Abbreviations Pharmacovigilance – Interview Help
- ADRs adverse reactions to medicines (adverse drug reactions)
- ATC Anatomic Therapeutic Chemical (Classification for medicines)
- BCPNN Bayesian Confidence Propagating Neural Network
- CEM cohort event monitoring
- CemFlow Cohort Event Monitoring data entry and analytical tool
- DD (WHO) Drug dictionary
- ICD 10 WHO International classification of diseases version 10
- IMAI integrated management of adolescent and adult illness
- ICSR individual case safety report(s)
- MedDRA Medical dictionary for drug regulatory activities
- OI opportunistic infection
- IMMP (The New Zealand) Intensive Medicines Monitoring Programme
- PEM prescription event monitoring
- PvC Pharmacovigilance Centre
- SOC system organ class
- SOP standard operating procedure
- UMC the Uppsala Monitoring Centre
- VigiBase WHO database of individual case safety (ADR) reports
- VigiFlow spontaneous reporting data entry and analytical tool
- VigiMine data mining tool available as part of VigiSearch
- VigiSearch search tool for searching the VigiBase database
- WHO World Health Organization
- WHO-ART WHO adverse reactions terminology
Definitions of Pharmacovigilance you must know before attending Interview
WHO defines Pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.”
Pharmacovigilance is the process and science of monitoring the safety of medicines and taking action to reduce risks and increase benefits from medicines.
A drug includes any substance or mixture of substances manufactured, sold or represented for use in:
• the diagnosis, treatment, mitigation or prevention of a disease, disorder or
• abnormal physical state, or its symptoms, in human beings or animals,
• restoring, correcting or modifying organic functions in human beings or animals, or disinfection in premises in which food is manufactured, prepared or kept.
Adverse Event (or Adverse Experience)
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Adverse Drug Reaction (ADR)
In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established:
all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.
Regarding marketed medicinal products, a well-accepted definition of an adverse drug reaction in the post-marketing setting is found in WHO Technical Report 498  and reads as follows:
A response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.
The evaluation of the likelihood that a medicine was the causative agent of an observed adverse event. Causality assessment is usually made according to established algorithms.
A sophisticated data management tool created by the UMC data entry and analysis in cohort event monitoring programmes.
Cohort event monitoring
A prospective observational cohort study of adverse events associated with one or more medicines.
At the UMC, this refers to the use of an automated tool, based on Bayesian logic, for the scanning of the WHO database (Vigibase) in the process of detecting adverse reactions associated with medicines:
the Bayesian Confidence Propagating Neural Network (BCPNN). Knowledge-detection is the preferred term for the process.
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
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.
Administration of a suspect product by any route.
The withdrawal of a drug from a patient; the point from which the continuity, reduction or disappearance of adverse effects may be observed. The response to withdrawal may be followed over a period of time.
Withdrawal of a suspect product from a patient’s therapeutic regimen.
Continued presence of an adverse experience after withdrawal of the suspect product.
Partial or complete disappearance of an adverse experience after withdrawal of the suspect product.
Reintroduction of a suspect product suspected of having caused an adverse experience following a positive dechallenge.
Failure of the product, when reintroduced, to produce signs or symptoms similar to those observed when the suspect product was previously introduced.
Reoccurrence of similar signs and symptoms upon reintroduction of the suspect product.
Serious Adverse Event or Adverse Drug Reaction
A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose:
* results in death,
* is life-threatening,
The term “life-threatening” in the definition of “serious” refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
* requires inpatient hospitalisation or prolongation of existing hospitalisation,
* results in persistent or significant disability/incapacity,
* is a congenital anomaly/birth defect.
Unlisted / Unexpected Adverse Drug Reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator’s Brochure for an unapproved investigational medicinal product and prescribing information / Summary of Product Characteristics (SmPC) for marketed products).
Listed / Expected Adverse Drug Reaction
An ADR whose nature, severity, specificity, and outcome are consistent with the information in the CCSI.
National pharmacovigilance centers
Organizations recognized 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