Lesson 3-Introduction to PV Flashcards
(35 cards)
What’s the scope of PV under medicine use and quality?
A.Medication Use
Adverse effects
Medication errors
Drug interactions
Off-label use
Abuse/misuse
Antimicrobial resistance
B. Quality
Product manufacturing, storage and distribution
Substandard or Falsified products
Lack Efficacy
Define medication error and how it should be addressed.
Unintended failure in drug treatment causing harm; addressed via non-punitive culture focused on systemic fixes.
What is off-label use? Give an example.
Using a drug for unapproved purposes, e.g., different dosage, age group, or indication.
Why is antimicrobial resistance part of PV’s scope?
- Threatens our ability to treat common infectious diseases
- Without effective antimicrobial therapy procedures ( surgery, chemotherapy, HIV, cancer) become very risky
What risks do falsified medical products pose?
Wrong/no active ingredients, leading to treatment failure, toxicity, or death. WHO estimates 10-50% in LMICs.
public health programs focus on?
-Preventing and managing the most important diseases affecting the population
What is the life-cycle approach in PV?
Continuous risk management from first human exposure through post-marketing, ensuring ongoing benefit-risk assessment.
List six stakeholders in pharmacovigilance.
Regulators, PV centers, pharmaceutical industry, healthcare professionals, patients, academia.
What role do patients play in PV?
Report ADRs, provide real-world safety data, and participate in risk communication.
Why are clinical trials insufficient for detecting all ADRs?
Small sample sizes miss rare ADRs
Short durations miss long-term effects
They exclude children, elderly, and pregnant women.
Define Lack of Efficay
- Unexpected failure of a drug to produce the intended effect as determined by previous scientific investigation
- Serious health implication for the patient example: if contraceptive product fails, resulting in unintended pregnancy
How do comorbidities affect ADR detection in trials?
Trials often exclude comorbid patients, missing risks from drug-disease interactions.
What population gaps exist in clinical trials?
Underrepresentation of elderly, children, pregnant women, and polypharmacy patients.
What is the primary aim of Phase I trials?
Test safety and dose-ranging in healthy volunteers (20–100 participants).
How does Phase IV differ from earlier phases?
Post-marketing surveillance to monitor long-term safety in diverse populations.
What is tested in Phase 0 trials?
Pharmacodynamics/pharmacokinetics in 10 people using sub-therapeutic doses.
Distinguish Adverse Event (AE) and Adverse Drug Reaction (ADR).
AE: Temporal association with drug use (no proven causality).
ADR: Causal link established.
Define Serious Adverse Drug Event (SADE).
AE causing death, hospitalization, disability, birth defects, or life-threatening conditions.
What determines causality in ADRs?
Time overlap with drug use, rechallenge response, exclusion of confounding factors (e.g., disease).
What is expectedness in PV?
Whether an ADR is previously documented in product information (e.g., investigator’s brochure).
What constitutes substandard medicines?
Authorized products failing quality standards (e.g., incorrect potency, contamination).
How does poor storage/distribution affect drug quality?
Leads to degradation, contamination, or labeling errors, causing inefficacy or harm.
Why are traditional medicines included in PV?
To monitor safety and efficacy, given their widespread use and potential risks.
How does PV support biotherapeutics and vaccines?
Tracks rare/long-term ADRs and ensures safety in diverse populations post-approval.
