Dataset Information

Off-label drug prescriptions in French general practice: a cross-sectional study.

ABSTRACT:

Objectives

Off-label drug prescribing is a public health and economic issue. The aim of this study was to describe off-label prescription in general practice in France, in terms of frequency and nature, and to identify its main determining factors.

Design

Multicentre cross-sectional study SETTING: Twenty-three training general practice offices PARTICIPANTS: All the voluntary patients coming for a medical consultation or visited at home over a cumulative period of 5?days per office between November 2015 and January 2016.

Methods

Eleven interns, acting as observers, collected data. Two reviewers analysed the drugs prescribed by the trainers, in order to identify those prescribed off-label in terms of their indication or the age of the patient. We used a univariate, then a multivariate model, based on hierarchical mixed-effects logistic regression.

Results

Among the 4932 drug prescriptions registered, 911 (18.5%[95%?CI17.4% to 19.6%]) were off-label, of which 865 (17.6%) due to the indication of the drug and 58 (1.2%) due to the age of the patient. The prescription never mentioned the off-label use, neither was the patient informed of it, as required by the French law. With the multivariate analysis, variables contributing to off-label prescription were the number of drugs (OR=1.05 for each additional drug), the initiation of new drug therapy (OR=1.26) and the non-specific goal of the prescription (OR=1.43); the age of the patient ?14 years (OR=1.42); the rural location of the physician's practice (OR=1.38) and the low frequency of the visits of national health insurance representatives (OR=0.93).

Conclusion

Almost one out of five drugs prescribed in French general practice was off-label. It seems necessary to better train physicians in clinical pharmacology, to provide them with more effective drug prescription software, to reinforce postmarketing surveillance and to clearly define off-label use by consensus.

SUBMITTER: Drogou F

PROVIDER: S-EPMC6500201 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Off-label drug prescriptions in French general practice: a cross-sectional study.

Drogou François F Netboute Allison A Giai Joris J Dode Xavier X Darmon David D Kassai Behrouz B Letrilliart Laurent L

BMJ open 20190409 4

<h4>Objectives</h4>Off-label drug prescribing is a public health and economic issue. The aim of this study was to describe off-label prescription in general practice in France, in terms of frequency and nature, and to identify its main determining factors.<h4>Design</h4>Multicentre cross-sectional study SETTING: Twenty-three training general practice offices PARTICIPANTS: All the voluntary patients coming for a medical consultation or visited at home over a cumulative period of 5 days per office ...[more]

PMID: 30967407

Similar Datasets

Project description:The integration of Connected Health Devices (CHDs) is growing within mobile health (mHealth) and telemedicine, encouraged by institutions and industries. The idea is to improve lifestyle habits and health behaviors as a preventive goal in an aging population with fewer physicians available. However, their ill-defined place in health care does not promote their use in current medical practice.The primary objective of this study was to quantify CHDs' use rate by general practitioners (GPs). A secondary objective was to evaluate their benefits and limitations in usual care.A cross-sectional study through an Internet-based survey was addressed to French GPs via regional medical unions and continuous education agencies, supplemented with an informative website, from March 2015 to July 2015. Surveys where either the form was insufficiently filled or the main question was left unanswered were excluded from the study.A total of 1084 answers were analyzed, of which 19.46% (211/1084, 95% CI 17.1-21.8) GPs used CHDs, and 10.15% (110/1084, 95% CI 8.5-12.1) prescribed a CHD. CHD users statistically prescribed more CHDs (7.38% [80/1084] in the user group vs 2.86% [31/1084] in nonusers; P<.001) and were more likely to use them in the future. Major interests in their utilization were in patient monitoring for 84.96% (921/1084) and patient education for 75.83% (822/1084), especially for diabetes (89.67%, 972/1084) and hypertension (84.13%, 912/1084). Generated data had to be managed securely by the patient primarily for 85.79% (930/1084) of the GPs. CHDs had to not constrain GPs outside clinical consultation, nor restrain their time for 75.83% (822/1084). Additional actors in patient care were not desired for 79.98% (867/1084) of the GPs. Questions about data management issues and technical difficulties were raised.CHDs are little used by French GPs and even less prescribed to their patients, as only a few GPs use these tools. Their benefits as tools of patient empowerment, although expected, remain to be demonstrated in real-life setups.

Project description:BackgroundPrevious studies of inter-practice variation of the prevalence of hypertension and diabetes mellitus showed wide variations between practices. However, in these studies inter-practice variation was calculated without controlling for clustering of patients within practices and without adjusting for patient and practice characteristics. Therefore, in the present study inter-practice variation of diagnosed hypertension and diabetes mellitus prevalence rates was calculated by 1) using a multi-level design and 2) adjusting for patient and practice characteristics.MethodsData were used from the Netherlands Information Network of General Practice (LINH) in 2004. Of all 168.045 registered patients, the presence of hypertension, diabetes mellitus and all available ICPC coded symptoms and diseases related to hypertension and diabetes, were determined. Also, the characteristics of practices were used in the analyses. Multilevel logistic regression analyses were performed.ResultsThe 95% prevalence range for the practices for the prevalence of diagnosed hypertension and diabetes mellitus was 66.3 to 181.7 per 1000 patients and 22.2 to 65.8 per 1000 patients, respectively, after adjustment for patient and practice characteristics. The presence of hypertension and diabetes was best predicted by patient characteristics. The most important predictors of hypertension were obesity (OR = 3.5), presence of a lipid disorder (OR = 3.0), and diabetes mellitus (OR = 2.6), whereas the presence of diabetes mellitus was particularly predicted by retinopathy (OR = 8.5), lipid disorders (OR = 2.8) and hypertension (OR = 2.7).ConclusionAlthough not the optimal case-mix could be used in this study, we conclude that even after adjustment for patient (demographic variables and risk factors for hypertension and diabetes mellitus) and practice characteristics (practice size and presence of a practice nurse), there is a wide difference between general practices in the prevalence rates of diagnosed hypertension and diabetes mellitus.

Project description:BACKGROUND: In July, 2009, French health authorities, like those in many other countries, decided to embark on a mass vaccination campaign against the pandemic A(H1N1) influenza. Private general practitioners (GPs) were not involved in this campaign. We studied GPs' pandemic vaccine (pvaccine) uptake, quantified the relative contribution of its potential explanatory factors and studied whether their own vaccination choice was correlated with their recommendations to patients about pvaccination. METHODOLOGY/PRINCIPAL FINDINGS: In this cross-sectional telephone survey, professional investigators interviewed an existing panel of randomly selected private GPs (N = 1431; response rate at inclusion in the panel: 36.8%; participation rate in the survey: 100%). The main outcome variable was GPs' own pvaccine uptake. We used an averaging multi-model approach to quantify the relative contribution of factors associated with their vaccination. The pvaccine uptake rate was 61% (95%CI = 58.3-63.3). Four independent factors contributed the most to this rate (partial Nagelkerke's R(2)): history of previous vaccination against seasonal influenza (14.5%), perception of risks and efficacy of the pvaccine (10.8%), opinions regarding the organization of the vaccination campaign (7.1%), and perception of the pandemic's severity (5.2%). Overall, 71.3% (95%CI = 69.0-73.6) of the participants recommended pvaccination to young adults at risk and 40.1% (95%CI = 37.6-42.7) to other young adults. GPs' own pvaccination was strongly predictive of their recommendation to both young adults at risk (OR = 9.6; 95%CI = 7.2-12.6) and those not at risk (OR = 8.5; 95%CI = 6.4-11.4). CONCLUSIONS/SIGNIFICANCE: These results suggest that around 60% of French private GPs followed French authorities' recommendations about vaccination of health care professionals against the A(H1N1) influenza. They pinpoint priority levers for improving preparedness for future influenza pandemics. Besides encouraging GPs' own uptake of regular vaccination against seasonal influenza, providing GPs with clear information about the risks and efficacy of any new pvaccine and involving them in the organization of any future vaccine campaign may improve their pvaccine uptake.

Project description:ObjectivesThe acceleration in the number of female doctors has led to questions about differences in how men and women practice medicine. The aim of this study was to assess the influence of general practitioner (GP) gender on the use of the three main categories of diagnostic procedures-clinical examinations, laboratory tests and imaging investigations.DesignCross-sectional nationwide multicentre study.SettingFrench training general practices.ParticipantsThe patient sample included all the voluntary patients over a cumulative period of 5 days per office between November 2011 and April 2012. The GP sample included 85 males and 43 females.Methods54 interns in general practice, observing their GP supervisors, collected data about the characteristics of GPs and consultations, as well as the health problems managed during the visit and the processes of care associated with them. Using hierarchical multilevel mixed-effect logistic regression models, we performed multivariable analyses to assess differences in each of the three main categories of diagnostic procedures, and two specific multivariable analyses for each category, distinguishing screening from diagnostic or follow-up procedures. We searched for interactions between GP gender and patient gender or type of health problem managed.ResultsThis analysis of 45 582 health problems managed in 20 613 consultations showed that female GPs performed more clinical examinations than male GPs, both for screening (OR 1.75; 95% CI 1.19 to 2.58) and for diagnostic or follow-up purposes (OR 1.41; 95% CI 1.08 to 1.84). Female GPs also ordered laboratory tests for diagnostic or follow-up purposes more frequently (OR 1.21; 95% CI 1.03 to 1.43). Female GPs performed even more clinical examinations than male GPs to diagnose or follow-up injuries (OR 1.69; 95% CI 1.19 to 2.40).ConclusionFurther research on the appropriateness of diagnostic procedures is required to determine to what extent these differences are related to underuse or overuse.

Project description:The study investigated (1) the association between comorbidity and multidrug prescribing compared with the index condition, and (2) the association between vascular comorbidity and non-vascular condition key drug prescribing.Cross-sectional study linking anonymised computer consultations with prescription records for a 2-year time period.11 general practices in North Staffordshire, England.Study groups aged 40?years and over (N=12?875). Within six conditions, comorbid group with the other five conditions was compared with an 'alone' group without them. Additionally, how the 'vascular' (one of diabetes, cardiovascular disease and cerebrovascular disease) comorbidity influenced chronic obstructive pulmonary disease (COPD), osteoarthritis (OA) or depression drug prescribing was investigated.Based on the British National Formulary, five main drug chapters constituted a measure of drug counts, with low count as 2 or less and high multidrug count as 3 or more. Key drugs prescribed for COPD, OA and depression were derived from guidelines.The adjusted associations between the comorbid groups and higher multidrug count compared with their respective 'alone' group were: odds ratio (OR) 7.1 (95% CI 5.6 to 9.0) for depression, OR 5.4 (95% CI 4.6 to 6.3) for cardiovascular disease, OR 3.7 (95% CI 2.8 to 5.0) for cerebrovascular disease, OR 3.6 (95% CI 3.1 to 4.3) for OA, OR 3.5 (95% CI 3.0 to 4.2) for diabetes and OR 3.2 (95% CI 2.6 to 4.0) for COPD. In COPD, vascular comorbidity was associated with a significant reduction in key COPD drug treatments (adjusted OR 0.6 (95% CI 0.4 to 0.8). In depression, vascular comorbidity was associated with a reduction in key depression drug treatments (OR 0.6 (95% CI 0.4 to 0.7)).Our findings show that multidrug prescribing for different body systems is higher with comorbidity and may be associated with lower likelihood of prescribing for specific conditions. Further research is required on whether multidrug prescribing influences the outcomes of care for chronic conditions.

Dataset Information

Off-label drug prescriptions in French general practice: a cross-sectional study.

Objectives

Design

Methods

Results

Conclusion

Publications

Off-label drug prescriptions in French general practice: a cross-sectional study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets