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Safety Monitoring of Medicinal Products: Guidelines for Setting Up and Running a Pharmacovigilance Centre
(2000; 28 pages) [French]
Índice de contenido
Ver el documentoINTRODUCTION
Ver el documento2. DEFINITION AND AIMS
Abrir esta carpeta y ver su contenido3. HOW TO START A PHARMACOVIGILANCE CENTRE
Abrir esta carpeta y ver su contenido4. REPORTING OF ADVERSE DRUG REACTIONS
Abrir esta carpeta y ver su contenido5. SPECIAL ISSUES IN REPORTING
Abrir esta carpeta y ver su contenido7. ASSESSMENT OF CASE REPORTS
Abrir esta carpeta y ver su contenido8. USE OF THE DATA
Abrir esta carpeta y ver su contenido9. RELATIONS WITH OTHER PARTIES
Ver el documento11. FUNDING
Ver el documentoREFERENCES
Ver el documentoGLOSSARY
Ver el documentoWHO CONTACTS


A drug or medicine is ‘a pharmaceutical product, used in or on the human body for the prevention, diagnosis or treatment of disease, or for the modification of physiological function’.

An unexpected adverse reaction is ‘an adverse reaction, the nature or severity of which is not consistent with domestic labelling or market authorisation, or expected from characteristics of the drug’. Here the predominant element is that the phenomenon is unknown.

A side effect is ‘any unintended effect of a pharmaceutical product occurring at doses normally used in man, which is related to the pharmacological proprieties of the drug’. Essential elements in this definition are the pharmacological nature of the effect, that the phenomenon is unintended, and that there is no overt overdose.

An adverse reaction is ‘a response to a medicine which is noxious and unintended, and which occurs at doses normally used in man’. In this description it is of importance that it concerns the response of a patient, in which individual factors may play an important role, and that the phenomenon is noxious (an unexpected therapeutic response, for example, may be a side effect but not an adverse reaction).

A signal refers to ‘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.

In these definitions drug or drug food interactions are also included. It should be added that many patients have only suspected adverse reactions in which the causal role of the drug is unproven and may be doubtful, and that pharmacovigilance data usually refer to only suspected adverse reactions and side effects.

An adverse event or experience is defined as ‘any untoward medical occurrence that may present during treatment with a medicine but which does not necessarily have a causal relationship with this treatment’. The basic point here is the coincidence in time without any suspicion of a causal relationship.

Serious adverse events can be defined as those that:

a. are life-threatening or fatal
b. cause or prolong hospital admission
c. cause persistent incapacity or disability; or
d. concern misuse or dependence.

Type A effects (‘drug actions’) are those which are due to (exaggerated) pharmacological effects. Type A effects tend to be fairly common, dose related (i.e. more frequent or severe with higher doses) and may often be avoided by using doses which are appropriate to the individual patient. Such effects can usually be reproduced and studied experimentally and are often already identified before marketing.

Interactions between drugs, especially pharmacokinetic interactions, may often be classified as Type A effects, although they are restricted to a defined sub-population of patients (i.e. the users of the interacting drug).

Type B effects (‘patient reactions’) characteristically occur in only a minority of patients and display little or no dose relationship. They are generally rare and unpredictable, and may be serious and are notoriously difficult to study. Type B effects are either immunological or non-immunological and occur only in patients, with - often unknown - predisposing conditions. Immunological reactions may range from rashes, anaphylaxis, vasculitis, inflammatory organ injury, to highly specific autoimmune syndromes. Also non-immunological Type B effects occur in a minority of predisposed, intolerant, patients, e.g. because of an inborn error of metabolism or acquired deficiency in a certain enzyme, resulting in an abnormal metabolic pathway or accumulation of a toxic metabolite. Examples are chloramphenicol aplastic anaemia and isoniazid hepatitis.

Type C effects refer to situations where the use of a drug, often for unknown reasons, increases the frequency of a ‘spontaneous’ disease. Type C effects may be both serious and common (and include malignant tumours) and may have pronounced effects on public health. Type C effects may be coincidental and often concern long term effects; there is often no suggestive time relationship and the connection may be very difficult to prove.

Confidentiality: Maintenance of the privacy of patients, healthcare providers and institutes, including personal identities and all personal medical information.

Verification: The procedures carried out in pharmacovigilance to ensure that the data contained in a final report matches the original observations. These procedures may apply to medical records, data in case-report forms (in hard copy or electronic form), computer printouts, and statistical analyses and tables.

Validation: The action of proving that any procedure, process, equipment (including the software or hardware used), material, activity or system used in pharmacovigilance actually leads to the expected results.

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