Podcast
Questions and Answers
What is the purpose of pharmacovigilance?
What is the purpose of pharmacovigilance?
Which of the following describes low external validity in clinical trials?
Which of the following describes low external validity in clinical trials?
Which group is often underrepresented in pre-authorization clinical trials?
Which group is often underrepresented in pre-authorization clinical trials?
What is a common limitation of the patients included in pre-authorization clinical trials?
What is a common limitation of the patients included in pre-authorization clinical trials?
Signup and view all the answers
What aspect of pharmacovigilance is crucial to address after a drug has been approved?
What aspect of pharmacovigilance is crucial to address after a drug has been approved?
Signup and view all the answers
Which organization focuses on the harmonization of medical sciences on an international level?
Which organization focuses on the harmonization of medical sciences on an international level?
Signup and view all the answers
What is the primary purpose of a signal in pharmacovigilance?
What is the primary purpose of a signal in pharmacovigilance?
Signup and view all the answers
What are Periodic Safety Update Reports (PSURs) primarily intended for?
What are Periodic Safety Update Reports (PSURs) primarily intended for?
Signup and view all the answers
Which statement about signal generation is true?
Which statement about signal generation is true?
Signup and view all the answers
Which of the following is NOT a role typically associated with stakeholders in pharmacovigilance?
Which of the following is NOT a role typically associated with stakeholders in pharmacovigilance?
Signup and view all the answers
What is the primary role of the Pharmacovigilance Risk Assessment Committee (PRAC)?
What is the primary role of the Pharmacovigilance Risk Assessment Committee (PRAC)?
Signup and view all the answers
Which of the following is not a function of regulatory authorities in pharmacovigilance?
Which of the following is not a function of regulatory authorities in pharmacovigilance?
Signup and view all the answers
What does the European Medicines Agency (EMA) do in relation to pharmacovigilance?
What does the European Medicines Agency (EMA) do in relation to pharmacovigilance?
Signup and view all the answers
What is the main responsibility of the Uppsala Monitoring Centre (UMC)?
What is the main responsibility of the Uppsala Monitoring Centre (UMC)?
Signup and view all the answers
Which statement accurately describes one of the key functions of regulatory authorities in pharmacovigilance?
Which statement accurately describes one of the key functions of regulatory authorities in pharmacovigilance?
Signup and view all the answers
What is the primary purpose of Periodic Safety Update Reports (PSURs)?
What is the primary purpose of Periodic Safety Update Reports (PSURs)?
Signup and view all the answers
Which regulatory agency is responsible for overseeing drugs in the USA?
Which regulatory agency is responsible for overseeing drugs in the USA?
Signup and view all the answers
What historical event catalyzed the development of spontaneous adverse reaction reporting schemes?
What historical event catalyzed the development of spontaneous adverse reaction reporting schemes?
Signup and view all the answers
Which of the following is NOT a function of the Market Authorization Holder (MAH)?
Which of the following is NOT a function of the Market Authorization Holder (MAH)?
Signup and view all the answers
What does the Medicines and Healthcare products Regulatory Agency (MHRA) focus on?
What does the Medicines and Healthcare products Regulatory Agency (MHRA) focus on?
Signup and view all the answers
Study Notes
Pharmacovigilance
- Pharmacovigilance is the monitoring of medicinal products after authorization to ensure maximum safety and the best possible balance between benefits and risks
- Pharmacovigilance is a science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs)
- The aim is to improve patient safety and contribute to public health protection
Historical Milestones
- Tragic crises like thalidomide tragedy in the 1960s were major drivers for change in pharmacovigilance
- Early pharmacovigilance initiatives, such as the WHO Programme for International Drug Monitoring, began in the 1960s
- The thalidomide tragedy led to increased awareness of the importance of monitoring drug safety
- Czechoslovakia was one of the first countries engaged in WHO's International Drug Monitoring Program
Adverse Drug Reactions (ADRs)
- ADR is a noxious and unintended response to a medicinal product, at doses used for prophylaxis, diagnosis or therapy of disease
- ADRs may occur within or outside the terms of the marketing authorization
- or from occupational exposure
Types of ADRs
- Serious ADRs: results in death, life-threatening, hospitalization, or prolongation of existing hospitalization, persistent or significant disability, or a birth defect
- Unexpected ADRs: nature or severity is not consistent with information in the summary of product characteristics (SmPC)
Types of Adverse Drug Reactions (classification)
- Augmented: dose-dependent, predictable (eg,anticoagulants → bleeding)
- Bizarre: hypersensitivity reactions (eg, penicillin → anaphylaxis)
- Chronic: cumulative (eg., amiodarone → pulmonary fibrosis)
- Delayed: (eg., teratogens: thalidomide, warfarin, lithium, valproate)
- End of Use: rebound phenomenon, withdrawal syndrome (eg., abrupt withdrawal of beta-blockers)
- Failure of Therapy: lack of effectiveness (eg., due to drug-interactions)
- Immediate: rapid titration (eg., ACEI → orthostatic hypotension)
Classification of ADRs by Frequency
- Very common: ≥ 1/10 patients
- Common: 1/100 to 1/10 patients
- Uncommon: 1/1000 to 1/100 patients
- Rare: 1/10 00 to 1/1000 patients
- Very rare: < 1/10 000 patients
Classification according to the organ system class
- Hematologic toxicity, hepatotoxicity, cardiac toxicity, nephrotoxicity & rhabdomyolysis
Stakeholders in Pharmacovigilance
- Health Care Providers (HCPs): report suspected serious or unexpected ADRs
- Marketing Authorization Holders (MAHs): collect, review, analyze information on suspected ADRs, and report to regulatory authorities
- Regulatory Authorities (e.g., EMA, FDA, SÚKL): manage ICSR databases, guidelines, inspections, benefit-risk assessment, and regulatory actions
- Patients and Patient Organisations: report directly to health authorities, and their views inform benefit-risk decision-making
Signal Detection
- Signal = information from multiple sources suggesting new causal associations between an intervention and an adverse event
- Signal detection involves gathering information from various sources and analyzing for potential relationships
Periodic Safety Update Reports (PSURs)
- MAHs provide comprehensive and critical analysis of the risk-benefit balance of a product.
- MAHs report this information to regulatory authorities
Regulatory Actions
- Withdrawal from the market: If risks outweigh benefits, the product may be removed.
- Risk Minimization Measures (RMMs): This is an intervention used to reduce the occurrence or severity of ADRs
Risk Minimization Measures
- Update of product summary and patient information leaflets (PIL)
- New drug warnings and contraindications
- Legal status changes (e.g., from OTC to prescription-only)
- Package changes to reduce risks (eg. maximum supply days)
- Communication; e.g., pregnancy prevention programs, medical education
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
Related Documents
Description
Test your knowledge on pharmacovigilance, its historical milestones, and the significance of monitoring adverse drug reactions (ADRs). This quiz covers the evolution of safety practices in medication use and their impact on patient care and public health. Delve into the lessons learned from historical crises and current practices in drug safety monitoring.
