One-year care pathway after acute myocardial infarction in 2018: Prescription, medical care and medication adherence, using a French health insurance reimbursement database.

BACKGROUND: Myocardial infarction is a major cause of morbidity and mortality. Guidelines have been published to optimize medical care and involve optimization of the care pathway and hospital-city coordination. AIMS: To describe the myocardial infarction care pathway during the year following hospital discharge, and the use of and adherence to secondary prevention drugs. METHODS: A cohort study was conducted using data from the main French health insurance reimbursement database of the ex-Aquitaine region. Information about the medical and pharmaceutical care of hospitalized patients in 2018 was collected for 12 months. Medication adherence was assessed by using the proportion of days covered by the treatment and persistence. RESULTS: A total of 3015 patients were included, and the mean age was 66 years. Almost 76% of the patients had a reimbursement for BAS (combined prescription of beta-blocker/antiplatelet/lipid-lowering drug), BASI (combined prescription of beta-blocker/antiplatelet/lipid-lowering drug/angiotensin-converting enzyme inhibitor) or AS (combined prescription of antiplatelet/lipid-lowering drug) treatment. Medication adherence was around 83% for aspirin and 75% for lipid-lowering drugs for the 1-year persistence. During the same time, the proportion of days covered was suboptimal. Almost 4% of patients died after leaving hospital, 45% went to a cardiac rehabilitation centre and 23% had at least one hospital readmission, whatever the reason. Patients had a mean number of 11 general practitioner consultations during the year. Almost 41% of patients did not have a consultation with a cardiologist, and 38.4% had at least two consultations. Rehabilitation and general practitioner consultations were associated with adherence. CONCLUSIONS: These new results provide clear information on the medical care environment of patients, and help us to improve care transition. Close collaboration between healthcare practitioners is very important in the early stages of outpatient follow-up.

Dual antiplatelet therapy after myocardial infarction and percutaneous coronary intervention: analysis of patient adherence using a French health insurance reimbursement database.

AIMS: Current guidelines recommend the use of dual antiplatelet therapy (DAT) (aspirin+clopidogrel) for patients after acute myocardial infarction (MI). In relation to this, we sought to examine the adherence to this recommended treatment regimen in a population of patients admitted with MI and subsequent percutaneous coronary intervention (PCI). METHODS AND RESULTS: A cohort study was conducted using data from the main health insurance reimbursement database of South West France. Patients hospitalised for MI in 2008 were identified, and then their reimbursement form of DAT for the subsequent 12 months was reviewed. Adherence was assessed by using the proportion of days covered by the treatment and persistence. Among the 634 patients included in the study, 34 had no reimbursement for DAT immediately after discharge. For the remaining patients, the probability of stopping DAT at least for one month was 18.6% (95% CI [15.4;21.8]) during the first three months and 49.1% (95% CI [44.9;53.2]) at 12 months, although the medication availability was 90%. CONCLUSIONS: These results suggest that while this medication is available to patients, the treatment is often stopped before one year. This may account for what has been reported as "resistance" to antiplatelet therapy described in a subset of patients.

Adherence with statins in a real-life setting is better when associated cardiovascular risk factors increase: a cohort study.

BACKGROUND: While the factors for poor adherence for treatment with statins have been highlighted, the impact of their combination on adherence is not clear. AIMS: To estimate adherence for statins and whether it differs according to the number of cardiovascular risk factors. METHODS: A cohort study was conducted using data from the main French national health insurance system reimbursement database. Newly treated patients with statins between September 1 and December 31, 2004 were included. Patients were followed up 15 months. The cohort was split into three groups according to their number of additional cardiovascular risk factors that included age and gender, diabetes mellitus and cardiovascular disease (using co-medications as a proxy). Adherence was assessed for each group by using four parameters: (i) proportion of days covered by statins, (ii) regularity of the treatment over time, (iii) persistence, and (iv) the refill delay. RESULTS: 16,397 newly treated patients were identified. Of these statin users, 21.7% did not have additional cardiovascular risk factors. Thirty-one percent had two cardiovascular risk factors and 47% had at least three risk factors. All the parameters showed a sub-optimal adherence whatever the group: days covered ranged from 56% to 72%, regularity ranged from 23% to 33% and persistence ranged from 44% to 59%, but adherence was better for those with a higher number of cardiovascular risk factors. CONCLUSIONS: The results confirm that long-term drug treatments are a difficult challenge, particularly in patients at lower risk and invite to the development of therapeutic education.

Use of principal component analysis in the evaluation of adherence to statin treatment: a method to determine a potential target population for public health intervention.

The prevalence of statin use is high but adherence low. For public health intervention to be rational, subpopulations of nonadherent subjects must be defined. To categorise statin users with respect to patterns of reimbursement, this study was performed using the main French health reimbursement database for the Aquitaine region of south-western France. The cohort included subjects who submitted a reimbursement for at least one delivery of a statin (index) during the inclusion period (1st of September 2004-31st of December 2004). Indicators of adherence from reimbursement data were considered for principal component analysis. The 119,570 subjects included and analysed had a sex ratio of 1.1, mean (SD) age of 65.9 (11.9), and 13% were considered incident statin users. Principal component analysis found three dimensions that explained 67% of the variance. Using a K-means classification combined with a hierarchical ascendant classification, six groups were characterised. One group was considered nonadherent (10% of study population) and one group least adherent (1%). This novel application of principal component analysis identified groups that may be potential targets for intervention. The least adherent group appears to be one of the most appropriate because of both its relatively small size for case review with prescribing physicians and its very poor adherence.

How reimbursement databases can be used to support drug utilisation studies: example using the main French national health insurance system database.

INTRODUCTION: Reimbursement databases are potentially invaluable tools to develop and conduct pharmacoepidemiological studies on drug use. However, two types of factors that may influence the performance of a database can be distinguished: firstly, factors related to the constitution of the database, and secondly, factors related to the data. For the latter, we think that two are important: the presence of the drug in the database and the capacity to capture real-life use, both of which are influenced by the marketing status (e.g., OTC) and whether reimbursement is possible. OBJECTIVES: To illustrate and discuss to what extent reimbursement databases are relevant tools to conduct drug utilization studies with regard to the data on drugs. METHODS: In order to illustrate the reliability of data in reimbursement databases, data from the main French national health insurance database (55 million individuals) were compared to national drug sales in France (units) during the same year. RESULTS: Depending on the ATC class, the capture in the database of drugs actually sold ranged from 32 to 81%. DISCUSSION: Capture of classes of drugs in the database may be explained by the specific characteristics of the French health insurance system (reimbursable drugs, OTC market share). These characteristics influence the studies that can be performed both in terms of the topic but also the methodology. This problem probably exists for the other reimbursement databases used worldwide. CONCLUSION: Studies should be designed according to the strengths and weaknesses of reimbursement databases that were not originally developed for pharmacoepidemiology.

Risk of death related to psychotropic drug use in older people during the European 2003 heatwave: a population-based case-control study.

OBJECTIVE: The authors investigated the association between death of older people and use of psychotropic drugs before and during the Western European August 2003 heatwave. METHOD: A retrospective population-based case-control study was conducted using the French social security insurance national database. Exposure to psychotropic drugs in cases aged 70-100 years who died before (N = 2,093) and during (N = 9,531) the August 2003 heatwave was compared with those of survivors matched for age, gender, and presence of chronic illness, by using conditional logistic regressions. RESULTS: The association between death and psychotropic drug use was modified by level of external temperature (Wald chi(2) = 13.1, degree of freedom = 1, p <0.001). Use of any psychotropic drug was associated with a 30% increased risk of death during the heatwave, with a significant dose-response relationship between the number of psychotropic drugs and the risk of death (adjusted odds ratio [aOR] for linear trend 1.25, 95% confidence interval [95% CI]: 1.21-1.29). During the heatwave, therapeutic classes independently associated with an increased risk of death were antidepressants (aOR 1.71, 95% CI: 1.57-1.86) and antipsychotics (aOR 2.09, 95% CI: 1.89-2.35), whereas exposure to anxiolytics/hypnotics use (aOR 0.85, 0.79-0.91) was associated with a decreased risk. Findings remained unchanged after adjustment on cardiotropic, antidementia, or anti-parkinsonian drug use. CONCLUSION: Our findings suggest that a causal relationship may exist between psychotropic drug use during a heatwave and increased risk of death in older people. The risk/benefit ratio of antidepressant and antipsychotic drugs should be carefully assessed in older people during a heatwave.

Adherence to anti-inflammatory treatment for asthma in clinical practice in France.

OBJECTIVES: This study evaluated adherence to anti-inflammatory controller medication for asthma in a French population. METHODS: This was an observational cohort study that employed data from the health insurance database for the Aquitaine region of France. Eligible subjects were aged between 15 and 45 years and had > or = 1 reimbursement claim for anti-inflammatory controller medication between December 1, 2003, and December 31, 2003. Data were collected from June 1, 2003, to May 28, 2005. New users were defined as those having no reimbursement claim for any asthma controller medication in the 6 months preceding the index date; all others were considered previous users. All subjects were followed for 17 months. Continuous multiple-interval measures of medication availability and medication gaps, treatment persistence, and time to first renewal were calculated for users of inhaled corticosteroids (ICS) alone, users of ICS combined with a long-acting beta2-agonist (LABA) in a single inhaler (ICS/LABA) or in separate inhalers (ICS + LABA), and users of oral leukotriene antagonists. RESULTS: The study population contained 12,502 new and previous users of anti-inflammatory controller medication for asthma. Their mean (SD) age was 32.0 (8.9) years and 58.3% were female. Previous users had better adherence to treatment than new users with respect to all measures. Adherence was best in previous users of leukotriene antagonists. However, only 40.2% of previous users of leukotriene antagonists had sufficient medication (95% CI, 37.6-42.9), compared with 56.8% of previous users of ICS + LABA (95% CI, 50.7-62.8), 65.5% of previous users of ICS only (95% CI, 63.1-67.9), and 69.8% of previous users of ICS/LABA (95% CI, 68.2-71.4). The rate of persistence over a 1-year period was 44.3% for previous users of leukotriene antagonists (95% CI, 41.7-46.8), compared with 27.1% for previous users of ICS only (95% CI, 25.1-29.1), 32.1% for previous users of ICS/LABA (95% CI, 30.5-33.6), and 44.1% for previous users of ICS + LABA (95% CI, 38.2-50.0). CONCLUSION: Adherence to treatment was poor (< or = 44%) in these users of anti-inflammatory controller medications for asthma.

Psychotropic drugs use and risk of heat-related hospitalisation.

OBJECTIVE: To assess if use of psychotropic drugs is associated with an increased risk of admission for heat-related pathologies during a heat wave period. METHOD: We conducted a matched case-control study. Cases were defined as subjects admitted to an emergency department for heat-related pathology (hyperthermia or heat stroke) over the August 2003 heat wave. Controls were defined as subjects living in the same area but not hospitalised over the same period and who had at least one prescription form submitted for refunding by the social security insurance in July 2003. Multivariate analyses were used to identify psychotropic drugs independently associated with hospital referral during the heat wave period. RESULTS: Out of the 1405 patients admitted to the emergency department, 56 (4%) presented with heat-related pathology. The mean age of cases was 83 years. Multivariate analyses showed that cases were more likely than controls to be treated with anticholinergic drugs (OR 6.0, 95% CI 1.8-19.6), antipsychotics (OR 4.6, 95% CI 1.9-11.2) or anxiolytics (OR 2.4, 95% CI 1.3-4.4). CONCLUSION: In special risk situations such as heat waves, the risk/benefit ratio of psychotropic drugs which could interfere with body temperature regulation has to be carefully assessed, particularly in the elderly.

Use of psychotropic drugs in 0 to 5 years old children in Aquitaine (France): prevalence and associated factors.

PURPOSE: To describe the use of psychotropic drugs in children aged 0-5 years, in the Aquitaine region of South-west France and identify associated socio-demographic, familial and medical factors. METHODS: Data used in this study come from the regional drug claims database of the National Health Insurance System of Aquitaine and from postal self-questionnaires sent to parents and prescribing physicians. RESULTS: In Aquitaine, psychotropic drugs were redeemed at least once in 2002 for 3.2% of young children. Hydroxyzine, niaprazide or diazepam were claimed at least once by 2.7% of children registered in the database. Prescribers were mostly general practitioners (76.7%) and pediatricians (20.1%). Psychotropic claims were more frequent in children having the highest number of medical consultations in 2002 (more than 7: odds ratio (OR) = 1.5 [95% confidence interval (CI): 1.3-1.7]) or of drug deliveries (7-15 deliveries: OR = 1.8 [95%CI: 1.6-2.1]; more than 15 deliveries: OR = 3.2 [95%CI: 2.7-3.9]). Psychotropic claim frequency increased with age. No association of psychotropic use with parental psychotropic use, socio-professional category and familial situation was found. CONCLUSIONS: Psychotropic delivery prevalence in Aquitaine in young children was below 5% in 2002. It notably concerned drugs of which the use is not devoid of toxicity because of anticholinergic properties.

[Celecoxib prescription: data from the "Sécurité Sociale" database of the Aquitaine Region, South-Western, France]. / Prescription du célécoxib (Célébrex) lors de sa commercialisation : une étude conduite à partir de la base de données du régime général de l'assurance maladie de la région Aquitaine.

OBJECTIVE: The objective of this study was to describe the characteristics of subjects beginning celecoxib treatment and the evolution of treatment over a 6-month period. METHODS: All the subjects (n = 14 323) for whom reimbursement of celecoxib was submitted to the "Sécurité Sociale" d'Aquitaine in December 2000 were included in the study. Their mean age was 61.9 years, and the male/female sex ratio was equal to 0.45. Almost two-thirds of the subjects were previous typical nonsteroidal anti-inflammatory drug users (NSAIDs-typical). RESULTS: Fifteen percent of the subjects had a gastroprotective agent prescribed, either on the same form as celecoxib or during the following 30 days. New reimbursements of celecoxib involved 41% of the subjects. Among the subjects who received a repeat prescription of celecoxib, 41% had used a gastroprotective agent at least once during the 6 months before study inclusion and 44% during the 6 months after inclusion. Among the subjects who did not renew their celecoxib prescription, the respective proportions were 32.2% and 33.7%. DISCUSSION: These results show that celecoxib is mainly prescribed to previous NSAIDs-typical users. The small difference in the prescription of gastroprotective agents between the period preceding and that following the initiation of celecoxib treatment does not indicate an advantage of celecoxib in terms of a lower rate of use of gastroprotective agents.

Differences between clinical trials and postmarketing use.

AIMS: Clinical trials constitute the gold standard to assess the efficacy and safety of new medicines. However, because they are conducted in standardized conditions far from the real world of prescription and use, discrepancies in patient selection or treatment conditions may alter both the effectiveness and risks. On the basis of three examples, our objectives were to study the differences between the characteristics of treated populations and treatment patterns in clinical trials and in postmarketing settings and to discuss the potential consequences on actual efficacy and safety. METHODS: Treated populations were compared with patients included in premarketing clinical trials. Comparisons were made on the basis of demographic characteristics and treatment patterns. RESULTS: Whatever the indicator and the drug studied, differences were observed: from 0.04% to 63% for tacrine, from 0% to 37% for celecoxib and from 6% to 52% for simvastatin, with possible consequences on the effectiveness and safety of the drug concerned. Our results confirm the under-representation of women and elderly patients in premarketing clinical trials, e.g. an M : F ratio of 4.6 in clinical trails of simvastatin vs 1.0 in the joint population. Moreover, the concomitant use of medicines was made extremely restrictive by the protocols of these trials while this was not the case in the postmarketing phase. This has possible consequences on the effectiveness and safety of the drug concerned. CONCLUSIONS: These results plead for systematic ad hoc observational postmarketing studies for any novel and/or expensive medicine to assess the relevance of premarketing data.