Author:
Ramírez-Telles Mariana,Argotti-Rodríguez Urimara
Abstract
Abstract
Objective
To describe the status of drug regulations in Latin America and the Caribbean, in force as of May 2021, and assess through a comparative exercise the differences between the countries under scope on prescribing information of drugs for human use.
Materials and Methods
A narrative review allowed the identification of the regulations concerning the prescribing information of drugs in 25 countries in Latin America and the Caribbean for the registration of prescription medications. On this basis, terms and concepts regarding this topic, the general provisions by the regulatory authorities for these products, applications for health registration and further amendments were identified for each country.
Results
The Latin American and the Caribbean countries included, manage and regulate drug prescribing information differently in terms of concepts, information publishing, structure for product information, among other criteria. Few health authorities publish product information on their website. Additionally, the patient information leaflet is not requested for prescription drugs in most of the studied countries. There is no standardized structure for drug product information within the region.
Conclusions
A poor level of harmonization among the regulations from these countries regarding the content and management (e.g. if physical package insert is required or not, if it is subject to notification or approval) of the prescribing information of human use drugs became evident. Also, there is a visible lack of standardization of concepts for referring to a specific document (e.g., package insert for healthcare professionals, patient information leaflet and technical information for the drug product) and in the content itself.
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Public Health, Environmental and Occupational Health,Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Reference75 articles.
1. European Medicines Agency. Product Information. https://www.ema.europa.eu/en/glossary/product-information.
2. Aronson JK. From prescription-only to over-the-counter medicines ('PoM to P’): time for an intermediate category. Br Med Bull. 2009;90:63–9.
3. Australian Government, Department of Health. Prescription Medicines Overview. https://www.tga.gov.au/prescription-medicines-overview.
4. U.S. Food and Drug Administration (FDA). Prescription Drugs and Over-the-Counter (OTC) Drugs: Questions and Answers. https://www.fda.gov/drugs/questions-answers/prescription-drugs-and-over-counter-otc-drugs-questions-and-answers.
5. World Health Organization. WHO Technical Report Series. Guidelines on packaging for pharmaceutical products. 2002;902.
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献