Post-Marketing Surveillance (PMS)

Post-Marketing Surveillance (PMS) refers to the monitoring of pharmaceutical products or medical devices after they have been released on the market and is an important part of the pharmacovigilance. PMS is crucial for ensuring the continued safety, efficacy, and performance of products as it can further refine, confirm or deny, the safety of a drug or device after it is used in the general population by large numbers of people who have a wide variety of medical conditions. PMS generally involves the following key aspects:

Purpose:

The main goal of PMS is to identify and evaluate any adverse effects or other safety concerns that may not have been apparent during the pre-market clinical trials. This helps in maintaining public health and safety.

Methods:

PMS can include various methods such as:

• Spontaneous reporting: Healthcare professionals and consumers report any adverse effects they observe.
• Registry studies: Collecting data from patients who are using the product over a long period.
• Observational studies: Monitoring the product’s performance in real-world settings.
• Electronic health records: Analyzing data from digital health records to identify patterns or issues.

Regulatory requirements:

Regulatory agencies like the FDA (Food and Drug Administration) in the US or EMA (European Medicines Agency) in Europe often require PMS as part of the approval process for new drugs. Companies must submit regular reports on the product’s safety and efficacy.

Benefits:

PMS helps in:

• Detecting rare or long-term adverse effects.
• Ensuring that the benefits of the product continue to outweigh the risks.
• Providing data that can lead to updates in product labeling, usage guidelines, or even withdrawal of the product if necessary.

In summary, PMS is a vital component of the lifecycle of pharmaceutical products and medical devices, ensuring they remain safe and effective for public use.