Prevention of risks associated with inappropriate use/unnecessary consumption of medicines

Abstract

In the code of public health, misuse is defined as intentional and inappropriate use of a medicine or product, which is not in accordance with the terms of the marketing authorisation or the registration as well as with good practice recommendations. Very often this involves an individual or the interaction of several individuals including the patient, his/her carers, prescriber(s) and/or dispensers. Misuse is common; it is the source of medicinal adverse effects for which a significant part is avoidable. Medicines initially prescribed or dispensed in the context of their marketing authorization (MA) can also be the subject of primary dependency and misappropriation. Companies which develop medicines nationally make declarations to the ANSM (French National Agency for the Safety of Medicines and Health Products) and implement measures to limit non-compliant use of their products. Recently, the coronavirus disease-2019 (COVID-19) pandemic has highlighted the influence and societal impact of drug misuse. The finding of the existence of systemic misuse, the impossibility of proposing simple solutions leads us to propose two main areas for improved information and the training of users and health professionals in medicines in the context of multi-faceted interventions: prevention of misuse on the one hand and its identification and treatment on the other hand.

Incidence and preventability of hospital admissions for adverse drug reactions in France: A prospective observational study (IATROSTAT)

“…Based on the methodology of Jonville‐Béra et al, 11 the committee assessed the potential compliance or not of drug use involved in the ADR‐HA occurrence and its preventability. The assessment of noncompliance was based on the official recommendations for the use of the drug, as stated in the French SPC, package leaflets or other validated therapeutic guidelines 12 . The situations of noncompliance were as follows: absolute noncompliance: contraindication (must never be violated), warning (situation to be avoided whenever possible, except after a thorough examination of the benefit/risk ratio and requiring a close monitoring of the patient), dosage (dose/duration) not respected and indication outside the marketing authorization (off‐label). relative noncompliance: precautionary use (possible use but after implementation of recommendations for preventive measures to limit or avoid the occurrence of adverse effects). …”

“…The assessment of noncompliance was based on the official recommendations for the use of the drug, as stated in the French SPC, package leaflets or other validated therapeutic guidelines. 12 The situations of noncompliance were as follows:…”