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The Saudi Society of Clinical Pharmacy (SSCP) is a scientific and professional society in the field of clinical pharmacy that operates under the Saudi Commission for Health Specialties governance. The SSCP believes that there is a need to define and describe many aspects related to the clinical pharmacy profession in Saudi Arabia. Moreover, there is an increasing demand for promoting the concept of clinical pharmacy and developing a consensus regarding the scope of practice and clinical pharmacist's required postgraduate education and training in Saudi Arabia. This paper is intended to present several position statements by the SSCP that define the concept of clinical pharmacy, describe the required education and training, and highlight clinical pharmacists' scope of practice in Saudi Arabia. This paper calls for further investigations that examine the impact of clinical pharmacists on individual and population health levels.
On the 2nd of March 2020, Kingdom of Saudi Arabia confirmed its first case of the coronavirus's newly emerging strain, causing coronavirus disease 2019 (COVID-19). Soon after, the number of confirmed cases started to increase nationally. In light of the emerging outbreak, all healthcare professionals, including pharmacists, began to function with maximum capacity and efforts. The Saudi Society of Clinical Pharmacy (SSCP) acknowledges the substantial impact pharmacists can play during outbreaks. Based on the existing scientific knowledge during this outbreak, the SSCP established an expert writing task force to conceptualize and draft the proposed recommendations that highlights the roles and responsibilities of pharmacists during epidemics and pandemics. The SSCP writing task force issued 28 recommendations. In addition to the national and institutional guidelines, these recommendations could serve as guidance for the impacted entities.
Background and Aim: Management of genotype 4 hepatitis C virus (HCV) has shifted to interferon‐free regimens with a high sustained virological response (SVR‐12), especially with NS5B/NS5A inhibitor combinations such as sofosbuvir and ledipasvir (Sof‐Led). The guidelines have recommended the combination of sofosbuvir and another NS5A inhibitor, daclatasvir, to manage HCV genotypes 1–3. However, its use was extended to genotype 4 HCV based on extrapolating evidence. Our aim is to assess the efficacy of generic sofosbuvir + branded daclatasvir (Sof‐Dac) compared to the Sof‐Led combination in treating genotype 4 HCV.Methods: This study is an open‐label, 2‐period, noninferiority study that compared patients receiving a combination of generic sofosbuvir 400 mg and daclatasvir 60 mg orally daily (Group 2) prospectively to a historical control (Group 1) that included patients who received a combination of sofosbuvir/ledipasvir 400/90 mg orally daily. The primary endpoint is the proportion of patients who achieved SVR‐12.Results: The study included 111 patients in the (Sof‐Led) Group 1 and 109 patients (Sof‐Dac) Group 2. For the primary outcome, SVR‐12 was achieved in 106 (95.5%) of the patients in Group 1 versus 108 (99.1%) in Group 2 (p = 0.2). In addition, all patients who achieved SVR‐12 also achieved SVR‐24.Conclusion: Generic sofosbuvir combined with branded daclatasvir was safe and effective for treating genotype 4 HCV compared to Sof‐Led. This combination may significantly reduce the cost burden, enabling a larger pool of treated patients. Office of research affairs at KFSHRC RAC# 2171 036.
Tacrolimus is an essential immunosuppressive medication in paediatric patients' post-liver transplantation. Achieving tacrolimus target concentration in early post-transplantation is crucial to minimise the risk of acute rejection; however, this is challenging due to inter- and intra-patient variability in tacrolimus metabolism and clearance. Therefore, our study aims to describe tacrolimus trough concentration variability and pharmacokinetics in paediatric post-liver transplantation during the first two weeks post-transplantation. This retrospective multicentre observational study included paediatric patients post-liver transplantation. Post-operative data was collected within the initial 14 days using electronic health records, including daily tacrolimus doses, measured trough concentrations, graft data, surgical data, and documented acute rejection. Pharmacokinetic analysis was completed using the Monolix software. We used the empirical Bayesian estimates of clearance and volume of distribution for covariate testing to assess possible correlations. We performed a stepwise regression analysis (alpha = 0.05). Ninety-one paediatric patients were included in the study, with a mean age of 4.1 years (SD = 4.6). The mean graft-to-recipient weight ratio (GRWR) was 3% (SD = 6). The vast majority of the patients received the liver from living donors (n = 84, 92.3%). The average time needed to reach therapeutic concentration was 4.6 (SD = 2.8) days. The initial clearance (Clini) was very low at baseline (0.012 L/h), then increased dramatically to 9.84 L/h at 14 days post-transplantation. The clearance appeared to be time-dependent, and the time needed to reach 50% of maximum clearance was five days post-transplantation. The covariates that significantly affected clearance included bodyweight and aspartate transaminase, while the only significant covariate for volume of distribution was bodyweight. Tacrolimus is a drug with high intra- and interindividual variability, making dosing challenging in the paediatric liver transplantation population. Prospective studies with more intensive sampling are needed to address the time-dependent changes in clearance, which will aid in establishing the optimal dosing regimens in this population.