Difficult-to-treat primary immune thrombocytopenia in adults: Prevalence and burden. Results from the CARMEN-France registry.

The aim of this study was to assess the prevalence and the burden of difficult-to-treat primary ITP (pITP), defined by the need for another ITP treatment after romiplostim and eltrombopag. Adult patients were selected in the prospective, real-world CARMEN-France registry up to December 2021. Out of 821 adult patients with pITP, 29 had difficult-to-treat ITP (3.5%; 95% confidence interval [CI]: 2.3%-4.8% in total; 7.6%; 95% CI: 4.9%-10.2% of patients needing ≥2nd line treatment). The 3-year cumulative incidence of bleeding, infection and thrombosis was 100%, 24.1% and 13.8% respectively. The median cumulative duration of hospital stays was 31 days (median follow-up: 30.3 months).

Patterns of opioid analgesic prescribing in cancer outpatients during the last year of life in France: A pharmacoepidemiological cohort study based on the French health insurance database.

Cancer pain management with adequate analgesics for cancer outpatients can be particularly challenging. This representative retrospective cohort study aimed to investigate the prevalence and timing of weak and strong opioid analgesic prescriptions in cancer outpatients during their last year of life, with a focus on factors associated to potential late strong opioid initiation. Factors associated with late strong opioid initiation were investigated through multivariate logistic regression analyses stratified by place of death. A retrospective cohort of cancer outpatients, who died between 2014 and 2016, was identified from the general sample of beneficiaries. Among N=4704 cancer patients (median age 76 years, 42.7% women), 3002 (63.8%) were prescribed and dispensed ≥1 weak or strong opioid analgesic during their last year of life; of whom, 2458 (52.3%) received ≥1 weak opioid analgesic (tramadol as single-ingredient accounting for 25.9%) and 1733 (36.8%) ≥1 strong opioid analgesic dispensation (fentanyl 21.6%). Median interval between the first prescription for any strong opioid and death was 18 weeks (interquartile range: 8-38), and for weak opioids 33 weeks (interquartile range: 20-47). Among weak opioid users, 1229 (50.0%) patients had received ≥1 weak opioid analgesic dispensation during the year n-2 before death. Among strong opioid users, 986 (56.9%) patients had received ≥1 weak opioid analgesic dispensation during the year n-2 before death and 381 (21.9%) patients ≥1 strong opioid analgesic dispensation. Patients with an outpatient death were more likely to have a late strong opioid initiation compared to patients with an inpatient death. Late strong opioid initiation (<18 weeks before death) was significantly associated with a lower number of hospitalization days and prior weak opioid exposure for patients with an inpatient death and, with older age, social, prior weak opioid exposure, and a prescription initiation by general practitioner for patients with an outpatient death. Our gained knowledge of opioid prescribing patterns in cancer patients during the last year of life might help to progress opioid analgesic treatment and to improve patient outcomes.

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.

Trends of atropinic (anticholinergic) exposure in the elderly: a 10-year analysis in the French EGB database.

Atropinic drugs are known to potentially induce physical and/or mental impairments in the elderly. The aim of this study was to investigate trends of atropinic exposure in patients ≥65 years in France between 2006 and 2015. A repeated cross-sectional study was performed quarterly from January 1, 2006 to December 31, 2015, in the 'Echantillon Généraliste des Bénéficiaires (EGB)', a representative sample of the French population. Exposed patients were identified using the Anticholinergic Durán's list. Outcomes were rate of patients exposed to at least one atropinic drug (atropinic prevalence rate) and atropinic burden per patient (sum of atropinic burden scores). Interrupted time series were used to analyze the impact of market withdrawal of some drugs with atropinic properties during the period of the study. The number of patients ≥65 years registered in the EGB ranged from 75 611 in 2006 to 95 389 in 2015. Atropinic prevalence rate decreased significantly from 45.6% in 2006 to 33.2% in 2015 (-12.4%, slope significance P < 0.05). Subjects aged ≥85 years were the most exposed. Total atropinic burden decreased significantly between 2006 and 2015 (2.2 ± 1.7 in 2006; 2.0 ± 1.5 in 2015; slope significance P < 0.05), especially in patients ≥85 years. Market withdrawals for safety reasons of some atropinic drugs were significantly associated with a decrease in the atropinic prevalence rate (P < 0.05) and atropinic burden per patient (P < 0.05). In conclusion, atropinic drug exposure in the elderly significantly decreased in France between 2006 and 2015. This decrease can be partly explained by regulatory measures against some atropinic drugs.

Correction to: Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase.

Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated.

Drug-Induced Dental Caries: A Disproportionality Analysis Using Data from VigiBase.

INTRODUCTION: Dental caries is defined as a pathological breakdown of the tooth. It is an infectious phenomenon involving a multifactorial aetiology. The impact of drugs on cariogenic risk has been poorly investigated. OBJECTIVES: In this study, we identified drugs suspected to induce dental caries as adverse drug reactions (ADRs) and then studied a possible pathogenic mechanism for each drug that had a statistically significant disproportionality. METHODS: We extracted individual case safety reports of dental caries associated with drugs from VigiBase® (the World Health Organization global individual case safety report database). We calculated disproportionality for each drug with a reporting odds ratio (ROR) and 99% confidence interval. We analysed the pharmacodynamics of each drug that had a statistically significant disproportionality. RESULTS: In VigiBase®, 5229 safety reports for dental caries concerning 733 drugs were identified. Among these drugs, 88 had a significant ROR, and for 65 of them (73.9%), no information about dental caries was found in the summaries of the product characteristics, the Micromedex® DRUGDEX, or the Martindale databases. Regarding the pharmacological classes of drugs involved in dental caries, we identified bisphosphonates, atropinic drugs, antidepressants, corticoids, immunomodulating drugs, antipsychotics, antiepileptics, opioids and ß2-adrenoreceptor agonist drugs. Regarding possible pathogenic mechanisms for these drugs, we identified changes in salivary flow/composition for 54 drugs (61.4%), bone metabolism changes for 31 drugs (35.2%), hyperglycaemia for 32 drugs (36.4%) and/or immunosuppression for 23 drugs (26.1%). For nine drugs (10.2%), the mechanism was unclear. CONCLUSION: We identified 88 drugs with a significant positive disproportionality for dental caries. Special attention has to be paid to bisphosphonates, atropinic drugs, immunosuppressants and drugs causing hyperglycaemia.

[Outpatient consumption of antibiotics with a bacterial resistance risk in 2014 in France]. / Consommation ambulatoire des antibiotiques à risque de résistances bactériennes en 2014 en France.

AIM: This article proposes a description of French regional consumption of antibiotics with a bacterial resistance risk (amoxicillin+clavulanic acid, third-generation cephalosporins [C3G] and fluoroquinolones). METHODS: Antibiotics reimbursements data were obtained by Open Medic website. The antibiotic consumption profile has been established using some indicators of the European Surveillance of Antimicrobial Consumption (ESAC) in daily-defined dose per 1000 inhabitants per day (DID) or in percentage. RESULTS: Provence-Alpes-Côte d'Azur-Corse (34.4 DID) and Midi-Pyrénées-Languedoc-Roussillon (33.5 DID) consume the most of both, systemic antibiotics and antibiotics with a bacterial resistance risk. Pays-de-la-Loire (26.7 DID), Bretagne (29.1 DID), Centre-Val-de-Loire (29.7 DID) et Auvergne-Rhône-Alpes (29.7 DID) consume the less of both, systemic antibiotics and antibiotics with a bacterial resistance risk. CONCLUSION: Even if some environmental and socioeconomic factors could explain variabilities between regions, a link between consumption intensity and misuse is not excluded.

Psychotropic drug initiation during the first diagnosis and the active treatment phase of B cell non-Hodgkin's lymphoma: a cohort study of the French national health insurance database.

PURPOSE: Patients with B cell non-Hodgkin's lymphomas (B-NHLs) are known to be at risk of developing psychological disorders. The aims of this study were to measure the incidence of psychotropic drug use during the diagnosis and the active treatment phase in comparison with controls from the general population, and to identify factors associated with this use. METHODS: B-NHL patients were selected through the French national health insurance database in the Midi-Pyrénées region (southwestern France) from January 1, 2011, to April 31, 2013. Patients with a previous history of B-NHL and/or psychotropic drug treatment were excluded. RESULTS: Among 745 newly diagnosed B-NHL patients, psychotropic treatment was initiated in 31.5 % (95 % CI [28.1-34.9]), compared to 7.6 % (95 % CI [7.57-7.64]) in the general population during the same period. This incidence was comparable in colorectal cancer patients (33.5 %) but higher than that in patients with myocardial infarction (23.5 %) or with a first knee replacement surgery (22.4 %). Anxiolytics and hypnotics were the most frequently used drugs. Median duration of treatment was 37 days for anxiolytics and 58 days for hypnotics, with 20.8 % of patients remaining under treatment at 8 months. Factors associated with psychotropic drug initiation were young age, health care consumption in the year before diagnosis, and initial care at a university hospital. CONCLUSION: The high rate of psychotropic drug initiation reflects a high level of anxiety at the initial phase of B-NHL patients' trajectory. This pharmacoepidemiological study reveals inappropriate use in some patients, which should now be investigated in lymphoma survivorship.

Ambulatory Medical Assistance--After Cancer (AMA-AC): A model for an early trajectory survivorship survey of lymphoma patients treated with anthracycline-based chemotherapy.

BACKGROUND: Cancer survivorship has emerged as an important aspect of oncology due to the possibility of physical and psychosocial complications. The purpose of this study was to assess the feasibility of the Ambulatory Medical Assistance for After Cancer (AMA-AC) procedure for monitoring lymphoma survivorship during the first year after chemotherapy. METHODS: AMA-AC is based on systematic general practitioner (GP) consultations and telephone interventions conducted by a nurse coordinator (NC) affiliated to the oncology unit, while an oncologist acts only on demand. Patients are regularly monitored for physical, psychological and social events, as well as their health-related quality of life (HRQoL). Inclusion criteria were patients newly diagnosed with non-Hodgkin or Hodgkin lymphomas, who had been treated with anthracycline-based chemotherapy and were in complete remission after treatment. RESULTS: All 115 patients and 113 collaborating GPs agreed to participate in the study. For patients who achieved one year of disease-free survival (n = 104) their assessments (438 in total) were fully completed. Eleven were excluded from analysis (9 relapses and 2 deaths). The most frequent complications when taking into account all grades were arthralgia (64.3%) and infections (41.7%). About one third of patients developed new diseases with cardiovascular complications as the most common. Psychological disorders such as anxiety, depression and post-traumatic stress disorder were diagnosed in 42.6% of patients. The data collected showed that Hodgkin lymphoma patients, females, and patients with lower HRQoL (mental component) at study entry were at greater risk for developing at least one psychological disorder. CONCLUSION: This study showed that AMA-AC is a feasible and efficient procedure for monitoring lymphoma survivorship in terms of GP and patient participation rates and adherence, and provides a high quality of operable data. Hence, the AMA-AC procedure may be transferable into clinical daily practice as an alternative to standard oncologist-based follow-up.