Post Marketing Surveillance Methods – European Union

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Post Marketing Survelliance Methods – European Union

Objective : Post marketing  safety surveillance program are to assess and quantify known or suspected drug safety issues, identify and characterize potential new risks and risk factors following product marketing, and to monitor medication use patterns.

Types of PMS:-

Active Surveillance: It is defined within the European Commission Volume 9A to be the ongoing, proactive monitoring of product use and potential adverse events (AEs) “To ascertain more completely the number of adverse events in a given population via a continuous organised process.” One objective of active surveillance is to detect safety issues early in the post-marketing environment that were not identified during development, such as rare events or latent onset.

Passive surveillance : It is primarily includes the analysis of spontaneous adverse event reports. Sources for reports include regulatory systems. Passive surveillance often involves assembling a series of cases to examine specific types of events, such as overdose and product re-challenge. This method of safety surveillance is limited by incomplete reporting information (which can impede determination of causality), potential underreporting of events, and unknown parameters for calculation of incidence (denominator and numerator).

Stimulated reporting : It is achieved through direct encouragement of event reporting through communication with potential reporters, such as via a Dear Healthcare Provider Letter. Stimulated reporting can be limited by the same factors as passive surveillance: underreporting,

Comparative observational studies : It  can be analytic, such as case-control studies, or descriptive, including cross-sectional surveys and cohort studies. Observational studies do not recruit participants into a controlled environment, as in a random-controlled trial, but instead observe the outcome of interest (e.g., a specific adverse or other drug event) in a population that already takes the drug compared to a population that does not. These studies are commonly used to identify side effects rather than evaluate treatment effectiveness, and may be used to calculate relative risk, but usually cannot be used to calculate absolute risk.

Data Collection and Analytical Methods: There are many tools and resources available for post-marketing safety surveillance: spontaneous adverse event report databases, large administrative databases (e.g., Medicaid, managed care organizations, insurers), registries, and electronic medical records. In the UK, for example, Prescription Event Monitoring (PEM,) developed in the 1980’s, uses a questionnaire to collect outcomes information from a panel of all physicians who prescribe a new drug. Notably, PEM does not require the clinician to determine whether there is a causal relationship to the product. This reporting also allows for follow-up on events of interest, such as pregnancy or death.


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