Medikamente UAW Definitionen

Term Definitions

Adverse event Any adverse medical occurrence that happens to a patient or study participant who has been administered a medicinal product and that is not necessarily causally related to that treatment. An adverse event may therefore be any unwanted and unintended sign (e.g. an abnormal laboratory finding), symptom, or disease that is temporarily related to the administration of the medicinal product, whether or not the medicinal product is considered the cause.

Adverse reaction A reaction to a medicinal product that is harmful and unintended. Reaction in this context means that a causal relationship between a medicinal product and an adverse event is at least a realistic possibility.

Product complaint

A product complaint is an oral, written or electronic expression of dissatisfaction with the identity, quality, durability, reliability, safety, efficacy, performance or use of a product. A product complaint can specifically be one of the following:

- Product Quality Complaint (PQC): a product complaint regarding a defective product or a suspicion that the product is counterfeit.

- Medical Complaint (MC): A product complaint related to the efficacy and/or safety of a product (e.g. efficacy: absence/loss of effect; safety: adverse event).

Specific reporting situations These refer to situations where information must be obtained, whether or not in the case of an associated adverse event/side-effect. These include 1) during pregnancy (i.e. drug exposure to the fetus in utero, whether by the mother who took the drug or by paternal transmission through semen), 2) drug exposure during breastfeeding/lactation, 3) overdose (whether intentional, accidental or prescribed), 4) drug misuse or abuse, 5) medication errors (incl. dispensing errors, accidental exposure, accidental exposure to drugs, or misuse of medicines), 5) drug abuse or misuse of medicines, 5) drug abuse or misuse of medicines, 5) drug abuse or misuse of medicines, 5) drug abuse or misuse of medicines, 5) drug abuse or misuse of medicines, 5) drug abuse or misuse of medicines. dispensing errors, accidental exposure, misadministration, etc.), 6) unauthorised off-label use (i.e. intentional medical use of a product outside the authorised product information), 7) lack of therapeutic effect/lack of efficacy, 8) withdrawal symptoms / discontinuation effect, 9) exacerbation of an existing disease, 10) suspected use of a counterfeit / adulterated/manipulated medicine, 11) drug-drug interaction / drug-food interaction, 12) suspected transmission of an infectious agent through a medicine, 13) occupational exposure (as a result of his/her professional or non-professional work), 15) unexpected benefits.