Post Marketing Surveillance

Postmarketing surveillance (PMS) systematically monitors medications’ safety and effectiveness after they hit the market. Surveillance enhances the likelihood of detecting previously undiscovered medication effects. This works by examining medications used by individuals over a long time and under different situations, which would be limited in premarketing evaluation. PMS reveals not only undesirable drug responses but also the advantages of the medication. It can also be used to evaluate the drug’s off-label use, broadening its application. PMS is the critical phase 4 in clinical studies.

PMS is a critical and required part of pharmacovigilance. It is also an essential component of pharmacoepidemiology, which assists clinicians in making educated treatment decisions.

PMS is jointly responsible for the manufacturer, national regulatory authorities, health ministries, public health agencies, and other governmental drug regulating organizations. Consumers, healthcare practitioners, parents, caregivers, and whistleblowers may file complaints, and it is the manufacturer’s responsibility to keep a complaint registry and examine it further. The medication may be cancelled or discontinued if any side effects are observed during the PMS period. This procedure guarantees that medications are standardized and that customers are safe.

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