Pharmacovigilance and Stakeholders

Pharmacovigilance

• The process of continuously monitoring medicines and drugs to detect, evaluate, and prevent adverse effects.

### Stakeholders

• Patients
• Nurses
• Pharmacists
• Doctors
• Journalists
• Administrators

Thalidomide (1957-1960)

• It was originally used to prevent nausea and vomiting during pregnancy.
• The case highlights the importance of "primum non nocere," meaning "first, do no harm," which should guide healthcare decisions.

Why Nurses are Interested in Vigilance

• Driven by humanitarian concerns and ethical considerations.

Important Considerations

• Adverse drug reactions can be costly.
• Maintaining public confidence in medication safety is crucial.
• Medicines are intended to provide benefits and improve health outcomes.

Monitoring & Reporting

• Homogeneity: Involves standardizing the process of pharmacovigilance activities.
• Case Report: Data entry and documentation of adverse events.
• Medical Risk Assessment: Evaluating the severity and potential risk of the adverse event to determine appropriate action.
• Quality Control: Ensuring the accuracy and completeness of data submitted to regulatory bodies.

Detection

• Data Collection: Individual case reports are collected. Reports can be solicited (mandatory) or unsolicited.
• Assessment: Understanding the causes and patterns of adverse effects to develop strategies for prevention.

Data Collection Sources

• Individual case reports from healthcare professionals.
• Solicited reports, often mandatory, are requested from specific sources.
• Unsolicited reports are received without a request, such as spontaneous reports from patients.
• Clinical trials data provide valuable insights into drug safety during development.
• Registries, such as disease registries, can track adverse events and patterns of drug use.
• Targeted data collection campaigns can gather information on specific drugs or populations.