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Objective To determine the extent of off-label and unlicensed prescribing in hospitalized newborns and to identify patient-related risk factors associated with off-label prescribing. Methods A prospective cohort study was conducted between January and March 2016 at a neonatology department of a tertiary-care hospital in the Eastern province. All consecutive admissions to all neonatal care levels meeting the inclusion and exclusion criteria were eligible for enrollment. All prescriptions were classified as off-label or unlicensed according to drug product monograph. Clinical and prescription data were extracted using a pilot-tested structured data collection sheet. Results During the study period 583 prescriptions were made for 138 newborns, of which 29.7% (173/583) and 12.9% (75/583) were classified as off-label and unlicensed drugs respectively for use in neonates. Thirty-four percent (47/138) of patients received at least one off-label/unlicensed medicine. Mechanical ventilation, admission to the neonatal intensive care unit and length of hospital stay were identified as independent risk factors associated with prescribing of at least one off-label medication. Conclusion Use of off-label and unlicensed drugs in hospitalized newborns seems to be a common practice in this Saudi hospital. Future research should evaluate safety and efficacy of off-label and/or unlicensed use of drugs in neonates. [ABSTRACT FROM AUTHOR]

This study was aimed to evaluate the impact of community pharmacy (CP)-based medication therapy management (MTM) program on clinical and humanistic outcomes in patients with uncontrolled diabetes. An open label, parallel-group randomised controlled trial was undertaken at a community pharmacy in Riyadh city, Kingdom of Saudi Arabia. Patients with a diagnosis of uncontrolled diabetes (HbA1c of ≥ 8%) meeting the eligibility criteria were randomised to receive either the MTM programme provided by pharmacists or standard care. The primary outcome was change in HbA1c over 6 months. Secondary outcomes included: changes in clinical parameters (blood pressure (BP), lipid profile, serum creatinine (SCr) and albumin-to- creatinine ratio (ACR)), types of drug-related problems (DRPs), health service utilization (HSU), adherence, diabetes distress and overall patient satisfaction with the service at 6-month. A sufficiently powered sample of 160 participants with a mean age was 50 years (SD ± 11.9) was recruited. The majority of the patients (68.1%) were male and had diabetes for more than eight years [IQR 3, 14]. After adjusting for baseline HbA1c, compared to the control group, the mean HbA1c level was 0.02% (p = 0.929) and 0.2% (p = 0.47) lower in the intervention arm at 3-month and 6-month respectively. However, these differences were not statistically significant. Nonetheless, within each arm, there was a significant improvement in HbA1c from baseline. Furthermore, the intervention arm demonstrated improvement in BP control (SBP lowered by 3.2 mmHg (p = 0.05) and DBP lowered by 3.8 mmHg (p = 0.008)). During the study period, none of the participants in the intervention group reported hospitalization or ER visits compared to 14 patients in the control group [OR 0.069 (95% CI 0.004, 1.3)]. Patient satisfaction as measured by Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0) was significantly higher among MTM program participants compared to standard care (p = 0.00001). Patients in the MTM program were eight times more likely to be adherent compared to the patients in the standard care [OR 7.89 (95% CI 3.6, 17.4)]. MTM program metrics showed that per patient, the pharmacists spent a median of 35 [IQR 30, 44.5] minutes at the initial visit and 20 [IQR 10, 25] minutes during the 6-month visit. The number of DRPs had significantly dropped in the intervention arm at 3 and 6-month (p = 0.0001). In conclusion, CP-based MTM program can improve health outcomes and prevent hospitalisations in patients with diabetes. These findings support the implementation of CP-based MTM services for patients with diabetes in the Kingdom of Saudi Arabia., (© 2024. The Author(s).)

Background: Understanding patient satisfaction is key to advancing pharmacy services and improving health outcomes. There is a lack of a translated and psychometrically validated tool in the Arabic language to measure patient satisfaction with pharmacy services., Objective: To translate the English version of the PSPSQ 2.0 into Arabic language, culturally adapt, and verify its reliability and validity., Setting: A community pharmacy in Riyadh, Saudi Arabia., Method: A cross-sectional study was conducted between April 2021 and June 2022 among patients with diabetes attending a community pharmacy. The International Society for Pharmacoeconomics and Outcomes Research good practice guidelines for linguistic translation and cultural adaptation were used to translate and culturally adapt the English version of PSPSQ 2.0 into Arabic. The Arabic version of PSPSQ 2.0 was subjected to factor analysis using principal component analysis with varimax rotation to evaluate its validity and Cronbach's alpha was used to assess the reliability of PSPSQ 2.0., Results: A total of 129 (68.2% male, and mean age 50 (SD: 11.9) years) patients with diabetes participated in the study. The analysis was undertaken for the items in each of the three domains of PSPSQ 2.0: quality of care, interprofessional relationship and overall care. Exploratory factor analysis revealed validity of 92.7%, 80.5% and 96.2%, respectively. The Arabic version of PSPSQ 2.0 had high internal consistency with Cronbach's alpha scores 0.99, 0.95 and 0.98 for the three measured domains, respectively. The sample adequacy was 0.924., Conclusion: The PSPSQ 2.0 was successfully translated and culturally adapted into the Arabic language and had acceptable validity and reliability to measure patient satisfaction with services provided by pharmacists in community pharmacies., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Albabtain et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Objectives: To assess the community pharmacists' knowledge, attitude, perception and current practices towards generic medicines substitution in Saudi Arabia., Methods: A cross-sectional study was conducted between February and March 2016 in the Makkah region, Saudi Arabia. A 25-item, structured, validated, pilot-tested and self-completed questionnaire was used to achieve study objectives. A 4-step systematic sampling technique was used to recruit community pharmacists. Data were analysed using SPSS version 20., Results: Of 128 community pharmacists approached, 121 participated in the study (response rate=95%). Majority of the participants (n=108; 89.3%) had graduated from Egypt, were working as staff pharmacists (n=85; 70%) and had BPharm degree (97; 80.2%). Only 26 (22%) of the participants correctly answered all knowledge questions accurately. No statistically significant difference in total knowledge score was observed across different sociodemographic characteristics of participants (all P>0.05).Two-thirds of the respondents (83; 68.2%) supported the use of generic substitution. Medicines cost and patients' request were the most commonly cited reasons for performing generic substitution. Country of graduation (P=0.01) and number of years of practicing in Saudi Arabia (P=0.02) was associated with the pharmacists' support towards generic substitution., Conclusion: The community pharmacists had clear knowledge deficits about generic medicines and their substitution which may partly explain low consumption of generic medicines in Saudi Arabia. Healthcare policy makers need to improve awareness about the safety and efficacy of generic medicines and promote their use in order to cut down cost of medicines and overall healthcare expenditure., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)