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A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies

The Drug Regulatory Authority of Pakistan (DRAP) in response to the public outcry on increasing medicines prices in the country issued notifications to direct healthcare professionals to prescribe medicines with their generic names. Like DRAP, many regulators in the low- and middle-income countries...

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Autores principales: Merchant, Hamid A., Babar, Zaheer-Ud-Din, Hussain, Izhar M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9773520/
https://www.ncbi.nlm.nih.gov/pubmed/36550588
http://dx.doi.org/10.1186/s40545-022-00501-4
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author Merchant, Hamid A.
Babar, Zaheer-Ud-Din
Hussain, Izhar M.
author_facet Merchant, Hamid A.
Babar, Zaheer-Ud-Din
Hussain, Izhar M.
author_sort Merchant, Hamid A.
collection PubMed
description The Drug Regulatory Authority of Pakistan (DRAP) in response to the public outcry on increasing medicines prices in the country issued notifications to direct healthcare professionals to prescribe medicines with their generic names. Like DRAP, many regulators in the low- and middle-income countries (LMICs) are also inspiring from the west to legally enforce generic prescribing in a bid to reduce the out-of-pocket public expenditures. However, there are pitfalls in the LMICs drug regulatory framework, which if left unaddressed can severely jeopardise the foreseen benefits of medicines prescribing by generic names. This article critically appraises the impact of prescribing by generic names regulations in LMICs and highlights the key considerations that are vital to address before legally enforcing generic prescribing. The ethics, regulatory compliance, and good governance are the key to success; better generics for a better tomorrow.
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spelling pubmed-97735202022-12-23 A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies Merchant, Hamid A. Babar, Zaheer-Ud-Din Hussain, Izhar M. J Pharm Policy Pract Commentary The Drug Regulatory Authority of Pakistan (DRAP) in response to the public outcry on increasing medicines prices in the country issued notifications to direct healthcare professionals to prescribe medicines with their generic names. Like DRAP, many regulators in the low- and middle-income countries (LMICs) are also inspiring from the west to legally enforce generic prescribing in a bid to reduce the out-of-pocket public expenditures. However, there are pitfalls in the LMICs drug regulatory framework, which if left unaddressed can severely jeopardise the foreseen benefits of medicines prescribing by generic names. This article critically appraises the impact of prescribing by generic names regulations in LMICs and highlights the key considerations that are vital to address before legally enforcing generic prescribing. The ethics, regulatory compliance, and good governance are the key to success; better generics for a better tomorrow. BioMed Central 2022-12-22 /pmc/articles/PMC9773520/ /pubmed/36550588 http://dx.doi.org/10.1186/s40545-022-00501-4 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Commentary
Merchant, Hamid A.
Babar, Zaheer-Ud-Din
Hussain, Izhar M.
A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies
title A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies
title_full A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies
title_fullStr A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies
title_full_unstemmed A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies
title_short A leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (LMICs): pitfalls, limitations, and recommendations for local drug regulatory agencies
title_sort leap towards enforcing medicines prescribing by generic names in low- and middle-income countries (lmics): pitfalls, limitations, and recommendations for local drug regulatory agencies
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9773520/
https://www.ncbi.nlm.nih.gov/pubmed/36550588
http://dx.doi.org/10.1186/s40545-022-00501-4
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