Pharmacovigilance
Also known as: Drug Safety Monitoring · Adverse Event Reporting
Definition
Pharmacovigilance (abbreviated as PV) is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine- or vaccine-related problems. In the Philippines, the Food and Drug Administration (FDA) operates the national pharmacovigilance program to monitor both registered pharmaceutical drugs and dietary supplements. (Wikipedia)
Identities
| Source Type | Identity |
|---|---|
| Wikipedia | Pharmacovigilance |
| Wikidata | Q956102 |
| DBpedia | Pharmacovigilance |
| ProductOntology | N/A |
| Wiktionary | pharmacovigilance |
| Library of Congress Subject Headings (LCSH) | Pharmacovigilance |
| MeSH | Pharmacovigilance |
| NCBI Taxonomy | N/A |
| AGROVOC | N/A |
| Google Scholar | pharmacovigilance adverse drug reactions monitoring FDA Philippines |
| ConceptNet | pharmacovigilance |
| OpenCyc | N/A |
Also Known As
- Drug Safety Monitoring
- Adverse Event Reporting
Examples and Analogies
Supplement Advisory: The FDA issuing a public warning about an over-the-counter supplement found to cause liver enzyme spikes.
Adverse Event Portal: A clinical system where doctors report unusual patient side effects from a newly registered health product.
Usage Scenarios
1. Reporting a Side Effect
A pharmacist logs a report on the FDA VigiFlow system after a customer experiences an allergic reaction to a local herbal brand.
2. Post-Market Safety Review
A supplement distributor reviews customer feedback data quarterly to detect potential safety trends.
Strategies
- Establish a clear internal operating procedure for logging and investigating adverse customer reports.
- Provide consumer-friendly contact information on packaging to facilitate direct feedback and reporting.
Security and Safety Measures
- Promptly forward serious adverse event reports to the FDA within the legally mandated reporting window.
- Cross-reference reports with global safety databases to check if a specific batch has been recalled internationally.
Historical Context
Modern pharmacovigilance was established globally following the thalidomide tragedy of the 1960s. The Philippine FDA set up its national adverse reaction monitoring program in the late 20th century, later expanding it under Republic Act 9711 to include online and post-market safety tracking of health products and supplements.
Challenges and Controversies
Underreporting
Many consumers and healthcare workers experience adverse reactions but fail to file formal reports.
Cause Analysis
Determining whether a reaction was caused by the supplement itself, an underlying medical condition, or a drug interaction.
Related Topic
- Food and Drug Administration (Philippines)
- Dietary Supplement Regulation in the Philippines
- Republic Act 9711