Glossary of terms used in Pharmacovigilance

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Adherence: A patient’s careful and willing observance of the guidelines for taking a medicine or managing a therapy. He/she takes the prescription without doing any change, missing any take or day. This term has largely replaced the term compliance.

Adverse drug event: Any untoward medical occurrence that may be present during treatment with a medicine but does not necessarily have a causal relationship with this treatment, that is, an adverse outcome that occurs while the patient is taking the medicine but is not, or not necessarily, attributable to it.

Adverse drug reaction: A response to a medicine 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.



Consumer: A consumer in a healthcare is anyone who uses, has used, or may use any health or health-related service. It is not limited to those currently using a service. The terms "patients" and "users" generally apply only to those currently undergoing some form of treatment.


Drug interaction: A drug interaction is a situation in which a substance affects the activity of a drug, i.e. the effects are increased or decreased, or they produce a new effect not produced on its own. Typically, the interaction between drugs comes to mind (drug-drug interaction). However, interactions may also exist between drugs and food (drug-food interactions), as well as drugs and herbs (drug-herb interactions).





Healthcare professional: A Health professional means a person who is registered by the relevant body as a professional to protect human health or provide service.

Health institution: A health institution is any governmental, non-governmental or private institution that carries out promotive, preventive, curative and rehabilitative activities or medicine trade or services.






Medical instrument: Means any instrument or supply that may be used on the inner or outer part of the body for diagnosis or treatment of a disease in human, and includes various diagnostic, laboratory, surgery, dental medical instruments and suturing materials, syringes and needles.

Medication errors: “A medication error is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including:

  • prescribing,
  • order communication,
  • product labeling, packaging, and nomenclature,
  • compounding,
  • dispensing,
  • distribution,
  • administration,
  • education,
  • monitoring and use.

Medicine: Medicine means any substance or mixture of substances used in the diagnosis, treatment, mitigation or prevention of a disease in human and includes narcotic drugs, psychotropic substances and precursor chemicals, traditional medicines, complementary or alternative medicine; poisons, blood and blood products, vaccine, radioactive pharmaceuticals, cosmetics and sanitary items and medical instruments.

Misuse: This refers to situations where the medicinal product is intentionally and inappropriately used not in accordance with the terms of the marketing authorization.



Off-label use: This relates to situations where the medicinal product is intentionally used for a medical purpose not in accordance with the terms of the marketing authorization.

Overdose: This refers to the administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorized product information. Clinical judgment should always be applied.


Pharmacovigilance: "The science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.”

Post-marketing: The stage when a drug is approved and generally available on the market. See also Conditional market authorisation. [1]

Pre-marketing: The developmental stage before a drug is approved and available for prescription or sale to the public. [2]

Prevalence: Number of existing cases of an outcome in a defined population at a given point in time. Note. Prevalence is calculated as a proportion (cases divided by total in population), often expressed as a percentage. [3]

Product quality defect: Quality problems of products i.e; suspected contamination, questionable stability, defective components, poor packaging or labeling, or unexpected therapeutic ineffectiveness.

Proportion: Number of cases of an outcome divided by the total number of individuals in the studied population. Note. A percentage is a proportion (cases divided by total in population) multiplied by 100. [4]



Regulatory authority: The legal authority in any country with the responsibility for regulating all matters relating to drugs. [5]

Risk: The probability of harm being caused; the probability (chance, odds) of an occurrence. Note 1. The term risk normally, but not always, refers to a negative outcome. Note 2. Contrary to harm, the concept of risk does not involve any reference to the nature or severity of an outcome. [6]


Serious adverse event/reaction: A serious adverse event or reaction is any untoward medical occurrence that at any dose: results in death,

  • is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers to an event/reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/ reaction which hypothetically might have caused death if it were more severe),
  • requires inpatient hospitalization or results in prolongation of existing hospitalization,
  • results in persistent or significant disability/incapacity, * is a congenital anomaly/birth defect,
  • is a medically important event or reaction.

Medical and scientific judgment should be exercised in deciding whether other situations should be considered serious such as important medical events that might not be immediately life-threatening or result in death or hospitalization but might jeopardize the patient or might require intervention to prevent one of the other outcomes listed in the definition above. Examples of such events are intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that do not result in hospitalization or development of drug dependency or drug abuse.

Signal: A reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.” An additional note says: “Usually more than one report is required to generate a signal, depending on the seriousness of the event and the quality of the information.”

Stakeholder: Individual, or group of individuals, with a legitimate interest and responsibility in a human endeavor, e.g. pharmacovigilance. Their interest may be because they will have a role in implementing decisions, or because they will be affected by actions taken. [7]










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