10 Questions
What is the primary goal of pharmacovigilance?
To ensure the safe use of medicines
Why is pharmacovigilance necessary in different countries?
All of the above
What is the limitation of premarketing clinical studies in detecting adverse drug reactions?
All of the above
What is the importance of pharmacovigilance in assessing drug safety in special populations?
To assess drug safety in children, elderly, and pregnant women
What is the difference between efficacy and effectiveness of a drug?
Efficacy is measured under ideal conditions, while effectiveness is measured under real-life conditions
What was Thalidomide originally used as?
A sedative
What is the term for the congenital malformation caused by Thalidomide?
Phocomelia
What is the main goal of Pharmacovigilance?
To detect and prevent adverse drug effects
What is a 'Signal' in Pharmacovigilance?
A reported information on a possible causal relationship between an adverse event and a drug
What is the cycle of Pharmacovigilance?
Signal detection, signal investigation, risk evaluation, risk minimization, safety communication
Study Notes
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.
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