Hospital databases for the identification of adverse drug reactions: A 2-year multicentre study in 9 French general hospitals.

AIMS: To estimate the actual number of adverse drug reactions (ADRs), we used the French medical administrative database (PMSI) in addition to ADRs spontaneously reported in the French Pharmacovigilance Database (FPVDB). METHODS: Capture-recapture method was applied to these 2 sources (PMSI and FPVDB), checking their independence via a third data source. The study ran from 1 July 2014 to 30 June 2016 in 9 French general hospitals. From PMSI, all discharge summaries including a selection of 10th International Classification of Diseases codes related to ADRs were analysed. This selection was based on the results of a previous study. All ADRs corresponding to these codes, spontaneously reported in the FPVDB, were included. RESULTS: In PMSI, 56.9% of hospital stays were related to an ADR (628 out of 1104). In the FPVDB, we retained 115 cases. A total of 43 ADRs were common to the 2 databases. In both sources, the most frequently reported ADRs were cutaneous (33.1 and 19.1%) and renal (25.2% and 11.6%). The most frequently suspected drugs were anti-infectives in PMSI (31.1%) and antineoplastic drugs in the FPVDB (30.4%). Using the capture-recapture method, the estimated number of ADRs was 1657 [95% CI: 1273 to 2040]. CONCLUSION: The use of the PMSI could constitute an additional tool for the estimation of the actual number of ADRs in French hospitals. A model involving a third data source enabled the independence of the 2 sources (PMSI and FPVDB) to be checked before applying the capture-recapture method.

[Drug interactions with colchicine, are the contraindications well respected? A descriptive study of prescriptions in Brittany based on data from the French National Health Data System]. / Interactions médicamenteuses avec la colchicine, les contre-indications sont-elles bien respectées ? Étude descriptive des prescriptions en Bretagne à partir des données de l'Assurance maladie.

Although the French Health Authority "ANSM" widely informed healthcare professionals about the risk factors for colchicine overdose, its impact and suitable dosages, cases of potentially fatal preventable overdose continue to be reported in France. Using the French National Health Insurance of the Brittany area, we quantified the proportion of prescriptions presenting an absolute drug contraindication (CI) to colchicine (according to the ANSM Drug Interactions "Thesaurus") and its impact in terms of hospitalisation. Between 2013 and 2016, nearly 77,000 patients (mean age, 66±15 years) were reimbursed for at least one colchicine-based drug (Colchimax®, Colchicine Opocalcium®), representing nearly 205,000 prescriptions. General practitioners were the main prescribers (93%). Among the prescriptions, 0.5% had absolute IC with colchicine: in 51% of cases with pristinamycin, followed by azithromycin (15.6%), clarithromycin (15.2%) and roxithromycin (11.9%). In the 15 days following the simultaneous prescription of colchicine and a contraindicated drug, 53 hospital stays were recorded. However, using only the primary diagnosis of hospitalization was not sufficiently relevant to conclude that there was no potential overdose of colchicine. Over the study period, the Thesaurus contained inconsistencies that confused clinicians: mention of absolute IC with colchicine in the "macrolide" and "pristinamycin" sections but not in the sections of 'potent CYP inhibitors' or macrolide class molecules. Overall, very few prescriptions included absolute IC with colchicine. Regular training and information of healthcare professionals remains essential to limit the risk of colchicine overdose and to remind them of the potentially fatal consequences.

[Management of cancer patients with oral therapy at home in Brittany and Pays de la Loire areas: Survey (end of 2016) and cartography]. / Prise en charge des patients sous voies orales anticancéreuses au domicile en Bretagne et Pays de la Loire : enquête fin 2016 et cartographie.

INTRODUCTION: The Cancer Observatory, from the OMEDITs (Observatory for Medicines and Medical Devices and Treatment Innovations) of Bretagne and Pays de la Loire areas has conducted a survey aiming to know and map the current practices of management of patients by Oral Anti-cancer Drug (OAD) in inter-region. METHODS: Forty eight cancer centers received by e-mail in July and October 2016 a questionnaire concerning the management of OADs : from prescription by the specialist of oncology, to the intervention of the pharmacist (analysis and pharmaceutical consulting), to follow-up by nurse, as well as the financing of this activity and the feelings of the actors about this organizational set up. RESULTS: Fifty-seven professionals from 31 centers, including the most important ones, responded to the survey. As a result, half of the establishments carry out a pharmaceutical analysis for some or all of the OAD prescriptions and only 30% carry out a pharmaceutical consulting. The nurse consultation is, on the other hand, more largely implanted (74% of the centers) as well as the telephone follow-up (6%). More than 90% of professionals believe that the organizational set up could be improved and more secure by, at least, the stronger involvement of pharmacists, the development of tools for nurse (for monitoring, therapeutic education…) and by improving the city-hospital link. CONCLUSION: This survey shows the variability in the management of patients under OAD because of the lack of resources to ensure the fairness and sustainability of the organizational set up. The hospital/city link could still be optimized to secure patient care.