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Roger Bate - One of the best experts on this subject based on the ideXlab platform.
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pilot study of Essential Drug quality in two major cities in india
PLOS ONE, 2009Co-Authors: Roger Bate, Richard Tren, Lorraine Mooney, Kimberly Hess, Barun Mitra, Bibek Debroy, Amir AttaranAbstract:Background: India is an increasingly influential player in the global pharmaceutical market. Key parts of the Drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit Drugs available in the market and to discuss how the Indian state and federal governments could improve Drug regulation and more importantly regulatory enforcement to combat these Drugs.Methodology/Principal Findings: Random samples of antimalarial, antibiotic, and antimycobacterial Drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard Drugs (30% and 0% respectively), as was product heterogeneity, with some Drugs being more or less frequently substandard (12% and 7% respectively).Conclusions/Significance: In a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard Drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, important spatial and product heterogeneity exists, which suggests that India's substandard Drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the Drug regulatory system in India needs to be improved for domestic consumption, and because India is an increasingly important exporter of Drugs for both developed and developing countries. Some poor countries with high burdens of disease have weak Drug regulatory systems and import many HIV/AIDS, tuberculosis and malaria Drugs from India.
Adrian P. Mundt - One of the best experts on this subject based on the ideXlab platform.
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Prescription patterns of psychotropic medications for the treatment of psychotic disorders in the largest mental health institutions of Uganda.
Journal of Clinical Psychopharmacology, 2014Co-Authors: Annika Rukat, Seggane Musisi, Andreas Ströhle, Adrian P. MundtAbstract:The study describes prescription patterns of psychotropic medications for patients treated for psychosis in psychiatric hospitals of Uganda. A cross-sectional quantitative survey of age, sex, diagnoses, and psychotropic medication of 682 psychiatric inpatients of the 2 national referral hospitals in Uganda was conducted on 1 day in March 2012. The percentage of patients treated with the same substance within the diagnostic categories schizophrenia, bipolar affective disorder, unspecified psychosis, and depressive disorder was calculated. Close to 90% of the patients with conditions diagnosed with any psychotic disorder were treated with first-generation antipsychotic Drugs (eg, chlorpromazine, haloperidol, trifluoperazine, and depot fluphenazine). Carbamazepine in combination with first-generation antipsychotics was prescribed frequently (45%) for the treatment of bipolar affective disorder. The use of second-generation antipsychotics, lithium, and valproic acid was exceptional. Patients with depression usually received a combination (63%) of first-generation antipsychotics and antidepressants (fluoxetine or amitriptyline). Benzodiazepines were only infrequently used for patients diagnosed with psychoses. First-generation antipsychotics, antidepressants, and carbamazepine were the most frequently used medications for treatment of psychosis in Uganda. Although lithium and valproic acid were on the Essential Drug list in Uganda, their use was still infrequent. There is a need to ensure the practical availability of the Drugs listed on the Essential Drug list and to support the implementation of their use in clinical practice.
K Weerasuriya - One of the best experts on this subject based on the ideXlab platform.
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do national medicinal Drug policies and Essential Drug programs improve Drug use a review of experiences in developing countries
Social Science & Medicine, 2001Co-Authors: Sauwakon Ratanawijitrasin, Stephen B Soumerai, K WeerasuriyaAbstract:Increasing concerns regarding access to and appropriateness of medicinal Drug use have led many governments in developing countries to develop national policies and regulations intended to increase the affordability, supply, safety, and rational use of pharmaceuticals. However, little is known about the intended and unintended impacts of these social experiments on actual Drug use. We conducted a critical review and synthesis of the international literature in an attempt to define the current state of knowledge regarding Drug policy effects on Drug use, and to extract from the evidence important lessons for future policy and research. Literature sources included the archives and computerized databases, articles published in medical and pharmacy journals, as well as published annotated bibliographies. The evaluated interventions included three broad categories: (1) multi-component national Drug policies including Essential Drug programs; (2) Drug supply and cost-sharing programs; and (3) regulatory measures. Most of these studies utilized weak research designs that evaluated programs solely on the basis of post-intervention measures. Only two studies measured pre-policy utilization, but did not include a control group. Thus, none of the results are conclusive, and the findings represent, at best, hypotheses for more rigorous studies of policy impacts. Some suggestive findings include an association between increases in the supply of Essential Drugs (combined with training) and more appropriate use of medications in primary care settings. In addition, preliminary data suggest some unintended effects of de-registration of Drugs or upward reclassification of specific medicines. Similarly, loosening restrictions have sometimes been accompanied by increased dispensing of specific Drugs by unqualified personnel. The available studies focused only on a few categories of national and regulatory policies. Because of poor study design, the results do not provide valid data to determine whether national Drug policies improve Drug use. Moreover, no studies have evaluated the effects of major and recent changes, such as increased use of product patents, national pharmaceutical insurance policies, and increased privatization of pharmaceutical products and services. Future studies need to explore the consequences of these emerging developments on Drug access and use. Despite the difficulties inherent in evaluation of national policies, stronger research designs can and should be carried out. Interrupted time-series analysis and other more rigorous designs should become standard designs for policy evaluation in the same way that standard treatment guidelines are intended to guide medical practice.
Subish Palaian - One of the best experts on this subject based on the ideXlab platform.
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a prospective surveillance of Drug prescribing and dispensing in a teaching hospital in western nepal
Journal of Pakistan Medical Association, 2009Co-Authors: Saurav Ghimire, Sushil Nepal, Sushil Bhandari, Prabha Nepal, Subish PalaianAbstract:Objective: To evaluate the Drug dispensing practices and patients' knowledge on Drug use among the outpatients and to identify and analyze the problems in Drug prescribing and dispensing. Methods: A prospective cross-sectional descriptive study was conducted using World Health Organization (WHO) core Drug use indicators from July 13, 2008 to August 15, 2008 in Manipal Teaching Hospital, Pokhara, Nepal. Results: A total of 4231 prescriptions were encountered with the total of 10591 Drugs prescribed. The average number of Drug per prescription was 2.5. Only 13% (n= 10591) of Drugs were prescribed by generic name. Percentage of Drug prescribed from WHO model list of Essential Drugs, Essential Drug list of Nepal and Nepalese National Formulary was 21.7%, 32.8% and 42.3% respectively. Antibiotics and injections encountered were 28.3% and 3.1% respectively. Average cost per prescription was found to be Nepalese Rupees (NRs) 285.99 (US $ 3.73). Patient knowledge on correct use of Drugs and appropriate labeling was found to be 81% and 1.4% respectively. Average dispensing time per prescription was 52 seconds. Conclusion: The finding from current study shows a trend towards irrational prescribing and dispensing. Hence, there is a need for effective intervention programme to encourage the physicians and dispensing pharmacists in promoting more rational Drug use (JPMA 59:726; 2009).
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a study on rational Drug prescribing and dispensing in outpatients in a tertiary care teaching hospital of western nepal
Kathmandu University Medical Journal, 2006Co-Authors: Kadir Alam, Pranaya Mishra, Mukhyaprana Prabhu, P R Shankar, Subish Palaian, R B Bhandari, D BistaAbstract:Objectives: To analyze the prescriptions of out-patients for rational prescribing and dispensing and to evaluate the patient’s knowledge regarding use of Drugs, using INRUD indicators. Methods: A cross-sectional, descriptive study was conducted at the Manipal Teaching Hospital, Pokhara, Nepal during the time period from June 10 th to August 19 th 2004. Results: Totally 247 prescriptions were randomly selected for analysis, wherein 720 Drugs were prescribed. Only 15% of Drugs were prescribed by generic name, 21.67% of the total Drugs consisted of fixed-dose combinations, only 40% of Drugs were from the Essential Drug list of Nepal and 29.44% (n=212) were from the WHO Essential Drug list. It was found that more than half (54.17 %) of the Drugs were from Nepalese National Formulary and 35.69% were from WHO model formulary. Dermatological products were most commonly prescribed followed by Drugs acting on central nervous system, antimicrobials and Drugs acting on cardiovascular system. Among the Drugs dispensed, 79.16% were oral followed by topical (18.19%) and parenteral forms (2.98%). Diagnosis was mentioned only in 3.23% (n=8) of the prescriptions and the average cost per prescription was found to be 241.11 Nepalese rupees (US$ 3.26). It was found out that pharmacist labelled only 0.4% of the medication envelopes with the name of the patient. However, 82.6% of the medication envelopes were labelled with name of the Drug and 87.0 % with Drug strength. Only 53.8% (n=133) of the patient knew both the duration of the therapy and administration time of Drugs. Conclusion: There is a need for educational intervention for prescribers and both managerial and educational intervention for the hospital pharmacists to improve prescribing and dispensing.
Amir Attaran - One of the best experts on this subject based on the ideXlab platform.
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pilot study of Essential Drug quality in two major cities in india
PLOS ONE, 2009Co-Authors: Roger Bate, Richard Tren, Lorraine Mooney, Kimberly Hess, Barun Mitra, Bibek Debroy, Amir AttaranAbstract:Background: India is an increasingly influential player in the global pharmaceutical market. Key parts of the Drug regulatory system are controlled by the states, each of which applies its own standards for enforcement, not always consistent with others. A pilot study was conducted in two major cities in India, Delhi and Chennai, to explore the question/hypothesis/extent of substandard and counterfeit Drugs available in the market and to discuss how the Indian state and federal governments could improve Drug regulation and more importantly regulatory enforcement to combat these Drugs.Methodology/Principal Findings: Random samples of antimalarial, antibiotic, and antimycobacterial Drugs were collected from pharmacies in urban and peri-urban areas of Delhi and Chennai, India. Semi-quantitative thin-layer chromatography and disintegration testing were used to measure the concentration of active ingredients against internationally acceptable standards. 12% of all samples tested from Delhi failed either one or both tests, and were substandard. 5% of all samples tested from Chennai failed either one or both tests, and were substandard. Spatial heterogeneity between pharmacies was observed, with some having more or less substandard Drugs (30% and 0% respectively), as was product heterogeneity, with some Drugs being more or less frequently substandard (12% and 7% respectively).Conclusions/Significance: In a study using basic field-deployable techniques of lesser sensitivity rather than the most advanced laboratory-based techniques, the prevalence of substandard Drugs in Delhi and Chennai is confirmed to be roughly in accordance with the Indian government's current estimates. However, important spatial and product heterogeneity exists, which suggests that India's substandard Drug problem is not ubiquitous, but driven by a subset of manufacturers and pharmacies which thrive in an inadequately regulated environment. It is likely that the Drug regulatory system in India needs to be improved for domestic consumption, and because India is an increasingly important exporter of Drugs for both developed and developing countries. Some poor countries with high burdens of disease have weak Drug regulatory systems and import many HIV/AIDS, tuberculosis and malaria Drugs from India.