Baseline characteristics
Factors that describe study participants at the beginning of the study (e.g., age, sex, disease severity). In comparison studies, it is importantthat these characteristics be initially similar between groups; if…
Analysis of covariance (ANCOVA)
A statistical method for making comparisons between groups, whiletaking into account different variables measured at the start of atrial. It is a form of multiple regression. Source: (CIOMS VI: Clinical…
Alert
An identified risk associated with the use of medicinal products which requires urgent measures to protect patients. Source: (CIOMS VIII: Signal detection 2010)
AGREE Instrument
A tool that assesses the methodological rigour and transparency in which a guideline is developed. Source: (CIOMS XI: Patient involvement 2022)
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Adoption
One of 5 dimensions in the RE-AIM evaluation model (Reach, Efficacy, Adoption, Implementation, Maintenance). Adoption refers to the participation rate and representativeness of both the settings in which an intervention…
Additional Risk Minimisation Measure
A risk minimisation measure which is in addition to the routine risk minimisation activities which apply to all medicinal products in a particular region or territory. Synonyms: Additional risk minimisation…
Active Surveillance System
A system for the collection of case safety information as a continuous pre-organized process. Active surveillance can be: Drug based: identifying adverse events in patients taking certain products; Identifying adverse…
Acceptable Risk
The degree of risk (likelihood of an adverse event or outcome) that a person or group is prepared to take or considers reasonable. However, what may be acceptable for one…
Academia
The environment or community concerned with research, education, and scholarship. Source: (CIOMS XI: Patient involvement 2022)
Absolute Risk
The number of people in a group who experience an adverse effect divided by the number in that group who could experience that adverse effect. Source: (CIOMS VI: Clinical trial…
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Risk Management System (RMS)
A set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal products, including the assessment of the effectiveness of those activities and interventions.
Regulatory Authority
The legal authority that is responsible for regulating all matters relating to drugs and medicinal products (e.g.: EMA, FDA, MHRA)
Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)
Pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product for submission by marketing authorisation holders at defined time points during the post-authorisation phase.
International Birth Date (IBD)
The date of the first marketing authorisation for any product containing the active substance granted to any company in any country in the world.
Development Safety Update Report (DSUR)
Comprehensive, thoughtful annual review and evaluation of pertinent safety information collected during the reporting period related to a drug under investigation, whether or not it is marketed
Developmental International Birth Date (DIBD)
Date of approval of the first authorization for conducting an interventional clinical trial in any country. Determines the start of regulatory requirement. The first data lock point for the DSUR…
Important Risk
Definition according to GVP Annex I (Rev 3): An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for…
Potential Risk
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this…
Identified Risk
Definition according to GVP Annex I (Rev 3):An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest. Explanatory wording provided in GVP…
Temporal Relationship
Temporal relationship is considered positive if the event occurred during the use of the drug and/or within a plausible range based on the half-life of the drug. Categories for temporal…
Seriousness vs. Severity
The term ‘severe’ must not be confused with ‘serious’. In the English language, ‘severe’ is used to describe the intensity (severity) of a specific event (mild, moderate or severe); the…
Abuse
Persistent or sporadic, intentional excessive use of medicinal product, which is accompanied by harmful physical or psychological effects.
Suspected Unexpected Serious Adverse Reaction (SUSAR)
A SUSAR is a serious ADR whose nature or severity is unexpected based on the applicable product information.
Unexpected Adverse Reaction
An adverse reaction, the nature, severity or outcome of which is not consistent with the applicable product information. Any event that is not expected, in accordance with the label (USPI…
Side Effect
Unintended effect occurring at normal dose related to the pharmacological properties.
WHO DD (WHO Drug Dictionary)
An international classification of drugs providing the names and active ingredient of medicinal products used in different countries.
WHOART (WHO Adverse Reactions Terminology)
Dictionary meant for rational coding of adverse reaction terms, maintained by the Uppsala Monitoring Centre (UMC), the World Health Organization Collaborating Centre for International Drug Monitoring.
United States Prescribing Information (USPI)
It sets out the agreed usage of the drug in the USA and provides information for healthcare professionals on the drug’s usage, efficiency and safety. This is part if the…
Unexpected Adverse Drug Reaction
An adverse reaction whose nature, severity, specificity, or outcome is not consistent with the description given in product labelling or market authorization (USPI in the US, SmPC in Europe).
Type (A to F) of Adverse Drug Reaction
A (augmented): common dose-related reaction, related to a pharmacological action of the drug, predictable and with low mortality.B (bizarre): uncommon non-dose-related reaction, not related to a pharmacological action of the…
Spontaneous Reporting
Reporting of AE cases by health professionals and pharmaceutical companies which does not derive from a study or any organized data collection scheme (i.e. is not solicited). Stimulated reporting Reporting…
Solicited Reports
Reports derived from organized data collection systems, including: Clinical trialsClinical registriesPost-approval patient use programsPatient support programsPatient disease management programsSurveys of patients or healthcare providersInformation on efficacy or patient compliance
Signal Validation
Evaluation of the data supporting a detected signal to verify that there is sufficient evidence demonstrating a new potentially causal association, or a new aspect of a known association.
Signal Management Process
A set of activities performed to determine whether there are signals associated with medicinal product (based on ICSRs, data from active surveillance systems or studies, literature information, etc.) including: Signal…
Signal
Reported information on a new possible causal relationship (or a new aspect of a known relationship) between an adverse event and a drug. A signal is considered important and warrants…
Safety Specification
This part of an RMP provides a synopsis of a medicinal product’s safety. It should be a summary of: The important identified risksImportant potential risksMissing information It should also address:…
Safety Concern
An important identified risk, important potential risk or important missing information. Medicinal product safety concerns are identified, characterized, and monitored in the DSUR, RMP and PSUR.
Safety
Evidence of an absence of harm (not absence of evidence of harm). Judgement about safety takes into account the degree to which a given risk is acceptable.
International Serious Adverse Events Consortium (SAEC)
Non-profit consortium formed between the US FDA, industry, academia and the Wellcome Trust to identify genetic variants associated with SAEs.
Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR)
results in deathrequires patient hospitalizationresults in persistent or significant disability or incapacityis life-threateningor is a congenital anomaly/birth defect.“Severe” describes the intensity of an event (mild, moderate or severe), the event…
Risk Minimization Activity
Product informationHealthcare professional communications / educational materialsPatient communications / educational materials
Risk Management Plan (RMP)
MAHs must prepare an RMP (Risk Management Plan) to implement the risk management system.
Risk Management
Activity that aims to ensure that the benefits of a medicinal product exceed the risks by the greatest achievable margin, by increasing the benefits or reducing the risks in three…
Risk
The probability of developing an outcome (refers normally but not always to a negative outcome). Absolute risk or Incidence Rate: The observed or calculated probability of the occurrence of an event in a…
Reference Risk (or Baseline Risk)
Risk in a population of unexposed persons. It can be measured over time (incidence) or at a given time (prevalence).
Rational Drug Use
Therapeutic practice where drugs are prescribed and used appropriately for the indication and the patient’s specific characteristics.
Prevalence
The proportion of total cases in a population at a particular time and a descriptive statistic, rather than a measurement of risk.
Prescription Event Monitoring (PEM)
System created to monitor adverse drug events for identified patients receiving a specified drug (prescribers are requested to report all events, suspected adverse or not).
Predisposing Factors
Aspects of the patient’s history which might explain reported adverse events (genetic, other drugs, disease history…).
Postmarketing Surveillance
The study of drug use and effects after release into the market.
Pharmacovigilance System
A system used by an organization to comply with pharmacovigilance regulations and designed to monitor the safety of authorized medicinal products.
Pharmacovigilance Master File
A compilation of information, maintained by the MAH. containing a detailed description of the pharmacovigilance system they use, available to competent authorities upon request.
Pharmacovigilance
The science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem, in order to: Prevent harm from ADRs in humans arising…
Pharmacoepidemiology
The study of the use and effects of drugs in large numbers of people using an epidemiological approach
Post-Authorization Safety Study (PASS)
Study relating to an authorized medicinal product conducted with the aim of studying a safety hazard, confirming the safety profile of the product, or evaluating risk management measures.
Overdose
Administration of a quantity of a medicinal product above the maximum recommended dose allowed by the authorized product information.
Off-Label Use or Misuse
Situations where a medicinal product is intentionally used for a medical purpose not in accordance with the marketing authorization. For instance, medicine used: For disease that it is not approved…
Odds and Odds Ratio
An Odds is the probability of an occurrence divided by the probability of its non-occurrence. The Odds ratio is the ratio of the Odds between two populations.
Number Needed to Harm (NNH)
Number of individuals needed to be treated for some specified period in order that one person would have one harmful event.
Near-Misses
Medication errors with high potential for causing harm but did not (cancelled before reaching a patient or reaching the patient but who did not have untoward consequences).
National Pharmacovigilance Centers or National Competent Authority (NCA)
Regulatory authority within a country with the clinical and scientific expertise to collect, analyze and advise on drug safety.
Missing Information
Potentially clinically significant gap in knowledge about the safety of a medicinal product for a specific patient population or concerning certain anticipated utilization (for instance long term use). Typical examples…
Minimum Criteria for Reporting
An identifiable reporter, patient, event and a suspect medicinal product are required for reporting cases of suspected adverse events.
Medication Error
Any mistake in the way a medication is taken or administered (prescription, storage, dispensing, preparation, administration…), that has the potential to harm the patient. Medication errors are outside the use…
Unlabeled (or Labelled)
Any reaction not mentioned in the official approved product information is unlabeled (otherwise it is termed labelled).
Incidence
The rate of new cases of an outcome occurring per number of known at risk or exposed; and is a measurement of risk.
Important Medical Event (IME)
MedDRA includes a term list of important medical events (available on the EMA website), which aims to facilitate the classification of suspected ADRs, data analysis and the assessment of ICSRs.
ICH
International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals.
Harm
The nature and extent of actual damage that can be caused by a drug. Damage is measured by frequency of occurrence, severity or duration.
Good Pharmacovigilance Practice
The EMA has issued these guidelines for the conduct of pharmacovigilance in the EU for human medical products.