A
- Adverse Event (AE) – Any unwanted medical occurrence during treatment that may or may not be related to the drug.
- Adverse Drug Reaction (ADR) – A harmful reaction that occurs when a drug is used at normal doses.
- Aggregate Report – A summary report of adverse events over a specified period.
- Active Surveillance – Actively seeking data on adverse events rather than waiting for spontaneous reports.
- Adverse Event Reporting System (AERS) – A system used to collect reports of adverse events.
- Approved Drug Labeling – Official documentation describing the drug's uses, risks, and benefits.
- Atypical Reaction – An unusual response to a drug that is not commonly seen.
- Assessment of Causality – The process of determining whether a drug caused an adverse event.
- Accelerated Reporting – Expedited submission of adverse event data to regulators.
- Auditing in Pharmacovigilance – A systematic examination of pharmacovigilance processes to ensure compliance.
B
- Benefit-Risk Assessment – Evaluation of the positive effects of a drug versus its potential risks.
- Black Box Warning – The strictest warning required by the FDA, indicating serious drug risks.
- Biological Product Deviation Report – Report for adverse events related to biological products.
- Biosimilar – A biological product highly similar to an already approved biological drug.
- Breach in Good Clinical Practice (GCP) – Non-compliance with GCP standards in drug safety trials.
- Breach in Good Pharmacovigilance Practices (GVP) – Failure to comply with GVP regulations.
- Biosurveillance – Monitoring and analysis of data to track biological events, including adverse reactions.
- Benefit Risk Management Plan (BRMP) – Plan outlining how to manage risks and maximize benefits of a drug.
- Biovigilance – Monitoring the safety of biological products like vaccines and gene therapies.
- Batch Recall – Withdrawal of a batch of drugs due to safety concerns.
C
- Causality Assessment – Process of determining the likelihood of a causal relationship between a drug and an adverse event.
- Clinical Trial – A study conducted to evaluate a drug’s efficacy and safety in human subjects.
- Case Report Form (CRF) – A document used to collect data on a participant in a clinical trial.
- Confounding Factor – A variable that affects both the independent and dependent variables in a study, making it difficult to determine causality.
- Compliance Monitoring – Ensuring adherence to regulatory requirements for pharmacovigilance.
- Controlled Study – A clinical trial in which one group receives the experimental treatment while another receives a placebo or standard treatment.
- Cost-Effectiveness Analysis (CEA) – A method of comparing the costs and outcomes of different interventions.
- Cohort Event Monitoring (CEM) – Active surveillance involving follow-up of patients in a cohort for adverse events.
- Coding of Adverse Events – The process of assigning standardized codes to adverse events using dictionaries like MedDRA.
- Corporate Safety Database – A central repository where all adverse events reported to a pharmaceutical company are stored.
D
- Data Lock Point (DLP) – The cut-off date for data inclusion in a safety report.
- Development Safety Update Report (DSUR) – An annual report that summarizes safety information from clinical trials.
- Disproportionality Analysis – Statistical analysis used to identify unusual patterns in adverse event reporting.
- Drug Utilization Review (DUR) – An evaluation of drug prescription practices and their outcomes.
- Drug Interaction – An interaction between two or more drugs that causes a change in effect.
- Drug-Induced Liver Injury (DILI) – Liver damage caused by a drug.
- Dechallenge – The process of stopping a drug to see if an adverse event resolves.
- Direct Healthcare Professional Communication (DHPC) – A letter sent to healthcare professionals to alert them of new or urgent safety information about a drug.
- Drug Safety Monitoring Board (DSMB) – An independent group that monitors the safety of ongoing clinical trials.
- Drug Recall – Withdrawal of a drug from the market due to safety concerns.
E
- EudraVigilance – The European database for collecting reports of adverse drug reactions.
- Electronic Health Record (EHR) – A digital version of a patient’s medical history, which may be used in pharmacovigilance.
- Expedited Reporting – Rapid reporting of adverse events to regulatory authorities within specified timeframes.
- Epidemiology – The study of the distribution and determinants of health and disease conditions in populations.
- Efficacy – The ability of a drug to produce the desired therapeutic effect.
- Expectedness – Classification of an adverse event as "expected" or "unexpected" based on known safety data.
- Event of Special Interest (ESI) – An adverse event that is of particular concern to regulators or sponsors.
- Evidence-Based Medicine (EBM) – The use of current best evidence in making decisions about the care of patients.
- Effective Dose (ED50) – The dose of a drug that produces a therapeutic effect in 50% of the population.
- European Medicines Agency (EMA) – The regulatory agency responsible for the evaluation and supervision of medicines in the European Union.
F
- FAERS (FDA Adverse Event Reporting System) – A database managed by the FDA for collecting adverse drug event reports.
- Follow-Up Report – A report submitted to provide additional information about a previously reported adverse event.
- False Positive – A test result that incorrectly indicates that a particular condition or attribute is present.
- Full Case Report – A detailed report of an adverse event, containing all relevant information.
- False Negative – A test result that incorrectly indicates that a condition is absent.
- Fatal Outcome – An adverse event that results in death.
- Food and Drug Administration (FDA) – The US regulatory body responsible for the approval and oversight of pharmaceuticals.
- Fetal Exposure – Exposure of a fetus to a drug taken by the mother during pregnancy.
- Frequency of Adverse Events – How often a specific adverse event occurs in a patient population.
- Follow-Up Monitoring – Ongoing safety monitoring of patients after they experience an adverse event.
G
- Good Pharmacovigilance Practices (GVP) – Guidelines developed to ensure effective drug safety monitoring.
- Generic Drug – A drug that is equivalent to a brand-name product but is typically less expensive.
- Global Safety Database – A centralised system that collects and manages worldwide safety information for a pharmaceutical company.
- Good Clinical Practice (GCP) – An international standard for designing, conducting, and reporting clinical trials.
- Good Manufacturing Practice (GMP) – Regulations that ensure pharmaceutical products are consistently produced and controlled according to quality standards.
H
- Hepatotoxicity – Liver damage caused by a drug or chemical, often identified during drug safety evaluations.
- Health Canada Vigilance Program – The Canadian pharmacovigilance program responsible for monitoring the safety of health products.
- Hypersensitivity Reaction – An exaggerated immune response to a drug that may result in allergic reactions.
- Health Outcome of Interest (HOI) – A specific health condition or event of focus in pharmacovigilance studies, such as myocardial infarction or stroke.
- Human Data Review – The evaluation of safety data obtained from human use of a drug, either in clinical trials or post-marketing.
- Hazard Identification – The process of determining potential adverse effects a drug may have on health.
- Harmonization – The process of aligning pharmacovigilance practices and regulations across different regions to ensure consistency.
- Health-Related Quality of Life (HRQoL) – A measure of how a patient's well-being is affected by a medical condition and its treatment.
- Herbal Pharmacovigilance – The monitoring of safety related to the use of herbal products.
- Health Technology Assessment (HTA) – A systematic evaluation of the properties and impacts of health technologies, often used to inform policy-making.
I
- Individual Case Safety Report (ICSR) – A report containing information on an adverse event for a specific patient and drug.
- ICH E2E Guideline – The International Council for Harmonisation guideline on pharmacovigilance, covering definitions and standards for drug safety monitoring.
- Identified Risk – A risk that has been confirmed with sufficient evidence through clinical trials or post-marketing surveillance.
- Interim Safety Report – A report submitted during an ongoing clinical trial to provide updates on the drug’s safety profile.
- Incidence Rate – The frequency at which new cases of an adverse event occur in a population during a specific period.
- Immunogenicity – The ability of a substance, such as a vaccine or biologic, to provoke an immune response, which can sometimes lead to adverse reactions.
- Informed Consent – A process in which patients are educated about the risks and benefits of a treatment and voluntarily agree to participate.
- Investigational New Drug (IND) – A drug that is being tested in clinical trials but has not yet received approval for marketing.
- International Nonproprietary Name (INN) – The official generic name of a pharmaceutical substance, used globally for identification.
- In Silico Testing – The use of computer models and simulations to predict how a drug will interact with biological systems.
J
- Judgment of Causality – A decision made by experts or algorithms regarding whether a drug is likely responsible for an adverse event.
- Joint Safety Data Monitoring – A collaborative effort between sponsors, researchers, and regulatory authorities to monitor safety data during drug development.
- Japanese Adverse Drug Event Report (JADER) – Japan’s database for adverse event reporting, managed by the Pharmaceuticals and Medical Devices Agency (PMDA).
- Justification for Regulatory Action – Documentation provided to explain the need for regulatory changes, such as drug label updates or recalls, based on safety concerns.
- Juvenile Toxicity – Adverse effects caused by a drug when administered to children or adolescents during clinical trials or post-marketing.
K
- Key Performance Indicators (KPIs) – Metrics used to measure the performance of pharmacovigilance activities, such as the timeliness of adverse event reporting.
- Known Risk – A risk that is already well established in the scientific literature or based on clinical experience.
- Knowledge Management in PV – The process of collecting, analyzing, and applying knowledge to improve pharmacovigilance processes and decision-making.
- Kidney Toxicity (Nephrotoxicity) – Damage to the kidneys caused by drugs, often identified during safety evaluations.
- Key Opinion Leader (KOL) – An expert in a particular medical field who can influence drug safety decisions and policies.
L
- Lack of Efficacy – When a drug does not produce the intended therapeutic effect in a patient, sometimes requiring regulatory review.
- Literature Monitoring – The systematic review of published scientific and medical literature to identify reports of adverse drug reactions.
- Labeling Change – An update to a drug’s official label to reflect new safety information, such as additional warnings or adverse reactions.
- Late Phase Trials – Clinical trials conducted after a drug is approved for marketing to further assess its safety and efficacy in a larger population.
- Longitudinal Study – A study that follows a group of patients over an extended period to monitor long-term drug safety and effects.
M
- MedDRA (Medical Dictionary for Regulatory Activities) – A standardized medical terminology used for coding adverse events in pharmacovigilance.
- Marketing Authorization Holder (MAH) – The company or individual responsible for the marketing and safety of a medicinal product.
- Meta-Analysis – A statistical technique that combines the results of multiple studies to improve estimates of drug safety or efficacy.
- Monitoring and Reporting – The ongoing process of observing and documenting adverse events and safety concerns associated with a drug.
- Mild Adverse Event – An adverse event that is not life-threatening and does not require hospitalization but may still affect a patient’s well-being.
- Missing Information – Gaps in knowledge about a drug's safety or efficacy that require further investigation.
- Molecular Pharmacovigilance – The study of how drug molecules interact with the body, focusing on identifying molecular-level adverse reactions.
- Medication Error – A preventable event that may cause inappropriate use of a drug and harm the patient.
- Mixed Treatment Comparison (MTC) – A method used in pharmacovigilance to compare the safety and efficacy of different treatments using data from multiple sources.
- Mortality Rate – The rate at which patients die from an adverse event associated with a drug, often used to assess drug safety.
N
- No Observed Adverse Effect Level (NOAEL) – The highest drug dose at which no adverse effects are observed in safety studies.
- Non-serious Adverse Event – An adverse event that does not meet the criteria for being classified as serious.
- Neurotoxicity – Damage to the nervous system caused by exposure to certain drugs or chemicals.
- Natural History Study – A study that tracks the progression of a disease without intervention, providing baseline data for safety assessments.
- National Pharmacovigilance Center (NPC) – A government entity responsible for collecting and assessing drug safety information within a country.
- Non-Interventional Study – A study where no experimental treatments are given, and patients are observed under standard conditions.
- Notification of Adverse Event – The formal process of informing regulatory bodies about an adverse event related to a drug.
- Negligible Risk – A risk associated with a drug that is considered too small to warrant concern.
- Non-proprietary Name – The generic name of a drug, as opposed to its brand name.
- Naranjo Algorithm – A questionnaire used to determine the likelihood that a drug caused an adverse event.
O
- Off-Label Use – When a drug is prescribed for conditions or patient groups that are not listed in the official product label.
- Overdose – The ingestion or administration of a drug in quantities greater than recommended, which may result in harmful effects.
- Outcome of Interest – The specific event or health outcome being monitored in a pharmacovigilance study.
- Omission Error – The failure to administer a medication dose, which can lead to adverse consequences for the patient.
- Observational Study – A study in which patients are observed in a natural setting without any intervention, often used in post-marketing surveillance.
- Orphan Drug – A drug developed for the treatment of rare diseases or conditions.
- Open Label Trial – A type of clinical trial in which both the researcher and the participant know which treatment is being administered.
- Over-the-Counter (OTC) Drugs – Drugs that can be purchased without a prescription, which are still subject to pharmacovigilance monitoring for safety.
- Outcome Reporting – The process of documenting the effects of a drug on patients during clinical trials or post-marketing studies.
- Overmedication – The excessive use of medication, which may result in an increased risk of adverse events.
P
- Pharmacovigilance System Master File (PSMF) – A comprehensive document detailing the pharmacovigilance system maintained by a company, including roles, processes, and structures.
- Post-Marketing Surveillance (PMS) – Monitoring the safety of a drug after it has been released to the market.
- Periodic Benefit-Risk Evaluation Report (PBRER) – A detailed report submitted periodically to regulatory authorities that assesses the balance between a drug’s benefits and risks.
- Pharmacodynamics (PD) – The study of how a drug affects the body, including the mechanisms of action and drug-receptor interactions.
- Pharmacokinetics (PK) – The study of how a drug is absorbed, distributed, metabolized, and excreted in the body.
- Pregnancy Exposure Registry – A registry that collects data on the effects of drugs taken during pregnancy to monitor potential risks to the mother and fetus.
- Pharmacogenomics – The study of how genetic factors influence an individual’s response to drugs, including adverse drug reactions.
- Periodic Safety Update Report (PSUR) – A report that provides an evaluation of the worldwide safety data for a drug, submitted at regular intervals.
- Preclinical Safety Testing – Testing performed on animals to assess the safety of a drug before it is tested in humans.
- Post-Authorization Safety Study (PASS) – A study conducted after a drug is approved to gather additional safety information, usually required by regulatory authorities.
Q
- Qualified Person for Pharmacovigilance (QPPV) – The individual responsible for ensuring the pharmaceutical company complies with all pharmacovigilance obligations, typically in the EU.
- Quality Management System (QMS) – A system of policies and procedures designed to ensure the quality of pharmacovigilance processes.
- Quality Review of Safety Reports – The process of evaluating the accuracy, completeness, and regulatory compliance of safety reports before submission.
- Quantitative Risk Assessment – The use of statistical methods to estimate the probability and severity of adverse events.
- Quality Assurance (QA) – Procedures implemented to ensure that pharmacovigilance activities are conducted in compliance with regulatory standards and best practices.
- Query Resolution – The process of addressing any questions or requests for clarification from regulatory authorities regarding safety data or reports.
- Quarantine of Products – The temporary suspension of distribution of a drug due to safety concerns or the need for further evaluation.
- Qualitative Signal Detection – The process of identifying potential safety signals based on narrative data or case reports, without statistical analysis.
- Questionnaire-Based Safety Monitoring – Using structured questionnaires to collect data on adverse events from patients or healthcare professionals.
- Quasi-Experimental Study – A study that aims to evaluate the effects of an intervention but lacks the random assignment of participants to treatment and control groups.
R
- Risk Management Plan (RMP) – A document that outlines strategies to identify, assess, and mitigate risks associated with a medicinal product.
- Risk Minimization Measures (RMMs) – Strategies designed to reduce the occurrence of adverse events associated with a drug.
- Rechallenge – The re-administration of a drug after an adverse event to assess whether the event reoccurs, which can help establish causality.
- Risk Evaluation and Mitigation Strategy (REMS) – A plan required by the FDA to ensure the safe use of certain medications.
- Real-World Evidence (RWE) – Data collected from everyday healthcare settings (as opposed to controlled clinical trials) to evaluate the safety and effectiveness of a drug.
- Regulatory Authority – A government agency responsible for ensuring the safety, efficacy, and quality of medicinal products (e.g., FDA, EMA, MHRA).
- Reproductive Toxicity – The harmful effects of a drug on fertility, embryonic development, or postnatal growth.
- Risk-Benefit Ratio – The comparison of the potential risks of a drug with its therapeutic benefits to determine if the drug’s benefits outweigh its risks.
- Risk Communication – The process of informing healthcare providers, patients, and regulatory authorities about the potential risks associated with a drug.
- Revised Product Labeling – Updating a drug’s label to reflect new safety information, such as newly identified risks or contraindications.
S
- Signal Detection – The process of identifying potential safety signals from various data sources, such as spontaneous reports, clinical studies, or literature.
- Suspected Unexpected Serious Adverse Reaction (SUSAR) – An adverse event that is both serious and unexpected, requiring expedited reporting to regulatory authorities.
- Serious Adverse Event (SAE) – Any adverse event that results in death, is life-threatening, requires hospitalization, or results in permanent damage or disability.
- Safety Data Exchange Agreement (SDEA) – A contract between companies to outline how safety data will be exchanged, reviewed, and reported.
- Safety Signal – A new or known safety concern that arises from the analysis of adverse event data.
- Standard Operating Procedure (SOP) – A set of instructions or guidelines used to ensure consistency in pharmacovigilance processes.
- Spontaneous Reporting – The voluntary reporting of adverse events by healthcare professionals or patients, typically used in post-marketing surveillance.
- Summary of Product Characteristics (SmPC) – A document that provides detailed information on the use, risks, and benefits of a drug.
- Signal Management – The process of detecting, validating, prioritizing, and assessing safety signals.
- Systematic Review – A detailed review and synthesis of the available literature and studies on a particular topic, often used in pharmacovigilance to assess safety data.
T
- Therapeutic Window – The range of drug dosages which are effective without being toxic.
- Toxicity Testing – The process of assessing the potential harmful effects of a drug, often performed during preclinical or early clinical trials.
- Targeted Safety Study – A study designed to investigate specific safety concerns for a drug or class of drugs.
- Treatment-Emergent Adverse Event (TEAE) – An adverse event that occurs after a patient begins treatment with a drug.
- Thalidomide Incident – A historical pharmacovigilance event in the 1950s and 1960s, leading to stricter drug safety regulations due to birth defects caused by thalidomide.
- Tolerability – The degree to which adverse effects can be tolerated by patients, often evaluated in clinical trials.
- Tachyphylaxis – A rapidly decreasing response to a drug following repeated administration over a short period of time.
- Traceability – The ability to track a drug from manufacturing through distribution to ensure safety and quality.
- Therapeutic Equivalence – Drugs that provide the same therapeutic effect, but may differ in formulation or brand.
- Time-to-Onset Analysis – The evaluation of how long it takes for an adverse event to appear after drug administration.
U
- Unexpected Adverse Reaction – An adverse reaction that is not consistent with the information in the drug’s label or SmPC.
- Uppsala Monitoring Centre (UMC) – A WHO center responsible for coordinating the global pharmacovigilance efforts.
- Unblinded Study – A study where both the patient and the researcher know which treatment is being administered.
- Under-Reporting – When fewer adverse events are reported than actually occur, often seen in spontaneous reporting systems.
- Unanticipated Problems – Issues that arise during clinical trials or post-marketing surveillance that were not predicted in the study design.
- Urgent Safety Restriction (USR) – A rapid action taken by regulatory authorities to restrict the use of a drug due to safety concerns.
- Ultrasound Toxicology – The use of ultrasound in animal studies to evaluate potential drug toxicity in prenatal development.
- Usage Pattern – The way in which a drug is used by patients, including off-label or incorrect usage, which can impact safety monitoring.
- Urogenital Toxicity – Harmful effects of a drug on the urinary or reproductive systems, often evaluated during preclinical studies.
- Updated Risk Information – New safety data that emerges post-marketing, requiring updates to the drug’s labeling or SmPC.
V
- Vaccine Adverse Event Reporting System (VAERS) – A system for collecting and analyzing adverse events related to vaccines, managed by the CDC and FDA in the United States.
- Voluntary Recall – A company-initiated action to remove a drug from the market due to safety concerns.
- Validated Signal – A safety signal that has undergone assessment and is confirmed to require further action.
- Vulnerable Populations – Groups at higher risk of experiencing adverse drug reactions, such as pregnant women, children, and the elderly.
- Vigilance Monitoring – The continuous observation and assessment of drug safety data to identify potential risks.
- Voluntary Safety Reporting – The submission of adverse event reports by healthcare professionals or patients without being mandated by regulation.
- Validation of Adverse Event – The process of confirming the accuracy and relevance of an adverse event report.
- Viral Vector Safety – The assessment of risks associated with drugs or vaccines that use viral vectors for delivery.
- Variable Reporting Rate – The fluctuation in the number of adverse event reports over time, which can impact the detection of safety signals.
- Vaccine Pharmacovigilance – The specialized monitoring of vaccine safety, focusing on identifying and managing adverse reactions associated with immunization.
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