Evidence map›Paper›PMID 31384423›Full record

ReviewTherapeutic advances in drug safety2019

Postmarket surveillance: a review on key aspects and measures on the effective functioning in the context of the United Kingdom and Canada.

Nikhil Raj, Swapnil Fernandes, Narayana R Charyulu, Akhilesh Dubey, Ravi G S, Srinivas Hebbar

Abstract readReview
In one paragraph

Review in Therapeutic advances in drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Nikhil RajDepartment of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.
Swapnil FernandesDepartment of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.
Narayana R CharyuluDepartment of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.
Akhilesh DubeyDepartment of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.
Ravi G SDepartment of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru 575018, Karnataka, India.ORCID https://orcid.org/0000-0001-9591-4742
Srinivas HebbarDepartment of Pharmaceutical Regulatory Affairs, N.G.S.M. Institute of Pharmaceutical Sciences, Nitte (Deemed to be University), Deralakatte, Mangaluru, Karnataka, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

adverse drug reactionsblack triangle drugsHealth CanadaMHRApostmarketing surveillanceYellow Card scheme

Identifiers

PMID31384423
PMCPMC6661791

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.