Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada
| Autor: | Swapnil Dylan Fernandes, Nikhil Raj, Akhilesh Dubey, Narayana Rompicherla Charyulu, G S Ravi, Srinivas Hebbar |
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| Rok vydání: | 2019 |
| Předmět: |
Population
Postmarketing surveillance Context (language use) Review Yellow Card scheme 03 medical and health sciences 0302 clinical medicine medicine postmarketing surveillance Pharmacology (medical) 030212 general & internal medicine Medical prescription Health Canada 030223 otorhinolaryngology education License adverse drug reactions education.field_of_study business.industry MHRA lcsh:RM1-950 medicine.disease black triangle drugs Clinical trial Product (business) lcsh:Therapeutics. Pharmacology Medical emergency business Yellow Card Scheme |
| Zdroj: | Therapeutic Advances in Drug Safety Therapeutic Advances in Drug Safety, Vol 10 (2019) |
| ISSN: | 2042-0994 2042-0986 |
| DOI: | 10.1177/2042098619865413 |
| Popis: | Regulatory approvals for the marketing of medicinal products authorize medical practitioners to prescribe drugs to a group of patients that are defined within the license of the medicinal product. However, such prescriptions are carried out in a controlled manner. Prior to being approved, the medicinal product will have been evaluated in a population pool containing fewer than 5,000 patients and in a predesigned environment where several factors may be lacking, such as the absence of women of childbearing potential, geriatric patients and paediatric patients. Therefore, it is not surprising that several major adverse drug reactions are detected only when the product has been prescribed to the general population. National and international regulatory bodies have devised systems for monitoring medicinal products after marketing, commonly known as postmarketing surveillance systems. Postmarketing surveillance refers to the process of monitoring the safety of drugs once they reach the market, after the successful completion of clinical trials. The primary purpose for conducting postmarketing surveillance is to identify previously unrecognized adverse effects as well as positive effects. The Yellow Card scheme, practiced in the United Kingdom and the Canada Vigilance Program adopted in the Canadian jurisdiction, are two of the most successful postmarketing surveillance systems implemented across the world. Therefore, this article intends to discuss postmarketing surveillance and its role in the context of the United Kingdom and Canadian jurisdictions with a view on presenting key aspects and measures that are employed for operating an efficient postmarketing surveillance system in regulated markets. |
| Databáze: | OpenAIRE |
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