Platform trials.

For the past few years, platform trials have experienced a significant increase, recently amplified by the COVID-19 pandemic. The implementation of a platform trial is particularly useful in certain pathologies, particularly when there is a significant number of drug candidates to be assessed, a rapid evolution of the standard of care or in situations of urgent need for evaluation, during which the pooling of protocols and infrastructure optimizes the number of patients to be enrolled, the costs, and the deadlines for carrying out the investigation. However, the specificity of platform trials raises methodological, ethical, and regulatory issues, which have been the subject of the round table and which are presented in this article. The round table was also an opportunity to discuss the complexity of sponsorship and data management related to the multiplicity of partners, funding, and governance of these trials, and the level of acceptability of their findings by the competent authorities.

Outpatient healthcare and clinical trials in the care pathway: Organisational and regulatory aspects and tools.

Clinical research in outpatient healthcare, particularly in general practice, which is the first line of contact with the population, is now a public health issue. However, this type of research has specific characteristics that differentiate it from clinical research conducted in a hospital setting and requires an adaptation of its conditions of practice: in terms of organisation, the development of research in outpatient healthcare relies on the appropriation of its fundamentals by the investigators, which implies their presentation, upstream, from the initial cycle, and the participation of practitioners in training modules adapted to research in primary care, such as those already organised by several GIRCI (Groupement Inter régional de la Recherche Clinique et de l'Innovation [French Interregional Clusters for Clinical Research and Innovation]). To compensate for the fragmented nature of their location, on the model of the EMRCs (équipes mobiles de recherche clinique [mobile clinical research teams]) in oncology, mobile research teams should enable general medical practices to participate in clinical trials. This presupposes, on the one hand, the allocation of earmarked funding to ensure the sustainability of a base of dedicated personnel and, on the other hand, the impetus of a national dynamic through the setting up of a multi-organisation thematic institute for "research in primary care" associated, at the operational level, with a national scale investigation network supported by a platform of excellence. The use of digital tools and innovations (telemedicine; data collection via connected tools; e-consent; electronic signature) which make it possible to digitise and relocate all or part of the research procedures for both the participant and the investigation teams. An adaptation of the legal framework in order to bring the place of research closer to the patient and not the other way round, which means moving the equipment and investigations closer to the patient. Taking into account the acceptability of the patient, thus limiting the disruption that may be caused by his or her participation in a research protocol and motivating the practitioner by valuing his or her contribution and providing all the guarantees of scientific relevance and independence of practice. In view of the contextual analysis, positive feedback and the availability of organisational and digital support points facilitating the delocalisation and digitisation of the conduct of research activity as close as possible to the patient and his or her doctor, the round table concluded that opportunities exist today which favour the development of clinical research in general practice. It is important to seize this opportunity and make the most of it without delay.

Drug Shortages in Canada and Selected European Countries: A Cross-Sectional, Institution-Level Comparison.

BACKGROUND: Drug shortages represent a complex global problem affecting patients and health care professionals on a daily basis. OBJECTIVES: To identify, describe, and compare drug shortages in health care facilities in Canada and 4 European countries in early 2018. METHODS: A descriptive cross-sectional study was conducted in 1 hospital in each of 5 countries: Canada, France, Belgium, Spain, and Switzerland. Over a 4-week period, shortage data were collected daily by each hospital using a standardized grid and a standard process. RESULTS: From January 8 to February 2, 2018, there were a total of 84 shortages (median duration 32 days) in the Canadian hospital, 62 shortages (median duration 9 days) in the French hospital, 46 shortages (median duration 37 days) in the Belgian hospital, 28 shortages (median duration 25 days) in the Spanish hospital, and 98 shortages (median duration 68 days) in the Swiss hospital. The number of manufacturers implicated in the shortages was 28 for the Canadian hospital, 30 for the French hospital, 19 for the Belgian hospital, 16 for the Spanish hospital, and 42 for the Swiss hospital. Most of the shortages involved parenteral drugs, with both innovative and generic manufacturers being affected. Most therapeutic classes were affected by shortages to some extent, with the top 3 classes being anti-infective agents (accounting for 21.1% of shortages overall), central nervous system drugs (11.3%), and cardiovascular drugs (8.2%). CONCLUSIONS: Drug shortages occurred almost daily in all of the study hospitals. Across the 5 hospitals, the frequency of shortages varied by a factor of 3, which may imply similar variability at the national level. All stakeholders should work more diligently to prevent and manage drug shortages.

CONTEXTE: Les pénuries de médicaments représentent un problème mondial complexe qui touche quotidiennement les patients et les professionnels de la santé. OBJECTIFS: Recenser, décrire et comparer les pénuries de médicaments ayant eu lieu au début de 2018 dans des établissements de soins de santé du Canada et de quatre pays d'Europe. MÉTHODES: Une étude descriptive et transversale a été menée dans un hôpital de chacun des cinq pays suivants: le Canada, la France, la Belgique, l'Espagne et la Suisse. Sur une période de quatre semaines, chaque hôpital a recueilli quotidiennement les données sur les pénuries à l'aide d'une grille et d'un processus normalisés. RÉSULTATS: Pour la période allant du 8 janvier au 2 février 2018, on a recensé 84 pénuries (durée médiane de 32 jours) dans l'hôpital canadien, 62 pénuries (durée médiane de 9 jours) dans l'hôpital français, 46 pénuries (durée médiane de 37 jours) dans l'hôpital belge, 28 pénuries (durée médiane de 25 jours) dans l'hôpital espagnol et 98 pénuries (durée médiane de 68 jours) dans l'hôpital suisse. Vingt-huit (28) fabricants étaient impliqués dans les cas de pénuries dans l'hôpital canadien, 30 dans l'hôpital français, 19 dans l'hôpital belge, 16 dans l'hôpital espagnol et 42 dans l'hôpital suisse. La plupart des pénuries touchaient les médicaments parentéraux et mettaient en cause tant les fabricants de médicaments novateurs que ceux de médicaments génériques. Les pénuries ont affecté d'une manière ou d'une autre la plupart des classes de médicaments, mais les trois classes les plus touchées étaient les agents anti-infectieux (21,1 %) les médicaments agissant sur le système nerveux central (11,3 %) et les agents cardiovasculaires (8,2 %). CONCLUSIONS: Des pénuries survenaient presque quotidiennement dans chaque hôpital de l'étude. Dans l'ensemble des hôpitaux, la fréquence des pénuries variait selon un facteur de trois, ce qui pourrait se traduire par une variabilité semblable à l'échelle nationale. Toutes les parties prenantes doivent travailler avec plus d'ardeur à la prévention et à la gestion des pénuries de médicaments.

How the new European data protection regulation affects clinical research and recommendations?

Clinical research on human subjects or their data is confronted with conflicting requirements with, on one hand, the principle of open science (transparency and data sharing), the possibilities offered by big data and the reuse of healthcare or research data, and on the other, changes to the regulatory and legislative framework, including the general data protection regulation (GDPR). A roundtable was organized in Giens, France in October 2018 to identify problem areas, the need for clarification and streamlining, and to make recommendations to promote clinical research while ensuring a high level of patient protection. After details were given about these developments, the roundtable participants were able to propose recommendations, primarily (1) to clarify: what is considered anonymized data, and what is "public interest" within the meaning of the GDPR; (2) for the French data protection authority (CNIL) to continue preparing reference methodologies to simplify the approval system; (3) to promote the secondary use of data by making it easier to inform patients and obtain broad patient consent, by specifying the circumstances under which their withdrawal and opposition rights apply, so as to limit the risk of bias; (4) to facilitate access to data warehouses by providing technological and methodological aids. The roundtable also recommends increasing discussions between authorities in Europe on research topics, encouraging French authorities to contribute to the preparation of codes of conduct and setting up a voluntary harmonization procedure to coordinate the opinions of data protection authorities, while ensuring that key documents are available in English.

Hospital pharmacy technicians practice and perceptions in France and Quebec, Canada.

OBJECTIVES: To describe practice and perceptions of hospital pharmacy technicians (HPTs) in France and in Quebec, Canada. The secondary objective was to compare both work settings to identify differences. METHODS: Cross-sectional online survey in December 2016 and February 2017. The survey was comprised of four sections: demographic, factors contributing to career choice and satisfaction, perceptions regarding training, skills and recognition and interest in new opportunities. The proportion of responses from respondents in France and Quebec was compared with a chi-squared test. KEY FINDINGS: There were 101 respondents from France and 224 from Quebec. In comparison with Quebec respondents, French respondents came from large hospitals (France: 87%, 84/97 versus Quebec: 50%, 112/223, P < 0.001). Few HPTs supported pharmacists' clinical activities (France: 4%, 4/97 versus Quebec: 29%, 65/222, P < 0.001). A majority of HPTs indicated that working in the healthcare field contributed to their job satisfaction (France: 94%, 87/93 versus Quebec: 90%, 188/209). Respondents found their training sufficient (France: 54%, 49/90 versus Quebec: 78%, 159/205, P < 0.001). However, few identified having access to sufficient continuing education (France: 40%, 36/90 versus Quebec: 29%, 59/205). Not many thought that their job was well recognized in their centre (France: 13%, 12/90 versus Quebec: 13%, 26/203). However, they felt it had a direct impact on the quality of care, especially in Quebec (France: 86%, 77/90 versus Quebec: 98%, 199/203, P < 0.001). The majority was interested in supporting the pharmacists' clinical activities (France: 91%, 78/86 versus Quebec: 82%, 163/199). CONCLUSIONS: Overall, HTP from France and Quebec shared a satisfaction about their profession. They showed an interest in increased recognition and responsibilities (e.g. training, pharmacist support).

Roles and Impacts of the Transplant Pharmacist: A Systematic Review.

BACKGROUND: Pharmacists have been involved in the care of transplant recipients for several decades, and a growing body of literature shows the beneficial effects of clinical pharmacist care on important outcomes for these patients. OBJECTIVES: The primary objective was to describe the roles and impacts of pharmacists in a solid organ transplant setting. The secondary objective was to describe and rate the pharmacists' interventions. DATA SOURCES: Three databases-PubMed, Embase, and Evidence-Based Medicine Reviews-were searched from January 1, 1990, to June 16, 2015. STUDY SELECTION AND DATA EXTRACTION: All studies addressing the roles of pharmacists and the impacts of clinical pharmacy services on the care of solid organ transplant recipients were considered. Only studies providing a statistical analysis were included. Design, setting, sample size, patient characteristics, pharmacists' interventions, study bias, and outcomes were extracted for analysis. DATA SYNTHESIS: Four randomized controlled trials, 4 cohort studies, 3 pre-post studies, and 1 quasi-randomized controlled trial were included in the review, representing a total of 1837 patients. Of the 12 studies included, 8 specifically focused on renal transplant, and 1 each focused on liver, lung, abdominal organ, and general solid organ transplant. The pivotal pharmacist activities leading to the main patient outcomes were medication counselling (n = 8 studies), medication reconciliation (n = 5), and reviewing and optimizing drug therapy (n = 3). Improvements to medication adherence (n = 6 studies), morbidity (n = 4), costs (n = 2), and medication errors (n = 2) were reported. CONCLUSION: Currently available evidence suggests that pharmacists can improve patient outcomes in the solid organ transplant setting. Adherence, morbidity, costs, and medication errors were identified as the main outcomes that were improved by pharmaceutical interventions. Transplant programs need to invest more in this resource.

CONTEXTE: Les pharmaciens participent aux soins des greffés depuis plusieurs décennies et un nombre croissant de publications révèlent les effets bénéfiques des soins prodigués par les pharmaciens cliniciens quant aux résultats thérapeutiques importants pour ces patients. OBJECTIFS: L'objectif principal était de décrire les rôles des pharmaciens et leurs influences par rapport aux greffes d'organes solides. L'objectif secondaire était de décrire et d'évaluer les interventions des pharmaciens. SOURCES DES DONNÉES: Les bases de données PubMed, Embase et Evidence-Based Medicine Reviews ont été interrogées pour la période allant du 1cr janvier 1990 au 16 juin 2015. SÉLECTION DES ÉTUDES ET EXTRACTION DES DONNÉES: Toutes les études abordant les rôles des pharmaciens et l'influence des services de pharmacie clinique sur les soins des receveurs d'organes solides ont été prises en considération. Seules les études présentant des analyses statistiques ont été retenues. Le plan d'étude, le contexte, la taille de l'échantillon, les caractéristiques des patients, les interventions des pharmaciens, les biais et les résultats thérapeutiques ont servi à l'analyse. SYNTHÈSE DES DONNÉES: Quatre études contrôlées à répartition aléatoire, 4 études de cohorte, 3 études avant-après et 1 essai comparatif à répartition quasi-aléatoire ont été retenus pour l'analyse, ce qui représentait au total 1837 patients. Parmi les 12 études retenues, 8 abordaient spécifiquement la greffe rénale et chacune des 4 autres concernait respectivement une greffe hépatique, une greffe pulmonaire, une greffe d'organe abdominal et une greffe d'organe solide. Les activités clés des pharmaciens menant aux principaux résultats thérapeutiques étaient les conseils sur les médicaments (n = 8 études), l'établissement du bilan comparatif des médicaments (n = 5) ainsi que l'examen et l'optimisation de la pharmacothérapie (n = 3). On a constaté des améliorations des taux d'observance pharmacothérapeutique (n = 6 études), des taux de morbidité (n = 4), des coûts (n = 2) et des taux d'erreurs de médicaments (n = 2). CONCLUSION: Les données probantes disponibles laissent croire que les pharmaciens peuvent améliorer les résultats thérapeutiques en ce qui concerne les greffes d'organes solides. Les taux d'observance pharmacothérapeutique, les taux de morbidité, les coûts et les taux d'erreurs de médicaments ont été désignés comme les résultats principaux qui ont été améliorés par les interventions pharmaceutiques. Les programmes de greffe doivent investir davantage dans cette ressource.

Investigating the cost and efficiency of incident reporting in a specialist paediatric NHS hospital and impact on patient safety.

OBJECTIVES: The aim of this study was to investigate the incident reporting process (IR1s), to calculate the costs of reporting incidents in this context and to gain an indication of how economic the process was and whether it could be improved to yield better outcomes. METHODS: A retrospective analysis of a sample, 10.47% (n=150) selected from 1432 medication incident report summaries, generated at Birmingham Children's Hospital, a specialist tertiary referral paediatric centre, during 2014 and collated through the national Datix incident reporting system software was analysed and the associated staff time required to complete each step of the incident reporting process was costed. The staff costs for various grades of staff were averaged across the staff actually involved, using data calculated by the Personal Social Services Research Unit. RESULTS: The analysis showed that the incident reporting process involved 262 staff on 2942 occasions (19.16 staff episodes per incident form completed) at a cost of £337.16 per incident form completed. CONCLUSIONS: The study showed that the incident reporting system was a labour intensive process. The numbers of staff involved in the process particularly as a result of the email distribution activity did appear to have room for efficiencies. However, it proved to be relatively inexpensive from a cost perspective. With redesign, arguably the emphasis could be moved away from the recording process to learning in order to gain improved patient safety outcomes.

[Drugs and pregnancy: A survey of 374 women in France]. / Médicaments et grossesse : une enquête menée auprès de 374 femmes en France.

OBJECTIVES: The objectives of this study were to describe drug use during pregnancy in a context of acute and chronic diseases during pregnancy. An additional aim was to analyze the maternal socio-demographic and lifestyle factors associated with medication use in pregnancy. METHODS: Cross-sectional, web-based descriptive study conducted among French women using a 33-item web-based questionnaire. Multiple logistic regression analyzes were performed to assess the association between socio-demographic/lifestyle factors and medication use in pregnancy. RESULTS: A total of 374 women completed the questionnaire. Of these, 75.1% (n=280) and 12.6% (n=47) used medication for treatment for acute and chronic diseases, respectively. A total of 68.9% (n=258) of women surveyed have deliberately avoided taking non-prescribed drugs when they were pregnant. Non-users of folic acid were less often taking medications (78.9%) than folic acid users (89.5%) OR=0.44 [0.24; 0.79]. CONCLUSION: More than eight out of ten women have taken medication during pregnancy especially analgesics. The maternal socio-demographic and lifestyle factors do not seem to impact on the use of medication during pregnancy.

Change management in pharmacy: a simulation game and pharmacy leaders' rating of 35 barriers to change.

OBJECTIVES: The primary objective was to rank barriers to change in pharmacy practice. Our secondary objective was to create a simulation game to stimulate reflection and discussion on the topic of change management. METHODS: The game was created by the authors and used during a symposium attended by 43 hospital pharmacy leaders from all regions of Canada (Millcroft Conference, Alton, Ontario, June 2013). The main theme of the conference was 'managing change'. KEY FINDINGS: The simulation game, the rating of 35 barriers to change and the discussion that followed provided an opportunity for hospital pharmacy leaders to reflect on potential barriers to change, and how change might be facilitated through the use of an organized approach to change, such as that described in Kotter's eight-step model. CONCLUSIONS: This simulation game, and the associated rating of barriers to change, provided an opportunity for a group of hospital pharmacy leaders in Canada to reflect on the challenges associated with managing change in the healthcare setting. This simulation game can be modified and used by pharmacy practitioners in other countries to help identify and rank barriers to change in their particular pharmacy practice setting.

Accidents and Incidents Related to Intravenous Drug Administration: A Pre-Post Study Following Implementation of Smart Pumps in a Teaching Hospital.

INTRODUCTION: Smart pumps are expected to prevent and reduce medication errors. The implementation of smart pumps requires a significant effort and collaboration of physicians, nurses, pharmacists, and other stakeholders. OBJECTIVES: The main objective of this study was to evaluate the impact of new smart pumps on reported drug-related accidents and incidents (AIs). METHOD: This is a descriptive retrospective pre-post study conducted at a women's and pediatric hospital with 500 beds. A strong multidisciplinary team (nurse, pharmacist, pharmacy resident, physician, biomedical technician, information technology technician, patient safety officer, manager) was involved in the planning, implementation, and monitoring technology implementation. A total of 1045 smart pumps were implemented in 2011 in our hospital. The reported number of AIs related to intravenous drug administration (AIIV) before and after the implementation of 1045 smart pumps were collected. RESULTS: A total of 2911 AI events related to medications, devices, and equipment were self-reported by clinical staff in the pre-phase (Y0), 3523 in the post-phase (Y1), and 2788 in the post-phase (Y2). The total AIIV increased from 1432 in Y0 to 1834 in Y1 and decreased to 1389 in Y2. CONCLUSIONS: We observed no risk reduction associated with the implementation of smart pumps in a 500 bed mother-child hospital. Further studies are required to explore the details of the potential risk reduction associated with the use of smart pumps.

Paediatric clinical research from the perspective of hospital pharmacists from France and Canada.

OBJECTIVES: To compare pharmacy support for paediatric research services in France and Canada and to describe the perception of pharmacists and rank the paediatric clinical research issues. METHODS: This was a cross-sectional descriptive study. All paediatric hospitals from Canada and the main hospitals from France were contacted. A survey was conducted from May-September 2012. Descriptive statistics were performed. KEY FINDINGS: Results from 11 paediatric hospitals in Canada (11/12, 92%) and 11 (11/18, 61%) in France were obtained. There was a similar number of ongoing paediatric clinical trials per hospital in France versus Canada (38 (10-81) versus 20 (4-178)). A lower number of pharmacists per hospital was observed in France (17 (11.5-35) versus 45 (18.9-76.8)), but a similar number of pharmacists were assigned to clinical trials (1.5 (1-3) versus 1.9 (0.2-17.4)). Institutional protocols represented the majority of paediatric clinical trials in France (61% (14-100) versus 25% (0-100)). Similar pharmacy support services were offered, but the majority of French respondents also offered help for institutional protocol development (91 versus 50% P = 0.063). The main issues associated with paediatric clinical research were absence of financial interest from the pharmaceutical industry, prohibitive cost versus profit ratio, small patient cohorts and the non-availability of the appropriate drug formulations. CONCLUSIONS: Difficulties related to pharmaceutical compounding were identified as the main hindrance to paediatric clinical research; particular attention should be paid to these details when setting up a paediatric trial.