Evaluating the costs of adverse drug events in hospitalized patients: a systematic review.

BACKGROUND: Adverse drug events (ADEs) are not only a safety and quality of care issue for patients, but also an economic issue with significant costs. Because they often occur during hospital stays, it is necessary to accurately quantify the costs of ADEs. This review aimed to investigate the methods to calculate these costs, and to characterize their nature. METHODS: A systematic literature review was conducted to identify methods used to assess the cost of ADEs on Medline, Web of Science and Google Scholar. Original articles published from 2017 to 2022 in English and French were included. Economic evaluations were included if they concerned inpatients. RESULTS: From 127 studies screened, 20 studies were analyzed. There was a high heterogeneity in nature of costs, methods used, values obtained, and time horizon chosen. A small number of studies considered non-medical (10%), indirect (20%) and opportunity costs (5%). Ten different methods for assessing the cost of ADEs have been reported and nine studies did not explain how they obtained their values. CONCLUSIONS: There is no consensus in the literature on how to assess the costs of ADEs, due to the heterogeneity of contexts and the choice of different economic perspectives. Our study adds a well-deserved overview of the existing literature that can be a solid lead for future studies and method implementation. TRIAL REGISTRATION: PROSPERO registration CRD42023413071.

Clinical impact of pharmaceutical consultations in patients treated for chronic obstructive pulmonary disease: Study protocol for a randomized controlled trial (BPCObs study).

Background: Chronic obstructive pulmonary disease (COPD) is an irreversible chronic respiratory disease which outcome depends on medication adherence. Pharmacists may increase this adherence by advising patients on inhaler devices proper use. This paper presents the protocol for a randomized controlled trial, which assesses impact of pharmaceutical consultations on COPD exacerbations, medical care, adherence to inhaler devices and quality of life. Methods: This trial will include 226 COPD patients treated with inhaler devices: 94 in a control group, 66 receiving a pharmaceutical consultation at hospital and 66 receiving up to 12 pharmaceutical consultations corresponding to dispensing at their community pharmacy. The aim of these interventions is to inform patients about COPD medication, train them in the use of inhaler devices and improve adherence. Patients included by hospital pharmacist will be randomly assigned to the control and hospital experimental groups. Community pharmacists (CP) will include patients in the experimental community group. CPs will follow-up all study patients for 12 months. Primary outcome is the mean number of COPD exacerbations. Secondary outcomes include number of medical consultations, emergency visits and hospitalizations, patients' adherence devices and quality of life. Discussion: This is the first French trial which assesses both hospital and community pharmaceutical interventions on COPD patients. Study limitations include recruitment and CP adherence to follow-up. Indeed, the success of this trial depends on the willingness of CPs to collect the data. This work is the first step towards building a network of CPs trained for clinical research. Trial registration: Clinicaltrials.gov, NCT03704545. Registered on October 12th, 2018. https://clinicaltrials.gov/ct2/show/NCT03704545?cond=COPD&cntry=FR&city=nimes&draw=2&rank=1.

How a hospital pharmacist can contribute to a more sustainable operating theater.

Healthcare sectors, particularly operating theaters, are major consumers of resources. Given today's climate-related issues, its seems vital that the different healthcare professionals in operating areas become aware of their roles. This is pronouncedly the case for hospital pharmacists, who fulfill cross-sectional functions in the proper use and management of healthcare products and sterile medical devices. The objective of this review of the literature is to identify the actions a hospital pharmacist can take to impel evolution toward ecologically responsible care in the operating theater. Seven areas in which a pharmacist can assume a leading, supporting or composite role in rendering an operating theater ecologically responsible have been highlighted: purchasing, procurement and storage, harmonization of practices, modification of practices, professional attire, waste elimination and research/teaching. The active participation of all healthcare professionals, including the hospital pharmacist, is essential to the development of a sustainable approach to healthcare.

Usefulness of dynamic regression time series models for studying the relationship between antimicrobial consumption and bacterial antimicrobial resistance in hospitals: a systematic review.

BACKGROUNG: Antimicrobial resistance (AMR) is on the rise worldwide. Tools such as dynamic regression (DR) models can correlate antimicrobial consumption (AMC) with AMR and predict future trends to help implement antimicrobial stewardship programs (ASPs). MAIN BODY: We carried out a systematic review of the literature up to 2023/05/31, searching in PubMed, ScienceDirect and Web of Science. We screened 641 articles and finally included 28 studies using a DR model to study the correlation between AMC and AMR at a hospital scale, published in English or French. Country, bacterial species, type of sampling, antimicrobials, study duration and correlations between AMC and AMR were collected. The use of ß-lactams was correlated with cephalosporin resistance, especially in Pseudomonas aeruginosa and Enterobacterales. Carbapenem consumption was correlated with carbapenem resistance, particularly in Pseudomonas aeruginosa, Klebsiella pneumoniae and Acinetobacter baumannii. Fluoroquinolone use was correlated with fluoroquinolone resistance in Gram-negative bacilli and methicillin resistance in Staphylococcus aureus. Multivariate DR models highlited that AMC explained from 19 to 96% of AMR variation, with a lag time between AMC and AMR variation of 2 to 4 months. Few studies have investigated the predictive capacity of DR models, which appear to be limited. CONCLUSION: Despite their statistical robustness, DR models are not widely used. They confirmed the important role of fluoroquinolones, cephalosporins and carbapenems in the emergence of AMR. However, further studies are needed to assess their predictive capacity and usefulness for ASPs.

Intervention of pharmacist included in multidisciplinary team to reduce adverse drug event: a qualitative systematic review.

BACKGROUND: Preventable harm in healthcare is a growing public health challenge. In addition to the economic costs of safety failures, adverse drug events (ADE) may lead to complication or even death. Multidisciplinary care team involving a pharmacist appears to be an adequate response to prevention of adverse drug event. This qualitative systematic review aims to identify and describe multidisciplinary planned team-based care involving at least one pharmacist to limit or prevent adverse drug events in the adult patients. METHODS: To determine the type of interprofessional collaboration to prevent adverse drug event in which a pharmacist was involved, we conducted a qualitative systematic review of the literature of randomized controlled trials. Two independent reviewers screened trials in three databases: Medline, Web of Science, ScienceDirect. Prospective studies of at least three different health professionals' interventions, one of whom was a pharmacist in the last five years were included. Two reviewers performed data extraction and quality appraisal independently. We used TIDieR checklist to appraise articles quality. RESULTS: In total 803 citations were retrieved, 34 were analysed and 16 full-text articles were reviewed. Only 3 studies published an implementation evaluation. More than half of the interventions (62%) targeted elderly patients including 6 whom lived in nursing homes. Studies outcomes were heterogeneous, and we did not perform a statistical analysis of the impact of these interventions. Most teams are composed of a physician/pharmacist/nurse trio (94%; 100%; 88%). Half of the teams were composed of the primary care physician. Other professionals were included such as physical therapists (25%), social worker (19%), occupational therapists (12%), and community health educator (6%). Multidisciplinary medication review was the most common intervention and was generally structured in four steps: data collection and baseline assessment, appraisal report by health professionals, a multidisciplinary medication review meeting and a patient follow-up. CONCLUSIONS: The most common multidisciplinary intervention to prevent ADE in the adult population is the multidisciplinary drug review meeting at least the physician/pharmacist/nurse trio. Interventions target mostly elderly people in nursing homes, although complex chronic patients could benefit from this type of assessment. TRIAL REGISTRATION: PROSPERO registration: CRD42022334685.

Comparison of the validity, perceived usefulness, and usability of I-MeDeSA and TEMAS, two tools to evaluate alert system usability.

OBJECTIVE: Two tools are currently available in the literature to evaluate the usability of medication alert systems, the instrument for evaluating human factors principles in medication-related decision support alerts (I-MeDeSA) and the tool for evaluating medication alerting systems (TEMAS). This study aimed to compare their convergent validity, perceived usability, usefulness, strengths, and weaknesses, as well as users' preferences. METHOD: To evaluate convergent validity, two experts mapped TEMAS' items against I-MeDeSA's items with respect to the usability dimensions they target. To assess perceived usability, usefulness, strengths, and weaknesses of both tools, staff with expertise in their medication alerting system were asked to use French versions of the TEMAS and I-MeDeSA. After the use of each tool, participants were asked to complete the System Usability Scale (SUS) and answer questions about the understandability and usefulness of each tool. Finally, participants were asked to name their preferred tool. Numeric scores were statistically compared. Free-text responses were analyzed using an inductive approach. RESULTS: Forty-five participants from 10 hospitals took part in the study. In terms of convergent validity, I-MeDeSA focuses more on the usability of the graphical user interface while TEMAS considers a wider range of usability principles. Both tools have a fair level of perceived usability (I-MeDeSA' SUS score = 61.85 and TEMAS' SUS score = 62.87), but results highlight that revisions are necessary to both tools to improve their usability. Participants found TEMAS more useful than I-MeDeSA (t = -3.63, p =.005) and had a clear preference for TEMAS to identify problems in formative evaluation (39 of 45; 0.867, p <.001) and to compare the usability of alert systems during the procurement process (36 of 45; 0.8, p <.001). CONCLUSIONS: The TEMAS is perceived as more useful and is preferred by participants. The I-MeDeSA seems more relevant for quick evaluations that focus on the graphical user interface. The TEMAS seems to be more suitable for in-depth usability evaluations of alert systems. Even if both tools are perceived to be equally usable, they suffer from wording, instructional, and organizational problems that hinder their use. The results of this study will be used to improve the design of I-MeDeSA and TEMAS.

Effect of antimicrobial consumption on Escherichia coli resistance: assessment and forecasting using Dynamic Regression models in a French university hospital (2014-2019).

INTRODUCTION: The aim of this study was to determine the correlation between antimicrobial consumption (AMC) and antimicrobial resistance (AMR) in Escherichia coli at a hospital level, and assess the capacity of dynamic regression (DR) models to predict AMR for their use in deployment of antimicrobial stewardship programs (ASPs). METHODS: A retrospective epidemiological study was conducted in a French tertiary hospital between 2014 and 2019. DR models were used to assess the correlation between AMC and AMR from 2014 to 2018. The predictive abilities of the models were estimated by comparing the predicted data with those observed in 2019. RESULTS: Rates of fluoroquinolone and cephalosporin resistance decreased. AMC increased overall but decreased for fluoroquinolone. DR models highlighted that the decrease in use of fluoroquinolone and the increase in use of anti-pseudomonal activity penicillin with beta-lactamase inhibitor (AAPBI) explained 54% of the decrease in fluoroquinolone resistance and 15% of the decrease in cephalosporin resistance. In addition, penicillin/beta-lactamase inhibitor (PBI) consumption explained 53% of PBI resistance, and beta-lactam use explained 36% of penicillin resistance, with both remaining stable over time. DR models had predictive capabilities with margins of error from 8% to 34%. CONCLUSION: Over a six-year period in a French tertiary hospital, decreasing rates of resistance to fluoroquinolones and cephalosporins were correlated with decreasing use of fluoroquinolone and increasing use of AAPBI, whereas rates of resistance to penicillin remained high and stable. The results indicate that DR models should be used with caution for AMR forecasting and ASP implementation.

Assessment of adherence to at-home oral anti-infective therapy among paediatric patients discharged from a Quebec hospital.

OBJECTIVES: Non-adherence to anti-infective therapy contributes to treatment failure and the emergence of bacterial resistance. This study aimed to assess at-home adherence, by paediatric patients, to oral anti-infective (OAI) therapy prescribed for treatment of acute infections and to explore the factors contributing to non-adherence. METHODS: This prospective descriptive study involved French-speaking patients under 16 years of age who were discharged with one or more OAIs prescribed for home administration for a maximum of 30 days. Telephone surveys were used to assess overall adherence, which consisted of primary adherence (patient's ability to procure the medication) and secondary adherence (patient's ability to take the treatment as prescribed). RESULTS: Overall, 51.7% (30/58) of patients were adherent to OAI therapy, with 100% primary adherence (n=69/69) and 51.7% secondary adherence (n=30/58). On average, patients took 98% of the total number of doses prescribed, and non-adherence was related mostly to not following medication administration schedules (63.3% of patients followed the exact schedule). Indeed, the adherence rate for patients taking one or two doses per day was twice the rate for patients taking more than two doses per day (81.8% vs 44.7%, p=0.043). CONCLUSIONS: Half of the paediatric patients treated for acute infections were non-adherent to OAI therapy at home. Interventions are needed to improve this situation.

Pharmaceutical Analysis of Peripherally Inserted Central Catheter Requests Increases the Use of Single-Lumen Catheters: A Prospective Pilot Study.

OBJECTIVES: Several studies have suggested a strong relationship between the number of peripherally inserted central catheter (PICC) lumens and the risk of complications. The purpose of this study is to evaluate the impact of the intervention of a clinical pharmacist (CP) on the number of lumens of PICC inserted and assess PICC-related complications. METHOD: This prospective monocentric study included all consecutive patients from 5 different units who underwent PICC insertions from September 2017 to March 2018. In the intervention group, the CP validated the pertinence of each PICC request according to the patients' records, choice of device (single or double lumen), and incompatibilities between treatments. The control group consisted of patients who underwent PICC insertions without a CP intervention. Complications were prospectively recorded up to PICC removal. Multivariate analyses adjusted for sex, age, and PICC line duration were performed. RESULTS: In the intervention group, 207 PICCs were inserted, 81.2% (n = 168) were single-lumen devices and 18.8% (n = 39) were double-lumen devices. In the control group (n = 77), the use of single-lumen PICCs was significantly lower (n = 48, 62.3%; P = 0.002). After intervention, the overall complication incidence rate decreased from 4.42 to 3.23 per 1000 catheter days ( P = 0.082). Considering the overall population, 216 single-lumen PICCs were inserted with significantly fewer complications than double-lumens (respectively n = 16, 16/216 = 7.4%, versus n = 15, 15/68 = 22.1%, P = 0.002). The adjusted odds ratio of double-lumen PICC was 3.83 (95% confidence interval, 1.46-10.07; P = 0.007). CONCLUSIONS: Our study showed the intervention of a CP in the PICC insertion process could increase the use of single-lumen PICCs and tended to reduce associated complications.

What Is the Medication Iatrogenic Risk in Elderly Outpatients for Chronic Pain?

PURPOSE: Medication iatrogeny is a major public health problem that increases as the population ages. Therapeutic escalation to control pain and associated disorders could increase polypharmacy and iatrogeny. This study aimed to characterize the medication iatrogenic risk of elderly outpatients with chronic pain. METHODS: This was a prospective cohort study recruiting patients 65 years or older with chronic pain. A medication iatrogenic assessment was performed based on the best possible medication history to record risk of adverse drug events (Trivalle score), STOPP (Screening Tool of Older Person's Prescriptions)/START (Screening Tool to Alert doctors to Right Treatment) criteria, and potentially inappropriate medications. RESULTS: We recruited 100 patients with an average age of 71 years. The median number of medications before pain consultation was 8 (interquartile range = [7;11]). Trivalle score showed that 43% of patients were at moderate or high medication iatrogenic risk. Before consultation, 79% and 75% of patients had at least 1 STOPP or START criterion on their orders, respectively. One-third of orders mentioned benzodiazepine prescribed for more than 4 weeks. At least 1 potentially inappropriate medication was prescribed for 54% of the patients, with a median of 1 per patient (interquartile range = [0;1]). A combination of several anticholinergics was prescribed in 23% of patients. CONCLUSION: Elderly patients with chronic pain are at risk of medication iatrogeny. Preventive measures as multidisciplinary medication review could reduce the iatrogenic risk in these outpatients.This study is registered at clinicaltrials.gov as NCT04006444 on July 3, 2019.

Impact of a pharmacist and geriatrician medication review on drug-related problems in older outpatients with cancer.

OBJECTIVES: Older patients with cancer have increased risk for comorbidity, polypharmacy (PP) and drug related problems (DRP). The aim of this study was to assess the effect of a clinical pharmacist and geriatrician medication review (MR) among older outpatients with cancer to optimize management of comorbidities during comprehensive geriatric assessment (CGA). MATERIAL AND METHODS: We conducted a single-center prospective study among older outpatients with cancer (≥75 years). A pharmacist consultation was added into CGA process. The clinical pharmacist detected and assessed PP and DRP such as potentially inappropriate medications (PIM) according to the Laroche French list and STOPP criteria, START criteria and adverse drug events (ADE) risk. After a multidisciplinary MR, the proposals for prescription modification were sent to general practitioners (GPs). RESULTS: Fifty-one consenting patients were recruited between May 2016 and March 2017, with a median age of 83 years. Prevalence of PP was 80.4%. 165 DRP were detected among 86% patients (median number of DRP = 3.0): 19.4% were misuse, 43.6% underuse, and 37.0% overuse. A significant decrease was observed in prevalence of PIM use (Laroche: 31.4% versus 5.9%, p = 0.002), START criteria (66.7% to 5.9%; P < 0.001) and ADE score (4.0 before MR versus 2.0 after, p = 0.023). A trend was observed for a lower number of medications (10.0 versus 8.0, p = 0.092) and on STOPP criteria prevalence (56.9% versus 31.4%, p = 0.12). CONCLUSION: A clinical pharmacist and a geriatrician MR is effective to detect and reduce DRP in older outpatients with cancer.

Health economic evaluation of a clinical pharmacist's intervention on the appropriate use of devices and cost savings: A pilot study.

BACKGROUND: Good management of disposable and reusable supplies may improve surgical efficiency in the operating room (OR) and also corresponds to the best eco-responsible approach. The purpose of this study was to assess the impact of a clinical pharmacist's intervention in the OR on the non-compliant use of medical devices. We also assessed the economic impact of the pharmaceutical intervention. MATERIALS AND METHODS: We conducted a monocentric prospective study in the OR of a University hospital over one year. Three surgical specialties: urologic, digestive and gynecologic were audited after a preparatory phase to optimize usage of medical devices used for surgeries. The supply costs concerning the three specialties were compared before and after the pharmacist intervention. RESULTS: One hundred and fifty surgical procedures were audited in digestive (33.3%, n = 50), gynecologic (32%, n = 48) and urologic (34.7%, n = 52) surgeries. With the pharmacist in OR, 51 procedures (34% CI95%[26.4%; 41.6%]) with a non-compliance concerning at least one medical device were found compared to the 50% rate without the pharmacist reported previously (P < .0001). Eighteen percent of surgical procedures had at least one circulator retrieval for the reason "incomplete case cart despite device listed on the case cart list" versus 29.1% before pharmacist intervention (P = .0028). A €33 014 saving associated with the presence of the pharmacist in OR was observed. CONCLUSIONS: This prospective interventional study showed that the intervention of a pharmacist specialized in the medical device field could significantly reduce non-compliances in medical device use and reduce costs in OR.

Impact of a preoperative pharmaceutical consultation in scheduled orthopedic surgery on admission: a prospective observational study.

BACKGROUND: Medication errors have a high prevalence in surgery and management of home medication is strongly involved in these errors. In scheduled surgery, the preoperative consultation is a privileged time to inform the patient about the management of her/his home medication before admission. This study assessed the impact of a pre-anesthesia best possible medication history (PA-BPMH) on admission. The PA-BPMH was performed by a clinical pharmacist prior to the anesthesia consultation for anesthesiologists to prescribe admission medical orders for scheduled orthopedic surgery patients. METHODS: This was a prospective observational study which was carried out in an orthopedic surgery department. All patients over 18 years old with an elective orthopedic surgery were eligible except ambulatory surgery patients. The pharmacist registered the PA-BPMH into the software making it available for anesthesiologists for the pre-admission medication order. Finally, a medication reconciliation was performed at admission. The main outcome was the percentage of patients with at least one unintended medication discrepancy (UMD) at admission. The nature, potential clinical impact and acceptance rate of each UMD detected were assessed. Also, the PA-BPMH process was described and patients and anesthesiologists satisfaction was evaluated. RESULTS: A total of 455 patients had a pharmaceutical consultation. Medication reconciliation was performed at admission for 360 patients. Overall, at least one UMD was observed in 13.0% of patients (n = 47). A total of 63 UMD were detected. The most common type of UMD was omission (25.4%) and incorrect drug (23.8%).Two UMD (3.2%) were evaluated as life threatening. All the UMD detected were corrected on the admission medication order. CONCLUSION: A preoperative pharmacist-anesthesiologist teamwork seems to improve the safety of perioperative management of home medication for scheduled orthopedic surgery patients. This process needs a randomized clinical trial across a wider range of surgeries before its implementation.

Assessment of anti-infective medication adherence in pediatric outpatients.

The objective of this pilot study was to assess the overall adherence rate of the pediatric population to anti-infective drugs prescribed for acute infection at hospital discharge and to identify risk factors for non-adherence behavior. Pediatric patients discharged from a French university hospital with at least one oral drug prescription for acute infection were included for 3 months. Medication adherence and antibiotic knowledge were assessed through data collected by calling the parents. Overall adherence was assessed according to seven items: medication order filling, administered dose, time of intake, frequency of doses, medication omission, dose modification, and length of treatment. Seventy-five patients were included, and 63 interviews were exploited. The median age was 1.4 years, IQR = [0.7; 3.3]. Overall adherence to anti-infective agents concerned 34.9% of patients. The most frequently prescribed antibiotics were amoxicillin (29.3%), amoxicillin associated with clavulanic acid (25.3%), cotrimoxazole (18.7%), and cefixime (12.0%). A lack of parents' anti-infective knowledge was associated with non-adherence to anti-infective drugs.Conclusion: Two-thirds of outpatients were non-adherent to anti-infectives in acute infectious diseases. The misunderstanding of anti-infective treatment could be a risk factor for non-adherence. Implementation of preventive actions such as therapeutic education or pharmaceutical counseling at hospital discharge could improve adherence to anti-infective agents. What Is Known: • Non-adherence to anti-infective drugs involves the emergence and spread of antibiotic resistance. • Very few studies have assessed medication adherence in acute infectious diseases in pediatrics after hospital discharge. What Is New: • Only 35% of children were overall adherent to anti-infective drugs in acute infectious disease after hospital discharge. • Most patients (89%) had a good primary adherence but very few (40%) had good secondary adherence mainly due to dose omission and dose modification.

Impact of pharmacist-led multidisciplinary medication review on the safety and medication cost of the elderly people living in a nursing home: a before-after study.

Objectives: Adverse drug events (ADE) are a common cause of morbidity and mortality in elderly patients. In this study, we assessed the impact of multidisciplinary medication review (MMR) for nursing home residents on patient safety and costs incurred by the hospital and the national health service. Methods: Medical files of residents were retrospectively assessed for medications prescribed in the previous six months. A pharmacist reviewed the prescriptions and suggested modifications to the patient's medical team. Patients were followed for six months. Trivalle's ADE geriatric risk score was calculated before and after MMR, as were number of potentially inappropriate medications, and economic impact from the perspective of the health care system and the nursing home. Results: Forty-nine patients were recruited. ADE score dropped one risk level (median score of 4 before versus 1 after, p < 0.0001). The number of patients taking at least one potentially inappropriate medication decreased from 30.6% before to 6.1% after MMR (p = 0.005). A mean saving of €232 per patient was made from the nursing home perspective following MMR (p = 0.008). Conclusion: The MMR reduced the iatrogenic drug risk for elderly residents and costs from the nursing home perspective, particularly drug expenditure.

[Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Final validation]. / Élaboration d'un guide standardisé d'informations d'optimisation de l'adhésion médicamenteuse à dispenser lors d'une consultation pharmaceutique au patient atteint de myélome multiple : validation finale.

An initial validation of a standardized pharmaceutical counselling guide was carried out in a previous study to improve medication adherence in patients treated for multiple myeloma with oral anticancer therapies. The main objective of this work was the final validation of this guide with 10 naive patients. The main secondary objectives were to assess for the patient the evolution of knowledge about the treatment, understanding of the purpose of the pharmaceutical counselling, adherence to the tools. Each patient completed a self-administered questionnaire: before and after the first pharmaceutical counselling. The primary endpoint was the average success rate per question after the pharmaceutical counselling (a value of ≥ 90% validated knowledge acquisition). Secondary judgement criteria were: change in average success rates per patient and question, rate of reformulation of the objective of the pharmaceutical counselling, response rate to presentation questions, readability and understanding. No average success rate per question after the pharmaceutical counselling was statistically less than 90%. The average success rates per patient before and after the pharmaceutical counselling were 78.9±13.7% vs 96.1±3.9% (P=0.01). The average success rates per question were different for 4 questions. All patients were able to reformulate the objective of the pharmaceutical counselling and validated the presentation, readability and understanding of the documents. This study led to the final validation of the pharmaceutical counselling guide.

[Development of a standardized guide for optimizing drug adherence information to be dispensed during a pharmaceutical counseling with a multiple myeloma patient: Initial validation]. / Élaboration d'un guide standardisé d'informations d'optimisation de l'adhésion médicamenteuse à dispenser lors d'une consultation pharmaceutique au patient atteint de myélome multiple : validation initiale.

The safety of the community treatment with oral anticancer therapies is a strong theme of the cancer plan 2014-2019. The objective of this study was to develop a Pharmaceutical Counseling Guide to improve medication adherence in patients treated for multiple myeloma with oral anticancer therapies. A multidisciplinary professional working group selected a list of relevant medication adherence-related items that served as the framework for the design of the pharmaceutical counseling support materials in patient-accessible language. The readability, understanding and memorization of the information were validated in ten patients treated for myeloma. Twelve items were selected for treatment information (5 items), treatment planning (5 items), and adverse drug effects (2 items). A pharmacist guide, a patient guide, a medication schedule, and three self-questionnaires to evaluate medication knowledge and understanding of patients were developed. The patient test resulted in changes in these documents. This study carried out the initial validation of documents to standardize the pharmaceutical counseling for patients treated for myeloma so that it can be reproduced from one patient to another regardless of the pharmacist, by standardizing the information issued. This study needs to be completed by a final validation in myeloma patients, free from oral anticancer therapies.

Impact of collaborative pharmaceutical care on in-patients' medication safety: study protocol for a stepped wedge cluster randomized trial (MEDREV study).

BACKGROUND: Clinical pharmaceutical care has long played an important role in the improvement of healthcare safety. Pharmaceutical care is a collaborative care approach, implicating all the actors of the medication circuit in order to prevent and correct drug-related problems that can lead to adverse drug events. The collaborative pharmaceutical care performed during patients' hospitalization requires two mutually reinforcing activities: medication reconciliation and medication review. Until now, the impact of the association of these two activities has not been clearly studied. METHODS: This is a multicentric stepped wedge randomized study involving six care units from six French University Hospitals (each unit corresponding to a cluster) over seven consecutive 14-day periods. Each hospital unit will start with a control period and switch to an experimental period after a randomized number of 14-day periods. Patients aged at least 65 years hospitalized in one of the participating care units and having given their consent to be called for a 30-day and 90-day follow-up can be enrolled. For each 14-day period, 15 patients will be recruited in each care unit to obtain a total of 630 patients enrolled in all centers. Patients with a hospital stay of more than 21 days will be excluded. During the control period, there will be no clinical pharmacist in the care unit, whereas during the experimental period a clinical pharmacist will perform medication reconciliation and review with the healthcare team. The primary outcome will assess the impact of collaborative pharmaceutical care on preventable medication error rate. The secondary outcomes will evaluate the clinical impact of the strategy, the acceptance rate of pharmaceutical interventions, the induced and avoided costs of the strategy (cost-consequence analysis), and the healthcare team's satisfaction. DISCUSSION: This study will assess the impact of collaborative pharmaceutical care associating medication reconciliation and review at patient admission to hospital in terms of preventable medication error rate and costs. This activity will prevent and correct medication errors arising earlier in the hospitalization. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02598115 . Registered on 4 November 2015.