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.

This quiz explores the key concepts of pharmacovigilance, focusing on the stakeholders involved such as patients, nurses, and healthcare professionals. It highlights historical cases like Thalidomide to underline the importance of monitoring drug safety and maintaining public confidence in medications.