10 Questions
What is the Dose classification of osteoporosis due to corticosteroids according to the DoTS classification?
Collateral effect
What is the purpose of the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC)?
To promote ADR reporting in Malaysia
What is one of the pharmacovigilance requirements for pharmaceutical companies?
Establishing a pharmacovigilance system within their organizations
What is the name of the committee that serves as the secretariat to MADRAC?
National Pharmaceutical Regulatory Agency (NPRA)
What is the purpose of the Spontaneous ADR Reporting method in pharmacovigilance?
To identify rare adverse drug reactions
When did Malaysia become a member of the WHO Programme for International Drug Safety Monitoring?
1990
What is the significance of the DOTS approach?
It addresses the limitations of the Type A/B scheme
Who does MADRAC provide information to?
Doctors, pharmacists, and other healthcare professionals
What is the purpose of Prescription Event Monitoring (PEM)?
To monitor the outcomes of patients who have been prescribed a particular drug
What is the main goal of pharmacovigilance?
To monitor and ensure drug safety
Study Notes
Definition of Adverse Drug Events (ADEs)
- An injury resulting from the use of a drug, which can occur regardless of whether the drug is suspected to be the cause.
ADRs vs ADEs
- The main difference between these terms is that ADR is a harm usually suspected to be related to the drug, whereas ADE is harm associated with any dose of a drug, whether or not the dose is "normally used in man" or due to other confounders that arise during treatment.
Development of Pharmacovigilance as a Discipline
- Origins: Pharmacovigilance traces its roots back to the mid-20th century, when researchers began recognizing the need for systematic monitoring of adverse drug reactions (ADRs).
- Thalidomide Tragedy: The thalidomide disaster of the 1950s and 1960s, where the drug caused severe birth defects, served as a wake-up call for the necessity of pharmacovigilance.
- Regulatory Responses: In response to the thalidomide tragedy, regulatory agencies worldwide started implementing pharmacovigilance systems to monitor drug safety more effectively.
Milestones in Pharmacovigilance History
- WHO Program: The World Health Organization (WHO) initiated its Programme for International Drug Monitoring in 1968, aiming to facilitate the exchange of information on ADRs among member countries and promote collaboration in pharmacovigilance activities.
- Pharmacovigilance Guidelines: International bodies, such as the International Conference on Harmonisation (ICH) and the Council for International Organizations of Medical Sciences (CIOMS), developed guidelines and standards for pharmacovigilance practices.
Adverse Drug Reactions (ADRs) Classification
- Rawlins and Thompson classification: ADRs are classified into two broad categories, Types A and B.
- DoTS Classification Example: Osteoporosis due to corticosteroids, classified as: Dose: collateral effect, Time: late, Susceptibility: age, sex.
ADR Reporting System
- MADRAC, DCA & NPRA: Malaysia set up its national pharmacovigilance system with the establishment of the Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) in 1987, which acts as an advisory body to the Drug Control Authority (DCA) on local and international drug safety issues.
Pharmacovigilance System
- One of the pharmacovigilance requirements for pharmaceutical companies is the establishment of a pharmacovigilance system within their organizations, ensuring patient safety.
Pharmacovigilance Evaluating Methods
- Spontaneous ADR Reporting
- Prescription Event Monitoring (PEM)
- Case–Control and Case–Crossover Studies
- Cohort Studies
- Randomized Controlled Trials
This quiz covers the definition and monitoring of adverse drug events, including the role of national centers and the World Health Organization.
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