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Citation
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Laroche ML, Gautier S, Polard E, Rabier MB, Chouchana L, Lebrun-Vignes B, Faillie JL, Petitpain N, Lagarce L, Jonville-Bera AP. Br. J. Clin. Pharmacol. 2022; ePub(ePub): ePub. |
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Abstract
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AIMS: In the last French study in 2007, the incidence of hospital admissions related to adverse drug reactions (ADR-HA) was 3.6%. The objective was to assess the current ADR-HA incidence in France and to describe both its characteristics and preventability.
METHODS: A prospective multicentre study was conducted among randomly selected French public hospital medical wards (April-July 2018). Patients admitted during a 2-week period were included. ADR-HA cases were collected by the French Regional Pharmacovigilance Centres network. An independent committee validated potential cases and ADR preventability.
RESULTS: ADR-HA incidence was 8.5% (95%CI: 7.6%-9.4%), increasing with age (3.3% [95%CI: 1.8%-5.5%] ≤16 years versus 10.6% [95%CI: 9.3%-12.0%] ≥65 years). The most common ADRs were haemorrhagic events (8.8%), haematological disorders (6.5%), acute renal failure (6.3%), fluid and electrolyte disorders (6.0%), and falls (5.2%). New drugs were involved: targeted therapies (22.8% of antineoplastics), direct oral anticoagulants (29.6% of antithrombotics) and incretin-based drugs (20.0% of antidiabetics). ADRs were preventable in 16.1% of cases because the drugs involved had not been used in accordance with monographies, package leaflets or other therapeutic guidelines. The main situations of non-compliance addressed either dose or duration of use (27.9%), warning (23.2%), use precaution (18.6%) and inappropriate self-medication or misuse by patients (11.6%).
CONCLUSION: In France, ADR-HA incidence dramatically increased over the last decade. A significant proportion was related to new pharmacological classes and considered as preventable. These findings should lead to an in-depth thought on preventive actions on at-risk drug classes.
Language: en |