Pharmacovigilance History: Thalidomide Tragedy

Pharmacovigilance History

• Thalidomide tragedy: 10,000 cases of congenital malformation (phocomelia) due to its use as a sedative and in pregnancy for morning sickness

Pharmacovigilance (PV)

• Definition: "The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems"
• Main aims:
  • Detect adverse drug effects and other drug-related problems
  • Assess and evaluate adverse effects (severity, frequency, etc.)
  • Identify and understand predisposing risk factors
  • Prevent adverse effects and minimize risk

Cycle of Pharmacovigilance

• Safety communication
• Signal investigation
• Signal detection
• Risk-benefit minimization evaluation
• Signal: Reported information on a possible causal relationship between an adverse event and a drug

Key Features of Medications

• Safety
• Efficacy
• Quality

Scope of Pharmacovigilance

• Adverse drug effects
• Medication errors
• Drug interactions
• Lack of efficacy
• Antibiotic resistance
• Drug misuse and abuse
• Products covered: conventional medicines, herbal medicines, biologicals and biosimilars, blood products, vaccines, medical devices

Pharmacovigilance Intercountry & Interbrand Variations

• Need for pharmacovigilance due to health, economic, and humanitarian concerns
• Variations in:
  • Population characteristics (genetics, ethnicity, etc.)
  • Medications use culture
  • Quality of pharmaceutical production
  • Sources of APIs, excipients, manufacturing lines, and supply chain
  • Quality of pharmaceutical production

Drug Repositioning/Repurposing

• Drug development

Clinical Development of Medicines

• Continuous safety monitoring throughout drug lifecycle
• Limitations of premarketing clinical studies:
  • Limited patient number
  • Limited duration of drug exposure
  • Restricted patient population
• Importance of pharmacovigilance (post-marketing surveillance)
  • Identify previously unknown drug-related problems
  • Assess drug safety in special populations
  • Identify different types of potential drug interactions
  • Identify predisposing risk factors for adverse drug effects

Learn about the history of pharmacovigilance, including the Thalidomide tragedy, its original use, and its impact on pregnancy and congenital malformations.