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Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.
Ther Adv Drug Saf 2019; 10:2042098619865413TA

Abstract

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.

Authors+Show Affiliations

Department of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.Department of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.Department of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.Department of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.Department of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru 575018, Karnataka, India.Department of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

31384423

Citation

Raj, Nikhil, et al. "Postmarket Surveillance: a Review On Key Aspects and Measures On the Effective Functioning in the Context of the United Kingdom and Canada." Therapeutic Advances in Drug Safety, vol. 10, 2019, p. 2042098619865413.
Raj N, Fernandes S, Charyulu NR, et al. Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. Ther Adv Drug Saf. 2019;10:2042098619865413.
Raj, N., Fernandes, S., Charyulu, N. R., Dubey, A., G S, R., & Hebbar, S. (2019). Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. Therapeutic Advances in Drug Safety, 10, p. 2042098619865413. doi:10.1177/2042098619865413.
Raj N, et al. Postmarket Surveillance: a Review On Key Aspects and Measures On the Effective Functioning in the Context of the United Kingdom and Canada. Ther Adv Drug Saf. 2019;10:2042098619865413. PubMed PMID: 31384423.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada. AU - Raj,Nikhil, AU - Fernandes,Swapnil, AU - Charyulu,Narayana R, AU - Dubey,Akhilesh, AU - G S,Ravi, AU - Hebbar,Srinivas, Y1 - 2019/07/26/ PY - 2019/05/06/received PY - 2019/07/02/accepted PY - 2019/8/7/entrez PY - 2019/8/7/pubmed PY - 2019/8/7/medline KW - Health Canada KW - MHRA KW - Yellow Card scheme KW - adverse drug reactions KW - black triangle drugs KW - postmarketing surveillance SP - 2042098619865413 EP - 2042098619865413 JF - Therapeutic advances in drug safety JO - Ther Adv Drug Saf VL - 10 N2 - 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. SN - 2042-0986 UR - https://www.unboundmedicine.com/medline/citation/31384423/Postmarket_surveillance:_a_review_on_key_aspects_and_measures_on_the_effective_functioning_in_the_context_of_the_United_Kingdom_and_Canada L2 - http://journals.sagepub.com/doi/full/10.1177/2042098619865413?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -