Feasibility study and evaluation of expert opinion on the semi-automated meta-analysis and the conventional meta-analysis.

PURPOSE: To assess the feasibility and acceptance of the semi-automated meta-analysis (SAMA). The objectives are twofold, namely (1) to compare expert opinion on the quality of protocols, methods, and results of one conventional meta-analysis (CMA) and one SAMA and (2) to compare the time to execute the CMA and the SAMA. METHODS: Experts evaluated the protocols and manuscripts/reports of the CMA and SAMA conducted independently on the safety of metronidazole in pregnancy. Expert opinion was collected using AMSTAR 2 checklist. Time spent was recorded using case report forms. RESULTS: The overall scores of the opinion of all experts for protocols, methods, and results for SAMA (6.75) and CMA (6.87) were not statistically different (p = 0.88). The experts' confidence in the results of each MA was 7.89 ± 1.17 and 8.11 ± 0.92, respectively. The time to completion was 14 working days for SAMA and 24.7 for CMA. MA tasks such as calculation of effect estimates, subgroup/sensitivity analysis, and publication bias investigation required no investment in time for SAMA. CONCLUSION: In conclusion, our study demonstrated the feasibility of SAMA and suggests acceptance for risk assessment by an expert committee. Our results suggest that SAMA reduces the time required for a MA without altering expert confidence in the methodological and scientific rigor. As our study was limited to one example, the generalization of our results requires confirmation by other studies.

Biases associated with epidermal necrolysis reporting in pharmacovigilance: An exploratory analysis using World Health Organization VigiBase.

BACKGROUND: Possible biases in pharmacovigilance reporting may impact epidermal necrolysis (EN) and drugs associations. OBJECTIVES: To assess biases associated with EN-reporting. METHODS: Using VigiBase, the World Health Organization-pharmacovigilance database, among drugs associated with EN between 2016 and 2020, we used an unsupervised clustering including reports characteristics, that is, reporter quality, time from drug intake to EN onset, and only one suspected drug in the report. RESULTS: Among 152 drugs, three clusters were identified. Cluster 1 (n = 41) exhibited drugs frequently reported within a time from intake to onset longer than 4 days, in 57 ± 13% of reports. It corresponded to well-reported drugs and was composed mainly of antivirals and antiepileptics. Cluster 2 (n = 42) exhibited drugs frequently reported within a time from drug intake to onset shorter than 4 days, in 31 ± 12% of reports. It corresponded to drugs with a high risk of protopathic bias and was composed of nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, and antibiotics. Cluster 3 (n = 69) exhibited drugs frequently reported with an unavailable time from drug intake to reaction, in 66 ± 11% of reports, and reported by a high frequency of consumers (9 ± 9%). It corresponded to drugs reported with a high risk of classification bias, and was composed of anticancer therapies and cardiovascular drugs. CONCLUSION: Protopathic and classification biases impact EN-reporting and should be considered regarding associations with antibiotics, NSAIDs, analgesics, anticancer therapies, and cardiovascular drugs.

Trend of antibiotic consumption and its association with influenza-like illnesses in France between 2004 and 2018.

BACKGROUND: Antibiotic consumption has been reported to be driven by the treatment of respiratory tract infections. Our objectives were to describe the trend of antibiotic consumption in France compared with that of other European countries; to describe the evolution of each antibiotic class in France; and to explore the relationship between antibiotic consumption and incidence of influenza-like illnesses. METHODS: In this observational study, antibiotic consumption was reported as defined daily doses per 1000 inhabitants per day in the community and hospital sectors in descriptive and graphical formats, using data from the European Surveillance of Antimicrobial Consumption Network database. The total consumption and the consumption of different classes of antibiotics in France according to time and influenza-like illnesses were studied using multiple linear regression models. RESULTS: The total consumption of antibiotics in France was constant over the 15 years. It was driven by the community sector (92.8%) and was higher than the consumption of other European Union countries (P-value < 0.001). The beta-lactam penicillins were the most consumed antibiotic class and the only class that increased with time. The multiple linear regression models showed a positive correlation between antibiotic consumption in the community sector and incidence of influenza-like illnesses [B = 0.170, 95% CI (0.088-0.252)]. Similar significant results were shown between other antibiotic classes used in the management of influenza-like illnesses (other beta-lactams, and macrolides, lincosamides and streptogramins) and influenza-like illnesses. CONCLUSION: Our results suggest that antibiotics used in the management of respiratory tract infections might be involved in the irrational use of antibiotics.

Trends in analgesic consumption in France over the last 10 years and comparison of patterns across Europe.

AIMS: The aims of the present study were to describe the consumption trends of three groups of analgesics (non-opioids, and mild and strong opioids) between 2006 and 2015 in France, and compare this pattern of use with six European countries in 2015. METHODS: Annual drugs sales were extracted from the French national authority's consumption database, and from the IMS Multinational Integrated Data Analysis System and national databases for European countries. RESULTS: The use of mild opioids in France was found to have decreased by 53% over the past 10 years, owing to the declining use of dextropropoxyphene combinations, along with an increase in the use of non-opioids and strong opioids (from 72 to 93, and 2 to 2.8 defined daily doses/1000 inhabitants/day, respectively). Paracetamol, the most consumed analgesic, increased over this period, particularly for the adult high dose (+140%). The use of tramadol and codeine combinations also increased, by 62% and 42%, respectively. Morphine remained the most used strong opioid, although there were also large increases in the consumption of oxycodone (+613%) and fentanyl (+263% and +72% for transmucosal and transdermal forms, respectively). A comparison of the patterns of use in Europe in 2015 showed a higher consumption of mild and strong opioids in the UK. France ranked first and third place, respectively, for paracetamol and mild opioid consumption, whereas its use of strong opioids was among the lowest. CONCLUSIONS: Paracetamol consumption is clearly highest in France, whereas its use of strong opioids is among the lowest in Europe, although its consumption of oxycodone has increased significantly. Further studies are required specifically to monitor these drugs.

[Supply disruptions and drug shortages: the example of benzathine benzylpenicillin]. / Tensions d'approvisionnement et ruptures de stock des médicaments : l'exemple de la benzathine benzylpénicilline.

Supply disruptions and drug shortages : the example of benzathine benzylpenicillin. Despite collective mobilisation, drug shortages have increased in recent years, creating a strong impact on public health. Anti-infective drugs, mainly injectable antibiotics, are particularly affected by these shortages. Although the causes of these ruptures are multiple, they are mainly related to the effects of globalisation and industrial strategies of rationalisation of production costs. The shortage of benzathine benzylpenicillin illustrates the action of the French Medicines Agency (ANSM), and the various actors to guarantee access to care and limit the consequences for the patient. Beyond measures taken at national level by the regulatory authorities in connection with the pharmaceutical companies, it is necessary to set up a concerted action at European level to fight effectively against drug shortages.

Tensions d'approvisionnement et ruptures de stock des médicaments : l'exemple de la benzathine benzylpénicilline. Malgré une mobilisation collective, les ruptures de stock des médicaments se sont multipliées ces dernières années, créant un fort retentissement en matière de santé publique. Les médicaments anti-infectieux, principalement les antibiotiques injectables, sont particulièrement impactés par ces pénuries. Bien que les causes de ces ruptures soient multiples, elles sont principalement liées aux effets de la mondialisation et des stratégies industrielles de rationalisation des coûts de production. La rupture de la benzathine benzylpénicilline illustre l'action de l'Agence nationale de sécurité du médicament et des produits de santé et des différents acteurs pour garantir l'accès aux soins et limiter les conséquences pour le patient. Au-delà des mesures prises au plan national par les autorités sanitaires en lien avec les laboratoires pharmaceutiques, il est nécessaire de mettre en place une action concertée au niveau européen pour lutter efficacement contre les pénuries de médicaments.

A randomized, double-blind, placebo-controlled trial evaluating cysteamine in Huntington's disease.

BACKGROUND: Cysteamine has been demonstrated as potentially effective in numerous animal models of Huntington's disease. METHODS: Ninety-six patients with early-stage Huntington's disease were randomized to 1200 mg delayed-release cysteamine bitartrate or placebo daily for 18 months. The primary end point was the change from baseline in the UHDRS Total Motor Score. A linear mixed-effects model for repeated measures was used to assess treatment effect, expressed as the least-squares mean difference of cysteamine minus placebo, with negative values indicating less deterioration relative to placebo. RESULTS: At 18 months, the treatment effect was not statistically significant - least-squares mean difference, -1.5 ± 1.71 (P = 0.385) - although this did represent less mean deterioration from baseline for the treated group relative to placebo. Treatment with cysteamine was safe and well tolerated. CONCLUSIONS: Efficacy of cysteamine was not demonstrated in this study population of patients with Huntington's disease. Post hoc analyses indicate the need for definitive future studies. © 2017 International Parkinson and Movement Disorder Society.

Urological complications following unstented pediatric renal transplantation.

Urological complications which develop post-renal transplantation can be associated with significant morbidity especially in children. We evaluated the occurrence and management of all urological complications in a series of unstented pediatric renal transplants in a tertiary pediatric hospital. We reviewed the medical records of children who underwent unstented renal transplant between January 1996 and December 2014. Postoperative urological complications and the outcomes of their management were analyzed. A total of 160 unstented renal transplants were performed, and 32 urological complications were noted in 29 transplants (18%). There were 20 boys and nine girls with an age range of 2.5 years to 18.4 years. Nine (31%) of these patients had LUTD. The most common complication was VUR occurring in 17 patients (10.6%). Urine leaks occurred in six patients (3.8%) and ureteric obstruction in six patients (3.8%), and three patients (1.9%) had unexplained hydronephrosis. Loss of graft occurred in three patients (1.9%), and one patient died from sepsis post-uretero-ureterostomy. Patients with LUTD had more urological complications (P = .037). Unstenting is feasible in most pediatric renal transplants. LUTD is associated with a higher incidence of urological complications, especially VUR.

Circumcision-related tragedies seen in children at the Komfo Anokye Teaching Hospital, Kumasi, Ghana.

BACKGROUND: Circumcision is a common minor surgical procedure and it is performed to a varying extent across countries and religions. Despite being a minor surgical procedure, major complications may result from it. In Ghana, although commonly practiced, circumcision-related injuries have not been well documented. This study is to describe the scope of circumcision-related injuries seen at the Komfo Anokye Teaching Hospital in Kumasi, Ghana. METHODS: The study was conducted at the Urology Unit of the Komfo Anokye Teaching Hospital in Kumasi. Consecutive cases of circumcision-related injuries seen at the unit over an 18 month period were identified and included in the study. Data was collected using a structured questionnaire. Data was entered and analysed using SPSS version 16. Charts and tables were generated using Microsoft Excel. RESULTS: A total of 72 cases of circumcision-related injuries were recorded during the 18 month period. Urethrocutaneous fistula was the commonest injury recorded, accounting for 77.8 % of cases. Other injuries recorded were glans amputations (6.9 %); iatrogenic hypospadias (5.6 %), and epidermal inclusion cysts (2.8 %). The majority of children were circumcised in health facilities (75 %) and nurses were the leading providers (77.8 %). The majority of circumcisions were conducted in the neonatal period (94.7 %). CONCLUSION: Circumcision-related injuries commonly occurred in the neonatal period. Most of the injuries happened in health facilities. The most common injury recorded was urethrocutaneous fistula but the most tragic was penile amputation. There is the need for education and training of providers to minimise circumcision-related injuries in Ghana.

Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes.

The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload.

Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.

AIMS: The aim was to evaluate the comprehension of participants of an improved informed consent document (ICD). METHOD: This was a randomized controlled French multicentre study performed in real conditions. Participants were adult patients undergoing screening for enrolment in biomedical research studies, who agreed to answer a validated questionnaire evaluating objective and subjective comprehension scored from 0 (no comprehension) to 100 (excellent comprehension). Patients were provided either the original ICD or an ICD modified in terms of structure and readability. The primary end point was the score of objective comprehension. The secondary end-points were the enrolment rate in the clinical study and patient characteristics associated with the score of objective comprehension. RESULTS: Four hundred and eighty-one patients were included, 241 patients in the original ICD group and 240 patients in the modified ICD group. There was no difference between the two groups for the score of objective comprehension (original ICD 72.7 (95% CI 71.3, 74.1) vs. modified ICD 72.5 (95% CI 71.0, 74.0); P = 0.81). However, the rate of enrolment in the clinical study was lower in the group who received the modified ICD (64.4% (95% CI 58.3, 70.5)) than for the original ICD (73.0% (95% CI 67.4, 78.7)) (P = 0.042). Only female gender and high educational level were associated with a better objective comprehension. CONCLUSIONS: Improving ICDs had no effect on participants' understanding, whereas the rate of enrolment was lower in this group. In attempts at improving potential participants' understanding of clinical research information, efforts and future trials should focus on other ways to improve comprehension.

The unified Huntington's Disease Rating Scale for advanced patients: validation and follow-up study.

The Unified Huntington's Disease Rating Scale (UHDRS) adequately measures decline in patients at early and moderate stages of Huntington's disease (HD). In patients with advanced HD, floor effects hamper the evaluation, thus calling for an adjusted scale. We designed the UHDRS-For Advanced Patients (UHDRS-FAP) to improve longitudinal assessment of patients at the advanced disease stage. Sixty-nine patients with a Total Functional Capacity score ≤ 5 were recruited in France and the Netherlands. Among them, 45 patients were followed longitudinally (mean ± standard deviation, 1.6 ± 1.2 years) with the UHDRS-FAP; 30 patients also were assessed with the UHDRS. In cross-sectional analyses, the psychometric properties and inter-rater reliability of the scale were evaluated. Longitudinal analyses were used to evaluate the sensitivity to decline of the UHDRS-FAP compared with the UHDRS. Internal consistency was higher for motor (0.84) and cognitive (0.91) scores than for somatic (0.70) and behavioral (0.49) scores. Inter-rater reliability was ≥ 0.88 for all scores. The somatic score, which was specific to the UHDRS-FAP, declined over time along with motor and cognitive performance on both scales. Although performance with the two scales was correlated, the UHDRS-FAP appeared to be more sensitive to change and was the only scale that detected decline in patients with a Total Functional Capacity score ≤ 1. Neither scale detected a significant decline in behavioral scores. The results indicate that the UHDRS-FAP is reliable and more sensitive to change than the original UHDRS for cognitive and motor domains. It offers items that are relevant for daily care. Behavioral scores tended to decline, but this may reflect the decline in patients' communicative abilities.

Unified Huntington's disease rating scale for advanced patients: validation and follow-up study.

The Unified Huntington's Disease Rating Scale (UHDRS) adequately measures decline in patients at early and moderate stages of Huntington's disease (HD). In advanced patients, floor effects hamper the evaluation, thus calling for an adjusted scale. We designed the UHDRS-For Advanced Patients (UHDRS-FAP), in order to improve longitudinal assessment of patients at advanced disease stage. Sixty-nine patients with a Total Functional Capacity (TFC) ≤ 5 were recruited in France and in the Netherlands. Among them, 45 patients were followed longitudinally (mean 1.6 ± 1.2 years) with the UHDRS-FAP; 30 were also assessed with the UHDRS. Cross-sectional analyses evaluated psychometric properties and interrater reliability of the scale. Longitudinal analyses evaluated the sensitivity to decline compared to the UHDRS. Internal consistency was higher for motor and cognitive scores than for somatic and behavioral scores (0.84, 0.91, 0.70, and 0.49, respectively). Interrater reliability was ≥ 0.88 in all scores. The somatic score, specific to the UHDRS-FAP, declined over time, as well as motor and cognitive performance with both scales. Although performance with the 2 scales correlated, the UHDRS-FAP appeared more sensitive to change and was the only scale that detected decline in patients with a TFC ≤ 1. Neither scale detected a significant decline in behavioral scores. The UHDRS-FAP is reliable and more sensitive to change than the original UHDRS for cognitive and motor domains. It offers items relevant for daily care. Behavioral scores tended to decline but this may reflect the decline in the communicative abilities of the patients.

Relationship between recommended chronic heart failure treatments and mortality over 8 years in real-world conditions: a pharmacoepidemiological study.

PURPOSE: We previously reported that chronic heart failure (CHF) treatments reduce the duration of hospitalisation, even in elderly patients. The present study aimed to determine whether CHF treatment also provides long-term benefits in terms of reduced mortality at 8 years. METHODS: A cohort of 281 patients who were admitted to a French teaching hospital with a main diagnosis of CHF were followed through the health insurance databases for 1 year and through the national mortality database for 8 years. RESULTS: Diuretics (236 patients, 84 %) and angiotensin-converting enzyme (ACE) inhibitors (193 patients, 69 %) were the most-frequently prescribed medications. The median duration of survival was 46 months. Mortality rates were significantly lower for patients administered beta-blockers (59 %) and statins (56 %) than for patients not exposed to these drugs (82 %, p < 0.001 and 78 %, p = 0.001 respectively). No significant differences in mortality were observed for spironolactone, diuretics or ACE inhibitors. After adjustment, beta-blocker treatment remained associated with a significantly lower risk of mortality (hazard ratio, HR = 0.54 [0.34-0.84]). After adjustment, the use of two or three CHF drugs was associated with longer survival (HR = 0.53 [0.36-0.77]) than the use of zero or one CHF drug. Statins were also associated with longer survival after adjustment (HR = 0.53 [0.31-0.89]). In patients 75 years of age or older (n = 73), only beta-blocker treatment was associated with a significantly lower risk of mortality (HR = 0.31 [0.16-0.63]) in multivariate analysis. CONCLUSIONS: The use of beta-blockers was associated with better survival rates. The use of statins was also associated with better survival at 8 years. Randomised controlled trials are required to confirm these observations.

Prevalence of medication administration errors in hospitalized adults: A systematic review and meta-analysis up to 2017 to explore sources of heterogeneity.

Previous estimates to meta-analyze administration error rates were limited by the high statistical heterogeneity, restricting their use. This study aimed to investigate sources of heterogeneity in pooled administration error rates in hospitalized adults. We systematically searched scientific databases up to November 2017 for studies presenting error rates/relevant numerical data in hospitalized adults. We conducted separate meta-analyses for the numerators: One Medication Error (OME) (each dose can be correct or incorrect) and Total Number of Errors (TNE) (more than one error per dose could be counted), using the generic inverse variance with a 95% confidence interval. Heterogeneity was assessed using the I2 and Cochran's Q test. We meta-analyzed 33 studies. The global pooled analyses based on the OME and TNE numerators showed very high heterogeneity (I2  = 100%; p < 0.00001). For each meta-analysis, subgroup analyses based on study characteristics (countries, wards, population, routes of administration, error detection methods, and medications) yielded results with consistently elevated heterogeneity. Beyond these characteristics, we stratified the studies according to the mean error prevalence level as the threshold. Based on the OME numerator, we identified two subgroups of low (0.15[0.13-0.17]; I2  = 0%; p = 0.43) and high (0.26[0.24-0.27]; I2  = 38%; p = 0.17) pooled prevalence rates, with controlled heterogeneity. Similarly, for the TNE numerator, we identified two subgroups of low (0.10[0.09-0.10]; I2  = 0%; p = 0.76) and high (0.28[0.27-0.29]; I2  = 0%; p = 0.89) pooled prevalence rates, with controlled heterogeneity. These subgroups differed regarding the denominators used: Total opportunities for errors versus others (doses, observations, administrations). Calculation methods, specifically the denominator, seem a primary factor in explaining heterogeneity in error rates. Standardizing numerators, denominators, and definitions is necessary.

Estimation of the influenza-associated respiratory hospitalization burden using sentinel surveillance data, Lebanon, 2015-2020.

Introduction: Influenza epidemics cause around 3 to 5 million cases of severe illness worldwide every year. Estimates are needed for a better understanding of the burden of disease especially in low- and middle-income countries. The objective of this study is to estimate the number and rate of influenza-associated respiratory hospitalizations in Lebanon during five influenza seasons (2015-2016 to 2019-2020) by age and province of residence in addition to estimating the influenza burden by level of severity. Methods: The severe acute respiratory infection sentinel surveillance system was used to compute influenza positivity from the influenza laboratory confirmed cases. The total of respiratory hospitalizations under the influenza and pneumonia diagnosis was retrieved from the Ministry of Public Health hospital billing database. Age-specific and province-specific frequencies and rates were estimated for each season. Rates per 100 000 population were calculated with 95% confidence levels. Results: The estimated seasonal average of influenza-associated hospital admission was 2866 for a rate of 48.1 (95% CI: 46.4-49.9) per 100 000. As for the distribution by age group, the highest rates were seen in the two age groups ≥65 years and 0-4 years whereas the lowest rate was for the age group 15-49 years. For the distribution by province of residence, the highest influenza-associated hospitalization rates were reported from the Bekaa-Baalback/Hermel provinces. Conclusion: This study shows the substantial burden of influenza in Lebanon mainly on high-risk groups (≥65 years and <5 years). It is crucial to translate these findings into policies and practices to reduce the burden and estimate the illness-related expenditure and indirect costs.

Clinical Trial Authorisation: A Final Look Back to Better Appraise the New European Regulation.

The implementation of the new European Clinical Trial Regulation on 31 January 2022, is a major step to promote clinical research in Europe. The French National Agency for Medicines and Health Products Safety (ANSM) proposes to share some key aspects of the preparation for the application of the Regulation initiated in 2017 and to discuss shared indicators that should be considered to monitor clinical trials opportunities on a territory with regards to access to innovation for patients and attractiveness for sponsors. New criteria based on the time from the first request for authorisation to the first inclusion could be of particular interest to appraise the implementation of the European Clinical Trial Regulation.

Regulatory assessment of nano-enabled health products in public health interest. Position of the scientific advisory board of the French National Agency for the Safety of Medicines and Health Products.

Nanomaterials are present in a wide variety of health products, drugs and medical devices and their use is constantly increasing, varying in terms of diversity and quantity. The topic is vast because it covers nanodrugs, but also excipients (that includes varying proportions of NMs) and medical devices (with intended or not-intended (by-products of wear) nanoparticles). Although researchers in the field of nanomedicines in clinical research and industry push for clearer definitions and relevant regulations, the endeavor is challenging due to the enormous diversity of NMs in use and their specific properties. In addition, regulatory hurdles and discrepancies are often cited as obstacles to the clinical development of these innovative products. The scientific council of the Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM) undertook a multidisciplinary analysis encompassing fundamental, environmental and societal dimensions with the aim of identifying topics of interest for regulatory assessment and surveillance. This analysis allowed for proposing some recommendations for approximation and harmonization of international regulatory practices for the assessment of the risk/benefit balance of these products, considering as well the public expectations as regards efficacy and safety of nanomaterials used in Health products, in terms of human and environmental health.

Prevention and management of health products shortages by the French national agency (ANSM), 10 years of experience.

Shortages of drugs and medical devices have tended to increase in France and worldwide, with consequences for patients and healthcare professionals. Preventing shortages of health products has become a priority for regulatory authorities, including the French National Agency for Medicines and Health Products Safety (ANSM). To highlight perspectives for a better prevention, we described and analyzed the management of shortages in the availability of health products in France over the last 10 years. The supply chain was mapped to identify the main causes of shortages and stakeholders involved in managing shortages throughout the supply chain. National and European initiatives and regulatory measures were reviewed. A retrospective nationwide data analysis from the French reporting system of health product shortage reports was conducted over 10 years for drugs (2013-2022) and over an 18-month period for medical devices, from 1st March 2022 to 31st August 2023. An increase in drug shortage reports was observed, rising from 404 in 2013 to 3,761 in 2022 for drugs, with a relatively constant distribution of affected therapeutic classes. In 2022, the main reported causes of drug shortage risk were insufficient production capacity (27.1%), increased sales volume (21.5%), or lack of supply (13.6%). Over half of the reports on medical devices (55.4%) were objectified as indispensable, and their causes were mainly due to a lack of supply (48.2%), discontinuation of marketing (14.9%), increased sales volume (13.2%), and regulatory reasons (9.6%). ANSM and French authorities have engaged a public health policy for prevention and management of health product shortages including financial penalties, minimum safety stocks for Major Therapeutic Interest drugs, and a shortage management plan. Based on 10 years of experience, four priority measures have been identified to anticipate the risk of heath products shortages based: the importance of a national coordination from raw materials to local market, the implementation of new prevention and management actions in the supply chain, strengthening European cooperation and regulation including the establishment of a list of critical drugs, and promoting transparency and information.

Patterns of Medication Errors Involving Older Adults Reported to the French Medication Error Guichet.

OBJECTIVES: The aims of the study were to describe medication errors (MEs) involving older adults reported to the French Medication Error Guichet and to compare them with MEs in younger adults, in each of the hospital and community settings. METHODS: Retrospective secondary data analysis of MEs reported throughout 2013 to 2017 was performed. Descriptive and multivariate analyses were performed to compare actual and potential ME reports between older adults (aged ≥60 y) and younger adults (aged ≥18, <60 y). RESULTS: We analyzed 4979 reports. In older adults, both in hospital (n = 1329) and community (n = 1264) settings, antithrombotic agents were frequently reported in MEs and were significantly more likely to be associated with reported MEs in older adults compared with younger adults. In hospital setting, antibacterials for systemic use (adjusted odds ratio [aOR] = 1.87, 95% confidence interval [CI] = 1.19-2.93) and antineoplastic agents (aOR = 2.22, 95% CI = 1.34-3.69), whereas in community setting, psycholeptics (aOR = 1.43, 95% CI = 1.04-1.98) and drugs used in diabetes (aOR = 6.01, 95% CI = 3.21-11.2) were more likely to be associated with reported MEs in older adults. In both settings, wrong dose and wrong drug were the most frequently reported error types in older adults; however, wrong technique error type (aOR = 2.06, 95% CI = 1.30-3.28) in hospital setting and wrong patient (aOR = 2.17, 95% CI = 1.30-3.60) in community setting were more likely to be associated with reported MEs in older adults. CONCLUSIONS: We identified specific ME patterns for older adults, including antithrombotic agents in both settings; antibacterials for systemic use, antineoplastic agents, and wrong technique in hospital setting; and psycholeptics, drugs used in diabetes, and wrong patient in community setting. These findings inform future studies investigating population-specific medication safety strategies.