Drug-Related Problems and Pharmacists' Interventions in Hypertensive Outpatients: A Multicenter Prospective Study in 3 Vietnamese Hospitals.

Background: Clinical pharmacists' interventions (PIs) on drug-related problems (DRPs) in Vietnamese hypertensive outpatients are limited. Objectives: The objective was to investigate the prevalence and nature of DRPs, and factors which are likely to have DRPs, types of PIs, and their acceptance rate in 3 Vietnamese hospitals. Method: A prospective interventional study was conducted over a period of 3 months in 3 hospitals (from October 2021 to March 2022). Clinical pharmacists conducted medication reviews after collecting patient information from prescriptions and patient interviewing, and then identified the DRPs and suggested PIs according to the Vi-Med tool. These DRPs and PIs were reviewed by other superior clinical pharmacists and a consensus meeting with 3 cardiologists. Results: Of 381 patients included, 344 (90.23%) experienced 1 or more DRPs. A total of 820 DRPs were identified with an average of 2.15 DRPs per patient and 415 (50.61%) were hypertension-related issues. The most common DRPs identified were "administration mode" (46.34%), "missing indication" (18.05%), "non-conformity indication" (17.80%), and "dosage" (11.95%). Comorbidity (adjusted odds ratio [AOR] = 3.985, 95% CI: 1.597-9.942, P = 0.003) was the predictor of DRPs. Clinical pharmacists provided 739 PIs and 94.45% were accepted by physicians. Conclusion: The results of this study showed that DRPs were very common in hypertensive outpatients and highlighted the role of clinical pharmacists to identify and resolve DRPs through prompt interventions.

CLEO: a multidimensional tool to assess clinical, economic and organisational impacts of pharmacists' interventions.

OBJECTIVES: Clinical pharmacists' interventions (PIs) are an important element in ensuring good pharmaceutical care. We aimed to develop and validate a comprehensive multidimensional tool for assessing the potential impact of PIs for daily practice of medication review. METHODS: Experts of the French Society of Clinical Pharmacy (SFPC) developed the CLinical, Economic and Organisational (CLEO) tool, consisting of three independent dimensions concerning clinical, economic and organisational impact. They were asked to analyse 30 scenarios of PIs, and re-rated 10 PIs with a washout of 1 month (internal validation). Then, seven external experts not involved in the development of the tool rated 60 scenarios collected when using the CLEO in daily practice. Inter- and intra-rater reliabilities were determined by calculation of the intra-class correlation (ICCA,1). Users' satisfaction and acceptability of the tool were assessed on a 7-level Likert scale with a 17-item questionnaire. RESULTS: For internal reliability, the inter-rater reliability for the CLEO tool was good for clinical dimensions (ICCA,1=0.693), excellent for economic dimensions (ICCA,1=0.815) and fair for organisational dimensions (ICCA,1=0.421); and the intra-rater reliability was good for clinical dimensions (ICCA,1=0.822), excellent for economic dimensions (ICCA,1=0.918) and good for organisational dimensions (ICCA,1=0.738). For external reliability, the inter-rater reliability was good for clinical dimensions (ICCA,1=0.649), excellent for economic dimensions (ICCA,1=0.814) and fair for organisational dimensions (ICCA,1=0.500). CLEO was viewed as relevant (mean±SD 4.93±1.27), acceptable (4.81±1.78), practicable (5.56±1.45) and precise (5.38±1.47). CONCLUSIONS: CLEO is a comprehensive tool assessing clinical, economic and organisational impacts of PIs which has been developed, validated and was reliable and feasible for use in routine clinical practice.

Development of a Good Clinical Practice inspection checklist to assess clinical trial sites in Vietnam.

BACKGROUND: Assessing the capacity of a healthcare institution to conduct and manage clinical research studies is challenging, especially in developing countries where resources are limited. The objective of this study was to develop a practical and transparent tool for the Vietnam Ministry of Health (MOH) to assess institutions' capacity to lead clinical trials in line with local and international regulations. METHODS: We reviewed the literature, relevant official international and national guidelines, regulations and checklists for clinical sites' assessment to identify key indicators of clinical research capacity. We developed a Good Clinical Practice (GCP) inspection checklist consisting of a questionnaire with 30 key criteria, including 16 core criteria and 14 recommended criteria, related to four central aspects of clinical research management (ie, governance, operations, infrastructures and human resources). Following a detailed review and assessment by a panel of experts, sponsors and academic investigators, we assessed the checklist's applicability in a pilot study involving 10 sites with various clinical research experiences. RESULTS: Independently of their clinical research experience, all participating institutions fulfilled most of the core criteria. In contrast, a significant variability was observed in the compliance to recommended capacity criteria, especially those related to governance (certifications and reporting) as well as operations (existence of a clinical research coordination unit or electronic trial management system). CONCLUSIONS: A GCP inspection checklist was successfully developed to support the MOH in the assessment of institutions' capacity to conduct clinical research. Additional efforts from all stakeholders are now warranted to provide local sites with sustainable capacity development resources that will further build up and harmonise Vietnamese clinical research settings.