Glossary of terms used in Pharmacovigilance (PART-3)
The balance between the rate of effectiveness of a medicine versus the risk of harm is a quantitative assessment of the merit of a medicine used in routine clinical practice.
Comparative information between therapies is most useful. This is more useful than the efficacy and hazard predictions from pre-marketing information that is limited and based on selected
The ability of a drug to produce the intended effect as determined by scientific methods, for example in pre-clinical research conditions (opposite of hazard).
The science concerned with the study of the factors determining and influencing the frequency and distribution of disease, injury and other health-related events and their causes in a defined human population for the purpose of establishing programs to prevent and control their development and spread (Dorland’s Illustrated Medical Dictionary).
Essential medicines are those that satisfy the priority health care needs of the population. They are selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness. See http://www.who.int/selection_medicines/en/
The European Union data-processing network and management system, established by the European Medicines Agency (EMA) to support the electronic exchange, management, and scientific evaluation of Individual Case Safety Reports related to all medicinal products authorised in the European Economic Area (EEA). EudraVigilance also incorporates data analysis facilities.
All materials included to make a pharmaceutical formulation (e.g. a tablet) except the active drug substance(s).
A listing of medicinal drugs with their uses, methods of administration, available dose forms, side effects, etc, sometimes including their formulas and methods of preparation.
Frequency of ADRs
In giving an estimate of the frequency of ADRs the following standard categories are
Very common* > 10%
Common (frequent) >1% and <10%
Uncommon (infrequent) >0.1% and < 1%
Rare >0.01% and <0.1%
Very rare* <0.01%
* Optional categories
Generic (multisource product)
The term ‘generic product’ has somewhat different meanings in different jurisdictions. Generic products may be marketed either under the non-proprietary approved name or under a new brand (proprietary) name. They are usually intended to be interchangeable with the innovator product, which is usually manufactured without a license from the innovator company and marketed after the expiry of patent or other exclusivity rights.
The nature and extent of actual damage that could be caused by a drug. Not to be confused with risk.
Includes herbs, herbal materials, herbal preparations and finished herbal products.
Homeopathy is a therapeutic system which works on the principle that ‘like treats like’. An illness is treated with a medicine which could produce similar symptoms in a healthy person.
The active ingredients are given in highly diluted form to avoid toxicity. Homeopathic remedies are virtually 100% safe.
Information component (IC)
The Information component (IC) measures the disproportionality in the reporting of a drug- ADR pair in an ICSR database, relative to the reporting expected based on the overall reporting of the drug and the ADR. Positive IC values indicate higher reporting than expected.
The IC has also been implemented on electronic health records, to detect interesting temporal relationships between drug prescriptions and medical events.
Number of new cases of an outcome which develop over a defined time period in a defined population at risk.
Individual Case Safety Report (ICSR)
A report that contains ‘information describing a suspected adverse drug reaction related to the administration of one or more medicinal products to an individual patient…’. (Volume 9 of the Rules Governing Medicinal Products for Human and Veterinary Use in the European Union).
MedDRA is the Medical Dictionary for Regulatory Activities. WHO-ART, the WHO Adverse Reactions Terminology, is now mapped to MedDRA.
“An unintended act (either of omission or commission) or one that does not achieve its intended outcomes.”
Leape, Lucien. Error in Medicine. Journal of the American Medical Association 272(23):1851-57 (Dec. 21, 1994).
Countries which comply with the criteria for, and have joined the WHO Programme for International Drug Monitoring.
National pharmacovigilance centres
Organisations recognised by governments to represent their country in the WHO Programme (usually the drug regulatory agency). A single, governmentally recognized centre (or integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse and give advice on all information related to drug safety.
Probability of an occurrence p divided by the probability of its non-ocurrence (1 – p).
Ratio of the Odds in a given population and the
Odds in another population.