GPs' practices when prescribing buprenorphine in primary care: A survey among the Sentinelles network.

INTRODUCTION: France is a leading country for opioid agonist treatment providing, with a predominance of buprenorphine. General practitioners (GPs) are the main prescribers of buprenorphine, but they seem to be less involved over the last 10 years. This work is the second part of a larger study analysing buprenorphine prescribing among French GPs working in primary care, and aims to describe GPs' practices when prescribing buprenorphine. METHODS: This is a cross-sectional study conducted in France from March to July 2021 among a sample of GPs in the Sentinelles network, a national epidemiologic surveillance system. Data about the last situations of initiation and renewal of buprenorphine were collected. RESULTS: Among the 237 participants (34.3% response rate), 156 responded to the questionnaire about the last situation of renewal and 41 about the last situation of initiation. The last initiation occurred more than 12 months earlier for 46.3% of respondents, whereas the last renewal occurred less than 1 month ago for 68.6%. There was an over-representation of the male gender among the patients who were consulting (initiation 70.7%, renewal 68.6%). A majority of patients had an illicit opioid use disorder (initiation 78.0%, renewal 82.7%). Overall, GPs were involved in the general care of patients with opioids use disorder and in opioids harm reduction (initiation 87.8% and 82.9%, renewal 88.5% and 51.9%). CONCLUSION: Among buprenorphine prescribers, initiations were infrequent unlike renewals and involved mainly illicit opioid users.

Triptan use in elderly over 65 years and the risk of hospitalization for serious vascular events.

BACKGROUND: Several studies have focused on the use of triptan and the risk of acute vascular events but the existence of such association is still debated and has never been quantified in patients over 65 years. To assess whether triptan use among older is associated with an increased risk of hospitalization for acute vascular events. METHODS: A propensity score-matched cohort study was designed using the French national health insurance database linked to hospital stays. Patients aged ≥ 65 years, newly treated by triptans between 2011 and 2014, were included… The primary event was hospitalization for an acute ischemic vascular event within de 90 days following triptan initiation. Association with triptan exposure was investigated through cox regression model, considering exposure at inclusion, and with exposure as a time-varying variable A case-crossover (CCO) and a self-controlled case series (SCCS) analyses were also conducted to address potential residual confounding. RESULTS: The cohort included 24, 774 triptan users and 99 096 propensity matched controls (mean (SD) age: 71 years (5.9), 74% of women). Within 90 days after cohort entry, 163 events were observed in the triptan group, and 523 in the control group (0.66% vs. 0.53%, adjusted hazard ratio (aHR) exposed/not exposed 1.25 95%CI [1.05-1.49]; aHR time-varying 8.74 [5.21-14.66]). The association was significant (CCO) for all events (adjusted odds ratio (aOR1.63 [1.22-2.19]) with a more consistent association with cerebral events (aOR 2.14 [1.26-3.63]). The relative incidence (RI) for all events was 2.13 [1.76-2.58] in the SCCS, for cardiac (RI: 1.67 [1.23-2.27]) and for cerebral events (RI: 3.20, [2.30-4.45]). CONCLUSION: The incidence of acute vascular events was low among triptan users. We found that triptan use among older may be associated with a low increased risk for acute vascular events, which may be more marked for cerebral events such as stroke, than for cardiac events.

Barriers and facilitators to the involvement of general practitioners in the prescription of buprenorphine.

INTRODUCTION: France has one of the highest opioid agonist treatment (OAT) coverage rates in the world. French general practitioners (GPs) are providing the majority of prescriptions. However, a fall in the number of GPs initiating buprenorphine has been observed over the last decade. METHODS: The objective of this study was to explore the obstacles and facilitators to the involvement of GPs in the prescription of buprenorphine. A qualitative study comprising 14 individual interviews and a focus group bringing together 5 GPs was conducted among GPs based in France between June 2021 and March 2022. We performed data analysis using a grounded theory methodology. RESULTS: The interviews showed a great diversity in the level of involvement of GPs, depending on their experience, their representations of patients with OUD, their mode of exercise, and their personal preferences. The negative representations of the patients associated with the feeling of physical and ethical endangerment, the feeling of powerlessness, the fear of a disruption of the practice and the feeling of incompetence appeared at the forefront of the difficulties stated. Conversely, the strengthening of initial training and the facilitation of access to self-training tools and multidisciplinarity, the consideration of opioid use disorder (OUD) as a chronic illness with the application of a patient-centered motivational approach, as well as the defining and respecting one's own limits when prescribing buprenorphine seem to be the keys to a balanced and fulfilling practice. CONCLUSION: Raising awareness of the frequency of OUD appeared to be an additional lever to enhance the interest of the GPs concerned. Additional studies focusing on the evolution of professional practices would be necessary to extend these findings.

Prescribing buprenorphine for opioid use disorder in primary care: A survey of French general practitioners in the Sentinelles network.

INTRODUCTION: Although opioid substitution coverage in France is high and patient care with buprenorphine is mainly managed by general practitioners (GPs), buprenorphine sales have been decreasing since 2011, suggesting that French GPs are prescribing less buprenorphine. Yet this possible change in GP practices has not yet been investigated. This study aimed to examine primary care GPs' opinions about buprenorphine and habits related to prescribing buprenorphine. METHODS: The study team conducted a cross-sectional survey from March 2021 to July 2021 among a sample of GPs in the Sentinelles network, a French epidemiologic surveillance system based on primary care practitioners. The study collected information about substance use disorder (SUD) training, opinions on buprenorphine, and habits related to buprenorphine prescription were collected (initiation and renewal within the past two years). FINDINGS: Among the 237 participants (34 % response rate), 15.2 % reported having had specific training for SUD management. A majority reported a very positive (16 %) or positive (63.7 %) opinion of buprenorphine. Most participants agreed (61.2 %) or strongly agreed (31.2 %) that buprenorphine was efficacious in the treatment of illicit opioid use disorder. Of the 206 GPs who reported having treated patients with opioid use disorder in the past two years, 47 (22.8 %) had initiated a buprenorphine prescription, whereas 177 (85.9 %) had renewed a buprenorphine prescription. Previous SUD training was associated with initiating buprenorphine (OR 4.66; 95 % CI [2.15-10.08]), while female gender was associated with not initiating buprenorphine prescribing (OR 0.46; 95 % CI [0.22-0.98]). CONCLUSION: A sample of French GPs who work in primary care has a positive view of buprenorphine, but the absence of SUD training among this population may be a barrier to their prescribing buprenorphine.

Potential inappropriate use of strong opioid analgesics in cancer outpatients during the last year of life in France and associated factors.

AIMS: A better knowledge of opioid prescribing patterns would help to identify areas of potential improvement in cancer pain management. This study aimed to identify potential inappropriate use (PIU) of strong opioid analgesics in cancer outpatients in their last year of life. METHODS: A retrospective cohort of cancer patients who died between 2011 and 2014 and were exposed as outpatient to a strong opioid analgesic in the last year of life was identified in the Echantillon Généraliste de Bénéficiaires (a 1/97th random sample of the French general population). Prescribing patterns of strong opioids were analysed and PIU was defined by at least 1 of these criteria: overlapping prescriptions; contraindicated prescriptions; lack of laxatives; potential drug interactions; prescription in patients hospitalized for opioid-related disorders. Factors associated with PIU were investigated through a multiple logistic regression model. RESULTS: One third of the 2236 patients (median age 72 years [interquartile range: 61-82], 44.1% women) presented a PIU (insufficient laxative prescription [19.6% of patients], insufficient background treatment with transmucosal fentanyl [14.8%], overlapping prescriptions [2.6%]). The rate of PIU significantly decreased from 37.6% (2011) to 29.8% (2014). For patients with a duration of opioid use ≥3 months, factors associated with PIU were fentanyl prescription (adjusted odds ratio = 2.36; 95% confidence interval [1.86-3.00]) and previous use of strong opioid (adjusted odds ratio = 1.88; [1.50-2.36]). CONCLUSION: In France, 1/3 of cancer patients exposed to strong opioids experienced PIU and this proportion tended to decrease over time. There is still room for progress in cancer pain management at the end of life.

Psychotropic drug initiation in patients diagnosed with chronic myeloid leukemia: a population-based study in France.

Psychotropic drugs (PD) are often used close to a cancer diagnosis and may be considered as a way of coping. We aimed to determine the incidence of anxiolytics, hypnotics, antidepressants, and antipsychotics initiation around a diagnosis of chronic myelogenous leukemia (CML). Population-based cohort: Data were extracted from Systeme National des données de Santé (SNDS, the French health insurance database) at the regional level (Midi-Pyrenees area, 2.9 million inhabitants). All newly diagnosed patients treated by a CML tyrosine kinase inhibitor (TKI) between 10/01/2011 and 04/01/2014 were included. Pre-CML (9 months before to 3 months before first TKI prescription-F-TKI) and CML (3 months before to 9 months after F-TKI) phases were defined. The main evaluation criterion was the initiation of PD during CML phase. Determinants associated with this incident PD use were studied through a logistic regression model. We compared pre-CML and CML healthcare consumption. The cohort included 103 patients (mean age of 60.8 years). PD initiation rate was 35.9%, anxiolytics being the most initiated PD (59.5%). Advanced age was associated with PD initiation (adjusted OR = 1.029, 95% CI = 1.001-1.056). The number of consultations during the pre-CML phase and female gender tended to be associated with increased risk of PD initiation in univariate analysis. For PD initiators, healthcare consumption was greater in CML but not in pre-CML phase. PD initiation is a frequent finding around a CML diagnosis. Its risk increases with age. It could be a way to identify a subgroup with higher healthcare consumption.

Availability of Effective Evidence-Based Symptomatic Treatments for Cluster Headache in the EU Countries-A Survey of the European Headache Alliance and European Headache Federation.

AIMS: To assess the reimbursement options and accessibility of three effective medicines for cluster headache (CH) (subcutaneous sumatriptan, oxygen, and zolmitriptan spray) across the European Union (EU). METHODS: A brief survey investigating the availability of symptomatic treatments for CH was sent by email in January 2017 to at least one headache specialist for every single country in the EU. RESULTS: The questionnaire was completed by 26 headache specialists (93% of the EU countries, representing 99.75% of the European population) and by 10 CH patients representative of patient organizations. Oxygen was reimbursable for 63% of the CH population. Oxygen device was reimbursable for 50% of the CH EU population. Subcutaneous sumatriptan was reimbursable for 66% and was accessible without restrictions for 45% of the CH EU population. Zolmitriptan spray was reimbursable for 23.7% and accessible without restrictions for 30.9% of the CH EU population. CONCLUSION: Only 47% of the EU population had unrestricted access to effective CH treatments, with unacceptable inequalities between eastern countries and the rest of Europe. Headache societies and patient associations should pressure European and national health authorities to improve the availability of effective symptomatic treatments for CH.

Cross-national health care database utilization between Spain and France: results from the EPICHRONIC study assessing the prevalence of type 2 diabetes mellitus.

AIM: The EPICHRONIC (EPIdemiology of CHRONIC diseases) project investigated the possibility of developing common procedures for French and Spanish electronic health care databases to enable large-scale pharmacoepidemiological studies on chronic diseases. A feasibility study assessed the prevalence of type 2 diabetes mellitus (T2DM) in Navarre and the Basque Country (Spain) and the Midi-Pyrénées region (France). PATIENTS AND METHODS: We described and compared database structures and the availability of hospital, outpatient, and drug-dispensing data from 5.9 million inhabitants. Due to differences in database structures and recorded data, we could not develop a common procedure to estimate T2DM prevalence, but identified an algorithm specific to each database. Patients were identified using primary care diagnosis codes previously validated in Spanish databases and a combination of primary care diagnosis codes, hospital diagnosis codes, and data on exposure to oral antidiabetic drugs from the French database. RESULTS: Spanish and French databases (the latter termed Système National d'Information Inter-Régimes de l'Assurance Maladie [SNIIRAM]) included demographic, primary care diagnoses, hospital diagnoses, and outpatient drug-dispensing data. Diagnoses were encoded using the International Classification of Primary Care (version 2) and the International Classification of Diseases, version 9 and version 10 (ICD-9 and ICD-10) in the Spanish databases, whereas the SNIIRAM contained ICD-10 codes. All data were anonymized before transferring to researchers. T2DM prevalence in the population over 20 years was estimated to be 6.6-7.0% in the Spanish regions and 6.3% in the Midi-Pyrénées region with ~2% higher estimates for males in the three regions. CONCLUSION: Tailored procedures can be designed to estimate the prevalence of T2DM in population-based studies from Spanish and French electronic health care records.

Patterns of direct oral anticoagulant drug prescription in France in 2010-2013: a study in the Midi-Pyrénées area.

AIM: The aim of our study was to study the pattern of prescription of direct-acting oral anticoagulants (DOACs) according to the French recommendations. METHODS: We performed a cross-sectional study using anonymous data of patients covered by the French National Health Insurance information system (SNIIRAM) from 1 January 2010 to 31 December 2013 in the area of Midi-Pyrénées (southwest of France). RESULTS: Of the 355,608 patients identified, 325,216 (91.5%) were included, of whom 22,142 received at least one DOAC. About 39.1% (8,652 patients) had DOAC in an orthopedic indication, 46.5% (10,303 patients) in a cardiac indication, and 16.1% (3568 patients) in an indeterminate indication. Overall, guidelines were largely followed as for renal function monitoring, prescribing in orthopedic indications, in cardiac indications in patients aged 80 years and older, and in the case of concomitant use of verapamil. However, inappropriate prescriptions were observed for cardiac indications, and for dosage adjustments in orthopedic indications, with respect to both the age of patients (75 years and older) and those taking verapamil or amiodarone concomitantly. Guidelines were more followed in women and patients aged 80 or more. CONCLUSIONS: Among patients receiving DOACs, 58% were exposed to a prescription falling outside the guidelines. This study on DOAC prescription patterns revealed insufficiencies in the compliance with the French guidelines in certain indications.

Efficacy and safety of biologics in relapsing polychondritis: a French national multicentre study.

OBJECTIVES: To assess the efficacy and the safety of biologics in a cohort of patients with relapsing polychondritis (RP). METHODS: We conducted a French multicentre retrospective cohort study including patients treated with biologics for RP. Efficacy outcomes were clinical response (partial or complete) and complete response during the first 6 months of exposure, plus daily corticosteroid dose at 6 months. Other outcomes were adverse drug reactions (ADRs), persistence of biologics and factors associated with a response. RESULTS: This study included 41 patients exposed to 105 biologics (tumour-necrosis factor (TNF) inhibitors, n=60; tocilizumab, n=17; anakinra, n=15; rituximab, n=7; abatacept, n=6). Overall response rate during the first 6 months of exposure was 62.9%. Complete response rate was 19.0%. Reduced corticosteroid doses were highly variable among patients. ADRs were mostly infections (n=42). Reasons for biologic withdrawal (73.3%) were insufficient efficacy (34.3%; ranging from 23.5% for tocilizumab to 72.7% for etanercept), loss of efficacy (18.1%) and ADRs (20.9%; mostly for anakinra: 46.7%). Persistence was comparable among biologic classes. Among TNF inhibitors, the highest persistence was observed with adalimumab. Differences in clinical response rates were observed depending on biologics and organ involvement. There were trends towards a lower response rate in cases with associated myelodysplastic syndrome and for a higher response rate for nasal/auricular chondritis, sternal chondritis and concomitant exposure to non-biologic disease-modifying antirheumatic drugs. CONCLUSIONS: This study describes the efficacy of biologics for refractory RP. However, the number of complete responses was low and there were concerns about the risk of ADRs, particularly infections.

Utilization and costs of HIV antiretroviral drugs in Europe during the last ten years: Impact of generic antiretroviral drugs on cost reduction.

INTRODUCTION: Simulation studies showed that generic antiretroviral (ARV) drug utilization could lead to significant cost reduction of HIV treatment in developed world. This study aimed to quantify ARV utilization and costs in European countries between 2006 and 2015. We also assessed the impact of generic ARV drug utilization on cost reduction in real-life. METHODS: ARV drug utilization in 14 European countries (France, Italy, Germany, Denmark, Netherlands, Norway, Sweden, Finland, Iceland, Croatia, Czech Republic, Estonia, Latvia, and Lithuania) were analysed using defined daily dose (DDD)/1000 inhabitants/year. ARV drug cost was estimated in million euro/year and euro/1000 inhabitants/year. The impact of generics on cost reduction was assessed in three countries: France, Denmark, and Czech Republic, using four parameters: expected savings, observed savings, brand price-reduction savings and overall savings. RESULTS: Between 2006 and 2015, median ARV drug utilization increased from 234 DDDs per 1000 inhabitants per year (IQR 124-388) to 385 (229-670). The median cost increased from €3751/1000 inhabitants/year (1109-4681) to €9158 (3269-10,646). Between 2013 and 2015, overall savings of €0.9, €1.6, and €33.7 million were respectively observed in Denmark, Czech Republic, and France. CONCLUSION: Overall savings observed in real-life from generic ARV drugs in Denmark were related to high rate of low-price generic utilization, contrarily to France and Czech Republic where these were more related to brand price-reduction than generic utilization itself.

A novel approach for medical research on lymphomas: A study validation of claims-based algorithms to identify incident cases.

The use of claims database to study lymphomas in real-life conditions is a crucial issue in the future. In this way, it is essential to develop validated algorithms for the identification of lymphomas in these databases. The aim of this study was to assess the validity of diagnosis codes in the French health insurance database to identify incident cases of lymphomas according to results of a regional cancer registry, as the gold standard.Between 2010 and 2013, incident lymphomas were identified in hospital data through 2 algorithms of selection. The results of the identification process and characteristics of incident lymphomas cases were compared with data from the Tarn Cancer Registry. Each algorithm's performance was assessed by estimating sensitivity, predictive positive value, specificity (SPE), and negative predictive value.During the period, the registry recorded 476 incident cases of lymphomas, of which 52 were Hodgkin lymphomas and 424 non-Hodgkin lymphomas. For corresponding area and period, algorithm 1 provides a number of incident cases close to the Registry, whereas algorithm 2 overestimated the number of incident cases by approximately 30%. Both algorithms were highly specific (SPE = 99.9%) but moderately sensitive. The comparative analysis illustrates that similar distribution and characteristics are observed in both sources.Given these findings, the use of claims database can be consider as a pertinent and powerful tool to conduct medico-economic or pharmacoepidemiological studies in lymphomas.

Analgesic Drug Prescription After Carpal Tunnel Surgery: A Pharmacoepidemiological Study Investigating Postoperative Pain.

BACKGROUND AND OBJECTIVES: Carpal tunnel syndrome is a frequent cause of neuropathic pain of the upper limb. Surgery is often proposed in second-line treatment, leading to an expected decrease in analgesic drug consumption. The main objective of this study was to investigate the variations in analgesic drug prescriptions, with a special focus on constant or increasing prescription patterns, before and after surgery for carpal tunnel syndrome. METHODS: We designed a retrospective cohort study of French beneficiaries from the health insurance system in Midi-Pyrénées area. All patients undergoing carpel tunnel surgery during a specified period were identified and included. Definition of increased or constant prescription of analgesics was based on the comparison of the accumulated defined daily doses received by months and a difference between early preoperative (2 months before) and late postoperative period (2-12 months after surgery) superior to a -3.5 margin. We performed 4 multivariate logistic regression models to identify factors associated with increased or constant analgesic drug prescription patterns (for all analgesics, opioid, antineuropathic, nonopioid drugs). RESULTS: Among the 3665 patients included, 3255 (89%) received at least 1 analgesic drug during the late postoperative period (39% [n = 1426] for opioids and 15% [n = 563] for antineuropathic drugs). Prescription of analgesic, opioid, or antineuropathic drugs was maintained or increased in the late postoperative period in 11%, 5%, and 3% of the population, respectively. High levels of preoperative pain and female sex were associated with an increase in opioid use, whereas inpatient surgery (vs ambulatory surgery), high levels of preoperative pain, and psychiatric disorders were found to be associated with an increase in antineuropathic drug use. CONCLUSIONS: This study revealed that approximately 3% to 5% of patients undergoing carpal tunnel surgery had persistent and even increased use of opioid or antineuropathic drugs more than 2 months after surgery, in relation with possible chronic postoperative pain. Considering the incidence of carpal tunnel syndrome, the risks associated with persistent opioid use in this population should be further monitored.

Identifying cancer drug regimens in French health insurance database: An application in multiple myeloma patients.

PURPOSE: There is no consensus on how to handle complex drug combinations of cancer drugs through medico-administrative databases. Our objective was to develop an algorithm for identifying the nature and patterns of treatment lines in a cohort of newly treated multiple myeloma patients. METHODS: A cohort of multiple myeloma patients starting a first treatment line was built using both ambulatory and hospital data from regional data of the French national healthcare system database (SNIIRAM). Patients were identified from January 2011 to September 2013 using ICD-10 codes for multiple myeloma ('C90') within long-term conditions or diagnosis from hospital data. Drugs of interest for cycle identification included bortezomib, imids (thalidomide, lenalidomide), alkylating drugs (cyclophosphamide, melphalan, bendamustine, doxorubicin) and dexamethasone. An algorithm was applied to define combinations of treatment received in the first 6 months of treatment. RESULTS: Among the 236 patients included, 45% received bortezomib-melphalan-prednisone (VMP: n = 107), 22% bortezomib-thalidomide-dexamethasone (VTD/VTD-PACE: n = 52) and 21% melphalan-prednisone-thalidomide (MPT: n = 49). Other drug regimens consisted in melphalan-prednisone (MP: 7%, n = 17), lenalidomide-dexamethasone (RD) (4%, n = 9), bortezomib-cyclophosphamide-dexamethasone (VCD: n = 1) and bortezomib-bendamustine-dexamethasone (VBD: n = 1). Type of drug regimens and allocation by age class (±65 years) were in accordance with current recommendations. CONCLUSIONS: This study demonstrates the feasibility of identifying complex drug regimens in onco-haematology, using both outpatient and inpatient drug records in French health insurance databases.

Mortality Associated With Time in and Out of Buprenorphine Treatment in French Office-Based General Practice: A 7-Year Cohort Study.

In France, most cases of opioid use disorder are treated with buprenorphine by general practitioners in private practice. Using reimbursement data of a representative sample of the French population, Echantillon Généraliste des Bénéficiaires, we investigated mortality during periods when patients were in and out of treatment in a cohort of 713 new users of buprenorphine having a mean (SD) follow-up of 4.5 (1.5) years. The mortality rate was 0.63 per 100 person-years (95% CI, 0.40-0.85) overall. In a multivariate Cox regression model, compared with being in treatment, being out of treatment was associated with a markedly increased risk of death (hazard ratio = 29.04; 95% CI, 10.04-83.99). Buprenorphine appears to be a strong protective factor against mortality.

Immeasurable time bias due to hospitalization in medico-administrative databases: which impact for pharmacoepidemiological studies?

PURPOSE: Drugs administered to hospitalized patients are not available within almost all health insurance databases. However, this unobservable exposure time bias is very rarely taken into account in pharmacoepidemiology. The objective was to model unobservable periods due to hospitalization and to assess their impact on risk estimates in the context of the association between benzodiazepines and mortality. METHODS: A cohort study was identified using the General Sample of Beneficiaries in France for the period 2006-2012. Benzodiazepines incident users were matched to incident users of antidepressants/non-benzodiazepine sedatives and to controls (non-users) according to age and gender. All-cause mortality at 1 year (Cox regression model) was studied using time-dependent variables (exposed/unexposed or under two hypotheses, inpatients are exposed or inpatients are unexposed), complemented with a multistate model based on observable/unobservable/death status. RESULTS: In each group, 57 242 patients were included. All-cause mortality was significantly higher among those exposed to benzodiazepines (adjusted hazard ratio (aHR) = 1.17, 95% confidence interval (CI) = 1.04, 1.32), as compared with controls. Use of benzodiazepines exposure as a time-dependent variable resulted in significant results after adjustment (aHR = 1.45, 95%CI = 1.16, 1.80). When inpatients were considered as unexposed, all-cause mortality was not significantly increased (aHR = 0.85, 95%CI = 0.76, 1.10), but was significantly augmented when inpatients were considered as exposed (aHR = 2.93, 95%CI = 2.46, 3.48). CONCLUSIONS: This study highlights the need to take account of the impact of unobservable exposure periods on risk estimates. Copyright © 2017 John Wiley & Sons, Ltd.

Identifying multiple myeloma patients using data from the French health insurance databases: Validation using a cancer registry.

This study aimed to assess the performance of several algorithms based on hospital diagnoses and the long-term diseases scheme to identify multiple myeloma patients.Potential multiple myeloma patients in 2010 to 2013 were identified using the presence of hospital records with at least 1 main diagnosis code for multiple myeloma (ICD-10 "C90"). Alternative algorithms also considered related and associated diagnoses, combination with long-term conditions, or at least 2 diagnoses. Incident patients were those with no previous "C90" codes in the past 24 or 12 months. The sensitivity, specificity, and positive and negative predictive values (PPVs and NPVs) were computed, using a French cancer registry for the corresponding area and period as the criterion standard.Long-term conditions data extracted concerned 11,559 patients (21,846 for hospital data). The registry contained 125 cases of multiple myeloma. Sensitivity was 70% when using only main hospital diagnoses (specificity 100%, PPV 79%), 76% when also considering related diagnoses (specificity 100%, PPV 74%), and 90% with associated diagnoses included (100% specificity, 64% PPV).In relation with their good performance, selected algorithms can be used to study the benefit and risk of drugs in treated multiple myeloma patients.

Real-life practices for preventing venous thromboembolism in multiple myeloma patients: a cohort study from the French health insurance database.

PURPOSE: The risk of venous thromboembolic event (VTE) in multiple myeloma is particularly increased. Current guidelines recommend systematic VTE prophylaxis with vitamin K antagonists (VKA) or low weight molecular heparin (LWMH) or unfractionated heparin (UFH) in high-risk patients, based on treatment received [e.g. use of IMiDs (thalidomide, lenalidomide and pomalidomide), alkylating agents or erythropoietin] and individual risk factors (e.g. history of VTE). The aim of this study was to describe strategy of VTE prophylaxis and prescribing of other antithrombotic agents during the first 6 months of multiple myeloma therapy, with stratification on IMiD-based regimens and drug and disease-related risk factors. METHODS: A retrospective cohort study of French beneficiaries from the health insurance database (SNIIRAM, Système National d'Information Inter-Régime de l'Assurance Maladie) was designed in the Midi-Pyrénées area (South West France). Patients starting a treatment for multiple myeloma in the period 2011-2014 were identified through hospital and chronic disease diagnoses. RESULTS: Among the 236 incident multiple myeloma patients, 56% male (n = 133), 67% >65 years (n = 159) and 47% (n = 110) patients received an IMiD-based regimen. In these patients, 63% (n = 69) were identified as high-risk patients with indication for low molecular weight heparin or equivalent, and 37% (n = 41) were identified as low-risk with aspirin recommended. Among the high-risk IMiDs patients, 43% (30/69) currently received a VTE prophylaxis after starting their first regimen: 70% LWMH (21/30), 40% VKA (12/30), 10% UFH (3/30) and 13% (4/30) other drugs (rivaroxaban and fondaparinux); 33% of the patients (23/69) received an antiplatelet drug only, and 23% (16/69) did not receive any antithrombotic drug. CONCLUSIONS: These results revealed lack of implementation of VTE prophylaxis in one out of high-risk multiple myeloma patients with IMiD. Copyright © 2017 John Wiley & Sons, Ltd.

Early signal of diverted use of tropicamide eye drops in France.

AIMS: Tropicamide is a mydriatic drug used as eye-drops for diagnostic or therapeutic purposes. From 2013, a diverted use by intravenous route has been suspected in Eastern Europe in opioids users. To date, no signal of misuse has been identified in France. The aims of this study were to investigate any early signals of a diverted use of tropicamide eye drops and to collect information regarding motives for the misuse and tropicamide-induced effects. METHODS: Information was obtained at three levels: (1) at regional level (Midi-Pyrénées area), from reimbursement data and pharmacists' reports on suspicious requests; (2) at national level: from reimbursement data and prescriptions suggesting possible abuse from the OSIAP (Ordonnances Suspectes, Indicateur d'Abus Possible) survey; and (3) at international level: from VigiBase® reports and Web sources. Beta-blocker eye-drops were used as comparators. RESULTS: In France, in 2014-2015, 17 (0.91%, 95% CI [0.53-1.46%]) falsified prescriptions involving tropicamide were identified in the OSIAP survey (compared with 0%, 95% CI [0-0.19%] for beta-blockers). Moreover, 37 other suspicious prescriptions were presented in 2015 (notified in 2016). In Midi-Pyrénées, seven patients aged 35-49 were reimbursed for 19-45 vials of 10 ml, in a year. Since September 2014, the regional Addictovigilance Centre has received 91 notifications of suspicious requests to obtain tropicamide. In VigiBase® , two cases were identified but none in France. An increased interest in tropicamide-related Internet searches was observed from Russia and Ukraine. CONCLUSIONS: These results represent the first early warnings of a tropicamide diverted use in France. Tropicamide abusers would seek euphoria or hallucinations. The high doses involved in intravenous administration could lead to serious complications.

Does substitution of brand name medications by generics differ between pharmacotherapeutic classes? A population-based cohort study in France.

PURPOSE: The purpose of this study was to measure the rate of substitution failure to generic antiepileptic drugs (AEDs) compared to two other pharmacotherapeutic classes (neuroleptics, beta-blockers). METHODS: We conducted a cohort study involving beneficiaries of the French health insurance system from January 2009 to November 2012. Substitution failure to generic drugs was estimated by the rate of switchback (i.e. from generic drug back to its branded drug). We selected the patients who had a dispensation of a branded AED for 60 days or more during the 90 days preceding the generic substitution. Cox proportional hazard regression was used to model time to switchback for antiepileptics vs. other therapeutic classes in the 90 days after generic substitution, adjusting for age, gender and polytherapy. RESULTS: The cohort included 6727 patients of whom 1947 were exposed to AEDs, 2398 to neuroleptics and 2382 to beta-blockers. The switchback rate was 62% for AEDs. AED users were more likely to switch back as compared to beta-blocker (crude hazard ratio 1.87; 95% CI 1.68-2.07 for patients under 75) or neuroleptic users. The same observation was made in patients above 75 years (crude hazard ratio 1.36; 95% CI 1.16-1.60). CONCLUSIONS: Compared to beta-blocker users, AED users were more likely to switch back to the branded drug, whereas this difference was not observed with neuroleptics. These results could reflect a poor acceptance of switching AEDs to generic compounds in France.