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Questions and Answers
What did the Kefauver-Harris amendment of 1962 focus on?
In which country did Thalidomide enter the market in 1957?
How many children in how many countries were born with limb malformations due to Thalidomide?
What did the new law require regarding cosmetics, medical devices, and drugs?
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What connection was proposed by Dr. McBride between Thalidomide and congenital malformations?
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What is the aim of pharmacovigilance?
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Which of the following is not a part of pharmacovigilance activities?
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What was the significance of the Chloroform Tragedy in 1848?
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What was the major impact of the Sulfanilamide Elixir Tragedy in 1937?
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Which program manages information on suspected adverse drug reactions in Europe?
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According to historical developments, what was mandated by the US Federal Food and Drug Act?
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What tragic event led to the UK implementing the 'Yellow Card' system for reporting malformations?
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Which year marked the establishment of the European Medicines Agency (EMA)?
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What was the cause of death in the Chloroform Tragedy?
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Which solvent was considered responsible for the deaths during the Sulfanilamide Elixir Tragedy?
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What major event led to the development of the WHO Program for International Drug Monitoring (PIDM)?
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Which act was signed by the FDA on 25 June 1938?
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What was the primary purpose of the Yellow Card Scheme implemented by the UK in 1964?
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Which of the following countries was NOT part of the initial group of 10 countries that agreed to submit reports to the WHO Drug Monitoring Project in 1968?
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What was the main objective behind the establishment of EudraVigilance in 2001?
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What key function did the WHO-UMC serve when it was created in 1968?
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What was the role of the European Medicines Agency (EMA) when it was established in 1995?
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Which action was NOT a part of the objectives of the European Medicines Agency (EMA)?
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What is the responsibility of the Ministry of Health and Prevention (MOHAP) in the UAE?
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In what year did the UAE launch its National Pharmacovigilance program?
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Which country represents only 0.6% of all reported cases in VigiBase Adverse Event and Safety-Related Information Collection?
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What is an example of a reason for product recall mentioned in the text?
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Which organization may mandate a product recall under certain circumstances?
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What kind of reports does MOHAP receive regarding adverse drug reactions?
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Study Notes
Kefauver-Harris Amendment
- Focused on drug safety and efficacy, introduced in response to the Thalidomide tragedy.
- Mandated that drugs must be proven safe for human use before marketing.
Thalidomide Background
- Launched in 1957 in West Germany.
- Caused limb malformations in approximately 10,000 children across 46 countries.
New Law Requirements
- Required rigorous testing and approval processes for cosmetics, medical devices, and drugs to ensure safety and efficacy.
Connection to Malformations
- Dr. McBride proposed a direct link between Thalidomide use during pregnancy and congenital malformations in infants.
Aim of Pharmacovigilance
- To monitor and evaluate the safety of medications post-marketing, ensuring that adverse drug reactions are reported and analyzed.
Non-Pharmacovigilance Activities
- Activities unrelated to the monitoring or reporting of drug safety incidents are excluded from pharmacovigilance.
Chloroform Tragedy Significance
- Highlighted the need for drug safety regulations following the poisoning of patients due to chloroform-based anesthetics in 1848.
Sulfanilamide Elixir Tragedy Impact
- Resulted in over 100 deaths due to the toxic solvent diethylene glycol in a poorly tested formulation in 1937.
Suspected Adverse Drug Reactions in Europe
- Managed through the EudraVigilance program, which collects data on adverse drug reactions in the European Union.
US Federal Food and Drug Act Mandates
- Required accurate labeling and safety evaluation of drugs to protect public health.
Yellow Card System Implementation
- Established in the UK following the Thalidomide incident to report and monitor adverse drug reactions.
Establishment of the European Medicines Agency
- Founded in 1995 to oversee the evaluation and supervision of medicinal products within the EU.
Cause of Death in Chloroform Tragedy
- Deaths were primarily caused by chloroform poisoning in clinical use.
Sulfanilamide Elixir Tragedy Responsible Solvent
- Diethylene glycol, a toxic ingredient, led to numerous fatalities.
WHO Program for International Drug Monitoring Development
- Created in response to the need for global drug safety monitoring following various drug-related tragedies.
FDA Act of 1938
- The Federal Food, Drug, and Cosmetic Act was signed to ensure more stringent drug testing and approval processes.
Primary Purpose of Yellow Card Scheme
- To identify and address potential safety issues with drugs and enable swift reporting of adverse effects.
Countries in WHO Drug Monitoring Project
- Initial group consisted of 10 countries; the specific non-participant is not indicated.
EudraVigilance Establishment Objective
- Aimed to facilitate effective monitoring of drug safety across Europe.
WHO-UMC Function in 1968
- Provided a global center for monitoring and assessing drug safety data from member countries.
Role of European Medicines Agency in 1995
- Oversaw the evaluation and supervision of new drugs and maintained drug safety across Europe.
European Medicines Agency Non-Objectives
- Any actions not related to assessing drug safety, efficacy, or regulatory compliance were not part of EMA’s objectives.
MOHAP Responsibilities in UAE
- Tasked with overseeing drug regulation, including monitoring adverse drug reactions and ensuring public health safety.
UAE National Pharmacovigilance Program Launch
- Established in 2017 to enhance drug safety monitoring and reporting in the UAE.
Country Representing 0.6% in VigiBase
- A specific unnamed country contributes only 0.6% of all reported adverse drug reaction cases.
Example of Product Recall Reason
- Product recalls can arise from safety issues or adverse reactions linked to medication use.
Organization Mandating Product Recall
- Health authorities, such as the FDA or similar regulatory bodies, have the power to mandate recalls when necessary.
MOHAP Reported Adverse Drug Reaction Reports
- Receives detailed reports documenting incidents of adverse reactions to drugs from healthcare professionals and the public.
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Description
Learn about the definition, aim, history, and significance of pharmacovigilance, including medicine safety monitoring and the pharmacovigilance system in the UAE. Explore the WHO international drug monitoring program and understand the learning outcomes associated with pharmacovigilance.
