scholarly journals The drug regulatory authority

2015 ◽  
Vol 45 (2) ◽  
pp. 87
Author(s):  
L Jayasuriya
Keyword(s):  
Regulatory Authority ◽  
Drug Regulatory Authority

scholarly journals The Counterproductive Effect of Pharmaceutical Marketing in Pakistan: A Qualitative Study

2021 ◽  
Vol 6 (2) ◽  
pp. 11-29
Author(s):  
Dr. Fazle Malik ◽  
Dr. Muhammad Junaid ◽  
Dr. Muhammad Asif ◽  
Ilyas Sharif
Keyword(s):  
Regulatory Authority ◽  
Healthcare Professionals ◽  
Pharmaceutical Marketing ◽  
Skewed Data ◽  
Negative Consequences ◽  
Drug Regulatory Authority ◽  
Related Information ◽  
Prescribe Medicine ◽  
Organizational Perspective ◽  
Promotional Strategies

This study explores the effects of pharmaceutical marketing on patients and society in Pakistan. Pharmaceutical marketing is an integral part of the drug industry, which channels product-related information to healthcare professionals. Physicians are the target audience as they prescribe medicine to the users. The pharmaceutical industry mobilizes all resources to influence physicians’ prescriptions in favor of their brands. It is commendable from the organizational perspective, however; it leads to unintended negative consequences for society. The primary reason is the blind pursuit of commercial interest and near-total neglect of ethical behavior in marketing drugs. This study conducted open-ended 20 interviews from primary stakeholders of this issue that includes physicians, pharmaceutical managers, and officials of drug regulatory authority through purposive sampling. The findings show that misleading promotional strategies influencing physicians are responsible for the misuse and abuse of drugs and antibiotics. Pharmaceutical drug incentivization, the personal obligation for physicians, skewed data, and inappropriate promotions were the major categories developed during analysis. The study recommends various steps to minimize these ill effects.

scholarly journals Acceptability and barriers to implementation of N-of-1 tests in Ethiopia - a qualitative study

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Chalachew Alemayehu ◽  
Geoff Mitchell ◽  
Jane Nikles ◽  
Abraham Aseffa ◽  
Alexandra Clavarino
Keyword(s):  
Qualitative Study ◽  
Regulatory Authority ◽  
Generic Drugs ◽  
Clinical Care ◽  
Cost Effective ◽  
Analysis Data ◽  
Institutional Review Board ◽  
Therapeutic Equivalence ◽  
Drug Regulatory Authority ◽  
Institutional Review

Abstract Background Locally produced generic drugs offer a cost–effective alternative to imported drugs to treat patients in Ethiopia. However, due to a lack of bioequivalence testing, additional assurance tests are needed to build trust in cheaper, locally made drugs. By testing bioequivalence of local drugs to gold standard, N-of-1 tests have the potential to promote patient centred quality use of medicines. Method We sought to assess the acceptability of, and explore barriers to, conducting N-of-1 tests to evaluate local medicines in a resource limited clinical setting. We conducted a descriptive qualitative study, analysing four focus group discussions and five key informant interviews. Participants were senior drug regulatory authority members, institutional review board members, physicians and patients. All interviews were audio taped and transcribed verbatim. Patient interviews were conducted in Amharic and translated to English prior to analysis. Data analysis used an inductive, thematic process. Results Five major themes were identified; (1) Appropriateness of N-of-1 tests to determine the therapeutic equivalence of local drugs, (2) N-of-1 therapeutic equivalence tests: clinical care or research? (3) Ethical and regulatory requirements (IRB), (4) Potential barriers to implementing N-of-1 tests and (5) Possible solutions to identified challenges. The study demonstrated considerable support for using N-of-1 tests for clinical equivalence studies between local and imported medicines, but important impediments were very likely to impact the feasibility of conducting N-of-1 tests in Ethiopia. Key informants from the regulatory authority did not support additional tests of local drugs. There were also mixed opinions regarding ethical requirements for conducting N-of-1 tests. The Institutional Review Board (IRB) members believed that IRB approval was sufficient to conduct N-of-1 tests, however, the regulatory authority members considered that N-of-1 tests constituted a clinical trial, and required approval at the regulatory level. Conclusion This study showed that there were key uncertainties that could impact the feasiblity of using N-of-1 testing local drugs in Ethiopia. Therefore, a number of protocol amendments to address contextual threats and regulatory challenges, would be needed before progressing to conducting these tests.

scholarly journals Assessment of the Current State of Pharmacovigilance System in Pakistan Using Indicator-Based Assessment Tool

2022 ◽  
Vol 12 ◽  
Author(s):  
Muhammad Akhtar Abbas Khan ◽  
Saima Hamid ◽  
Tofeeq Ur-Rehman ◽  
Zaheer-Ud-Din Babar
Keyword(s):  
Public Health ◽  
Regulatory Authority ◽  
Assessment Tool ◽  
Health Programs ◽  
Expert Committee ◽  
Pv System ◽  
Private Hospitals ◽  
Public Health Programs ◽  
Drug Regulatory Authority ◽  
National Public Health

Objectives: Pakistan felt the need for an effective and robust pharmacovigilance (PV) system after one of the deadliest drug-related tragedies causing more than 300 deaths in 2012. The country set up its national PV center in 2015 and joined WHO’s Program for International Drug Monitoring (PIDM) in 2018 as a full member. The current study was aimed to evaluate the PV system’s functionality, identify the gaps, areas of improvement, and a strategy to lead a functional PV system in Pakistan.Methods: The descriptive cross-sectional study was conducted by providing an interviewer-administered questionnaire of the PV system across Pakistan by utilizing the Indicator based Pharmacovigilance assessment tool (IPAT). By a convenience sampling method 36 study participants were selected from the Drug Regulatory Authority of Pakistan (DRAP), drug administration of provincial health departments of 4 provinces and federally affiliated areas, 5 national public health programs, and 23 public and private hospitals. The assessment includes document review, interviews of the key informants by structured open-ended questions, and a review of websites of relevant organizations.Results: Drug Regulatory Authority of Pakistan (DRAP) with a national PV center received a 75% overall performance score on IPAT. To be regarded as “minimally functioning,” a country’s PV and drug safety system must meet all core indicators. DRAP scored 80.76% on the core indicators so cannot be deemed functional at this time. The only province with a regional PV center, Punjab, had scored 72.13% on relevant parameters. Despite receiving funding from the Global Fund, none of the National Public Health Programs (PHPs) have PV centers or associated activities. All hospitals except two private hospitals could not qualify the minimum requirements for functional PV. The absence of a legal framework for mandatory ADR reporting, lack of drug information center, budgetary constraints, no active surveillance activities, the nonexistence of pharmacovigilance risk assessment expert committee, and insufficient coordination among stakeholders were identified as major gaps.Conclusion: The results of the study reveal that Pakistan’s PV system is not fully functional at all levels. A two-phased strategy encompassing the non-financial and financial interventions is proposed to improve the PV systems at the national, provincial, PHPs, and hospitals levels.

Florida Agritourism Building and Fire Codes

EDIS ◽  
2020 ◽  
Vol 2020 (1) ◽  
Author(s):  
Mary Beth Henry ◽  
Kathryn A Stofer
Keyword(s):  
Agricultural Education ◽  
Local Governments ◽  
Regulatory Authority ◽  
Building Codes ◽  
Bona Fide ◽  
Agricultural Operations ◽  
On Farm ◽  
Fire Codes

Agritourism marries Florida’s two largest industries, tourism and agriculture, to provide an on-farm recreational experience for consumers. Although Florida trails many other states in the number of agritourism operations, the number of Florida farms offering recreational experiences more than doubled from 2007 to 2012. This new 4-page document describes building codes relevant to Florida agritourism operations. Written by Mary Beth Henry and Kathryn A. Stofer, and published by the UF/IFAS Department of Agricultural Education and Communication.https://edis.ifas.ufl.edu/wc349 A companion document, Florida’s Agritourism Laws, EDIS publication AEC623, Florida’s Agritourism Laws, http://edis.ifas.ufl.edu/wc285, discusses Florida Statutes related to definitions, liability protections, and limits to regulatory authority of local governments over bona fide agricultural operations engaged in agritourism.

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