid receptors and is not a centrally acting agent. Administered intramuscularly, peak plasma levels are reached in 45 to 50 minutes. It is administered as a 30- or 60-mg intramuscular (IM) loading dose followed by 15- or 30-mg doses IM every 6 hours, with a maximum first-day dose of 150 mg and 120 mg on subsequent days up to a recommended maximum of 5 days. The lower dose range is recommended for elderly patients, patients weighing less than 50 kg, and patients with impaired kidney function. Initial studies show that use of ketorolac decreases the overall amount of opioid analgesia needed for postoperative pain control. To date, reported occurrence of side effects is low. A case study presents a healthy ambulatory surgical patient admitted for inguinal hernia repair using epidural anesthesia. Use of ketorolac has shown initial favorable results. More research is needed to further define its role and side effects in postoperative pain management.

  6. Management of clandestine drug laboratories: need for evidence-based environmental health policies.

    PubMed

    Al-Obaidi, Tamara A; Fletcher, Stephanie M

    2014-01-01

    Clandestine drug laboratories (CDLs) have been emerging and increasing as a public health problem in Australia, with methamphetamine being the dominant illegally manufactured drug. However, management and remediation of contaminated properties are still limited in terms of regulation and direction, especially in relation to public and environmental health practice. Therefore, this review provides an update on the hazards and health effects associated with CDLs, with a specific look at the management of these labs from an Australian perspective. Particularly, the paper attempts to describe the policy landscape for management of CDLs, and identifies current gaps and how further research may be utilised to advance understanding and management of CDLs and inform public health policies. The paper highlights a significant lack of evidence-based policies and guidelines to guide regulatory authority including environmental health officers in Australia. Only recently, the national Clandestine Drug Laboratory Guidelines were developed to assist relevant authority and specialists manage and carry out investigations and remediation of contaminated sites. However, only three states have developed state-based guidelines, some of which are inadequate to meet environmental health requirements. The review recommends well-needed inter-sectoral collaborations and further research to provide an evidence base for the development of robust policies and standard operating procedures for safe and effective environmental health management and remediation of CDLs.

  7. Regional solid waste management study

    SciTech Connect

    Not Available

    1992-09-01

    In 1990, the Lower Savannah Council of Governments (LSCOG) began dialogue with the United States Department of Energy (DOE) regarding possibilities for cooperation and coordination of solid waste management practices among the local governments and the Savannah River Site. The Department of Energy eventually awarded a grant to the Lower Savannah Council of Governments for the development of a study, which was initiated on March 5, 1992. After careful analysis of the region`s solid waste needs, this study indicates a network approach to solid waste management to be the most viable. The network involves the following major components: (1) Rural Collection Centers, designed to provide convenience to rural citizens, while allowing some degree of participation in recycling; (2) Rural Drop-Off Centers, designed to give a greater level of education and recycling activity; (3) Inert landfills and composting centers, designed to reduce volumes going into municipal (Subtitle D) landfills and produce useable products from yard waste; (4) Transfer Stations, ultimate landfill disposal; (5) Materials Recovery Facilities, designed to separate recyclables into useable and sellable units, and (6) Subtitle D landfill for burial of all solid waste not treated through previous means.

  8. Evaluating Environmental Management Approaches to Alcohol and Other Drug Abuse Prevention. Prevention Updates

    ERIC Educational Resources Information Center

    DeJong, William; Langford, Linda M.

    2006-01-01

    Recent years have seen an upsurge in prevention work focused on changing the campus and community environments in which college students make decisions about alcohol and other drug (AOD) use. This approach, called "environmental management," is based on three fundamental premises: (1) Substance use problems are aggravated by a physical, social,…

  9. A Randomized Trial of Probation Case Management for Drug-Involved Women Offenders

    ERIC Educational Resources Information Center

    Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha A.; Davis, Thomas B.; Marsh, Cheryl

    2011-01-01

    This article reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to PCM (n = 92) or standard probation (n = 91) and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support, and service utilization.…

  10. General Practitioners' Management of Psychostimulant Drug Misuse: Implications for Education and Training

    ERIC Educational Resources Information Center

    Alkhamis, Ahmed; Matheson, Catriona; Bond, Christine

    2009-01-01

    Aims: To provide baseline data regarding GPs' knowledge, experience, and attitudes toward the management of PsychoStimulant Drug Misuse (PSDM) patients to inform future education and training initiatives. Methods: A structured cross-sectional postal questionnaire was developed following initial content setting interviews, piloted then sent to a…

  11. An exploratory study of drug use in bar environments

    PubMed Central

    Trocki, Karen; Michalak, Laurence; McDaniel, Patricia

    2010-01-01

    The purpose of this paper is to explore the characteristics of bars where drug use was observed compared to those where no drug use was observed. The study was done through a combination of qualitative and quantitative techniques gleaned through observations and interviews. Among the most important of indicators were the type of activity (particularly dancing) and the level of rowdiness evident in the bars. In addition drug use bars had higher levels of other types of rule-breaking. Patron characteristics (more men) and behavioral patterns (more sexual risk-taking) also distinguished these bars. PMID:25221431

  12. Thermoresponsive polymeric gel as an on-demand transdermal drug delivery system for pain management.

    PubMed

    Indulekha, S; Arunkumar, P; Bahadur, D; Srivastava, R

    2016-05-01

    The main aim of this work is to design a heat triggered transdermal drug delivery system (TDDS) using a thermoresponsive polymer, poly (N-vinyl caprolactam) [PNVCL] based gel, where in patients can themselves administer a pulse of drug on mere application of heat pad over the TDDS, whenever pain is experienced. The phase transition temperature of PNVCL was tuned to 35 °C by grafting it onto a pH sensitive biopolymer, Chitosan, to synthesize Chitosan-g-PNVCL (CP) co-polymer which render the gel both thermo- and pH-responsive property. The application of triggered delivery was explored by loading acetamidophenol (a model hydrophilic drug) and etoricoxib (a model hydrophobic drug). In vitro drug release experiments were performed at three different temperatures (25, 32 and 39 °C) at two different pH (5.5 and 7) to study its drug release with response to temperature and pH. Drug release profiles obtained were found to have enhanced release for both the drugs respectively at 39 °C (above LCST) and pH5.5 when compared to other release conditions. In vitro skin permeation of both the drugs performed in rat abdominal skin using Franz diffusion cell showed enhanced drug release when the skin was subjected to higher temperature (39 °C). Moreover, it was also found that skin permeation for hydrophobic drug was better than that of hydrophilic drug. The in vivo biocompatibility studies of the CP gel in rat skin proved that the gel is biocompatible. The results obtained demonstrated the potential use of the thermoresponsive CP gel as an on-demand localized drug delivery system.

  13. Knowledge Management Analysis: A Case Study

    ERIC Educational Resources Information Center

    Mecha, Ezi I.; Desai, Mayur S.; Richards, Thomas C.

    2009-01-01

    It is imperative for businesses to manage knowledge and stay competitive in the marketplace. Knowledge management is critical and is a key to prevent organizations from duplicating their efforts with a subsequent improvement in their efficiency. This study focuses on overview of knowledge management, analyzes the current knowledge management in…

  14. Drugs.

    ERIC Educational Resources Information Center

    Hurst, Hunter, Ed.; And Others

    1984-01-01

    This document contains the third volume of "Today's Delinquent," an annual publication of the National Center for Juvenile Justice. This volume deals with the issue of drugs and includes articles by leading authorities in delinquency and substance abuse who share their views on causes and cures for the drug problem among youth in this country.…

  15. Theoretical and experimental studies of the stability of drug-drug interact

    NASA Astrophysics Data System (ADS)

    Soares, Monica F. R.; Alves, Lariza D. S.; Nadvorny, Daniela; Soares-Sobrinho, José L.; Rolim-Neto, Pedro J.

    2016-11-01

    Several factors can intervene in the molecular properties and consequently in the stability of drugs. The molecular complexes formation often occur due to favor the formation of hydrogen bonds, leading the system to configuration more energy stable. This work we aim to investigate through theoretical and experimental methods the relation between stability and properties of molecular complexes the molecular complex formed between the drugs, efavirenz (EFV), lamivudine (3TC) and zidovudine (AZT). With this study was possible determining the most stable complex formed between the compounds evaluated. In addition the energy and structural properties of the complex formed in relation to its individual components allowed us to evaluate the stability of the same.

  16. Insights into drug metabolism from modelling studies of cytochrome P450-drug interactions.

    PubMed

    Maréchal, Jean-Didier; Sutcliffe, Michael J

    2006-01-01

    The cytochromes P450 (CYPs) comprise a vast superfamily of enzymes found in virtually all life forms. In mammals, xenobiotic metabolising CYPs provide crucial protection from the harmful effects of exposure to a wide variety of chemicals, including environmental toxins and therapeutic drugs. Elucidating the structural features of CYPs that contribute to their metabolism of structurally diverse substrates impacts on the rational design of improved therapeutic drugs and specific inhibitors. Models capable of predicting the possible involvement of CYPs in the metabolism of drugs or drug candidates are thus important tools in drug discovery and development. Ideally, functional information would be obtained from crystal structures of all the CYPs of interest. Initially only crystal structures of distantly related bacterial CYPs were available - comparative modelling techniques were used to bridge the gap and produce structural models of human CYPs, and thereby obtain some useful functional information. A significant step forward in the reliability of these models came six years ago with the first crystal structure of a mammalian CYP, rabbit CYP2C5, followed by the structures of five human enzymes, CYP2A6, CYP2C8, CYP2C9, CYP2D6 and CYP3A4, and a second rabbit enzyme, CYP2B4. The evolution of a CYP2D6 model, leading to the validation of the model as an in silico tool for predicting binding and metabolism, is presented as a case study. PMID:16918473

  17. Drug Targets for Cardiovascular-Safe Anti-Inflammatory: In Silico Rational Drug Studies

    PubMed Central

    Shahbazi, Sajad; Sahrawat, Tammanna R.; Ray, Monalisa; Dash, Swagatika; Kar, Dattatreya; Singh, Shikha

    2016-01-01

    Cyclooxygenase-2 (COX-2) plays an important role in memory consolidation and synaptic activity, the most fundamental functions of the brain. It converts arachidonic acid to prostaglandin endoperoxide H2. In contrast, if over-expressed, it causes inflammation in response to cytokine, pro-inflammatory molecule, and growth factor. Anti-inflammatory agents, by allosteric or competitive inhibition of COX-2, alleviate the symptoms of inflammation. Coxib family drugs, particularly celecoxib, are the most famous anti-inflammatory agents available in the market showing significant inhibitory effect on COX-2 activity. Due to high cardiovascular risk of this drug group, recent researches are focused on the investigation of new safer drugs for anti-inflammatory diseases. Natural compounds, particularly, phytochemicals are found to be good candidates for drug designing and discovery. In the present study, we performed in silico studies to quantitatively scrutinize the molecular interaction of curcumin and its structural analogs with COX-2, COX-1, FXa and integrin αIIbβIII to investigate their therapeutic potential as a cardiovascular-safe anti-inflammatory medicine (CVSAIM). The results of both ADMET and docking study indicated that out of all the 39 compounds studied, caffeic acid had remarkable interaction with proteins involved in inflammatory response. It was also found to inhibit the proteins that are involved in thrombosis, thereby, having the potential to be developed as therapeutic agent. PMID:27258084

  18. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2011 CFR

    2011-10-01

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  19. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 1 2010-10-01 2010-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the Secretary..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS)...

  20. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 49 Transportation 1 2014-10-01 2014-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the...

  1. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 49 Transportation 1 2013-10-01 2013-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the...

  2. 49 CFR Appendix H to Part 40 - DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ..., App. H Appendix H to Part 40—DOT Drug and Alcohol Testing Management Information System (MIS) Data... 49 Transportation 1 2012-10-01 2012-10-01 false DOT Drug and Alcohol Testing Management Information System (MIS) Data Collection Form H Appendix H to Part 40 Transportation Office of the...

  3. [Recommendations of the Spanish Society for Pediatric Infectious Diseases (SEIP) on the management of drug-resistant tuberculosis].

    PubMed

    Mellado Peña, M J; Baquero-Artigao, F; Moreno-Perez, D

    2009-11-01

    Drug resistant tuberculosis (TB-R), and in particular, multidrug resistant tuberculosis (MDR-TB) is a global public health problem, as well as a problem in our country. Cases of TB-R and MDR-TB have increased mainly in HIV, immigrant and socially disadvantaged populations, but a notable increase in the general population has also been observed. This aspect reinforces the need for a systematic study of sensitivity of all the isolates in a reference laboratory to optimally guide the treatment. Children are especially vulnerable to this severe disease due to the limited knowledge of second line anti-tuberculous drugs, in terms of their pharmacokinetic data, optimal doses, or their long term toxicity, all this eventually resulting in the compassionate use of drugs. Another aspect which further complicates the management of R-TB in children is the limited yield of cultures, which frequently leads to clinician designing drug combinations according to the sensitivity of the initial strain. The epidemiological pattern in our country has currently changed. There is a reported increase in isoniazid-resistant strains; therefore, a four drugs regime is mandatory for the initial period in children, until reliable sensitivity results are available. Treatment should be directly observed or at least supervised by paediatricians. The management of latent infections or exposure to a resistant TB case also requires an accurate, strict and prolonged supervision by expert paediatricians. Authorities and health care professionals who deal with TB should be prepared to face this new phenomenon with appropriate measures. The knowledge of second line drugs for children, as well as mechanisms to ensure the therapeutic adherence and long term control of disease, are essential.

  4. [Risk Management of Teratogenic Drugs ~The Current States of Practice in Europe, US and Japan~].

    PubMed

    Takagi, Tatsuya; van Bennekom, Carla; Amann, Steffen; Hattori, Chizuko; Shirakuni, Yuko; Sato, Tsugumichi; Nasu, Masao

    2015-01-01

    Thalidomide was approved for the treatment of multiple myeloma in Japan under a risk management program, named TERMS, in 2008. Since then, we have been conducting a survey of the stakeholders to assess the effectiveness of TERMS. These surveys showed patients had enough knowledge of the risks of thalidomide. In the USA, legislation in 2007 granted its U.S. Food and Drug Administration (FDA) the authority to require Risk Evaluation and Mitigation Strategies (REMS) when necessary to ensure that a drug's benefits outweigh its risks. As of 2015, more than 70 drugs, including thalidomide, have REMS programs. In Germany, in the early 1960s, over 5000 children were born with deformities. Therefore, the safety regulations in Germany go far beyond the European Medicines Agency (EMA) safety regulations at the time of thalidomide re-approval; thalidomide can be prescribed by a special prescribing form, including both proof of the patients' awareness of information about the risks, and participation in a pregnancy prevention program. While Japan has taken similar safety measures, a portion of thalidomide is still privately imported there. By March 2013, 594 patients have been registered to Japan's Safety Management System for Unapproved Drugs (SMUD), which was introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2009. The number of females of child bearing potential (FCBPs) was 33 and the fraction (33/594=5.6%) was higher than that (48/7370=0.7%) in the case of TERMS. Risk management of thalidomide is described in this review.

  5. Management of human resources associated with misuse of prescription drugs: analysis of a national survey.

    PubMed

    Lee, Doohee; Ross, Michael W

    2011-01-01

    Nonmedical use of prescription drugs is increasingly prevalent in the United States, but limited research is available on prescription drugs misuse in the workforce. We investigated whether absenteeism and turnover are associated with having problems linked to prescription drug misuse among employees. We also further explored the moderating effects of employee drug policy and testing on the relation between having problems linked to misuse of prescription pain relievers (PPRs) and absenteeism and turnover. This is a cross-sectional study (n = 2,249) using the 2007 U.S. national survey data ("National Survey on Drug Use and Health"). The multivariate logistic analysis results illustrate, after controlling confounding factors (gender, age, tobacco use, and heroin use), absenteeism and turnover linked to having problems of PPRs misuse. Our findings suggest the moderating effects of employee drug policy on the association between absenteeism and turnover and having problems linked to misuse of PPRs. Also, drug testing was found to moderate the link between having negative outcomes of misuse of PPRs and absenteeism. Having problems associated with misuse of PPRs is linked to absenteeism and turnover. A drug policy program including drug testing may play a significant role in reducing absenteeism and turnover in relation to having problems linked to misuse of PPRs.

  6. [Between scientific management and research-action: the problem of overconsumption of drugs in Kasongo (Zaire)].

    PubMed

    De Brouwere, V; Van Lerberghe, W; Criel, B; Van Dormael, M

    1996-01-01

    A Primary Health Care (PHC) system may be effective and efficient to the extent that essential drugs are available in health services and financially accessible to the population. In developing countries, besides the difficulties related to supplying health services with adequate amounts of drugs, the control of drug consumption is one of the frequent problems encountered by health authorities. Literature is relatively abundant in the field of rationalization of the diagnosis and drug prescription processes, and also in the field of drug financing mechanisms; publications are however rather scarce when topics related to corruption or drug misappropriation are concerned. The case study submitted hereafter reports a drug overconsumption problem in the health centres (HC) of the Kasongo district (Zaire). Despite the existence of direct control mechanisms as well as indirect ones (monitoring of drug consumption by HC), the problem has been identified belatedly. The district staff then used a step-by-step analysis of the HC drug consumption profiles; this analysis allowed to demonstrate that misappropriation would be the most plausible hypothesis. In order to solve the misappropriation problem-the consequences of which jeopardized the functioning of the very health system-the district staff chose to involve the nurses, in charge of the HC, in the entire problem-solving process. This participative approach, involving different actors as partners, allowed to deepen the situation analysis and to elaborate solutions congruent with PHC principles and acceptable to all concerned.

  7. Adverse drug reaction profile of microtubule-damaging antineoplastic drugs: A focused pharmacovigilance study in India

    PubMed Central

    Manohar, Hasitha Diana; Adiga, Shalini; Thomas, Joseph; Sharma, Ajitha

    2016-01-01

    Objectives: The aim of the study was to analyze the adverse drug reaction (ADR) profile of microtubule-damaging antineoplastic drugs (taxanes and vinca alkaloids) and to look for unexpected ADRs among the local population. Focused study on these drugs, rampantly used in oncology department for a wide variety of tumors including early and advanced malignancies, would enable better treatment care by physicians. Materials and Methods: Data on ADRs were collected from the cancer patients belonging to both gender and of all ages, on taxanes- or vinca-based cancer chemotherapy and reported in the Indian Pharmacopoeia Commission form. Causality was assessed using the WHO criteria and Naranjo's Algorithm. Preventability and severity of ADRs were also assessed. Results: A total of 97 ADRs were reported among 488 patients on microtubule-damaging anticancer drugs admitted over a period of 1 year. The incidence rate was 19.87%. Gastrointestinal system (40.2%) was the most affected followed by bone marrow (33%) and skin (8.2%). The highest incidence of ADRs was reported among paclitaxel (54.6%), and vincristine (39.2%). Most of the reported ADRs were of milder nature and preventable. The WHO causality assessment scale indicated 71.1% possible reactions. Conclusions: This study showed that most ADRs are preventable with effective ADR monitoring. There is a great need to create awareness among healthcare professionals regarding the importance of the pharmacovigilance system. Judicious use of the preventive measures will lead to a reduction in the incidence of ADRs due to the drug armamentarium, thereby enabling additional economic benefit to the patient and society. PMID:27721535

  8. The ethics of postmarketing observational studies of drug safety under section 505(o)(3) of the Food, Drug, and Cosmetic Act.

    PubMed

    Evans, Barbara J

    2012-01-01

    In 2007, Congress granted the Food and Drug Administration (FDA) new powers to order pharmaceutical companies to conduct drug safety studies and clinical trials in the postmarketing period after drugs are approved The methodologies include observational studies that examine patients' insurance claims data and clinical records to infer whether drugs are safe in actual clinical practice. Such studies offer a valuable tool for improving drug safety, but they raise ethical and privacy concerns because they would entail widespread use of patients' health information in commercial research by drug manufacturers. This is the first article to explore the ethics of these section 505(0)(3) observational studies, so named after the section of the Food, Drug, and Cosmetic Act that authorizes them. Data access problems threaten to make the FDA's section 505(0)(3) study requirements unenforceable. Under existing federal privacy regulations, it appears highly unlikely that pharmaceutical companies will have reliable access to crucial data resources, such as insurance claims data and healthcare records, to use in these studies. State privacy laws present another potential barrier to data access. If pharmaceutical companies do manage to gain access to the needed data, this will raise serious privacy concerns because section 505(0)(3) observational studies do not appear to be covered by any of the major federal regulations that afford ethical and privacy protections to persons whose data are used in research. If the FDA's program of section 505(o)(3) observational studies fails because of the above problems, this failure will have a number of bad consequences: the public will be exposed to avoidable drug safety risks; taxpayers may be forced to bear the costs of having the FDA conduct drug safety investigations that would have been funded by drug manufacturers if data had been available; and, perhaps most troubling, the FDA may be forced to order postmarketing clinical trials to

  9. Software for Managing Parametric Studies

    NASA Technical Reports Server (NTRS)

    Yarrow, Maurice; McCann, Karen M.; DeVivo, Adrian

    2003-01-01

    The Information Power Grid Virtual Laboratory (ILab) is a Practical Extraction and Reporting Language (PERL) graphical-user-interface computer program that generates shell scripts to facilitate parametric studies performed on the Grid. (The Grid denotes a worldwide network of supercomputers used for scientific and engineering computations involving data sets too large to fit on desktop computers.) Heretofore, parametric studies on the Grid have been impeded by the need to create control language scripts and edit input data files painstaking tasks that are necessary for managing multiple jobs on multiple computers. ILab reflects an object-oriented approach to automation of these tasks: All data and operations are organized into packages in order to accelerate development and debugging. A container or document object in ILab, called an experiment, contains all the information (data and file paths) necessary to define a complex series of repeated, sequenced, and/or branching processes. For convenience and to enable reuse, this object is serialized to and from disk storage. At run time, the current ILab experiment is used to generate required input files and shell scripts, create directories, copy data files, and then both initiate and monitor the execution of all computational processes.

  10. Chronic Care Management for Dependence on Alcohol and Other Drugs: The AHEAD Randomized Trial

    PubMed Central

    Saitz, Richard; Cheng, Debbie M.; Winter, Michael; Kim, Theresa W.; Meli, Seville M.; Allensworth-Davies, Don; Lloyd-Travaglini, Christine A.; Samet, Jeffrey H.

    2014-01-01

    Importance People with substance dependence have health consequences, high healthcare utilization and frequent comorbidity but often receive poor quality care overall and for dependence. Chronic care management has been proposed as an approach to improve care and outcomes. Objective To determine whether chronic care management (CCM) for alcohol and other drug (AOD) dependence improves substance use outcomes compared to usual primary care. Design, Setting, and Participants The AHEAD study was a randomized trial in people with AOD dependence, not necessarily seeking treatment, at a Boston hospital-based primary care practice. Of the 655 eligible participants, 563 (86%) were randomized. Study participants were recruited from September 2006 to September 2008 from a free-standing residential detoxification unit (74%) and referrals from an urban teaching hospital and advertisements (26%). Participants were randomized to CCM (n=282) or no CCM (n=281). Intervention CCM included longitudinal care coordinated with a primary care clinician, motivational enhancement therapy, relapse prevention counseling, and on-site medical, addiction and psychiatric treatment, social work assistance and referrals (including mutual help). The no CCM group received a primary care appointment, and a list of treatment resources including a phone number to arrange counseling. Main Outcome and Measure The primary outcome was self-reported abstinence from opioids, stimulants or heavy drinking. Biomarkers were secondary outcomes. We employed longitudinal analyses for data from 3, 6 and 12 months (last interview January 21, 2010). Results Of 563 participants, 95% completed 12-month follow-up. Baseline characteristics of the study participants were similar across randomization groups, but differed significantly for race and depressive symptoms. There was no significant difference in abstinence from opioids, stimulants or heavy drinking between the CCM (44%) and control (42%) groups (adjusted odds

  11. Managing potential drug-drug interactions between gastric acid-reducing agents and antiretroviral therapy: experience from a large HIV-positive cohort.

    PubMed

    Lewis, J M; Stott, K E; Monnery, D; Seden, K; Beeching, N J; Chaponda, M; Khoo, S; Beadsworth, M B J

    2016-02-01

    Drug-drug interactions between antiretroviral therapy and other drugs are well described. Gastric acid-reducing agents are one such class. However, few data exist regarding the frequency of and indications for prescription, nor risk assessment in the setting of an HIV cohort receiving antiretroviral therapy. To assess prevalence of prescription of gastric acid-reducing agents and drug-drug interaction within a UK HIV cohort, we reviewed patient records for the whole cohort, assessing demographic data, frequency and reason for prescription of gastric acid-reducing therapy. Furthermore, we noted potential drug-drug interaction and whether risk had been documented and mitigated. Of 701 patients on antiretroviral therapy, 67 (9.6%) were prescribed gastric acid-reducing therapy. Of these, the majority (59/67 [88.1%]) were prescribed proton pump inhibitors. We identified four potential drug-drug interactions, which were appropriately managed by temporally separating the administration of gastric acid-reducing agent and antiretroviral therapy, and all four of these patients remained virally suppressed. Gastric acid-reducing therapy, in particular proton pump inhibitor therapy, appears common in patients prescribed antiretroviral therapy. Whilst there remains a paucity of published data, our findings are comparable to those in other European cohorts. Pharmacovigilance of drug-drug interactions in HIV-positive patients is vital. Education of patients and staff, and accurate data-gathering tools, will enhance patient safety.

  12. Preparing for safety issues following drug approval: pre-approval risk management considerations

    PubMed Central

    Sharrar, Robert G.

    2013-01-01

    Risk management plans and risk minimization plans as well as postapproval commitment studies are based on risks identified pre-approval that need to be further characterized or minimized in the postmarketing environment. Although the implementation of these activities are conducted in the postapproval arena, the design of the plans and studies as well as the development of effective postapproval tools and mitigation strategies should be carried out pre-approval. The pre-approval period also provides the opportunity to fully understand the treatment population that is included in the clinical trial program and to determine how the target population for the drug after approval may differ from the clinical trial patient population. When regulators or sponsors have expressed concerns about safety issues identified during clinical development, the result may be a postapproval commitment in the form of a registry or an observational safety study or, in the US, a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval. Specific examples are given for risk mitigation activities that can be conducted pre-approval. PMID:25114783

  13. Nitazoxanide: Nematicidal Mode of Action and Drug Combination Studies

    PubMed Central

    Somvanshi, Vishal S.; Ellis, Brian L.; Hu, Yan; Aroian, Raffi V.

    2014-01-01

    Intestinal nematodes or roundworms (aka soil-transmitted helminths or STHs) cause great disease. They infect upwards of two billion people, leading to high morbidity and a range of health problems, especially in infected children and pregnant women. Development of resistance to the two main classes of drugs used to treat intestinal nematode infections of humans has been reported. To fight STH infections, we need new and more effective drugs and ways to improve the efficacy of the old drugs. One promising alternative drug is nitazoxanide (NTZ). NTZ, approved for treating human protozoan infections, was serendipitously shown to have therapeutic activity against STHs. However, its mechanism of action against nematodes is not known. Using the laboratory nematode Caenorhabditis elegans, we show that NTZ acts on the nematodes through avr-14, an alpha-type subunit of a glutamate-gated chloride ion channel known for its role in ivermectin susceptibility. In addition, a forward genetic screen to select C. elegans mutants resistant to NTZ resulted in isolation of two NTZ resistant mutants that are not in avr-14, suggesting that additional mechanisms are involved in resistance to NTZ. We found that NTZ combines synergistically with other classes of anthelmintic drugs, i.e. albendazole and pyrantel, making it a good candidate for further studies on its use in drug combination therapy of STH infections. Given NTZ acts against a wide range of nematode parasites, our findings also validate avr-14 as an excellent target for pan-STH therapy. PMID:24412397

  14. Rooting out institutional corruption to manage inappropriate off-label drug use.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. PMID:24088156

  15. Rooting out institutional corruption to manage inappropriate off-label drug use.

    PubMed

    Rodwin, Marc A

    2013-01-01

    Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use.

  16. 42 CFR 423.153 - Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...-utilization and under-utilization of prescribed medications; and (3) Provides CMS with information concerning... examination of claims data and other records, through computerized drug claims processing and information retrieval systems, in order to identify patterns of inappropriate or medically unnecessary care...

  17. 77 FR 9946 - Draft Guidance for Industry on Drug Interaction Studies-Study Design, Data Analysis, Implications...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-21

    ... Federal Register of September 12, 2006 (71 FR 53696), FDA announced the availability of a draft guidance... in vivo studies of drug metabolism, drug transport, and drug-drug, or drug-therapeutic protein... metabolism and/or drug transport abruptly in individuals who previously had been receiving and tolerating...

  18. Nanobiological studies on drug design using molecular mechanic method

    PubMed Central

    Ghaheh, Hooria Seyedhosseini; Mousavi, Maryam; Araghi, Mahmood; Rasoolzadeh, Reza; Hosseini, Zahra

    2015-01-01

    Background: Influenza H1N1 is very important worldwide and point mutations that occur in the virus gene are a threat for the World Health Organization (WHO) and druggists, since they could make this virus resistant to the existing antibiotics. Influenza epidemics cause severe respiratory illness in 30 to 50 million people and kill 250,000 to 500,000 people worldwide every year. Nowadays, drug design is not done through trial and error because of its cost and waste of time; therefore bioinformatics studies is essential for designing drugs. Materials and Methods: This paper, infolds a study on binding site of Neuraminidase (NA) enzyme, (that is very important in drug design) in 310K temperature and different dielectrics, for the best drug design. Information of NA enzyme was extracted from Protein Data Bank (PDB) and National Center for Biotechnology Information (NCBI) websites. The new sequences of N1 were downloaded from the NCBI influenza virus sequence database. Drug binding sites were assimilated and homologized modeling using Argus lab 4.0, HyperChem 6.0 and Chem. D3 softwares. Their stability was assessed in different dielectrics and temperatures. Result: Measurements of potential energy (Kcal/mol) of binding sites of NA in different dielectrics and 310K temperature revealed that at time step size = 0 pSec drug binding sites have maximum energy level and at time step size = 100 pSec have maximum stability and minimum energy. Conclusions: Drug binding sites are more dependent on dielectric constants rather than on temperature and the optimum dielectric constant is 39/78. PMID:26605248

  19. AC biosusceptometry in the study of drug delivery.

    PubMed

    Corá, L A; Romeiro, F G; Stelzer, M; Américo, M F; Oliveira, R B; Baffa, O; Miranda, J R A

    2005-06-15

    Conventionally, pharmaceutical substances are administered orally because the gastrointestinal tract possesses the appropriate features for drug absorption. Nevertheless, the gastrointestinal tract physiology is complex and influenced by many factors. These factors must be completely understood for the optimization of oral drug delivery systems. Although in vitro tests provide information about release and drug absorption profiles, in vivo studies are essential, due to the biological variability. Several techniques have been employed in an attempt to conveniently characterize the behavior of solid dosage forms in vivo. The noninvasive biomagnetic technique of alternate current biosusceptometry (ACB) has been used in studies focusing on gastrointestinal motility and, more recently, to evaluate the performance of magnetic dosage forms. This article will discuss the main characteristics of AC biosusceptometry and its applicability for determination of the relationship between the human gastrointestinal tract and orally administered pharmaceutical dosage forms.

  20. Decision analysis and drug development portfolio management: uncovering the real options value of your projects.

    PubMed

    Rosati, Nicoletta

    2002-04-01

    Project selection and portfolio management are particularly challenging in the pharmaceutical industry due to the high risk - high stake nature of the drug development process. In the recent years, scholars and industry experts have agreed that traditional Net-Present-Value evaluation of the projects fails to capture the value of managerial flexibility, and encouraged adopting a real options approach to recover the missed value. In this paper, we take a closer look at the drug development process and at the indices currently used to rank projects. We discuss the economic value of information and of real options arising in drug development and present decision analysis as an ideal framework for the implementation of real options valuation. PMID:19807328

  1. Ontology-based knowledge management for personalized adverse drug events detection.

    PubMed

    Cao, Feng; Sun, Xingzhi; Wang, Xiaoyuan; Li, Bo; Li, Jing; Pan, Yue

    2011-01-01

    Since Adverse Drug Event (ADE) has become a leading cause of death around the world, there arises high demand for helping clinicians or patients to identify possible hazards from drug effects. Motivated by this, we present a personalized ADE detection system, with the focus on applying ontology-based knowledge management techniques to enhance ADE detection services. The development of electronic health records makes it possible to automate the personalized ADE detection, i.e., to take patient clinical conditions into account during ADE detection. Specifically, we define the ADE ontology to uniformly manage the ADE knowledge from multiple sources. We take advantage of the rich semantics from the terminology SNOMED-CT and apply it to ADE detection via the semantic query and reasoning. PMID:21893837

  2. DigiSpenser--a GSM-based drug management and compliance monitoring system.

    PubMed

    Schukat, M; Rudroju, B

    2011-01-01

    Approximately one-third of all independently living elderly people are not compliant with their drug therapy. This lack of medication management results either in undermedication or overmedication, causing unnecessary and often serious health risks. This problem will worsen in the future with the change of demographics and cost constraints in the health sector. Therefore there is a need for (cost-) effective reliable approaches to compliance monitoring. To date numerous care schemes, retrospective assessment procedures and compliance supports tools have been introduced, but none of them has fully solved the problem of medication non-compliance yet. This paper will address some of the factors that need to be considered when designing such systems and will showcase DigiSpenser, a recently developed compliance monitoring and drug management system. PMID:22255537

  3. Implementing a new drug record system: a qualitative study of difficulties perceived by physicians and nurses

    PubMed Central

    Andersen, S

    2002-01-01

    Objectives: To identify organisational difficulties faced by physicians and nurses when using drug prescribing sheets for recording both drug prescriptions and drug administration. Design: Qualitative interview study. Setting: Two general internal medicine wards. Participants: Seven physicians and eight nurses. Main outcome measures: Difficulties explicitly identified by the participants during the interviews. Results: The implementation of procedures conflicted with existing structure, culture, and routines. Insufficient competence within the system to use the drug prescribing sheets created resistance and made people down the line create their own interpretations and solutions to the problems they faced. A total of nine problems were identified: (1) insufficient knowledge and uncertainty about procedures, (2) ignorance of sources of error, (3) unclear responsibilities, (4) low community spirit, (5) insufficient communication, (6) clinician autonomy and low acceptance of change, (7) strong professional identity, (8) low priority task, and (9) logistical problems. Conclusions: Unawareness of procedures, insufficient dissemination of knowledge, and insufficient cooperation and scepticism among those who put drug handling into practice is likely to have an impact on the quality of health care. The identification of these obstacles may help managers to improve the quality of the drug handling process on internal medicine wards and make it possible to select a framework for changing the clinical behaviour of doctors and nurses. PMID:12078363

  4. Drug-drug interactions with sodium-glucose cotransporters type 2 (SGLT2) inhibitors, new oral glucose-lowering agents for the management of type 2 diabetes mellitus.

    PubMed

    Scheen, André J

    2014-04-01

    Inhibitors of sodium-glucose cotransporters type 2 (SGLT2) reduce hyperglycaemia by decreasing renal glucose threshold and thereby increasing urinary glucose excretion. They are proposed as a novel approach for the management of type 2 diabetes mellitus. They have proven their efficacy in reducing glycated haemoglobin, without inducing hypoglycaemia, as monotherapy or in combination with various other glucose-lowering agents, with the add-on value of promoting some weight loss and lowering arterial blood pressure. As they may be used concomitantly with many other drugs, we review the potential drug-drug interactions (DDIs) regarding the three leaders in the class (dapagliglozin, canagliflozin and empagliflozin). Most of the available studies were performed in healthy volunteers and have assessed the pharmacokinetic interferences with a single administration of the SGLT2 inhibitor. The exposure [assessed by peak plasma concentrations (Cmax) and area under the concentration-time curve (AUC)] to each SGLT2 inhibitor tested was not significantly influenced by the concomitant administration of other glucose-lowering agents or cardiovascular agents commonly used in patients with type 2 diabetes. Reciprocally, these medications did not influence the pharmacokinetic parameters of dapagliflozin, canagliflozin or empagliflozin. Some modest changes were not considered as clinically relevant. However, drugs that could specifically interfere with the metabolic pathways of SGLT2 inhibitors [rifampicin, inhibitors or inducers of uridine diphosphate-glucuronosyltransferase (UGT)] may result in significant changes in the exposure of SGLT2 inhibitors, as shown for dapagliflozin and canagliflozin. Potential DDIs in patients with type 2 diabetes receiving chronic treatment with an SGLT2 inhibitor deserve further attention, especially in individuals treated with several medications or in more fragile patients with hepatic and/or renal impairment.

  5. The role of metabolic biomarkers in drug toxicity studies.

    PubMed

    Schnackenberg, Laura K; Beger, Richard D

    2008-01-01

    ABSTRACT Metabolic profiling is a technique that can potentially provide more sensitive and specific biomarkers of toxicity than the current clinical measures benefiting preclinical and clinical drug studies. Both nuclear magnetic resonance (NMR) and mass spectrometry (MS) platforms have been used for metabolic profiling studies of drug toxicity. Not only can both techniques provide novel biomarker(s) of toxicity but the combination of both techniques gives a broader range of metabolites evaluated. Changes in metabolic patterns can provide insight into mechanism(s) of toxicity and help to eliminate a potentially toxic new chemical entity earlier in the developmental process. Metabolic profiling offers numerous advantages in toxicological research and screening as sample collection and preparation are relatively simple. Further, sample throughput, reproducibility, and accuracy are high. The area of drug toxicity of therapeutic compounds has already been impacted by metabolic profiling studies and will continue to be impacted as new, more specific biomarker(s) are found. In order for a biomarker or pattern of biomarkers to be accepted, it must be shown that they originate from the target tissue of interest. Metabolic profiling studies are amenable to any biofluid or tissue sample making it possible to link the changes noted in urine for instance as originating from renal injury. Additionally, the ease of sample collection makes it possible to follow a single animal or subject over time in order to determine whether and when the toxicity resolves itself. This review focuses on the advantages of metabolic profiling for drug toxicity studies.

  6. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    PubMed

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  7. Socioeconomic factors, morbidity and drug utilization--an ecological study.

    PubMed

    Henricson, K; Stenberg, P; Rametsteiner, G; Ranstam, J; Hanson, B S; Melander, A

    1998-07-01

    The aim of the present study was to elucidate the relations between demographic and socioeconomic factors, morbidity and the utilization of major drug groups in an urban Swedish population. The study was performed as an ecological analysis during November 1991 in the 17 different districts of Malmö, the third largest Swedish city (235,000 inhabitants). The material comprised 86,228 ACT-coded drug items which corresponded to 76% of all prescriptions dispensed during the study month. Of these, 43,032, dispensed to patients aged 15-64 years, were analysed in the present work. Age standardized drug utilization was expressed as the number of dispensed Defined Daily Doses per 1000 inhabitants per day. Morbidity was measured in terms of reimbursed days on sick leave. The sociodemographic parameters used were socioeconomic status (SES), employment rate, median income per family, households on social allowance, and ethnicity. For four of the five major pharmacological groups (ATC-groups A, C, J, N and R, i.e. alimentation, circulation, infectious diseases, nervous system and respiration), most pronouncedly group N and least so group R, utilization correlated positively with not only the extent of morbidity but also with an unfavourable socioeconomic situation, high proportion of immigrants, and households on social allowance or with low income and/or with a low employment rate. The utilization of antibiotics (group J), however, instead correlated negatively with these parameters. For all five drug groups, these trends were similar among men and women, albeit with varying strength. In conclusion, socioeconomic factors may have a profound influence on the utilization of several major drug groups. At least in the case of antibiotics, the consequence of this influence is irrational drug use. PMID:15073988

  8. Recognizing and Managing Antipsychotic Drug Treatment Side Effects in the Elderly

    PubMed Central

    Saltz, Bruce L.; Robinson, Delbert G.; Woerner, Margaret G.

    2004-01-01

    Although atypical antipsychotics differ from conventional antipsychotics in their decreased ability to cause reversible drug-induced movement disorders/motor side effects such as dystonia, drug-induced parkinsonism, and akathisia and potentially persistent drug-induced movement disorders/motor side effects such as tardive dyskinesia, no antipsychotic agent completely eradicates this risk. Antipsychotic agents are frequently used in facilities for the elderly and in general hospitals to treat older patients with behavioral problems. Drug-induced movement disorders are more common and more persistent in elderly patients than in younger patients, and this problem is exacerbated by the fact that antipsychotic medications are often misused by practitioners lacking adequate psychopharmacologic training. Movement disorders can be detrimental to an elderly patient's quality of life and may transform what were otherwise routine activities into difficult tasks. Educational programs are needed to teach primary care physicians, specialists, and patients and their families how to identify and manage drug-induced movement disorders in order to achieve safer and more efficacious care for elderly patients. PMID:16001096

  9. Studies on pharmacokinetic drug interaction potential of vinpocetine

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Background: Vinpocetine, a semi-synthetic derivative of vincamine, is a popular dietary supplement used for the treatment of several central nervous system related disorders. Despite its wide use, no pharmacokinetic drug interaction studies are reported in literature. Due to increasing use of dietar...

  10. Drug Taking Beliefs of Australian Adolescents: A Pilot Study

    ERIC Educational Resources Information Center

    Skrzypiec, Grace; Owens, Laurence

    2013-01-01

    In this study adolescents offered their insights and perspectives of factors associated with adolescent illicit drug taking intentions. The factors explored were identified using a cross-disciplinary approach involving the Theory of Planned Behavior (TPB) and criminological theories, and these formed the framework for data analysis. Interviews…

  11. Quantitative Methods in the Study of Drug Use.

    ERIC Educational Resources Information Center

    Huba, George J.

    1983-01-01

    Addresses the use of data sources and multivariate data analysis methods for modeling naturally occurring data. Two studies in this special section deal with longitudinal perspectives on drug use and emotional adjustment and an application of log-linear model to examine the stress-buffering function of alcohol. (LLL)

  12. 21 CFR 330.12 - Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI).

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 21 Food and Drugs 5 2011-04-01 2011-04-01 false Status of over-the-counter (OTC) drugs previously reviewed under the Drug Efficacy Study (DESI). 330.12 Section 330.12 Food and Drugs FOOD AND DRUG... Register concerning previously unpublished OTC drugs reviewed by the National Academy of...

  13. 21 CFR 310.303 - Continuation of long-term studies, records, and reports on certain drugs for which new drug...

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... reports on certain drugs for which new drug applications have been approved. 310.303 Section 310.303 Food... HUMAN USE NEW DRUGS Records and Reports § 310.303 Continuation of long-term studies, records, and reports on certain drugs for which new drug applications have been approved. (a) A new drug may not...

  14. Theoretical and experimental studies of the stability of drug-drug interact.

    PubMed

    Soares, Monica F R; Alves, Lariza D S; Nadvorny, Daniela; Soares-Sobrinho, José L; Rolim-Neto, Pedro J

    2016-11-01

    Several factors can intervene in the molecular properties and consequently in the stability of drugs. The molecular complexes formation often occur due to favor the formation of hydrogen bonds, leading the system to configuration more energy stable. This work we aim to investigate through theoretical and experimental methods the relation between stability and properties of molecular complexes the molecular complex formed between the drugs, efavirenz (EFV), lamivudine (3TC) and zidovudine (AZT). With this study was possible determining the most stable complex formed between the compounds evaluated. In addition the energy and structural properties of the complex formed in relation to its individual components allowed us to evaluate the stability of the same. PMID:27267283

  15. [Comparative neurophysiological study of the nootropic drugs piracetam and centrophenoxine].

    PubMed

    Krapivin, S V; Voronina, T A

    1987-01-01

    Effects of nootropic drugs on transcallosal evoked potential (TEP) and EEG spectra of the animal brain cortex and hippocamp were studied. It was found that piracetam and centrophenoxine exert similar effects on the amplitude of the primary TEP components, produce its increase and also a rise and stabilization of the predominant peak in distribution of EEG power spectrum that corresponds to the improvement of theta rhythm organization. The drugs exert different effects on the secondary positive TEP component; centrophenoxine induces a change in non-basic rhythm of EEG in rats. Based on the results obtained, the authors consider possible neurophysiological mechanisms of the nootropic effect and make a comparative analysis of the actions of the drugs.

  16. Colonization with Multi-Drug Resistant Organisms in Nursing Homes: Scope, Importance, and Management

    PubMed Central

    Cassone, Marco; Mody, Lona

    2015-01-01

    Bacterial infections are among the most common causes of morbidity and mortality in Nursing Homes (NH) and other long term care facilities. Multi-drug resistant organisms (MDROs) represent an ever-increasing share of causative agents of infection, and their prevalence in NHs is now just as high as in acute-care facilities, or even higher. Indeed, NHs are now considered a major reservoir of MDROs for the community at large. Asymptomatic colonization is usually a prerequisite to development of symptomatic infection. While progress has been made in defining epidemiology of MDROs in NHs, few studies have evaluated the role of changing healthcare delivery in introducing and further transmitting MDROs in this setting. Furthermore, the factors influencing the spread of colonization and the key prognostic indicators leading to symptomatic infections in the burgeoning short stay population need to be explored further. The difficulty of this task lies in the heterogeneity of NHs in terms of focus of care, organization and resources, and on the diversity among the many MDRO species encountered, which harbor different resistance genes and with a different prevalence depending on the geographic location, local antimicrobial pressure and residents risk factors such as use of indwelling devices, functional disability, wounds and other comorbidities. We present literature findings on the scope and importance of colonization as a pathway to infection with MDROs in NHs, underline important open questions that need further research, and discuss the strength of the evidence for current and proposed screening, prevention, and management interventions. PMID:25664233

  17. Drug promotional practices in Mumbai: a qualitative study.

    PubMed

    Roy, Nobhojit; Madhiwalla, Neha; Pai, Sanjay A

    2007-01-01

    We conducted a qualitative study to determine the range of promotional practices influencing drug usage in Mumbai. Open-ended interviews were conducted with 15 senior executives in drug companies, 25 chemists and 25 doctors; focus group discussions were held with 36 medical representatives. The study provided a picture of what might be described as an unholy alliance: manufacturers, chemists and doctors conspire to make profits at the expense of consumers and the public's health, even as they negotiate with each other on their respective shares of these profits. Misleading information, incentives and unethical trade practices were identified as methods to increase the prescription and sale of drugs. Medical representatives provide incomplete medical information to influence prescribing practices; they also offer incentives including conference sponsorship. Doctors may also demand incentives, as when doctors' associations threaten to boycott companies that do not comply with their demands for sponsorship. Manufacturers, chemists and medical representatives use various unethical trade practices. Of particular interest was the finding that chemists are major players in this system, providing drug information directly to patients. The study also reinforced our impression that medical representatives are the least powerful of the four groups. PMID:18630221

  18. Enrollment Management Study: Five Scenarios.

    ERIC Educational Resources Information Center

    Albers, James R.; Burns, James A.

    The effect of enrollment level changes on the long-range future of Western Washington University are investigated. Due to the high rate of Washington state in-migration, declining enrollments are not projected for Western Washington University. The impact of managed enrollment goals was examined to help the university determine the most…

  19. 77 FR 48491 - Regulatory New Drug Review: Solutions for Study Data Exchange Standards; Notice of Meeting...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I Regulatory New Drug Review: Solutions for... Administration (FDA) is announcing a meeting entitled ``Regulatory New Drug Review: Solutions for Study Data... Planning & Informatics, Center for Drug Evaluation and Research, Food and Drug Administration, 10903...

  20. Biomembrane models and drug-biomembrane interaction studies: Involvement in drug design and development

    PubMed Central

    Pignatello, R.; Musumeci, T.; Basile, L.; Carbone, C.; Puglisi, G.

    2011-01-01

    Contact with many different biological membranes goes along the destiny of a drug after its systemic administration. From the circulating macrophage cells to the vessel endothelium, to more complex absorption barriers, the interaction of a biomolecule with these membranes largely affects its rate and time of biodistribution in the body and at the target sites. Therefore, investigating the phenomena occurring on the cell membranes, as well as their different interaction with drugs in the physiological or pathological conditions, is important to exploit the molecular basis of many diseases and to identify new potential therapeutic strategies. Of course, the complexity of the structure and functions of biological and cell membranes, has pushed researchers toward the proposition and validation of simpler two- and three-dimensional membrane models, whose utility and drawbacks will be discussed. This review also describes the analytical methods used to look at the interactions among bioactive compounds with biological membrane models, with a particular accent on the calorimetric techniques. These studies can be considered as a powerful tool for medicinal chemistry and pharmaceutical technology, in the steps of designing new drugs and optimizing the activity and safety profile of compounds already used in the therapy. PMID:21430952

  1. Solvent drag effect in drug intestinal absorption. II. Studies on drug absorption clearance and water influx.

    PubMed

    Karino, A; Hayashi, M; Awazu, S; Hanano, M

    1982-09-01

    In order to study the solvent drag effect, it was shown that back flux of absorbed drug from blood to intestinal lumen can be ignored but the back flux of water cannot. Then, apparent water influx was calculated as a new measure of solvent drag based on the model in which the back flux of D2O from blood to lumen was considered during absorption. Consequently, the correlation between drug absorption clearance (CLdrug) and apparent water influx was highly significant for benzoic acid, salicylic acid, p-hydroxybenzoic acid, antipyrine, cephalexin (CEX) and cefroxadine (CXD), resulting the high solvent drag effects were detected. The mean values of the slopes in the regression lines of CLdrug versus apparent water influx, i.e., sieving coefficients, were smaller than one for benzoic acid and salicylic acid, but the values were not significantly different from one. The sieving coefficients of the other drugs were significantly smaller than one. From these results, the molecular size dependence in the reflection from the intestinal membrane during absorption was clearly shown. And the intercepts of the regression lines including diffusive permeabilities were found to be significantly different from zero in CEX and CXD. On the basis of the sieving coefficients and intercept values obtained in such ways, the appropriateness of this model was discussed.

  2. Carer involvement with drug services: a qualitative study

    PubMed Central

    Orr, Linda C; Barbour, Rosaline S; Elliott, Lawrie

    2013-01-01

    BackgroundEmpirical research suggests that involving carers brings benefits to families and services. Consequently, drug-related policy and guidance has increasingly encouraged drug services to involve carers at all levels of service provision. ObjectiveTo explore the purpose and scope of carer involvement with adult drug services in North-east Scotland. Design, Setting and ParticipantsA total of 82 participants (20 informal carers, 43 service providers and 19 policy makers) were purposively selected to take part in a qualitative study. Eight focus groups and 32 interviews were conducted between 2007 and 2008. FindingsThree themes were identified through thematic coding: ‘Current levels of involvement’, ‘Use of the term carer’ and ‘Opportunities for change?’ Carer involvement was described as limited, unplanned and unstructured, and consisted largely of information and advice, practical and emotional support, and signposting of services. Although use of the term ‘carer’ was contested within and across the groups, caring in a drug context was considered the ‘same but different’ from caring in other contexts. Carers remained sceptical that services actually wanted to involve them in supporting their relative or to offer carers support in their own right. Many service providers and policy makers regarded carer involvement as an aspiration. ConclusionEncouraging carers, service providers and policy makers to reach a shared understanding of caring in a drug context may help translation of policy into practice. However, there is also a fundamental need for drug services to widen the level and type of involvement activities on offer to carers. PMID:23216899

  3. Pilot Study on Conflict Management. Final Report.

    ERIC Educational Resources Information Center

    Zeigler, Harmon; And Others

    This extensive survey pretest utilized in-depth interviews with school superintendents and city managers in selected cities throughout Oregon and in Los Angeles. The purpose of the pilot study was to explore the similarities and differences in conflict management between the two professions. The study reveals that superintendents and city managers…

  4. Integration of biosensors and drug delivery technologies for early detection and chronic management of illness.

    PubMed

    Ngoepe, Mpho; Choonara, Yahya E; Tyagi, Charu; Tomar, Lomas Kumar; du Toit, Lisa C; Kumar, Pradeep; Ndesendo, Valence M K; Pillay, Viness

    2013-01-01

    Recent advances in biosensor design and sensing efficacy need to be amalgamated with research in responsive drug delivery systems for building superior health or illness regimes and ensuring good patient compliance. A variety of illnesses require continuous monitoring in order to have efficient illness intervention. Physicochemical changes in the body can signify the occurrence of an illness before it manifests. Even with the usage of sensors that allow diagnosis and prognosis of the illness, medical intervention still has its downfalls. Late detection of illness can reduce the efficacy of therapeutics. Furthermore, the conventional modes of treatment can cause side-effects such as tissue damage (chemotherapy and rhabdomyolysis) and induce other forms of illness (hepatotoxicity). The use of drug delivery systems enables the lowering of side-effects with subsequent improvement in patient compliance. Chronic illnesses require continuous monitoring and medical intervention for efficient treatment to be achieved. Therefore, designing a responsive system that will reciprocate to the physicochemical changes may offer superior therapeutic activity. In this respect, integration of biosensors and drug delivery is a proficient approach and requires designing an implantable system that has a closed loop system. This offers regulation of the changes by means of releasing a therapeutic agent whenever illness biomarkers prevail. Proper selection of biomarkers is vital as this is key for diagnosis and a stimulation factor for responsive drug delivery. By detecting an illness before it manifests by means of biomarkers levels, therapeutic dosing would relate to the severity of such changes. In this review various biosensors and drug delivery systems are discussed in order to assess the challenges and future perspectives of integrating biosensors and drug delivery systems for detection and management of chronic illness. PMID:23771157

  5. Integration of Biosensors and Drug Delivery Technologies for Early Detection and Chronic Management of Illness

    PubMed Central

    Ngoepe, Mpho; Choonara, Yahya E.; Tyagi, Charu; Tomar, Lomas Kumar; du Toit, Lisa C.; Kumar, Pradeep; Ndesendo, Valence M. K.; Pillay, Viness

    2013-01-01

    Recent advances in biosensor design and sensing efficacy need to be amalgamated with research in responsive drug delivery systems for building superior health or illness regimes and ensuring good patient compliance. A variety of illnesses require continuous monitoring in order to have efficient illness intervention. Physicochemical changes in the body can signify the occurrence of an illness before it manifests. Even with the usage of sensors that allow diagnosis and prognosis of the illness, medical intervention still has its downfalls. Late detection of illness can reduce the efficacy of therapeutics. Furthermore, the conventional modes of treatment can cause side-effects such as tissue damage (chemotherapy and rhabdomyolysis) and induce other forms of illness (hepatotoxicity). The use of drug delivery systems enables the lowering of side-effects with subsequent improvement in patient compliance. Chronic illnesses require continuous monitoring and medical intervention for efficient treatment to be achieved. Therefore, designing a responsive system that will reciprocate to the physicochemical changes may offer superior therapeutic activity. In this respect, integration of biosensors and drug delivery is a proficient approach and requires designing an implantable system that has a closed loop system. This offers regulation of the changes by means of releasing a therapeutic agent whenever illness biomarkers prevail. Proper selection of biomarkers is vital as this is key for diagnosis and a stimulation factor for responsive drug delivery. By detecting an illness before it manifests by means of biomarkers levels, therapeutic dosing would relate to the severity of such changes. In this review various biosensors and drug delivery systems are discussed in order to assess the challenges and future perspectives of integrating biosensors and drug delivery systems for detection and management of chronic illness. PMID:23771157

  6. Causes of Health Care Workers’ Exposure to Antineoplastic Drugs: An Exploratory Study

    PubMed Central

    Hon, Chun-Yip; Abusitta, Dina

    2016-01-01

    Background: The exposure of health care workers to antineoplastic drugs is associated with several adverse health effects, including reproductive toxicities and mutagenic effects. Recent studies have confirmed that Canadian health care workers are at risk of exposure to these agents. However, the causes leading to occupational exposure to antineoplastic drugs are unknown. Objective: To perform an exploratory study to ascertain the immediate and contributing causes of health care workers’ exposure to antineoplastic drugs. Methods: Participants were recruited from 6 acute care facilities in Vancouver, British Columbia. Those agreeing to participate were asked to complete a questionnaire about previous exposure to antineoplastic drugs while at work and to describe the circumstances of each exposure incident. Responses were qualitatively analyzed, and the causes of each incident were classified as immediate (unsafe work acts and/or unsafe working conditions) or contributing (related to the management of the organization, the environment, and/or the physical and mental status of the worker). Results: Completed questionnaires were received from 120 participants, 18 (15.0%) of whom reported having had previous occupational exposure to antineoplastic drugs. Qualitative analysis of the responses showed 4 categories of immediate causes (needlestick injury, spill, direct contact, and other unintended exposure) and 3 categories of contributing causes (poor communication, inadequate controls, and lack of training). Some incidents had multiple immediate and/or contributing causes. Conclusions: According to a review of the immediate and contributing causes identified in this study, many of the exposure incidents were deemed preventable. A “hierarchy of controls” should be implemented, including (in the following order) engineering controls, administrative controls, and personal protective equipment. The findings of this study can be used to develop job safety analyses

  7. 75 FR 17417 - Joint Meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-06

    ... Management Advisory Committee. This meeting was announced in the Federal Register of March 8, 2010 (75 FR... drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis....

  8. Medical databases in studies of drug teratogenicity: methodological issues.

    PubMed

    Ehrenstein, Vera; Sørensen, Henrik T; Bakketeig, Leiv S; Pedersen, Lars

    2010-01-01

    More than half of all pregnant women take prescription medications, raising concerns about fetal safety. Medical databases routinely collecting data from large populations are potentially valuable resources for cohort studies addressing teratogenicity of drugs. These include electronic medical records, administrative databases, population health registries, and teratogenicity information services. Medical databases allow estimation of prevalences of birth defects with enhanced precision, but systematic error remains a potentially serious problem. In this review, we first provide a brief description of types of North American and European medical databases suitable for studying teratogenicity of drugs and then discuss manifestation of systematic errors in teratogenicity studies based on such databases. Selection bias stems primarily from the inability to ascertain all reproductive outcomes. Information bias (misclassification) may be caused by paucity of recorded clinical details or incomplete documentation of medication use. Confounding, particularly confounding by indication, can rarely be ruled out. Bias that either masks teratogenicity or creates false appearance thereof, may have adverse consequences for the health of the child and the mother. Biases should be quantified and their potential impact on the study results should be assessed. Both theory and software are available for such estimation. Provided that methodological problems are understood and effectively handled, computerized medical databases are a valuable source of data for studies of teratogenicity of drugs.

  9. Drugs of abuse in urban groundwater. A case study: Barcelona.

    NASA Astrophysics Data System (ADS)

    Jurado, A.; Mastroianni, N.; Vazquez-Suñe, E.; Carrera, J.; Tubau, I.; Pujades, E.; Postigo, C.; Lopez de Alda, M.; Barceló, D.

    2012-04-01

    This study is concerned with drugs of abuse (DAs) and their metabolites in urban groundwater at field scale in relation to (1) the spatial distribution of the groundwater samples, (2) the depth of the groundwater sample, (3) the presence of DAs in recharge sources, and (4) the identification of processes affecting the fate of DAs in groundwater. To this end, urban groundwater samples were collected in the city of Barcelona and a total of 21 drugs were analyzed including cocainics, amphetamine-like compounds, opioids, lysergics and cannabinoids and the prescribed drugs benzodiazepines. Overall, the highest groundwater concentrations and the largest number of detected DAs were found in zones basically recharged by a river that receives large amounts of effluents from waste water treatment plants (WWTPs). In contrast, the urbanized areas yielded not only lower concentrations but also a much smaller number of drugs, which suggests a local origin. In fact, cocaine and its metabolite were dominant in more prosperous neighbourhoods, whereas the cheaper (MDMA) was the dominant DA in poorer districts. Concentrations of DAs estimated mainly from the waste water fraction in groundwater samples were consistently higher than the measured ones, suggesting that DAs undergo removal processes in both reducing and oxidizing conditions.

  10. Bioresorbable polymer coated drug eluting stent: a model study.

    PubMed

    Rossi, Filippo; Casalini, Tommaso; Raffa, Edoardo; Masi, Maurizio; Perale, Giuseppe

    2012-07-01

    In drug eluting stent technologies, an increased demand for better control, higher reliability, and enhanced performances of drug delivery systems emerged in the last years and thus offered the opportunity to introduce model-based approaches aimed to overcome the remarkable limits of trial-and-error methods. In this context a mathematical model was studied, based on detailed conservation equations and taking into account the main physical-chemical mechanisms involved in polymeric coating degradation, drug release, and restenosis inhibition. It allowed highlighting the interdependence between factors affecting each of these phenomena and, in particular, the influence of stent design parameters on drug antirestenotic efficacy. Therefore, the here-proposed model is aimed to simulate the diffusional release, for both in vitro and the in vivo conditions: results were verified against various literature data, confirming the reliability of the parameter estimation procedure. The hierarchical structure of this model also allows easily modifying the set of equations describing restenosis evolution to enhance model reliability and taking advantage of the deep understanding of physiological mechanisms governing the different stages of smooth muscle cell growth and proliferation. In addition, thanks to its simplicity and to the very low system requirements and central processing unit (CPU) time, our model allows obtaining immediate views of system behavior.

  11. "Let's Talk about Drugs": Pilot Study of a Community-Level Drug Prevention Intervention Based on Motivational Interviewing Principles

    ERIC Educational Resources Information Center

    Newbery, Natasha; McCambridge, Jim; Strang, John

    2007-01-01

    Purpose: The feasibility of a community-level drug prevention intervention based upon the principles of motivational interviewing within a further education college was investigated in a pilot study. Design/methodology/approach: The implementation over the course of a single term of "Let's Talk about Drugs" was studied with both action research…

  12. Studying illicit drug trafficking on Darknet markets: Structure and organisation from a Canadian perspective.

    PubMed

    Broséus, J; Rhumorbarbe, D; Mireault, C; Ouellette, V; Crispino, F; Décary-Hétu, D

    2016-07-01

    Cryptomarkets are online marketplaces that are part of the Dark Web and mainly devoted to the sale of illicit drugs. They combine tools to ensure anonymity of participants with the delivery of products by mail to enable the development of illicit drug trafficking. Using data collected on eight cryptomarkets, this study provides an overview of the Canadian illicit drug market. It seeks to inform about the most prevalent illicit drugs vendors offer for sale and preferred destination countries. Moreover, the research gives an insight into the structure and organisation of distribution networks existing online. In particular, we provide information about how vendors are diversifying and replicating across marketplaces. We inform on the number of listings each vendor manages, the number of cryptomarkets they are active on and the products they offer. This research demonstrates the importance of online marketplaces in the context of illicit drug trafficking. It shows how the analysis of data available online may elicit knowledge on criminal activities. Such knowledge is mandatory to design efficient policy for monitoring or repressive purposes against anonymous marketplaces. Nevertheless, trafficking on Dark Net markets is difficult to analyse based only on digital data. A more holistic approach for investigating this crime problem should be developed. This should rely on a combined use and interpretation of digital and physical data within a single collaborative intelligence model. PMID:26978791

  13. Studying illicit drug trafficking on Darknet markets: Structure and organisation from a Canadian perspective.

    PubMed

    Broséus, J; Rhumorbarbe, D; Mireault, C; Ouellette, V; Crispino, F; Décary-Hétu, D

    2016-07-01

    Cryptomarkets are online marketplaces that are part of the Dark Web and mainly devoted to the sale of illicit drugs. They combine tools to ensure anonymity of participants with the delivery of products by mail to enable the development of illicit drug trafficking. Using data collected on eight cryptomarkets, this study provides an overview of the Canadian illicit drug market. It seeks to inform about the most prevalent illicit drugs vendors offer for sale and preferred destination countries. Moreover, the research gives an insight into the structure and organisation of distribution networks existing online. In particular, we provide information about how vendors are diversifying and replicating across marketplaces. We inform on the number of listings each vendor manages, the number of cryptomarkets they are active on and the products they offer. This research demonstrates the importance of online marketplaces in the context of illicit drug trafficking. It shows how the analysis of data available online may elicit knowledge on criminal activities. Such knowledge is mandatory to design efficient policy for monitoring or repressive purposes against anonymous marketplaces. Nevertheless, trafficking on Dark Net markets is difficult to analyse based only on digital data. A more holistic approach for investigating this crime problem should be developed. This should rely on a combined use and interpretation of digital and physical data within a single collaborative intelligence model.

  14. Indigenous Studies Speaks to Environmental Management

    NASA Astrophysics Data System (ADS)

    Richmond, Laurie; Middleton, Beth Rose; Gilmer, Robert; Grossman, Zoltán; Janis, Terry; Lucero, Stephanie; Morgan, Tukoroirangi; Watson, Annette

    2013-11-01

    This article describes the increasing connections between the fields of Indigenous studies and environmental management and examines some of the ways that an Indigenous studies perspective can guide thinking about environmental management. Indigenous groups have been involved in the management of environmental and natural resources on their lands since time immemorial. Indigenous groups have also become increasingly involved in Western practices of environmental management with the advent of co-management institutions, subsistence boards, traditional ecological knowledge forums, and environmental issues affecting Indigenous resources. Thus, it is an important time for scholarship that explores how Indigenous groups are both shaping and being affected by processes of environmental management. This article summarizes key findings and themes from eight papers situated at the intersection of these two fields of study and identify means by which environmental managers can better accommodate Indigenous rights and perspectives. It is the authors’ hope that increased dialog between Indigenous studies and environmental management can contribute to the building of sustainable and socially just environmental management practices.

  15. Indigenous studies speaks to environmental management.

    PubMed

    Richmond, Laurie; Middleton, Beth Rose; Gilmer, Robert; Grossman, Zoltán; Janis, Terry; Lucero, Stephanie; Morgan, Tukoroirangi; Watson, Annette

    2013-11-01

    This article describes the increasing connections between the fields of Indigenous studies and environmental management and examines some of the ways that an Indigenous studies perspective can guide thinking about environmental management. Indigenous groups have been involved in the management of environmental and natural resources on their lands since time immemorial. Indigenous groups have also become increasingly involved in Western practices of environmental management with the advent of co-management institutions, subsistence boards, traditional ecological knowledge forums, and environmental issues affecting Indigenous resources. Thus, it is an important time for scholarship that explores how Indigenous groups are both shaping and being affected by processes of environmental management. This article summarizes key findings and themes from eight papers situated at the intersection of these two fields of study and identify means by which environmental managers can better accommodate Indigenous rights and perspectives. It is the authors' hope that increased dialog between Indigenous studies and environmental management can contribute to the building of sustainable and socially just environmental management practices.

  16. A prospective study of adverse drug reactions in hospitalized children

    PubMed Central

    Martínez-Mir, Inocencia; García-López, Mercedes; Palop, Vicente; Ferrer, José M; Rubio, Elena; Morales-Olivas, Francisco J

    1999-01-01

    Aims There are few publications of adverse drug reactions (ADRs) among paediatric patients, though ADR incidence is usually stated to be higher during the first year of life and in male patients. We have carried out a prospective study to assess the extent, pattern and profile risk for ADRs in hospitalized patients between 1 and 24 months of age. Methods An intensive events monitoring scheme was used. A total of 512 successive admissions to two medical paediatric wards (47 beds) were analysed. The hospital records were screened daily during two periods (summer, 105 days and winter, 99 days), and adverse clinical events observed were recorded. Results A total of 282 events were detected; of these, 112 were considered to be manifestations of ADRs. The cumulative incidence was 16.6%, no differences being observed between periods. Although there were no differences between patients under and over 12 months of age, risk was found to be significantly higher among girls compared with boys (RR = 1.66, 95% CI 1.03–2.52). The gastro-intestinal system was most frequently affected. The therapeutic group most commonly implicated was anti-infective drugs and vaccines (41.5%). The ADRs were mild or moderate in over 90% of cases. A consistent relationship was noted between the number of drugs administered and the incidence of ADRs. Conclusions Hospitalized patients exhibited an ADR risk profile that included female sex and the number of drugs administered. No particular age predisposition was observed. The most commonly prescribed drugs are those most often implicated in ADRs in paediatric patients. PMID:10383547

  17. Pharmacogenetic studies of epilepsy drugs: are we there yet?

    PubMed

    Spurr, Nigel K

    2006-05-01

    One of the mantras of scientists working in the field of pharmacogenetics is 'the right dose for the right patient'. A recent article has gone someway towards demonstrating that this goal can be achieved using genetic approaches. It is one of the first reports to show that a specific polymorphism can predict the maximum tolerated dose of two anti-epileptic drugs. However, further studies are necessary to validate these observations.

  18. Examining factors that influence the effectiveness of cleaning antineoplastic drugs from drug preparation surfaces: a pilot study.

    PubMed

    Hon, Chun-Yip; Chua, Prescillia Ps; Danyluk, Quinn; Astrakianakis, George

    2014-06-01

    Occupational exposure to antineoplastic drugs has been documented to result in various adverse health effects. Despite the implementation of control measures to minimize exposure, detectable levels of drug residual are still found on hospital work surfaces. Cleaning these surfaces is considered as one means to minimize the exposure potential. However, there are no consistent guiding principles related to cleaning of contaminated surfaces resulting in hospitals to adopt varying practices. As such, this pilot study sought to evaluate current cleaning protocols and identify those factors that were most effective in reducing contamination on drug preparation surfaces. Three cleaning variables were examined: (1) type of cleaning agent (CaviCide®, Phenokil II™, bleach and chlorhexidine), (2) application method of cleaning agent (directly onto surface or indirectly onto a wipe) and (3) use of isopropyl alcohol after cleaning agent application. Known concentrations of antineoplastic drugs (either methotrexate or cyclophosphamide) were placed on a stainless steel swatch and then, systematically, each of the three cleaning variables was tested. Surface wipes were collected and quantified using high-performance liquid chromatography-tandem mass spectrometry to determine the percent residual of drug remaining (with 100% being complete elimination of the drug). No one single cleaning agent proved to be effective in completely eliminating all drug contamination. The method of application had minimal effect on the amount of drug residual. In general, application of isopropyl alcohol after the use of cleaning agent further reduced the level of drug contamination although measureable levels of drug were still found in some cases.

  19. Use of immobilized enzymes in drug metabolism studies.

    PubMed

    Dulik, D M; Fenselau, C

    1988-04-01

    The immobilization of drug-metabolizing enzymes onto polymeric supports offers several advantages over use of conventional microsomal or soluble enzyme preparations. These include increased storage stability, facilitated separation of products from the incubation mixture, the ability to recover and reuse the enzyme catalyst, and in many cases, stabilization of the tertiary structure of membrane-bound enzymes. Attachment of the protein to the solid support may be accomplished by adsorption, covalent bonding, or entrapment techniques. This methodology has been successfully utilized for studies with such enzymes as cytochrome P-450, UDP-glucuronyltransferases, glutathione S-transferases, S-methyltransferases, and N-acetyltransferases. Although often employed for the synthesis of xenobiotic metabolites, immobilized enzymes have been used for mechanistic and relative reactivity studies, limited kinetic studies, and extracorporeal detoxification. Co-immobilization of multiple drug-metabolizing enzyme systems has made possible the sequential formation of metabolites arising from oxidation followed by conjugation. Immobilized enzymes may also be used in the prediction of species-dependent metabolic pathways. The potential for large-scale synthesis of drug metabolites using this methodology has been explored. PMID:3127263

  20. Mining hidden knowledge for drug safety assessment: topic modeling of LiverTox as a case study

    PubMed Central

    2014-01-01

    Background Given the significant impact on public health and drug development, drug safety has been a focal point and research emphasis across multiple disciplines in addition to scientific investigation, including consumer advocates, drug developers and regulators. Such a concern and effort has led numerous databases with drug safety information available in the public domain and the majority of them contain substantial textual data. Text mining offers an opportunity to leverage the hidden knowledge within these textual data for the enhanced understanding of drug safety and thus improving public health. Methods In this proof-of-concept study, topic modeling, an unsupervised text mining approach, was performed on the LiverTox database developed by National Institutes of Health (NIH). The LiverTox structured one document per drug that contains multiple sections summarizing clinical information on drug-induced liver injury (DILI). We hypothesized that these documents might contain specific textual patterns that could be used to address key DILI issues. We placed the study on drug-induced acute liver failure (ALF) which was a severe form of DILI with limited treatment options. Results After topic modeling of the "Hepatotoxicity" sections of the LiverTox across 478 drug documents, we identified a hidden topic relevant to Hy's law that was a widely-accepted rule incriminating drugs with high risk of causing ALF in humans. Using this topic, a total of 127 drugs were further implicated, 77 of which had clear ALF relevant terms in the "Outcome and management" sections of the LiverTox. For the rest of 50 drugs, evidence supporting risk of ALF was found for 42 drugs from other public databases. Conclusion In this case study, the knowledge buried in the textual data was extracted for identification of drugs with potential of causing ALF by applying topic modeling to the LiverTox database. The knowledge further guided identification of drugs with the similar potential and most

  1. Quantitative ToF-SIMS studies of protein drug release from biodegradable polymer drug delivery membranes

    NASA Astrophysics Data System (ADS)

    Burns, Sarah A.; Gardella, Joseph A.

    2008-12-01

    Biodegradable polymers are of interest in developing strategies to control protein drug delivery. The protein that was used in this study is Keratinocyte Growth Factor (KGF) which is a protein involved in the re-epithelialization process. The protein is stabilized in the biodegradable polymer matrix during formulation and over the course of polymer degradation with the use of an ionic surfactant Aerosol-OT (AOT) which will encapsulate the protein in an aqueous environment. The release kinetics of the protein from the surface of these materials requires precise timing which is a crucial factor in the efficacy of this drug delivery system. Time-of-flight secondary ion mass spectrometry (ToF-SIMS) was used in the same capacity to identify the molecular ion peak of the surfactant and polymer and use this to determine surface concentration. In the polymer matrix, the surfactant molecular ion peak was observed in the positive and negative mode at m/ z 467 and 421, respectively. These peaks were determined to be [AOT + Na +] and [AOT - Na +]. These methods are used to identify the surfactant and protein from the polymer matrix and are used to measure the rate of surface accumulation. The second step was to compare this accumulation rate with the release rate of the protein into an aqueous solution during the degradation of the biodegradable film. This rate is compared to that from fluorescence spectroscopy measurements using the protein autofluorescence from that released into aqueous solution [C.M. Mahoney, J. Yu, A. Fahey, J.A.J. Gardella, SIMS depth profiling of polymer blends with protein based drugs, Appl. Surf. Sci. 252 (2006), 6609-6614.].

  2. Novel anticoagulants - an update on the latest developments and management for clinicians treating patients on these drugs.

    PubMed

    Green, Ben; Mendes, Rui Amaral; Van der Valk, Ruben; Brennan, Peter A

    2016-09-01

    There are several novel anticoagulant agents that are being increasingly used as an alternative to warfarin, with these drugs being reported to be at least as effective if not better. Their increased use means that oral care clinicians should have a sound understanding of the mechanism of action, pharmacology, reversal strategies and management of bleeding in patients taking these drugs. Surprisingly, there is little published in the current literature specific to professionals involved in oral health care. In this review, we provide an overview of these drugs and discuss the management of patients who need an oral procedure based on currently available literature and clinical trials.

  3. Laser-Assisted Periodontal Management of Drug-Induced Gingival Overgrowth under General Anesthesia: A Viable Option.

    PubMed

    Muralikrishna, Tupili; Kalakonda, Butchibabu; Gunupati, Sumanth; Koppolu, Pradeep

    2013-01-01

    Gingival overgrowth/hyperplasia can be attributed to several causes, but drug-induced gingival overgrowth/hyperplasia arises secondarily to prolonged use of antihypertensive drugs, anticonvulsants and immunosuppressants. The management is complex in nature considering the multitude of factors involved such as substitution of drug strict plaque control along with excision of the tissue to be performed under local anesthesia as outpatient. In the recent times, the patient's psychological fear of the treatment with the use of surgical blade and multiple visits has developed the concept of single visit treatment under general anesthesia incorporating a laser as viable option. The present case highlights the new method of management of gingival overgrowth.

  4. Case Studies for Management Development in Bangladesh.

    ERIC Educational Resources Information Center

    McLean, Gary N.

    Eight case studies appropriate for use in a course in management development were prepared and are provided in this document. The typical case describes a real business situation in which a real manager had to reach a decision. The case gives quantitative and qualitative information that is, or may be, relevant to that decision. Questions for…

  5. Natural Resources Management: Course of Study.

    ERIC Educational Resources Information Center

    Ingvalson, Brian

    The document presents a course outline for the study of natural resources management by junior and senior year high school students. Basic information and practical experiences are offered to the student in the classroom and through several field trips in order to acquire more knowledge in various areas of natural resources and their management.…

  6. Study on Case Teaching of Financial Management

    ERIC Educational Resources Information Center

    Che, Zhenghong; Che, Zhengmei

    2011-01-01

    Case teaching is an efficient teaching method of management. It plays an important role to enhance the students' ability to practice the theory. However, case teaching of financial management has not achieved the expected results. The paper aims to study the importance, characteristics and corresponding methods of case teaching method of financial…

  7. Clinical management of metastatic kidney cancer: the role of new molecular drugs.

    PubMed

    Vitale, Maria Giuseppa; Cartenì, Giacomo

    2016-01-01

    Over the last few years, the most recent advances of the molecular mechanisms involved in renal cell carcinoma have led to the use of new drugs targeting VEGF, such as bevacizumab plus interferon, sorafenib, sunitinib, pazopanib, and axitinib, or the mTOR, such as temsirolimus and everolimus. The purpose of this review is to analyze the results of Phase III trial with these targeted agents, and on the management of the treatment and, in particular, when to start and to stop therapy and the use of alternative schedule of sunitinib. Recent developments in immunotherapy are also discussed. PMID:26617188

  8. Managing Chronic Pain in Special Populations with Emphasis on Pediatric, Geriatric, and Drug Abuser Populations.

    PubMed

    Baumbauer, Kyle M; Young, Erin E; Starkweather, Angela R; Guite, Jessica W; Russell, Beth S; Manworren, Renee C B

    2016-01-01

    In the adult population chronic pain can lead to loss of productivity and earning potential, and decreased quality of life. There are distinct groups with increased vulnerability for the emergence of chronic pain. These groups may be defined by developmental status and/or life circumstances. Within the pediatric, geriatric, and drug abuser populations, chronic pain represents a significant health issue. This article focuses on known anatomic, physiologic, and genetic mechanisms underlying chronic pain in these populations, and highlights the need for a multimodal approach from multiple health care professionals for management of chronic pain in those with the most risk.

  9. Managing Chronic Pain in Special Populations with Emphasis on Pediatric, Geriatric, and Drug Abuser Populations.

    PubMed

    Baumbauer, Kyle M; Young, Erin E; Starkweather, Angela R; Guite, Jessica W; Russell, Beth S; Manworren, Renee C B

    2016-01-01

    In the adult population chronic pain can lead to loss of productivity and earning potential, and decreased quality of life. There are distinct groups with increased vulnerability for the emergence of chronic pain. These groups may be defined by developmental status and/or life circumstances. Within the pediatric, geriatric, and drug abuser populations, chronic pain represents a significant health issue. This article focuses on known anatomic, physiologic, and genetic mechanisms underlying chronic pain in these populations, and highlights the need for a multimodal approach from multiple health care professionals for management of chronic pain in those with the most risk. PMID:26614727

  10. Validation of the Drug Abuse Screening Test (DAST-10): A study on illicit drug use among Chinese pregnant women

    PubMed Central

    Lam, Lap Po; Leung, Wing Cheong; Ip, Patrick; Chow, Chun Bong; Chan, Mei Fung; Ng, Judy Wai Ying; Sing, Chu; Lam, Ying Hoo; Mak, Wing Lai Tony; Chow, Kam Ming; Chin, Robert Kien Howe

    2015-01-01

    We assessed the Chinese version of the Drug Abuse Screening Test (DAST-10) for identifying illicit drug use during pregnancy among Chinese population. Chinese pregnant women attending their first antenatal visit or their first unbooked visit to the maternity ward were recruited during a 4-month study period in 2011. The participants completed self-administered questionnaires on demographic information, a single question on illicit drug use during pregnancy and the DAST-10. Urine samples screened positive by the urine Point-of-Care Test were confirmed by gas chromatography-mass spectrometry. DAST-10 performance was compared with three different gold standards: urinalysis, self-reported drug use, and evidence of drug use by urinalysis or self-report. 1214 Chinese pregnant women participated in the study and 1085 complete DAST-10 forms were collected. Women who had used illicit drugs had significantly different DAST-10 scores than those who had not. The sensitivity of DAST-10 for identify illicit drug use in pregnant women ranged from 79.2% to 33.3% and specificity ranged from 67.7% to 99.7% using cut-off scores from ≥1 to ≥3. The ~80% sensitivity of DAST-10 using a cut-off score of ≥1 should be sufficient for screening of illicit drug use in Chinese pregnant women, but validation tests for drug use are needed. PMID:26091290

  11. Validation of the Drug Abuse Screening Test (DAST-10): A study on illicit drug use among Chinese pregnant women.

    PubMed

    Lam, Lap Po; Leung, Wing Cheong; Ip, Patrick; Chow, Chun Bong; Chan, Mei Fung; Ng, Judy Wai Ying; Sing, Chu; Lam, Ying Hoo; Mak, Wing Lai Tony; Chow, Kam Ming; Chin, Robert Kien Howe

    2015-06-19

    We assessed the Chinese version of the Drug Abuse Screening Test (DAST-10) for identifying illicit drug use during pregnancy among Chinese population. Chinese pregnant women attending their first antenatal visit or their first unbooked visit to the maternity ward were recruited during a 4-month study period in 2011. The participants completed self-administered questionnaires on demographic information, a single question on illicit drug use during pregnancy and the DAST-10. Urine samples screened positive by the urine Point-of-Care Test were confirmed by gas chromatography-mass spectrometry. DAST-10 performance was compared with three different gold standards: urinalysis, self-reported drug use, and evidence of drug use by urinalysis or self-report. 1214 Chinese pregnant women participated in the study and 1085 complete DAST-10 forms were collected. Women who had used illicit drugs had significantly different DAST-10 scores than those who had not. The sensitivity of DAST-10 for identify illicit drug use in pregnant women ranged from 79.2% to 33.3% and specificity ranged from 67.7% to 99.7% using cut-off scores from ≥ 1 to ≥ 3. The ~ 80% sensitivity of DAST-10 using a cut-off score of ≥ 1 should be sufficient for screening of illicit drug use in Chinese pregnant women, but validation tests for drug use are needed.

  12. Validation of the Drug Abuse Screening Test (DAST-10): A study on illicit drug use among Chinese pregnant women.

    PubMed

    Lam, Lap Po; Leung, Wing Cheong; Ip, Patrick; Chow, Chun Bong; Chan, Mei Fung; Ng, Judy Wai Ying; Sing, Chu; Lam, Ying Hoo; Mak, Wing Lai Tony; Chow, Kam Ming; Chin, Robert Kien Howe

    2015-01-01

    We assessed the Chinese version of the Drug Abuse Screening Test (DAST-10) for identifying illicit drug use during pregnancy among Chinese population. Chinese pregnant women attending their first antenatal visit or their first unbooked visit to the maternity ward were recruited during a 4-month study period in 2011. The participants completed self-administered questionnaires on demographic information, a single question on illicit drug use during pregnancy and the DAST-10. Urine samples screened positive by the urine Point-of-Care Test were confirmed by gas chromatography-mass spectrometry. DAST-10 performance was compared with three different gold standards: urinalysis, self-reported drug use, and evidence of drug use by urinalysis or self-report. 1214 Chinese pregnant women participated in the study and 1085 complete DAST-10 forms were collected. Women who had used illicit drugs had significantly different DAST-10 scores than those who had not. The sensitivity of DAST-10 for identify illicit drug use in pregnant women ranged from 79.2% to 33.3% and specificity ranged from 67.7% to 99.7% using cut-off scores from ≥ 1 to ≥ 3. The ~ 80% sensitivity of DAST-10 using a cut-off score of ≥ 1 should be sufficient for screening of illicit drug use in Chinese pregnant women, but validation tests for drug use are needed. PMID:26091290

  13. Usual care and management of fall risk increasing drugs in older dizzy patients in Dutch general practice

    PubMed Central

    Stam, Hanneke; Harting, Thomas; van der Sluijs, Marjolijn; van Marum, Rob; van der Horst, Henriëtte; van der Wouden, Johannes C.; Maarsingh, Otto R.

    2016-01-01

    Objective For general practitioners (GPs) dizziness is a challenging condition to deal with. Data on the management of dizziness in older patients are mostly lacking. Furthermore, it is unknown whether GPs attempt to decrease Fall Risk Increasing Drugs (FRIDs) use in the management of dizziness in older patients. The aim of this study is to gain more insight into GP’s management of dizziness in older patients, including FRID evaluation and adjustment. Design Data were derived from electronic medical records, obtained over a 12-month period in 2013. Setting Forty-six Dutch general practices. Patients The study sample comprised of 2812 older dizzy patients of 65 years and over. Patients were identified using International Classification of Primary Care codes and free text. Main outcome measures Usual care was categorized into wait-and-see strategy (no treatment initiated); education and advice; additional testing; medication adjustment; and referral. Results Frequently applied treatments included a wait-and-see strategy (28.4%) and education and advice (28.0%). Additional testing was performed in 26.8%; 19.0% of the patients were referred. Of the patients 87.2% had at least one FRID prescription. During the observation period, GPs adjusted the use of one or more FRIDs for 11.7% of the patients. Conclusion This study revealed a wide variety in management strategies for dizziness in older adults. The referral rate for dizziness was high compared to prior research. Although many older dizzy patients use at least one FRID, FRID evaluation and adjustment is scarce. We expect that more FRID adjustments may reduce dizziness and dizziness-related impairment. Key PointsIt is important to know how general practitioners manage dizziness in older patients in order to assess potential cues for improvement.This study revealed a wide variety in management strategies for dizziness in older patients.There was a scarcity in Fall Risk Increasing Drug (FRID) evaluation and adjustment

  14. Non interventional drug studies in oncology: Why we need them?

    PubMed

    Mishra, Divya; Vora, Jesal

    2010-10-01

    Oncology is a highly researched therapeutic area with an ever expanding armamentarium of drugs entering the market. It is unique in how the heterogeneity of tumor, patient and treatment factors is critical in determining outcomes of interventions. When it comes to decision making in the clinic, the practicing physician often seeks answers in populations with obvious deviations from the ideal selected populations included in the pivotal phase III randomized controlled trials (RCTs). While the randomized nature of the RCT ensures its high internal validity by removing bias, their 'controlled' nature casts a doubt on their generalizability to the real world population. It is for this reason that trials done in a naturalistic setting post the marketing authorization of a drug are increasingly required. This article discusses the importance of non interventional drug studies in oncology as an important tool in testing the external validity of controlled trial results and its value in generation of new hypothesis. It also discusses the limitations of such studies while outlining the steps in their effective conduct. PMID:21350727

  15. Progress of drug-loaded polymeric micelles into clinical studies.

    PubMed

    Cabral, Horacio; Kataoka, Kazunori

    2014-09-28

    Targeting tumors with long-circulating nano-scaled carriers is a promising strategy for systemic cancer treatment. Compared with free small therapeutic agents, nanocarriers can selectively accumulate in solid tumors through the enhanced permeability and retention (EPR) effect, which is characterized by leaky blood vessels and impaired lymphatic drainage in tumor tissues, and achieve superior therapeutic efficacy, while reducing side effects. In this way, drug-loaded polymeric micelles, i.e. self-assemblies of amphiphilic block copolymers consisting of a hydrophobic core as a drug reservoir and a poly(ethylene glycol) (PEG) hydrophilic shell, have demonstrated outstanding features as tumor-targeted nanocarriers with high translational potential, and several micelle formulations are currently under clinical evaluation. This review summarizes recent efforts in the development of these polymeric micelles and their performance in human studies, as well as our recent progress in polymeric micelles for the delivery of nucleic acids and imaging. PMID:24993430

  16. A prospective study of adverse drug reactions to antiepileptic drugs in children

    PubMed Central

    Anderson, Mark; Egunsola, Oluwaseun; Cherrill, Janine; Millward, Claire; Fakis, Apostolos; Choonara, Imti

    2015-01-01

    Objectives To prospectively determine the nature and rate of adverse drug reactions (ADRs) in children on antiepileptic drugs (AEDs) and to prospectively evaluate the effect of AEDs on behaviour. Setting A single centre prospective observational study. Participants Children (<18 years old) receiving one or more AEDs for epilepsy, at each clinically determined follow-up visit. Primary and secondary outcomes Primary outcome was adverse reactions of AEDs. Behavioural and cognitive functions were secondary outcomes. Results 180 children were recruited. Sodium valproate and carbamazepine were the most frequently used AEDs. A total of 114 ADRs were recorded in 56 of these children (31%). 135 children (75%) were on monotherapy. 27 of the 45 children (60%) on polytherapy had ADRs; while 29 (21%) of those on monotherapy had ADRs. The risk of ADRs was significantly lower in patients receiving monotherapy than polytherapy (RR: 0.61, 95% CI 0.47 to 0.79, p<0.0001). Behavioural problems and somnolence were the most common ADRs. 23 children had to discontinue their AED due to an ADR. Conclusions Behavioural problems and somnolence were the most common ADRs. Polytherapy significantly increases the likelihood of ADRs in children. Trail registration number EudraCT (2007-000565-37). PMID:26033949

  17. Ranolazine: Drug overview and possible role in primary microvascular angina management.

    PubMed

    Cattaneo, Mattia; Porretta, Alessandra Pia; Gallino, Augusto

    2015-02-15

    Ranolazine is a novel well-tolerated anti-ischemic drug, which selectively inhibits late sodium current and exerts metabolic properties without any hemodynamic effect. Ranolazine has been approved as a second-line medical treatment for symptomatic stable coronary artery disease. Primary microvascular angina (MVA) is suspected when angina symptoms occur in patients with demonstrated myocardial ischemia, absence of myocardial disease and normal coronary artery angiography. Recent clinical data suggest that MVA represents a complex entity, which has been increasingly recognized as a significant cause of morbidity. High variability and low response to traditional anti-anginal treatment characterize primary MVA. Despite the fact that clinical and preclinical evidence provides information regarding ranolazine usefulness in primary MVA management, only three recent small randomized trials have investigated this issue. By selecting peer-reviewed literature in Pubmed and Cochrane Library, this review provides an overview on ranolazine pharmacology and efficacy, focusing on recent evidence suggesting its usefulness in management of primary MVA.

  18. [Psychotropic drugs induced weight gain: a review of the literature concerning epidemiological data, mechanisms and management].

    PubMed

    Ruetsch, O; Viala, A; Bardou, H; Martin, P; Vacheron, M N

    2005-01-01

    , antipsychotic drugs) and weight gain despite reduced appetite which can be explained by an altered resting metabolic rate (TCA, SSRI, Monoaminoxidase Inhibitors MAO I). According to current concepts, appetite and feeding are regulated by a complex of neurotransmitters, neuromodulators, cytokines and hormones interacting with the hypothalamus, including the leptin and the tumor necrosis factor system. The pharmacologic mechanisms underlying weight gain are presently poorly understood: maybe the different activities at some receptor systems may induce it, but also genetic predisposition. Understanding of the metabolic consequences of psychotropic drugs (weight gain, diabetes, dyslipidemia) is essential: the insulin-like effect of lithium is known; treatment with antipsychotic medications increases the risk of impaired glucose tolerance and diabetes mellitus. Several management options of weight gain are available from choosing or switching to another drug, dietary advices, increasing physical activities, behavioural treatment, but the best approach seems to attempt to prevent the weight gain : patients beginning maintenance therapy should be informed of that risk, and nutritional assessment and counselling should be a routine part of treatment management, associated with monitoring of weight, BMI, blood pressure, biological parameters (baseline and three months monitoring of fasting glucose level, fasting cholesterol and triglyceride levels, glycosylated haemoglobin). Psychiatrics must pay attention to concomitant medications and individual factors underlying overweight and obesity. Weight gain has been described since the discovery and the use of the firstpsychotropic drugs, but seems to intensify with especially some of the second generation antipsychotic medications ; understanding of the side effects of psychotropic drugs, including their metabolic consequences (weight gain, diabetes, dyslipidemia) is essential for the psychiatrics to avoid on the one hand a risk of lack of

  19. Adverse drug reactions to unlicensed and off-label drugs on paediatric wards: a prospective study.

    PubMed

    Turner, S; Nunn, A J; Fielding, K; Choonara, I

    1999-09-01

    To determine the incidence of adverse drug reactions (ADRs) to unlicensed and off-label drugs used in paediatric inpatients, we carried out prospective surveillance on five different paediatric wards in a regional children's hospital for 13 wk. Comparison of the use of each drug with its summary of product characteristics was made to determine whether the drug was used in an unlicensed or off-label manner. The presence of an ADR was determined using previously defined criteria. In total, 4455 courses of drugs were administered to 936 patients in 1046 admissions. In 507 (48%) of the 1046 admissions, patients received one or more unlicensed or off-label drugs. ADRs occurred in 116 (11%) of the 1046 patient admissions. ADRs were associated with 112 (3.9%) of the 2881 licensed drug prescriptions and 95 (6%) of the 1574 unlicensed or off-label drug prescriptions. Use of drugs in an off-label or unlicensed manner to treat children is widespread. ADRs are a significant problem following unlicensed or off-label drug prescriptions. PMID:10519338

  20. Interval Management Display Design Study

    NASA Technical Reports Server (NTRS)

    Baxley, Brian T.; Beyer, Timothy M.; Cooke, Stuart D.; Grant, Karlus A.

    2014-01-01

    In 2012, the Federal Aviation Administration (FAA) estimated that U.S. commercial air carriers moved 736.7 million passengers over 822.3 billion revenue-passenger miles. The FAA also forecasts, in that same report, an average annual increase in passenger traffic of 2.2 percent per year for the next 20 years, which approximates to one-and-a-half times the number of today's aircraft operations and passengers by the year 2033. If airspace capacity and throughput remain unchanged, then flight delays will increase, particularly at those airports already operating near or at capacity. Therefore it is critical to create new and improved technologies, communications, and procedures to be used by air traffic controllers and pilots. National Aeronautics and Space Administration (NASA), the FAA, and the aviation industry are working together to improve the efficiency of the National Airspace System and the cost to operate in it in several ways, one of which is through the creation of the Next Generation Air Transportation System (NextGen). NextGen is intended to provide airspace users with more precise information about traffic, routing, and weather, as well as improve the control mechanisms within the air traffic system. NASA's Air Traffic Management Technology Demonstration-1 (ATD-1) Project is designed to contribute to the goals of NextGen, and accomplishes this by integrating three NASA technologies to enable fuel-efficient arrival operations into high-density airports. The three NASA technologies and procedures combined in the ATD-1 concept are advanced arrival scheduling, controller decision support tools, and aircraft avionics to enable multiple time deconflicted and fuel efficient arrival streams in high-density terminal airspace.

  1. Screening hallucinogenic drugs: systematic study of three behavioral tests.

    PubMed

    Silva, M T; Calil, H M

    1975-05-28

    The effects of several hallucinogenic and non-hallucinogenic drugs have been studied on three behavioral tests proposed as useful indexes of hallucinogenic activity: "head-twitching" in mice, defecation in an open-field, and suppression of responding on a differential reinforcement of low rates (DRL) schedule of reinforcement. According to the original propositions, after administration of hallucinogenic agents the frequency of head-twitches would increase in mice, the defecation of rats in an open field would decrease without consistent change in ambulation, rearing and grooming, and the responding of rats on a DRL schedule would yield a typical cumulative record pattern. It was found that the head-twitch test was sensitive to mescaline and LSD-25, but not to delta9-THC or to myristicin and elemicin. Besides, the data on interobserver agreement suggested there is a high degree of subjectivity involved in assessing this response. In the open-field test, non-hallucinogenic drugs such as chlorpromazine and apomorphine fell into the hallucinogenic pattern proposed. In addition, the post-injection interval selected seemed to critically affect defecation scores. The DRL "hallucinogenic" pattern occurred nonspecifically after administration of hallucinogenic and non-hallucinogenic drugs. It was concluded that the three tests have limited value for screening purposes.

  2. Effective management tools for participants at Codex Committee on Residues of Veterinary Drugs meetings.

    PubMed

    Kay, Jack F

    2016-05-01

    The Codex Committee on Residues of Veterinary Drugs in Food (CCRVDF) fulfils a number of functions revolving around standard setting. The core activities of the CCRVDF include agreeing priorities for assessing veterinary drug residues, recommending maximum residue limits for veterinary drugs in foods of animal origin, considering methods of sampling and analyses, and developing codes of practice. Draft standards are developed and progress through an agreed series of steps common to all Codex Alimentarius Commission Committees. Meetings of the CCRVDF are held at approximately 18-month intervals. To ensure effective progress is made with meetings at this frequency, the CCRVDF makes use of a number of management tools. These include circular letters to interested parties, physical and electronic drafting groups between plenary sessions, meetings of interested parties immediately prior to sessions, as well as break out groups within sessions and detailed discussions within the CCRVDF plenary sessions. A range of these approaches is required to assist advances within the standards setting process and can be applied to other Codex areas and international standard setting more generally. Copyright © 2016 John Wiley & Sons, Ltd. PMID:27443198

  3. A stewardship intervention program for safe medication management and use of antidiabetic drugs

    PubMed Central

    Zhao, Rui-yi; He, Xiao-wen; Shan, Yan-min; Zhu, Ling-ling; Zhou, Quan

    2015-01-01

    Background Diabetes patients are complex due to considerations of polypharmacy, multimorbidities, medication adherence, dietary habits, health literacy, socioeconomic status, and cultural factors. Meanwhile, insulin and oral hypoglycemic agents are high-alert medications. Therefore it is necessary to require a multidisciplinary team’s integrated endeavors to enhance safe medication management and use of antidiabetic drugs. Methods A 5-year stewardship intervention program, including organizational measures and quality improvement activities in storage, prescription, dispensing, administration, and monitoring, was performed in the Second Affiliated Hospital of Zhejiang University, People’s Republic of China, a 3,200-bed hospital with 3.5 million outpatient visits annually. Results The Second Affiliated Hospital of Zhejiang University has obtained a 100% implementation rate of standard storage of antidiabetic drugs in the Pharmacy and wards since August 2012. A zero occurrence of dispensing errors related to highly “look-alike” and “sound-alike” NovoMix 30® (biphasic insulin aspart) and NovoRapid® (insulin aspart) has been achieved since October 2011. Insulin injection accuracy among ward nurses significantly increased from 82% (first quarter 2011) to 96% (fourth quarter 2011) (P<0.05). The number of medication administration errors related to insulin continuously decreased from 20 (2011) to six (2014). The occurrence rate of hypoglycemia in non–endocrinology ward diabetes inpatients during 2011–2013 was significantly less than that in 2010 (5.03%–5.53% versus 8.27%) (P<0.01). Percentage of correct management of hypoglycemia by nurses increased from 41.5% (April 2014) to 67.2% (August 2014) (P<0.01). The percentage of outpatient diabetes patients receiving standard insulin injection education increased from 80% (April 2012) to 95.2% (October 2012) (P<0.05). Insulin injection techniques among diabetes outpatients who started to receive insulin were

  4. Dental management considerations for the patient with an acquired coagulopathy. Part 2: Coagulopathies from drugs.

    PubMed

    Lockhart, P B; Gibson, J; Pond, S H; Leitch, J

    2003-11-01

    Dental patients often give a medical history that suggests the possibility of a coagulopathy from drugs, with a corresponding risk for prolonged bleeding during and following an invasive procedure. Identification of patients who may be prone to oral bleeding requires specific medical history information and the proper use of laboratory tests. Some NSAIDs are reported to cause prolonged oral bleeding, but scientific evidence is lacking. Likewise, the risk of oral bleeding from anticoagulants such as warfarin is often over stated, and unnecessary adjustment of NSAID or warfarin dosage puts patients at risk for significant morbidity and mortality. Some commonly employed laboratory tests such as the prothrombin time provide helpful information when used in the appropriate setting, but others, such as the bleeding time test, provide little or no predictive value in the determination of patients at risk for oral bleeding. Dental management of patients with potential coagulopathies from medications requires an understanding of basic principles of coagulation. The vast majority of these patients can be managed in the community setting without risk and without alteration of anticoagulant drug regimes.

  5. The role of general practitioners in the management of erectile dysfunction-a qualitative study.

    PubMed

    Ng, C J; Low, W Y; Tan, N C; Choo, W Y

    2004-02-01

    The objective of this study was to explore the roles and perceptions of general practitioners (GPs) in the management of erectile dysfunction (ED). This qualitative study used focus group discussions and in-depth interviews. This study was conducted based on 28 GPs from an urban area in Malaysia who had managed patients with ED and prescribed anti-ED drugs. Main outcome measures included the roles of GPs in managing patients with ED (active or passive), perceptions regarding ED and the treatment, and factors influencing their decision to prescribe. Majority of the GPs assumed a passive role when managing patients with ED. This was partly due to their perception of the disease being nonserious. Some also perceived ED as mainly psychological in nature. The anti-ED drugs were often viewed as a lifestyle drug with potentially serious side effects. The fear of being perceived by patients as 'pushing' for the drug and being blamed if the patients were to develop serious side effects also hampered the management of this disease. GPs who participated in this study remained passive in identifying and treating patients with ED and this was attributed to their perception of the disease, drug treatment and patient's background. PMID:14963472

  6. The role of general practitioners in the management of erectile dysfunction-a qualitative study.

    PubMed

    Ng, C J; Low, W Y; Tan, N C; Choo, W Y

    2004-02-01

    The objective of this study was to explore the roles and perceptions of general practitioners (GPs) in the management of erectile dysfunction (ED). This qualitative study used focus group discussions and in-depth interviews. This study was conducted based on 28 GPs from an urban area in Malaysia who had managed patients with ED and prescribed anti-ED drugs. Main outcome measures included the roles of GPs in managing patients with ED (active or passive), perceptions regarding ED and the treatment, and factors influencing their decision to prescribe. Majority of the GPs assumed a passive role when managing patients with ED. This was partly due to their perception of the disease being nonserious. Some also perceived ED as mainly psychological in nature. The anti-ED drugs were often viewed as a lifestyle drug with potentially serious side effects. The fear of being perceived by patients as 'pushing' for the drug and being blamed if the patients were to develop serious side effects also hampered the management of this disease. GPs who participated in this study remained passive in identifying and treating patients with ED and this was attributed to their perception of the disease, drug treatment and patient's background.

  7. 75 FR 45641 - Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-03

    ... HUMAN SERVICES Food and Drug Administration Guidance for Industry on Label Comprehension Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for...

  8. 76 FR 58018 - Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for...

  9. Nanostructured Delivery Systems: Augmenting the Delivery of Antiretroviral Drugs for Better Management of HIV/AIDS.

    PubMed

    Singh, Gurinder; Pai, Roopa S; Mustafa, Sanaul

    2015-01-01

    In the last two decades, HIV-1, the retrovirus associated with acquired immunodeficiency syndrome (AIDS), is globally one of the primary causes of morbidity and mortality. Unfortunately, existing approaches for interventions are not able to suppress the progression of infection due to this virus. Of the many obstacles, viral entry into the mono-nuclear phagocyte system encompassing monocytes/macrophages and dendritic cells is a major concern. Viral infection is also responsible for the subsequent distribution of the virus into various tissues throughout the organism. Tremendous progress has been made during the past few years to diagnose and treat patients with HIV/AIDS infection, yet much remains to be done. Recommended treatment involves long-term and multiple drug therapy that causes severe side effects. With almost 12% of the world population suffering from HIV/AIDS, better management of this global threat is highly desired. Nanostructured delivery systems hold promise for improving the situation. Such systems can facilitate the uptake of antiretroviral drugs, causing a considerable improvement in HIV/AIDS therapy. Nanoscale systems have intriguing potential to drastically improve existing HIV/AIDS diagnosis and treatment platforms. Nanosystems constitute a wide range of systems varying from polymeric nanoparticles, to solid-lipid nanoparticles, liposomes, micro- and nanoemulsions, dendrimers, and self-nanoemulsifying systems. Improved bioavailability, solubility, stability, and biocompatibility make them an ideal choice for delivery of antiretroviral drugs. The present review initially describes an updated bird's-eye view account of the literature. Then, we provide a relatively sententious overview on updated patents of recent nanostructured delivery systems for antiretroviral drugs. Finally, we discuss low-cost therapy (such as antioxidants and immune modulators) for the treatment and prevention of HIV/AIDS. PMID:26559551

  10. Adverse event management in mass drug administration for neglected tropical diseases.

    PubMed

    Caplan, Arthur; Zink, Amanda

    2014-03-01

    The ethical challenges of reporting and managing adverse events (AEs) and serious AEs (SAEs) in the context of mass drug administration (MDA) for the treatment of neglected tropical diseases (NTDs) require reassessment of domestic and international policies on a global scale. Although the World Health Organization has set forth AE/SAE guidelines specifically for NTD MDA that incorporate suspected causality, and recommends that only SAEs get reported in this setting, most regulatory agencies continue to require the reporting of all SAEs exhibiting even a merely temporal relationship to activities associated with an MDA program. This greatly increases the potential for excess "noise" and undue risk aversion and is not only impractical but arguably unethical where huge proportions of populations are being treated for devastating diseases, and no good baseline exists against which to compare possible AE/SAE reports. Other population-specific variables that might change the way drug safety ought to be assessed include differing efficacy rates of a drug, background morbidity/mortality rates of the target disease in question, the growth rate of the incidence of disease, the availability of rescue or salvage therapies, and the willingness of local populations to take risks that other populations might not. The fact that NTDs are controllable and potentially eradicable with well-tolerated, effective, existing drugs might further alter our assessment of MDA safety and AE/SAE tolerability. At the same time, diffuseness of population, communication barriers, lack of resources, and other difficult surveillance challenges may present in NTD-affected settings. These limitations could impair the ability to monitor an MDA program's success, as well as hinder efforts to obtain informed consent or provide rescue therapy. Denying beneficial research interventions and MDA programs intended to benefit millions requires sound ethical justification based on more than the identification of

  11. Adverse reactions to antiepileptic drugs: a follow-up study of 355 patients with chronic antiepileptic drug treatment. Collaborative Group for Epidemiology of Epilepsy.

    PubMed

    1988-01-01

    Three hundred fifty-five patients receiving chronic antiepileptic drug (AED) treatment were followed in 15 university and hospital centers for an average of 11 months to assess the effects of intensive monitoring of adverse drug reactions (ADRs) on the frequency of reports and on the overall management of epilepsy. One hundred forty-eight patients (41.6%) had one or more ADRs during the entire follow-up period. ADRs were reported by 31% of patients at admission and by 20% at last visit, with a downward trend in the number of reports. Concurrently, the number of patients who were seizure-free rose from 24.5 to 42.8%. During the observation period, the number of prescriptions fell from 640 to 568, mostly for phenobarbital (PB), phenytoin (PHT), and valproate (VPA). The outcome of the most common ADR was only partially related to drug changes. Even with the limitations of the unstandardized criteria used for ADR reporting, the present study shows that intensive monitoring of drug-related clinical events is not only a valuable tool to provide a comprehensive survey of drug toxicity in clinical practice, but is also an educational effort to improve the quality of care for patients with epilepsy. PMID:3191896

  12. Cytochrome P450 pharmacogenetics in drug development: in vitro studies and clinical consequences.

    PubMed

    Rodrigues, A David; Rushmore, Thomas H

    2002-06-01

    Members of the human cytochrome P450 (CYP) superfamily play a role in the metabolism of many drugs and several of them, CYP2D6, CYP2C9 and CYP2C19, have been shown to be polymorphic as a result of single nucleotide polymorphisms (SNPs), gene deletions, and gene duplications. These polymorphisms can impact the pharmacokinetics (PK), metabolism, safety and efficacy of drugs, and because of the availability of automation, genotyped human tissue, recombinant CYP preparations (rCYPs) and reagents, most pharmaceutical companies have increasingly screened out compounds that are metabolized solely by polymorphic CYPs. In the absence of suitable animal models, it has been widely accepted that such in vitro data are useful because one can obtain information prior to dosing in man and select the most appropriate clinical studies with prospectively genotyped and phenotyped subjects. Overall, current trends in the industry have been fueled by increased managed healthcare, the desire to minimize the need for therapeutic drug monitoring and CYP genotyping in medical practice, and a very competitive market place. In the past, such paradigms have not been as influential and there are numerous examples of marketed drugs that are metabolized by polymorphic CYPs.

  13. Opposite Drug Prescription and Cost Trajectories following Integrative and Conventional Care for Pain – A Case-Control Study

    PubMed Central

    Sundberg, Tobias; Petzold, Max; Kohls, Niko; Falkenberg, Torkel

    2014-01-01

    Objectives Pharmacotherapy may have a limited role in long-term pain management. Comparative trajectories of drug prescriptions and costs, two quality-of-care indicators for pain conditions, are largely unknown subsequent to conventional or integrative care (IC) management. The objectives of this study were to compare prescribed defined daily doses (DDD) and cost of first line drugs for pain patients referred to conventional or anthroposophic IC in Stockholm County, Sweden. Methods In this retrospective high quality registry case-control study, IC and conventional care patients were identified through inpatient care registries and matched on pain diagnosis (ICD-10: M79), age, gender and socio-demographics. National drug registry data was used to investigate changes in DDD and costs from 90/180 days before, to 90/180 days after, index visits to IC and conventional care. The primary selected drug category was analgesics, complemented by musculo-skeletal system drugs (e.g. anti-inflammatories, muscle relaxants) and psycholeptics (e.g. hypnotics, sedatives). Results After index care visits, conventional care pain patients (n = 1050) compared to IC patients (n = 213), were prescribed significantly more analgesics. The average (95% CI) group difference was 15.2 (6.0 to 24.3), p = 0.001, DDD/patient after 90 days; and 21.5 (7.4 to 35.6), p = 0.003, DDD/patient after 180 days. The cost of the prescribed and sold analgesics was significantly higher for conventional care after 90 days: euro/patient 10.7 (1.3 to 20.0), p = 0.025. Changes in drug prescription and costs for the other drug categories were not significantly different between groups. Conclusions Drug prescriptions and costs of analgesics increased following conventional care and decreased following IC, indicating potentially fewer adverse drug events and beneficial societal cost savings with IC. PMID:24827981

  14. A long and winding road; evolution of antimicrobial drug development - crisis management.

    PubMed

    Echols, Roger M

    2012-11-01

    The development of antimicrobial drugs has evolved from observational case reports to complex randomized prospective clinical trials in specific treatment indications. Beginning around the year 2000, the US FDA has evolved its approach on study design and other study characteristics, which has made the conduct of these studies more difficult and the outcomes for sponsors more risky. This has contributed to the decline in the discovery and development of new antimicrobials, which are needed to address the increasing problem of bacterial resistance to existing marketed products. This study reviews the historical basis for the current regulatory climate including the various crises that have led to considerable political pressures on the agency. Recent efforts to resolve development uncertainties and to provide economic incentives for future antimicrobial drug development are presented.

  15. Practical Guide to the Management of Acute and Chronic Pain in the Presence of Drug Tolerance for the Healthcare Practitioner

    PubMed Central

    Vadivelu, Nalini; Singh-Gill, Harman; Kodumudi, Gopal; Kaye, Aaron Joshua; Urman, Richard D.; Kaye, Alan David

    2014-01-01

    Background Drug tolerance has been on the rise in recent years worldwide, and consequently, pain management in our population has become challenging. Methods Discussed in this review are commonly abused drugs and considerations for treating acute and chronic pain states in patients with substance disorders. Results After marijuana, alcohol, and tobacco, the most widely abused substances are oxycodone (Oxycontin), diazepam (Valium), and methylphenidate (Ritalin). Urine testing can detect metabolites of drugs used by patients and is useful for assessing drug abuse, medication diversion, and drug interactions. The comprehensive treatment of pain in a patient with addictive disorder or tolerance must address 3 issues: the patient's addiction, any associated psychiatric conditions, and the patient's pain. Eliciting a detailed history of drug abuse—illicit drugs as well as prescription drugs—and ascertaining if the patient is currently enrolled in a methadone maintenance program for the treatment of drug addiction is vital. Conclusion Medical observation, supportive care, multidisciplinary pain management, and timely interventions as necessary are the keys to safe outcomes in these patients. PMID:25249810

  16. 75 FR 10490 - Joint Meeting of the Arthritis Drugs Advisory Committee and the Drug Safety and Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-08

    ... discuss new drug application (NDA) 22-478, naproxcinod0 375 milligram capsule, sponsored by NicOx S.A., a... be made to the contact person on or before April 28, 2010. Oral presentations from the public will...

  17. Drug-induced sleep endoscopy changes snoring management plan very significantly compared to standard clinical evaluation.

    PubMed

    Pilaete, Karen; De Medts, Joris; Delsupehe, Kathelijne Godelieve

    2014-05-01

    Drug-induced sleep endoscopy (DISE) is a new tool in the work-up of patients with sleep-disordered breathing (SDB). We assessed the impact of DISE on the treatment plan of snoring patients. This is a single institution prospective longitudinal clinical trial. The setting is a private teaching hospital. A consecutive series of 100 snoring patients prospectively underwent a standardised questionnaire, clinical examination, rhinomanometry, allergy skin prick testing, DISE and polysomnography. Management plan before and after DISE evaluation was compared. In 61 patients (excluding 16 patients sent for continuous positive airway pressure, three patients refused sleep endoscopy and 20 were lost to follow-up), we compared the treatment plans. DISE showed single level airway collapse in 13 and multilevel collapse in 48 patients. The site of flutter did not add additional information as compared to the pattern and the location of the collapse. After DISE, the initial management plan changed in 41% of patients irrespective of the type of initial management plan. The only somewhat accurate initial treatment plan was uvulopalatopharyngoplasty (unchanged in 11/13 patients). Excluding moderate to severe obstructive sleep apnea patients DISE is an indispensable tool in treatment decision in all SDB patients. We suggest to simplify the protocol for DISE reporting.

  18. Teaching older adults to self-manage medications: preventing adverse drug reactions.

    PubMed

    Curry, Linda Cox; Walker, Charles; Hogstel, Mildred O; Burns, Paulette

    2005-04-01

    Older adults use more prescription and OTC medications than any other age group. Because their medication regimens often are complicated by many medications and different doses, times, and administration methods, older adults are at high risk for medication mismanagement. The most common errors associated with medication mismanagement include mixing OTC and prescription medications, discontinuing prescriptions, taking wrong dosages, using incorrect techniques, and consuming inappropriate foods with specific medications. Both human and environmental factors contribute to medication mismanagement among older adults. Human factors include faulty communication between the health care provider and the patient; the patient's lack of knowledge; ADRs; alcohol-drug interactions; use of OTC medications and herbal products; cognitive, sensory, and motor impairments; and polypharmacy. Environmental factors include high cost of prescribed medications, improper medication storage, and absence of clearly marked expiration dates. Nurses need to take advantage of both formal and informal teaching opportunities in all settings to prepare a patient for medication self-management. Teaching should be individualized and based on a thorough assessment of the patient's abilities to administer medication safely and the specific medication regimen. By involving older adults as active partners in their health care, many errors and medication-related health problems can be prevented. New technologies and devices have the potential for improving the patient's self-management of medications. The role of nurses in educating older adults and their families about proper medication management is vital. PMID:15839523

  19. Drug Education Based on a Knowledge, Attitude, and Experience Study

    ERIC Educational Resources Information Center

    Grant, John A.

    1971-01-01

    Results of a questionnaire concerning factual knowledge of attitudes toward, and experience with a variety of drugs are reported. It was concluded that marihuana and other drugs are readily available to secondary school students, and widespread experimentation exists; however, a strict dichotomy exists between marihuana and other drugs. (Author/BY)

  20. Drug-Induced Liver Injury Network (DILIN) Prospective Study

    PubMed Central

    Fontana, Robert J.; Watkins, Paul B.; Bonkovsky, Herbert L.; Chalasani, Naga; Davern, Timothy; Serrano, Jose; Rochon, James

    2013-01-01

    Background Drug-induced liver injury (DILI) is an uncommon adverse drug reaction of increasing importance to the medical community, pharmaceutical industry, regulatory agencies and the general public. Objectives The Drug-Induced Liver Injury Network (DILIN) was established to advance understanding and research into DILI by initiating a prospective registry of patients with bona fide DILI for future studies of host clinical, genetic, environmental and immunological risk factors. The DILIN was also charged with developing standardized nomenclature, terminology and causality assessment instruments. Methods Five clinical sites, a data coordinating centre and senior scientists from the National Institute of Diabetes and Digestive and Kidney Diseases initiated the DILIN prospective study in September 2004. Eligible patients are required to meet minimal laboratory or histological criteria within 6 months of DILI onset and have other competing causes of liver injury excluded. Patients in the general community setting with pre-existing HIV, hepatitis B virus or hepatitis C virus infections and/or abnormal baseline liver biochemistries are eligible for enrolment. In addition, subjects with liver injury due to herbal products are eligible to participate. Control patients without DILI are also to be recruited in the future. Results All referred subjects undergo an extensive review of available laboratory, pathology and imaging studies. Subjects who meet pre-defined eligibility criteria at the 6-month study visit are followed for 2 years to better define the natural history of chronic DILI. Causality assessment is determined by a panel of three hepatologists who independently assign a causality score ranging from 1 (definite) to 5 (unlikely) as well as a severity score ranging from 1 (mild) to 5 (fatal). During the first 3 years, 367 subjects were enrolled into the DILIN prospective study. Conclusion DILIN is a multicentre research network charged with improving our

  1. Open Source Drug Discovery in Practice: A Case Study

    PubMed Central

    Årdal, Christine; Røttingen, John-Arne

    2012-01-01

    Background Open source drug discovery offers potential for developing new and inexpensive drugs to combat diseases that disproportionally affect the poor. The concept borrows two principle aspects from open source computing (i.e., collaboration and open access) and applies them to pharmaceutical innovation. By opening a project to external contributors, its research capacity may increase significantly. To date there are only a handful of open source R&D projects focusing on neglected diseases. We wanted to learn from these first movers, their successes and failures, in order to generate a better understanding of how a much-discussed theoretical concept works in practice and may be implemented. Methodology/Principal Findings A descriptive case study was performed, evaluating two specific R&D projects focused on neglected diseases. CSIR Team India Consortium's Open Source Drug Discovery project (CSIR OSDD) and The Synaptic Leap's Schistosomiasis project (TSLS). Data were gathered from four sources: interviews of participating members (n = 14), a survey of potential members (n = 61), an analysis of the websites and a literature review. Both cases have made significant achievements; however, they have done so in very different ways. CSIR OSDD encourages international collaboration, but its process facilitates contributions from mostly Indian researchers and students. Its processes are formal with each task being reviewed by a mentor (almost always offline) before a result is made public. TSLS, on the other hand, has attracted contributors internationally, albeit significantly fewer than CSIR OSDD. Both have obtained funding used to pay for access to facilities, physical resources and, at times, labor costs. TSLS releases its results into the public domain, whereas CSIR OSDD asserts ownership over its results. Conclusions/Significance Technically TSLS is an open source project, whereas CSIR OSDD is a crowdsourced project. However, both have enabled high quality

  2. Directional reflectance analysis for identifying counterfeit drugs: Preliminary study.

    PubMed

    Wilczyński, Sławomir; Koprowski, Robert; Błońska-Fajfrowska, Barbara

    2016-05-30

    The WHO estimates that up to 10% of drugs on the market may be counterfeit. In order to prevent intensification of the phenomenon of drug counterfeiting, the methods for distinguishing genuine medicines from fake ones need to be developed. The aim of this study was to try to develop simple, reproducible and inexpensive method for distinguishing between original and counterfeit medicines based on the measurement of directional reflectance. The directional reflectance of 6 original Viagra(®) tablets (Pfizer) and 24 (4 different batches) counterfeit tablets (imitating Viagra(®)) was examined in six spectral bands: from 0.9 to 1.1 μm, from 1.9 to 2.6 μm, from 3.0 to 4.0 μm, from 3.0 to 5.0 μm, from 4.0 to 5.0 μm, from 8.0 to 12.0 μm, and for two angles of incidence, 20° and 60°. Directional hemispherical reflectometer was applied to measure directional reflectance. Significant statistical differences between the directional reflectance of the original Viagra(®) and counterfeit tablets were registered. Any difference in the value of directional reflectance for any spectral band or angle of incidence identifies the drug as a fake one. The proposed method of directional reflectance analysis enables to differentiate between the real Viagra(®) and fake tablets. Directional reflectance analysis is a fast (measurement time under 5s), cheap and reproducible method which does not require expensive equipment or specialized laboratory staff. It also seems to be an effective method, however, the effectiveness will be assessed after the extension of research. PMID:26977587

  3. From Abstinence to Relapse: A Preliminary Qualitative Study of Drug Users in a Compulsory Drug Rehabilitation Center in Changsha, China

    PubMed Central

    Yang, Mei; Mamy, Jules; Gao, Pengcheng; Xiao, Shuiyuan

    2015-01-01

    Background Relapse among abstinent drug users is normal. Several factors are related to relapse, but it remains unclear what individuals’ actual life circumstances are during periods of abstinence, and how these circumstances facilitate or prevent relapse. Objective To illuminate drug users’ experiences during abstinence periods and explore the real-life catalysts and inhibitors contributing to drug use relapse. Method Qualitative in-depth interviews were conducted with 20 drug users recruited from a compulsory isolated drug rehabilitation center in Changsha. The interviews were guided by open-ended questions on individuals’ experiences in drug use initiation, getting addicted, treatment history, social environment, abstinence, and relapse. Participants were also encouraged to share their own stories. Interviews were digitally recorded and fully transcribed. The data of 18 participants who reported abstinence experiences before admission were included in the analyses. The data were analyzed using a thematic analysis with inductive hand coding to derive themes. Results Most drug users were able to successfully abstain from drugs. During abstinence, their lives were congested with challenges, such as adverse socioeconomic conditions, poor family/social support, interpersonal conflicts, and stigma and discrimination, all of which kept them excluded from mainstream society. Furthermore, the police’s system of ID card registration, which identifies individuals as drug users, worsened already grave situations. Relapse triggers reported by the participants focused mainly on negative feelings, interpersonal conflicts, and stressful events. Craving was experienced but not perceived as a relapse trigger by most participants. Conclusions This study of in-depth interview with drug users found evidence of situations and environments they live during abstinence appear rather disadvantaged, making it extremely difficult for them to remain abstinent. Comprehensive programs

  4. Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

    PubMed Central

    Bojnanska, Erika; Kalina, Michal; Bartonickova, Eva; Opravil, Tomas; Vesely, Michal; Pekar, Miloslav

    2014-01-01

    The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different suppliers. The target was to design a sufficiently robust drug substance specification allowing to obtain a satisfactory drug product. For this reason, five batches of the drug substance and five samples of the final peroral drug products were analysed with the use of solid state analysis methods on the bulk level. Besides polymorphism, particle size distribution, surface area, zeta potential, and water content were identified as important parameters, and the zeta potential and the particle size distribution of the drug substance seem to be critical quality attributes affecting the dissolution rate of the drug substance released from the final peroral drug formulation. PMID:25317424

  5. “Pressured to prescribe” The impact of economic and regulatory factors on South-Eastern ED physicians when managing the drug seeking patient

    PubMed Central

    Kelly, Sharon; Johnson, Giffe T.; Harbison, Raymond D.

    2016-01-01

    Objective: The purpose of this study was to elicit the opinions of Emergency Department (ED) physicians, currently practicing in the United States, regarding the impact of economic and regulatory factors on their management of patients exhibiting “drug seeking” behavior. Methods: A descriptive, cross-sectional study, utilizing a convenience sample of ED physicians located in Florida and Georgia was conducted for a period of 2 months. The inclusion criteria specified that any ED physician, currently practicing within the United States, could participate. Results: Of the ED physicians surveyed (n = 141), 71% reported a perceived pressure to prescribe opioid analgesics to avoid administrative and regulatory criticism and 98% related patient satisfaction scores as being too highly emphasized by reimbursement entities as a means of evaluating their patient management. Rising patient volumes and changes in the healthcare climate were cited by ED physicians as impacting their management of patients exhibiting “drug seeking” behavior. Conclusions: The ED physician faces unique challenges in changing healthcare and economic climates. Requirements to address pain as the “fifth vital sign,” patient satisfaction based reimbursement metrics and an economically driven rise in ED patient volume, may have inadvertently created an environment conducive to exploitation by prescription opioid abusers. There is an identified need for the development of continuing medical education and standardized regulatory and legislative protocols to assist ED physicians in the appropriate management of patients exhibiting “drug seeking” behavior. PMID:27162437

  6. Programmatic Management of Drug-Resistant Tuberculosis: An Updated Research Agenda

    PubMed Central

    Mitnick, Carole D.; Hatton, Marita L.; Brigden, Grania; Cobelens, Frank; Grobusch, Martin P.; Horsburgh, Robert; Lange, Christoph; Lienhardt, Christian; Oren, Eyal; Podewils, Laura J.; Seaworth, Barbara; van den Hof, Susan; Daley, Charles L.; Gebhard, Agnes C.; Wares, Fraser

    2016-01-01

    Introduction There are numerous challenges in delivering appropriate treatment for multidrug-resistant tuberculosis (MDR-TB) and the evidence base to guide those practices remains limited. We present the third updated Research Agenda for the programmatic management of drug-resistant TB (PMDT), assembled through a literature review and survey. Methods Publications citing the 2008 research agenda and normative documents were reviewed for evidence gaps. Gaps were formulated into questions and grouped as in the 2008 research agenda: Laboratory Support, Treatment Strategy, Programmatically Relevant Research, Epidemiology, and Management of Contacts. A survey was distributed through snowball sampling to identify research priorities. Respondent priority rankings were scored and summarized by mean. Sensitivity analyses explored weighting and handling of missing rankings. Results Thirty normative documents and publications were reviewed for stated research needs; these were collapsed into 56 research questions across 5 categories. Of more than 500 survey recipients, 133 ranked priorities within at least one category. Priorities within categories included new diagnostics and their effect on improving treatment outcomes, improved diagnosis of paucibacillary and extra pulmonary TB, and development of shorter, effective regimens. Interruption of nosocomial transmission and treatment for latent TB infection in contacts of known MDR−TB patients were also top priorities in their respective categories. Results were internally consistent and robust. Discussion Priorities retained from the 2008 research agenda include shorter MDR-TB regimens and averting transmission. Limitations of recent advances were implied in the continued quest for: shorter regimens containing new drugs, rapid diagnostics that improve treatment outcomes, and improved methods of estimating burden without representative data. Conclusion There is continuity around the priorities for research in PMDT. Coordinated

  7. Optimization of combinational intranasal drug delivery system for the management of migraine by using statistical design.

    PubMed

    Kumar, Animesh; Garg, Tarun; Sarma, Ganti S; Rath, Goutam; Goyal, Amit Kumar

    2015-04-01

    Migraine is a chronic disorder characterized by significant headache and various associated symptoms which worsen with exertion. Zolmitriptan approved for use in the acute treatment of migraine and related vascular headaches but are limited by high pain recurrence due to rapid drug elimination. Combinationalformulationof triptans and a nonsteroidal anti-inflammatory drug may provide a quicker and longer duration of relief from the subsequent pain during the attack. In this study, we formulate a Zolmitriptan (ZT) & ketorolac tromethamine (KT) loaded thermo reversible in-situ mucoadhesive intranasal gel (TMISG) formulation which gels at the nasal mucosal temperature and contains a bioadhesive polymer (Xyloglucan) that lengthens the residence time will enhance the bioavailability of the combinational drugs. This study uses Box-Behnken design for the first time to develop, optimize the TMISG and assess factors affecting the critical quality attributes. Histopathological study of the nasal mucosa suggested that the formulation was safe for nasal administration. The statistical difference in absolute bioavailability between oral and intranasal route suggested that intranasal route had almost 21% increases in bioavailability for ZT and for KT there was 16% increase over oral formulations. Optimized formulation would help mitigate migraine associated symptoms much better over the currently available formulations.

  8. Predicting Heavy Drug Use. Results of a Longitudinal Study, Youth Characteristics Describing and Predicting Heavy Drug Use by Adults

    ERIC Educational Resources Information Center

    Schildhaus, Sam; Shaw-Taylor, Yoku; Pedlow, Steven; Pergamit, Michael R.

    2004-01-01

    The primary aim of this study was to describe the movement of adolescents and young adults into and out of drug use and to predict heavy drug use. The data source is the Department of Labor's National Longitudinal Survey of Youth, which began in 1979 with a sample of 12,686 adolescents aged 14-21. After 17 rounds and 19 years, the response rate in…

  9. Pain management in trauma: A review study

    PubMed Central

    Ahmadi, Alireza; Bazargan-Hejazi, Shahrzad; Heidari Zadie, Zahra; Euasobhon, Pramote; Ketumarn, Penkae; Karbasfrushan, Ali; Amini-Saman, Javad; Mohammadi, Reza

    2016-01-01

    Abstract: Background: Pain in trauma has a role similar to the double-edged sword. On the one hand, pain is a good indicator to determine the severity and type of injury. On the other hand, pain can induce sever complications and it may lead to further deterioration of the patient. Therefore, knowing how to manage pain in trauma patients is an important part of systemic approach in trauma. The aim of this manuscript is to provide information about pain management in trauma in the Emergency Room settings. Methods: In this review we searched among electronic and manual documents covering a 15-yr period between 2000 and 2016. Our electronic search included Pub Med, Google scholar, Web of Science, and Cochrane databases. We looked for articles in English and in peer-reviewed journals using the following keywords: acute pain management, trauma, emergency room and injury. Results: More than 3200 documents were identified. After screening based on the study inclusion criteria, 560 studies that had direct linkage to the study aim were considered for evaluation based World Health Organization (WHO) pain ladder chart. Conclusions: To provide adequate pain management in trauma patients require: adequate assessment of age-specific pharmacologic pain management; identification of adequate analgesic to relieve moderate to severe pain; cognizance of serious adverse effects of pain medications and weighting medications against their benefits, and regularly reassessing patients and reevaluating their pain management regimen. Patient-centered trauma care will also require having knowledge of barriers to pain management and discussing them with the patient and his/her family to identify solutions. PMID:27414816

  10. Management of Biomedical Waste: An Exploratory Study

    PubMed Central

    Abhishek, K N; Suryavanshi, Harshal N; Sam, George; Chaithanya, K H; Punde, Prashant; Singh, S Swetha

    2015-01-01

    Background: Dental operatories pose a threat due to the high chances of infection transmission both to the clinician and the patients. Hence, management of dental waste becomes utmost importance not only for the health benefit of the dentist himself, but also people who can come into contact with these wastes directly or indirectly. The present study was conducted to find out the management of biomedical waste in private dental practice among 3 districts of Karnataka. Materials and Methods: The study population included 186 private practitioners in 3 districts of Karnataka (Coorg, Mysore, Hassan), South India. A pre-tested self-administered questionnaire was distributed to assess the knowledge and practices regarding dental waste management. Descriptive statistics was used to summarize the results. Results: Out of 186 study subjects, 71 (38%) were females and 115 (62%) were males. The maximum number of participants belonged to the age group of 28-33 years (29%). Undergraduate qualification was more (70%). 90 (48%) participants had an experience of 0-5 years. Chi-square analysis showed a highly significant association between participant who attended continuing dental education (CDE) program and their practice of dental waste management. Conclusion: Education with regards to waste management will help in enhancing practices regarding the same. In order to fill this vacuum CDE programs have to be conducted in pursuance to maintain health of the community. PMID:26435621

  11. Stem cell models for drug discovery and toxicology studies.

    PubMed

    Liu, Wenwei; Deng, Yaguang; Liu, Ying; Gong, Wenrong; Deng, Wenbin

    2013-01-01

    Human stem cells and their derivatives could provide virtually unlimited sources of tissue for a wide range of toxicity models that could complement conventional animal models with more relevant, humanized versions. Human embryonic stem cells (hESCs) have already been proven valuable for drug/toxicity screens and mechanistic studies including analysis of disease pathway and developmental toxicity. Human-induced pluripotent stem cells (iPSCs), which are generated by reprogramming somatic cells back to become hESC-like cells, allow assays to be designed where the contribution of an individual's genetic background or environmental exposure history to toxicity response can be determined. Comprehensive profiling of hESC/iPSCs via genomics, proteomics, transcriptomics, and metabolomics could be used to elucidate pathway perturbations that underlie toxicity and disease, enabling the development of predictive assays for toxicity. While technological hurdles still exist for widespread use and implementation, incorporation of human stem cell based assays into drug discovery and toxicity testing offers the potential for safer, more customized medicines and more accurate risk assessment for environmental toxicants, as well as reduced costs and decreased use of animal models. We examine limitations and deficiencies of current toxicology approaches and how human stem cell based in vitro assays may overcome them. We describe how human stem cells are used for predictive toxicology. We also identify technological limitations that prevent stem cells from being integrated into standard practice, as well as new tools and technologies that may overcome them. We discuss research priorities that are most useful for transforming cell-based toxicology models into reality, and research areas in which stem cell technology could make substantial contributions to the development and implementation of stem cell based models for toxicity testing. Increased use of human in vitro models of

  12. [Multicenter study on the use of drugs during pregnancy in Spain (II). Drugs used during pregnancy. Spain DUP workshop].

    PubMed

    1991-01-12

    A structured questionnaire administered to the 1,371 participating women was used for data collection on drug use in the multicentric study on Drug Use during Pregnancy in Spain. This paper describes and discusses the pattern of the use of medicines during pregnancy. Only 104 women (7%) stated that they had not taken any drug during their pregnancy, while 627 (45%) had taken 3 or more medicines; 39% of all medicines used were fixed-dose combinations of two or more drugs, the mean number of these taken by the participating women being 8.9. The most frequent reason for taking medicines during pregnancy was vitamin supplementation (823 women, 60%), and out of the 1,119 medicines taken to this end, 443 (30%) contained vitamin A. Other reasons for using medicines were the treatment of anaemia (497, 36%), dispepsia (235, 17%), nausea and/or vomiting (204, 14%), colds, pain, urinary tract infections, headache, and genital infections.

  13. Meta-Analysis of Day Treatment and Contingency-Management Dismantling Research: Birmingham Homeless Cocaine Studies (1990-2006)

    ERIC Educational Resources Information Center

    Schumacher, Joseph E.; Milby, Jesse B.; Wallace, Dennis; Meehan, Dawna-Cricket; Kertesz, Stefan; Vuchinich, Rudy; Dunning, Jonathan; Usdan, Stuart

    2007-01-01

    Four successive randomized clinical trials studying contingency management (CM), involving various treatment arms of drug-abstinent housing and work therapy and day treatment (DT) with a behavioral component, were compared on common drug abstinence outcomes at 2 treatment completion points (2 and 6 months). The clinical trials were conducted from…

  14. Detection and management of drug-resistant tuberculosis in HIV-infected patients from lower income countries

    PubMed Central

    Ballif, Marie; Nhandu, Venerandah; Wood, Robin; Dusingize, Jean Claude; Carter, E. Jane; Cortes, Claudia P.; McGowan, Catherine C.; Diero, Lameck; Graber, Claire; Renner, Lorna; Hawerlander, Denise; Kiertiburanakul, Sasisopin; Du, Quy Tuan; Sterling, Timothy R.; Egger, Matthias; Fenner, Lukas

    2015-01-01

    Setting Drug resistance threatens tuberculosis (TB) control, particularly among HIV-infected persons. Objective We surveyed antiretroviral therapy (ART) programs from lower-income countries on prevention and management of drug-resistant TB. Design We used online questionnaires to collect program-level data in 47 ART programs in Southern Africa (14), East Africa (8), West Africa (7), Central Africa (5), Latin America (7) and Asia-Pacific (6 programs) in 2012. Patient-level data were collected on 1,002 adult TB patients seen at 40 of the participating ART programs. Results Phenotypic drug susceptibility testing was available at 36 (77%) ART programs, but only used for 22% of all TB patients. Molecular drug resistance testing was available at 33 (70%) programs and used for 23% of all TB patients. Twenty ART programs (43%) provided directly observed therapy (DOT) during the whole treatment, 16 (34%) during intensive phase only and 11 (23%) did not follow DOT. Fourteen (30%) ART programs reported no access to second-line TB regimens; 18 (38%) reported TB drug shortages. Conclusions Capacity to diagnose and treat drug-resistant TB was limited across ART programs in lower income countries. DOT was not always implemented and drug supply was regularly interrupted, which may contribute to the global emergence of drug resistance. PMID:25299866

  15. Management System for EMR Work Study Program.

    ERIC Educational Resources Information Center

    Columbia County Board of Public Instruction, Lake City, FL. Exceptional Child Education Dept.

    A computerized information management system involving the specification of objectives, the coding of teacher evaluations of students, and a variety of possible outputs has been used in a work study program for educable mentally retarded adolescents. Instructional objectives are specified and coded by number and category. Evaluation is by means of…

  16. Novel Approaches to the Management of Advanced Peripheral Artery Disease: Perspectives on Drug-Coated Balloons, Drug-Eluting Stents, and Bioresorbable Scaffolds.

    PubMed

    Zeller, Thomas; Rastan, Aljoscha; Macharzina, Roland; Beschorner, Ulrich; Noory, Elias

    2015-09-01

    Introducing anti-restenotic drug-based treatment modalities in femoropopliteal interventions is the potential revolutionizing reperfusion treatment of peripheral artery disease. Durability of recanalization procedures using drug-coated balloons (DCB) and drug-eluting stents (DES) yields in excellent mid-term and long-term technical and clinical outcomes and may be cost saving on the long term as compared to traditional treatment modalities such as plain old balloon angioplasty (POBA) and bare metal nitinol stent implantation. Drug-eluting bioresorbable scaffolds are another drug-based promising treatment option but are still investigational. In particular, DCB provide a novel method to locally deliver paclitaxel into the arterial wall without the need of a chronically implanted delivery system or even if those devices will be indicated, they can be delivered focally. Following the first positive pilot studies, two large pivotal trials have confirmed superiority of DCB over plain old balloon angioplasty (POBA) in the treatment of TASC II A and B femoropopliteal lesions. Even for more complex femoropopliteal lesions such as long lesions and instent restenosis, single center studies and small randomized studies have shown promising mid-term technical and clinical results. For DES, follow-up data for the only commercially available device are now presented up to 5 years with excellent clinical outcome regarding freedom from target lesion revascularization and improvement of walking capacity. This review article summarizes the current knowledge and perspectives of drug-based endovascular treatment modalities in femoropopliteal interventions and discusses still unresolved needs.

  17. Case study: applying management policies to manage distributed queuing systems

    NASA Astrophysics Data System (ADS)

    Neumair, Bernhard; Wies, René

    1996-06-01

    The increasing deployment of workstations and high performance endsystems in addition to the operation of mainframe computers leads to a situation where many companies can no longer afford for their expensive workstations to run idle for long hours during the night or with little load during daytime. Distributed queuing systems and batch systems (DQSs) provide an efficient basis to make use of these unexploited resources and allow corporations to replace expensive supercomputers with clustered workstations running DQSs. To employ these innovative DQSs on a large scale, the management policies for scheduling jobs, configuring queues, etc must be integrated in the overall management process for the IT infrastructure. For this purpose, the concepts of application management and management policies are introduced and discussed. The definition, automatic transformation, and implementation of policies on management platforms to effectively manage DQSs will show that policy-based application management is already possible using the existing management functionality found in today's systems.

  18. Spacelab data management subsystem phase B study

    NASA Technical Reports Server (NTRS)

    1974-01-01

    The Spacelab data management system is described. The data management subsystem (DMS) integrates the avionics equipment into an operational system by providing the computations, logic, signal flow, and interfaces needed to effectively command, control, monitor, and check out the experiment and subsystem hardware. Also, the DMS collects/retrieves experiment data and other information by recording and by command of the data relay link to ground. The major elements of the DMS are the computer subsystem, data acquisition and distribution subsystem, controls and display subsystem, onboard checkout subsystem, and software. The results of the DMS portion of the Spacelab Phase B Concept Definition Study are analyzed.

  19. Vehicle Systems and Excipients Used in Minipig Drug Development Studies.

    PubMed

    Weaver, Margaret L; Grossi, Anette Blak; Schützsack, Jorgen; Parish, Joanna; Løgsted, Jeanet; Bøgh, Ingrid Brück; Cameron, David; Harvey, Warren; Festag, Matthias; Downes, Noel; Venturella, Silvana; Schlichtiger, Julia; Mhedhbi, Sofiene; Ross, Vanessa; Kissner, Thomas; Stark, Claudia; Milano, Stephane; Heining, Peter; Sanchez-Felix, Manual

    2016-04-01

    Minipigs have been used for dermal drug development studies for decades, and they are currently more frequently considered as the second nonrodent species for pivotal nonclinical studies, in lieu of the dog or nonhuman primate, for compounds delivered via standard systemic routes of administration. Little is known about the tolerability of different excipients in minipigs; sharing knowledge of excipient tolerability and compositions previously used in nonclinical studies may avoid testing of inadequate formulations, thereby contributing to reduced animal usage. This article reviews vehicles employed in the Göttingen(®)minipig based on the combined experience from a number of pharmaceutical companies and contract research organizations. The review includes vehicles tolerated for single or multiple dosing by the Göttingen minipig, some of which are not appropriate for administration to other common nonrodent species (e.g., dogs). By presenting these data for dermal, oral, subcutaneous, and intravenous routes of administration, studies to qualify these vehicles in minipigs can be minimized or avoided. Additionally, investigators may more frequently consider using the minipig in place of higher species if the tolerability of a vehicle in the minipig is known. PMID:26674803

  20. Experimental Pilot Study of a Novel Endobronchial Drug Delivery Catheter

    PubMed Central

    Tsukada, Hisashi; Seward, Kirk P.; Rafeq, Samaan; Kocher, Olivier; Ernst, Armin

    2015-01-01

    Background An endobronchial infusion catheter introduced through a flexible bronchoscope channel has not been previously described. The aim of this study was to evaluate the technical feasibility of a new device. Methods Four porcine models underwent bronchoscopy with the infusion catheter. In the first experiment, Methylene blue was injected into airway in volumes of 0.1 ml, 0.3 ml or 1.0 ml into two animals. One animal was sacrificed at 1 hour and one at 24 hours after the procedure and gross dye diffusion was visually assessed. In the second experiment, a mixture of 80% sterile normal saline and 20% contrast media was injected into the airway in volumes of 0.3 ml, 1.0 ml and 3.0 ml into two animals. One animal was sacrificed at 7 days and one at 20 days. Histological evaluations were performed according to a bronchial damage scoring system. Results There was no perioperative morbidity. In the first experiment, infusion volumes of 0.1ml, 0.3ml and 1.0ml resulted in dye surrounding 67±29%, 55±17% and 80±20% of the infusion site circumference, and longitudinal distribution of 4.0±1.7mm, 8.1±4.1mm and 18.0±3.0mm, each respectively. In the second experiment, infusion of 0.3 to 3.0 ml resulted in mild injury, inflammation and hemorrhage/fibrin/thrombus at 7 and 20 days after surgery. Conclusion Endobronchial infusion of dye and contrast media by the Endobronchial Drug Delivery Catheter [EDDC] showed dose dependent fashion spread media macroscopically and histologically. Further investigation will be required to assess the catheter as a new tool for localized drug delivery into the airway. PMID:26492604

  1. Drugs: A Pilot Study of Minneapolis Secondary School Students.

    ERIC Educational Resources Information Center

    Faunce, R. W.; Johnson, Larry

    The results of a survey of over 1800 junior high and senior high school students are presented. Purposes of the survey were: (1) to obtain information about the extent of drug use and experimentation; (2) to obtain suggestions for improving Minneapolis Public Schools' health education curriculum; and (3) to pretest the drug education questionnaire…

  2. 75 FR 16629 - Office of Safe and Drug-Free Schools Overview Information; Emergency Management for Higher...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-04-01

    ... Office of Safe and Drug-Free Schools Overview Information; Emergency Management for Higher Education...) Develop or enhance a written plan for preventing violence on campus by assessing and addressing the mental health needs of students, staff, and faculty who may be at risk of causing violence by harming...

  3. Pharmacokinetic Drug Interactions of Antimicrobial Drugs: A Systematic Review on Oxazolidinones, Rifamycines, Macrolides, Fluoroquinolones, and Beta-Lactams

    PubMed Central

    Bolhuis, Mathieu S.; Panday, Prashant N.; Pranger, Arianna D.; Kosterink, Jos G. W.; Alffenaar, Jan-Willem C.

    2011-01-01

    Like any other drug, antimicrobial drugs are prone to pharmacokinetic drug interactions. These drug interactions are a major concern in clinical practice as they may have an effect on efficacy and toxicity. This article provides an overview of all published pharmacokinetic studies on drug interactions of the commonly prescribed antimicrobial drugs oxazolidinones, rifamycines, macrolides, fluoroquinolones, and beta-lactams, focusing on systematic research. We describe drug-food and drug-drug interaction studies in humans, affecting antimicrobial drugs as well as concomitantly administered drugs. Since knowledge about mechanisms is of paramount importance for adequate management of drug interactions, the most plausible underlying mechanism of the drug interaction is provided when available. This overview can be used in daily practice to support the management of pharmacokinetic drug interactions of antimicrobial drugs. PMID:24309312

  4. Drug-DNA Interaction Studies of Acridone-Based Derivatives.

    PubMed

    Thimmaiah, Kuntebomanahalli; Ugarkar, Apoorva G; Martis, Elvis F; Shaikh, Mushtaque S; Coutinho, Evans C; Yergeri, Mayur C

    2015-01-01

    N10-alkylated 2-bromoacridones are a novel series of potent antitumor compounds. DNA binding studies of these compounds were carried out using spectrophotometric titrations, Circular dichroism (CD) measurements using Calf Thymus DNA (CT DNA). The binding constants were identified at a range of K=0.3 to 3.9×10(5) M(-1) and the percentage of hypochromism from the spectral titrations at 28-54%. This study has identified a compound 9 with the good binding affinity of K=0.39768×10(5) M(-1) with CT DNA. Molecular dynamics (MD) simulations have investigated the changes in structural and dynamic features of native DNA on binding to the active compound 9. All the synthesized compounds have increased the uptake of Vinblastine in MDR KBChR-8-5 cells to an extent of 1.25- to1.9-fold than standard modulator Verapamil of similar concentration. These findings allowed us to draw preliminary conclusions about the structural features of 2-bromoacridones and further chemical enhancement will improve the binding affinity of the acridone derivatives to CT-DNA for better drug-DNA interaction. The molecular modeling studies have shown mechanism of action and the binding modes of the acridones to DNA.

  5. Multidrug Resistant and Extensively Drug Resistant Bacteria: A Study

    PubMed Central

    Basak, Silpi; Singh, Priyanka; Rajurkar, Monali

    2016-01-01

    Background and Objective. Antimicrobial resistance is now a major challenge to clinicians for treating patients. Hence, this short term study was undertaken to detect the incidence of multidrug-resistant (MDR), extensively drug-resistant (XDR), and pandrug-resistant (PDR) bacterial isolates in a tertiary care hospital. Material and Methods. The clinical samples were cultured and bacterial strains were identified in the department of microbiology. The antibiotic susceptibility profile of different bacterial isolates was studied to detect MDR, XDR, and PDR bacteria. Results. The antibiotic susceptibility profile of 1060 bacterial strains was studied. 393 (37.1%) bacterial strains were MDR, 146 (13.8%) strains were XDR, and no PDR was isolated. All (100%) Gram negative bacterial strains were sensitive to colistin whereas all (100%) Gram positive bacterial strains were sensitive to vancomycin. Conclusion. Close monitoring of MDR, XDR, or even PDR must be done by all clinical microbiology laboratories to implement effective measures to reduce the menace of antimicrobial resistance. PMID:26942013

  6. Breast cancer resistance protein (ABCG2) in clinical pharmacokinetics and drug interactions: practical recommendations for clinical victim and perpetrator drug-drug interaction study design.

    PubMed

    Lee, Caroline A; O'Connor, Meeghan A; Ritchie, Tasha K; Galetin, Aleksandra; Cook, Jack A; Ragueneau-Majlessi, Isabelle; Ellens, Harma; Feng, Bo; Taub, Mitchell E; Paine, Mary F; Polli, Joseph W; Ware, Joseph A; Zamek-Gliszczynski, Maciej J

    2015-04-01

    Breast cancer resistance protein (BCRP; ABCG2) limits intestinal absorption of low-permeability substrate drugs and mediates biliary excretion of drugs and metabolites. Based on clinical evidence of BCRP-mediated drug-drug interactions (DDIs) and the c.421C>A functional polymorphism affecting drug efficacy and safety, both the US Food and Drug Administration and European Medicines Agency recommend preclinical evaluation and, when appropriate, clinical assessment of BCRP-mediated DDIs. Although many BCRP substrates and inhibitors have been identified in vitro, clinical translation has been confounded by overlap with other transporters and metabolic enzymes. Regulatory recommendations for BCRP-mediated clinical DDI studies are challenging, as consensus is lacking on the choice of the most robust and specific human BCRP substrates and inhibitors and optimal study design. This review proposes a path forward based on a comprehensive analysis of available data. Oral sulfasalazine (1000 mg, immediate-release tablet) is the best available clinical substrate for intestinal BCRP, oral rosuvastatin (20 mg) for both intestinal and hepatic BCRP, and intravenous rosuvastatin (4 mg) for hepatic BCRP. Oral curcumin (2000 mg) and lapatinib (250 mg) are the best available clinical BCRP inhibitors. To interrogate the worst-case clinical BCRP DDI scenario, study subjects harboring the BCRP c.421C/C reference genotype are recommended. In addition, if sulfasalazine is selected as the substrate, subjects having the rapid acetylator phenotype are recommended. In the case of rosuvastatin, subjects with the organic anion-transporting polypeptide 1B1 c.521T/T genotype are recommended, together with monitoring of rosuvastatin's cholesterol-lowering effect at baseline and DDI phase. A proof-of-concept clinical study is being planned by a collaborative consortium to evaluate the proposed BCRP DDI study design.

  7. The Affordable Care Act, health care reform, prescription drug formularies and utilization management tools.

    PubMed

    Ung, Brian L; Mullins, C Daniel

    2015-01-01

    The U.S. Patient Protection and Affordable Care Act (hence, Affordable Care Act, or ACA) was signed into law on March 23, 2010. Goals of the ACA include decreasing the number of uninsured people, controlling cost and spending on health care, increasing the quality of care provided, and increasing insurance coverage benefits. This manuscript focuses on how the ACA affects pharmacy benefit managers and consumers when they have prescriptions dispensed. PBMs use formularies and utilization control tools to steer drug usage toward cost-effective and efficacious agents. A logic model was developed to explain the effects of the new legislation. The model draws from peer-reviewed and gray literature commentary about current and future U.S. healthcare reform. Outcomes were identified as desired and undesired effects, and expected unintended consequences. The ACA extends health insurance benefits to almost 32 million people and provides financial assistance to those up to 400% of the poverty level. Increased access to care leads to a similar increase in overall health care demand and usage. This short-term increase is projected to decrease downstream spending on disease treatment and stunt the continued growth of health care costs, but may unintentionally exacerbate the current primary care physician shortage. The ACA eliminates limitations on insurance and increases the scope of benefits. Online health care insurance exchanges give patients a central location with multiple insurance options. Problems with prescription drug affordability and control utilization tools used by PBMs were not addressed by the ACA. Improving communication within the U.S. healthcare system either by innovative health care delivery models or increased usage of health information technology will help alleviate problems of health care spending and affordability. PMID:25217142

  8. The Affordable Care Act, health care reform, prescription drug formularies and utilization management tools.

    PubMed

    Ung, Brian L; Mullins, C Daniel

    2015-01-01

    The U.S. Patient Protection and Affordable Care Act (hence, Affordable Care Act, or ACA) was signed into law on March 23, 2010. Goals of the ACA include decreasing the number of uninsured people, controlling cost and spending on health care, increasing the quality of care provided, and increasing insurance coverage benefits. This manuscript focuses on how the ACA affects pharmacy benefit managers and consumers when they have prescriptions dispensed. PBMs use formularies and utilization control tools to steer drug usage toward cost-effective and efficacious agents. A logic model was developed to explain the effects of the new legislation. The model draws from peer-reviewed and gray literature commentary about current and future U.S. healthcare reform. Outcomes were identified as desired and undesired effects, and expected unintended consequences. The ACA extends health insurance benefits to almost 32 million people and provides financial assistance to those up to 400% of the poverty level. Increased access to care leads to a similar increase in overall health care demand and usage. This short-term increase is projected to decrease downstream spending on disease treatment and stunt the continued growth of health care costs, but may unintentionally exacerbate the current primary care physician shortage. The ACA eliminates limitations on insurance and increases the scope of benefits. Online health care insurance exchanges give patients a central location with multiple insurance options. Problems with prescription drug affordability and control utilization tools used by PBMs were not addressed by the ACA. Improving communication within the U.S. healthcare system either by innovative health care delivery models or increased usage of health information technology will help alleviate problems of health care spending and affordability.

  9. Research influence on antimalarial drug policy change in Tanzania: case study of replacing chloroquine with sulfadoxine-pyrimethamine as the first-line drug

    PubMed Central

    Mubyazi, Godfrey M; Gonzalez-Block, Miguel A

    2005-01-01

    Introduction Research is an essential tool in facing the challenges of scaling up interventions and improving access to services. As in many other countries, the translation of research evidence into drug policy action in Tanzania is often constrained by poor communication between researchers and policy decision-makers, individual perceptions or attitudes towards the drug and hesitation by some policy decision-makers to approve change when they anticipate possible undesirable repercussions should the policy change as proposed. Internationally, literature on the role of researchers on national antimalarial drug policy change is limited. Objectives To describe the (a) role of researchers in producing evidence that influenced the Tanzanian government replace chloroquine (CQ) with sulfadoxine-pyrimethamine (SP) as the first-line drug and the challenges faced in convincing policy-makers, general practitioners, pharmaceutical industry and the general public on the need for change (b) challenges ahead before a new drug combination treatment policy is introduced in Tanzania. Methods In-depth interviews were held with national-level policy-makers, malaria control programme managers, pharmaceutical officers, general medical practitioners, medical research library and publications officers, university academicians, heads of medical research institutions and district and regional medical officers. Additional data were obtained through a review of malaria drug policy documents and participant observations were also done. Results In year 2001, the Tanzanian Government officially changed its malaria treatment policy guidelines whereby CQ – the first-line drug for a long time was replaced with SP. This policy decision was supported by research evidence indicating parasite resistance to CQ and clinical CQ treatment failure rates to have reached intolerable levels as compared to SP and amodiaquine (AQ). Research also indicated that since SP was also facing rising resistance trend

  10. In silico study on the effects of matrix structure in controlled drug release

    NASA Astrophysics Data System (ADS)

    Villalobos, Rafael; Cordero, Salomón; Maria Vidales, Ana; Domínguez, Armando

    2006-07-01

    Purpose: To study the effects of drug concentration and spatial distribution of the medicament, in porous solid dosage forms, on the kinetics and total yield of drug release. Methods: Cubic networks are used as models of drug release systems. They were constructed by means of the dual site-bond model framework, which allows a substrate to have adequate geometrical and topological distribution of its pore elements. Drug particles can move inside the networks by following a random walk model with excluded volume interactions between the particles. The drug release time evolution for different drug concentration and different initial drug spatial distribution has been monitored. Results: The numerical results show that in all the studied cases, drug release presents an anomalous behavior, and the consequences of the matrix structural properties, i.e., drug spatial distribution and drug concentration, on the drug release profile have been quantified. Conclusions: The Weibull function provides a simple connection between the model parameters and the microstructure of the drug release device. A critical modeling of drug release from matrix-type delivery systems is important in order to understand the transport mechanisms that are implicated, and to predict the effect of the device design parameters on the release rate.

  11. Emerging Trends and Innovations in the Identification and Management of Drug Use among Adolescents and Young Adults

    PubMed Central

    Lord, Sarah; Marsch, Lisa

    2014-01-01

    One in four youths aged 12 to 17 years and more than half of young adults aged 18 to 25 years in the United States have used an illicit drug in their lifetime. A significant number progress to problematic use, and only 1 in 10 young people who meet criteria for dependence or abuse receive some form of treatment. Despite advances in the field, effectively intervening along the continuum of drug use involvement remains a challenge. In this article, we review the current epidemiology of illicit drug use by young people; describe recent advances in assessment, intervention and treatment; and highlight how technology can help overcome barriers to effective management of drug use among young people. PMID:22423469

  12. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... or submission or existence of adequate data), such qualification is not necessary. When the Food and... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Disclosure of drug efficacy study evaluations...

  13. 21 CFR 201.200 - Disclosure of drug efficacy study evaluations in labeling and advertising.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Commissioner of Food and Drugs from the National Academy of Sciences (1969).” As the report notes, this review... or submission or existence of adequate data), such qualification is not necessary. When the Food and... 21 Food and Drugs 4 2011-04-01 2011-04-01 false Disclosure of drug efficacy study evaluations...

  14. Methodological Issues in Controlled Studies on Effects of Prenatal Exposure to Drug Abuse. Research Monograph 114.

    ERIC Educational Resources Information Center

    Kilbey, M. Marlyne, Ed.; Asghar, Khursheed, Ed.

    This monograph presents the proceedings of the first National Institute on Drug Abuse technical review related to the conduct of controlled studies on prenatal exposure to drugs of abuse. Papers in the monograph are categorized by session. The first session (two papers) focused on the detection and quantification of prenatal drug exposure in…

  15. Proposed recommendations for the management of HIV post-exposure prophylaxis after sexual, injecting drug or other exposures in Europe.

    PubMed

    Almeda, J; Casabona, J; Simon, B; Gerard, M; Rey, D; Puro, V; Thomas, T

    2004-06-01

    Post-exposure prophylaxis (PEP) is the standard of care for a healthcare worker (HCW) accidentally exposed to an HIV infected source person (occupational exposure), but this is not the case for non-occupational exposures. Very few national guidelines exist for the management of non-occupational exposures to HIV in Europe, contrarily to the occupational ones. The administration of non-occupational post-exposure prophylaxis (NONOPEP) for HIV may be justified by: a biological plausibility, the effectiveness of PEP in animal studies and occupational exposures in humans, efficacy in the prevention of mother to child HIV transmission, and cost effectiveness studies. These evidences, the similar risk of HIV transmission for certain non-occupational exposures to occupational ones, and the conflicting information about attitudes and practices among physicians on NONOPEP led to the proposal of these European recommendations. Participant members of the European project on HIV NONOPEP, funded by the European Commission, and acknowledged as experts in bloodborne pathogen transmission and prevention, met from December 2000 to December 2002 at three formal meetings and a two day workshop for a literature review on risk exposure assessment and the development of the European recommendations for the management of HIV NONOPEP. NONOPEP is recommended in unprotected receptive anal sex and needle or syringe exchange when the source person is known as HIV positive or from a population group with high HIV prevalence. Any combination of drugs available for HIV infected patients can be used as PEP and the simplest and least toxic regimens are to be preferred. PEP should be given within 72 hours from the time of exposure, starting as early as possible and lasting four weeks. All patients should receive medical evaluation including HIV antibody tests, drug toxicity monitoring and counseling periodically for at least 6 months after the exposure. NONOPEP seems to be a both feasible and

  16. Anthelmintic drugs and nematicides: studies in Caenorhabditis elegans.

    PubMed

    Holden-Dye, Lindy; Walker, Robert J

    2014-01-01

    Parasitic nematodes infect many species of animals throughout the phyla, including humans. Moreover, nematodes that parasitise plants are a global problem for agriculture. As such, these nematodes place a major burden on human health, on livestock production, on the welfare of companion animals and on crop production. In the 21st century there are two major challenges posed by the wide-spread prevalence of parasitic nematodes. First, many anthelmintic drugs are losing their effectiveness because nematode strains with resistance are emerging. Second, serious concerns regarding the environmental impact of the nematicides used for crop protection have prompted legislation to remove them from use, leaving agriculture at increased risk from nematode pests. There is clearly a need for a concerted effort to address these challenges. Over the last few decades the free-living nematode Caenorhabditis elegans has provided the opportunity to use molecular genetic techniques for mode of action studies for anthelmintics and nematicides. These approaches continue to be of considerable value. Less fruitful so far, but nonetheless potentially very useful, has been the direct use of C. elegans for anthelmintic and nematicide discovery programmes. Here we provide an introduction to the use of C. elegans as a 'model' parasitic nematode, briefly review the study of nematode control using C. elegans and highlight approaches that have been of particular value with a view to facilitating wider-use of C. elegans as a platform for anthelmintic and nematicide discovery and development. PMID:25517625

  17. Human hepatoma cell lines on gas foaming templated alginate scaffolds for in vitro drug-drug interaction and metabolism studies.

    PubMed

    Stampella, A; Rizzitelli, G; Donati, F; Mazzarino, M; de la Torre, X; Botrè, F; Giardi, M F; Dentini, M; Barbetta, A; Massimi, M

    2015-12-25

    Liver in vitro systems that allow reliable prediction of major human in vivo metabolic pathways have a significant impact in drug screening and drug metabolism research. In the present study, a novel porous scaffold composed of alginate was prepared by employing a gas-in-liquid foaming approach. Galactose residues were introduced on scaffold surfaces to promote cell adhesion and to enhance liver specific functions of the entrapped HepG2/C3A cells. Hepatoma cells in the gal-alginate scaffold showed higher levels of liver specific products (albumin and urea) and were more responsive to specific inducers (e.g. dexamethasone) and inhibitors (e.g. ketoconazole) of the CYP3A4 system than in conventional monolayer culture. HepG2/C3A cells were also more efficient in terms of rapid elimination of testosterone, used as a model substance, at rates comparable to those of in vivo excretion. In addition, an improvement in metabolism of testosterone, in terms of phase II metabolite formation, was also observed when the more differentiated HepaRG cells were used. Together the data suggest that hepatocyte/gas templated alginate-systems provide an innovative high throughput platform for in vitro drug metabolism and drug-drug interaction studies, with broad fields of application, and might provide a valid tool for minimizing animal use in preclinical testing of human relevance.

  18. The 3-metros study of drugs and crime in South Africa: findings and policy implications.

    PubMed

    Parry, Charles D; Plüddemann, Andreas; Louw, Antoinette; Leggett, Ted

    2004-01-01

    This study examined the drug-crime nexus by investigating the prevalence of recent drug use among persons arrested by the police. Data were gathered during August/September 2000 from 1050 adult arrestees in eight police stations in Cape Town, Durban, and Johannesburg (South Africa). Measures included urinalysis results for cannabis, methaqualone (Mandrax), opiates, cocaine, amphetamines, and benzodizepines, and a questionnaire designed to assess socioeconomic and demographic backgrounds of arrestees, history of prior arrests and imprisonment, current arrest information, profile of substance use, etc. Results of the study show high levels of drug use among arrestees, with 45% testing positive for at least one drug (mainly cannabis and Mandrax). A greater proportion of arrestees in Cape Town tested positive for drugs than in the other sites. Data were also analyzed in terms of gender, age, race, location (site and police station), and offense category. Persons arrested on charges of housebreaking or for drugs/alcohol offenses were particularly likely to test positive for drugs. Drug positive arrestees were more likely to have had a prior arrest. Among the conclusions of the study are that 1) strategies to reduce drug use and drug related crime must be area specific, 2) particular attention needs to focus on young offenders, 3) police need to be trained to recognize particular symptoms and to establish protocols on handling arrestees under the influence of drugs, and 4) diversion to treatment of drug using offenders deserves more consideration.

  19. Individual response to drug therapy: bases and study approaches.

    PubMed

    León-Cachón, Rafael Baltazar Reyes; Ascacio-Martínez, Jorge Angel; Barrera-Saldaña, Hugo Alberto

    2012-01-01

    Genomic variation largely explains the differences in an individual's response to drug treatments. A field of genomic medicine focuses on the identification of genetic polymorphisms and gene mutations involved in the development and progression of disease. Another part focuses on the development of genetic tests to accompany medical prescriptions, to predict how certain patients respond to therapy with a given pharmacological agent. The field of predicting responses to drugs has different strategies and methods, among which we find: the use of liver microsomes, cell models, monitoring of probe drugs, assays with recombinant proteins and recently the use of microarray platforms or DNAchips.

  20. Drugs under preclinical and clinical study for treatment of acute and chronic lymphoblastic leukemia

    PubMed Central

    Jacob, Joe Antony; Salmani, Jumah Masoud Mohammad; Chen, Baoan

    2016-01-01

    Targeted therapy has modernized the treatment of both chronic and acute lymphoblastic leukemia. The introduction of monoclonal antibodies and combinational drugs has increased the survival rate of patients. Preclinical studies with various agents have resulted in positive outputs with Phase III trial drugs and monoclonal antibodies entering clinical trials. Most of the monoclonal antibodies target the CD20 and CD22 receptors. This has led to the approval of a few of these drugs by the US Food and Drug Administration. This review focuses on the drugs under preclinical and clinical study in the ongoing efforts for treatment of acute and chronic lymphoblastic leukemia. PMID:27382259

  1. Drug-polymer interaction between glucosamine sulfate and alginate nanoparticles: FTIR, DSC and dielectric spectroscopy studies

    NASA Astrophysics Data System (ADS)

    El-Houssiny, A. S.; Ward, A. A.; Mostafa, D. M.; Abd-El-Messieh, S. L.; Abdel-Nour, K. N.; Darwish, M. M.; Khalil, W. A.

    2016-06-01

    This work involves the preparation and characterization of alginate nanoparticles (Alg NPs) as a new transdermal carrier for site particular transport of glucosamine sulfate (GS). The GS-Alg NPs were examined through transmission electron microscopy (TEM), Fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC) and dielectric spectroscopy. GS-Alg NPs was efficiently prepared via ionic gelation method which generates favorable conditions for the entrapment of hydrophilic drugs. The TEM studies revealed that GS-Alg NPs are discrete and have spherical shapes. FTIR studies showed a spectral change of the characteristic absorptions bands of Alg NPs after encapsulation with GS because of the amine groups of GS and the carboxylic acid groups of Alg. The DSC data showed changes in the thermal behavior of GS-Alg NPs after the addition of GS indicating signs of main chemical interaction among the drug (GS) and the polymer (Alg). The absence of the drug melting endothermic peak within the DSC thermogram of GS-Alg NPs indicating that GS is molecularly dispersed in the NPs and not crystallize. From the dielectric study, it was found modifications within the dielectric loss (ɛ″) and conductivity (σ) values after the addition of GS. The ɛ″ and σ values of Alg NPs decreased after the addition of GS which indicated the successful encapsulation of GS within Alg NPs. Furthermore, the dielectric study indicated an increase of the activation energy and the relaxation time for the first process in the GS-Alg NPs as compared to Alg NPs. Consequently, the existing observations indicated an initiation of electrostatic interaction among the amine group of GS and carboxyl group of Alg indicating the successful encapsulation of GS inside Alg NPs which could provide favorable circumstance for the encapsulation of GS for topical management.

  2. Management of dengue shock syndrome. A prospective study.

    PubMed

    Tjandra, H

    1991-01-01

    Since dengue hemorrhagic fever (DHF) was first reported 20 years ago, the only serious variant of the disease, dengue shock syndrome (DSS), still continues to cause a relatively high mortality. An effective yet simple management of DSS which can be carried out in every hospital is certainly necessary if the dead toll is to be reduced. Prospective study of a simple procedure in managing DSS patients in Bhayangkara Police Hospital Kediri is reported. Depends on the severity of the disease, for DHF grade III: 30 ml/kg bw Lactated-Ringer solution was given at free rate. This is followed by 20 ml/kg bw of synthetic plasma expander (Expafusin) in a rate of thrice the body weight and continued with lactated-ringer and 5% dextrose in 1/2 Saline alternately with a rate of twice the body weight per minute for the remaining first 24 hours. For DHF grade IV, the same fluids were given, except for the amount and the infusion rate. Drugs administered and medical care were all the same for both groups. A close observation, a critical assessment, and an accurate as well as a rapid action are very important factors. Totally there were 115 patients of which 8 died. The mortality rate was 7%. A better management and/or treatment has to be developed to further reduce the mortality.

  3. Prescribing Patterns of Drugs in Acute Respiratory Distress Syndrome (ARDS): An Observational Study

    PubMed Central

    Rao, Shobitha; Chogtu, Bharti

    2015-01-01

    Introduction: Acute respiratory distress syndrome (ARDS) is characterized by acute respiratory failure and is associated with wide range of clinical disorders. Controversy prevails over the pharmacological intervention in this disease. The aim of the study was to observe the prescribing pattern of drugs in patients with ARDS managed at a tertiary care hospital. Materials and Methods: This observational study was conducted at tertiary care hospital in India. Data of patients admitted from January 2010 to December 2012 was collected. Patients aged more than 18 years admitted in ICU, who were diagnosed to have ARDS during the study period, were included. A total of 150 patients of ARDS were selected. Data was collected as per the pre designed proforma and it included patients’ age, gender, clinical disorders precipitating ARDS, prescribing pattern of drugs and outcome. The data of the subjects was collected till discharge from hospital or death. Results: Infection was the cause of ARDS in 81.3% (n=122) of subjects. Antibiotics were prescribed in all the subjects and beta-lactams were prescribed in 97.3% (n=146). 41.3% (n=62) were prescribed corticosteroids, 39.3% (n=59) diuretics and 89.3% (n=134) intravenous fluids. Conclusion: The outcome of patients on different pharmacological treatment did not show any statistically significant difference. PMID:25859465

  4. Environmental Management: An Approach to Alcohol and Other Drug Prevention. Prevention Updates

    ERIC Educational Resources Information Center

    Higher Education Center for Alcohol and Other Drug Abuse and Violence Prevention, 2002

    2002-01-01

    Most campus alcohol and other drug (AOD) programs include prevention, intervention, and treatment services designed to address individual students' knowledge of the consequences of alcohol and other drug use, to improve their skills in resisting such behavior, or to address existing problematic use of or addiction to alcohol or other drugs.…

  5. Topical nonsteroidal anti-inflammatory drugs for management of osteoarthritis in long-term care patients

    PubMed Central

    Argoff, Charles E; Gloth, F Michael

    2011-01-01

    Osteoarthritis is common in patients ≥65 years of age. Although nonsteroidal anti-inflammatory drugs (NSAIDs) are often prescribed for osteoarthritis pain, they pose age-related cardiovascular, renal, and gastrointestinal risks. Two topical NSAIDs, diclofenac sodium 1% gel (DSG) and diclofenac sodium 1.5% in 45.5% dimethylsulfoxide solution (D-DMSO), are approved in the US for the treatment of osteoarthritis pain. Topical NSAIDs have shown efficacy and safety in knee (DSG, D-DMSO) and hand (DSG) osteoarthritis. Analyses of data from randomized controlled trials of DSG in hand and knee osteoarthritis demonstrate significant improvement of pain and function in both younger patients (<65 years) and older patients (≥65 years) and suggest good safety and tolerability. However, long-term safety data in older patients are limited. Topical NSAIDs can ease medication administration and help address barriers to pain management in older patients, such as taking multiple medications and inability to swallow, and are a valuable option for long-term care providers. PMID:22076115

  6. Antiresorptive drugs beyond bisphosphonates and selective oestrogen receptor modulators for the management of postmenopausal osteoporosis.

    PubMed

    Reginster, J Y; Neuprez, A; Beaudart, C; Lecart, M P; Sarlet, N; Bernard, D; Disteche, S; Bruyere, O

    2014-06-01

    Osteoporotic fractures are a major cause of morbidity in the elderly population. Since postmenopausal osteoporosis is related to an increase in osteoclastic activity at the time of menopause, inhibitors of bone resorption have genuinely been considered an adequate strategy for prevention and treatment of osteoporosis. Bisphosphonates and selective oestrogen receptor modulators are widely prescribed to treat osteoporosis. However, other antiresorptive drugs have been developed for the management of osteoporosis, with the objective of providing a substantial reduction in osteoporotic fractures at all skeletal sites, combined with an acceptable long-term skeletal and systemic safety profile. Denosumab, a human monoclonal antibody to receptor activator for nuclear factor kappa B ligand, has shown efficacy against vertebral, nonvertebral and hip fractures. Its administration every 6 months as a subcutaneous formulation might significantly influence compliance and persistence to therapy. Additional results regarding long-term skeletal safety (i.e. osteonecrosis of the jaw and atypical diaphyseal femoral fracture) are needed. Odanacatib, a selective cathepsin K inhibitor, is a promising new approach to the inhibition of osteoclastic resorption, with the potential to uncouple bone formation from bone resorption. Results regarding its anti-fracture efficacy are expected in the coming months.

  7. Classification and practical approach to the diagnosis and management of hypersensitivity to nonsteroidal anti-inflammatory drugs.

    PubMed

    Kowalski, M L; Asero, R; Bavbek, S; Blanca, M; Blanca-Lopez, N; Bochenek, G; Brockow, K; Campo, P; Celik, G; Cernadas, J; Cortellini, G; Gomes, E; Niżankowska-Mogilnicka, E; Romano, A; Szczeklik, A; Testi, S; Torres, M J; Wöhrl, S; Makowska, J

    2013-10-01

    Hypersensitivity reactions to aspirin (acetylsalicylic acid) and other nonsteroidal anti-inflammatory drugs (NSAIDs) constitute only a subset of all adverse reactions to these drugs, but due to their severity pose a significant burden to patients and are a challenge to the allergist. In susceptible individuals, NSAIDs induce a wide spectrum of hypersensitivity reactions with various timing, organ manifestations, and severity, involving either immunological (allergic) or nonimmunological mechanisms. Proper classification of reactions based on clinical manifestations and suspected mechanism is a prerequisite for the implementation of rational diagnostic procedures and adequate patient management. This document, prepared by a panel of experts from the European Academy of Allergy and Clinical Immunology Task Force on NSAIDs Hypersensitivity, aims at reviewing the current knowledge in the field and proposes uniform definitions and clinically useful classification of hypersensitivity reactions to NSAIDs. The document proposes also practical algorithms for the diagnosis of specific types of NSAIDs hypersensitivity (which include drug provocations, skin testing and in vitro testing) and provides, when data are available, evidence-based recommendations for the management of hypersensitive patients, including drug avoidance and drug desensitization.

  8. Toxicology screening in urban trauma patients: drug prevalence and its relationship to trauma severity and management.

    PubMed

    Sloan, E P; Zalenski, R J; Smith, R F; Sheaff, C M; Chen, E H; Keys, N I; Crescenzo, M; Barrett, J A; Berman, E

    1989-12-01

    Although toxicology screening is often used when treating trauma patients, its utility and significance remain controversial. Data from 623 toxicology screens performed in urban trauma center patients with mental status alterations are reported. The study patients were predominantly black and male, with a mean age of 32 (+/- 22) years. Overall, 86% of screens were positive. Substances of abuse, including ethanol, were noted in 525 (84%) of urine toxicology screens. Ethanol, cannabinoids, and cocaine were the drugs most commonly found in urine, with positivity noted in 53%, 37%, and 34% of screens. Serum analysis was 44% positive, with ethanol noted in 41% of patients. In blacks, the odds ratio of illicit drug use before trauma ranged from 1.9 to 4.2 (p less than 0.005), and in those aged 17 to 40 years, the odds ratio for illicit urine drugs ranged from 4.7 to 16.8 (p less than 0.001). In patients older than 40 years, the odds of a positive serum ethanol level were 1.7 times greater than in younger patients, and a level above 300 mg% was 3.8 times more likely in this age group (p less than 0.001). When serum ethanol was detected, the odds ratio of a head injury was 1.4 relative to patients without serum ethanol (p less than 0.06), and the odds ratio for abdominal injury was 1.6 for patients with serum ethanol (p less than 0.03). The odds of a TS less than 12 were 1.8 (p less than 0.05), and the odds of a GCS less than 12 were 3.3 (p less than 0.001) with ethanol levels greater than 100 mg%.(ABSTRACT TRUNCATED AT 250 WORDS) PMID:2593195

  9. A Study on the Dispensing Pattern of Over the Counter Drugs in Retail Pharmacies in Sarjapur Area, East Bangalore

    PubMed Central

    Chakraborty, Ananya; Srinivas, B.N

    2015-01-01

    Background Over the counter drugs (OTC) are sold without the prescription of a registered medical practitioner. There are reports that OTC drug market in India is on the rise. This is attributed to the rising cost of health care, difficulty in accessing healthcare, and an alarming tendency to self manage symptoms. The outcome of this is OTC related adverse effects, abuse, and hospitalizations. Literature on OTC is sparse. Hence this study was undertaken to evaluate the dispensing pattern of OTC drugs in retail pharmacies in Sarjapur area, East Bangalore. Materials and Methods The study was conducted in 3 retail pharmacies in Sarjapur area, Bangalore East. The duration of the study was for a period of 10 days from August 1st to August 10th 2014. The common complaints for which the patients frequented the pharmacies were observed and recorded .The investigator personally interviewed the patients between 6pm to 9pm, near the respective pharmacies. During this study period around 216 patients visited pharmacies without prescription. The drugs supplied to 216 patients by private pharmacies without prescription was recorded. Data was analysed by descriptive statistics using Microsoft Excel. Results and Observations Most commonly dispensed OTC drugs were analgesics (26.8%). The other categories of medications dispensed were antihistamines (15.2%), antacids (14.8%), antibiotics (10%), antipyretics (7.8%), Oral contraceptive (OC pills) (5.09%) and others (20%). The commonly dispensed antibiotics were Cefadroxil (250mg) for dental infection and Levofloxacin (500mg) for upper respiratory tract infection. The most common complaint for the use of OTC drugs was pain (25%). It was noted that 55.09% of the dispensed drugs belonged to schedule H. However, 13% patients were aware regarding the harmful effects of drugs. Conclusion The use of OTC drugs is alarmingly high in Bangalore East. Pharmacists have to be trained and educated regarding rationale dispensing of drugs. The need

  10. The Honeywell Studies: How Managers Learn to Manage.

    ERIC Educational Resources Information Center

    Zemke, Ron

    1985-01-01

    Describes how a group of Honeywell Corporation human resources specialists determined how the organization's management development process could be improved to support the needs of the business. Discusses corporate management development strategy, curriculum, conference center, on-the-job experiences, and how experience, relationships, and…

  11. Driving Under the Influence of Non-Alcohol Drugs--An Update Part I: Epidemiological Studies.

    PubMed

    Gjerde, H; Strand, M C; Mørland, J

    2015-07-01

    Epidemiological studies of the association between drug use and involvement in road traffic crashes (RTCs) published from January 1998 to February 2015 have been reviewed. Cohort andpopulation studies compared RTC involvement among drug users and non-drug users, case-control studies compared drug use among RTC-involved and non-RTC-involved drivers, and responsibility studies and case-crossover studies were performed for RTC-involved drivers. Difficulties associated with the types of studies are discussed with a special focus on case-control studies. Statistically significant associations between drug use and RTC involvement were found for benzodiazepines and z-hypnotics in 25 out of 28 studies, for cannabis in 23 out of 36 studies, for opioids in 17 out of 25 studies, for amphetamines in 8 out of 10 studies, for cocaine in 5 out of 9 studies, and for antidepressants in 9 out of 13 studies. It was a general trend among studies that did not report significant associations between the use of these drugs and increased RTC risk that they often had either poor statistical power or poor study design compared to studies that found an association. Simultaneous use of two or more psychoactive drugs was associated with higher RTC risk. Studies on the combination of alcohol and drugs have not been reviewed in this article even though this combination is known to be associated with the highest RTC risk. PMID:26227253

  12. Hydrodynamic Effects on Drug Dissolution and Deaggregation in the Small Intestine-A Study with Felodipine as a Model Drug.

    PubMed

    Lindfors, Lennart; Jonsson, Malin; Weibull, Emelie; Brasseur, James G; Abrahamsson, Bertil

    2015-09-01

    The aim of this study was to understand and predict the influence of hydrodynamic effects in the small intestine on dissolution of primary and aggregated drug particles. Dissolution tests of suspensions with a low-solubility drug, felodipine, were performed in a Couette cell under hydrodynamic test conditions corresponding to the fed small intestine. Dissolution was also performed in the USP II apparatus at two paddle speeds of 25 and 200 rpm and at different surfactant concentrations below critical micelle concentration. The experimental dissolution rates were compared with theoretical calculations. The different levels of shear stress in the in vitro tests did not influence the dissolution of primary or aggregated particles and experimental dissolution rates corresponded very well to calculations. The dissolution rate for the aggregated drug particles increased after addition of surfactant because of deaggregation, but there were still no effect of hydrodynamics. In conclusion, hydrodynamics do not influence dissolution and deaggregation of micronized drug particles in the small intestine of this model drug. Surface tension has a strong effect on the deaggregation and subsequent dissolution. Addition of surfactants at in vivo relevant surface tension levels is thus critical for in vivo predictive in vitro dissolution testing. PMID:25980801

  13. Hydrodynamic Effects on Drug Dissolution and Deaggregation in the Small Intestine-A Study with Felodipine as a Model Drug.

    PubMed

    Lindfors, Lennart; Jonsson, Malin; Weibull, Emelie; Brasseur, James G; Abrahamsson, Bertil

    2015-09-01

    The aim of this study was to understand and predict the influence of hydrodynamic effects in the small intestine on dissolution of primary and aggregated drug particles. Dissolution tests of suspensions with a low-solubility drug, felodipine, were performed in a Couette cell under hydrodynamic test conditions corresponding to the fed small intestine. Dissolution was also performed in the USP II apparatus at two paddle speeds of 25 and 200 rpm and at different surfactant concentrations below critical micelle concentration. The experimental dissolution rates were compared with theoretical calculations. The different levels of shear stress in the in vitro tests did not influence the dissolution of primary or aggregated particles and experimental dissolution rates corresponded very well to calculations. The dissolution rate for the aggregated drug particles increased after addition of surfactant because of deaggregation, but there were still no effect of hydrodynamics. In conclusion, hydrodynamics do not influence dissolution and deaggregation of micronized drug particles in the small intestine of this model drug. Surface tension has a strong effect on the deaggregation and subsequent dissolution. Addition of surfactants at in vivo relevant surface tension levels is thus critical for in vivo predictive in vitro dissolution testing.

  14. Factorial design studies of antiretroviral drug-loaded stealth liposomal injectable: PEGylation, lyophilization and pharmacokinetic studies

    NASA Astrophysics Data System (ADS)

    Sudhakar, Beeravelli; Krishna, Mylangam Chaitanya; Murthy, Kolapalli Venkata Ramana

    2016-01-01

    The aim of the present study was to formulate and evaluate the ritonavir-loaded stealth liposomes by using 32 factorial design and intended to delivered by parenteral delivery. Liposomes were prepared by ethanol injection method using 32 factorial designs and characterized for various physicochemical parameters such as drug content, size, zeta potential, entrapment efficiency and in vitro drug release. The optimization process was carried out using desirability and overlay plots. The selected formulation was subjected to PEGylation using 10 % PEG-10000 solution. Stealth liposomes were characterized for the above-mentioned parameters along with surface morphology, Fourier transform infrared spectrophotometer, differential scanning calorimeter, stability and in vivo pharmacokinetic studies in rats. Stealth liposomes showed better result compared to conventional liposomes due to effect of PEG-10000. The in vivo studies revealed that stealth liposomes showed better residence time compared to conventional liposomes and pure drug solution. The conventional liposomes and pure drug showed dose-dependent pharmacokinetics, whereas stealth liposomes showed long circulation half-life compared to conventional liposomes and pure ritonavir solution. The results of statistical analysis showed significance difference as the p value is (<0.05) by one-way ANOVA. The result of the present study revealed that stealth liposomes are promising tool in antiretroviral therapy.

  15. Update on administration of anesthetics and psychoactive drugs for pain management in China.

    PubMed

    Gu, Weiping

    2015-06-01

    Anesthetics and psychoactive drugs could relieve diseases, if used properly. However, they can cause dependency, and their misuse or abuse could adversely affect people's health and social stability. For a long time, the Chinese government has been reinforcing the regulation on anesthetics and psychoactive drugs to ensure their legal and proper usage, and to prevent abuse. The state council issued 'the regulations on the administration of anesthetic drugs and psychotropic drugs' in 2005, based on which a legal system was established for administration of anesthetics and psychoactive drugs with the objectives of ensuring their legitimate medical utilization, and preventing illegal abuse.

  16. Drug therapy and adverse drug reactions to terbutaline in obstetric patients: a prospective cohort study in hospitalized women.

    PubMed

    Hernández-Hernández, Dulce; Vargas-Rivera, María; Nava-Ocampo, Alejandro A; Palma-Aguirre, José; Sumano-López, Héctor

    2002-04-01

    BACKGROUND: Adverse drug reactions (ADR's) could be expected more frequently in pregnant women. This study was performed in order to identify ADR's to tocolytic drugs in hospitalised pregnant women. METHODS: A prospective cohort study was performed in two General Hospitals of the Instituto Mexicano del Seguro Social (IMSS) in Mexico City. Two hundred and seven women undergoing labor, premature labor, threatened abortion or suffering any obstetric related disease were included. Drug prescription and signs and symptoms of any potential ADR were registered daily during the hospital stay. Any potential ADR to tocolytic drugs was evaluated and classified by three of the authors using the Kramer's algorithm. RESULTS: Of the 207 patients, an ADR was positively classified in 25 cases (12.1%, CI95% 8.1 to 17.5%). All ADR's were classified as minor reactions. Grouping patients with diagnosis of threatened abortion, premature labor or under labor (n= 114), 24 ADR's were related to terbutaline, accounting for a rate of 21.1 ADR's per 100 obstetric patients. Obstetric patients suffering an ADR were older than obstetric patients without any ADR. However, the former received less drugs/day x patient-1 and had a shorter hospital stay (p < 0.05) whereas the dose of terbutaline was similar between the two groups. Terbutaline inhibited uterine motility in women with and without any ADR at a similar rate, 70 and 76% respectively (x2 = 0.07; p = 0.8). CONCLUSION: Terbutaline, used as a tocolytic drug, was related to a high frequency of minor ADRs and to a high rate of effcicacy. PMID:11934352

  17. A Study on Polypharmacy and Potential Drug-Drug Interactions among Elderly Patients Admitted in Department of Medicine of a Tertiary Care Hospital in Puducherry

    PubMed Central

    Kalyansundaram, Dharani; Bahurupi, Yogesh

    2016-01-01

    Introduction The proportion of elderly population has been constantly increasing over last few years. Polypharmacy is unavoidable in the elderly as they often suffer from multiple co-morbidities. Potential drug-drug interaction due to polypharmacy and potential inappropriate medication among the elderly must be carefully assessed. Aim To find out polypharmacy and potential drug-drug interactions among elderly patients admitted and discharged in Department of Medicine. Materials and Methods This study was carried out on 100 patients above 65 years of age both males and females. Data was collected through review of case sheets. Polypharmacy was observed based on admission and discharge prescriptions. Frequently occurring drug-drug interactions were assessed using online checks. Results Mean number of drugs prescribed to patients on admission (7.61 ± 3.37) was more than that on discharge (5.48±2.46). More than half of these patients received 5 to 9 number of drugs. On admission 52.69% potential drug-drug interactions were observed and on discharge 52.91%. Most common drug interactions observed in both the groups were of moderate grade. Conclusion From the present study we can conclude that polypharmacy leads to more potential drug-drug interactions. To improve drug safety in this high-risk population, appropriate prescribing is very important. PMID:27042480

  18. The Science Manager's Guide to Case Studies

    SciTech Connect

    Branch, Kristi M.; Peffers, Melissa S.; Ruegg, Rosalie T.; Vallario, Robert W.

    2001-09-24

    This guide takes the science manager through the steps of planning, implementing, validating, communicating, and using case studies. It outlines the major methods of analysis, describing their relative merits and applicability while providing relevant examples and sources of additional information. Well-designed case studies can provide a combination of rich qualitative and quantitative information, offering valuable insights into the nature, outputs, and longer-term impacts of the research. An objective, systematic, and credible approach to the evaluation of U.S. Department of Energy Office of Science programs adds value to the research process and is the subject of this guide.

  19. Automation impact study of Army Training Management

    SciTech Connect

    Sanquist, T.F.; Schuller, C.R.; McCallum, M.C.; Underwood, J.A.; Bettin, P.J.; King, J.L.; Melber, B.D.; Hostick, C.J.; Seaver, D.A.

    1988-01-01

    The main objectives of this impact study were to identify the potential cost savings associated with automated Army Training Management (TM), and to perform a cost-benefit analysis for an Army-wide automated TM system. A subsidiary goal was to establish baseline data for an independent evaluation of a prototype Integrated Training Management System (ITMS), to be tested in the fall of 1988. A structured analysis of TM doctrine was performed for comparison with empirical data gathered in a job analysis survey of selected units of the 9ID (MTZ) at Ft. Lewis, Washington. These observations will be extended to other units in subsequent surveys. The survey data concerning staffing levels and amount of labor expended on eight distinct TM tasks were analyzed in a cost effectiveness model. The main results of the surveys and cost effectiveness modelling are summarized. 18 figs., 47 tabs.

  20. Consistency of self-reported drug use events in a mixed methods study of people who inject drugs

    PubMed Central

    Dyal, Stephanie R.; Kral, Alex H.; Gonzalez, Karina Dominguez; Wenger, Lynn; Bluthenthal, Ricky N.

    2015-01-01

    Background Little is known about the consistency of information provided by people who inject drugs (PWID) during quantitative and qualitative interviews in mixed methods studies. Objectives We illustrate the use of the intraclass correlation coefficient, descriptive statistics, and regression to assess the consistency of information provided during a mixed methods study of PWID living in Los Angeles and San Francisco, California, USA. Methods Age of first use of heroin, methamphetamine, marijuana, powder cocaine, and crack cocaine and first injection of heroin, methamphetamine, and powder cocaine were collected during an interviewer administered computer-assisted personal interview followed by an in-depth qualitative interview (N=102). Results Participants were 63% male, racially/ethnically diverse. 80.4% between the ages of 40 and 60 years old, 89% US-born, and 57% homeless. Consistency of self-reported data was adequate for most drug use events. Exact concordance between quantitative and qualitative measures of age of onset ranged from 18.2% to 50%. Event ordering was consistent across qualitative and quantitative results for 90.2% of participants. Analyses indicated that age of onset for heroin use, heroin injection, and injection of any drug was significantly lower when assessed by qualitative methods as compared to quantitative methods. Conclusion While inconsistency will emerge during mixed method studies, confidence in the timing and ordering of major types of events such as drug initiation episodes appear to be warranted. PMID:25970020

  1. Overdose of drugs for attention-deficit hyperactivity disorder: clinical presentation, mechanisms of toxicity, and management.

    PubMed

    Spiller, Henry A; Hays, Hannah L; Aleguas, Alfred

    2013-07-01

    The prevalence of attention-deficit hyperactivity disorder (ADHD) in the USA is estimated at approximately 4-9% in children and 4% in adults. It is estimated that prescriptions for ADHD medications are written for more than 2.7 million children per year. In 2010, US poison centers reported 17,000 human exposures to ADHD medications, with 80% occurring in children <19 years old and 20% in adults. The drugs used for the treatment of ADHD are diverse but can be roughly separated into two groups: the stimulants such as amphetamine, methylphenidate, and modafinil; and the non-stimulants such as atomoxetine, guanfacine, and clonidine. This review focuses on mechanisms of toxicity after overdose with ADHD medications, clinical effects from overdose, and management. Amphetamine, dextroamphetamine, and methylphenidate act as substrates for the cellular monoamine transporter, especially the dopamine transporter (DAT) and less so the norepinephrine (NET) and serotonin transporter. The mechanism of toxicity is primarily related to excessive extracellular dopamine, norepinephrine, and serotonin. The primary clinical syndrome involves prominent neurological and cardiovascular effects, but secondary complications can involve renal, muscle, pulmonary, and gastrointestinal (GI) effects. In overdose, the patient may present with mydriasis, tremor, agitation, hyperreflexia, combative behavior, confusion, hallucinations, delirium, anxiety, paranoia, movement disorders, and seizures. The management of amphetamine, dextroamphetamine, and methylphenidate overdose is largely supportive, with a focus on interruption of the sympathomimetic syndrome with judicious use of benzodiazepines. In cases where agitation, delirium, and movement disorders are unresponsive to benzodiazepines, second-line therapies include antipsychotics such as ziprasidone or haloperidol, central alpha-adrenoreceptor agonists such as dexmedetomidine, or propofol. Modafinil is not US FDA approved for treatment of ADHD

  2. Drug utilization study in medical emergency unit of a tertiary care hospital in north India.

    PubMed

    Kaur, Sharonjeet; Rajagopalan, Sujit; Kaur, Navjot; Shafiq, Nusrat; Bhalla, Ashish; Pandhi, Promila; Malhotra, Samir

    2014-01-01

    Objective. To generate data on the drug utilization pattern and cost of drug treatment and to determine the rationality of prescriptions. Methods. A retrospective cross-sectional drug utilization study was conducted in the medical emergency unit of our hospital. Patient case records were reviewed to extract data on the pattern of drug use. Cost of drug treatment for the emergency visit was calculated by referring to the cost mentioned in Monthly Index of Medical Specialties and the rationality of prescriptions was evaluated using WHO core indicators of drug utilization. Results. 1100 case records were reviewed. Majority of patients received proton pump inhibitors followed by multivitamins. The median cost per prescription was 119.23$ (7.32$-7663.46$). Majority (49.9%) of drug cost was driven by antibiotics alone. An average of 4.9 drugs was prescribed per prescription. There were 14.89% encounters with antibiotics. 75.17% of the drugs were given as injectables and only 29.27% of the drugs were prescribed as generics. Conclusion. There is need to rationalize the drug therapy in terms of increasing prescribing of drugs by generic name and to avoid overuse of PPIs and multivitamins in emergency unit. Also the hospital pharmacy should be encouraged to procure more cost effective alternative antibiotics in future. PMID:24883208

  3. A 2013 workshop: vaccine and drug ontology studies (VDOS 2013)

    PubMed Central

    2014-01-01

    The 2013 “Vaccine and Drug Ontology Studies” (VDOS 2013) international workshop series focuses on vaccine- and drug-related ontology modeling and applications. Drugs and vaccines have contributed to dramatic improvements in public health worldwide. Over the last decade, tremendous efforts have been made in the biomedical ontology community to ontologically represent various areas associated with vaccines and drugs – extending existing clinical terminology systems such as SNOMED, RxNorm, NDF-RT, and MedDRA, as well as developing new models such as Vaccine Ontology. The VDOS workshop series provides a platform for discussing innovative solutions as well as the challenges in the development and applications of biomedical ontologies for representing and analyzing drugs and vaccines, their administration, host immune responses, adverse events, and other related topics. The six full-length papers included in this thematic issue focuses on three main areas: (i) ontology development and representation, (ii) ontology mapping, maintaining and auditing, and (iii) ontology applications. PMID:24650607

  4. The Role of Drug-Drug Interactions in Hydrogel Delivery Systems: Experimental and Model Study.

    PubMed

    Rossi, Filippo; Castiglione, Franca; Ferro, Monica; Moioli, Marta; Mele, Andrea; Masi, Maurizio

    2016-06-01

    To address the increasing need for improved tissue substitutes, tissue engineering seeks to create synthetic, three-dimensional scaffolds made from polymeric materials able to incorporate cells and drugs. The interpretation of transport phenomena is a key step, but comprehensive theoretical data is still missing and many issues related to these systems are still unsolved. In particular, the contribution of solute-solute interactions is not yet completely understood. Here, we investigate a promising agar-carbomer (AC) hydrogel loaded with sodium fluorescein (SF), a commonly used drug mimetic. The self-diffusion coefficient of SF in AC formulations was measured by using high resolution magic angle spinning NMR spectroscopy (HR-MAS NMR). Starting from experimental data, a complete overview on SF transport properties is provided, in particular a mathematical model that describes and rationalizes the differences between gel and water environments is developed and presented. The hydrogel molecular environment is able to prevent SF aggregation, owing to the adsorption mechanism that reduces the number of monomers available for oligomer formation at low solute concentration. Then, when all adsorption sites are saturated free SF molecules are able to aggregate and form oligomers. The model predictions satisfactorily match with experimental data obtained in water and the gel environment, thus indicating that the model presented here, despite its simplicity, is able to describe the key phenomena governing device behavior and could be used to rationalize experimental activity. PMID:26919298

  5. A Guide for the Management of Speical Education Programs. 4.0 Drug Information for Educators, Parents, and Students. Newday Operations Guide for Drug Dependent Minor Programs.

    ERIC Educational Resources Information Center

    Santa Cruz County Superintendent of Schools, CA.

    Presented is the fourth component of a special day class program for drug dependent minors, Drug Information for Educators, Parents, and Students. The first section, intended for educators, includes a drug abuse chart, information on the drug subculture, information on patterns of drug abuse and misconceptions about drugs, and suggested activities…

  6. Analytical methodologies for metallomics studies of antitumor Pt-containing drugs.

    PubMed

    Esteban-Fernández, Diego; Moreno-Gordaliza, Estefanía; Cañas, Benito; Palacios, María Antonia; Gómez-Gómez, María Milagros

    2010-01-01

    Pt-containing drugs are nowadays essential components in cancer chemotherapy. However, drug resistance and side effects limit the efficiency of the treatments. In order to improve the response to Pt-based drugs, different administration strategies or new Pt-compounds have been developed with little success. The reason for this failure could be that the mechanism of action of these drugs is not completely understood. In this way, metallomics studies may contribute to clarify the interactions of Pt-containing drugs within the organism. This review is mainly focused on the role of Analytical Chemistry on the study of the interactions between Pt-based drugs and biomolecules. A summary of the analytical techniques and the most common sample treatment procedures currently used in metallomics studies of these drugs is presented. Both are of paramount importance to study these complex samples preserving the drug-biomolecule interaction. Separation and detection techniques must be carefully selected in order to achieve the intended goals. The use of multidimensional hyphenated techniques is usually necessary for a better understanding of the Pt-based drugs interactions in the organism. An overview of Pt-drugs biological interactions is presented, considering the different sample matrices and the drugs course through the organism. Samples analysed in the included studies are blood, urine, cell cytosol, DNA as well as the drugs themselves and their derivatives. However, most of these works are based on in vitro experiments or incubations of standards, leading in some cases to contradictory results depending on the experimental conditions used. Though in vivo experiments represent a great challenge due to the high complexity and the low concentrations of the Pt-adducts in real samples, these studies must be undertaken to get a deeper understanding of the real interactions concerning Pt-containing drugs.

  7. Decellularized skeletal muscle as an in vitro model for studying drug-extracellular matrix interactions

    PubMed Central

    Wassenaar, Jean W.; Boss, Gerry R.; Christman, Karen L.

    2015-01-01

    Several factors can affect drug absorption after intramuscular (IM) injection: drug solubility, drug transport across cell membranes, and drug metabolism at the injection site. We found that potential interactions between the drug and the extracellular matrix (ECM) at the injection site can also affect the rate of absorption post-injection. Using decellularized skeletal muscle, we developed a simple method to model drug absorption after IM injection, and showed that the nature of the drug-ECM interaction could be investigated by adding compounds that alter binding. We validated the model using the vitamin B12 analog cobinamide with different bound ligands. Cobinamide is being developed as an IM injectable treatment for cyanide poisoning, and we found that the in vitro binding data correlated with previously published in vivo drug absorption in animals. Commercially available ECM products, such as collagen and GelTrex, did not recapitulate drug binding behavior. While decellularized ECM has been widely studied in fields such as tissue engineering, this work establishes a novel use of skeletal muscle ECM as a potential in vitro model to study drug-ECM interactions during drug development. PMID:26125502

  8. Study on microvisualizing assay of delivered drug infiltration using 2-color optical coherence dosigraphy

    NASA Astrophysics Data System (ADS)

    Nakamichi, Yu; Saeki, Souichi; Saito, Takashi; Hiro, Takafumi; Matsuzaki, Masunori

    2009-02-01

    Recently, clinical treatments applying drug delivery system (DDS) have been being developed. However, it is quite difficult to in vivo diagnose spatiotemporal distribution of drug infiltration, so the validation study should be too insufficient to progress the DDS development. In this study, we propose a visualizing assay of DDS, namely 2-Color Optical Coherence Dosigraphy (2C-OCD). 2C-OCD is based on optical coherence tomography using two waveband "2-Color" light sources having different optical absorbance of drug. This can simultaneously provide microscale tomographic images of scatterer density and drug concentration. In order to evaluate the efficacy of this technique, this was applied to drug-diffusion phenomena in microchannel and lipidrich plaques of rabbit with drug administration, respectively. As a result of diffusion experiment, it was confirmed that 2C-OCD can visualize a cross-sectional map of drug concentration, with spatial resolution 5 micro m × 10 μm and accuracy plus-minus 13.0 μM. In ex vivo animal experiment, the enhancement of absorptivity could be observed inside lipidrich plaques, in which DDS drug could be therein uptaken by drug administration. The absorption maps corresponding to drug concentration were calculated, comparing with their histological images. Consequently, they had good coincidence with histological examinations, therefore, it was concluded that 2C-OCD could visualize drug infiltration in biological tissue with almost the same spatial resolution as OCT system.

  9. Case management of malaria fever at community pharmacies in Pakistan: a threat to rational drug use

    PubMed Central

    Malik, Madeeha; Hassali, Mohamed A.; Shafie, Asrul A.; Hussain, Azhar; Aljadhey, Hisham; Saleem, Fahad

    Objective To document the case management of uncomplicated malaria fever at community pharmacies located in the two major cities of Pakistan; Islamabad (national capital) and Rawalpindi (twin city). Methods A comparative, cross-sectional study was designed to document the management of uncomplicated malaria fever at community pharmacies in twin cities of Pakistan through simulated patient visits. Visits were conducted in 238 randomly selected pharmacies to request advice for a simulated patient case of malaria. The pharmacy’s management was scored on a checklist including history taking and provision of advice and information. Kruskal-Wallis test and Mann-Whitney U test were used to compare management of uncomplicated malaria fever by different types of dispensers working at community pharmacies situated at different locations in the twin cities. Results The simulated patients were handled by salesmen (74.8%, n=178), pharmacist (5.4%, n=13) and diploma holders (19.8 %, n=47). Medication was dispensed in 83.1 % (n=198) of the visits, but only few of the treated cases were in accordance to standard treatment guidelines for malaria. However, in 14.8% (n=35) of the cases the simulated patients were directly referred to a physician. There was a significant difference observed in the process of history taking performed by different dispensers (e.g. pharmacist, pharmacy assistant, pharmacy diploma holders and salesman) while no significant differences in the provision of advice by these dispensers was observed. Pharmacists were seen more frequently involved in the process of history taking if available at the community pharmacies. On the other hand, no significant differences were observed in the case management (history taking and provision of advice) for the treatment of malaria fever among community pharmacies situated at different locations (e.g. near hospital/super market/small market) in the twin cities. Conclusions The results of the study revealed that the

  10. Antibiotic-loaded chitosan-Laponite films for local drug delivery by titanium implants: cell proliferation and drug release studies.

    PubMed

    Ordikhani, Farideh; Dehghani, Mehdi; Simchi, Arash

    2015-12-01

    In this study, chitosan-Laponite nanocomposite coatings with bone regenerative potential and controlled drug-release capacity are prepared by electrophoretic deposition technique. The controlled release of a glycopeptide drug, i.e. vancomycin, is attained by the intercalation of the polymer and drug macromolecules into silicate galleries. Fourier-transform infrared spectrometry reveals electrostatic interactions between the charged structure of clay and the amine and hydroxyl groups of chitosan and vancomycin, leading to a complex positively-charged system with high electrophoretic mobility. By applying electric field the charged particles are deposited on the surface of titanium foils and uniform chitosan films containing 25-55 wt% Laponite and 937-1655 µg/cm(2) vancomycin are obtained. Nanocomposite films exhibit improved cell attachment with higher cell viability. Alkaline phosphatase assay reveals enhanced cell proliferation due the gradual dissolution of Laponite particles into the culture medium. In-vitro drug-release studies show lower release rate through a longer period for the nanocomposite compared to pristine chitosan. PMID:26507202

  11. Two cholesterol derivative-based PEGylated liposomes as drug delivery system, study on pharmacokinetics and drug delivery to retina

    NASA Astrophysics Data System (ADS)

    Geng, Shengyong; Yang, Bin; Wang, Guowu; Qin, Geng; Wada, Satoshi; Wang, Jin-Ye

    2014-07-01

    In this study, two cholesterol derivatives, (4-cholesterocarbonyl-4‧-(N,N,N-triethylamine butyloxyl bromide) azobenzene (CAB) and 4-cholesterocarbonyl-4‧-(N,N-diethylamine butyloxyl) azobenzene (ACB), one of which is positively charged while the other is neutral, were synthesized and incorporated with phospholipids and cholesterol to form doxorubicin (DOX)-loaded liposomes. PEGylation was achieved by including 1,2-distearoyl-sn-glycero-3-phosphatiylethanol-amine-N-[methoxy-(polyethylene glycol)-2000 (DSPE-PEG2000). Our results showed that PEGylated liposomes displayed significantly improved stability and the drug leakage was decreased compared to the non-PEGylated ones in vitro. The in vivo study with rats also revealed that the pharmacokinetics and circulation half-life of DOX were significantly improved when liposomes were PEGylated (p < 0.05). In particular, the neutral cholesterol derivative ACB played some role in improving liposomes’ stability in systemic circulation compared to the conventional PC liposome and the positively charged CAB liposome, with or without PEGylation. In addition, in the case of local drug delivery, the positively charged PEG-liposome not only delivered much more of the drug into the rats’ retinas (p < 0.001), but also maintained much longer drug retention time compared to the neutral PEGylated liposomes.

  12. Surface Modifications of Titanium Implants by Multilayer Bioactive Coatings with Drug Delivery Potential: Antimicrobial, Biological, and Drug Release Studies

    NASA Astrophysics Data System (ADS)

    Ordikhani, Farideh; Zustiak, Silviya Petrova; Simchi, Abdolreza

    2016-04-01

    Recent strategies to locally deliver antimicrobial agents to combat implant-associated infections—one of the most common complications in orthopedic surgery—are gaining interest. However, achieving a controlled release profile over a desired time frame remains a challenge. In this study, we present an innovative multifactorial approach to combat infections which comprises a multilayer chitosan/bioactive glass/vancomycin nanocomposite coating with an osteoblastic potential and a drug delivery capacity. The bioactive drug-eluting coating was prepared on the surface of titanium foils by a multistep electrophoretic deposition technique. The adopted deposition strategy allowed for a high antibiotic loading of 1038.4 ± 40.2 µg/cm2. The nanocomposite coating exhibited a suppressed burst release with a prolonged sustained vancomycin release for up to 6 weeks. Importantly, the drug release profile was linear with respect to time, indicating a zero-order release kinetics. An in vitro bactericidal assay against Staphylococcus aureus confirmed that releasing the drug reduced the risk of bacterial infection. Excellent biocompatibility of the developed coating was also demonstrated by in vitro cell studies with a model MG-63 osteoblast cell line.

  13. A Statistical Perspective on the Design of Drug-Court Studies

    ERIC Educational Resources Information Center

    Merrall, Elizabeth L. C.; Bird, Sheila M.

    2009-01-01

    Recent meta-analyses of drug-court studies recognized the poor methodological quality of the evaluations, with only a few being randomized. This article critiques the design of the randomized studies from a statistical perspective. Learning points are identified for future drug-court studies and are applicable to evaluations both of other…

  14. QSPR studies on aqueous solubilities of drug-like compounds.

    PubMed

    Duchowicz, Pablo R; Castro, Eduardo A

    2009-06-01

    A rapidly growing area of modern pharmaceutical research is the prediction of aqueous solubility of drug-sized compounds from their molecular structures. There exist many different reasons for considering this physico-chemical property as a key parameter: the design of novel entities with adequate aqueous solubility brings many advantages to preclinical and clinical research and development, allowing improvement of the Absorption, Distribution, Metabolization, and Elimination/Toxicity profile and "screenability" of drug candidates in High Throughput Screening techniques. This work compiles recent QSPR linear models established by our research group devoted to the quantification of aqueous solubilities and their comparison to previous research on the topic. PMID:19582218

  15. QSPR studies on aqueous solubilities of drug-like compounds.

    PubMed

    Duchowicz, Pablo R; Castro, Eduardo A

    2009-06-03

    A rapidly growing area of modern pharmaceutical research is the prediction of aqueous solubility of drug-sized compounds from their molecular structures. There exist many different reasons for considering this physico-chemical property as a key parameter: the design of novel entities with adequate aqueous solubility brings many advantages to preclinical and clinical research and development, allowing improvement of the Absorption, Distribution, Metabolization, and Elimination/Toxicity profile and "screenability" of drug candidates in High Throughput Screening techniques. This work compiles recent QSPR linear models established by our research group devoted to the quantification of aqueous solubilities and their comparison to previous research on the topic.

  16. A Review of Compression, Ventilation, Defibrillation, Drug Treatment, and Targeted Temperature Management in Cardiopulmonary Resuscitation

    PubMed Central

    Pan, Jian; Zhu, Jian-Yong; Kee, Ho Sen; Zhang, Qing; Lu, Yuan-Qiang

    2015-01-01

    Objective: Important studies of cardiopulmonary resuscitation (CPR) techniques influence the development of new guidelines. We systematically reviewed the efficacy of some important studies of CPR. Data Sources: The data analyzed in this review are mainly from articles included in PubMed and EMBASE, published from 1964 to 2014. Study Selection: Original articles and critical reviews about CPR techniques were selected for review. Results: The survival rate after out-of-hospital cardiac arrest (OHCA) is improving. This improvement is associated with the performance of uninterrupted chest compressions and simple airway management procedures during bystander CPR. Real-time feedback devices can be used to improve the quality of CPR. The recommended dose, timing, and indications for adrenaline (epinephrine) use may change. The appropriate target temperature for targeted temperature management is still unclear. Conclusions: New studies over the past 5 years have evaluated various aspects of CPR in OHCA. Some of these studies were high-quality randomized controlled trials, which may help to improve the scientific understanding of resuscitation techniques and result in changes to CPR guidelines. PMID:25673462

  17. Adverse drug reactions to self-medication: a study in a pharmacovigilance database.

    PubMed

    Berreni, Aurélia; Montastruc, François; Bondon-Guitton, Emmanuelle; Rousseau, Vanessa; Abadie, Delphine; Durrieu, Geneviève; Chebane, Leila; Giroud, Jean-Paul; Bagheri, Haleh; Montastruc, Jean-Louis

    2015-10-01

    Although self-medication is widely developed, there are few detailed data about its adverse drug reactions (ADRs). This study investigated the main characteristics of ADRs with self-medication recorded in the Midi-Pyrénées PharmacoVigilance between 2008 and 2014. Self-medication included first OTC drugs and second formerly prescribed drugs later used without medical advice (reuse of previously prescribed drugs). Among the 12 365 notifications recorded, 160 (1.3%) were related to SM with 186 drugs. Around three-forth of the ADRs were 'serious'. Mean age was 48.8 years with 56.3% females. The most frequent ADRs were gastrointestinal and neuropsychiatric and main drug classes involved NSAIDs, analgesics, and benzodiazepines. Phytotherapy-homeopathy accounted for 9.1% of drugs.

  18. Semantic Web Ontology and Data Integration: a Case Study in Aiding Psychiatric Drug Repurposing.

    PubMed

    Liang, Chen; Sun, Jingchun; Tao, Cui

    2016-01-01

    Despite ongoing progress towards treating mental illness, there remain significant difficulties in selecting probable candidate drugs from the existing database. We describe an ontology - oriented approach aims to represent the nexus between genes, drugs, phenotypes, symptoms, and diseases from multiple information sources. Along with this approach, we report a case study in which we attempted to explore the candidate drugs that effective for both bipolar disorder and epilepsy. We constructed an ontology that incorporates the knowledge between the two diseases and performed semantic reasoning task on the ontology. The reasoning results suggested 48 candidate drugs that hold promise for a further breakthrough. The evaluation was performed and demonstrated the validity of the proposed ontology. The overarching goal of this research is to build a framework of ontology - based data integration underpinning psychiatric drug repurposing. This approach prioritizes the candidate drugs that have potential associations among genes, phenotypes and symptoms, and thus facilitates the data integration and drug repurposing in psychiatric disorders. PMID:27570661

  19. Semantic Web Ontology and Data Integration: a Case Study in Aiding Psychiatric Drug Repurposing.

    PubMed

    Liang, Chen; Sun, Jingchun; Tao, Cui

    2016-01-01

    Despite ongoing progress towards treating mental illness, there remain significant difficulties in selecting probable candidate drugs from the existing database. We describe an ontology - oriented approach aims to represent the nexus between genes, drugs, phenotypes, symptoms, and diseases from multiple information sources. Along with this approach, we report a case study in which we attempted to explore the candidate drugs that effective for both bipolar disorder and epilepsy. We constructed an ontology that incorporates the knowledge between the two diseases and performed semantic reasoning task on the ontology. The reasoning results suggested 48 candidate drugs that hold promise for a further breakthrough. The evaluation was performed and demonstrated the validity of the proposed ontology. The overarching goal of this research is to build a framework of ontology - based data integration underpinning psychiatric drug repurposing. This approach prioritizes the candidate drugs that have potential associations among genes, phenotypes and symptoms, and thus facilitates the data integration and drug repurposing in psychiatric disorders.

  20. EPR studies of intermolecular interactions and competitive binding of drugs in a drug-BSA binding model.

    PubMed

    Akdogan, Y; Emrullahoglu, M; Tatlidil, D; Ucuncu, M; Cakan-Akdogan, G

    2016-08-10

    Understanding intermolecular interactions between drugs and proteins is very important in drug delivery studies. Here, we studied different binding interactions between salicylic acid and bovine serum albumin (BSA) using electron paramagnetic resonance (EPR) spectroscopy. Salicylic acid was labeled with a stable radical (spin label) in order to monitor its mobilized (free) or immobilized (bound to BSA) states. In addition to spin labeled salicylic acid (SL-salicylic acid), its derivatives including SL-benzoic acid, SL-phenol, SL-benzene, SL-cyclohexane and SL-hexane were synthesized to reveal the effects of various drug binding interactions. EPR results of these SL-molecules showed that hydrophobic interaction is the main driving force. Whereas each of the two functional groups (-COOH and -OH) on the benzene ring has a minute but detectable effect on the drug-protein complex formation. In order to investigate the effect of electrostatic interaction on drug binding, cationic BSA (cBSA) was synthesized, altering the negative net charge of BSA to positive. The salicylic acid loading capacity of cBSA is significantly higher compared to that of BSA, indicating the importance of electrostatic interaction in drug binding. Moreover, the competitive binding properties of salicylic acid, ibuprofen and aspirin to BSA were studied. The combined EPR results of SL-salicylic acid/ibuprofen and SL-ibuprofen/salicylic acid showed that ibuprofen is able to replace up to ∼83% of bound SL-salicylic acid, and salicylic acid can replace only ∼14% of the bound SL-ibuprofen. This indicates that ∼97% of all salicylic acid and ibuprofen binding sites are shared. On the other hand, aspirin replaces only ∼23% of bound SL-salicylic acid, and salicylic acid replaces ∼50% of bound SL-aspirin, indicating that ∼73% of all salicylic acid and aspirin binding sites are shared. These results show that EPR spectroscopy in combination with the spin labeling technique is a very powerful

  1. EPR studies of intermolecular interactions and competitive binding of drugs in a drug-BSA binding model.

    PubMed

    Akdogan, Y; Emrullahoglu, M; Tatlidil, D; Ucuncu, M; Cakan-Akdogan, G

    2016-08-10

    Understanding intermolecular interactions between drugs and proteins is very important in drug delivery studies. Here, we studied different binding interactions between salicylic acid and bovine serum albumin (BSA) using electron paramagnetic resonance (EPR) spectroscopy. Salicylic acid was labeled with a stable radical (spin label) in order to monitor its mobilized (free) or immobilized (bound to BSA) states. In addition to spin labeled salicylic acid (SL-salicylic acid), its derivatives including SL-benzoic acid, SL-phenol, SL-benzene, SL-cyclohexane and SL-hexane were synthesized to reveal the effects of various drug binding interactions. EPR results of these SL-molecules showed that hydrophobic interaction is the main driving force. Whereas each of the two functional groups (-COOH and -OH) on the benzene ring has a minute but detectable effect on the drug-protein complex formation. In order to investigate the effect of electrostatic interaction on drug binding, cationic BSA (cBSA) was synthesized, altering the negative net charge of BSA to positive. The salicylic acid loading capacity of cBSA is significantly higher compared to that of BSA, indicating the importance of electrostatic interaction in drug binding. Moreover, the competitive binding properties of salicylic acid, ibuprofen and aspirin to BSA were studied. The combined EPR results of SL-salicylic acid/ibuprofen and SL-ibuprofen/salicylic acid showed that ibuprofen is able to replace up to ∼83% of bound SL-salicylic acid, and salicylic acid can replace only ∼14% of the bound SL-ibuprofen. This indicates that ∼97% of all salicylic acid and ibuprofen binding sites are shared. On the other hand, aspirin replaces only ∼23% of bound SL-salicylic acid, and salicylic acid replaces ∼50% of bound SL-aspirin, indicating that ∼73% of all salicylic acid and aspirin binding sites are shared. These results show that EPR spectroscopy in combination with the spin labeling technique is a very powerful

  2. Approach to the Diagnosis and Management of Drug-Induced Immune Thrombocytopenia

    PubMed Central

    Arnold, Donald M.; Nazi, Ishac; Warkentin, Theodore E.; Smith, James W.; Toltl, Lisa J.; George, James N.; Kelton, John G.

    2013-01-01

    Drug-induced immune thrombocytopenia (DITP) is a challenging clinical problem that is under-recognized, difficult to diagnose and associated with severe bleeding complications. DITP may be caused by classic drug-dependent platelet antibodies (eg, quinine); haptens (eg, penicillin); fiban-dependent antibodies (eg, tirofiban); monoclonal antibodies (eg, abciximab); autoantibody formation (eg, gold); and immune complex formation (eg, heparin). A thorough clinical history is essential in establishing the diagnosis of DITP and should include exposures to prescription medications, herbal preparations and even certain foods and beverages. Clinical and laboratory criteria have been established to determine the likelihood of a drug being the cause of thrombocytopenia, but these criteria can only be applied retrospectively. The most commonly implicated drugs include quinine, quinidine, trimethoprim/sulfamethoxazole and vancomycin. We propose a practical approach to the diagnosis of the patient with suspected DITP. Key features are: the presence of severe thrombocytopenia (platelet nadir <20 × 109/L); bleeding complications; onset 5 to 10 days after first drug exposure, or within hours of subsequent exposures or after first exposure to fibans or abciximab; and exposure to drugs that have been previously implicated in DITP reactions. Treatment involves stopping the drug(s), administering platelet transfusions or other therapies if bleeding is present and counselling on future drug avoidance. The diagnosis can be confirmed by a positive drug re-challenge, which is often impractical, or by demonstrating drug-dependent platelet reactive antibodies in vitro. Current test methods, which are mostly flow cytometry-based, must show drug-dependence, immunoglobulin binding, platelet specificity and ideally should be reproducible across laboratories. Improved standardization and accessibility of laboratory testing should be a focus of future research. PMID:23845922

  3. Approach to the diagnosis and management of drug-induced immune thrombocytopenia.

    PubMed

    Arnold, Donald M; Nazi, Ishac; Warkentin, Theodore E; Smith, James W; Toltl, Lisa J; George, James N; Kelton, John G

    2013-07-01

    Drug-induced immune thrombocytopenia (DITP) is a challenging clinical problem that is under-recognized, difficult to diagnose and associated with severe bleeding complications. DITP may be caused by classic drug-dependent platelet antibodies (eg, quinine); haptens (eg, penicillin); fiban-dependent antibodies (eg, tirofiban); monoclonal antibodies (eg, abciximab); autoantibody formation (eg, gold); and immune complex formation (eg, heparin). A thorough clinical history is essential in establishing the diagnosis of DITP and should include exposures to prescription medications, herbal preparations and even certain foods and beverages. Clinical and laboratory criteria have been established to determine the likelihood of a drug being the cause of thrombocytopenia, but these criteria can only be applied retrospectively. The most commonly implicated drugs include quinine, quinidine, trimethoprim/sulfamethoxazole and vancomycin. We propose a practical approach to the diagnosis of the patient with suspected DITP. Key features are: the presence of severe thrombocytopenia (platelet nadir <20×10(9)/L); bleeding complications; onset 5 to 10days after first drug exposure, or within hours of subsequent exposures or after first exposure to fibans or abciximab; and exposure to drugs that have been previously implicated in DITP reactions. Treatment involves stopping the drug(s), administering platelet transfusions or other therapies if bleeding is present and counselling on future drug avoidance. The diagnosis can be confirmed by a positive drug re-challenge, which is often impractical, or by demonstrating drug-dependent platelet reactive antibodies in vitro. Current test methods, which are mostly flow cytometry-based, must show drug-dependence, immunoglobulin binding, platelet specificity and ideally should be reproducible across laboratories. Improved standardization and accessibility of laboratory testing should be a focus of future research. PMID:23845922

  4. New drug regimens for HIV in pregnancy and a national strategic plan to manage HIV: A South African perspective.

    PubMed

    Ngene, Nnabuike C; Moodley, Jagidesa

    2015-10-01

    In South Africa, new drug regimens (WHO treatment Option B) used to manage HIV infection in pregnancy and the national strategic plan on HIV have resulted in improved health outcomes. Among these outcomes are reductions in the following: mother-to-child transmission (MTCT) of HIV to 2.4%; maternal deaths attributable to HIV; and adverse reactions due to antiretroviral therapy (ART). The present article describes these new drug regimens and the national strategic HIV management plan, as well as their challenges and the implications of improved health outcomes. Such outcomes imply that further decreases in MTCT of HIV, and HIV attributable maternal deaths are possible if potential challenges are addressed and treatment option B+ offered. A confidential enquiry into each case of MTCT is advocated to reduce vertical transmission rates to zero levels.

  5. Prescription drugs in nursing homes: managing costs and quality in a complex environment.

    PubMed

    Mendelson, Dan; Ramchand, Rajeev; Abramson, Richard; Tumlinson, Anne

    2002-11-12

    This brief provides a description of prescription drug use in nursing homes and a summary of current policy issues in this area. The brief first profiles the nursing home pharmaceutical market, outlining the major trends in demographics and drug utilization, the supply chain by which drugs go from manufacturers to pharmacies to nursing home residents, and the alternative arrangements by which prescription drugs in nursing homes are financed. The brief then provides a synopsis of current policy issues, focusing in turn on cost containment and quality improvement initiatives.

  6. Current progress in the management of rare diseases and orphan drugs in China

    PubMed Central

    Gong, Shiwei; Jin, Si

    2012-01-01

    Summary Currently, the issues of how to treat rare diseases and to improve accessibility to orphan drugs are arousing more and more concerns in China. Here we describe the push and pull incentive policies for rare diseases and orphan drugs and analyze the coverage and reimbursement level of rare diseases in the current Chinese medical insurance system. Three key obstacle factors that hinder Chinese patients' accessibility to timely drug treatment are summarized. Based on a comprehensive analysis, the measures of orphan drugs legislation, incentive mechanism, supply mechanism, and reimbursement mechanism are urgently expected to be established with the purpose of improving healthcare for patients with rare diseases in China. PMID:25343073

  7. An Anthropological Paradigm for the Study of Youth and Drugs

    ERIC Educational Resources Information Center

    Soloway, Irving H.; And Others

    1977-01-01

    Authors note that the focus of their current research is substantive. They have begun to analyze and explicate the native defined views of an age-stratified set of peer groups with respect to numerous variables such as their concepts of health and sickness and their definitions of drugs. (Author/AM)

  8. Brief strategic family therapy for adolescent drug abusers: a multi-site effectiveness study.

    PubMed

    Robbins, Michael S; Szapocznik, José; Horigian, Viviana E; Feaster, Daniel J; Puccinelli, Marc; Jacobs, Petra; Burlew, Kathy; Werstlein, Robert; Bachrach, Ken; Brigham, Greg

    2009-05-01

    Brief strategic family therapy (BSFT) is a manualized treatment designed to address aspects of family functioning associated with adolescent drug use and behavior problems (J. Szapocznik, U. Hervis, S. Schwartz, (2003). Brief strategic family therapy for adolescent drug abuse. (NIH Publication No. 03-4751). Bethesda, MD: National Institute on Drug Abuse). Within the National Institute on Drug Abuse's (NIDA's) Clinical Trials Network, BSFT is being compared to treatment as usual (TAU) in a multisite, prospective randomized clinical trial for drug using adolescents and their families in outpatient settings. The effectiveness of BSFT is being compared to TAU in reducing adolescent drug use, conduct problems, and sexually risky behaviors as well as in improving family functioning and adolescent prosocial behaviors. This paper describes the following aspects of the study: specific aims, research design and study organization, assessment of primary and secondary outcomes, study treatments, data analysis plan, and data monitoring and safety reporting.

  9. Availability of antidotes and key emergency drugs in tertiary care hospitals of Punjab and assessment of the knowledge of health care professionals in the management of poisoning cases.

    PubMed

    Arslan, Naheed; Khiljee, Sonia; Bakhsh, Allah; Ashraf, Muhammad; Maqsood, Iram

    2016-03-01

    This study was conducted to evaluate the availability of antidotes/key emergency drugs in tertiary care hospitals of the Punjab province, and to assess the knowledge of health care professionals in the stocking and administration of antidotes in the proper management of poisoning cases. Seventeen (n=17) tertiary care hospitals of Punjab Pakistan were selected. Two performas (A and B) were designed for 26 antidotes/key emergency drugs and given to the hospital pharmacists and physicians respectively. It was observed that Activated Charcoal, being the universal antidote was found only in 6 hospitals (41%). Digoxin Immune Fab, Edentate Calcium disodium and Glucagon were not available in emergency department of any hospital and even not included in the formulary of any hospital. About 80% pharmacists were aware of the method of preparation of Activated Charcoal and 85% physicians were familiar with its route of administration. Data showed that tertiary care hospitals of Punjab do not stock antidotes according to national drug policy. Moreover the study strongly suggests the development of health care centers and professional by organizing antidote awareness programs, continuous education and record keeping of poisonous cases and availability of emergency drugs around the clock. PMID:27087082

  10. How innovative are new drugs launched in the UK? A retrospective study of new drugs listed in the British National Formulary (BNF) 2001–2012

    PubMed Central

    Ward, Derek J; Slade, Angharad; Genus, Tracey; Martino, Orsolina I; Stevens, Andrew J

    2014-01-01

    Objectives Innovative new drugs offer potential benefits to patients, healthcare systems, governments and the pharmaceutical industry. Recent data suggest annual numbers of new drugs launched in the UK have increased in recent years, and we sought to understand whether this represents increasing numbers of highly innovative drugs being made available or the introduction of increasing numbers of drugs with limited additional therapeutic value. Design and setting Retrospective observational study of new drug entries in the British National Formulary (BNF). Primary and secondary outcome measures Number of new drugs launched in the UK each year (based on first appearance in the BNF) from 2001 to 2012, including new chemical entities and new biological drugs, categorised by degree of innovativeness according to published criteria that incorporate both clinical usefulness and the nature of the innovation. Results Highly innovative, moderately innovative and slightly innovative drugs made up 26%, 18% and 56% of all newly launched drugs, respectively, for the study period (n=290). There was an upward trend in annual numbers of slightly innovative drugs from 2004 onwards (R2=0.44), which aligned closely with the recovery in total numbers of new drugs launched each year since that time. There were no discernible time trends in the highly or moderately innovative categories. New drugs for malignancy and skin disease were most likely to be characterised as highly innovative (44% and 57%, respectively). Conclusions Highly innovative new drugs comprise only around a quarter of all new drug launches in the UK. In contrast, drugs categorised as only slightly innovative comprised well over half of all new drugs and annual numbers in this category are increasing. Current policy initiatives that seek to increase the supply of innovative new drugs have long-lead times to impact, and will need careful assessment to ensure they deliver their aims without unintended consequences. PMID

  11. Implicit and Explicit Drug-Related Cognitions during Detoxification Treatment Are Associated with Drug Relapse: An Ecological Momentary Assessment Study

    ERIC Educational Resources Information Center

    Marhe, Reshmi; Waters, Andrew J.; van de Wetering, Ben J. M.; Franken, Ingmar H. A.

    2013-01-01

    Objective: Relapse is a major problem in drug addiction treatment. Both drug craving and drug-related cognitions (e.g., attentional bias and implicit attitudes to drugs) may contribute to relapse. Using ecological momentary assessments, we examined whether craving and cognitions assessed during drug detoxification treatment were associated with…

  12. Dilemma of managing asymptomatic children referred with “culture-confirmed” drug-resistant tuberculosis

    PubMed Central

    Loveday, Marian; Sunkari, Babu; Marais, Ben J; Master, Iqbal; Brust, James CM

    2016-01-01

    Background The diagnosis of drug-resistant tuberculosis (DR-TB) in children is challenging and treatment is associated with many adverse effects. Objective We aimed to assess if careful observation, without initiation of second-line treatment, is safe in asymptomatic children referred with “culture-confirmed” DR-TB. Setting KwaZulu-Natal, South Africa - an area with high burdens of HIV, TB and DR-TB. Design, Intervention, Main outcome measures We performed an outcome review of children with “culture-confirmed” DR-TB who were not initiated on second-line TB treatment, as they were asymptomatic with normal chest radiographs on examination at our specialist referral hospital. Children were followed up every other month for the first year, with a final outcome assessment at the end of the study. Results In total, 43 asymptomatic children with normal chest radiographs were reviewed. The median length of follow-up until final evaluation was 549 days (IQR 259-722 days); most (34; 83%) children were HIV-uninfected. Resistance patterns included 9 (21%) mono-resistant and 34 (79%) multidrug-resistant (MDR) strains. Fifteen children (35%) had been treated with first-line TB treatment, prior to presentation at our referral hospital. At the final evaluation 34 (80%) children were well, 7 (16%) were lost to follow up, 1 (2%) received MDR-TB treatment and 1 (2%) died of unknown causes. The child who received MDR-TB treatment developed new symptoms at the 12 month review and responded well to second-line treatment. Conclusion Bacteriological evaluation should not be performed in the absence of any clinical indication. If drug-resistant M. tuberculosis is detected in an asymptomatic child with a normal chest radiograph close observation may be an appropriate strategy, especially in settings where potential laboratory error and poor record keeping are constant challenges. PMID:27044259

  13. Investigation of parameters highlighting drug induced small changes of the T-wave's morphology for drug safety studies.

    PubMed

    Baas, Tobias; Gräfe, Ksenija; Khawaja, Antoun; Dössel, Olaf

    2011-01-01

    In guideline E14, the American Food and Drug Administration (FDA) requests for clinical studies to investigate the prolongation of the heart rate corrected QT-interval (QTc) of the ECG. As drug induced QT-prolongation can be caused by changes in the repolarisation of the ventricles, it is so far a thorough ECG biomarker of risk for ventricular tachyarrhythmias and Torsade de Pointes (TdP). Ventricular repolarisation changes not only change QT but also influence the morphology of the T-wave. In a (400 mg single dose) Moxifloxacin positive control study both, QTc and several descriptors describing the T-wave morphology have been measured. Moxifloxacin is changing two shape dependent descriptors significantly (P<0.05) about 3 to 4 hours after a 400 mg oral single dose of Moxifloxacin.

  14. Development, implementation and management of a drug testing program in the workplace

    SciTech Connect

    Burtis, C.A.

    1990-01-01

    To combat the rising use of drugs in the workplace many American companies have implemented drug testing programs and are testing employees and job applicants for use of illegal drugs. In addition, on September 15, 1986, Executive Order No.12564 was issued by President Reagan, which requires all federal agencies to develop programs and policies, one of the goals of which is to achieve a drug-free federal workplace. Included in this Executive Order is the requirement that federal agencies implement drug testing has become a prevalent practice as a means to detect and deter drug use in the workplace. Before a drug testing program is implemented, it is imperative that policies and procedures are developed that (1) ensure the accuracy of test results, (2) protect the validity and integrity of the specimen, (3) guarantee due process, and (4) maintain confidentiality. To make certain that these prerequisites were met in the government drug testing programs, the US Department of Health and Human Services (HHS) was directed to develop technical and scientific guidelines for conducting such programs. 15 refs., 1 fig., 2 tabs.

  15. Design Project on Controlled-Release Drug Delivery Devices: Implementation, Management, and Learning Experiences

    ERIC Educational Resources Information Center

    Xu, Qingxing; Liang, Youyun; Tong, Yen Wah; Wang, Chi-Hwa

    2010-01-01

    A design project that focuses on the subject of controlled-release drug delivery devices is presented for use in an undergraduate course on mass transfer. The purpose of the project is to introduce students to the various technologies used in the fabrication of drug delivery systems and provide a practical design exercise for understanding the…

  16. Remaining Off Alcohol and Drugs: A Self-Management Skills Program for Abstinence.

    ERIC Educational Resources Information Center

    Dunphy, Peter Hughes

    The Remaining Off Alcohol and Drugs Program (ROAD) was developed to teach newly abstinent chemical misusing clients how to remain alcohol and drug free. It provides its participants with a repertoire of knowledge, skills and behaviors that they can use in dealing with the most common problems caused by discontinuing chemical use and which can be…

  17. Evaluating Drugs and Food Additives for Public Use: A Case Studies Approach.

    ERIC Educational Resources Information Center

    Merritt, Sheridan V.

    1980-01-01

    Described is a case study used in an introductory college biology course that provides a basis for generating debate on an issue concerning the regulation of controversial food additives and prescription drugs. The case study contained within this article deals with drug screening, specifically with information related to thalidomide. (CS)

  18. Traumeel – an emerging option to nonsteroidal anti-inflammatory drugs in the management of acute musculoskeletal injuries

    PubMed Central

    Schneider, Christian

    2011-01-01

    Musculoskeletal injuries are on the rise. First-line management of such injuries usually employs the RICE (rest, ice, compression, and elevation) approach to limit excessive inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) are also commonly used to limit inflammation and to control pain. Traumeel®, a preparation with bioregulatory effects is also used to treat the symptoms associated with acute musculoskeletal injuries, including pain and swelling. Traumeel is a fixed combination of biological and mineral extracts, which aims to apply stimuli to multiple targets to restore normal functioning of regulatory mechanisms. This paper presents the accumulating evidence of Traumeel’s action on the inflammatory process, and of its efficacy and tolerability in randomized trials, as well as observational and surveillance studies for the treatment of musculoskeletal injuries. Traumeel has shown comparable effectiveness to NSAIDs in terms of reducing symptoms of inflammation, accelerating recovery, and improving mobility, with a favorable safety profile. While continued research and development is ongoing to broaden the clinical evidence of Traumeel in acute musculoskeletal injury and to further establish its benefits, current information suggests that Traumeel may be considered as an anti-inflammatory agent that is at least as effective and appears to be better tolerated than NSAIDs. PMID:21556350

  19. Toward a European definition for a drug shortage: a qualitative study

    PubMed Central

    De Weerdt, Elfi; Simoens, Steven; Casteels, Minne; Huys, Isabelle

    2015-01-01

    Background: Drug shortages are currently on the rise. In-depth investigation of the problem is necessary, however, a variety of definitions for ‘drug shortages’ are formulated in legislations, by different organizations, authorities, and other initiatives. For international comparison, the underlying definition for drug shortages is important to allow appropriate interpretation of national databases and the results of scientific studies. The objective is to identify the different elements which should be considered in a uniform definition for drug shortages in the European Union (EU) and to detect the different conditions for reporting drug shortages. Materials and Methods: Definitions of drug shortages were searched in the scientific databases as well as in the gray literature. Similar topics were identified and organizations were contacted to formulate the reasoning underlying the definitions. Results: Over 20 different definitions for drug shortages were identified. A distinction is made between general definitions of drug shortages and definitions used for the reporting of drug shortages. Differences and similarities are observed in the elements within the definitions, e.g., when does a supply problem become a drug shortage, permanent and/or temporally shortages, the typology and time frame of a drug shortage. The moment a supply problem is considered as a shortage, can be defined at four levels: (i) demand side, (ii) supply side, (iii) delivery of a drug, and (iv) availability of a drug. Permanent discontinuations of drugs are not always covered in definitions for drug shortages. Some definitions only consider those drugs used for the treatment of serious diseases or drugs for which no alternative is available. Different time frames were observed, varying between 1 day and 20 days. Conclusion: Obtaining a uniform definition for drug shortages is important as well as identifying which conditions are preferable to report drug shortages in order to facilitate

  20. Middle and High School Drug Testing and Student Illicit Drug Use: A National Study 1998–2011

    PubMed Central

    O’Malley, Patrick M.; Johnston, Lloyd D.

    2013-01-01

    Purpose This study uses 14 years of data from nationally representative samples of US middle and high school students in the Monitoring the Future study to examine associations between school student drug testing (SDT), substance use, and participation in extracurricular activities. Methods Analyses use questionnaire data collected from 1998–2011 from 89,575 students in 883 middle schools and 157,400 students in 1,463 high schools to examine: (1) the current prevalence of SDT; (2) SDT trends over time; (3) associations between substance use and SDT type, volume, or duration among the general student population or students participating in activities subject to testing; (4) associations between students’ beliefs/attitudes about marijuana use and SDT; and (5) associations between extracurricular participation rates and SDT. Results Moderately lower marijuana use was associated with any random testing of the general high school student population and for SDT of middle and high school sub-populations specifically subject to testing (athletes or participants in non-athletic extracurricular activities). However, SDT generally was associated with increased use of illicit drugs other than marijuana. Conclusions Because the study design is observational and the data are cross-sectional, no strong causal conclusions can be drawn. However, there is evidence of lower marijuana use in the presence of SDT, and evidence of higher use of illicit drugs other than marijuana. Until further research can clarify the apparent opposing associations, schools should approach SDT with caution. PMID:23406889

  1. Best practices for the use of itraconazole as a replacement for ketoconazole in drug-drug interaction studies.

    PubMed

    Liu, Lichuan; Bello, Akintunde; Dresser, Mark J; Heald, Donald; Komjathy, Steven Ferenc; O'Mara, Edward; Rogge, Mark; Stoch, S Aubrey; Robertson, Sarah M

    2016-02-01

    Ketoconazole has been widely used as a strong cytochrome P450 (CYP) 3A (CYP3A) inhibitor in drug-drug interaction (DDI) studies. However, the US Food and Drug Administration has recommended limiting the use of ketoconazole to cases in which no alternative therapies exist, and the European Medicines Agency has recommended the suspension of its marketing authorizations because of the potential for serious safety concerns. In this review, the Innovation and Quality in Pharmaceutical Development's Clinical Pharmacology Leadership Group (CPLG) provides a compelling rationale for the use of itraconazole as a replacement for ketoconazole in clinical DDI studies and provides recommendations on the best practices for the use of itraconazole in such studies. Various factors considered in the recommendations include the choice of itraconazole dosage form, administration in the fasted or fed state, the dose and duration of itraconazole administration, the timing of substrate and itraconazole coadministration, and measurement of itraconazole and metabolite plasma concentrations, among others. The CPLG's recommendations are based on careful review of available literature and internal industry experiences.

  2. Kinetic study on the reactions of platinum drugs with glutathione.

    PubMed

    Hagrman, Douglas; Goodisman, Jerry; Souid, Abdul-Kader

    2004-02-01

    The binding of platinum (Pt) drugs (oxaliplatin, carboplatin, and cisplatin) to glutathione (GSH, 6.75 mM) was investigated at 37 degrees C in Hepes (100 mM, pH approximately 7.4) or Tris-NO(3) (60 mM, pH 7.4) buffer and NaCl (4.62, 6.63, or 7.82 mM). The conditions were chosen to mimic passage of clinical concentrations of the drugs (135 microM) through the cytosol. The reactions were monitored by UV-absorption spectroscopy, high-performance liquid chromatography (HPLC), and atomic absorption spectroscopy. The initial rates, detected by UV absorbance, were similar for oxaliplatin and cisplatin reacting with GSH and were more than 5-fold faster than for carboplatin reacting with GSH. The Pt contents in HPLC eluates corresponding to unbound drug decreased exponentially with time, confirming that the reactions were first order in [Pt drug] and allowing determination of the pseudo first-order rate constants (k(1)). The second-order rate constants (k(2)) were calculated as k(1) divided by [GSH]. The k(2) value for oxaliplatin reacting with GSH was approximately 3.8 x 10(-2) M(-1) s(-1), for cisplatin reacting with GSH approximately 2.7 x 10(-2) M(-1) s(-1), and for carboplatin reacting with GSH approximately 1.2 x 10(-3) M(-1) s(-1) (approximately 32-fold slower than that of oxaliplatin and approximately 23-fold slower than that of cisplatin). These results demonstrate an influence of ligands surrounding the Pt coordination sphere on the reactivity of Pt(2+) with GSH.

  3. Use of illicit stimulant drugs in Finland: a wastewater study in ten major cities.

    PubMed

    Kankaanpää, Aino; Ariniemi, Kari; Heinonen, Mari; Kuoppasalmi, Kimmo; Gunnar, Teemu

    2014-07-15

    Estimations of drug use at the national level are generally based on various sources of information, such as drug seizures, socio-scientific studies, toxicological data and hospital records. Nevertheless, all of these approaches have limitations that cannot be overcome, even if conclusions are drawn from combined data retrieved from different sources. Drug epidemiology through wastewater analysis has the potential to provide unique perspectives, internationally comparable data, and up-to-date information on the use of both traditional illicit drugs and new psychoactive substances (NPSs). In Finland, no large-scale studies on regional illicit drug consumption, based on a wastewater approach, have been reported. In this study, 24-h influent composite samples were collected during two 1-week study periods from ten different wastewater treatment plants in May and November-December 2012. The cities included in the study represent the geographical areas throughout Finland and cover 40% of the Finnish population. The samples were analyzed with an in-house validated, ultra high-performance liquid-chromatography mass spectrometric (UHPLC-MS/MS) method for various common illicit drugs and some NPS type stimulant drugs. The results were also compared with available statistics, information on drug seizures and laboratory-confirmed toxicological data, as well as other studies available based on wastewater analysis. The data show that illicit stimulant drug use is more common in the larger cities of Southern Finland. Amphetamine was the most commonly used drug in all 10 cities during both collection periods (excluding the collection period in May in Lappeenranta). Cocaine consumption remains very low in Finland in comparison to other European countries; it was concentrated in the biggest cities in Southern Finland. This study shows interesting temporal and spatial differences in drug use in Finland, as well as the possibilities of using wastewater analytics to reveal local

  4. An evaluation of tandem mass spectrometry in drug metabolism studies.

    PubMed

    Naylor, S; Kajbaf, M; Lamb, J H; Jahanshahi, M; Gorrod, J W

    1993-07-01

    The use of precursor ion and constant neutral loss scanning as a means of rapidly detecting drug metabolites is evaluated. Four clinically useful drugs, namely (i) cyclophosphamide, (ii) mifentidine, (iii) cimetropium bromide and (iv) haloperidol, were subjected to microsomal incubations to afford phase I metabolites. Aside from a minor clean-up procedure involving zinc sulfate precipitation of microsomal proteins and solid-phase extraction of metabolites using a Sep-pak C-18 cartridge, the mixtures were analysed directly by fast atom bombardment tandem mass spectrometry. It is demonstrated that such screening strategies are important in detecting novel metabolites. However, there are some problems associated with only using such methods, including (i) the possibility of not detecting metabolites that undergo unusual collision-induced dissociation fragmentation pathways, (ii) the non-detection of metabolites that have undergone metabolic change at unusual sites of reactivity, and (iii) production of artifacts derived from the parent drug by the primary ionization process. Examples are discussed that highlight both the strengths and weaknesses of such an approach.

  5. Molecular modeling study of chiral drug crystals: lattice energy calculations.

    PubMed

    Li, Z J; Ojala, W H; Grant, D J

    2001-10-01

    The lattice energies of a number of chiral drugs with known crystal structures were calculated using Dreiding II force field. The lattice energies, including van der Waals, Coulombic, and hydrogen-bonding energies, of homochiral and racemic crystals of some ephedrine derivatives and of several other chiral drugs, are compared. The calculated energies are correlated with experimental data to probe the underlying intermolecular forces responsible for the formation of racemic species, racemic conglomerates, or racemic compounds, termed chiral discrimination. Comparison of the calculated energies among ephedrine derivatives reveals that a greater Coulombic energy corresponds to a higher melting temperature, while a greater van der Waals energy corresponds to a larger enthalpy of fusion. For seven pairs of homochiral and racemic compounds, correlation of the differences between the two forms in the calculated energies and experimental enthalpy of fusion suggests that the van der Waals interactions play a key role in the chiral discrimination in the crystalline state. For salts of the chiral drugs, the counter ions diminish chiral discrimination by increasing the Coulombic interactions. This result may explain why salt forms favor the formation of racemic conglomerates, thereby facilitating the resolution of racemates.

  6. Psychomotor developmental effects of prenatal exposure to psychotropic drugs: a study in EFEMERIS database.

    PubMed

    Hurault-Delarue, Caroline; Damase-Michel, Christine; Finotto, Laurent; Guitard, Claudine; Vayssière, Christophe; Montastruc, Jean-Louis; Montastruc, François; Lacroix, Isabelle

    2016-10-01

    Little is known about neurodevelopment of children exposed to psychotropic drugs during pregnancy. The purpose of this study was to evaluate the effects of prenatal exposure to psychotropic drugs on psychomotor development in children. This observational study used the EFEMERIS database. The database records the drugs prescribed and delivered during pregnancy and the resulting outcomes. Neurodevelopment at nine and 24 months of children born to women exposed to psychotropic drugs (anxiolytics, antidepressants, neuroleptics and anti-epileptics) during the second and/or third trimesters of pregnancy was compared to children who were not exposed to these drugs. Psychomotor development of 493 children (1.5%) exposed to psychotropic drugs during pregnancy was compared to 32 303 unexposed children. Exposure to psychotropic drugs during pregnancy was associated with an increased risk of abnormal motor development at 9 months (OR = 1.3 [1.1-2.2]) and abnormal motor and mental development at 24 months (OR = 4.8 [2.1-11.0] and OR = 2.3 [1.05-4.9]). Increased risk was observed in children born to women exposed to anti-epileptic drugs, neuroleptics or antidepressants during pregnancy. This study found a higher rate of deviation from the normal developmental milestones in children born to women exposed to psychotropic drugs during pregnancy and more particularly antidepressants, neuroleptics and anti-epileptics. PMID:27324073

  7. Knowledge, perceptions and use of generic drugs: a cross sectional study

    PubMed Central

    de Lira, Claudio Andre Barbosa; Oliveira, Jéssica Nathalia Soares; Andrade, Marília dos Santos; Vancini-Campanharo, Cássia Regina; Vancini, Rodrigo Luiz

    2014-01-01

    Objective To assess the level of knowledge, perceptions and usage profile for generic drugs among laypersons. Methods A cross-sectional study was conducted with 278 volunteers (180 women and 98 men, aged 37.1±15.8 years). A questionnaire was drawn up with questions on their use, perceptions and knowledge of generic drugs. Results Most respondents (99.6%) knew that generic drugs exist, but only 48.6% were able to define them correctly, while 78.8% of the respondents had some information about generics. This information was obtained mainly through television (49.3%). In terms of generic drug characteristics, 79.1% stated that they were confident about their efficacy, 74.8% believed that generic drugs have the same effect as branded medications, 88.8% said that generics were priced lower than branded medications, and 80.2% stated that they bought generic drugs because of price. With regard to drugs prescribed by medical practitioners, 17.6% of the participants said that their doctors never prescribed generics and only 7.5% confirmed that their doctors always prescribed generics. Conclusion For the lay public, the sample in this study has sufficient knowledge of generic drugs in terms of definition, efficacy and cost. Consequently, the volunteers interviewed are very likely to use generics. Furthermore, the results of this study indicate that programs should be implemented in order to boost generic drug prescriptions by medical practitioners. PMID:25295444

  8. Polymeric nanoparticles containing diazepam: preparation, optimization, characterization, in-vitro drug release and release kinetic study

    NASA Astrophysics Data System (ADS)

    Bohrey, Sarvesh; Chourasiya, Vibha; Pandey, Archna

    2016-03-01

    Nanoparticles formulated from biodegradable polymers like poly(lactic-co-glycolic acid) (PLGA) are being extensively investigated as drug delivery systems due to their two important properties such as biocompatibility and controlled drug release characteristics. The aim of this work to formulated diazepam loaded PLGA nanoparticles by using emulsion solvent evaporation technique. Polyvinyl alcohol (PVA) is used as stabilizing agent. Diazepam is a benzodiazepine derivative drug, and widely used as an anticonvulsant in the treatment of various types of epilepsy, insomnia and anxiety. This work investigates the effects of some preparation variables on the size and shape of nanoparticles prepared by emulsion solvent evaporation method. These nanoparticles were characterized by photon correlation spectroscopy (PCS), transmission electron microscopy (TEM). Zeta potential study was also performed to understand the surface charge of nanoparticles. The drug release from drug loaded nanoparticles was studied by dialysis bag method and the in vitro drug release data was also studied by various kinetic models. The results show that sonication time, polymer content, surfactant concentration, ratio of organic to aqueous phase volume, and the amount of drug have an important effect on the size of nanoparticles. Hopefully we produced spherical shape Diazepam loaded PLGA nanoparticles with a size range under 250 nm with zeta potential -23.3 mV. The in vitro drug release analysis shows sustained release of drug from nanoparticles and follow Korsmeyer-Peppas model.

  9. Collagen as a delivery system for hydrophobic drugs: studies with cyclosporine.

    PubMed

    Gebhardt, B M; Kaufman, H E

    1995-01-01

    The time-honored approach to delivering drugs to the ocular surface is through the use of liquid drops and semisolid ointments. Such delivery systems, however, are not efficient at delivering therapeutic concentrations of drugs to the cornea and intraocularly. Over the past several years, we tested the biopolymer, collagen, as a means of delivering both hydrophilic and hydrophobic drugs to the ocular surface. This study summarizes results obtained using the hydrophobic drug, cyclosporine, incorporated into collagen shields and collagen particles. Corn oil drops containing cyclosporine were used as the control. Groups of anesthetized rabbits were fitted with collagen shields containing cyclosporine, treated topically with collagen particles containing cyclosporine suspended in an ocular surface lubricant, or given topical drops of corn oil containing cyclosporine. At intervals after a single treatment with one of the drug formulations, corneas, aqueous humor, and blood were collected for analysis of cyclosporine concentration. With either of the two collagen vehicles, peak concentrations of the drug were found in the cornea 4 hours after application. The corn oil vehicle yielded a significantly lower and earlier peak concentration (1 hour after application). By 8 hours, significant amounts of the drug were still present in the corneas of the collagen-treated animals, whereas drug levels in the corn oil treatment group had returned to baseline. Drug delivery profiles in the aqueous humor were similar, except that the amounts of drug were five times lower. No cyclosporine was detected in the blood from any of the treated animals.(ABSTRACT TRUNCATED AT 250 WORDS)

  10. Drug delivering technology for endovascular management of infrainguinal peripheral artery disease.

    PubMed

    Sarode, Karan; Spelber, David A; Bhatt, Deepak L; Mohammad, Atif; Prasad, Anand; Brilakis, Emmanouil S; Banerjee, Subhash

    2014-08-01

    Endovascular intervention has become a well-recognized treatment modality for peripheral artery disease; however, mid- and long-term outcomes have been plagued by limited durability. Plain balloon angioplasty and bare-metal stents have historically suffered from high restenosis rates leading to the need for frequent repeat revascularization procedures. The innovation of locally administered, drug-delivering balloons and stents has been a direct result of technological innovations directed toward prevention and treatment of this limitation. Over the last 5 years, numerous clinical trials investigating the use of drug-coated stents and drug-coated balloons indicate a significant improvement in endovascular treatment durability and outcomes. This review provides an up-to-date assessment of the current evidence for the use of drug-coated stents and drug-coated balloons in the treatment of femoropopliteal and infrapopliteal peripheral artery disease. Additionally, it provides an overview of the development of this technology, highlights landmark ongoing and completed clinical trials, examines evidence to support the use of drug-coated technologies in combination with other modalities, and examines promising new technological developments. Last, it summarizes the challenges and safety concerns that have delayed U.S. Food and Drug Administration approval of these devices.

  11. Evidence based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century.

    PubMed

    Chawla, Raman; Thakur, Pallavi; Chowdhry, Ayush; Jaiswal, Sarita; Sharma, Anamika; Goel, Rajeev; Sharma, Jyoti; Priyadarshi, Smruti Sagar; Kumar, Vinod; Sharma, Rakesh Kumar; Arora, Rajesh

    2013-01-01

    Plants by virtue of its composition of containing multiple constituents developed during its growth under various environmental stresses providing a plethora of chemical families with medicinal utility. Researchers are exploring this wealth and trying to decode its utility for enhancing health standards of human beings. Diabetes is dreadful lifestyle disorder of 21st century caused due to lack of insulin production or insulin physiological unresponsiveness. The chronic impact of untreated diabetes significantly affects vital organs. The allopathic medicines have five classes of drugs, or otherwise insulin in Type I diabetes, targeting insulin secretion, decreasing effect of glucagon, sensitization of receptors for enhanced glucose uptake etc. In addition, diet management, increased food fiber intake, Resistant Starch intake and routine exercise aid in managing such dangerous metabolic disorder. One of the key factors that limit commercial utility of herbal drugs is standardization. Standardization poses numerous challenges related to marker identification, active principle(s), lack of defined regulations, non-availability of universally acceptable technical standards for testing and implementation of quality control/safety standard (toxicological testing). The present study proposed an integrated herbal drug development & standardization model which is an amalgamation of Classical Approach of Ayurvedic Therapeutics, Reverse Pharmacological Approach based on Observational Therapeutics, Technical Standards for complete product cycle, Chemi-informatics, Herbal Qualitative Structure Activity Relationship and Pharmacophore modeling and, Post-Launch Market Analysis. Further studies are warranted to ensure that an effective herbal drug standardization methodology will be developed, backed by a regulatory standard guide the future research endeavors in more focused manner. PMID:23822656

  12. Evidence based herbal drug standardization approach in coping with challenges of holistic management of diabetes: a dreadful lifestyle disorder of 21st century

    PubMed Central

    2013-01-01

    Plants by virtue of its composition of containing multiple constituents developed during its growth under various environmental stresses providing a plethora of chemical families with medicinal utility. Researchers are exploring this wealth and trying to decode its utility for enhancing health standards of human beings. Diabetes is dreadful lifestyle disorder of 21st century caused due to lack of insulin production or insulin physiological unresponsiveness. The chronic impact of untreated diabetes significantly affects vital organs. The allopathic medicines have five classes of drugs, or otherwise insulin in Type I diabetes, targeting insulin secretion, decreasing effect of glucagon, sensitization of receptors for enhanced glucose uptake etc. In addition, diet management, increased food fiber intake, Resistant Starch intake and routine exercise aid in managing such dangerous metabolic disorder. One of the key factors that limit commercial utility of herbal drugs is standardization. Standardization poses numerous challenges related to marker identification, active principle(s), lack of defined regulations, non-availability of universally acceptable technical standards for testing and implementation of quality control/safety standard (toxicological testing). The present study proposed an integrated herbal drug development & standardization model which is an amalgamation of Classical Approach of Ayurvedic Therapeutics, Reverse Pharmacological Approach based on Observational Therapeutics, Technical Standards for complete product cycle, Chemi-informatics, Herbal Qualitative Structure Activity Relationship and Pharmacophore modeling and, Post-Launch Market Analysis. Further studies are warranted to ensure that an effective herbal drug standardization methodology will be developed, backed by a regulatory standard guide the future research endeavors in more focused manner. PMID:23822656

  13. Driving under the influence of non-alcohol drugs--An update. Part II: Experimental studies.

    PubMed

    Strand, M C; Gjerde, H; Mørland, J

    2016-07-01

    Experimental studies on the impairing effects of drugs of relevance to driving-related performance published between 1998 and 2015 were reviewed. Studies with on-the-road driving, driving simulators, and performance tests were included for benzodiazepines and related drugs, cannabis, opioids, stimulants, GHB, ketamine, antihistamines, and antidepressants. The findings in these experimental studies were briefly discussed in relation to a review of epidemiological studies published recently. The studies mainly concluded that there may be a significant psychomotor impairment after using benzodiazepines or related drugs, cannabis, opioids, GHB, or ketamine. Low doses of central stimulants did not seem to cause impairment of driving behavior. PMID:27257716

  14. A Comparative Study of the Attitudes of College Students and Drug Treatment Center Residents Toward Drugs, Other Drug Users and Themselves.

    ERIC Educational Resources Information Center

    Page, Richard C.; Mitchell, Sam

    1986-01-01

    Assessed the attitudes of college students and drug treatment center residents with histories of using marijuana and amphetamines. The drug treatment center residents tended to devalue themselves, drugs, and peers in the drug culture to a greater extent than the students. (Author/BL)

  15. Management of Hypercholesterolemia, Appropriateness of Therapeutic Approaches and New Drugs in Patients with High Cardiovascular Risk.

    PubMed

    Agabiti Rosei, Enrico; Salvetti, Massimo

    2016-09-01

    Control of lipid levels is one of the most effective strategies for cardiovascular (CV) event prevention. In fact, many clinical trials have clearly demonstrated that low-density lipoprotein cholesterol (LDL-C) lowering, primarily with statins, reduces major CV events and mortality. The evidence from these trials has been useful in designing the cholesterol treatment guidelines, which are mainly aimed at preventing and managing cardiovascular disease (CVD). However, available data indicate that a large proportion of patients fail to achieve lipid goals, and this is particularly frequent in patients at high or very high CV risk. Furthermore, owing to side effects, a significant percentage of patients cannot tolerate statin treatment. Hence, researchers have focused their attention on novel LDL-C-lowering agents that act via mechanisms distinct from that of statins. Among the new compounds under investigation, the monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9) seem particularly promising, having recently been shown to be well tolerated and highly effective at lowering LDL-C, with a possible effect on the occurrence of CV events. Currently, alirocumab is approved by the US Food and Drug Administration (FDA) as an adjunct to diet and maximally tolerated statin therapy for use in adults with heterozygous familial hypercholesterolemia (FH) or those with atherosclerotic CV disease who require additional LDL-C lowering; it has also been recently approved by the European Medicines Agency (EMA) for use in patients with heterozygous FH, non-familial hypercholesterolemia or mixed dyslipidemia in whom statins are ineffective or not tolerated. Evolocumab is approved by the FDA as an adjunct to diet and maximally tolerated statins for adults with hetero- and homozygous FH and those with atherosclerotic CV disease who require additional lowering of LDL-C, and by the EMA in adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct

  16. Management of Hypercholesterolemia, Appropriateness of Therapeutic Approaches and New Drugs in Patients with High Cardiovascular Risk.

    PubMed

    Agabiti Rosei, Enrico; Salvetti, Massimo

    2016-09-01

    Control of lipid levels is one of the most effective strategies for cardiovascular (CV) event prevention. In fact, many clinical trials have clearly demonstrated that low-density lipoprotein cholesterol (LDL-C) lowering, primarily with statins, reduces major CV events and mortality. The evidence from these trials has been useful in designing the cholesterol treatment guidelines, which are mainly aimed at preventing and managing cardiovascular disease (CVD). However, available data indicate that a large proportion of patients fail to achieve lipid goals, and this is particularly frequent in patients at high or very high CV risk. Furthermore, owing to side effects, a significant percentage of patients cannot tolerate statin treatment. Hence, researchers have focused their attention on novel LDL-C-lowering agents that act via mechanisms distinct from that of statins. Among the new compounds under investigation, the monoclonal antibodies to proprotein convertase subtilisin/kexin type 9 (PCSK9) seem particularly promising, having recently been shown to be well tolerated and highly effective at lowering LDL-C, with a possible effect on the occurrence of CV events. Currently, alirocumab is approved by the US Food and Drug Administration (FDA) as an adjunct to diet and maximally tolerated statin therapy for use in adults with heterozygous familial hypercholesterolemia (FH) or those with atherosclerotic CV disease who require additional LDL-C lowering; it has also been recently approved by the European Medicines Agency (EMA) for use in patients with heterozygous FH, non-familial hypercholesterolemia or mixed dyslipidemia in whom statins are ineffective or not tolerated. Evolocumab is approved by the FDA as an adjunct to diet and maximally tolerated statins for adults with hetero- and homozygous FH and those with atherosclerotic CV disease who require additional lowering of LDL-C, and by the EMA in adults with primary hypercholesterolemia or mixed dyslipidemia, as an adjunct

  17. In Vivo Studies Evaluating the Use of Contact Lenses for Drug Delivery.

    PubMed

    Hui, Alex; Willcox, Mark

    2016-04-01

    This review highlights the current state of knowledge of in vivo testing of drug-delivering contact lenses. There has been a significant increase in interest in alternative means to deliver ocular pharmaceuticals, and within the past few decades, contact lenses have emerged as a vehicle of interest because of their biocompatibility and acceptance by both eye care professionals and the public. Using techniques such as molecular imprinting, vitamin E diffusion barriers, ionic reservoirs, and drug-impregnated films, significantly improved drug release kinetics have been observed in vitro. Extension of these results into in vivo studies has thus far been limited but has led to evidence of the viability of this drug delivery platform by demonstrating improved drug residence time, drug penetration, and clinical outcomes when compared with conventional therapy such as eye drops. The evidence supporting these improvements has occurred in both animal models and small human trials and is presented within this review.

  18. In Vivo Studies Evaluating the Use of Contact Lenses for Drug Delivery.

    PubMed

    Hui, Alex; Willcox, Mark

    2016-04-01

    This review highlights the current state of knowledge of in vivo testing of drug-delivering contact lenses. There has been a significant increase in interest in alternative means to deliver ocular pharmaceuticals, and within the past few decades, contact lenses have emerged as a vehicle of interest because of their biocompatibility and acceptance by both eye care professionals and the public. Using techniques such as molecular imprinting, vitamin E diffusion barriers, ionic reservoirs, and drug-impregnated films, significantly improved drug release kinetics have been observed in vitro. Extension of these results into in vivo studies has thus far been limited but has led to evidence of the viability of this drug delivery platform by demonstrating improved drug residence time, drug penetration, and clinical outcomes when compared with conventional therapy such as eye drops. The evidence supporting these improvements has occurred in both animal models and small human trials and is presented within this review. PMID:26784709

  19. Semantic Web Ontology and Data Integration: a Case Study in Aiding Psychiatric Drug Repurposing.

    PubMed

    Liang, Chen; Sun, Jingchun; Tao, Cui

    2015-01-01

    There remain significant difficulties selecting probable candidate drugs from existing databases. We describe an ontology-oriented approach to represent the nexus between genes, drugs, phenotypes, symptoms, and diseases from multiple information sources. We also report a case study in which we attempted to explore candidate drugs effective for bipolar disorder and epilepsy. We constructed an ontology incorporating knowledge between the two diseases and performed semantic reasoning tasks with the ontology. The results suggested 48 candidate drugs that hold promise for further breakthrough. The evaluation demonstrated the validity our approach. Our approach prioritizes the candidate drugs that have potential associations among genes, phenotypes and symptoms, and thus facilitates the data integration and drug repurposing in psychiatric disorders.

  20. Incorporation of tramadol drug into Li-fluorohectorite clay: A preliminary study of a medical nanofluid

    NASA Astrophysics Data System (ADS)

    Valdés, L.; Hernández, D.; de Ménorval, L. Ch.; Pérez, I.; Altshuler, E.; Fossum, J. O.; Rivera, A.

    2016-07-01

    During the last years, clays have been increasingly explored as hosts for drugs. In the present paper, we have been able to host the non-steroidal anti-inflammatory drug, Tramadol, into the clay Li-fluorohectorite (Li-Fh). We preliminary evaluate its incorporation by means of UV spectroscopy and X ray diffraction. Our results indicate that the clay hosts the drug molecule in its interlayer space. We suggest a set of parameters to guarantee an efficient incorporation process. Future studies will concentrate on the release of the drug from the clay nanofluid.

  1. Feasibility of Providing Interventions for Injection Drug Users in Pharmacy Settings: A Case Study Among San Francisco Pharmacists

    PubMed Central

    Rose, Valerie J.; Lutnick, Alexandra; Kral, Alex H.

    2014-01-01

    In addition to syringe exchange programs, pharmacies are important venues where injection drug users (IDUs) can access non-prescription syringes and other prevention interventions. This study assessed the feasibility of providing a range of interventions for IDUs in pharmacy settings. Semi-structured qualitative interviews were conducted with 23 participants (policy makers, owner/managers, dispensing pharmacists, and pharmacy staff) from independent and chain/retail pharmacies in San Francisco, California, USA. The highest level of support was for a coupon syringe program and educational materials. Several overarching themes illustrate challenges to implementing pharmacy-based preventive interventions: time, space, sufficient staff, pharmacist training, legal considerations, pharmacist attitudes toward IDUs, and cost and reimbursement issues. This study provides concrete examples of the types of preventive services that pharmacists support and consider feasible, and illustrates that pharmacists welcome the opportunity to broaden their role as critical partners in public health matters related to injection drug use. PMID:25052881

  2. Feasibility of providing interventions for injection drug users in pharmacy settings: a case study among San Francisco pharmacists.

    PubMed

    Rose, Valerie J; Lutnick, Alexandra; Kral, Alex H

    2014-01-01

    In addition to syringe exchange programs, pharmacies are important venues where injection drug users (IDUs) can access non-prescription syringes and other prevention interventions. This study assessed the feasibility of providing a range of interventions for IDUs in pharmacy settings. Semi-structured qualitative interviews were conducted with 23 participants (policy makers, owner/managers, dispensing pharmacists, and pharmacy staff) from independent and chain/retail pharmacies in San Francisco, California, USA. The highest level of support was for a coupon syringe program and educational materials. Several overarching themes illustrate challenges to implementing pharmacy-based preventive interventions: time, space, sufficient staff, pharmacist training, legal considerations, pharmacist attitudes toward IDUs, and cost and reimbursement issues. This study provides concrete examples of the types of preventive services that pharmacists support and consider feasible, and illustrates that pharmacists welcome the opportunity to broaden their role as critical partners in public health matters related to injection drug use. PMID:25052881

  3. Cannabis: a self-medication drug for weight management? The never ending story.

    PubMed

    Bersani, Francesco Saverio; Santacroce, Rita; Coviello, Marialuce; Imperatori, Claudio; Francesconi, Marta; Vicinanza, Roberto; Minichino, Amedeo; Corazza, Ornella

    2016-02-01

    In a society highly focused on physical appearance, people are increasingly using the so-called performance and image-enhancing drugs (PIEDs) or life-style drugs as an easy way to control weight. Preliminary data from online sources (e.g. websites, drug forums, e-newsletters) suggest an increased use of cannabis amongst the general population as a PIED due to its putative weight-loss properties. The use of cannabis and/or cannabis-related products to lose weight may represent a new substance-use trend that should be carefully monitored and adequately investigated, especially in light of the well-known adverse psychiatric and somatic effects of cannabis, its possible interaction with other medications/drugs and the unknown and potentially dangerous composition of synthetic cannabimimetics preparations.

  4. Drug-induced fatty liver disease: An overview of pathogenesis and management.

    PubMed

    Satapathy, Sanjaya K; Kuwajima, Vanessa; Nadelson, Jeffrey; Atiq, Omair; Sanyal, Arun J

    2015-01-01

    Over the past decades, many drugs have been identified, that can potentially induce steatohepatitis in the predisposed individual. Classically this has been incriminated to amiodarone, perhexiline, and 4,4'-diethylaminoethoxyhexestrol (DH), all of which have been found to independently induce the histologic picture of non-alcoholic steatohepatitis (NASH). Pathogenetic mechanisms of hepatotoxicity although still evolving, demonstrate that mitochondrial dysfunction, deranged ATP production and fatty acid catabolism likely play an important role. Drugs like steroid hormones can exacerbate the pathogenetic mechanisms that lead to NASH, and other drugs like tamoxifen, cisplatin and irenotecan have been shown to precipitate latent fatty liver as well. Further research aiming to elucidate the pathogenesis of drug-induced steatosis and steatohepatitis is needed in order to better design therapeutic targets.

  5. Demand for a Medicare prescription drug benefit: exploring consumer preferences under a managed competition framework.

    PubMed

    Cline, Richard R; Mott, David A

    2003-01-01

    Several proposals for adding a prescription drug benefit to the Medicare program rely on consumer choice and market forces to promote efficiency. However, little information exists regarding: 1) the extent of price sensitivity for such plans among Medicare beneficiaries, or 2) the extent to which drug-only insurance plans using various cost-control mechanisms might experience adverse selection. Using data from a survey of elderly Wisconsin residents regarding their likely choices from a menu of hypothetical drug plans, we show that respondents are likely to be price sensitive with respect to both premiums and out-of-pocket costs but that selection problems may arise in these markets. Outside intervention may be necessary to ensure the feasibility of a market-based approach to a Medicare drug benefit. PMID:13677564

  6. 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? PMID:26333920

  7. Tyramine studies and the safety of MAOI drugs.

    PubMed

    Simpson, G M; White, K

    1984-07-01

    A major source of concern in using MAOIs is the risk of hypertensive crises, often called the "cheese effect" and thought to represent a drug-induced enhancement of the tyramine pressor effect. Several approaches to reduction of this risk are being explored, including use of inhibitors specific for the B vs. the A type of the enzyme, coadministration of tricyclic with MAOI, and development of reversible inhibitors which might be competitively displaced by tyramine. Such approaches require assessment of sensitivity to tyramine, usually given by the intravenous route. The oral tyramine pressor test, while cumbersome and in need of technical refinement, represents a significantly closer laboratory analogue to the clinical situation.

  8. Drugs usage of drivers suspected of driving under the influence of alcohol and/or drugs. A study of one week's samples in 1979 and 1993 in Finland.

    PubMed

    Lillsunde, P; Korte, T; Michelson, L; Portman, M; Pikkarainen, J; Seppälä, T

    1996-01-12

    The extent of drug use among drivers suspected of driving under the influence of alcohol and/or drugs in Finland was studied. All blood samples submitted to the laboratory during 1 week in two study periods, in 1979 (n = 298) and 1993 (n = 332), were analyzed for alcohol and psychotropic drugs. Drugs classified as hazardous to traffic safety were detected in 7.0% of the samples in 1979 and 26.8% in 1993. Benzodiazepines were the most frequently found drugs in both years: 6.0% of the cases in 1979 and 22.9% in 1993. Illegal drugs were found in 4% of the cases in 1993. Of the samples tested, 296 in 1979 and 317 in 1993 were from drivers suspected of driving under the influence of alcohol only. In 1979 every fourteenth and in 1993 every fourth of these suspected drunken drivers had drugs in their blood. Drugs, other than alcohol, were found six times more often than expected by the police. The results indicate that the trend of drug use, multidrug use and drug abuse is increasing among cases suspected of driving under the influence of alcohol/drugs.

  9. Impact of Opioid and Nonopioid Drugs on Postsurgical Pain Management in the Rat.

    PubMed

    Wilson, Natalie M; Ripsch, Matthew S; White, Fletcher A

    2016-01-01

    Aim. Nonsteroidal anti-inflammatory drugs or opioids are commonly used to control surgical pain following veterinary and clinical procedures. This study evaluated the efficacy of postoperative ketorolac or buprenorphine following abdominal surgery. Main Methods. Mean arterial pressure (MAP), heart rate, animal activity, corticosterone levels, and a nociceptive sensitivity assay were used to evaluate 18 adult male Sprague-Dawley rats which underwent aortic artery occlusion for implantation of a radiotelemetry device. The animals were treated postoperatively with intraperitoneal injections of vehicle, ketorolac (10 mg/kg), or buprenorphine (0.06 mg/kg) every 8 hours for 3 days. Key Findings. There were no consistent significant changes in any of the telemetry parameters after treatment with ketorolac compared with no saline treatment with the exception of increased MAP in the buprenorphine group during the first 48 hours when compared with other treatment groups. There was a sustained increase in fecal corticosterone levels from baseline on days 2-7 with buprenorphine compared with vehicle- or ketorolac-treated animals. All treatment conditions displayed reduced paw withdrawal thresholds (PWTs) from day 1 to day 21 following surgery. Compared with the vehicle treatment group, buprenorphine-treated animals exhibited significantly lower PWT levels from day 4 to 14 days. Significance. Given the prolonged increase in fecal corticosterone levels and pronounced changes in tactile hyperalgesia behavior in rodents subjected to buprenorphine treatment, these data suggest that ketorolac may be superior to buprenorphine for the treatment of postprocedure pain behavior in rodents. PMID:27069684

  10. Impact of Opioid and Nonopioid Drugs on Postsurgical Pain Management in the Rat

    PubMed Central

    Wilson, Natalie M.; Ripsch, Matthew S.; White, Fletcher A.

    2016-01-01

    Aim. Nonsteroidal anti-inflammatory drugs or opioids are commonly used to control surgical pain following veterinary and clinical procedures. This study evaluated the efficacy of postoperative ketorolac or buprenorphine following abdominal surgery. Main Methods. Mean arterial pressure (MAP), heart rate, animal activity, corticosterone levels, and a nociceptive sensitivity assay were used to evaluate 18 adult male Sprague-Dawley rats which underwent aortic artery occlusion for implantation of a radiotelemetry device. The animals were treated postoperatively with intraperitoneal injections of vehicle, ketorolac (10 mg/kg), or buprenorphine (0.06 mg/kg) every 8 hours for 3 days. Key Findings. There were no consistent significant changes in any of the telemetry parameters after treatment with ketorolac compared with no saline treatment with the exception of increased MAP in the buprenorphine group during the first 48 hours when compared with other treatment groups. There was a sustained increase in fecal corticosterone levels from baseline on days 2–7 with buprenorphine compared with vehicle- or ketorolac-treated animals. All treatment conditions displayed reduced paw withdrawal thresholds (PWTs) from day 1 to day 21 following surgery. Compared with the vehicle treatment group, buprenorphine-treated animals exhibited significantly lower PWT levels from day 4 to 14 days. Significance. Given the prolonged increase in fecal corticosterone levels and pronounced changes in tactile hyperalgesia behavior in rodents subjected to buprenorphine treatment, these data suggest that ketorolac may be superior to buprenorphine for the treatment of postprocedure pain behavior in rodents. PMID:27069684

  11. HIV Seropositive Drug Users’ Attitudes Towards Partner Notification (PCRS): Results from the SHIELD Study in Baltimore, Maryland

    PubMed Central

    Tobin, Karin E.; Muessig, Kathryn E.; Latkin, Carl A.

    2009-01-01

    Objective To assess the attitudes of HIV seropositive current or former drug users towards HIV partner counseling and referral services (PCRS) and to determine if opinion varies by partner type. Methods We used a cross-sectional survey using structured and semi-structured questions to measure attitudes towards PCRS. Results The majority of the sample was African-American (97%), male (63%) and had been diagnosed with HIV for a mean of 7.9 years. Most agreed that PCRS would help stop the spread of HIV and AIDS (87%). A range of reactions to scenarios of their drug and sex partners being informed were observed and included positive reactions (e.g. PCRS as a means to facilitate testing of their partners and early treatment) to negative (e.g. feelings about guilt, shame and concern about partner responses). Conclusion Data from this study indicate that HIV positive drug users view PCRS as a viable practice for preventing the spread of HIV, though barriers exist to engaging clients to identify partners. Practice Implications The range of reactions noted in this study underscore the importance of providing flexible options for PCRS based on partner type. Additional training for counselors, time for case-management and meetings with sex and drug partners and fieldwork for locating contacts are important considerations for providers. PMID:17449216

  12. Binge Drinkers, Illicit Drug Users, and Polydrug Users: An Epidemiological Study of American Collegians.

    ERIC Educational Resources Information Center

    Feigelman, William; Gorman, Bernard S.; Lee, Julia A.

    1998-01-01

    Compares four subgroups of young adult drug users based on secondary analysis of data originally collected in 1993. Consistent with results from clinical studies, polydrug users were far more likely to engage in risk-taking behaviors. Findings demonstrate the need to offer a full complement of drug rehabilitation and education services to…

  13. Beyond the Theoretical Rhetoric: A Proposal to Study the Consequences of Drug Legalization.

    ERIC Educational Resources Information Center

    Yacoubian, George S., Jr.

    2001-01-01

    In this study, the arguments surrounding the drug legalization debate are synthesized into a proposal for future research. Such a proposal illustrates that the core elements surrounding drug legalization are not only testable, but that the time may be right to consider such an empirical effort. (Author)

  14. Longitudinal HIV Risk Behavior among the Drug Abuse Treatment Outcome Studies (DATOS) Adult Sample

    ERIC Educational Resources Information Center

    Murphy, Debra A.; Brecht, Mary-Lynn; Herbeck, Diane; Evans, Elizabeth; Huang, David; Hser, Yih-Ing

    2008-01-01

    Longitudinal trajectories for HIV risk were examined over 5 years following treatment among 1,393 patients who participated in the nationwide Drug Abuse Treatment Outcome Studies. Both injection drug use and sexual risk behavior declined over time, with most of the decline occurring between intake and the first-year follow-up. However, results of…

  15. Food, Drugs, and TV: The Social Study of Corporate Science

    ERIC Educational Resources Information Center

    Schleifer, David; Penders, Bart

    2011-01-01

    This article describes the contributions in this special issue, which brings together contributions that explore the varied ways in which science is practiced, managed, contested, and abandoned in corporate settings. From these empirical contributions, the authors aim to provoke reflection on the usefulness of the demarcations between for-profit…

  16. Self-nanoemulsifying drug delivery systems (SNEDDS) for oral delivery of protein drugs: II. In vitro transport study.

    PubMed

    Rao, Sripriya Venkata Ramana; Agarwal, Payal; Shao, Jun

    2008-10-01

    To develop a self-nanoemulsifying drug delivery system (SNEDDS) for protein drugs, and particularly, to test the in vitro transport of beta-lactamase (BLM) by SNEDDS across the cell monolayer. Fluorescently labeled BLM (FITC-BLM), a model protein, formulated into 16 SNEDDS preparations through a solid dispersion technique were studied for transport across MDCK monolayer. All the SNEDDS nanoemulsions resulted in higher transport rate than the free solution. The transport rate by SNEDDS depends on the SNEDDS composition. SNEDDS NE-12-7 (oil: Lauroglycol FCC, surfactant: Cremophor EL and a cosurfactant: Transcutol HP) at the ratio of 5:4:3, rendered the highest transportation rate, 33% as compared to negligible transport by the free solution. FITC-BLM solution mixed with the surfactant and the cosurfactant of SNEDDS NE-12-7 or with blank SNEDDS NE-12-7 increased the transport only by 3.3 and 1.5 folds, respectively, compared to free solution alone. It was found that the monolayer integrity was not compromised in the presence of SNEDDS NE-12-7 or its surfactant/cosurfactant. The SNEDDS significantly increased the transport of FITC-BLM across MDCK monolayer in vitro. SNEDDS may be a potential effective delivery system for non-invasive protein drug delivery.

  17. Implementation of Anaphylaxis Management Guidelines: A Register-Based Study

    PubMed Central

    Grabenhenrich, Linus; Hompes, Stephanie; Gough, Hannah; Ruëff, Franziska; Scherer, Kathrin; Pföhler, Claudia; Treudler, Regina; Mahler, Vera; Hawranek, Thomas; Nemat, Katja; Koehli, Alice; Keil, Thomas; Worm, Margitta

    2012-01-01

    Background Anaphylaxis management guidelines recommend the use of intramuscular adrenaline in severe reactions, complemented by antihistamines and corticoids; secondary prevention includes allergen avoidance and provision of self-applicable first aid drugs. Gaps between recommendations and their implementation have been reported, but only in confined settings. Hence, we analysed nation-wide data on the management of anaphylaxis, evaluating the implementation of guidelines. Methods Within the anaphylaxis registry, allergy referral centres across Germany, Austria and Switzerland provided data on severe anaphylaxis cases. Based on patient records, details on reaction circumstances, diagnostic workup and treatment were collected via online questionnaire. Report of anaphylaxis through emergency physicians allowed for validation of registry data. Results 2114 severe anaphylaxis patients from 58 centres were included. 8% received adrenaline intravenously, 4% intramuscularly; 50% antihistamines, and 51% corticoids. Validation data indicated moderate underreporting of first aid drugs in the Registry. 20% received specific instructions at the time of the reaction; 81% were provided with prophylactic first aid drugs at any time. Conclusion There is a distinct discrepancy between current anaphylaxis management guidelines and their implementation. To improve patient care, a revised approach for medical education and training on the management of severe anaphylaxis is warranted. PMID:22590513

  18. Evaluation of utility of pharmacokinetic studies in phase I trials of two oncology drugs

    PubMed Central

    Wu, Kehua; House, Larry; Ramírez, Jacqueline; Seminerio, Michael J.; Ratain, Mark J.

    2013-01-01

    Purpose There are many phase I trials of oncology drug combinations, very few of which report clinically significant pharmacokinetic interactions. We hypothesized that the utility of such pharmacokinetic drug-drug interaction (DDI) studies is low in the absence of a mechanistic hypothesis. Experimental Design We retrospectively reviewed 152 phase I (2 drug) combination studies published in 2007–2011. Results Only 28 (18%) studies had an implicit or explicit rationale, either inhibition/induction of a drug metabolizing enzyme or transporter, co-substrates for the same enzyme or transporter, potential for end-organ toxicity, or protein binding. Only 12 (8%) studies demonstrated a statistically significant DDI, based on change in clearance (or area under the curve) of parent drug and/or active metabolite. There was a strong association between a rationale and a demonstrable drug interaction, as only 2% of studies without a rationale demonstrated a DDI, compared to 32% of studies with a rationale (Fisher’s exact test, p<10−6). Conclusion DDI studies should not be routinely performed as part of phase I trials of oncology combinations. PMID:24056785

  19. Analysis of risk factors in human bioequivalence study that incur bioinequivalence of oral drug products.

    PubMed

    Yamashita, Shinji; Tachiki, Hidehisa

    2009-01-01

    In the study of human bioequivalence (BE), newly developed oral products sometimes fail to prove BE with a reference product due to the high variability in pharmacokinetic (PK) parameters after oral absorption. In this study, risk factors that incur bioinequivalence in BE study were analyzed by applying the Biopharmaceutics Classification System (BCS). Forty-four generic products were selected from a database of BE studies in the past 10 years at Towa Pharmaceutical Co., Ltd. (Osaka, Japan), and 90% confidence interval (CI) of AUC and C(max) in human BE study for all products were converted into coefficient of variation (CV(90)). Then, the required number of subjects to confirm BE was estimated from the 90% CI in human BE study of new products. It was found that both the permeability of drugs to human intestinal membrane (P(eff)) and the dose number calculated from their water solubility did not correlate well to CV(90) and the estimated subject number in human BE study, suggesting the contribution of other factors to cause the variability in oral drug absorption. As the PK parameter of drugs, the value of AUC/dose was calculated and plotted against CV(90) and the estimated subject number by classifying drugs into 4 BCS classes. For drugs in classes 1 and 3, AUC/dose gave a clear criterion to distinguish the drugs with a high risk of bioinequivalence, where drugs with low AUC/dose showed high CV(90) and large number of subjects. It was suggested that the high metabolic clearance (for class 1 drug) and low oral absorption (for class 3 drug) could be significant factors to incur bioinequivalence in human BE study, although for drugs in classes 2 and 4, clear factors were not defined. Consequently, for drugs in BCS classes 1 and 3, risks in human BE study to incur bioinequivalence could be predicted by calculating the AUC/dose. In the case of generic drugs, since the parameter of AUC/dose is available before initiating human BE study, this finding is expected to

  20. Choosing the right laboratory: a review of clinical and forensic toxicology services for urine drug testing in pain management.

    PubMed

    Reisfield, Gary M; Goldberger, Bruce A; Bertholf, Roger L

    2015-01-01

    Urine drug testing (UDT) services are provided by a variety of clinical, forensic, and reference/specialty laboratories. These UDT services differ based on the principal activity of the laboratory. Clinical laboratories provide testing primarily focused on medical care (eg, emergency care, inpatients, and outpatient clinics), whereas forensic laboratories perform toxicology tests related to postmortem and criminal investigations, and drug-free workplace programs. Some laboratories now provide UDT specifically designed for monitoring patients on chronic opioid therapy. Accreditation programs for clinical laboratories have existed for nearly half a century, and a federal certification program for drug-testing laboratories was established in the 1980s. Standards of practice for forensic toxicology services other than workplace drug testing have been established in recent years. However, no accreditation program currently exists for UDT in pain management, and this review considers several aspects of laboratory accreditation and certification relevant to toxicology services, with the intention to provide guidance to clinicians in their selection of the appropriate laboratory for UDT surveillance of their patients on opioid therapy.

  1. Studies on pectins as potential hydrogel matrices for controlled-release drug delivery.

    PubMed

    Sungthongjeen, S; Pitaksuteepong, T; Somsiri, A; Sriamornsak, P

    1999-12-01

    Polymeric hydrogels are widely used as controlled-release matrix tablets. In the present study, we investigated high-methoxy pectins for their potential value in controlled-release matrix formulations. The effects of compression force, ratio of drug to pectin, and type of pectin on drug release from matrix tablets were also investigated. The results of the in vitro release studies show that the drug release from compressed matrix tablets prepared from pectin can be modified by changing the amount and the type of pectin in the matrix tablets. However, compression force did not significantly affect the drug release. The mechanisms controlling release rate were discussed with respect to drug diffusion through the polymer matrices, but may be more complex.

  2. Adaptive Interventions May Optimize Outcomes in Drug Courts: A Pilot Study

    PubMed Central

    Marlowe, Douglas B.; Festinger, David S.; Arabia, Patricia L.; Dugosh, Karen L.; Benasutti, Kathleen M.; Croft, Jason R.

    2009-01-01

    Adaptive interventions apply a priori decision rules for adjusting treatment services in response to participants’ clinical presentation or performance in treatment. This pilot study (N = 30) experimentally examined an adaptive intervention in a misdemeanor drug court. The participants were primarily charged with possession of marijuana (73%) or possession of drug paraphernalia (23%). Results revealed that participants in the adaptive condition had relatively higher graduation rates and required significantly less time to graduate from the program and achieve a final resolution of the case. It took an average of nearly 4 fewer months for participants in the adaptive intervention to resolve their cases as compared to drug court as-usual. Participants in the adaptive condition also reported equivalent satisfaction with the program and therapeutic alliances with their counselors. These data suggest that adaptive interventions may enhance the efficiency and effectiveness of drug courts, and justify examining adaptive interventions in large-scale drug court studies. PMID:19785978

  3. Prehospital airway management: A prospective case study.

    PubMed

    Wilbers, N E R; Hamaekers, A E W; Jansen, J; Wijering, S C; Thomas, O; Wilbers-van Rens, R; van Zundert, A A J

    2011-01-01

    We conducted a one-year prospective study involving a prehospital Emergency Medical Service in the Netherlands to investigate the incidence of failed or difficult prehospital endotracheal intubation. During the study period the paramedics were asked to fill in a registration questionnaire after every endotracheal intubation. Of the 26,271 patient contacts, 256 endotracheal intubations were performed by paramedics in one year. Endotracheal intubation failed in 12 patients (4.8%). In 12.0% of 249 patients, a Cormack and Lehane grade III laryngoscopy was reported and a grade IV laryngoscopy was reported in 10.4%. The average number of endotracheal intubations per paramedic in one year was 4.2 and varied from zero to a maximum of 12. The median time between arrival on the scene and a positive capnograph was 7 min.38 s in the case of a Cormack and Lehane grade I laryngoscopy and 14 min.58 s in the case of a Cormack and Lehane grade 4 laryngoscopy. The incidence of endotracheal intubations performed by Dutch paramedics in one year was low, but endotracheal intubation was successful in 95.2%, which is comparable with findings in international literature. Early capnography should be used consistently in prehospital airway management. PMID:21612142

  4. The role of radiology in diagnosis and management of drug mules: an update with new challenges and new diagnostic tools.

    PubMed

    Bulakci, Mesut; Cengel, Ferhat

    2016-01-01

    Emergency physicians and radiologists have been increasingly encountering internal concealment of illegal drugs. The packages commonly contain powdered solid drugs such as cocaine, heroin, methamphetamine and hashish, but they may also contain cocaine in the liquid form. The second type of package has recently been more commonly encountered, and poses a greater diagnostic challenge. As clinical evaluation and laboratory tests frequently fail to make the correct diagnosis, imaging examination is typically required. Imaging methods assume a vital role in the diagnosis, follow-up and management. Abdominal X-ray, ultrasonography, CT and MRI are used for the imaging purposes. Among the aforementioned methods, low-dose CT is state-of-the-art in these cases. It is of paramount importance that radiologists have a full knowledge of the imaging characteristics of these packages and accurately guide physicians and security officials. PMID:26867003

  5. The role of radiology in diagnosis and management of drug mules: an update with new challenges and new diagnostic tools.

    PubMed

    Bulakci, Mesut; Cengel, Ferhat

    2016-01-01

    Emergency physicians and radiologists have been increasingly encountering internal concealment of illegal drugs. The packages commonly contain powdered solid drugs such as cocaine, heroin, methamphetamine and hashish, but they may also contain cocaine in the liquid form. The second type of package has recently been more commonly encountered, and poses a greater diagnostic challenge. As clinical evaluation and laboratory tests frequently fail to make the correct diagnosis, imaging examination is typically required. Imaging methods assume a vital role in the diagnosis, follow-up and management. Abdominal X-ray, ultrasonography, CT and MRI are used for the imaging purposes. Among the aforementioned methods, low-dose CT is state-of-the-art in these cases. It is of paramount importance that radiologists have a full knowledge of the imaging characteristics of these packages and accurately guide physicians and security officials.

  6. Packers, pushers and stuffers--managing patients with concealed drugs in UK emergency departments: a clinical and medicolegal review.

    PubMed

    Booker, R J; Smith, J E; Rodger, M P

    2009-05-01

    Body packing, pushing and stuffing are methods by which illicit drugs may be carried within the human body. Patients involved in these practices may present UK emergency departments with complex medical, legal and ethical considerations. This review article examines not only the evidence behind the clinical management of these patients, but also the legal powers afforded to the authorities to authorise the use of intimate searches and diagnostic imaging for forensic purposes. Serious complications from concealed drug packets are now rare, and most asymptomatic patients may be safely discharged from hospital after assessment. Emergency surgery is indicated for body packers with cocaine poisoning and for some cases of heroin poisoning. Urgent surgery is indicated for obstruction, perforation, the passage of packet fragments and failure of conservative treatment. Guidance is given for doctors who are faced with requests from the authorities to perform intimate searches and diagnostic imaging for forensic purposes.

  7. Minimally Invasive Swine Experimental Model for the In Vivo Study of Liver Metabolism of Drugs

    PubMed Central

    Piazza, O; Romano, R; Scarpati, G; Esposito, C; Cavaglià, E; Corona, M

    2012-01-01

    Purpose To develop a clinically relevant porcine model for the study of hepatic metabolism of drugs by means of hepatic vein catheterization. Materials and Methods: review of literature and elaboration of a hypothesis, design of an experimental method. Results: recent clinical studies were conducted by withdrawing cirrhotic patients’ blood from right hepatic vein during hepatic vein pressure gradient measurements. Basing on our personal clinical experience and evaluation of research needs, an experimental model is proposed. Conclusions: contemporary measurement of peripheral and hepatic concentration of drugs by peripheral vein and hepatic vein catheterization can be used to create a reliable and reproducible porcine model to study liver metabolism of drugs in vivo. PMID:23905064

  8. Active surveillance of visual impairment due to adverse drug reactions: findings from a national study in the United Kingdom

    PubMed Central

    Cumberland, Phillippa M; Russell-Eggitt, Isabelle; Rahi, Jugnoo S

    2015-01-01

    As visual impairment (VI) due to adverse drug reactions (ADR) is rare in adults and children, there is an incomplete evidence base to inform guidance for screening and for counseling patients on the potential risks of medications. We report on suspected drugs and the eye conditions found in a national study of incidence of diagnosis of visual impairment due to suspected ADR. Case ascertainment was via the British Ophthalmological Surveillance Unit (BOSU), between March 2010 and February 2012, with follow-up after 6 months. Case definition: any child or adult with bilateral or unilateral visual impairment due to a suspected ADR, using distance acuity worse than Snellen 6/18 (logMAR 0.48) in the better eye (bilateral) or affected eye (unilateral). Anonymized patient information on potential cases was provided by managing ophthalmologists, comprising visual status before and after suspected ADR, ophthalmic condition attributable to the ADR, preexisting eye disease and prescribed medications at the time of the ADR. Permanency and causality of the visual impairment were confirmed by the managing clinician, after 6 months, using the WHO Uppsala Monitoring Committee criteria. Over 2 years, 36 eligible cases were reported of whom 23 had permanent VI. While most cases were due to drugs known to have adverse side-effects, some were unanticipated sporadic cases. Visual impairment due to ADRs is rare. However, with for example, increasing polypharmacy in the elderly, monitoring of ocular ADRs, although challenging, is necessary. PMID:25692024

  9. Management of patients with multidrug-resistant/extensively drug-resistant tuberculosis in Europe: a TBNET consensus statement

    PubMed Central

    Lange, Christoph; Abubakar, Ibrahim; Alffenaar, Jan-Willem C.; Bothamley, Graham; Caminero, Jose A.; Carvalho, Anna Cristina C.; Chang, Kwok-Chiu; Codecasa, Luigi; Correia, Ana; Crudu, Valeriu; Davies, Peter; Dedicoat, Martin; Drobniewski, Francis; Duarte, Raquel; Ehlers, Cordula; Erkens, Connie; Goletti, Delia; Günther, Gunar; Ibraim, Elmira; Kampmann, Beate; Kuksa, Liga; de Lange, Wiel; van Leth, Frank; van Lunzen, Jan; Matteelli, Alberto; Menzies, Dick; Monedero, Ignacio; Richter, Elvira; Rüsch-Gerdes, Sabine; Sandgren, Andreas; Scardigli, Anna; Skrahina, Alena; Tortoli, Enrico; Volchenkov, Grigory; Wagner, Dirk; van der Werf, Marieke J.; Williams, Bhanu; Yew, Wing-Wai; Zellweger, Jean-Pierre; Cirillo, Daniela Maria

    2014-01-01

    The emergence of multidrug-resistant (MDR) and extensively drug-resistant (XDR) tuberculosis (TB) substantially challenges TB control, especially in the European Region of the World Health Organization, where the highest prevalence of MDR/XDR cases is reported. The current management of patients with MDR/XDR-TB is extremely complex for medical, social and public health systems. The treatment with currently available anti-TB therapies to achieve relapse-free cure is long and undermined by a high frequency of adverse drug events, suboptimal treatment adherence, high costs and low treatment success rates. Availability of optimal management for patients with MDR/XDR-TB is limited even in the European Region. In the absence of a preventive vaccine, more effective diagnostic tools and novel therapeutic interventions the control of MDR/XDR-TB will be extremely difficult. Despite recent scientific advances in MDR/XDR-TB care, decisions for the management of patients with MDR/XDR-TB and their contacts often rely on expert opinions, rather than on clinical evidence. This document summarises the current knowledge on the prevention, diagnosis and treatment of adults and children with MDR/XDR-TB and their contacts, and provides expert consensus recommendations on questions where scientific evidence is still lacking. PMID:24659544

  10. A 2012 Workshop: Vaccine and Drug Ontology in the Study of Mechanism and Effect (VDOSME 2012).

    PubMed

    He, Yongqun; Toldo, Luca; Burns, Gully; Tao, Cui; Abernethy, Darrell R

    2012-01-01

    Vaccines and drugs have contributed to dramatic improvements in public health worldwide. Over the last decade, there have been efforts in developing biomedical ontologies that represent various areas associated with vaccines and drugs. These ontologies combined with existing health and clinical terminology systems (e.g., SNOMED, RxNorm, NDF-RT, MedDRA, VO, OAE, and AERO) could play significant roles on clinical and translational research. The first "Vaccine and Drug Ontology in the Study of Mechanism and Effect" workshop (VDOSME 2012) provided a platform for discussing problems and solutions in the development and application of biomedical ontologies in representing and analyzing vaccines/drugs, vaccine/drug administrations, vaccine/drug-induced immune responses (including positive host responses and adverse events), and similar topics. The workshop covered two main areas: (i) ontologies of vaccines, of drugs, and of studies thereof; and (ii) analysis of administration, mechanism and effect in terms of representations based on such ontologies. Six full-length papers included in this thematic issue focus on ontology representation and time analysis of vaccine/drug administration and host responses (including positive immune responses and adverse events), vaccine and drug adverse event text mining, and ontology-based Semantic Web applications. The workshop, together with the follow-up activities and personal meetings, provided a wonderful platform for the researchers and scientists in the vaccine and drug communities to demonstrate research progresses, share ideas, address questions, and promote collaborations for better representation and analysis of vaccine and drug-related terminologies and clinical and research data.

  11. Cavity wounds management: a multicentre pilot study.

    PubMed

    Meaume, Sylvie; Facy, Olivier; Munoz-Bongrand, Nicolas; Ribemont, Annie-Claude; Sigal, Michele-Lea; Couffinhal, Jean-Claude; Trial, Chloe; Tacca, Olivier; Bohbot, Serge

    The objective of this study was to assess acceptability (based on pain at removal), efficacy and tolerance of an absorbent and cohesive rope(UrgoClean Rope, Laboratoires Urgo) in the local management of deep cavity wounds. This study was a prospective, multicentre (13), non comparative clinical study. Patients presenting with an acute or chronic non-infected cavity wound were followed up for four weeks and assessed weekly with a physical examination, in addition to volumetric,planimetric and photographic evaluations. Pain at removal was the primary criterion, assessed on a Visual Analogic Scale. The percentage of the wound surface area reduction and volumetric reduction were considered as secondary efficacy criteria. Forty three patients were included in this study. After one week of treatment dressing removal was painless and continued to be so throughout the period of the trial(four weeks). Median surface area at baseline was 7.74 cm2 and was reduced by 54.5% at week 4 (relative area reduction). Median wound volumetric value was noted 12 ml at baseline and was reduced by 72.7% by the end of treatment. The cohesiveness of the new rope was considered very good by health professionals. No residue was observed on the wound bed during the dressing change with the new rope. There were no adverse events related to the tested rope, during this trial.Pain-free removal associated with good efficacy and tolerance were observed with this new cohesive rope in the healing process of deep cavity wounds and could represent a therapeutic alternative to the usual ropes used in such indications. PMID:24180023

  12. [Circadian rhythm study from anticipatory behavior to drug treatment].

    PubMed

    Shibata, Shigenobu

    2005-10-01

    Precise, rhythmic, daily change of the internal milieu is a conspicuous feature of all living organisms. It affects temporal patterns of all kinds of behaviors during a day and deeply influences both the social structure and daily life of individual human beings. These daily variations arise from the internal circadian mechanisms. Three functions of the endogenous clock are discriminated as rhythm generation, entrainment to light-dark cycle and output from the clock. The endogenous clock is localized in the suprachiasmatic nucleus (SCN) in mammals. Recent papers demonstrated strong expression of clock genes such as Per1, Per2 and Per3 in the SCN. Circadian oscillation is basically regulated by the transcription/translation feedback system of the Per gene in mammals. As serotonin/antidepressant and GABA/benzodiazepine drugs affect the light and non-light-induced entrainment, these drugs can regulate the circadian oscillation of clock genes and environmental stimuli-induced change of Per gene expression in the SCN. There are two main stimuli that entrain circadian rhythm, the light-dark cycle (LD) and restricted feeding. Light resets the circadian clock with induction of Per1 and Per2 gene in the SCN, the locus of a main oscillator. Mice were allowed access to food for 4 h during daytime (7 h in advance of feeding time) under LD or constant darkness. The peaks of mPer1 and mPer2 mRNA in the cerebral cortex and liver were advanced 6-12 h after 6 days of RF, whereas those in SCN were unaffected. The increase of mPer expression by RF treatment was observed in SCN-lesioned mice. The present results suggest that RF strongly entrained the expression of mPer and clock-controlled genes in the cerebral cortex and liver without affecting light-dependent SCN clock function.

  13. Pharmacokinetic drug-drug interaction study of ranolazine and metformin in subjects with type 2 diabetes mellitus.

    PubMed

    Zack, Julia; Berg, Jolene; Juan, Axel; Pannacciulli, Nicola; Allard, Martine; Gottwald, Mildred; Zhang, Heather; Shao, Yongwu; Ben-Yehuda, Ori; Jochelson, Phil

    2015-03-01

    Ranolazine and metformin may be frequently co-administered in subjects with chronic angina and co-morbid type 2 diabetes mellitus (T2DM). The potential for a drug-drug interaction was explored in two phase 1 clinical studies in subjects with T2DM to evaluate the pharmacokinetics and safety of metformin 1000 mg BID when administered with ranolazine 1000 mg BID (Study 1, N = 28) or ranolazine 500 mg BID (Study 2, N = 25) as compared to metformin alone. Co-administration of ranolazine 1000 mg BID with metformin 1000 mg BID resulted in 1.53- and 1.79-fold increases in steady-state metformin Cmax and AUCtau , respectively; co-administration of ranolazine 500 mg BID with metformin 1000 mg BID resulted in 1.22- and 1.37-fold increases in steady-state metformin Cmax and AUCtau , respectively. Co-administration of ranolazine and metformin was well tolerated in these T2DM subjects, with no serious adverse events or drug-related adverse events leading to discontinuation. The most common adverse events were nausea, diarrhea, and dizziness. These findings are consistent with a dose-related interaction between ranolazine and metformin, and suggest that a dose adjustment of metformin may not be required with ranolazine 500 mg BID; whereas, the metformin dose should not exceed 1700 mg of total daily dose when using ranolazine 1000 mg BID. PMID:27128216

  14. Interdependency Management in Universities: A Case Study

    ERIC Educational Resources Information Center

    Braun, Dietmar; Benninghoff, Martin; Ramuz, Raphaël; Gorga, Adriana

    2015-01-01

    There remains uncertainty in scientific discussions regarding the governance of universities in new public management regimes in terms of who actually "rules" in the university. Apparently, a strengthened management leadership is confronted with continuing elements of academic self-regulation and professional autonomy in knowledge…

  15. Using standardized methods for research on HIV and injecting drug use in developing/transitional countries: case study from the WHO Drug Injection Study Phase II

    PubMed Central

    Des Jarlais, Don C; Perlis, Theresa E; Stimson, Gerry V; Poznyak, Vladimir

    2006-01-01

    Background Successful cross-national research requires methods that are both standardized across sites and adaptable to local conditions. We report on the development and implementation of the methodology underlying the survey component of the WHO Drug Injection Study Phase II – a multi-site study of risk behavior and HIV seroprevalence among Injecting Drug Users (IDUs). Methods Standardized operational guidelines were developed by the Survey Coordinating Center in collaboration with the WHO Project Officer and participating site Investigators. Throughout the duration of the study, survey implementation at the local level was monitored by the Coordinating Center. Surveys were conducted in 12 different cities. Prior rapid assessment conducted in 10 cities provided insight into local context and guided survey implementation. Where possible, subjects were recruited both from drug abuse treatment centers and via street outreach. While emphasis was on IDUs, non-injectors were also recruited in cities with substantial non-injecting use of injectable drugs. A structured interview and HIV counseling/testing were administered. Results Over 5,000 subjects were recruited. Subjects were recruited from both drug treatment and street outreach in 10 cities. Non-injectors were recruited in nine cities. Prior rapid assessment identified suitable recruitment areas, reduced drug users' distrust of survey staff, and revealed site-specific risk behaviors. Centralized survey coordination facilitated local questionnaire modification within a core structure, standardized data collection protocols, uniform database structure, and cross-site analyses. Major site-specific problems included: questionnaire translation difficulties; locating affordable HIV-testing facilities; recruitment from drug treatment due to limited/selective treatment infrastructure; access to specific sub-groups of drug users in the community, particularly females or higher income groups; security problems for users

  16. Sociodemographic characteristics and drug abuse patterns of treatment-seeking illicit drug abusers in Finland, 1997-2008: the Huuti study.

    PubMed

    Onyeka, Ifeoma N; Uosukainen, Hanna; Korhonen, Maarit Jaana; Beynon, Caryl; Bell, J Simon; Ronkainen, Kimmo; Föhr, Jaana; Tiihonen, Jari; Kauhanen, Jussi

    2012-01-01

    The epidemiological part of the Huume tietokanta (HUUTI) consortium research project is the first large-scale longitudinal study of treatment-seeking illicit drug abusers in Finland. The objective of this report was to describe the sociodemographic characteristics and drug abuse patterns of treatment-seeking clients at their first visit. This study analysed baseline data of 4817 clients (3365 men and 1452 women) aged 11-65 years who sought treatment for drug abuse between 1997 and 2008 at Helsinki Deaconess Institute. Data were collected using a structured questionnaire. The majority (56%) of clients were between 15 and 24 years, educated at elementary school level (75%), and unemployed (57%). Opiates (30%) were the primary drugs of abuse. The primary drugs were mostly injected (45%) and were abused daily during the past month (44%). Cannabis was the most common secondary drug of abuse (34%). The secondary drugs were predominantly smoked (39%) or taken orally (38%) and were abused once per week or less frequently during the past month (33%). Age at initiation of illicit drug abuse ranged from 5 to 49 years. Polydrug abuse was common, with a mean consumption of 3.5 concurrent polydrug use, which were combined from 3 or more drug classes. The prevalence of lifetime/ever intravenous drug abuse was 64% and past month intravenous drug abuse was 64%, respectively, and 13% reported sharing injecting equipment during the past month. Early initiation, polydrug abuse, and risky consumption of illicit drugs were major areas of concern among the study population. Injecting drug use could place considerable burden on health services in view of complications and transmission of infectious diseases.

  17. Poly(alkylcyanoacrylate) colloidal particles as vehicles for antitumour drug delivery: a comparative study.

    PubMed

    Arias, José L; Ruiz, M A Adolfina; López-Viota, Margarita; Delgado, Angel V

    2008-03-15

    Because of the fundamental importance of new therapeutic routes for cancer treatment, a number of systems based on colloidal particles as vehicles for the delivery of chemotherapeutic agents have been devised. The target is always to provide the proper dose of the antitumour agent only at the desired locus of action, thus reducing the unwanted side effects. The systems studied in this work are nanospheres of the biodegradable polymers poly(ethyl-2-cyanoacrylate), poly(butylcyanoacrylate), poly(hexylcyanoacrylate) and poly(octylcyanoacrylate), all suitable for parenteral administration, as vehicles for 5-fluorouracil, a well studied drug used for the treatment of solid tumours. Two loading methods have been analyzed: the first one is based on drug addition during the process of generation of the particles, by an anionic emulsion/polymerization procedure, and the subsequent drug trapping in the polymeric network. The second method is based on surface adsorption in already formed nanoparticles, after incubation in the drug solution. A detailed investigation of the capabilities of the polymer particles to load this drug is described. The main factors determining the drug incorporation to the polymer network were the type of monomer, the pH and the drug concentration. The release kinetics of 5-fluorouracil is found to be controlled by the pH of the release medium, the type of drug incorporation and the type of polymer.

  18. Approaches to Recording Drug Allergies in Electronic Health Records: Qualitative Study

    PubMed Central

    Fernando, Bernard; Morrison, Zoe; Kalra, Dipak; Cresswell, Kathrin; Sheikh, Aziz

    2014-01-01

    Background Drug allergy represent an important subset of adverse drug reactions that is worthy of attention because many of these reactions are potentially preventable with use of computerised decision support systems. This is however dependent on the accurate and comprehensive recording of these reactions in the electronic health record. The objectives of this study were to understand approaches to the recording of drug allergies in electronic health record systems. Materials and Methods We undertook a case study comprising of 21 in-depth interviews with a purposefully selected group of primary and secondary care clinicians, academics, and members of the informatics and drug regulatory communities, observations in four General Practices and an expert group discussion with 15 participants from the Allergy and Respiratory Expert Resource Group of the Royal College of General Practitioners. Results There was widespread acceptance among healthcare professionals of the need for accurate recording of drug allergies and adverse drug reactions. Most drug reactions were however likely to go unreported to and/or unrecognised by healthcare professionals and, even when recognised and reported, not all reactions were accurately recorded. The process of recording these reactions was not standardised. Conclusions There is considerable variation in the way drug allergies are recorded in electronic health records. This limits the potential of computerised decision support systems to help alert clinicians to the risk of further reactions. Inaccurate recording of information may in some instances introduce new problems as patients are denied treatments that they are erroneously believed to be allergic to. PMID:24740090

  19. Top management and management science: An exploratory study in 15 Federal civilian agencies

    NASA Technical Reports Server (NTRS)

    White, M. J.

    1971-01-01

    A study of the relation between top managers in Federal agencies and the operations research and management science (OR/MS) group is reported. Sixteen managers were questioned about the following characteristics: closeness of top managers to OR/MS groups; top managers' attitudes toward the OR/MS activities; relation between closeness and these attitudes; and top managers' use of OR/MS groups. It is concluded that OR/MS is relevant to many top managers and that OR/MS has begun to play a role in decisions. Top management attitudes and actions are not related in obvious ways. The consequences to top management's use of and closeness to an OR/MS group need not be the success of the group as a professional, innovative, research-oriented unit.

  20. Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an α-blocker (tamsulosin): study protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Urinary stone disease is common, with an estimated prevalence among the general population of 2% to 3%. Ureteric stones can cause severe pain and have a significant impact on quality of life, accounting for over 15,000 hospital admissions in England annually. Uncomplicated cases of smaller stones in the lower ureter are traditionally treated expectantly. Those who fail standard care or develop complications undergo active treatment, such as extracorporeal shock wave lithotripsy or ureteroscopy with stone retrieval. Such interventions are expensive, require urological expertise and carry a risk of complications. Growing understanding of ureteric function and pathophysiology has led to the hypothesis that drugs causing relaxation of ureteric smooth muscle, such as the selective α-blocker tamsulosin and the calcium-channel blocker nifedipine, can enhance the spontaneous passage of ureteric stones. The use of drugs in augmenting stone passage, reducing the morbidity and costs associated with ureteric stone disease, is promising. However, the majority of clinical trials conducted to date have been small, poor to moderate quality and lacking in comprehensive economic evaluation. This trial aims to determine the clinical and cost-effectiveness of tamsulosin and nifedipine in the management of symptomatic urinary stones. Methods/design The SUSPEND (Spontaneous Urinary Stone Passage ENabled by Drugs) trial is a multicentre, double-blind, randomized controlled trial evaluating two medical expulsive therapy strategies (nifedipine or tamsulosin) versus placebo. Patients aged 18 to 65 with a ureteric stone confirmed by non-contrast computed tomography of the kidney, ureter and bladder will be randomized to receive nifedipine, tamsulosin or placebo (400 participants per arm) for a maximum of 28 days. The primary clinical outcome is spontaneous passage of ureteric stones at 4 weeks (defined as no further intervention required to facilitate stone passage). The

  1. Prescribing drugs for Alzheimer's disease in primary care: managing cognitive symptoms.

    PubMed

    2014-06-01

    There are currently no interventions that cure or even alter the progressive course of dementia. In the UK, donepezil, galantamine and rivastigmine are licensed for symptomatic treatment of mild to moderate Alzheimer's disease, and memantine is licensed for use in moderate to severe Alzheimer's disease.1-4 These drugs improve cognitive function by a modest amount compared with placebo.5 Although the National Institute for Health and Care Excellence (NICE) stipulates that such treatment should be initiated by a specialist, in many parts of the UK responsibility for continued prescription of these drugs is being transferred to primary care. Here we review the evidence for drugs prescribed for cognitive symptoms in Alzheimer's disease and highlight key issues for those who are prescribing them. PMID:24924683

  2. Could Education Contribute to Reduce Prevalence of HIV among Injecting Drug Users? A Case Study of IDUs from the Rehabilitation Center for Drugs Users

    ERIC Educational Resources Information Center

    Rajbhandari, Mani Man Singh

    2008-01-01

    This study primarily focuses on Injecting Drug Users (IDUs) from the Narconon Nepal for drugs rehabilitation and prevention center. The study attempt to explore the changing behavior of IDUs from the education received from the rehabilitation center which contributes to reduce the prevalence of HIV among IDUs. The data were collected through semi…

  3. Knowledge and Adherence to the National Guidelines for Malaria Case Management in Pregnancy among Healthcare Providers and Drug Outlet Dispensers in Rural, Western Kenya

    PubMed Central

    Riley, Christina; Dellicour, Stephanie; Ouma, Peter; Kioko, Urbanus; ter Kuile, Feiko O.; Omar, Ahmeddin; Kariuki, Simon; Buff, Ann M.; Desai, Meghna; Gutman, Julie

    2016-01-01

    Background Although prompt, effective treatment is a cornerstone of malaria control, information on provider adherence to malaria in pregnancy (MIP) treatment guidelines is limited. Incorrect or sub-optimal treatment can adversely affect the mother and fetus. This study assessed provider knowledge of and adherence to national case management guidelines for uncomplicated MIP. Methods We conducted a cross-sectional study from September to November 2013, in 51 health facilities (HF) and a randomly-selected sample of 39 drug outlets (DO) in the KEMRI/CDC Health and Demographic Surveillance System area in western Kenya. Provider knowledge of national treatment guidelines was assessed with standardized questionnaires. Correct practice required adequate diagnosis, pregnancy assessment, and treatment with correct drug and dosage. In HF, we conducted exit interviews in all women of childbearing age assessed for fever. In DO, simulated clients posing as first trimester pregnant women or as relatives of third trimester pregnant women collected standardized information. Results Correct MIP case management knowledge and practice were observed in 45% and 31% of HF and 0% and 3% of DO encounters, respectively. The correct drug and dosage for pregnancy trimester was prescribed in 62% of HF and 42% of DO encounters; correct prescription occurred less often in first than in second/ third trimesters (HF: 24% vs. 65%, p<0.01; DO: 0% vs. 40%, p<0.01). Sulfadoxine-pyrimethamine, which is not recommended for malaria treatment, was prescribed in 3% of HF and 18% of DO encounters. Exposure to artemether-lumefantrine in first trimester, which is contraindicated, occurred in 29% and 49% of HF and DO encounters, respectively. Conclusion This study highlights knowledge inadequacies and incorrect prescribing practices in the treatment of MIP. Particularly concerning is the prescription of contraindicated medications in the first trimester. These issues should be addressed through comprehensive

  4. Exploiting the potential of intranet for managing drug spectrum a web base publication in a Tertiary Care Hospital in Mumbai

    PubMed Central

    Shetty, Yashashri Chandrakant; Patel, Tejal Chetan; Parmar, Urwashi Indrakumar

    2015-01-01

    Objective: The study surveyed the availability of the intranet in campus and also the knowledge related to drug spectrum an intranet publication. Materials and Methods: Institutional ethics committee permission was obtained. Verbal consent was taken from the faculty and resident doctors of departments where all the facilities were available. Universal sampling method was used for recruitment. Pre-validated questionnaires were given to approximately 100 faculty and 500 resident doctors in the year 2012-2013. The questionnaire contained 15 items. Content analysis was done. The study questionnaire focused on a survey to obtain participants feedback on the use of the intranet and to evaluate the use of intranet as a source of knowledge. It also dealt on the relevance of the drug spectrum in the context of their subject. The responses were taken after giving the participants sufficient time. Data was entered into an Excel 2003 spread sheet and analyzed by using descriptive statistics. Results: The total number of respondents who participated in our study was 134 including faculty and residents from various departments. A total of 117 (89.66%) respondents stated that their departments have access to the internet. Departments having access to intranet was 103 (76.29%). 67 (49.62%) respondents have accessed. 67 (49.62%) did not have the time to visit intranet site whereas 67 (49.62%) have not accessed intranet. 89 (65.92%) respondents were not aware of the drug spectrum. 101 (74.81%) respondents felt that drug spectrum is a useful activity on intranet. 45 (33.33%) knew about the intranet periodical drug spectrum, but most of the respondents (33.33%) explained the meaning of the word drug spectrum according to their understanding, but never knew about the online intranet journal drug spectrum. Conclusion: The study found that the intranet is available in the campus, but it is not being utilized. The awareness and knowledge regarding drug spectrum is lacking, but the

  5. Insights into drug metabolism by cytochromes P450 from modelling studies of CYP2D6-drug interactions.

    PubMed

    Maréchal, J-D; Kemp, C A; Roberts, G C K; Paine, M J I; Wolf, C R; Sutcliffe, M J

    2008-03-01

    The cytochromes P450 (CYPs) comprise a vast superfamily of enzymes found in virtually all life forms. In mammals, xenobiotic metabolizing CYPs provide crucial protection from the effects of exposure to a wide variety of chemicals, including environmental toxins and therapeutic drugs. Ideally, the information on the possible metabolism by CYPs required during drug development would be obtained from crystal structures of all the CYPs of interest. For some years only crystal structures of distantly related bacterial CYPs were available and homology modelling techniques were used to bridge the gap and produce structural models of human CYPs, and thereby obtain useful functional information. A significant step forward in the reliability of these models came seven years ago with the first crystal structure of a mammalian CYP, rabbit CYP2C5, followed by the structures of six human enzymes, CYP1A2, CYP2A6, CYP2C8, CYP2C9, CYP2D6 and CYP3A4, and a second rabbit enzyme, CYP2B4. In this review we describe as a case study the evolution of a CYP2D6 model, leading to the validation of the model as an in silico tool for predicting binding and metabolism. This work has led directly to the successful design of CYP2D6 mutants with novel activity-including creating a testosterone hydroxylase, converting quinidine from inhibitor to substrate, creating a diclofenac hydroxylase and creating a dextromethorphan O-demethylase. Our modelling-derived hypothesis-driven integrated interdisciplinary studies have given key insight into the molecular determinants of CYP2D6 and other important drug metabolizing enzymes. PMID:18026129

  6. Cryogenic Propellant Management Device: Conceptual Design Study

    NASA Technical Reports Server (NTRS)

    Wollen, Mark; Merino, Fred; Schuster, John; Newton, Christopher

    2010-01-01

    Concepts of Propellant Management Devices (PMDs) were designed for lunar descent stage reaction control system (RCS) and lunar ascent stage (main and RCS propulsion) missions using liquid oxygen (LO2) and liquid methane (LCH4). Study ground rules set a maximum of 19 days from launch to lunar touchdown, and an additional 210 days on the lunar surface before liftoff. Two PMDs were conceptually designed for each of the descent stage RCS propellant tanks, and two designs for each of the ascent stage main propellant tanks. One of the two PMD types is a traditional partial four-screen channel device. The other type is a novel, expanding volume device which uses a stretched, flexing screen. It was found that several unique design features simplified the PMD designs. These features are (1) high propellant tank operating pressures, (2) aluminum tanks for propellant storage, and (3) stringent insulation requirements. Consequently, it was possible to treat LO2 and LCH4 as if they were equivalent to Earth-storable propellants because they would remain substantially subcooled during the lunar mission. In fact, prelaunch procedures are simplified with cryogens, because any trapped vapor will condense once the propellant tanks are pressurized in space.

  7. Azilsartan as a Potent Antihypertensive Drug with Possible Pleiotropic Cardiometabolic Effects: A Review Study

    PubMed Central

    Georgiopoulos, Georgios; Katsi, Vasiliki; Oikonomou, Dimitrios; Vamvakou, Georgia; Koutli, Evangelia; Laina, Aggeliki; Tsioufis, Constantinos; Nihoyannopoulos, Petros; Tousoulis, Dimitrios

    2016-01-01

    Background: Hypertension related cardiovascular (CV) complications could be amplified by the presence of metabolic co-morbidities. Azilsartan medoxomil (AZL-M) is the eighth approved member of angiotensin II receptor blockers (ARBs), a drug class of high priority in the management of hypertensive subjects with diabetes mellitus type II (DMII). Methods: Under this prism, we performed a systematic review of the literature for all relevant articles in order to evaluate the efficacy, safety, and possible clinical role of AZL-M in hypertensive diabetic patients. Results: AZL-M was found to be more effective in terms of reducing indices of blood pressure over alternative ARBs or angiotensin-converting enzyme (ACE) inhibitors with minimal side effects. Preclinical studies have established pleiotropic effects for AZL-M beyond its primary antihypertensive role through differential gene expression, up-regulation of membrane receptors and favorable effect on selective intracellular biochemical and pro-atherosclerotic pathways. Conclusion: Indirect but accumulating evidence from recent literature supports the efficacy and safety of AZL-M among diabetic patients. However, no clinical data exist to date that evince a beneficial role of AZL-M in patients with metabolic disorders on top of its antihypertensive effect. Further clinical studies are warranted to assess the pleiotropic cardiometabolic benefits of AZL-M that are derived from preclinical research. PMID:27536242

  8. The Place of Drugs in the Management of Behavior Disorders after Traumatic Brain Injury.

    ERIC Educational Resources Information Center

    Rose, Martyn J.

    1988-01-01

    The article examines the role of drug treatment stressing the need to treat disorders of brain function rather than direct behavior control. Treatment principles concern classification, dosage, monitoring effects, timing of therapy, the distinction between passive and active disorders as well as syndromal, manipulative, ritualistic, cyclothymic,…

  9. Social policy and drug dependence: an historical case study.

    PubMed

    Smart, C

    1985-11-01

    A detailed examination is presented of the background to the reports and policy developments concerning drug dependence which emerged in Britain during the 1960s. Analysis of documents and interviews with policy makers, officials and doctors involved in the events of the period, reveal that explanatory models in terms of 'moral panic' or 'power struggle' tend to oversimplify the complex processes involved. The role in policy formation of the media, government departments and groups within the medical profession is considered. The patterns of conflict and convergence are seen to overlap simple lines of 'interest'--we find conflict within the medical profession, convergence between the Home Office (legal) and elements of the medical professions (medical). The resulting legal and institutional framework involved only loose guidelines from the centre about treatment, and the shape of policy was determined by individual doctors in the new hospital treatment centres. The apparent re-run of the 1960s being staged in the 1980s will require detailed research in the future in order to avoid superficial comparisons.

  10. Application of Caco-2 Cell Line in Herb-Drug Interaction Studies: Current Approaches and Challenges

    PubMed Central

    Awortwe, C.; Fasinu, P.S.; Rosenkranz, B.

    2015-01-01

    The Caco-2 model is employed in pre-clinical investigations to predict the likely gastrointestinal permeability of drugs because it expresses cytochrome P450 enzymes, transporters, microvilli and enterocytes of identical characteristics to the human small intestine. The FDA recommends this model as integral component of the Biopharmaceutics Classification System (BCS). Most dedicated laboratories use the Caco-2 cell line to screen new chemical entities through prediction of its solubility, bioavailability and the possibility of drug-drug or herb-drug interactions in the gut lumen. However, challenges in the inherent characteristics of Caco-2 cell and inter-laboratory protocol variations have resulted to generation of irreproducible data. These limitations affect the extrapolation of data from pre-clinical research to clinical studies involving drug-drug and herb-drug interactions. This review addresses some of these caveats and enumerates the plausible current and future approaches to reduce the anomalies associated with Caco-2 cell line investigations focusing on its application in herb-drug interactions. PMID:24735758

  11. [Study on risk factors of suicidal ideation in people with drug abuse].

    PubMed

    Morita, Nobuaki; Kouda, Minoru; Umeno, Mitsuru; Ikeda, Tomohiro; Yabe, Yohko; Endo, Keiko; Abe, Yukie; Hirai, Hideyuki; Takahashi, Koji; Aikawa, Yuzo; Senoo, Eiichi

    2012-02-01

    In Japan, the target mental disorders of preventive strategies for suicide had been limited to be mood disorder, but recently drug abuse are known to be significant as a cause of suicide because some researches has found the association between substance use disorder and suicidal behavior in Japan. However, the preventive plans for suicide of drug abusers has not been developed yet. In this study we would like to examine the risk factors of suicide ideation in Japanese drug abusers. We analyzed the data of 445 drug addicts from the Nationwide Research of Drug Addiction Rehabilitation Centers by Tokyo DARC and compared many variables including demographic factors, drug use status, family history, psychopathologies, treatment and daily life satisfactions between people with suicide ideations and without ideations. It was found that 182 cases (43.8%) had suicide ideations in a recent month, and that addicts who had suicide ideations had significantly shorter abstinence time, higher prevalence of victimized experiences before 15 years age, and more mental symptoms such as insomnia, depression, and psychotic symptoms, and more tendencies to use prescribed psychotropic drug than those without suicide ideation. These results suggested that to prevent suicide of drug abusers, we should pay attention to family histories, insomnia and abstinence periods, and help them recovery from psychological damages caused by childhood trauma without inappropriate medications. PMID:22586940

  12. Mutual interaction between guest drug molecules and host nanoporous silica xerogel studied using central composite design.

    PubMed

    Li, Jing; Wang, Hongyu; Li, Heran; Xu, Lu; Guo, Yingyu; Lu, Fangzheng; Pan, Weisan; Li, Sanming

    2016-02-10

    In the present study, three water-soluble drugs (propranolol hydrochloride, PNH; diltiazem hydrochloride, DZH; levofloxacin hydrochloride, LFH) with different number of hydrogen bonding acceptors were used as guest drug molecules, and three kinds of biomimetic synthesized nanoporous silica@poly(ethyleneimine)s xerogel (NS@P xerogel, 25%NS@P xerogel and 75%NS@P xerogel) were taken as host drug carriers. Mutural interaction formed between guest drug molecules and host drug carriers were investigated using a two-level three-factorial central composite design. The results confirmed that water-soluble drug loaded three nanoporous silica carriers presented the same regular controlled release effect, which was 75%NS@P xerogel>25%NS@P xerogel>NS@P xerogel. The main contribution to burst release was the pore diameter of host carrier. Accomplishment of cumulative release in 24h can be obtained when loading guest drug molecules with small number of hydrogen bonding acceptors to host carriers with either quite small or large pore diameter. The present work can favor to explore the mutural interaction between host carrier and guest drug molecules and thus promoted the development of nanoporous silica in pharmaceutical application.

  13. Drug delivery patterns for different stenting techniques in coronary bifurcations: a comparative computational study.

    PubMed

    Cutrì, Elena; Zunino, Paolo; Morlacchi, Stefano; Chiastra, Claudio; Migliavacca, Francesco

    2013-08-01

    The treatment of coronary bifurcation lesions represents a challenge for the interventional cardiologists due to the lower rate of procedural success and the higher risk of restenosis. The advent of drug-eluting stents (DES) has dramatically reduced restenosis and consequently the request for re-intervention. The aim of the present work is to provide further insight about the effectiveness of DES by means of a computational study that combines virtual stent implantation, fluid dynamics and drug release for different stenting protocols currently used in the treatment of a coronary artery bifurcation. An explicit dynamic finite element model is developed in order to obtain realistic configurations of the implanted devices used to perform fluid dynamics analysis by means of a previously developed finite element method coupling the blood flow and the intramural plasma filtration in rigid arteries. To efficiently model the drug release, a multiscale strategy is adopted, ranging from lumped parameter model accounting for drug release to fully 3-D models for drug transport to the artery. Differences in drug delivery to the artery are evaluated with respect to local drug dosage. This model allowed to compare alternative stenting configurations (namely the Provisional Side Branch, the Culotte and the Inverted Culotte techniques), thus suggesting guidelines in the treatment of coronary bifurcation lesions and addressing clinical issues such as the effectiveness of drug delivery to lesions in the side branch, as well as the influence of incomplete strut apposition and overlapping stents.

  14. Concurrent Use of Conventional Drugs with Chinese Herbal Products in Taiwan: A Population-based Study.

    PubMed

    Chen, Ming-Chen; Lai, Jung-Nien; Chen, Pau-Chung; Wang, Jung-Der

    2013-10-01

    The increased use of Chinese herbal products (CHPs) worldwide has raised the concern of herb-drug interactions. The aim of this study was to determine the prevalence and utilization patterns of concurrent use of conventional drugs and CHPs in Taiwan. The usage and frequency of services in the co-prescription of a CHP and a conventional drug were evaluated. Subjects were recruited from a simple random sample of 1,000,000 subjects from over 22 million beneficiaries of the National Health Insurance in 2007. The logistic regression method was employed to estimate the odds ratios (ORs) for the co-prescription of a CHP and a conventional drug (CH + D) and a conventional drug alone (D-alone). The prevalence of the CH + D was 14.1%. Females, regular salary earners, and elderly (65 years and above) were more likely to consume a CHP and a conventional drug concurrently. Painkillers, especially acetaminophen, and anti-cough medicines were the top two conventional drugs that were most frequently co-prescribed with a CHP. Anti-cough medication is the most common conventional drug co-prescribed with CHP, after painkillers. We recommend that safety issues be investigated in future research and integrating both healthcare technologies may be beneficial for the overall health and quality of life of patients.

  15. Study of warfarin utilization in hospitalized patients: analysis of possible drug interactions.

    PubMed

    Guidoni, Camilo Molino; Camargo, Helen Palmira Miranda; Obreli-Neto, Paulo Roque; Girotto, Edmarlon; Pereira, Leonardo Regis Leira

    2016-10-01

    Background Drug-drug interactions in patients taking warfarin may contribute to a higher risk of adverse events. Objective To identify and evaluate the prevalence and characteristics of potential DDIs with warfarin. Methods A cross-sectional study was performed in a Brazilian tertiary hospital. The electronic prescriptions of the patients receiving warfarin between January 2004 and December 2010 were analyzed. Socio-demographic, clinical, and therapeutic variables were collected. Warfarin drug-drug interactions were classified as either risk A, B, C, D, or X according to the Lexi-Interact™ Online database. Results A total of 3048 patients were identified who were prescribed warfarin. Of the 154,161 total drug prescriptions issued, 42,120 (27.3 %) were for warfarin. Evaluation of the prescriptions showed that 63.1 and 0.1 % of patients received concomitant drugs classified as having class D or X risk. It was found that 20,539 (48.7 %) prescriptions had at least one drug with a D or X risk. Patients were prescribed an average of 1.4 (±0.4) concomitant medications with a class D or X warfarin-DDI risk, the most frequent being acetylsalicylic acid and amiodarone. Conclusion The results demonstrate a high prevalence of concomitant drug prescriptions with the potential for clinically relevant DDIs with warfarin, the most frequent being acetylsalicylic acid and amiodarone. PMID:27365092

  16. Drug use and fatal motor vehicle crashes: a case-control study.

    PubMed

    Li, Guohua; Brady, Joanne E; Chen, Qixuan

    2013-11-01

    Drugged driving is a serious safety concern, but its role in motor vehicle crashes has not been adequately studied. Using a case-control design, the authors assessed the association between drug use and fatal crash risk. Cases (n=737) were drivers who were involved in fatal motor vehicle crashes in the continental United States during specific time periods in 2007, and controls (n=7719) were participants of the 2007 National Roadside Survey of Alcohol and Drug Use by Drivers. Overall, 31.9% of the cases and 13.7% of the controls tested positive for at least one non-alcohol drug. The estimated odds ratios of fatal crash involvement associated with specific drug categories were 1.83 [95% confidence interval (CI): 1.39, 2.39] for marijuana, 3.03 (95% CI: 2.00, 4.48) for narcotics, 3.57 (95% CI: 2.63, 4.76) for stimulants, and 4.83 (95% CI: 3.18, 7.21) for depressants. Drivers who tested positive for both alcohol and drugs were at substantially heightened risk relative to those using neither alcohol nor drugs (Odds Ratio=23.24; 95% CI: 17.79, 30.28). These results indicate that drug use is associated with a significantly increased risk of fatal crash involvement, particularly when used in combination with alcohol. PMID:24076302

  17. Rapid assessment response (RAR) study: drug use and health risk - Pretoria, South Africa

    PubMed Central

    2011-01-01

    Background Within a ten year period South Africa has developed a substantial illicit drug market. Data on HIV risk among drug using populations clearly indicate high levels of HIV risk behaviour due to the sharing of injecting equipment and/or drug-related unprotected sex. While there is international evidence on and experience with adequate responses, limited responses addressing drug use and drug-use-related HIV and other health risks are witnessed in South Africa. This study aimed to explore the emerging problem of drug-related HIV transmission and to stimulate the development of adequate health services for the drug users, by linking international expertise and local research. Methods A Rapid Assessment and Response (RAR) methodology was adopted for the study. For individual and focus group interviews a semi-structured questionnaire was utilised that addressed key issues. Interviews were conducted with a total of 84 key informant (KI) participants, 63 drug user KI participants (49 males, 14 females) and 21 KI service providers (8 male, 13 female). Results and Discussion Adverse living conditions and poor education levels were cited as making access to treatment harder, especially for those living in disadvantaged areas. Heroin was found to be the substance most available and used in a problematic way within the Pretoria area. Participants were not fully aware of the concrete health risks involved in drug use, and the vague ideas held appear not to allow for concrete measures to protect themselves. Knowledge with regards to substance related HIV/AIDS transmission is not yet widespread, with some information sources disseminating incorrect or unspecific information. Conclusions The implementation of pragmatic harm-reduction and other evidence-based public health care policies that are designed to reduce the harmful consequences associated with substance use and HIV/AIDS should be considered. HIV testing and treatment services also need to be made available in

  18. Using Social Media Data to Identify Potential Candidates for Drug Repurposing: A Feasibility Study

    PubMed Central

    Liu, Hongfang; Nambisan, Priya

    2016-01-01

    Background Drug repurposing (defined as discovering new indications for existing drugs) could play a significant role in drug development, especially considering the declining success rates of developing novel drugs. Typically, new indications for existing medications are identified by accident. However, new technologies and a large number of available resources enable the development of systematic approaches to identify and validate drug-repurposing candidates. Patients today report their experiences with medications on social media and reveal side effects as well as beneficial effects of those medications. Objective Our aim was to assess the feasibility of using patient reviews from social media to identify potential candidates for drug repurposing. Methods We retrieved patient reviews of 180 medications from an online forum, WebMD. Using dictionary-based and machine learning approaches, we identified disease names in the reviews. Several publicly available resources were used to exclude comments containing known indications and adverse drug effects. After manually reviewing some of the remaining comments, we implemented a rule-based system to identify beneficial effects. Results The dictionary-based system and machine learning system identified 2178 and 6171 disease names respectively in 64,616 patient comments. We provided a list of 10 common patterns that patients used to report any beneficial effects or uses of medication. After manually reviewing the comments tagged by our rule-based system, we identified five potential drug repurposing candidates. Conclusions To our knowledge, this is the first study to consider using social media data to identify drug-repurposing candidates. We found that even a rule-based system, with a limited number of rules, could identify beneficial effect mentions in patient comments. Our preliminary study shows that social media has the potential to be used in drug repurposing. PMID:27311964

  19. Management of EGFR-inhibitor associated rash: a retrospective study in 49 patients

    PubMed Central

    2012-01-01

    Background In recent years inhibitors directed against the epidermal growth factor receptor (EGFR) have evolved as effective targeting cancer drugs. Characteristic papulopustular exanthemas, often described as acneiform rashes, are the most frequent adverse effect associated with this class of novel cancer drugs and develop in > 90% of patients. Notably, the rash may significantly compromise the patients' quality of life, thereby potentially leading to incompliance as well as dose reduction or even termination of the anti-EGFR therapy. Yet, an effective dermatologic management of cutaneous adverse effects can be achieved. Whereas various case reports, case series or expert opinions on the management of EGFR-inhibitor (EGFRI) induced rashes have been published, data on systematic management studies are sparse. Methods Here, we present a retrospective, uncontrolled, comparative study in 49 patients on three established regimens for the management of EGFRI-associated rashes. Results Strikingly, patients' rash severity improved significantly over three weeks of treatment with topical mometason furoate cream, topical prednicarbate cream plus nadifloxacin cream, as well as topical prednicarbate cream plus nadifloxacin cream plus systemic isotretinoin. Conclusions In summary our results demonstrate that EGFRI-associated rashes can be effectively managed by specific dermatologic interventions. Whereas mild to moderate rashes should be treated with basic measures in combination with topical glucocorticosteroids or combined regiments using glucocorticosteroids and antiseptics/antibiotics, more severe or therapy-resistant rashes are likely to respond with the addition of systemic retinoids. PMID:22472354

  20. Verification of a Quality Management Theory: Using a Delphi Study

    PubMed Central

    Mosadeghrad, Ali Mohammad

    2013-01-01

    Background: A model of quality management called Strategic Collaborative Quality Management (SCQM) model was developed based on the quality management literature review, the findings of a survey on quality management assessment in healthcare organisations, semi-structured interviews with healthcare stakeholders, and a Delphi study on healthcare quality management experts. The purpose of this study was to verify the SCQM model. Methods: The proposed model was further developed using feedback from thirty quality management experts using a Delphi method. Further, a guidebook for its implementation was prepared including a road map and performance measurement. Results: The research led to the development of a context-specific model of quality management for healthcare organisations and a series of guidelines for its implementation. Conclusion: A proper model of quality management should be developed and implemented properly in healthcare organisations to achieve business excellence. PMID:24596883

  1. Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

    PubMed

    Layton, Deborah; Shakir, Saad A W

    2015-02-01

    The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications.

  2. Specialist Cohort Event Monitoring studies: a new study method for risk management in pharmacovigilance.

    PubMed

    Layton, Deborah; Shakir, Saad A W

    2015-02-01

    The evolving regulatory landscape has heightened the need for innovative, proactive, efficient and more meaningful solutions for 'real-world' post-authorization safety studies (PASS) that not only align with risk management objectives to gather additional safety monitoring information or assess a pattern of drug utilization, but also satisfy key regulatory requirements for marketing authorization holder risk management planning and execution needs. There is a need for data capture across the primary care and secondary care interface, or for exploring use of new medicines in secondary care to support conducting PASS. To fulfil this need, event monitoring has evolved. The Specialist Cohort Event Monitoring (SCEM) study is a new application that enables a cohort of patients prescribed a medicine in the hospital and secondary care settings to be monitored. The method also permits the inclusion of a comparator cohort of patients receiving standard care, or another counterfactual comparator group, to be monitored concurrently, depending on the study question. The approach has been developed in parallel with the new legislative requirement for pharmaceutical companies to undertake a risk management plan as part of post-authorization safety monitoring. SCEM studies recognize that the study population comprises those patients who may have treatment initiated under the care of specialist health care professionals and who are more complex in terms of underlying disease, co-morbidities and concomitant medications than the general disease population treated in primary care. The aims of this paper are to discuss the SCEM new-user study design, rationale and features that aim to address possible bias (such as selection bias) and current applications. PMID:25564333

  3. Practical Management of Patients with a History of Immediate Hypersensitivity to Common non-Beta-Lactam Drugs.

    PubMed

    Macy, Eric

    2016-01-01

    Immediate hypersensitivity reactions to medications are among the most feared adverse drug reactions, because of their close association with anaphylaxis. This review discusses a practical management approach for patients with a history of an immediate hypersensitivity to a non-beta-lactam medication, where reexposure to the implicated, or similar, medication is clinically necessary. Mechanisms associated with severe immediate hypersensitivity reactions include IgE-mediated mast cell activation, complement-mediated mast cell activation, and direct mast cell activation. Immediate hypersensitivity reactions may also be mediated by vasodilators, other pharmacologic mechanisms, or be secondary to underlying patient-specific biochemical abnormalities such as endocrine tumors or chronic spontaneous urticaria. The key features in the reaction history and the biochemistry of the implicated medication are discussed. Most individuals with a history of immediate hypersensitivity to a medication, who require reuse of that drug, can be safely retreated with a therapeutic course of the implicated drug after a full-dose challenge, graded challenge, or desensitization, with or without premedication and/or any preliminary diagnostic testing, depending on the specific situation.

  4. Prohibiting or 'managing' conflict of interest? A review of policies and procedures in three European drug regulation agencies.

    PubMed

    Lexchin, Joel; O'Donovan, Orla

    2010-03-01

    In light of debates about the relationship between interests and scientific expert judgments, and the potential for declarations of conflict of interest (COI) to minimize corporate bias, we reviewed the approach to COI in 3 European drug regulatory bodies. These bodies were the Irish Medicines Board, the Medicines and Healthcare products Regulatory Agency in the United Kingdom and the European Medicines Agency in the European Union. Official statements about COI laws and codes of practice in the 3 contexts suggest that COIs are prohibited. In practice, the approaches to COI in the 3 drug regulatory agencies presuppose and promote the ideas that COIs cannot and need not be eliminated as the risk of bias can be managed. Because the evidence about if and how COI affects micro-level decision-making in drug regulatory authorities is neither complete nor comprehensive, we advocate a precautionary principle model. Under this model COI would be prohibited on the grounds that it might influence the outcome of regulatory decisions. PMID:19782458

  5. Drug administration in animal studies of cardiac arrest does not reflect human clinical experience

    PubMed Central

    Reynolds, Joshua C.; Rittenberger, Jon C.; Menegazzi, James J.

    2007-01-01

    Introduction To date, there is no evidence showing a benefit from any advanced cardiac life support (ACLS) medication in out-of-hospital cardiac arrest (OOHCA), despite animal data to the contrary. One explanation may be a difference in the time to first drug administration. Our previous work has shown the mean time to first drug administration in clinical trials is 19.4 minutes. We hypothesized that the average time to drug administration in large animal experiments occurs earlier than in OOHCA clinical trials. Methods We conducted a literature review between 1990 and 2006 in MEDLINE using the following MeSH headings: swine, dogs, resuscitation, heart arrest, EMS, EMT, ambulance, ventricular fibrillation, drug therapy, epinephrine, vasopressin, amiodarone, lidocaine, magnesium, and sodium bicarbonate. We reviewed the abstracts of 331 studies and 197 full manuscripts. Exclusion criteria included: non-peer reviewed, all without primary animal data, and traumatic models. From these, we identified 119 papers that contained unique information on time to medication administration. The data are reported as mean, ranges, and 95% confidence intervals. Mean time to first drug administration in animal laboratory studies and clinical trials was compared with a t-test. Regression analysis was performed to determine if time to drug predicted ROSC. Results Mean time to first drug administration in 2378 animals was 9.5 minutes (range 3.0–28.0; 95% CI around mean 2.78, 16.22). This is less than the time reported in clinical trials (19.4 min, p<0.001). Time to drug predicted ROSC (Odds Ratio 0.844; 95% CI 0.738, 0.966). Conclusion Shorter drug delivery time in animal models of cardiac arrest may be one reason for the failure of animal studies to translate successfully into the clinical arena. PMID:17360097

  6. Using textual cause-of-death data to study drug poisoning deaths.

    PubMed

    Ossiander, Eric M

    2014-04-01

    Death certificate data are often used to study the epidemiology of poisoning deaths, but the International Classification of Diseases (ICD) codes used to tabulate death data do not convey all of the available information about the drugs and other substances named on death certificates. In the United States and some other countries, the SuperMICAR computer system is used to assign ICD codes to deaths. The SuperMICAR system also stores a verbatim record of the text entered for the cause of death. We used the SuperMICAR text entries to study the 7,817 poisoning deaths that occurred among Washington State residents between 2003 and 2010. We tabulated the drugs named on death certificates and computed age-adjusted and age-specific death rates for the top-named drugs and for prescription and illicit drugs. Methadone was named on 2,149 death certificates and was the most frequently named substance, followed by alcohol, opiate, cocaine, oxycodone, and methamphetamine. For both men and women and at all ages, prescription drugs were involved in more deaths than were illicit drugs. Among the 25 drugs named most frequently, only 4 have unique ICD codes; the other 21 can be identified only by using the SuperMICAR data.

  7. Study of drug utilization pattern in dental OPD at tertiary care teaching hospital.

    PubMed

    Rehan, H S; Singh, C; Tripathi, C D; Kela, A K

    2001-01-01

    Irrational prescribing is a global phenomenon. The objective of the study was to find out the prescribing practices of dental prescribers in a tertiary care teaching hospital with special emphasis on the utilization of antimicrobial agents. A prospective study was conducted in the month of March 2000. A total of 491 prescriptions were collected randomly. Prescribing pattern was analyzed using WHO basic drug indicators. The average number of drugs for prescription was 2.4. 78.8% of all prescriptions contained antimicrobial agents. It was most commonly prescribed (40.37%) group of drugs followed by anti-inflammatory and analgesics (33.8%). Fixed dose combination of ampicillin and cloxacillin was most commonly prescribed antimicrobial agents. Prophylactic use of AMA (78%) was more than therapeutic purpose (21.9%). Prophylactic use of antimicrobial agents was irrational in all the cases as duration for the use of antimicrobial agents was 5.1 +/- 0.5 days. Fixed dose combinations (45%), drugs by brand name (98.5%) were frequently used. Drug prescribed from Essential Drug List was maximum when one drug was prescribed. Results indicate that there is a scope for improving prescribing habits and minimizing the use of antimicrobial agents. This could be facilitated by periodic education to the prescribers.

  8. HPLC/ICP-MS in combination with "reverse" online isotope dilution in drug metabolism studies.

    PubMed

    Meermann, Björn; Hulstaert, Anne; Laenen, Aline; Van Looveren, Cis; Vliegen, Maarten; Cuyckens, Filip; Vanhaecke, Frank

    2012-03-01

    During the development of a new drug compound, its metabolism needs to be unraveled. For quantification of the metabolites formed, the drug under investigation is traditionally synthesized with a radiolabel ((14)C or (3)H) and the metabolites present in different matrixes (blood, urine, feces) upon drug administration are determined by means of high-performance liquid chromatography (HPLC) coupled to radiodetection. This approach allows for quantification of the metabolites formed and enables a straightforward distinction between exogenous (i.e., drug-related) and endogenous species (as only the radiolabeled species are detected). However, in some cases, the use of a radiolabeled compound in human in vivo studies is not advisible, e.g., for drug compounds or their metabolites showing a long plasma or tissue half-life. In cases where the candidate drug molecule contains an element detectable by means of inductively coupled plasma mass spectrometry (ICP-MS), HPLC/ICP-MS is a promising alternative approach. However, the method lacks specificity when a distinction between drug-related species and endogenous compounds containing the same target element needs to be accomplished. As a result, we have developed an HPLC/ICP-MS-based method combined with "reverse" online isotope dilution ("reverse" online ID) for metabolite quantification. The methodology was evaluated by the analysis of feces samples from rats dosed with a (81)Br-labeled drug compound. The method allows for both (i) valid quantification of the drug metabolites and (ii) distinction among endogenous, exogenous, and "mixed" species, based on their isotopic "fingerprint". A good repeatability (relative standard deviation of 4.2%) and limit of detection (0.35 mg of drug compound L(-1) of feces extract), of the same order of magnitude as those observed for "normal" online ID HPLC/ICP-MS and HPLC/radiodetection, were achieved.

  9. Magnetic Nanoparticle Drug Carriers and their Study by Quadrupole Magnetic Field-Flow Fractionation

    PubMed Central

    Williams, P. Stephen; Carpino, Francesca; Zborowski, Maciej

    2009-01-01

    Magnetic nanoparticle drug carriers continue to attract considerable interest for drug targeting in the treatment of cancers and other pathological conditions. The efficient delivery of therapeutic levels of drug to a target site while limiting nonspecific, systemic toxicity requires optimization of the drug delivery materials, the applied magnetic field, and the treatment protocol. The history and current state of magnetic drug targeting is reviewed. While initial studies involved micron-sized and larger carriers, and work with these microcarriers continues, it is the sub-micron carriers or nanocarriers that are of increasing interest. An aspect of magnetic drug targeting using nanoparticle carriers that has not been considered is then addressed. This aspect involves the variation in the magnetic properties of the nanocarriers. Quadrupole magnetic field-flow fractionation (QMgFFF) is a relatively new technique for characterizing magnetic nanoparticles. It is unique in its capability of determining the distribution in magnetic properties of a nanoparticle sample in suspension. The development and current state of this technique is also reviewed. Magnetic nanoparticle drug carriers have been found by QMgFFF analysis to be highly polydisperse in their magnetic properties, and the strength of response of the particles to magnetic field gradients is predicted to vary by orders of magnitude. It is expected that the least magnetic fraction of a formulation will contribute the most to systemic toxicity, and the depletion of this fraction will result in a more effective drug carrying material. A material that has a reduced systemic toxicity will allow higher doses of cytotoxic drugs to be delivered to the tumor with reduced side effects. Preliminary experiments involving a novel method of refining a magnetic nanoparticle drug carrier to achieve this result are described. QMgFFF is used to characterize the refined and unrefined material. PMID:19591456

  10. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study

    PubMed Central

    Wang, Bo; Franklin, Jessica M; Darrow, Jonathan J

    2015-01-01

    Objective To evaluate the use of special expedited development and review pathways at the US Food and Drug Administration over the past two decades. Design Cohort study. Setting FDA approved novel therapeutics between 1987 and 2014. Population Publicly available sources provided each drug’s year of approval, their innovativeness (first in class versus not first in class), World Health Organization Anatomic Therapeutic Classification, and which (if any) of the FDA’s four primary expedited development and review programs or designations were associated with each drug: orphan drug, fast track, accelerated approval, and priority review. Main outcome measures Logistic regression models evaluated trends in the proportion of drugs associated with each of the four expedited development and review programs. To evaluate the number of programs associated with each approved drug over time, Poisson models were employed, with the number of programs as the dependent variable and a linear term for year of approval. The difference in trends was compared between drugs that were first in class and those that were not. Results The FDA approved 774 drugs during the study period, with one third representing first in class agents. Priority review (43%) was the most prevalent of the four programs, with accelerated approval (9%) the least common. There was a significant increase of 2.6% per year in the number of expedited review and approval programs granted to each newly approved agent (incidence rate ratio 1.026, 95% confidence interval 1.017 to 1.035, P<0.001), and a 2.4% increase in the proportion of drugs associated with at least one such program (odds ratio 1.024, 95% confidence interval 1.006 to 1.043, P=0.009). Driving this trend was an increase in the proportion of approved, non-first in class drugs associated with at least one program for drugs (P=0.03 for interaction). Conclusions In the past two decades, drugs newly approved by the FDA have been associated with an

  11. Alcohol and Drug Use by Queensland School Children. The First Report in a Series on the Queensland Alcohol and Drug Study.

    ERIC Educational Resources Information Center

    Turner, Terence J.; McClure, Lyndall

    The principal aim of this study is to provide information on the use and abuse of alcohol and drugs by Queensland school children, and survey their attitudes toward and knowledge about alcohol and drugs. Various questionnaires were presented to a large sample of students from grades six to twelve. Some results were: (1) from grade six to twelve…

  12. Experimental Approaches to Evaluating Writing. Study 2: "Just Say No to Drugs" and Other Unwelcome Advice: Exploring the Creation and Interpretation of Drug Education Literature. Final Report.

    ERIC Educational Resources Information Center

    Schriver, Karen A.; And Others

    A study explored how teenage audiences interpreted brochures intended to discourage them from taking drugs, and more broadly, how readers respond to the visual and verbal messages presented through brochures that aim to inform and persuade. Over 100 brochures and handouts from national and local drug prevention agencies were collected. A subset of…

  13. Neoadjuvant Window Studies of Metformin and Biomarker Development for Drugs Targeting Cancer Metabolism.

    PubMed

    Lord, Simon R; Patel, Neel; Liu, Dan; Fenwick, John; Gleeson, Fergus; Buffa, Francesca; Harris, Adrian L

    2015-05-01

    There has been growing interest in the potential of the altered metabolic state typical of cancer cells as a drug target. The antidiabetes drug, metformin, is now under intense investigation as a safe method to modify cancer metabolism. Several studies have used window of opportunity in breast cancer patients before neoadjuvant chemotherapy to correlate gene expression analysis, metabolomics, immunohistochemical markers, and metabolic serum markers with those likely to benefit. We review the role metabolite measurement, functional imaging and gene sequencing analysis play in elucidating the effects of metabolically targeted drugs in cancer treatment and determining patient selection. PMID:26063894

  14. Management case study: Tampa Bay, Florida

    USGS Publications Warehouse

    Morrison, Gerold; Greening, Holly; Yates, Kimberly K.; Wolanski, Eric; McLusky, Donald S.

    2011-01-01

    Tampa Bay, Florida, USA, is a shallow, subtropical estuary that experienced severe cultural eutrophication between the 1940s and 1980s, a period when the human population of its watershed quadrupled. In response, citizen action led to the formation of a public- and private-sector partnership (the Tampa Bay Estuary Program), which adopted a number of management objectives to support the restoration and protection of the bay’s living resources. These included numeric chlorophyll a and water-clarity targets, as well as long-term goals addressing the spatial extent of seagrasses and other selected habitat types, to support estuarine-dependent faunal guilds. Over the past three decades, nitrogen controls involving sources such as wastewater treatment plants, stormwater conveyance systems, fertilizer manufacturing and shipping operations, and power plants have been undertaken to meet these and other management objectives. Cumulatively, these controls have resulted in a 60% reduction in annual total nitrogen (TN) loads relative to earlier worse-case (latter 1970s) conditions. As a result, annual water-clarity and chlorophyll a targets are currently met in most years, and seagrass cover measured in 2008 was the highest recorded since 1950. Factors that have contributed to the observed improvements in Tampa Bay over the past several decades include the following: (1) Development of numeric, science-based water-quality targets to meet a long-term goal of restoring seagrass acreage to 1950s levels. Empirical and mechanistic models found that annual average chlorophyll a concentrations were a primary manageable factor affecting light attenuation. The models also quantified relationships between TN loads, chlorophyll a concentrations, light attenuation, and fluctuations in seagrass cover. The availability of long-term monitoring data, and a systematic process for using the data to evaluate the effectiveness of management actions, has allowed managers to track progress and

  15. Space station human productivity study. Volume 5: Management plans

    NASA Technical Reports Server (NTRS)

    1985-01-01

    The 67 Management Plans represent recommended study approaches for resolving 108 of the 305 Issues which were identified. Each study Management Plan is prepared in three formats: Management Plan Overview (lists the subsumed Issues, study background, and related overview information); Study Plan (details the study approach by tasks, lists special needs, and describes expected study products); Schedule-Task Flow (provides a time-lined schedule for the study tasks and resource requirements). The Management Relationships Matrix, included in this volume, shows the data input-output relationships among all recommended studies. A listing is also included which cross-references the unresolved requirements to Issues to management plans. A glossary of all abbreviations utilized is provided.

  16. Organ-on-a-Chip Platforms for Studying Drug Delivery Systems

    PubMed Central

    Bhise, Nupura S.; Ribas, João; Manoharan, Vijayan; Zhang, Yu Shrike; Polini, Alessandro; Massa, Solange; Dokmeci, Mehmet R.; Khademhosseini, Ali

    2014-01-01

    Novel microfluidic tools allow new ways to manufacture and test drug delivery systems. Organ-on-a-chip systems – microscale recapitulations of complex organ functions – promise to improve the drug development pipeline. This review highlights the importance of integrating microfluidic networks with 3D tissue engineered models to create organ-on-a-chip platforms, able to meet the demand of creating robust preclinical screening models. Specific examples are cited to demonstrate the use of these systems for studying the performance of drug delivery vectors and thereby reduce the discrepancies between their performance at preclinical and clinical trials. We also highlight the future directions that need to be pursued by the research community for these proof-of-concept studies to achieve the goal of accelerating clinical translation of drug delivery nanoparticles. PMID:24818770

  17. Spectroscopic study of antileishmanial drug incubated in the promastigotes of Leishmania mexicana

    NASA Astrophysics Data System (ADS)

    Hung, J.; Castillo, J.; Jiménez, G.; Hasegawa, M.; Rodriguez, M.

    2003-11-01

    In this work we present spectroscopic study of Boldine (aporphine alkaloid) that possesses important biological activities, in particular, in interaction with the promastigotes of Leishmania mexicana. The results show the applicability of autofluorescence of this drug to determinate the possible mechanism of its biological action. The blue shift and hyperchromic effect in the emission spectrum of the drug in interaction with the parasite cells indicate an energy transference process between them. The morphological change of cell shape of the promastigotes treated with the drug is observed using confocal microscopy. This morphological cell-shape transformation evidences an important interaction between the drug studied and some protein of the parasite cell. Here we describe for the first time the fluorescence properties of the Boldine in the promastigotes of L. mexicana.

  18. Embarking on large-scale qualitative research: reaping the benefits of mixed methods in studying youth, clubs and drugs

    PubMed Central

    Hunt, Geoffrey; Moloney, Molly; Fazio, Adam

    2012-01-01

    Qualitative research is often conceptualized as inherently small-scale research, primarily conducted by a lone researcher enmeshed in extensive and long-term fieldwork or involving in-depth interviews with a small sample of 20 to 30 participants. In the study of illicit drugs, traditionally this has often been in the form of ethnographies of drug-using subcultures. Such small-scale projects have produced important interpretive scholarship that focuses on the culture and meaning of drug use in situated, embodied contexts. Larger-scale projects are often assumed to be solely the domain of quantitative researchers, using formalistic survey methods and descriptive or explanatory models. In this paper, however, we will discuss qualitative research done on a comparatively larger scale—with in-depth qualitative interviews with hundreds of young drug users. Although this work incorporates some quantitative elements into the design, data collection, and analysis, the qualitative dimension and approach has nevertheless remained central. Larger-scale qualitative research shares some of the challenges and promises of smaller-scale qualitative work including understanding drug consumption from an emic perspective, locating hard-to-reach populations, developing rapport with respondents, generating thick descriptions and a rich analysis, and examining the wider socio-cultural context as a central feature. However, there are additional challenges specific to the scale of qualitative research, which include data management, data overload and problems of handling large-scale data sets, time constraints in coding and analyzing data, and personnel issues including training, organizing and mentoring large research teams. Yet large samples can prove to be essential for enabling researchers to conduct comparative research, whether that be cross-national research within a wider European perspective undertaken by different teams or cross-cultural research looking at internal divisions

  19. Embarking on large-scale qualitative research: reaping the benefits of mixed methods in studying youth, clubs and drugs.

    PubMed

    Hunt, Geoffrey; Moloney, Molly; Fazio, Adam

    2011-12-21

    Qualitative research is often conceptualized as inherently small-scale research, primarily conducted by a lone researcher enmeshed in extensive and long-term fieldwork or involving in-depth interviews with a small sample of 20 to 30 participants. In the study of illicit drugs, traditionally this has often been in the form of ethnographies of drug-using subcultures. Such small-scale projects have produced important interpretive scholarship that focuses on the culture and meaning of drug use in situated, embodied contexts. Larger-scale projects are often assumed to be solely the domain of quantitative researchers, using formalistic survey methods and descriptive or explanatory models.In this paper, however, we will discuss qualitative research done on a comparatively larger scale-with in-depth qualitative interviews with hundreds of young drug users. Although this work incorporates some quantitative elements into the design, data collection, and analysis, the qualitative dimension and approach has nevertheless remained central. Larger-scale qualitative research shares some of the challenges and promises of smaller-scale qualitative work including understanding drug consumption from an emic perspective, locating hard-to-reach populations, developing rapport with respondents, generating thick descriptions and a rich analysis, and examining the wider socio-cultural context as a central feature. However, there are additional challenges specific to the scale of qualitative research, which include data management, data overload and problems of handling large-scale data sets, time constraints in coding and analyzing data, and personnel issues including training, organizing and mentoring large research teams. Yet large samples can prove to be essential for enabling researchers to conduct comparative research, whether that be cross-national research within a wider European perspective undertaken by different teams or cross-cultural research looking at internal divisions and

  20. Characterization of the Context of Drug Concepts in Research Protocols: An Empiric Study to Guide Ontology Development

    PubMed Central

    Cimino, James J.; Huser, Vojtech

    2015-01-01

    We examined a large body of research study documents (protocols) to identify mentions of drug concepts and established base concepts and roles needed to characterize the semantics of these instances. We found these concepts in three general situations: background knowledge about the drug, study procedures involving the drug, and other roles of the drug in the study. We identified 18 more specific contexts (e.g., adverse event information, administration and dosing of the drug, and interactions between the study drug and other drugs). The ontology was validated against a test set of protocol documents from NIH and ClinicalTrial.gov. The goal is to support the automated extraction of drug information from protocol documents to support functions such as study retrieval, determination of subject eligibility, generation of order sets, and creation of logic for decision support alerts and reminders. Further work is needed to formally extend existing ontologies of clinical research. PMID:26958176

  1. A cross-sectional study of factors related to gastrointestinal drug use in Korean adolescents.

    PubMed

    Lee, Kyung Eun; Hwang, Se Jung; Gwak, Hye Sun; Lee, Byung Koo; Bae, Seung Jin; Rhie, Sandy

    2013-10-01

    Adolescence is critical in the habituation of diverse lifestyles and is a base for future physical well-being. Although gastrointestinal disorders are frequently reported in adolescents, studies related to GI drug use or related factors in Korean adolescents are rare. Thus, this study examined Korean adolescents for the use of GI drugs for abdominal symptoms and analyzed the associated factors. This cross-sectional study was done with a total of 2,416 students who completed a given questionnaire. The health-related questions included GI medication intake, smoking, alcohol, caffeine, regular exercise, self-cognitive health level, GI symptom, non-steroidal anti-inflammatory drugs (NSAIDs) intake, and sleep problems. In questions about GI medication intake, drugs included digestives and antacids. And the intake of GI drugs more than once during the past 1 month was regarded as taking GI drugs. The sociodemographic questions included age, gender, grade, number of close friends, extracurricular activities, and school performance. The overall prevalence for taking GI drugs, including antacids and digestives, was 17.4 %. When students taking GI drugs were compared with those not taking GI drugs, the former group showed higher rates of girls (P < 0.001) and participants in extracurricular activities (P < 0.05) than the latter group. Factors including alcohol, caffeine, self-cognitive health levels, and GI symptoms showed statistical significance with the rate of GI drug intake. The rate of GI drug intake in NSAID users was 2.7 times higher than that in non-users (P < 0.001). The prevalence rate of every sleep problem was higher in students taking GI medications except snoring, witnessed apnea, and teeth grinding. From the multiple regression, it was found that gender (female), extracurricular activities, alcohol intake, self-cognitive health levels, NSAIDs intake, and nightmares were related factors to GI drug intake. Based on the results, it was conclude that

  2. Infrared spectroscopic studies to understand the effect of drugs at molecular level

    NASA Astrophysics Data System (ADS)

    Singh, Bhawana; Gautam, Rekha; Chandrasekar, Bhagawat; Rakshit, Srabanti; Kumar B. N., Vinay; Boopathy, Sivaraman; Nandi, Dipankar; Somasundaram, Kumaravel; Umapathy, Siva

    2012-06-01

    In the recent past, there have been enormous efforts to understand effect of drugs on human body. Prior to understand the effect of drugs on human body most of the experiments are carried out on cells or model organisms. Here we present our study on the effect of chemotherapeutic drugs on cancer cells and the acetaminophen (APAP) induced hepatotoxicity in mouse model. Histone deacetylase inhibitors (HDIs) have attracted attention as potential drug molecules for the treatment of cancer. These are the chemotherapeutic drugs which have indirect mechanistic action against cancer cells via acting against histone deacetylases (HDAC). It has been known that different HDAC enzymes are over-expressed in various types of cancers for example; HDAC1 is over expressed in prostate, gastric and breast carcinomas. Therefore, in order to optimise chemotherapy, it is important to determine the efficacy of various classes of HDAC inhibitor drugs against variety of over-expressed HDAC enzymes. In the present study, FTIR microspectroscopy has been employed to predict the acetylation and propionylation brought in by HDIs. The liver plays an important role in cellular metabolism and is highly susceptible to drug toxicity. APAP which is an analgesic and antipyretic drug is extensively used for therapeutic purposes and has become the most common cause of acute liver failure (ALF). In the current study, we have focused to understand APAP induced hepatotoxicity using FTIR microspectroscopy. In the IR spectrum the bands corresponding to glycogen, ester group and were found to be suitable markers to predict liver injury at early time point (0.5hr) due to APAP both in tissue and serum in comparison to standard biochemical assays. Our studies show the potential of FTIR spectroscopy as a rapid, sensitive and non invasive detection technique for future clinical diagnosis.

  3. Semantic Web Ontology and Data Integration: a Case Study in Aiding Psychiatric Drug Repurposing

    PubMed Central

    Liang, Chen; Sun, Jingchun; Tao, Cui

    2016-01-01

    Despite ongoing progress towards treating mental illness, there remain significant difficulties in selecting probable candidate drugs from the existing database. We describe an ontology — oriented approach aims to represent the nexus between genes, drugs, phenotypes, symptoms, and diseases from multiple information sources. Along with this approach, we report a case study in which we attempted to explore the candidate drugs that effective for both bipolar disorder and epilepsy. We constructed an ontology that incorporates the knowledge between the two diseases and performed semantic reasoning task on the ontology. The reasoning results suggested 48 candidate drugs that hold promise for a further breakthrough. The evaluation was performed and demonstrated the validity of the proposed ontology. The overarching goal of this research is to build a framework of ontology — based data integration underpinning psychiatric drug repurposing. This approach prioritizes the candidate drugs that have potential associations among genes, phenotypes and symptoms, and thus facilitates the data integration and drug repurposing in psychiatric disorders. PMID:27570661

  4. Diagnosis, monitoring and management of immune-related adverse drug reactions of anti-PD-1 antibody therapy.

    PubMed

    Eigentler, Thomas K; Hassel, Jessica C; Berking, Carola; Aberle, Jens; Bachmann, Oliver; Grünwald, Viktor; Kähler, Katharina C; Loquai, Carmen; Reinmuth, Niels; Steins, Martin; Zimmer, Lisa; Sendl, Anna; Gutzmer, Ralf

    2016-04-01

    PD-1 checkpoint inhibitors are associated with a specific spectrum of immune-related adverse events. This spectrum is different from toxicities known for kinase inhibitors or cytotoxic drugs. Since PD-1 directed therapies show effectivity in an increasing number of malignant diseases, their clinical usage will increase rapidly. Therefore clinicians from different specialities such as medical oncology, internal medicine, family doctors and emergency unit staff should be aware of the adverse effects of PD-1 checkpoint inhibitors to avoid delays in diagnosis and treatment. Based on pooled data from pivotal trials as reported by the European Medicines Agency, the present paper reviews incidences and kinetics of onset and resolution of immune-mediated "adverse events of specific interest" (AEOSI) of both approved PD-1 inhibitors nivolumab and pembrolizumab. In general, the severity of AEOSI is mild to moderate (grade 1-2); the frequency of immune-mediated but also idiopathic grade 3-4 adverse drug reactions is ⩽2% for any event term. Recommendations for the diagnosis, monitoring and management of the relevant dermatological, gastrointestinal, pulmonary, endocrine, renal and hepatic toxicities are convened by an expert panel that consolidated and clarified treatment recommendations after the onset of AEOSI. Although the time of onset is not predictable - the medians range from 1 to 6months - the huge majority of events is reversible, with no impact of the time of onset. By the systemic use of glucocorticoids, notably methylprednisolone or equivalents, most AEOSI are well manageable. Non-steroidal immunosuppressants may be used in certain cases of refractory/recalcitrant, long-lasting immune toxicities. With regard to the outstanding clinical activity of the anti-PD-1 antibodies, therapy restart is the principal therapeutic option after recovery of grade 2 AEOSI, or diminution of higher grade skin or endocrine events to mild severity. Early diagnosis and close clinical

  5. Impotence Drugs Won't Raise Melanoma Risk, Study Suggests

    MedlinePlus

    ... in these patients is likely due to more sun exposure To use the sharing features on this page, ... in some cases. In particular, they suggested that sun exposure may play a big role. The study was ...

  6. Quantitative analysis of multiple sclerosis patients’ preferences for drug treatment: a best–worst scaling study

    PubMed Central

    Lynd, Larry D.; Traboulsee, Anthony; Marra, Carlo A.; Mittmann, Nicole; Evans, Charity; Li, Kathy H.; Carter, Melanie; Hategekimana, Celestin

    2016-01-01

    Background: With recent developments in drug therapy for multiple sclerosis (MS), new treatment options have become available presenting patients with complex treatment decisions. Objectives: The objective of this study was to elicit patients’ preferences for different attributes of MS drug therapy. Methods: A representative sample of patients with MS across Canada (n=189) participated in a best–worst scaling study to quantify preferences for different attributes of MS drug therapy, including delaying progression, improving symptoms, preventing relapse, minor side effects, rare but serious adverse events (SAEs), and route of administration. Conditional logit models were fitted to estimate the relative importance of each attribute in influencing patients’ preferences. Results: A latent-class analysis revealed heterogeneity of preferences across respondents, with preferences differing across five classes. The most important attributes of drug therapy were the avoidance of SAEs for three classes and the improvement of symptoms for two other classes. Only a smaller group of patients demonstrated a specific preference for avoiding SAEs, and route of administration. Conclusion: This study shows that preferences for drug therapy among patients with MS are different, some of which can be explained by experiences with their disease and treatment. These findings can help to inform the focus of interactions that healthcare practitioners have with patients with MS, as well as further drug development. PMID:27366235

  7. Use of Prescription Drug Samples in the USA: A Descriptive Study with Considerations for Pharmacoepidemiology

    PubMed Central

    Hampp, Christian; Greene, Patty; Pinheiro, Simone P.

    2016-01-01

    Introduction Free prescription drug samples provided in physician offices can lead to exposure misclassification in pharmacoepidemiologic studies that rely on pharmacy claims data. Methods We quantified drug-specific sample provision rates based on nationally projected data from a survey of over 3200 US office-based physicians for 1993–2013. Results Between 2009 and 2013, a total of 44.7 % of newly initiated brand-only sitagliptin but only 3.6 % of generically available metformin therapy was provided as samples. We observed similar discrepancies between newly initiated rosuvastatin and simvastatin, dabigatran and warfarin, atomoxetine and methylphenidate, and between oral antibiotic drugs. During continued therapy, sample use was still present though to a lesser extent (sitagliptin 17.0 %, rosuvastatin 23.9 %), and remained high for some oral contraceptives (norethindrone 55.8 %). Oral contraceptives had the longest average days of sample supply (levonorgestrel, continued use 85.1 days). The average days of supply for all other chronically used study drugs ranged from 13.4 (dabigatran, new use) to 25.3 (exenatide, continued use) per sample provided. From 1993 to 2013, we found pronounced drops in sample provisions over time coinciding with more recent generic approval dates. Conclusions We observed markedly differential exposure to medication samples between branded and generic drugs. This can introduce bias in pharmacoepidemiologic studies, especially when adverse events that occur soon after drug initiation are of interest. PMID:26798052

  8. Drug-induced QT interval prolongation: does ethnicity of the thorough QT study population matter?

    PubMed Central

    Shah, Rashmi R

    2013-01-01

    Inter-ethnic differences in drug responses have been well documented. Drug-induced QT interval prolongation is a major safety concern and therefore, regulatory authorities recommend a clinical thorough QT study (TQT) to investigate new drugs for their QT-prolonging potential. A positive study, determined by breach of a preset regulatory threshold, significantly influences late phase clinical trials by requiring intense ECG monitoring. A few studies that are currently available, although not statistically conclusive at present, question the assumption that ethnicity of the study population may not influence the outcome of a TQT study. Collective consideration of available pharmacogenetic and clinical information suggests that there may be inter-ethnic differences in QT-prolonging effects of drugs and that Caucasians may be more sensitive than other populations. The information also suggest s that (a) these differences may depend on the QT-prolonging potency of the drug and (b) exposure–response (E–R) analysis may be more sensitive than simple changes in QTc interval in unmasking this difference. If the QT response in Caucasians is generally found to be more intense than in non-Caucasians, there may be significant regulatory implications for domestic acceptance of data from a TQT study conducted in foreign populations. However, each drug will warrant an individual consideration when extrapolating the results of a TQT studyfrom one ethnic population to another and the ultimate clinical relevance of any difference. Further adequately designed and powered studies, investigating the pharmacologic properties and E–R relationships of additional drugs with different potencies, are needed in Caucasians, Oriental/Asian and African populations before firm conclusions can be drawn. PMID:22882246

  9. Drugs As Instruments: Describing and Testing a Behavioral Approach to the Study of Neuroenhancement.

    PubMed

    Brand, Ralf; Wolff, Wanja; Ziegler, Matthias

    2016-01-01

    Neuroenhancement (NE) is the non-medical use of psychoactive substances to produce a subjective enhancement in psychological functioning and experience. So far empirical investigations of individuals' motivation for NE however have been hampered by the lack of theoretical foundation. This study aimed to apply drug instrumentalization theory to user motivation for NE. We argue that NE should be defined and analyzed from a behavioral perspective rather than in terms of the characteristics of substances used for NE. In the empirical study we explored user behavior by analyzing relationships between drug options (use over-the-counter products, prescription drugs, illicit drugs) and postulated drug instrumentalization goals (e.g., improved cognitive performance, counteracting fatigue, improved social interaction). Questionnaire data from 1438 university students were subjected to exploratory and confirmatory factor analysis to address the question of whether analysis of drug instrumentalization should be based on the assumption that users are aiming to achieve a certain goal and choose their drug accordingly or whether NE behavior is more strongly rooted in a decision to try or use a certain drug option. We used factor mixture modeling to explore whether users could be separated into qualitatively different groups defined by a shared "goal × drug option" configuration. Our results indicate, first, that individuals' decisions about NE are eventually based on personal attitude to drug options (e.g., willingness to use an over-the-counter product but not to abuse prescription drugs) rather than motivated by desire to achieve a specific goal (e.g., fighting tiredness) for which different drug options might be tried. Second, data analyses suggested two qualitatively different classes of users. Both predominantly used over-the-counter products, but "neuroenhancers" might be characterized by a higher propensity to instrumentalize over-the-counter products for virtually all

  10. Drugs As Instruments: Describing and Testing a Behavioral Approach to the Study of Neuroenhancement.

    PubMed

    Brand, Ralf; Wolff, Wanja; Ziegler, Matthias

    2016-01-01

    Neuroenhancement (NE) is the non-medical use of psychoactive substances to produce a subjective enhancement in psychological functioning and experience. So far empirical investigations of individuals' motivation for NE however have been hampered by the lack of theoretical foundation. This study aimed to apply drug instrumentalization theory to user motivation for NE. We argue that NE should be defined and analyzed from a behavioral perspective rather than in terms of the characteristics of substances used for NE. In the empirical study we explored user behavior by analyzing relationships between drug options (use over-the-counter products, prescription drugs, illicit drugs) and postulated drug instrumentalization goals (e.g., improved cognitive performance, counteracting fatigue, improved social interaction). Questionnaire data from 1438 university students were subjected to exploratory and confirmatory factor analysis to address the question of whether analysis of drug instrumentalization should be based on the assumption that users are aiming to achieve a certain goal and choose their drug accordingly or whether NE behavior is more strongly rooted in a decision to try or use a certain drug option. We used factor mixture modeling to explore whether users could be separated into qualitatively different groups defined by a shared "goal × drug option" configuration. Our results indicate, first, that individuals' decisions about NE are eventually based on personal attitude to drug options (e.g., willingness to use an over-the-counter product but not to abuse prescription drugs) rather than motivated by desire to achieve a specific goal (e.g., fighting tiredness) for which different drug options might be tried. Second, data analyses suggested two qualitatively different classes of users. Both predominantly used over-the-counter products, but "neuroenhancers" might be characterized by a higher propensity to instrumentalize over-the-counter products for virtually all

  11. Drugs As Instruments: Describing and Testing a Behavioral Approach to the Study of Neuroenhancement

    PubMed Central

    Brand, Ralf; Wolff, Wanja; Ziegler, Matthias

    2016-01-01

    Neuroenhancement (NE) is the non-medical use of psychoactive substances to produce a subjective enhancement in psychological functioning and experience. So far empirical investigations of individuals' motivation for NE however have been hampered by the lack of theoretical foundation. This study aimed to apply drug instrumentalization theory to user motivation for NE. We argue that NE should be defined and analyzed from a behavioral perspective rather than in terms of the characteristics of substances used for NE. In the empirical study we explored user behavior by analyzing relationships between drug options (use over-the-counter products, prescription drugs, illicit drugs) and postulated drug instrumentalization goals (e.g., improved cognitive performance, counteracting fatigue, improved social interaction). Questionnaire data from 1438 university students were subjected to exploratory and confirmatory factor analysis to address the question of whether analysis of drug instrumentalization should be based on the assumption that users are aiming to achieve a certain goal and choose their drug accordingly or whether NE behavior is more strongly rooted in a decision to try or use a certain drug option. We used factor mixture modeling to explore whether users could be separated into qualitatively different groups defined by a shared “goal × drug option” configuration. Our results indicate, first, that individuals' decisions about NE are eventually based on personal attitude to drug options (e.g., willingness to use an over-the-counter product but not to abuse prescription drugs) rather than motivated by desire to achieve a specific goal (e.g., fighting tiredness) for which different drug options might be tried. Second, data analyses suggested two qualitatively different classes of users. Both predominantly used over-the-counter products, but “neuroenhancers” might be characterized by a higher propensity to instrumentalize over-the-counter products for

  12. Open drug scenes and drug-related public nuisance: a visual rapid assessment research study in Dublin, Ireland.

    PubMed

    Van Hout, Marie Claire; Bingham, Tim

    2013-01-01

    The research was undertaken at a time of increasing public concerns for drug- and alcohol-related public nuisance in the city center of Dublin, Ireland. Rapid Assessment Research was conducted involving qualitative interviewing with drug service users; business, transport, community, voluntary, and statutory stakeholders (n = 61); and an environmental mapping exercise. The interplay between homelessness, loitering, an influx of drug users via city metro systems, transient open drug scenes, street drinking, drug injecting, intimidation, knife crime, and prescribed medication abuse was evident. Potential strategies to address drug and alcohol related public nuisance are advised to include the relocation of treatment services, targeted harm reduction initiatives, urban regeneration, improved community rehabilitation pathways, and heightened policing intensity.

  13. Assessment of the consistency among three drug compendia in listing and ranking of drug-drug interactions

    PubMed Central

    Nikolić, Božana S.; Ilić, Maja S.

    2013-01-01

    Inconsistent information about drug-drug interactions can cause variations in prescribing, and possibly increase the incidence of morbidity and mortality. The aim of this study was to assess whether there is an inconsistency in drug-drug interaction listing and ranking in three authoritative, freely accessible online drug information sources: The British National Formulary; The Compendium about Drugs Licensed for Use in the United Kingdom (the Electronic Medicines Compendium) and the Compendium about Drugs Licensed for Use in the United States (the DailyMed). Information on drug-drug interactions for thirty drugs which have a high or medium potential for interactions have been selected for analysis. In total, 1971 drug-drug interactions were listed in all three drug information sources, of these 992 were ranked as the interactions with the potential of clinical significance. Comparative analysis identified that 63.98% of interactions were listed in only one drug information source, and 66.63% of interactions were ranked in only one drug information source. Only 15.12% listed and 11.19% ranked interactions were identified in all three information sources. Intraclass correlation coefficient indicated a weak correlation among the three drug information sources in listing (0.366), as well as in ranking drug interactions (0.467). This study showed inconsistency of information on drug-drug interaction for the selected drugs in three authoritative, freely accessible online drug information sources. The application of a uniform methodology in assessment of information, and then the presentation of information in a standardized format is required to prevent and adequately manage drug-drug interactions. PMID:24289762

  14. Predictors of death among drug-resistant tuberculosis patients in Kuala Lumpur, Malaysia: A retrospective cohort study from 2009 to 2013.

    PubMed

    Mohd Shariff, Noorsuzana; Shah, Shamsul Azhar; Kamaludin, Fadzilah

    2016-09-01

    The emergence of drug-resistant tuberculosis (TB) is a major public health threat. However, little is known about the predictors of death in drug-resistant TB in Malaysia. This study aimed to determine the predictors of death in drug-resistant TB patients, including multidrug-resistant TB (MDR-TB), in Kuala Lumpur, Malaysia. This study adopted a retrospective cohort study design and involved laboratory-confirmed drug-resistant TB patients (n=426) from January 2009 to June 2013. A Cox regression model and Kaplan-Meier curves were used to model the outcome measure. Data were analysed by using SPSS v.20.0 for Windows. In this study, 15.3% (n=65) of the patients died. Among the study patients, 70.9% were monoresistant TB cases, 9.4% were poly-resistant TB and 19.7% were MDR-TB. MDR-TB [adjusted hazard ratio (aHR)=2.23, 95% confidence interval (CI) 1.26-3.95], ethnicity [Malay (aHR=5.95, 95% CI 2.30-15.41), Chinese (aHR=4.01, 95% CI 1.38-11.66) and Indian (aHR=3.76, 95% CI 1.19-11.85)], coronary heart disease (aHR=6.82, 95% CI 2.16-21.50), drug abuse (aHR=3.79, 95% CI 2.07-6.93) and treatment non-compliance (aHR=1.81, 95% CI 1.01-3.27) were independent predictors of poorer survival in the multivariate Cox regression analysis. This study suggests that MDR-TB, local ethnicity, coronary heart disease, history of drug abuse and treatment non-compliance are factors predicting poor survival in drug-resistant TB patients. More emphasis should be given to the management of drug-resistant TB patients with these characteristics to achieve better treatment outcomes.

  15. Predictors of death among drug-resistant tuberculosis patients in Kuala Lumpur, Malaysia: A retrospective cohort study from 2009 to 2013.

    PubMed

    Mohd Shariff, Noorsuzana; Shah, Shamsul Azhar; Kamaludin, Fadzilah

    2016-09-01

    The emergence of drug-resistant tuberculosis (TB) is a major public health threat. However, little is known about the predictors of death in drug-resistant TB in Malaysia. This study aimed to determine the predictors of death in drug-resistant TB patients, including multidrug-resistant TB (MDR-TB), in Kuala Lumpur, Malaysia. This study adopted a retrospective cohort study design and involved laboratory-confirmed drug-resistant TB patients (n=426) from January 2009 to June 2013. A Cox regression model and Kaplan-Meier curves were used to model the outcome measure. Data were analysed by using SPSS v.20.0 for Windows. In this study, 15.3% (n=65) of the patients died. Among the study patients, 70.9% were monoresistant TB cases, 9.4% were poly-resistant TB and 19.7% were MDR-TB. MDR-TB [adjusted hazard ratio (aHR)=2.23, 95% confidence interval (CI) 1.26-3.95], ethnicity [Malay (aHR=5.95, 95% CI 2.30-15.41), Chinese (aHR=4.01, 95% CI 1.38-11.66) and Indian (aHR=3.76, 95% CI 1.19-11.85)], coronary heart disease (aHR=6.82, 95% CI 2.16-21.50), drug abuse (aHR=3.79, 95% CI 2.07-6.93) and treatment non-compliance (aHR=1.81, 95% CI 1.01-3.27) were independent predictors of poorer survival in the multivariate Cox regression analysis. This study suggests that MDR-TB, local ethnicity, coronary heart disease, history of drug abuse and treatment non-compliance are factors predicting poor survival in drug-resistant TB patients. More emphasis should be given to the management of drug-resistant TB patients with these characteristics to achieve better treatment outcomes. PMID:27530850

  16. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products... drug moiety related in chemical structure or known pharmacological properties. (2) Where...

  17. 21 CFR 310.6 - Applicability of “new drug” or safety or effectiveness findings in drug efficacy study...

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... National Academy of Sciences-National Research Council (NAS-NRC), Drug Efficacy Study Group. Many products... drug moiety related in chemical structure or known pharmacological properties. (2) Where...

  18. The story of artesunate–mefloquine (ASMQ), innovative partnerships in drug development: case study

    PubMed Central

    2013-01-01

    Background The Drugs for Neglected Diseases initiative (DNDi) is a not-for profit organization committed to providing affordable medicines and access to treatments in resource-poor settings. Traditionally drug development has happened “in house” within pharmaceutical companies, with research and development costs ultimately recuperated through drug sales. The development of drugs for the treatment of neglected tropical diseases requires a completely different model that goes beyond the scope of market-driven research and development. Artesunate and mefloquine are well-established drugs for the treatment of uncomplicated malaria, with a strong safety record based on many years of field-based studies and use. The administration of such artemisinin-based combination therapy in a fixed-dose combination is expected to improve patient compliance and to reduce the risk of emerging drug resistance. Case description DNDi developed an innovative approach to drug development, reliant on strong collaborations with a wide range of partners from the commercial world, academia, government institutions and NGOs, each of which had a specific role to play in the development of a fixed dose combination of artesunate and mefloquine. Discussion and evaluation DNDi undertook the development of a fixed-dose combination of artesunate with mefloquine. Partnerships were formed across five continents, addressing formulation, control and production through to clinical trials and product registration, resulting in a safe and efficacious fixed dose combination treatment which is now available to treat patients in resource-poor settings. The south-south technology transfer of production from Farmanguinhos/Fiocruz in Brazil to Cipla Ltd in India was the first of its kind. Of additional benefit was the increased capacity within the knowledge base and infrastructure in developing countries. Conclusions This collaborative approach to drug development involving international partnerships and

  19. A prospective study of adverse drug reactions as a cause of admission to a paediatric hospital

    PubMed Central

    MARTÍNEZ-MIR, I.; GARCÍA-LÓPEZ, M.; PALOP, V.; FERRER, J. M.; ESTAÑ, L.; RUBIO, E.; MORALES-OLIVAS, F. J.

    1996-01-01

    1A total of 512 consecutive paediatric hospital admissions of children 2 years old or less were evaluated to assess the extent and pattern of admission caused by suspected adverse drug reactions (ADRs). The proportion of suspected ADRs related to hospital admissions was 4.3%. 2The organ-systems most commonly implicated were the central nervous system (40.5%), digestive system (16.7%), and skin and appendages (14.3%). Together, they accounted for 71.5% of admissions attributed to ADRs. The most common clinical manifestations inducing admission were convulsions (4 cases), dizziness (4), vomiting (3), and tremor, fever, itching and apnoea (2 cases each). 3The four classes of drugs most frequently suspected in admissions due to ADRs were respiratory drugs (35%), anti-infective agents (25%), drugs active on the central nervous system (15%) and drugs used in dermatology (10%). The most common drugs related to ADRs were a combination of chlorpheniramine, diphenhydramine, phenylephrine, guaiphenesin and salicylic acid (4 cases), followed by fenoterol, adrenaline, paracetamol, DTP vaccine and antipolio vaccine (2 cases each). 4There were no significant differences between children older and younger than 1 year (odds ratio 0.89; 95% CI 0.37–2.17) or between the sexes as regards hospital admittance due to suspected ADRs (odds ratio 1.94; 95% CI 0.72–5.42). 5The results of this kind of study may be influenced by patterns of drug utilization. Nevertheless, the lack of specific studies of drug effects in young children makes it desirable to carry out pharmacoepidemiological studies in this age group. PMID:8877022

  20. Comparative study of paediatric prescription drug utilization between the spanish and immigrant population

    PubMed Central

    2009-01-01

    Background The immigrant population has increased greatly in Spain in recent years to the point where immigrants made up 12% of the infant population in 2008. There is little information available on the profile of this group with regard to prescription drug utilization in universal public health care systems such as that operating in Spain. This work studies the overall and specific differences in prescription drug utilization between the immigrant and Spanish population. Methods Use was made of the Aragonese Health Service databases for 2006. The studied population comprises 159,908 children aged 0-14 years, 13.6% of whom are foreign nationals. Different utilization variables were calculated for each group. Prescription-drug consumption is measured in Defined Daily Doses (DDD) and DDD/1000 persons/day/(DID). Results A total of 833,223 prescriptions were studied. Utilization is lower for immigrant children than in Spanish children for both DID (66.27 v. 113.67) and average annual expense (€21.55 v. €41.14). Immigrant children consume fewer prescription drugs than Spanish children in all of the therapy groups, with the most prescribed (in DID) being: respiratory system, anti-infectives for systemic use, nervous system, sensory organs. Significant differences were observed in relation to the type of drugs and the geographical background of immigrants. Conclusion Prescription drug utilization is much greater in Spanish children than in immigrant children, particularly with reference to bronchodilators (montelukast and terbutaline) and attention-disorder hyperactivity drugs such as methylphenidate. There are important differences regarding drug type and depending on immigrants' geographical backgrounds that suggest there are social, cultural and access factors underlying these disparities. PMID:19995453