pharmacovigilance introduction & imp terms.pptx

Definition:
Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem.
Importance:
Ensures patient safety and the efficacy of drugs in clinical use.
Adverse Drug Reaction (ADR):
Any response to a drug that is harmful and unintended.
Signal Detection:
Process of identifying new safety information from data sources.
Risk Management:
Measures taken to mitigate identified risks.
Objectives of Pharmacovigilance
To identify and assess adverse drug reactions (ADRs).
To ensure the benefits of a drug outweigh its risks.
To contribute to the safe and effective use of medicines.
To provide information for the rational use of drugs.
Core Activities in Pharmacovigilance
Adverse Event Reporting: Documenting and reporting adverse drug reactions (ADRs).
Signal Detection: Identifying new risks or rare adverse effects.
Risk Assessment and Management: Analyzing risk-benefit ratio of drugs.
Communication: Informing healthcare professionals and the public about risks.
Definition: Dechallenge refers to the process of stopping or withdrawing a drug after an adverse event has been identified, in order to observe whether the adverse event improves or resolves.
Purpose: It helps establish a causal relationship between the drug and the adverse event by monitoring whether the symptoms diminish after the drug is discontinued.
Definition: Rechallenge refers to the re-administration of a drug after it was previously discontinued due to an adverse event, in order to observe whether the adverse event recurs.
Purpose: It is used to further confirm a causal relationship between the drug and the adverse event by determining if the adverse event reappears when the drug is given again.
Definition: Rechallenge refers to the re-administration of a drug after it was previously discontinued due to an adverse event, in order to observe whether the adverse event recurs.
Purpose: It is used to further confirm a causal relationship between the drug and the adverse event by determining if the adverse event reappears when the drug is given again.
Definition: Rechallenge refers to the re-administration of a drug after it was previously discontinued due to an adverse event, in order to observe whether the adverse event recurs.
Purpose: It is used to further confirm a causal relationship between the drug and the adverse event by determining if the adverse event reappears when the drug is given again.
A causal relationship in pharmacovigilance refers to the connection between a drug and an adverse event, indicating that the drug is responsible for causing the adverse event. Establishing a causal relationship is critical for understanding drug safety and making informed decisions about medication use.
A causal relationship in pharmacovigilance refers to the connection between a drug and an adverse event, indicating that the drug is responsible for causing the adverse event.

1. Ensuring Drug Safety and Monitoring Adverse Effects PRESENTED BY ZAMRAN KHAN INTRODUCTION TO PHARMACOVIGILANCE

2. Definition: Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem. Importance: Ensures patient safety and the efficacy of drugs in clinical use.

3. Objectives of Pharmacovigilance

4. Importance of Pharmacovigilance Pharmacovigilance is essential for ensuring patient safety and public health. It helps identify and mitigate risks associated with medications, leading to improved patient outcomes and reduced healthcare costs. By collecting and analyzing data on adverse drug events, healthcare professionals and regulatory agencies can make informed decisions about drug safety and efficacy. 1 Protecting Patients Pharmacovigilance plays a crucial role in protecting patients from potential harm caused by medications. It helps identify rare or delayed adverse effects that may not be apparent during clinical trials. 2 Improving Drug Safety By monitoring drug safety and identifying potential risks, pharmacovigilance helps to improve the overall safety profile of medications. This leads to more effective and safer drug treatments. 3 Ensuring Rational Drug Use Pharmacovigilance promotes rational drug use by providing healthcare professionals and patients with accurate information about the risks and benefits of medications. 4 Supporting Regulatory Decision Making Pharmacovigilance data is vital for regulatory agencies to make informed decisions about drug approval, labeling, and post-marketing surveillance.

5. Key Terms in Pharmacovigilance Adverse Drug Reaction (ADR) : Any response to a drug that is harmful and unintended. Signal Detection : Process of identifying new safety information from data sources. Risk Management : Measures taken to mitigate identified risks.

6. Regulatory Frameworks and Guidelines Pharmacovigilance is governed by stringent regulatory frameworks and guidelines, ensuring the safety and effectiveness of medications worldwide. These regulations provide a comprehensive framework for collecting, analyzing, and reporting adverse drug events. The Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe are key regulatory bodies responsible for overseeing pharmacovigilance activities. These agencies establish standards for pharmacovigilance systems, including requirements for reporting, investigating, and managing adverse drug events. Good Pharmacovigilance Practices (GVP) GVP are a set of guidelines developed by the EMA to ensure the quality, safety, and efficacy of medications. These guidelines provide a comprehensive framework for pharmacovigilance activities, including adverse event reporting, signal detection, and risk management. International Conference on Harmonisation (ICH) ICH is an international organization that develops guidelines for the registration of pharmaceuticals. ICH guidelines on pharmacovigilance address topics such as adverse event reporting, signal detection, and risk management. National Regulations Many countries have their own national regulations governing pharmacovigilance activities. These regulations may vary depending on the specific country and its healthcare system.

7. The Pharmacovigilance Process

8. Adverse Event Reporting and Monitoring Adverse event reporting is a crucial component of pharmacovigilance. It involves the collection and documentation of suspected adverse drug reactions (ADRs). Healthcare professionals, patients, and pharmaceutical companies are all involved in reporting adverse events. Reports are submitted to regulatory agencies and pharmacovigilance centers, which are responsible for collecting and analyzing these reports. Spontaneous Reporting Spontaneous reporting relies on healthcare professionals and patients to voluntarily report suspected ADRs. This method is widely used, but it can be limited by underreporting and the potential for bias. Passive Surveillance Passive surveillance involves monitoring for ADRs through databases and electronic health records. This approach can capture a larger volume of data but may not be as efficient as active surveillance in identifying new or emerging safety signals. Active Surveillance Active surveillance involves proactively collecting data on ADRs through targeted studies or surveys. This approach is more efficient at identifying new or emerging safety signals but can be resource-intensive.

9. Risk Assessment and Management Risk assessment is a crucial step in pharmacovigilance. It involves evaluating the potential risks associated with medications and developing strategies to mitigate those risks. Risk assessment takes into account the likelihood of an adverse event occurring, the severity of the event, and the potential benefits of the medication. Risk Identification Identifying potential risks associated with medications is the first step in risk assessment. This involves reviewing data from clinical trials, post-marketing surveillance, and literature. Risk Characterization Characterizing the risks involves understanding the likelihood of an adverse event occurring, the severity of the event, and the potential benefits of the medication. This information is used to determine the overall risk-benefit profile of the drug. Risk Management Risk management involves developing strategies to minimize the risks associated with medications. These strategies may include changing the labeling, restricting the use of the medication, or implementing post-marketing surveillance programs.

10. Pharmacovigilance in Clinical Trials Pharmacovigilance plays a crucial role in clinical trials, ensuring the safety of participants and providing valuable data on the safety profile of investigational drugs. The pharmacovigilance team monitors the trial closely, collecting and analyzing data on adverse events, reporting them to regulatory agencies, and taking appropriate actions to mitigate risks. Safety Monitoring Plan A detailed plan outlining how safety data will be collected, analyzed, and reported during the trial. Adverse Event Reporting Prompt and accurate reporting of all suspected ADRs to the ethics committee, regulatory agencies, and trial sponsors. Safety Data Review Regular review of safety data by the safety monitoring board or data safety monitoring committee to assess the safety profile of the investigational drug and make recommendations for trial continuation, modification, or termination.

11. Pharmacovigilance in Post-Marketing Surveillance Post-marketing surveillance is a critical part of pharmacovigilance, as it allows for continued monitoring of drug safety after a medication has been approved for use. This ongoing surveillance is essential to identify rare or delayed adverse effects that may not have been detected during clinical trials. 1 Spontaneous Reporting Healthcare professionals and patients continue to report suspected ADRs, contributing to a vast database of post-marketing safety information. 2 Active Surveillance Pharmacovigilance centers may conduct active surveillance programs, targeting specific patient populations or medications of interest to gather more detailed information on safety. 3 Risk Management Plans Risk management plans may be developed for specific medications to mitigate identified risks, including labeling changes, restrictions on use, or post-marketing studies. 4 Signal Detection and Evaluation Post-marketing data is continuously analyzed to detect and evaluate potential safety signals, leading to informed decision-making about drug safety.

12. Pharmacovigilance Data Management and Analysis Pharmacovigilance data management and analysis are essential for effectively monitoring drug safety and making informed decisions. These processes involve collecting, storing, and analyzing data on adverse events, clinical trials, and other relevant sources. Data Collection Data is collected from various sources, including adverse event reports, clinical trial data, and published literature. Data Storage Data is stored in secure databases, ensuring its integrity, availability, and confidentiality. Data Analysis Data analysis involves applying statistical methods, data mining techniques, and expert review to identify patterns, trends, and potential safety signals.

13. Global Pharmacovigilance Systems

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15. Defining Serious Adverse Events 1 Seriousness Criteria A serious adverse event (SAE) is an event that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. SAEs are considered a significant safety concern and require prompt investigation. 2 Examples of SAEs Examples of SAEs include heart attack, stroke, severe allergic reactions, organ failure, and death. These events require immediate medical attention and are often a priority for investigation in pharmacovigilance. 3 Reporting SAEs SAEs are typically reported to regulatory authorities and the drug manufacturer as they are a significant safety concern. Prompt and accurate reporting of SAEs is essential for ensuring patient safety and timely interventions.

16. Solicited Reports Definition : These reports are actively collected through structured programs, such as clinical trials, patient support programs, or registries. Key Features : Predefined data collection Typically involve large patient groups for systematic monitoring Examples : Adverse event reports from a post-marketing surveillance study conducted by a pharmaceutical company. Clinical Trial Reports Definition : Adverse events occurring during clinical trials (phases I-IV) are systematically collected and reported. Key Features : Controlled environment with predefined conditions Early detection of adverse events and side effects during drug development Examples : Reports of side effects or serious adverse events (SAEs) in patients participating in clinical trials for a new cancer drug.

17. Literature Reports Definition : Reports of adverse events published in scientific literature, including case studies, research articles, or reviews. Key Features : Often involves rare or serious adverse events that have been thoroughly documented by researchers Frequently used by regulatory bodies for drug safety evaluation Examples : A published article describing a rare allergic reaction to a newly approved drug. Foreign Reports Definition : These are reports of adverse events occurring outside the country where the drug is marketed or used. Key Features : Information from foreign sources may help identify global safety signals Often required for regulatory submissions in multiple countries Examples : An adverse event report from Europe about a drug that is under review for approval in the U.S.

18. Post-Marketing Surveillance (PMS) Reports Definition : These reports are generated after a drug has been approved and marketed to the general public. Key Features : Continuous monitoring of adverse events after the drug’s release Includes data from spontaneous reports, registries, and targeted surveys Examples : Reports collected after a diabetes drug was launched, revealing unexpected cardiovascular side effects. Expedited Reports Definition : These reports involve serious, unexpected adverse events that must be reported to regulatory agencies within a specific time frame (e.g., 7 to 15 days). Key Features : Rapid submission due to the seriousness of the event Used for events that may significantly impact public health Examples : A pharmaceutical company submits an expedited report about a patient’s death potentially linked to their newly approved drug.

19. Follow-Up Reports Definition : Additional information submitted after an initial case report to provide updates or clarify missing data. Key Features : Follow-up reports enhance the quality and completeness of initial case reports May include new information on the patient's condition, outcomes, or causality assessments Examples : A follow-up report updating a regulatory body about the recovery of a patient after a serious adverse reaction to a drug. Cluster Reports Definition : These are reports of multiple adverse events occurring in the same population, geographic location, or under similar conditions within a short time frame. Key Features : Suggest potential patterns or signals related to a specific drug or product Prompt further investigation into the cause of the clustered events Examples : Several patients in the same hospital experience severe allergic reactions to a specific batch of medication.

20. Individual Case Safety Reports (ICSRs) Definition : Structured reports detailing a single patient's adverse event associated with drug use. ICSRs are widely used for regulatory and pharmacovigilance purposes. Key Features : Contains essential information (e.g., patient details, drug, event, reporter) Submitted to regulatory agencies and used in global databases (e.g., VigiBase ) Examples : An ICSR submitted by a physician reporting a serious skin reaction in a patient taking an antibiotic. Aggregate Reports Definition : These summarize multiple adverse event reports over a specific period or involving a specific drug, providing a broader view of drug safety trends. Key Features : Usually compiled for regulatory submissions or drug safety evaluations Include cumulative data and trend analysis Examples : A periodic safety update report (PSUR) summarizing all adverse event reports for a drug over the past year.

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