Pascale Olivier

Hospitalizations because of Adverse Drug Reactions in Elderly Patients Admitted through the Emergency Department

Background and objectivesSeveral studies have been conducted to determine the frequency and characteristics of adverse drug reactions (ADRs) in elderly populations, focusing on those leading to hospital admission. However, most of these studies have been limited in their ability to assess risk factors, particularly the renal status of patients. Thus, the aim of this prospective study was to assess the incidence of ADRs and associated factors leading to hospital admissions in the elderly population.MethodsAll patients aged ≥65 years admitted to the Toulouse University Hospital through the Emergency Department during four non-consecutive weeks in 2002–3 were included in this study except for patients in ambulatory care or admitted for intentional overdoses. The characteristics of patients admitted for a suspected ADR were compared with those of patients admitted for other reasons.ResultsThe incidence of hospital admissions for ADRs was 8.37 per 100 admissions (95% CI 6.52, 10.52), corresponding to 66 patients with ADRs among 789 admissions. The most important factors associated with ADRs were the number of drugs being taken (odds ratio [OR] 1.18; 95% CI 1.08, 1.29), self-medication (OR 2.34; 95% CI 1.18, 4.66), use of antithrombotics (Anatomic Therapeutic and Chemical [ATC] classification B01; OR 2.26; 95% CI 1.33, 3.88) and use of antibacterial drugs (ATC J01; OR 4.04; 95% CI 1.50, 10.83). Surprisingly, exposure to drugs for acid-related disorders was associated with a low risk of ADRs (OR 0.26; 95% CI 0.09, 0.76).ConclusionA significant incidence of ADRs leading to hospital admissions was found among elderly people. Our study showed that there is a need to increase the availability of information for the general public concerning potential ADRs due to self-medication and for prescribers concerning ADRs due to drug-drug interactions and polypharmacy.

Assessing the feasibility of using an adverse drug reaction preventability scale in clinical practice: a study in a French emergency department.

AbstractObjective: To assess the preventability of adverse drug reactions (ADRs) leading to hospital admissions and to investigate the feasibility of the use of a standardised preventability scale in clinical practice. Design: The study was a prospective pharmacovigilance study. All patients more than 15 years old admitted to an emergency department during a period of 4 weeks were included. Characteristics of patients admitted for a suspected ADR (cases) were compared to those admitted for other reasons (controls). Preventability was assessed in two different ways: (i) by using a standardised preventability scale; and (ii) by the assessment of four reviewers without the scale. Results of the two methods were compared. Patients: In total, 671 patients were admitted to an emergency department during the study period. Results: Overall, 44 ADRs were identified involving 41 patients. The incidence of hospital admissions for ADRs was 6.1 per 100 admissions (95% CI 4.4–8.3). According to the French causality assessment method, 71% of ADRs were ‘possible’, 18% were ‘plausible’ and 11% were ‘likely’. Using the standardised preventability scale, one-third of all ADRs were considered as being preventable (9% ‘definitely’ and 25% ‘potentially’ preventable). Reviewers found that 54.5% of ADRs were ‘preventable’. Discrepancies between the two methods concerned mainly cases defined as not preventable by the scale. In general, reviewers overestimated the preventability of ADR compared with the scale. Conclusions: These results emphasise that ADRs leading to hospitalisation are frequent, with one-third of them likely to be preventable. Moreover, the risk of ADRs mainly involved a small number of drugs. Our experience suggests that there is a need for further studies to validate the French standardised scale of preventability assessment.

Gynecomastia Associated with Fenofibrate

Objective: To report a case of probable fenofibrate-induced gynecomastia. Case Summary: A 56-year-old white hypercholesterolemic man was treated with fenofibrate 160 mg/day for 1 year. During the course of treatment, he developed gynecomastia on the left side, which resolved after the drug was stopped and replaced with alpha tocopherol acetate. Sixteen months after fenofibrate discontinuation, the patient was rechallenged and subsequently developed gynecomastia symptoms on the right side. The usual etiologies of gynecomastia were excluded by careful assessment of the patients medical history, physical examination, and results of diagnostic tests such as chest X-ray, mammography, scrotal ultrasonography, routine blood chemistry, and extensive hormonal panel. Gynecomastia again resolved after discontinuation of fenofibrate. Discussion: In this case, the resolution of gynecomastia on discontinuation of fenofibrate and recurrence after rechallenge highly suggest the role of fenofibrate. Use of the Naranjo probability scale registered causality as probable. Case reports of gynecomastia caused by different drugs have been previously published, but, to our knowledge, this is the first report linking gynecomastia to the use of fenofibrate. The pathogenesis of this adverse drug reaction remains unclear. Conclusions: Although fenofibrate-induced gynecomastia appears to be uncommon, patients receiving this medication should be monitored for this adverse drug reaction.