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Questions and Answers
What categories does the guideline on GVP fall into?
What categories does the guideline on GVP fall into?
What is one of the overall quality objectives of a pharmacovigilance system?
What is one of the overall quality objectives of a pharmacovigilance system?
Who is primarily responsible for the pharmacovigilance system?
Who is primarily responsible for the pharmacovigilance system?
What does pharmacovigilance primarily monitor?
What does pharmacovigilance primarily monitor?
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Which population groups are addressed in the product- or population-specific considerations of GVP?
Which population groups are addressed in the product- or population-specific considerations of GVP?
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What type of recall is directed specifically to the end user?
What type of recall is directed specifically to the end user?
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Which of the following is likely issued first in the recall process?
Which of the following is likely issued first in the recall process?
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What additional communication might be included in a recall scenario aside from the recall letters?
What additional communication might be included in a recall scenario aside from the recall letters?
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Which type of recall is specifically associated with a clinical trial?
Which type of recall is specifically associated with a clinical trial?
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What document is typically targeted to medical professionals during a recall?
What document is typically targeted to medical professionals during a recall?
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What is the primary aim of risk management in the context of medicines?
What is the primary aim of risk management in the context of medicines?
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What document must be submitted by companies at the time of applying for marketing authorisation?
What document must be submitted by companies at the time of applying for marketing authorisation?
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How often must risk management plans be updated?
How often must risk management plans be updated?
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What is the purpose of Post Authorisation Surveillance (PASS)?
What is the purpose of Post Authorisation Surveillance (PASS)?
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What is the primary goal of pharmacovigilance?
What is the primary goal of pharmacovigilance?
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What type of information must be included in a risk management plan?
What type of information must be included in a risk management plan?
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Why would a risk management plan be modified?
Why would a risk management plan be modified?
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What is primarily determined during the pre-marketing phase of a drug?
What is primarily determined during the pre-marketing phase of a drug?
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Which of the following is a responsibility of pharmacovigilance?
Which of the following is a responsibility of pharmacovigilance?
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What is a key limitation of clinical trials during the pre-marketing phase?
What is a key limitation of clinical trials during the pre-marketing phase?
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Which of the following is NOT a reason for conducting a Post Authorisation Safety Study (PASS)?
Which of the following is NOT a reason for conducting a Post Authorisation Safety Study (PASS)?
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What significant change did Directive 2010/84/EU introduce to pharmacovigilance?
What significant change did Directive 2010/84/EU introduce to pharmacovigilance?
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Why is post-marketing surveillance important?
Why is post-marketing surveillance important?
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What is the purpose of the Eudravigilance database?
What is the purpose of the Eudravigilance database?
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What should the amount of information in a risk management plan reflect?
What should the amount of information in a risk management plan reflect?
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What does pharmacovigilance primarily focus on?
What does pharmacovigilance primarily focus on?
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What must healthcare professionals report in their practice?
What must healthcare professionals report in their practice?
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Which actions are required of Marketing Authorisation Holders (MAHs) regarding pharmacovigilance?
Which actions are required of Marketing Authorisation Holders (MAHs) regarding pharmacovigilance?
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Which committee was established within the EMA as part of the pharmacovigilance reforms?
Which committee was established within the EMA as part of the pharmacovigilance reforms?
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What type of monitoring is mandatory for specific products listed by the EMA?
What type of monitoring is mandatory for specific products listed by the EMA?
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What is essential in the post-marketing surveillance process?
What is essential in the post-marketing surveillance process?
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What is a consequence of failing to ensure effective pharmacovigilance?
What is a consequence of failing to ensure effective pharmacovigilance?
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What is the main goal of signal detection in pharmacovigilance?
What is the main goal of signal detection in pharmacovigilance?
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What aspect of clinical trials can lead to a lack of generalizability of findings?
What aspect of clinical trials can lead to a lack of generalizability of findings?
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What is considered a recall once the batch has been QP released and left the manufacturer site?
What is considered a recall once the batch has been QP released and left the manufacturer site?
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Which class of quality defects is potentially life-threatening?
Which class of quality defects is potentially life-threatening?
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What might be a remedial action taken in response to quality defects?
What might be a remedial action taken in response to quality defects?
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What is a potential reason for a recall related to product compliance?
What is a potential reason for a recall related to product compliance?
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Which of the following actions is NOT typically taken as a remedial response to product defects?
Which of the following actions is NOT typically taken as a remedial response to product defects?
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What defines a major quality defect?
What defines a major quality defect?
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What type of recall involves the withdrawal of specific batches from the market?
What type of recall involves the withdrawal of specific batches from the market?
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Which product defect was associated with a warning about increased cardiovascular risk?
Which product defect was associated with a warning about increased cardiovascular risk?
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Study Notes
Pharmacovigilance (PV)
- PV is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other medicine-related problem.
Adverse Drug Reactions (ADR)
- ADR is any response to a drug which is noxious, unintended, and occurs at doses used in humans for prophylaxis, diagnosis, or therapy.
- ADRs cause approximately 5% of all hospital admissions in the EU.
- Approximately 5% of hospitalized patients experience an ADR during their hospital stay.
- ADRs cause 197,000 deaths annually throughout the EU.
- Many ADRs can only be detected after a medicine has been authorized; the full safety profile isn't known until the medicine is on the market.
Timeline of events in Pharmacovigilance
- 1848: Hannah's death caused by chloroform.
- 1937: USA with solvent diethyl glycol.
- 1938 - Federal Food, Drug, and Cosmetic Act was established.
- 1955 - Gastrointestinal toxicity of ASA proved.
- 1961 - The Yellow Card was structured in the UK.
- 1964 - WHO Programme for International Drug Monitoring was instituted.
- 1965 - European legislation developed (EC Directive 65/65).
- 1968 - Continued in the timeline.
- 1995 - Continued in the timeline.
- 2001 - EMA was set up.
- 2012 - New European Pharmacovigilance Legislation (Directive 2010/84/EU).
- 2017 - Continued in the timeline.
McBride's Letter
- McBride's letter noted a high incidence of severe abnormalities in babies born to mothers who took thalidomide during pregnancy.
Pharmacovigilance (PV)
- ADR instances led to more sophisticated preclinical testing and clinical evaluation of drugs before marketing as well as increased awareness of adverse effects and methods of detection.
Good Pharmacovigilance Practices (GVP)
- A set of measures designed to facilitate PV in the EU.
- Applies to marketing authorisation holders, the European Medicines Agency (EMA), and member state regulatory authorities in the EU.
Pharmacovigilance in the product lifecycle
- Includes research and development, marketing authorization, and post-authorization.
Directive 2010/84/EU
- Key changes in European Pharmacovigilance in 2012.
- Modified the definition of adverse drug reactions (ADR) by increasing patient and citizen involvement in pharmacovigilance activities.
- Strengthened the Eudravigilance database by including reports of suspected reactions from EU member states.
- Increased transparency and timeliness of important information about problems in PV.
- Obligated “additional monitoring” for products in a list kept by the EMA.
- Allowed for the possibility of imposing further safety/efficacy studies on marketing authorization.
- Established the Pharmacovigilance Risk Assessment Committee (PRAC) within the EMA.
Guideline on good pharmacovigilance practices (GVP)
- A system for monitoring the safety of authorized medicinal products and detecting any changes to their risk-benefit balance.
- Comprises legal requirements and tasks for pharmacovigilance.
- Goals include preventing harm from adverse reactions, supporting the safe and effective use of medicines, and contributing to the protection of patients' and public health.
Principles of GVP
- Specific systems required for continuous monitoring of pharmacovigilance data, and scientific evaluation of all information on risks of medicinal products.
- Accurate and verifiable data submission on serious/non-serious adverse reactions.
- Effective communication between the marketing authorization holder and competent authorities, updating product information in line with scientific knowledge.
- Appropriate communication of relevant safety information to healthcare professionals and patients.
- Submission of adverse reaction data to EudraVigilance in a timely manner, retaining pharmacovigilance data, and keeping product information up-to-date.
Critical pharmacovigilance processes
- Continuous safety profile monitoring and benefit-risk evaluation of authorized medicinal products.
- Establishing, assessing, and implementing risk management systems for the effectiveness of risk minimization.
- Collection, processing, management, quality control, and follow-up of individual case safety reports (ICSRs).
- Developing and maintaining a signal management system and scheduling, preparation submission of periodic safety update reports.
- Establishing interaction between pharmacovigilance and product quality defect systems.
Overview of Pharmacovigilance
- A flowchart that describes the process from clinical trials to detecting signals, estimating incidence and severity, and finally, acting on identified risks.
QPPV
- Qualified person responsible for pharmacovigilance in the EU (QPPV).
- Responsible for implementing the PV system and receiving and analyzing information regarding safety concerns and the benefit-risk evaluation of medicinal products.
Role of QPPV
- Overview of medicinal product safety profiles, awareness of conditions, obligations, and risk minimization measures related to marketing authorizations.
- Conduct of pharmacovigilance, submission on relevant documents, provision of safety information to competent authorities and Member State countries.
Signal Detection
- A safety signal is information on a new or known adverse event that requires investigation, potentially caused by a medicine.
- Sources include spontaneous reports, clinical studies, and scientific literature.
Signal detection: Pre-marketing : Clinical Trials
- Main method to gather information in pre-marketing phase regarding cause-effect relationships, risk-benefit ratios, and information for clinical trial documents
- Limitations exist regarding a limited number of patients (not representative of the broader population), shorter durations of trials, difficulties in identifying rare ADRs, and potential for longer latency ADRs.
Post Authorization/Market Surveillance
- Clinical trials are planned carefully and conducted on a smaller number of patients.
- Post-marketing surveillance is crucial to identify drug safety issues, especially long-term effects and drug interactions.
Identifying and Reporting ADRs
- Detection and identification of ADRs results from reporting of suspected adverse reactions, new clinical trial data, and literature reports.
- Further evaluation includes gathering information, identifying potential risk factors, estimating the incidence, confirming or refuting signals, and verifying a causal relationship between the medicine and the reaction reported.
HPRA ADR Reporting
- The HPRA is Ireland's Health Products Regulatory Authority.
- It has a system for reporting suspected adverse effects.
Yellow Card
- A UK scheme for collecting and monitoring information on suspected safety concerns.
- Relies on voluntary reporting by health professionals and patients.
- Reports on side effects, medical device adverse incidents, and counterfeit medications.
- The system helps with early warning on the safety of products.
EudraVigilance
- A European database of suspected adverse reactions to medicines.
- Serves as a repository for information from healthcare practice and clinical trials.
- Supported by the PRAC for assessing safety concerns and recommending regulatory actions.
Risk Management
- Medicines are authorized based on their benefit outweighing the risk for the target population.
- Risk management plans are necessary for addressing any uncertainties related to safety.
Risk Management Plan - Contents
- Includes details on product overview, safety specifications, clinical trial exposures, post-authorisation experience, risk identification, risk minimisation measures, and risk management summary.
Post Authorization Surveillance (PASS)
- Post authorization safety study (PASS).
- May be conducted voluntarily or be imposed by a regulatory authority due to safety concerns regarding the authorized medicine.
- May be carried out to provide reassurance about the absence of a safety concern, investigate known safety concerns, or study the medicine's use in specific patient groups.
Additional monitoring
- Some post-authorized medicines are monitored more intensively.
- Identified by the inverted black triangle on package leaflets and HCPs information.
- Often because the medicine is new, there is less long-term information available.
- This does not indicate the medicine is unsafe.
Periodic Safety Update Reports (PSUR)
- Periodic safety update reports evaluate a medicine's risk and benefit profile after authorization.
- This includes considering new or emerging safety information and assessing if there are new risks or if the risk-benefit balance has changed.
Recalls
- Retrieval of manufactured batches from the marketplace when they are deemed to have quality defects.
- Product or quality defects are classified as critical, major, or minor based on the potential risk to patient health.
Consequences of Quality Defects
- Remedial measures include batch or product recalls, cessation of product issuance, warnings, and increased monitoring or review.
Recalls - Levels
- Recall levels vary depending upon the extent or severity of the defect (e.g. wholesale, retail, patient level)
The Different Levels of Recalls
- A visual representation of the various levels of recall actions (e.g. wholesale, retail, patient-level).
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Description
Test your knowledge on the guidelines for Good Pharmacovigilance Practices (GVP). This quiz covers essential concepts such as the responsibilities, objectives, and communication strategies involved in pharmacovigilance systems. Perfect for professionals in the field of medicine and pharmaceuticals.
