PHARMACOVIGILANCE

TERMINOLOGIES ASKED IN
INTERVIEWS
- ANAM SHAIKH

[email protected]
https://pristynresearch.com/
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but
which does not necessarily have a causal relationship with this treatment.
A response which is noxious and unintended, and which occurs at doses normally used in humans for the
prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. (WHO,
1972).
“A response to a medicinal product which is noxious and unintended.”
Non-traditional, western scientific therapy, usually using synthesised ingredients, but may also contain a
purified active ingredient extracted from a plant or other natural source, usually in opposition to the disease
Events associated in time but not necessarily linked as cause and effect
Difference between the risk in an exposed population (absolute risk) and the risk in an unexposed population
(reference risk). Attributable risk is the result of an absolute comparison between outcome frequency
measurements, such as incidence.
Medical products prepared from biological material of human, animal or microbiologic origin (such as blood
products, vaccines, insulin).
A relationship between one phenomenon or event (A) and another (B) in which A precedes and causes B. In
pharmacovigilance; a medicine causing an adverse reaction.
The evaluation of the likelihood that a medicine was the causative agent of an observed adverse reaction.
Causality assessment is usually made according established algorithms.
The formal advisory warning accompanying data release from the WHO Global ICSR Database: it specifies
the conditions and reservations applying to interpretations and use of the data.
Software developed by UMC for collection and analysis of data in Cohort Event Monitoring.
A systematic study on pharmaceutical products in human subjects (including patients and other volunteers)
in order to discover or verify the effects of and/or identify any adverse reaction to investigational products,
and/or to study the absorption, distribution, metabolism and excretion (ADME) of the products with the
objective of ascertaining their efficacy and safety.
Cohort Event Monitoring (CEM) is a prospective, observational study of events that occur during the use of
medicines, for intensified follow-up of selected medicinal products phase. Patients are monitored from the
time they begin treatment, and for a defined period of time.
Faithful adherence by the patient to the prescriber’s instructions.
The comparison group in drug-trials not being given the studied drug.
Some of the terms in WHO-ART are marked as ‘Critical Terms’. These terms either refer to or might be
indicative of serious disease states, and warrant special attention, because of their possible association with
the risk of serious illness which may lead to more decisive action than reports on other terms.
A general term for computerised extraction of potentially interesting patterns from large data sets often
based on statistical algorithms. A related term with essentially the same meaning is ‘pattern discovery’. In
pharmacovigilance, the commonest application of data mining is so called disproportionality analysis, for
example using the Information component (IC).
The withdrawal of a drug from a patient; the point at which the continuity, reduction or disappearance of
adverse effects may be observed.
Screening of ICSR databases for reporting rates which are higher than expected. For drugADR pairs,
common measures of disproportionality are the Proportional Reporting Ratio (PRR), the Reporting Odds
Ratio (ROR), The Information Component (IC), and the Empirical Bayes Geometrical Mean (EBGM).
There are also disproportionality measures for drug-drug-ADR triplets, such as Omega (Ω).
The balance between the rates 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 subjects.
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.
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.
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, dosage forms, side
effects, etc, sometimes including their formulas and methods of preparation.
In giving an estimate of the frequency of ADRs the following standard categories are recommended

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
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.
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.
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’.
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.”
Countries which comply with the criteria for, and have joined the WHO Programme for International Drug
Monitoring.
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.
A measure of disproportionate reporting for drug-drug-ADR triplets in ICSR databases, designed to
highlight potential signals of drug- drug interactions. Just like the more established disproportionality
measures for drug-ADR pairs, Ω is based on a contrast between the observed and expected number of
reports. A positive Ω indicates higher reporting than expected.
Medicinal product available to the public without prescription.
Software developed by UMC for collection and analysis of data in relation to vaccinations in a pandemic
situation.
A systematic review of the global safety data which became available to the manufacturer of a marketed
drug during a specific time period. Produced in an internationally agreed format.
Study of the use and effects of drugs in large populations.
Study of the uses, effects and modes of action of drugs.
The science and activities relating to the detection, assessment, understanding and prevention of adverse
effects or any other drug- related problem
Characteristic deformity caused by exposure to thalidomide in the womb, also very rarely occurring
spontaneously. Meaning: limbs like a seal
Western-style, scientific treatment using plant extracts or materials.
An inactive substance (often called a sugar pill) given to a group being studied to compare results with
the effects of the active drug.
The concomitant use of more than one drug, sometimes prescribed by different practitioners.
The stage when a drug is generally available on the market.
Any aspect of the patient’s history (other than the drug) which might explain reported adverse events
(genetic factors, diet, alcohol consumption, disease history, polypharmacy or use of herbal medicines, for
example).
The stage before a drug is available for prescription or sale to the public.
System created to monitor adverse drug events in a population. Prescribers are requested to report all
events, regardless of whether they are suspected adverse events, for identified patients receiving a
specified drug. Also more accurately named Cohort Event Monitoring.
Medicinal product available to the public only on prescription.
Number of existing cases of an outcome in a defined population at a given point in time.
Prevention or protection
The point at which a drug is again given to a patient after its previous withdrawal - also see de-challenge.
An ideal of therapeutic practice in which drugs are prescribed and used in exact accordance with the best
understanding of their appropriateness for the indication and the particular patient, and of their benefit, harm
effectiveness and risk.
Method of assembling information contained in two or more records, e.g. In different sets of medical
charts, and in vital records such as birth and death certificates. This makes it possible to relate significant
health events that are remote from one another in time and place.
Risk in a population of unexposed persons; also called baseline risk. Reference risk can be measured over
time (incidence) or at a given time (prevalence). The unexposed population refers to a reference
population, as closely comparable to the exposed population as possible, apart from the exposure.
The legal authority in any country with the responsibility of regulating all matters relating to drugs.
Ratio of the risk in an exposed population (absolute risk) and the risk in an unexposed population (reference
risk). Relative risk is the result of a relative comparison between outcome frequency measurements, e.g.
incidences.
The probability of harm being caused; the probability (chance, odds) of an occurrence.
A serious adverse event or reaction is any untoward medical occurrence that at any dose:
• results in death
• requires inpatient hospitalisation or prolongation of existing hospitalisation ; Results in persistent or
significant disability/incapacity
• is life-threatening
Any unintended effect of a pharmaceutical product occurring at normal dosage which is related to the
pharmacological properties of the drug.
Reported information on a possible causal relationship between an adverse event and a drug, the relationship
being unknown or incompletely documented previously. Usually more than a single report is required to
generate a signal, depending upon the seriousness of the event and the quality of the information. The
publication of a signal usually implies the need for some kind of review or action.

DRUG SIGNAL AE
A regulatory document attached to the marketing authorization which forms the basis of the product
information made available to prescribers and patients.
System whereby case reports of adverse drug events are voluntarily submitted from health professionals and
pharmaceutical manufacturers to the national regulatory authority.
Drug prescribed in the 1950s as a mild sleeping pill and remedy for morning-sickness for pregnant
women. Led to serious birth defects and the start of modern pharmacovigilance. Returning to favour in
treatment of serious diseases such as cancer and leprosy.
Traditional medicine is the sum total of the knowledge, skills, and practices based on the theories, beliefs,
and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of
health as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness.
An adverse reaction, the nature or severity of which is not consistent with domestic labelling or market
authorization, or expected from characteristics of the drug.
The name of the WHO Global ICSR Database.
Vigi-Flow is a complete ICSR management system created and maintained by the UMC. It is web-based
and built to adhere to the ICH-E2B standard. It can be used as the national database for countries in the
WHO Programme as it incorporates tools for report analysis, and facilitates sending reports to Vigi-Base.
Share point based conferencing facility, exclusive to member countries of the WHO Programme for
International Drug Monitoring for fast communication of topical pharmacovigilance issues.
A statistical tool within Vigi-Search with vast statistical material calculated for all DrugADR pairs
(combinations) available in Vigi-Base. The main features include the disproportionality measure (IC value)
stratified in different ways and useful filter capabilities.
A search service for accessing ICSRs stored in the Vigi-Base database offered by the UMC to national
pharmacovigilance centres and other third-party inquirers.
Terminology for coding clinical information in relation to drug therapy. WHO-ART is maintained by UMC.
The WHO Drug Dictionary is an international classification of drugs providing proprietary and non-
proprietary names of medicinal products used in different countries, together with all active ingredients.