What is Post-Marketing Surveillance?
Post-marketing surveillance (PMS) refers to the monitoring of pharmaceutical products after they have been released to the market. It ensures continued safety, efficacy, and quality of drugs in real-world settings and helps identify rare or long-term adverse effects.
Basic Concepts
- Pharmacovigilance: The science and activities related to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems.
- Adverse Drug Reaction (ADR): Any unintended and harmful reaction to a drug.
- Risk Management: Strategies to minimize risks associated with drug use.
Safety Monitoring
- Spontaneous reporting systems (e.g., FDA MedWatch, EudraVigilance)
- Active surveillance programs
- Prescription event monitoring
- Patient registries and cohort studies
- Signal detection and risk evaluation
Real-World Evidence (RWE)
- Data collected from electronic health records (EHR), insurance claims, and patient-reported outcomes
- Used to assess effectiveness, safety, and utilization patterns
- Supports regulatory decisions and label updates
Technologies and Tools
- Pharmacovigilance databases (e.g., VigiBase, FAERS)
- Natural language processing for adverse event extraction
- AI and machine learning for signal detection
- Mobile apps for patient reporting
- Blockchain for secure data sharing
Challenges in Post-Marketing Surveillance
- Underreporting and data quality issues
- Difficulty in establishing causality
- Privacy and data protection concerns
- Global harmonization of surveillance practices
- Timely signal detection and response
Real-World Examples
- Rofecoxib (Vioxx): Withdrawn due to increased cardiovascular risk identified post-marketing.
- Thalidomide: Historical example that led to stricter PMS regulations.
- COVID-19 vaccines: Ongoing global surveillance for rare adverse events.
Future Directions
- Global pharmacovigilance networks and data sharing
- Integration of wearable devices and digital biomarkers
- Real-time surveillance using big data analytics
- Patient-centric reporting and engagement
- Regulatory use of RWE for label expansion and safety updates