Podcast
Questions and Answers
What is the primary goal of active surveillance systems in pharmacovigilance?
What is the primary goal of active surveillance systems in pharmacovigilance?
Which of the following is a limitation of drug event monitoring?
Which of the following is a limitation of drug event monitoring?
What is the main difference between disease registries and drug registries?
What is the main difference between disease registries and drug registries?
What is the purpose of sending follow-up questionnaires in drug event monitoring?
What is the purpose of sending follow-up questionnaires in drug event monitoring?
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What can be a concern in drug event monitoring?
What can be a concern in drug event monitoring?
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What type of data can be collected through drug event monitoring?
What type of data can be collected through drug event monitoring?
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What is the benefit of collecting data through registries?
What is the benefit of collecting data through registries?
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What is the characteristic that defines a registry?
What is the characteristic that defines a registry?
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What is the purpose of intensive monitoring of sentinel sites?
What is the purpose of intensive monitoring of sentinel sites?
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What is drug event monitoring a method of?
What is drug event monitoring a method of?
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Study Notes
Decision to Approve a Drug
- The decision to approve a drug is based on its satisfactory balance of benefits and risks within the specified conditions in the product labeling.
- The decision is made based on the available information at the time of approval.
Safety Profile and Pharmacovigilance
- The safety profile of a product can change over time through expanded use, and new information is generated, which can impact the benefits or risks of the product.
- Evaluation of this information should be a continuous process, in consultation with regulatory authorities.
- Detailed evaluation of pharmacovigilance activities is essential to ensure the safe use of products.
Benefit-Risk Balance
- The benefit-risk balance can be improved by reducing risks to patients through effective pharmacovigilance.
- Pharmacovigilance enables information feedback to users of medicines in a timely manner.
Industry and Regulators
- Industry and regulators have identified the need for better and earlier planning of pharmacovigilance activities before a product is approved or licensed.
- The ICH guidance aims to encourage harmonization and consistency, preventing duplication of effort, and benefiting public health programs worldwide.
Epidemiology and Incidence Rates
- Discussions should include incidence, prevalence, mortality, and relevant co-morbidity, taking into account stratification by age, sex, and racial and/or ethnic origin.
- Differences in epidemiology across regions should be discussed, if available.
- Reviewing incidence rates of important adverse events among patients in whom the drug is indicated is useful.
Safety Specification and Pharmacovigilance Plan
- The safety specification should identify risks believed to be common to the pharmacological class.
- A summary of the safety specification should be provided, including important identified risks, important potential risks, and important missing information.
Pharmacovigilance Plan
- The pharmacovigilance plan should be based on the safety specification and updated as important information becomes available.
- The plan should include a summary of ongoing safety issues, routine pharmacovigilance practices, and an action plan for safety issues.
Routine Pharmacovigilance Practices
- Routine pharmacovigilance should include systems and processes to collect and collate adverse reaction information.
- Preparation of reports for regulatory authorities, including expedited adverse drug reaction reports and periodic safety update reports, is necessary.
- Continuous monitoring of the safety profile, including signal detection, issue evaluation, and updating of labeling, is required.
Action Plan for Safety Issues
- The plan for each important safety issue should be presented, including the safety issue, objective, proposed action, rationale, monitoring, and milestones.
Drug Event Monitoring and Registries
- Drug event monitoring is a method of active pharmacovigilance surveillance, involving the identification of patients from electronic prescription data or automated health insurance claims.
- Registries, such as disease registries or drug registries, can collect a battery of information using standardized questionnaires in a prospective fashion.
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Description
This quiz explores the process of approving drugs, considering the balance of benefits and risks, and how knowledge of safety profiles changes over time.
