Optimizing pharmaceutical management of clinical trials.

OBJECTIVES: The clinical trials pharmacists have an essential role in managing the pharmaceutical part of interventional studies. The primary objective of this article was to provide a template for improving trials management for the growing number of studies without increasing personnel resources. MATERIAL AND METHODS: A retrospective study was conducted between 2016 and 2020 at the service of pharmacy at Lausanne University Hospital in Switzerland. RESULTS: The number of clinical trials (in progress) managed at the pharmacy increased from 77 to 115 (+49%) between 2016 and 2020. The majority of these studies were in oncology and were sponsored by industry. Therefore, different changes in routine tasks were decided during the 5 years term to meet the above challenge. These modifications allowed to improve pharmaceutical and administrative management of clinical trials, without increasing personnel resources. The management template was accepted by the sponsors, and no issues were mentioned by national and international audit authorities. CONCLUSION: Changes could be made in the routine practice of the clinical trials pharmacists to improve the management of studies, while the number of trials is increasing every year.

Impact of Pharmaceutical Interventions with STOPP/START and PIM-Check in Older Hospitalized Patients: A Randomized Controlled Trial.

INTRODUCTION: Pharmaceutical interventions can reduce negative outcomes related to potentially inappropriate prescriptions (PIPs). OBJECTIVE: The objective of this study was to compare the impact of interventions on the reduction of PIPs and on different clinical outcomes using two electronic explicit tools. METHODS: A randomized controlled trial was conducted in patients hospitalized between 2018 and 2019 at the Acute Care for Elders unit at Lausanne University Hospital in Switzerland. A medication review was conducted using PIM-Check in the first arm and STOPP/START in the second arm. Proposed interventions were communicated to the physicians. Clinical outcomes evaluated were incidence of falls, delirium, activities of daily living (ADL), length of stay, number of drugs at discharge and hospital readmission. RESULTS: The 123 included patients (60 in the first arm and 63 in the second arm) were 86.3 ± 6.6 years old, had 3.5 ± 1.7 diseases and were treated by 6.2 ± 2.7 drugs at admission. There was a significant decrease in PIPs in each arm, but no significant difference between arms. The deprescription of nervous system drugs was significantly higher with STOPP/START than with PIM-Check (Chi-square p = 0.025). ADL scores between home and discharge were significantly higher in the STOPP/START arm than in the PIM-Check arm (4.42 vs 3.77; p = 0.040). The predictors of ADL score improvement were the deprescription of nervous system drugs (ß = 0.423; 95% CI 0.034-0.812; p = 0.033), the use of STOPP/START (ß = 0.798, 95% CI 0.305-1.290; p = 0.002) and a shorter length of hospital stay (ß = -0.033, 95% CI - 0.056 to - 0.010; p = 0.005). CONCLUSIONS: Although PIM-Check was non-inferior to STOPP/START in reducing the number of PIPs, STOPP/START had a significantly higher impact on ADL. The use of STOPP/START or the deprescription of two nervous system drugs would allow the patient to acquire almost one more basic function of living. On the other hand, a loss of one point on the ADL score was observed per month of hospitalization. CLINICAL TRIALS REGISTRATION NUMBER: NCT04028583.

Impact of Pharmaceutical Interventions in Hospitalized Patients: A Comparative Study Between Clinical Pharmacists and an Explicit Criteria-Based Tool.

BACKGROUND: It has been well recognized that pharmaceutical interventions (PIs) can prevent patient harm related to prescribing errors. Various tools have been developed to facilitate the detection and the reduction of inappropriate prescriptions and some have shown benefit on clinical outcomes. OBJECTIVE: The objective of this study was to evaluate the clinical, economical, and organizational impact of interventions generated by clinical pharmacists in hospitalized patients, and to evaluate the performance of an explicit tool, the Potentially Inappropriate Medication Checklist for Patients in Internal Medicine (PIM-Check), in detecting each pharmacist's intervention. METHODS: A cohort retrospective study was conducted on hospitalized patients. The impact of PIs based on pharmacists' standard examination was evaluated using the Clinical, Economic, and Organizational (CLEO) tool. The performance of PIM-Check in detecting each intervention was assessed by conducting a retrospective medication review based on available information collected from patients' records. A qualitative analysis was also conducted to identify the types of PIs that PIM-Check failed to detect. RESULTS: The study was performed on 162 patients with a median age of 68 years (interquartile range = 46-77 years) and a median hospital stay of 5 days (interquartile range = 4-7 days). The pharmacists generated 1.9 PIs per patient (n = 304) of which 31% were detected by PIM-Check. The acceptance rate of the interventions by physicians was 84% (n = 255). Among the accepted interventions, 53% (n = 136) had a clinical impact graded CL ≥ 2C (moderate or major), whereas the majority of them were not detected by PIM-Check (63%; 86 out of 136). In addition, 46% of accepted interventions (n = 117) were associated with a cost decrease, among which 62% were not detected by PIM-Check (73 out of 117). The qualitative analysis shows that PIM-Check mostly failed to detect PIs related to dose adjustment, overprescribing, and therapy monitoring. CONCLUSIONS: According to the CLEO tool evaluation of PIs, our results show that clinical pharmacists' interventions are associated with improved clinical outcomes. In comparison with pharmacists' interventions, PIM-Check failed in detecting the majority of interventions associated with a moderate or major impact.

Ability to detect potentially inappropriate prescribing in older patients: comparative analysis between PIM-Check and STOPP/STARTv2.

PURPOSE: Potentially inappropriate prescribing (PIP) is a source of preventable adverse drug events. The objective of this study was a comparative analysis (quantitative and qualitative) between two tools used to detect PIP, PIM-Check and STOPP/START. METHODS: First, a qualitative analysis (QAC) was conducted to evaluate the concordance between the criteria, which constitute PIM-Check and the gold standard STOPP/START. Second, a retrospective comparative and observational study was performed on the list of treatment at the admission of 50 older patients hospitalized in an acute geriatric ward of a university hospital in Switzerland in 2016 using both tools. RESULTS: The QAC has shown that 50% (57 criteria) of STOPP/START criteria are fully or partially concordant with those of PIM-Check. The retrospective study was performed on 50 patients aged 87 years, suffering from 5 co-morbidities (min-max 1-11) and treated by of 8 drugs (min-max 2-16), as medians. The prevalence of the detected PIP was 80% by PIM-Check and 90% by STOPP/START. Medication review shows that 4.2 PIP per patient were detected by PIM-Check and 3.5 PIP by STOPP/START among which 1.9 PIP was commonly detected by both tools, as means. PIM-Check detected more PIP related to cardiology, angiology, nephrology, and endocrinology in older patients but missed the PIP related to geriatric syndromes (e.g., fall, dementia, Alzheimer) detected by STOPP/START. CONCLUSIONS: By using PIM-Check in geriatric settings, some PIP will not be detected. It is considered as a limitation for this tool in this frail population but brings a certain complementarity in other areas of therapy not covered by STOPP/START.

Clinical and economic impacts of explicit tools detecting prescribing errors: A systematic review.

WHAT IS KNOWN AND OBJECTIVE: Many explicit tools have been developed to reduce prescribing errors and ensure patients' safety. The impact of explicit tools is not well studied. The objective of this study was (a) to conduct a systematic review of systematic reviews listing explicit tools developed to detect prescribing errors and (b) to assess their impact on clinical and economic outcomes. METHODS: This project includes two related parts. First, a systematic review of systematic reviews listing explicit tools dedicated to geriatrics or internal medicine was performed to develop an exhaustive list of explicit tools. Then, using the list compiled in the first step, a systematic review of randomized controlled trials (RCT) assessing clinical or economic impacts of tools was performed to evaluate their usefulness. RESULTS AND DISCUSSION: The systematic review of systematic reviews identified 49 explicit tools. The systematic review of RCT, using one or more of the 49 explicit tools, identified 5 RCT using explicit tools as intervention (3 STOPP/START and 2 FORTA RCT). The 5 studies evaluated clinical impacts with 3 RCT identifying significant clinical impacts (falls, activities of daily living and/or adverse drug reactions) and 2 STOPP/START RCT identifying significant economic impacts. WHAT IS NEW AND CONCLUSION: The systematic review of RCT showed that explicit tools can have some effect in improving patients' safety. Further studies are warranted to better characterize their clinical and economic impact.

Risk factors and quality of life of dyslipidemic patients in Lebanon: A cross-sectional study.

The main objective of this study was to identify the risk factors of dyslipidemia and measure its impact on patients' quality of life (QOL). Secondary objectives were to determine the percentage of dyslipidemia and assess the predictive factors affecting patients' QOL. A cross-sectional study was conducted in a sample of Lebanese population. A standardized questionnaire was developed to assess the QOL using the Short form-36 (SF-36) score. A total of 452 individuals were interviewed, of which 59.5% were females. The mean age was 43.3±15.6years, and 24.8% had dyslipidemia. The results show a lower overall QOL score among dyslipidemic patients compared with controls (57.9% and 76.5%, respectively; p<0.001). Waterpipe smoking [adjusted odds ratio (ORa)=4.113, 95% confidence interval (CI): 1.696-9.971, p=0.002], hypertension (ORa=3.597, 95% CI: 1.818-7.116, p<0.001), diabetes (ORa=3.441, 95% CI: 1.587-7.462, p=0.002), cigarette smoking (ORa=2.966, 95% CI: 1.516-5.804, p=0.001), and passive smoking (ORa=2.716, 95% CI: 1.376-5.358, p=0.004) were significantly associated with dyslipidemia in individuals older than 30years. A higher overall QOL score (p=0.013) was observed in patients treated with statins in comparison with other lipid-lowering medications. In addition to clinical and economical consequences, dyslipidemia may have a significant impact on patients' QOL. Further research is needed to confirm the impact of treatment on dyslipidemic patients' QOL in order to maximize the overall benefits of therapy.