Summary of National Implementation of Post-marketing Surveillance in The United States of America, Canada, European Union & UK
There are billions of medical products that have been successfully produced, marketed and even rebranded for its longevity. However, there are still numerous of drugs and instrumentations that have failed to enter the market and keep its active status. The healthcare world is considered as one of the toughest and most regulated [1], but also the most rewarding mentally and financially. In the pharmaceutical/medical industries, the practice of monitoring the safety of new drug or instrumentation that have been released to the market is called post-marketing surveillance. The post marketing surveillance is one of the major parts of pharmacovigilance also known as drug safety science.
The post marketing surveillance is a “break it or make it” part for any manufacturer, as this part will determine the ultimate entrance into the market [2]. Since many drugs and instrumentations alike go through clinical trials, it is usually targeted a small amount of sample size and this sample size is not enough to determine a safety for mass consumption. There are various techniques involved to determine post-marketing surveillance success and some of the strategies include reviewing of electronic health records, getting a direct feedback from the provider, health database review etc. Let’s consider some of the post-marketing surveillance details in different developed income countries.
The United States of America
In one of the most productive developers of drugs – The United States of America the post-marketing surveillance is conducted by organization called FDA (The Food and Drug Administration). In general, the FDA operates a passive surveillance system which is called MedWatch. The MedWatch is an open platform developed by FDA for specialized and general public. The healthcare professionals and general population alike can voluntarily enter the information into this platform for further investigation. However, it’s worth to note that in order for FDA to look into a specific problem, the entry must be substantial and volume based in order to go through a threshold of signal to notify epidemiologists for the review. Besides of MedWatch, there is also an active system when certain officers of FDA assigned to evaluate a certain drug or instrumentation released to the public. Some of the examples of active post-marketing surveillance are Post-Approval Study or also referred IV Clinical Trial [3] or 522 Post-market Surveillance Study.
Canada
In the neighbor’s country of Canada, The Health Canada agency is responsible for approval of drugs. Within Health Canada [4] there is a section called “Marketed Health Products Directorate (MHPD)” this particular division conducts post-marketing surveillance of drugs and instrumentations.
The United Kingdom
In the United Kingdom a division of Yellow Card Scheme [5] conducts surveillance and approval of drugs. The Yellow Scheme itself is operated by The Medicines and Healthcare Products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM). All reports are entered through MHRA website and is open to professionals as well as general public alike to use and contribute information.
The European Union
In the European union all new drugs and instrumentations are widely covered [6] and monitored by statues such as MEDDEV 2.12-1 rev 8. The European commission’s subdivision is overseeing this process and provides feedback, approves or withdraws the product from the marketing. The ANNEX III [7] provides a technical documentation on post-marketing surveillance and rules.
Summary:
It’s very interesting to note that in Europe, U.S and Canada the post-marketing surveillance is conducted by manufacturers themselves. It shows that government is giving some certain degree of freedom for manufacturers to conduct an ethical and effective implementation for the good of general public health. The post-marketing surveillance is a critical part for manufacturer and government alike, as it can potentially introduce a new drug or instrumentation to the market that can drastically improve lives or it can detrimentally harm the society that will consume it. At the end of the day it’s a fine line of ethical and personal responsibility of pharmaceutical and medical instrumentation manufacturer.
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References:
1. Field, Robert I. “Why is health care regulation so complex?.” P & T : a peer-reviewed journal for formulary management vol. 33,10 (2008): 607-8.
2. Alomar, Muaed et al. “Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future.” Therapeutic advances in drug safety vol. 11 2042098620938595. 10 Aug. 2020, doi:10.1177/2042098620938595
3. Zhang, Xinji et al. “Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.” BMJ open vol. 6,11 e010643. 23 Nov. 2016, doi:10.1136/bmjopen-2015-010643
4. Canada, H., 2021. Marketed Health Products Directorate - Canada.ca. [online] Canada.ca. Available at: <https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/marketed-health-products-directorate.html> [Accessed 7 December 2021].
5. Yellowcard.mhra.gov.uk. 2021. Yellow Card Scheme - MHRA. [online] Available at: <https://yellowcard.mhra.gov.uk/the-yellow-card-scheme/> [Accessed 7 December 2021].
6. Gough, Stephen. “Post-marketing surveillance: a UK/European perspective.” Current medical research and opinion vol. 21,4 (2005): 565-70. doi:10.1185/030079905X41426
7. Medical Device Regulation. 2021. ANNEX III - Medical Device Regulation. [online] Available at: <https://www.medical-device-regulation.eu/2019/07/25/annex-iii/> [Accessed 7 December 2021].