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The Importance of Pharmacovigilance - Safety Monitoring of Medicinal Products
(2002; 52 pages) View the PDF document
Table of Contents
View the documentPreface
View the documentChapter 1 - Introduction
View the documentChapter 2 - A Short History of Involvement in Drug Safety Monitoring by WHO
View the documentChapter 3 - Partners in Pharmacovigilance
View the documentChapter 4 - Pharmacovigilance in Drug Regulation
View the documentChapter 5 - Pharmacovigilance in Clinical Practice
View the documentChapter 6 - Pharmacovigilance in International Health
View the documentChapter 7 - Conclusion and considerations for the future
View the documentGlossary
View the documentReferences
View the documentBack Cover


Adverse Event/Adverse Experience - Any untoward medical occurrence that may appear during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with the treatment.

Adverse Reaction - A response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.

Active surveillance system - The collection of case safety information as a continuous pre-organized process.

Bayesian confidence propagation neural network (BCPNN) - A computer architecture that mimics the network of cerebral neurones (neural network) and that uses a logic that determines the disproportionality of relationships between any of the items in the database including complexes of items compared with the background of the remaining or selected items. Changes in the disproportionality can be monitored, as new data are added or different patterns of items selected.

Benefit - An estimated gain for an individual or a population. See also: Effectiveness/risk; benefit/harm.

Biologicals - A medical product prepared from biologic material of human, animal or microbiologic origin (such as blood products, vaccines, insulin).

Benefit/harm - Benefit and harm are the positive and negative subjective qualitative experiences of individual patients. These are not usually assessed except in modern quality of life studies or in case reports. Benefit and harm at a societal level may also be considered, but then must include relative effectiveness and risk, the impact of all the outcomes on society and include cost analysis.

Case control study - Study that identifies a group of persons with the unintended drug effect of interest and a suitable comparison group of people without the unintended effect. The relationship of a drug to the drug event is examined by comparing the groups exhibiting and not exhibiting the drug event with regard to how frequently the drug is present.

Clinical trial - 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 of the products with the objective of ascertaining their efficacy and safety. Clinical trials are generally classified into Phases I to IV. Phase IV trials are studies performed after marketing of the pharmaceutical product. They are carried out on the basis of the product characteristics for which the marketing authorization was granted and are normally in the form of post-marketing surveillance.

Cohort study - A study that identifies defined populations and follows them forward in time, examining their rates of disease. A cohort study generally identifies and compares exposed patients to unexposed patients or to patients who receive a different exposure.

Complementary/Alternative Medicine - These terms are used interchangeably with traditional medicine in some countries. They refer to a broad set of healthcare practices that are not part of that country’s own tradition and are not integrated into the dominant health care system. They have not usually been tested in specified clinical indications by an objective scientific discipline.

Counterfeit Medicine -A medicine that is deliberately and fraudulently mislabelled with respect to identity and/or content and/or source.

Drug/medicine -Any substance in a pharmaceutical product that is used to modify or explore physiological systems or pathological states for the benefit of the recipient. The term drug/medicinal product is used in a wider sense to include the whole formulated and registered product, including the presentation and packaging, and the accompanying information.

Drug Alerts -The action of notifying a wider audience than the initial information holder(s) of a suspected association between a drug and an adverse reaction. Note that the term is used in different contexts that can be confusing, for example, an alert may be from a manufacturer to a regulator or from a regulator to the public.

Effectiveness/risk - 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 subjects.

Ethics committee -An independent body (a review board or an institutional, regional or national committee), constituted of medical professionals and non-medical members whose responsibility is to verify that the safety, integrity and human rights of the subjects participating in a particular clinical trial are protected and to consider the general ethics of the trial, thereby providing public reassurance. Ethics committees should be constituted and operated so that their tasks can be executed free from bias and from any influence of those who are conducting the trial.

Generic (multisource pharmaceutical 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 licence from the innovator company and marketed after the expiry of patent or other exclusivity rights.

Herbal medicine -Includes herbs, herbal materials, herbal preparations and finished herbal products.

International Conference on Harmonization (ICH) - The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.

Lack of efficacy - Unexpected failure of a drug to produce the intended effect as determined by previous scientific investigation.

National pharmacovigilance centre - 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.

Pharmacoepidemiology - The study of the use and effects of drugs in large numbers of people.

Pharmacovigilance - The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

Prescription event monitoring -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.

Product stewardship - The demonstrable process by which a business can identify and manage its safety, health and environmental performance as applied to the development, manufacture, marketing, use and disposal of its products (including packaging).

Record linkage -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 evaluation -Risk evaluation is the complex process of determining the significance or value of the identified hazards and estimated risks to those concerned with or affected by the process.

Risk management - The making of decisions concerning risks, or action to reduce the consequences or probability of occurrence.

Side effect - Any unintended effect of a pharmaceutical product occurring at a dose normally used in man, which is related to the pharmacological properties of the drug.

Signal - 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.

Spontaneous reporting -System whereby case reports of adverse drug events are voluntarily submitted from health professionals and pharmaceutical manufacturers to the national regulatory authority.

Traditional Medicine - 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. The terms ‘complementary medicine’/‘alternative medicine’/‘non-conventional medicine’ are used inter-changeably with traditional medicine in some countries.

Unexpected Adverse Reaction - 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.


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