Dataset Information

A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.

ABSTRACT: PURPOSE:In June 2013, following recommendations from the World Health Organization (WHO) and Food and Drug Administration (FDA), the European Medicines Agency agreed updates to the codeine product information regarding use for pain in children younger than 12 years and children undergoing tonsillectomy or adenoidectomy (TA) for obstructive sleep apnoea. This study was conducted to (a) assess effectiveness of these measures on codeine prescribing in the "real-world" setting and (b) test feasibility of a study using a common protocol by regulators with access to databases. METHODS:The study was performed using BIFAP (Spain), CPRD (UK), and IMS® Disease Analyzer (France and Germany) databases. Prescribers included general practitioners (GPs) (France and UK), GPs and paediatricians together (Spain), and GPs, paediatricians, and ear, nose, and throat (ENT) specialists separately (Germany). Between January 2010 and June 2015, prevalence of codeine prescribing was obtained every 6 months, and a time series analysis (joinpoint) was performed. Codeine prescribing within ±30 days of TA was also identified. Furthermore, doses, durations, and prior prescribing of other analgesics were investigated. RESULTS:Over the 5-year period, codeine prescribing decreased in children younger than 12 years (by 84% in France and Spain, 44% in GP practices in Germany, and 33% in the United Kingdom). The temporal pattern was compatible with the regulatory intervention in France and the United Kingdom, whereas a decrease throughout the study period was seen in Germany and Spain. Decreased prescribing associated with TA was suggested in ENT practices in Germany. CONCLUSIONS:Codeine prescribing for children decreased in line with introduced regulatory measures. Multidatabase studies assessing impact of measures by EU regulators are feasible.

SUBMITTER: Hedenmalm K

PROVIDER: S-EPMC6771637 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature

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A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.

Hedenmalm Karin K Blake Kevin K Donegan Katherine K Macia Miguel-Angel MA Gil Miguel M Williams Julie J Montero Dolores D Candore Gianmario G Morales Daniel D Kurz Xavier X Arlett Peter P

Pharmacoepidemiology and drug safety 20190620 8

<h4>Purpose</h4>In June 2013, following recommendations from the World Health Organization (WHO) and Food and Drug Administration (FDA), the European Medicines Agency agreed updates to the codeine product information regarding use for pain in children younger than 12 years and children undergoing tonsillectomy or adenoidectomy (TA) for obstructive sleep apnoea. This study was conducted to (a) assess effectiveness of these measures on codeine prescribing in the "real-world" setting and (b) test f ...[more]

PMID: 31219227

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Project description:The epidemic of nonmedical use of prescription opioids has been fueled by the availability of legitimately prescribed unconsumed opioids. The aim of this study was to better understand the contribution of prescriptions written for pediatric patients to this problem by quantifying how much opioid is dispensed and consumed to manage pain after hospital discharge, and whether leftover opioid is appropriately disposed of. Our secondary aim was to explore the association of patient factors with opioid dispensing, consumption, and medication remaining on completion of therapy.Using a scripted 10-minute interview, parents of 343 pediatric inpatients (98% postoperative) treated at a university children's hospital were questioned within 48 hours and 10 to 14 days after discharge to determine amount of opioid prescribed and consumed, duration of treatment, and disposition of unconsumed opioid. Multivariable linear regression was used to examine predictors of opioid prescribing, consumption, and doses remaining.Median number of opioid doses dispensed was 43 (interquartile range, 30-85 doses), and median duration of therapy was 4 days (interquartile range, 1-8 days). Children who underwent orthopedic or Nuss surgery consumed 25.42 (95% confidence interval, 19.16-31.68) more doses than those who underwent other types of surgery (P < .001), and number of doses consumed was positively associated with higher discharge pain scores (P = .032). Overall, 58% (95% confidence interval, 54%-63%) of doses dispensed were not consumed, and the strongest predictor of number of doses remaining was doses dispensed (P < .001). Nineteen percent of families were informed how to dispose of leftover opioid, but only 4% (8 of 211) did so.Pediatric providers frequently prescribed more opioid than needed to treat pain. This unconsumed opioid may contribute to the epidemic of nonmedical use of prescription opioids. Our findings underscore the need for further research to develop evidence-based opioid prescribing guidelines for physicians treating acute pain in children.

Project description:INTRODUCTION:Multimorbidity is a major challenge for current healthcare systems and professionals. From the different approaches that have been proposed to analyse this issue, the hypothesis of the existence of association patterns of different chronic conditions is gaining visibility. In addition, multimorbidity can be associated to polypharmacy, which can lead to a higher risk of potentially inappropriate prescribing (PIP) and consequently to adverse drug reactions (ADRs). The general objective of this novel study is to identify the association between PIP, multimorbidity patterns, polypharmacy and the presence of ADRs in older patients admitted for exacerbation of chronic diseases. METHODS AND ANALYSIS:The MoPIM (morbidity, potentially inappropriate medication) study is a multicentre prospective cohort study of an estimated sample of 800 older (?65 years) patients admitted to five general hospitals in Spain due to an exacerbation of a chronic disease. Patients referred to home hospitalisation, admitted due to an acute process or with a fatal outcome expected at the time of admission are excluded. Sociodemographic data, chronic morbidities and geriatric syndromes, number of chronic prescribed medications, PIP at admission to hospital and on discharge, according to the newest screening tool of older screening tool of older person's potentially inappropriate prescriptions/screening tool to alert doctors to right treatment criteria, and ADRs during hospitalisation are being collected. Multimorbidity patterns will be identified using cluster analyses techniques, and the frequency of polypharmacy, PIP and ADRs will be calculated. Finally, the possible relationship between those indicators will be identified through bivariate and multivariate analyses. ETHICS AND DISSEMINATION:The project has been approved by the clinical research ethics committees of each centre: Comité Ético de investigación Clínica del Parc Taulí, Comitè Ètic d'Investigació Clínica Osona per a la Recerca i Educació Sanitàries (FORES), Comité de Ètica de la Investigación con Medicamentos (CEIm)-Parc de Salut MAR, Comité Ético de Investigación Clínica de Euskadi, Comité de Ética de Investigación del Hospital Universitario de Canarias. The results will be actively and mainly disseminated through publication in peer-reviewed journals and communications in scientific conferences. TRIAL REGISTRATION NUMBER:NCT02830425.

Dataset Information

A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.

Publications

A European multicentre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children.

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