[Drug dispensation at both community and hospital pharmacy, the highly active antiretrovirals example]. / Le double circuit de dispensation, exemple des traitements antirétroviraux : quelle pertinence ?

OBJECTIVES: Highly active antiretroviral therapies against the human immunodeficiency virus are available for patients in France in community pharmacy or in hospital pharmacy. More than 20 years after the implementation of the dual delivery system, it seems necessary to question the relevance of the dual dispensing circuit both in terms of service provided to patients and expenditure for health insurance. METHODS: The health insurance files were used to quantify the delivery of antiretrovirals therapies in the community pharmacy and in the hospital pharmacy. A survey was performed involving patients to find out their point of view on dispensing in hospital pharmacy and were the patients came from. The differential cost from the health insurance point of view between the two delivery system was calculated on the basis of the quantities delivered and the purchase prices at the hospital center in 2018. RESULTS: More than 80% of the quantities of antiretrovirals therapies are now delivered by community pharmacies. The arguments in favor of the antiretrovirals therapies dispensation by hospital pharmacy forwarded by patients are the anonymity and constant medicines availability. Health insurance is required to refund a drug at different prices depending on the delivery place, for about 37€ per box in favour of hospital dispensing. CONCLUSION: This study presents a complete inventory of the dual delivery system for antiretroviral therapies. Hospital and community therefore remain complementary to welcome outptients who will seek different delivery methods there. Little known to patients and professionals, this dual delivery system generates complexities at the stages of prescription, dispensing and reimbursement. It only concerns a minority of patients and its benefit for health insurance seems uncertain.

Covid-19: The impact of lockdown on the dispensing of hospital drugs to outpatients / COVID-19 : répercussions du confinement sur l'activité de délivrance des médicaments en rétrocession

Introduction: In response to the COVID-19 pandemic, France was under lockdown for the first time from March 17 to May 10, 2020. Purpose of the Research: The aim of this work is to study the impact of lockdown on outpatients' visits to the hospital pharmacy to collect chronic medication, in order to highlight the pharmaceutical classes concerned and to assess whether a decrease in medication adherence could be observed. Method: Retrospectively, using hospital dispensing traceability software, the dispensing of drugs during the eight weeks of lockdown was compared with that during the two eight-week periods before and after lockdown. Evolutions in the number of medicine lines dispensed and outpatient visits were analyzed over the three time periods, according to pharmaceutical classes. A specific analysis was performed between drugs only available at the hospital pharmacy and drugs available at both the community and hospital pharmacy. Results: During lockdown, 67% of patients still came regularly, but a significant decrease in the average number of lines dispensed was observed. 15% of regular patients limited their visits during this period. Patients taking drugs available at both the community and hospital pharmacy were significantly more impacted than those taking drugs that could only be dispensed at the hospital pharmacy. On the other hand, age is not a factor associated with the restriction of visits. Conclusions: Lockdown affected the visits to the hospital pharmacy of at least one in ten regular outpatients. Sending hospital drugs to community pharmacies and the help of home health care providers limited therapeutic disruptions.

Introduction: Du fait de la pandémie de COVID-19, la France a été confinée pour la première fois du 17 mars au 10 mai 2020. But de l'étude: L'objectif de ce travail est d'étudier les répercussions du confinement sur la venue des patients en rétrocession, sur les classes pharmaceutiques dispensées et sur l'observance thérapeutique. Méthodes: Les délivrances durant les huit semaines de confinement ont été comparées aux huit semaines précédentes et suivantes à partir du logiciel de traçabilité des rétrocessions. Les évolutions du nombre de lignes dispensées et de venues des patients ont été analysées sur ces trois périodes, en regard des classes pharmaceutiques. Une analyse spécifique sur les médicaments disponibles uniquement à l'hôpital et ceux disponibles également en pharmacie d'officine a été réalisée. Résultats: Durant le confinement, 67 % des patients ont continué à venir régulièrement, mais une baisse significative du nombre moyen de lignes dispensées est observée. Durant cette période, 15 % des patients réguliers ont été affectés par le confinement, n'ayant pas pu se rendre à la pharmacie. Les patients accueillis pour un médicament en double circuit ont été significativement plus affectés par le confinement que ceux accueillis pour un médicament seulement rétrocédable. L'âge n'est en revanche pas un facteur associé à la restriction des venues. Conclusions: Le confinement a influé sur les venues à la pharmacie hospitalière de près d'un patient régulier sur dix. L'envoi des médicaments rétrocédables en officine, ou l'aide des prestataires de santé à domicile, a permis de limiter les ruptures thérapeutiques.

[Funding of psychiatry in France, the problem of expensive drugs. Example of Esketamine in the case of resistant depressive episodes]. / Financement de la psychiatrie en France, la question des médicaments onéreux : exemple de l'Esketamine dans l'épisode dépressif caractérisé résistant.

In France, the funding of mental health institutions relies on an annual budget allocation. Esketamine, a non-competitive NMDA glutamate receptor antagonist, has been approved for adults with treatment-resistant major depressive disorder since 2019. However, due to its high cost (€200 per 28 mg device, excluding tax), the aim of this work was to evaluate whether the income received by an institution for the management of a patient treated with Esketamine could cover the purchase of devices, based on real clinical data. Within our institution, seven patients underwent treatment with Esketamine during the study period resulting in a total usage of 714 devices, amounting to a purchase cost of €142,800. Over the course of the follow-up period, the institution received €149,054 in revenue for the treatment of these patients. Our analysis reveals that the expense associated with Esketamine constitutes 95.8 % of the income generated from caring for these patients. This not only raises questions about the pricing of this drug but also highlights the lack of a funding system for costly psychiatric drugs. This concern extends to somatic treatments associated with psychiatric care.

Hydroxychloroquine in Coronavirus Disease 2019 Patients: What Still Needs to Be Known About the Kinetics.

Different dosage regimens of hydroxychloroquine are used to manage coronavirus disease 2019 (COVID-19) patients, without information on the pharmacokinetics in this population. Blood samples (n = 101) were collected from 57 COVID-19 patients for 7 days, and concentrations were compared with simulated kinetic profiles. Hydroxychloroquine exposure is low and cannot be predicted by other populations.

Hospital re-admission associated with adverse drug reactions in patients over the age of 65 years.

CONTEXT: Adverse drug reactions (ADRs) are responsible for 5 % of hospital admissions, but hospital re-admission induced by ADRs remains poorly documented. OBJECTIVE: The aim of this study was to estimate the rate of hospital re-admission and the factors associated with re-admission in the patients over the age of 65 years. Secondary, we described the characteristics of cases of ADRs leading to re-admission for drugs other than chemotherapy agents. METHODS: Data were extracted from hospital discharge summaries provided by the Department of Medical Information of Toulouse University Hospital. All patients over the age of 65 years admitted to the hospital in 2010 for an ADR, identified from ICD-10 codes, were selected. All subsequent admissions of members of this cohort within 1 year of discharge following the index admission were reviewed retrospectively. The risk factors associated with hospital re-admission for ADRs were analyzed. Medical records were used for descriptive analysis of re-admission due to drugs other than chemotherapy agents. RESULTS: We found that 553 of the 1000 patients admitted for ADRs in 2010 were re-admitted to hospital within 1 year. Among them, 87 cases were re-admitted for ADRs (estimated rate of 87/1000 re-admission for an ADR within 1 year). A comparison of the patients re-admitted for ADRs (n = 87) with those of patients re-admitted for other causes (n = 410) suggested that only cancer increased the risk of re-admission for ADRs (OR = 7.69 [4.59-12.88] 95 % CI). ADRs due to the same drug combination were the suspected cause of repeat admission in half the cases (other than chemotherapy). Hospital re-admission was considered avoidable in four cases (22 %). CONCLUSION: This study shows an estimated rate of re-admission for an ADR around 87/1000 within 1 year, and the same drug combination were the suspected cause of repeat admission in half the cases. At least, 11 % of cases were avoidable.

[Use of Nadis(®) software to improve adverse drug reaction reporting of antiretroviral drugs: experience in south west of France (midi-pyrénées)]. / Apport du logiciel Nadis(®) dans la collecte des effets indésirables des antirétroviraux : expérience en Midi-Pyrénées.

OBJECTIVES: To study the value of the module of pharmacovigilance in Nadis® to improve the antiretroviral (ARV) drugs-induced adverse drug reactions (ADRs) reporting. METHODS: We collected the ADRs reported for 17 months from November 2010 until April 2012. Following data were recorded: characteristics of patients, ADRs, ARV drugs. The number of ADRs was compared to those collected in the same period (17 months) before use of Nadis®. RESULTS: The 119 ADRs reported (an increase of 183%) for 109 patients ADRs were mainly gastrointestinal (21.8%) followed by renal (20.2%), neuro-psychiatric (16.8%), hepatic (13.5%), cutaneous (8.4%), metabolic (6.7%) and others (12.6%). The repartition of ARV drugs was: nucleoside (31.8%), nucleotide (13.6%) reverse transcriptase inhibitors respectively, non-nucleoside reverse transcriptase inhibitors (13.1%), protease inhibitors (36.4%), and integrase inhibitors (5.1%). CONCLUSION: Our results show the improvement of ARV-induced ADRs reporting by Nadis® which could be used to reduce the rate of under-reporting in patients exposed to these drugs.

Remdesivir for Patients Hospitalized with COVID-19 Severe Pneumonia: A National Cohort Study (Remdeco-19).

BACKGROUND: Given the rapidly evolving pandemic of COVID-19 in 2020, authorities focused on the repurposing of available drugs to develop timely and cost-effective therapeutic strategies. Evidence suggested the potential utility of remdesivir in the framework of an early access program. REMDECO-19 is a multicenter national cohort study assessing the ability of remdesivir to improve the outcome of patients hospitalized with COVID-19. METHODS: We conducted a retrospective real-life study that included all patients from the early access program of remdesivir in France. The primary endpoint was the clinical course evolution of critically ill and hospitalized COVID-19 patients treated with remdesivir. Secondary endpoints were the SOFA score evolution within 29 days following the admission and mortality at 29 and 90 days. RESULTS: Eighty-five patients were enrolled in 22 sites from January to April 2020. The median WHO and SOFA scores were respectively reduced by two and six points between days 1 and 29. Improvement in the WHO-CPS and the SOFA score were observed in 83.5% and 79.3% of patients, respectively, from day 10. However, there was no effect of remdesivir on the 90-day survival based on the control cohort for hospitalized COVID-19 patients with invasive ventilation. CONCLUSIONS: SOFA score appeared to be an attractive approach to assess remdesivir efficacy and stratify its utilization or not in critically ill patients with COVID-19. This study brings a new clinical benchmark for therapeutic decision making and supports the use of remdesivir for some hospitalized COVID-19 patients.

Case Report: Use of Subcutaneous Midazolam During an Episode of Catatonia.

Midazolam is a benzodiazepine (BZD) mainly used in anesthetic induction due to its pharmacokinetic features. Its place in the therapeutic management of catatonia remains to be determined. Here we present the case of a 65-year-old man who presented with a first episode of catatonia with opposition to any form of oral treatment, where a single dose of 1 mg of subcutaneous (SC) Midazolam permitted clinical improvement allowing oral treatment to be given. The patient's history notably included a renal transplant linked to Polycystic Kidney Disease (PKD) and no history of psychiatric illness nor of any use of psychotropic drugs. As the patient refused to drink or eat and ceased answering basic questions, a psychiatric assessment was required. A diagnosis of Catatonic disorder due to a general medical condition [DSM 5-293.89/ ICD10 [F06.1]] was made. A Bush-Francis Catatonia Rating Scale (BFCRS) analysis returned a score of 15 out of 62, with stupor, mutism, negativism, staring, withdrawal, rigidity, and stereotypy. As the negativism prevented the patient from taking any form of oral treatment, after a brief discussion with the unit's physician, it was decided to administer 1 mg of SC Midazolam. One hour later, the patient was more responsive and compliant, and agreed to drink, eat, and take medication. Thus, the catatonic signs of mutism, negativism, staring, and withdrawal were resolved, but waxy flexibility and catalepsy appeared, leading to a new BFCRS score of 10 out of 62. Oral treatment with 2.5 mg Lorazepam, 4 times a day, was then initiated. Midazolam could be a safer choice compared with the other options available, such as other SC BZD, considering the complex safety profile of this patient with renal insufficiency. This situation represents the first report of using SC Midazolam as an injectable treatment for catatonia. More studies are needed to assess the clinical pertinence of SC Midazolam in the treatment of catatonia.