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In 11 years, hospitalizations for adverse drug effects have increased by 136% in France, according to regional pharmacovigilance centers. Hospitalizations that could have been avoided in many cases.
The French Network of Regional Pharmacovigilance Centers conducted a national study for the ANSM, published on May 19. The goal? “Update data on hospitalizations linked to the occurrence of an adverse drug reaction (ADR)”.
The result is quite edifying: adverse drug reactions are on the rise.
+136% additional ADR hospitalizations in 11 years
“Each year in metropolitan France, around 212,500 people are hospitalized because of an ADR”, according to the press release from the French Network of Regional Pharmacovigilance Centers (RFCRPV). The mortality rate after these ADRs leading to hospitalization is estimated at 1.3%, or 2,760 deaths per year.
According to the statement, the incidence of hospitalizations for ADRs increased by 136% between 2007 and 2018. “The incidence of hospitalizations linked to an ADR has been estimated at 8.5% in short-stay medical specialty services in metropolitan France”, reports the press release. In 2007, it was 3.6%.
France is not the only country concerned, since it is a “a trend also observed in other countries”.
A well-defined patient profile
“The volume of drug consumption does not seem to be an explanatory factor since a modest drop (minus 4%) in this volume was observed between the 2 periods. On the other hand, the profile of the victims and the type of drugs involved in the occurrence of these ADRs could explain this increase”explains the press release.
Most patients hospitalized for an ADR therefore have common characteristics. For example, they are often over 65 since “the incidence of ADR-related hospitalizations increases with age”, according to the RFCPRV. Among the 309 patients hospitalized for an ADR studied, 4 died. All were old people.
Beyond their age, hospitalized patients very often followed a similar treatment. Among the drugs taken by patients causing an ADR: anticancer drugs, direct oral anticoagulants, incretinomimetic type antidiabetics or even targeted therapies.
According to the RFCRPV, “the profile of the drugs involved has evolved since 2007 in line with the arrival of new pharmacological classes”. The adverse effects are often the same: haemorrhagic manifestations (8.8% of cases), haematological damage (6.5%), acute renal failure (6.3%), hydroelectrolyte disorders (6.0%) or even falls ( 5.2%).
Avoidable hospitalizations
According to the press release from the pharmacovigilance centers, some hospitalizations could have been avoided. According to the study, 16.1% of hospitalizations could have been avoided “if the medicines had been used by healthcare professionals and patients in accordance with the recommendations for good use”. Of the 4 deaths that occurred following hospitalization, one of them “was deemed potentially preventable”.
The main causes of ADRs are:
- Failure to respect the dose or duration of use (27.9%)
- Non-compliance with the warning (23.2%)
- Non-compliance with a precaution for use (18.6%)
- Inappropriate self-medication or voluntary misuse by the patient (11.6%)
“The results of this study should lead to in-depth reflection on preventive actions on drug classes at risk and on clear information on the proper use of drugs made available to health professionals and patients.”, concludes the RFCRPV.