Saudi Pharmaceutical Journal最新文献

{"title":"Targeting triple-negative breast cancer: apoptotic and antitumor effects of Artemisia sieberi Besser extracts.","authors":"Fatimah G Albani, Sahar S Alghamdi, Sabine Matou-Nasri, Arwa Alsubait, Rasha Suliman, Rehab AlRoshody, Sarah M Huwaizi, Tlili Barhoumi, Afrah E Mohammed, Mohamed Boudjelal, Entissar S Alsuhaibani, Zeyad Alehaideb","doi":"10.1007/s44446-025-00047-x","DOIUrl":"10.1007/s44446-025-00047-x","url":null,"abstract":"<p><p>Artemisia sieberi Besser (A. sieberi) has shown promise as a natural source of safe cytotoxic agents for breast cancer therapy. However, its effects on triple-negative breast cancer (TNBC), a very aggressive subtype lacking targeted treatments, remain poorly studied. This study evaluates the anticancer activity of A. sieberi extracts against the MDA-MB-231 TNBC cell line, comparing results with hormone receptor-positive MCF-7 cells. Aerial parts of A. sieberi were extracted using ethanol and methanol and then chemically characterized via gas chromatography/mass spectrometry (GC/MS) to identify bioactive compounds. Cytotoxic effects were assessed using cell viability assays, while apoptosis induction was examined through flow cytometry (Annexin V/propidium iodide staining), caspase-3/-7 activation assays, and mitochondrial membrane permeabilization visualized using confocal microscopy. Western blotting analyzed the expression levels of apoptotic proteins. In silico molecular docking simulations explored the interactions between phytochemicals and apoptosis-regulating proteins. A. sieberi extracts exhibited higher cytotoxicity against MDA-MB-231 cells than against MCF-7 cells, with lower IC₅₀ values. Treatment of TNBC cells induced apoptosis, evidenced by increased caspase activity, mitochondrial membrane permeabilization, elevated Bax, and decreased Bcl-2 expression. Additionally, colony formation assays demonstrated a significant reduction in tumorigenic potential. Computational analyses indicate that β-sitosterol and stigmasterol, among the main compounds, exhibited strong interactions with apoptosis regulators by docking with Bcl-2, supporting their promising anticancer potential. A. sieberi extracts induce potent apoptosis and exert anti-tumour effects in TNBC cells, highlighting their potential as sources of novel anticancer agents. Further isolation and characterization of active constituents are warranted for therapeutic development.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 6","pages":"46"},"PeriodicalIF":4.3,"publicationDate":"2025-11-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12644357/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145589702","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of coverage of drug availability regulations across the supply chain cycle in Saudi Arabia.","authors":"Abdulmalik Alyousef, Mohammed Al Masoud, Mohammed Alturki, Faiyaz Shakeel, Sultan Alshehri","doi":"10.1007/s44446-025-00045-z","DOIUrl":"10.1007/s44446-025-00045-z","url":null,"abstract":"<p><p>There is a need for assessing the impact of current drug availability regulations across the various stages of the pharmaceutical supply chain and among different stakeholders involved. This mixed methods survey assessed the impact of pharmaceutical availability regulations across the drug supply chain in Saudi Arabia. This research utilized a cross-sectional study design involving a survey conducted at a single point in time to collect data from key stakeholders across the various stages of the pharmaceutical supply chain. Various metrics, such as availability ratings, accessibility issues, and stakeholder perspectives on regulatory effectiveness were examined. Mixed methods analysis combined survey statistics with qualitative insights. The data source for this study comprised an online survey targeting key stakeholders involved along the pharmaceutical supply chain (n = 27), including drug manufacturers (n = 10), distributors (n = 4), and healthcare settings, such as hospitals (n = 9) and pharmacies (n = 4). The data were collected in September 2023. Manufacturers (mean availability rating of 3.8) and distributors (mean availability rating of 3.5) viewed regulations to be more effective versus hospital/pharmacies (mean availability rating of 3.3) citing lack of harmonization and transparency as key efficiency deterrents. Centralized inventory monitoring and unified availability benchmarks were strongly advocated as enhancements alongside improved communication flows. Ultimately, a collaborative, yet guided approach is imperative for balancing industrial priorities and access imperatives to attain synchrony across the pharmaceutical value chain in order to augment both health and economic outcomes.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 6","pages":"44"},"PeriodicalIF":4.3,"publicationDate":"2025-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12623592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145543449","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Current status and trends of anti-tumor biosimilars in China from 2019 to 2023: A cross-sectional analysis.","authors":"Han Shan, Zihan Guo, Xuan Ye, Qiong Du, Jiyong Liu, Mengmeng Wang","doi":"10.1007/s44446-025-00042-2","DOIUrl":"10.1007/s44446-025-00042-2","url":null,"abstract":"<p><p>While several anti-tumor biosimilars have been approved in China, comprehensive nationwide analyses of their real-world utilization patterns remain limited, particularly regarding cross-regional adoption and indication-specific usage. We collected information on patients treated with bevacizumab, rituximab, trastuzumab and their biosimilars at 109 hospitals in nine Chinese cities from 2019 to 2023. Analysis of 264,527 prescriptions revealed rapid biosimilar adoption for bevacizumab (2023 originator share: 20.0%, -25.1%/year), moderate for rituximab (32.1%, -16.8%/year), and limited for trastuzumab (70.0%, -8.3%/year). Geographic variation was substantial (2023 city ranges: bevacizumab 2.3-43.0%; rituximab 6.7-70.3%; trastuzumab 42.4-92.4%). Tertiary hospitals showed faster biosimilar uptake than secondary hospitals (bevacizumab: + 23.7%). Free medical care patients preferred originators (bevacizumab: 64.1% vs 38-39% for other payers). Off-label use demonstrated significantly higher biosimilar adoption (bevacizumab: 69.0%; rituximab: 52.1%) versus approved indications (p < 0.00625). Cost distributions mirrored prescription trends but consistently favored originators. All trends were statistically significant (p < 0.05). The biosimilar market share showed steady annual growth, however the growth rates vary across different products. However, Patients with lower out-of-pocket costs remained more likely to choose original products. Enhanced regulatory oversight of both approved and off-label/extrapolated indications is needed to ensure appropriate biosimilar utilization.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 6","pages":"43"},"PeriodicalIF":3.4,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12612310/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145497363","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes and nonalcoholic fatty liver disease: A cohort study.","authors":"Rania Naguib, Nouran Aleyeidi, Hend Naguib","doi":"10.1007/s44446-025-00044-0","DOIUrl":"10.1007/s44446-025-00044-0","url":null,"abstract":"<p><p>Sodium-glucose cotransporter 2 inhibitors (SGLT2is) are a novel group of oral medications used to treat type 2 diabetes mellitus (T2DM). Nonalcoholic fatty liver disease (NAFLD), a complication of T2DM, is now recognized as one of the most frequent causes of chronic liver disorders. We aimed to investigate the effects of SGLT2is on hepatic function and glucose homeostasis in patients with T2DM and comorbid NAFLD. To our knowledge, this is the first study in the Arab region to compare the effects of SGLT2is and other antidiabetic medications and to evaluate the outcomes after a 6-month follow-up period in this patient cohort. This cohort study involved 100 patients with T2DM. The patients were divided equally into two groups. The exposed group comprised 50 patients receiving any of the SGLT2is (empagliflozin or dapagliflozin); the non-exposed group comprised 50 patients taking any other oral antidiabetic medication (other than glucagon-like peptide-1 receptor agonists or SGLT2is). The outcomes investigated were glycemic control, hepatic function, and liver fibrosis parameters, investigated at baseline and after 6 months. Significant improvements in glycemic control, hepatic function, and fibrosis parameters were observed in the SGLT2i group after 6 months, as evidenced by laboratory and clinical data (p < 0.001). Significant improvements were observed in hemoglobin A1c, Fibrosis-4 index, gamma-glutamyl transferase level, alanine aminotransferase level, and NAFLD fibrosis score (p < 0.05). The findings indicate that 6 months of SGLT2i therapy improved fibrosis and glucose homeostasis in patients with T2DM and NAFLD. Therefore, SGLT2is are effective therapeutic agents in this patient population.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 6","pages":"42"},"PeriodicalIF":4.3,"publicationDate":"2025-10-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12559501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145379256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The association between parenteral antimicrobials and bacterial resistance at King Khaled Hospital in Al-Kharj: A retrospective cohort study.","authors":"Nehad Jaser Ahmed, Zahaa Eid Alrashidi, Ziyad S Almalki, Nahed Ibrahim Alobaidi, Abdullah K Alahmari, Sameh Rabie","doi":"10.1007/s44446-025-00040-4","DOIUrl":"10.1007/s44446-025-00040-4","url":null,"abstract":"<p><p>Antimicrobial resistance (AMR) is rising alarmingly in Saudi Arabia, as evidenced by surveillance data. This retrospective cohort study evaluated the association between parenteral antimicrobial use and bacterial resistance at King Khaled Hospital, Al-Kharj, using electronic health records. Linear regression analyzed antibiotic exposure-resistance relationships over 36 months (January 2022-December 2024). Eligible participants were hospitalized ≥ 48 h and received ≥ 1 parenteral antimicrobial. The required sample size was 384 (calculated via Cochran's formula). Inclusion mandated laboratory-confirmed bacterial infections (positive cultures with susceptibility testing). Investigated pathogens included Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Acinetobacter baumannii, and Staphylococcus aureus. Among 4,007 participants, 59.02% were female, and 73.07% were Saudis. Findings revealed severe AMR, particularly in Escherichia coli and Klebsiella pneumoniae, with high resistance to multiple antibiotic classes. Acinetobacter baumannii exhibited near-pan-drug resistance (> 90% resistance to most antibiotics). Imipenem use strongly correlated with Escherichia coli resistance (R² = 1.000, p-value = 0.009), indicating significant carbapenem-driven selection pressure. Meropenem exposure also closely linked to Klebsiella pneumoniae resistance (R² = 0.994, p-value = 0.050). Widespread resistance to β-lactams, fluoroquinolones, and aminoglycosides-combined with near-pan-resistant Acinetobacter baumannii-highlights escalating treatment challenges. Crucially, carbapenem usage (imipenem/meropenem) strongly predicted resistance in Escherichia coli and Klebsiella pneumoniae, reinforcing antimicrobial pressure's role in resistance development. These results emphasize the urgent need for antimicrobial stewardship at King Khaled Hospital to curb carbapenem overuse and combat resistant infections.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 5","pages":"41"},"PeriodicalIF":4.3,"publicationDate":"2025-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12528614/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145294138","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic potential of canagliflozin in DEN/TAA-induced renal cancer: mechanistic insights into NLRP3/IL-6/STAT3 and AMPK signaling and oxidative stress regulation.","authors":"Rehab F Abdel-Rahman, Mahdi H Alsugoor, Naif ALSuhaymi, Hany M Fayed, Sawsan S Mahmoud, Fatma A Ibrahim, Marawan A Elbaset","doi":"10.1007/s44446-025-00039-x","DOIUrl":"10.1007/s44446-025-00039-x","url":null,"abstract":"<p><p>A novel class of antidiabetic drugs known as sodium-glucose cotransporter 2 inhibitors (SGLT2-Is) prevents the renal proximal tubules from reabsorbing glucose. While a recent study showed that SGLT2-Is may be able to slow the proliferation of cancer cells that express SGLT2, limited evidence exists regarding their effects on renal cell carcinoma (RCC). Here, we examine the ability of the SGLT2-I canagliflozin (Cana) to prevent experimentally induced kidney carcinogenesis in male rats. A total of twenty-four rats were divided into four groups, six in each: negative control, DEN/TAA control; rats (60-70 g) were fed a choline-deficient diet (CDD) for 4 weeks, then rats were subjected to four doses of 50 mg/kg diethyl nitrosamine (DEN) over 8 weeks followed by thioacetamide 100 mg/kg (TAA) intraperitoneal injections twice weekly for 15 weeks, treated groups: rats were given canagliflozin (10 and 20 mg/kg b.wt.) orally starting from the 24th week of the experiment till the end of the 29th week. The obtained findings showed that treatment with canagliflozin reduced renal oxidative stress and toxicity indicator levels and considerably reinforced renal antioxidant capacity. The histological changes further supported the biochemical findings. In addition, canagliflozin therapy activated AMPK and inhibited Nrf2, NLRP3 and IL-6/STAT3 pro-inflammatory pathway. Immunohistochemistry exhibited upregulation of pro-apoptotic protein caspase-3 and downregulation of PCNA expression in Cana-treated groups. Conclusion: the results showed that canagliflozin has anti-carcinogenic efficacy against renal carcinogenesis via activating AMPK and suppressing NLRP3/IL-6/STAT3 signaling pathways.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 5","pages":"38"},"PeriodicalIF":4.3,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145259811","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Acidifying agents impact erlotinib and gefitinib pharmacokinetic parameters and elevate liver enzymes in Wistar rats.","authors":"Amsha S Alsegiani, Aliyah Almomen, Maria Arafah, Nourah Z Alzoman, Abdullah K Alshememry","doi":"10.1007/s44446-025-00032-4","DOIUrl":"10.1007/s44446-025-00032-4","url":null,"abstract":"<p><p>Erlotinib (ERL) and Gefitinib (GEF) are weakly basic drugs with pH-dependent solubility profiles mainly dependent on stomach pH. We proposed possible drug and/or food-drug interactions with acidifying agents. Citric acid (CA) and phosphoric acid (PPA) are the most common acidifying agents used in food and medication to treat certain conditions. This study evaluated the impact of concomitant consumption of CA and PA on ERL and GEF pharmacokinetic parameters (PKs). The PKs of ERL and GEF were investigated in rats after four weeks of CA and PPA consumption in low (175 mg/kg) and high (100 mg/kg) doses using UPLC-MS/MS. Data indicated that acidifying agents altered PKs of ERL and GEF dose-dependently. High doses of CA and PPA significantly increased the Cmax of ERL by 103% and 218%, the AUC_0-72 by 35% and 78%, respectively, while reducing CL/F by 44% with CA and 74% with PPA. For GEF, Low and high doses of PPA increased C_max and T_max with a reduction of CL/F. A low dose of CA did not impact C_max, significantly decreased AUC_0-72 (28%), and increased CL/F (16%). The high dose of CA increased C_max (13%) with no impact on AUC_0-72 and decreased CL/F (23%). Furthermore, both doses of acidifying agents significantly increased liver enzyme levels and reduced body weight within two weeks. The results demonstrated that the PKs of both drugs were changed, and caution and close monitoring should be taken with ERL and GEF when co-administered with an acidifying agent.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 5","pages":"37"},"PeriodicalIF":4.3,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511468/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145253456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Myocarditis induced by durvalumab in a patient with hepatocellular carcinoma: A case report.","authors":"Lama Alfehaid, Nada Alsuhebany, Maha Aldoughaim, Rawan Bukhari, Walaa Sait, Kanan Alshammari, Mohammed Aziz","doi":"10.1007/s44446-025-00041-3","DOIUrl":"10.1007/s44446-025-00041-3","url":null,"abstract":"<p><p>Durvalumab is an immune checkpoint inhibitor that targets PD-L1 and is used for malignancies such as hepatocellular carcinoma. Although effective, it may cause immune-related adverse events, including rare cases of myocarditis (0.06% to 1%), which usually appear early. This complication results from immune response-induced damage to the myocardium, highlighting the importance of prompt detection and management to prevent potentially fatal outcomes. This report describes a 70-year-old woman with advanced hepatocellular carcinoma who developed myocarditis after receiving a single dose of durvalumab. The patient presented with atypical chest pain, shortness of breath, and gastrointestinal symptoms. Initial investigations revealed elevated cardiac biomarkers, including Troponin I and CK-MB, and an ECG showing sinus tachycardia and right bundle branch block. A cardiac MRI confirmed non-ischemic myocardial injury, leading to a diagnosis of ICI-induced myocarditis. The patient was treated with high-dose corticosteroids, resulting in rapid clinical improvement and stabilization of cardiac function. A multidisciplinary approach involving cardiology, oncology, and clinical pharmacy was crucial in managing this complex case. This case highlights the importance of heightened vigilance among healthcare providers when administering ICIs, particularly durvalumab, due to the risk of myocarditis. Early detection and prompt intervention are essential to manage ICI-related adverse events and prevent severe outcomes. The successful treatment of this patient demonstrates the importance of a multidisciplinary approach in tackling the complexities of ICI-induced myocarditis. Further research is necessary to optimize management strategies and follow-up protocols for patients experiencing this rare but serious adverse event.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 5","pages":"40"},"PeriodicalIF":4.3,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511464/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145259693","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Baicalin nano-micelles for dry eye disease: LC-MS/MS method validation, pharmacokinetics and pharmacodynamics in preclinical models.","authors":"Ziheng Wang, Yuchen Xu, Manting Liu, Yuchang Yang, Wenjuan Shi, Qian Zhu, Juan Liu, Lisha Yi, Huimin Wu, Xingbin Yin, Xiaoxv Dong, Jian Ni, Changhai Qu","doi":"10.1007/s44446-025-00037-z","DOIUrl":"10.1007/s44446-025-00037-z","url":null,"abstract":"<p><p>This study aimed to establish a method for quantifying baicalin (BC) in rabbit ocular tissues and plasma, and evaluate the pharmacological efficacy and pharmacokinetic properties of BC and BC@HS15/DSPE-PEG2000-L-Val, a novel ocular formulation for dry eye treatment. BC@HS15/DSPE-PEG2000-L-Val or free BC was administered via eye drops to benzalkonium chloride (BAC)-induced dry eye mice. Corneal and conjunctival tissues were assessed for anti-dry eye efficacy. BC concentrations in cornea, conjunctiva, aqueous humor, and ocular plasma were quantified using LC-MS/MS. Noncompartmental pharmacokinetic parameters (AUC, Tmax) were calculated using DAS 2.0 software. The method demonstrated excellent linearity (0.50-500.00 ng/mL, r > 0.9905), precision (RSD < 10%), and accuracy (± 13%). Compared to free BC, BC@HS15/DSPE-PEG2000-L-Val significantly increased tear secretion, reduced MMP-3/MMP-9 expression, and preserved corneal epithelium integrity. In the micelle group, corneal and conjunctival Cmax values were 2.7- and 3.6-fold higher than the solution group, respectively. A sensitive and validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed to measure baicalin concentrations in ocular plasma and tissues of rabbits. BC@HS15/DSPE-PEG2000-L-Val for treating dry eye demonstrated significantly superior outcomes. The nano-micelle notably enhanced BC concentration on the ocular surface and effectively prolonged its retention time.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 5","pages":"39"},"PeriodicalIF":4.3,"publicationDate":"2025-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12511513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145259714","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of the feasibility of including community pharmacies under the regulation of the saudi food and drug authority.","authors":"Ahmed H Alanazi, Hessa H Alhaidar, Mohammad A Altamimi","doi":"10.1007/s44446-025-00036-0","DOIUrl":"10.1007/s44446-025-00036-0","url":null,"abstract":"<p><p>In Saudi Arabia, the regulation of community pharmacies currently falls under the Ministry of Health (MOH). There is a need to shift the regulatory framework of community pharmacies to be under the Saudi Food and Drug Authority (SFDA) to align with global standards. However, there is limited knowledge about the perceptions of pharmacists regarding the current regulatory framework in community pharmacies in the Kingdom of Saudi Arabia (KSA).</p><p><strong>Objectives: </strong>This study aims to assess pharmacists' knowledge, perceptions, and preferences regarding the current regulatory framework of community pharmacies and feasibility of transitioning regulatory oversight to SFDA.</p><p><strong>Methodology: </strong>A cross-sectional survey design was used to assess the regulation of community pharmacies in Saudi Arabia. The sample consisted of 139 pharmacists from various sectors, selected through random sampling. A structured questionnaire focusing on regulation, awareness, and perceptions was distributed online. The questionnaire's validity and reliability were ensured through expert review. Descriptive statistics in SPSS were used for data analysis.</p><p><strong>Results: </strong>The survey findings revealed a diverse representation across the pharmaceutical sector. Hospital pharmacists formed the largest group (37.4%, n = 52), followed by regulatory field workers from the Ministry of Health (21.6%, n = 30) and SFDA (20.1%, n = 28), pharmaceutical industry professionals (11.5%, n = 16), and community pharmacists (9.4%, n = 13). Most participants (51.8%, n = 72) had 1-5 years of experience, while 31.7% (n = 44) had 6-10 years, and 16.5% (n = 23) had more than 10 years of experience. Regarding current regulatory oversight, the majority (82.7%, n = 115) reported being under MOH regulation, with 12.2% (n = 17) under SFDA oversight. The study revealed high awareness of current regulations (77.0%, n = 107), though most participants (62.6%, n = 87) expressed dissatisfaction with the current regulatory framework. Notably, 77.0% (n = 107) preferred SFDA as the future regulator, and 80.6% (n = 112) believed SFDA would perform better in regulating the sector. Most participants demonstrated strong agreement with proposed regulatory changes, with 78.4% (n = 109) agreeing to P1 and 79.1% (n = 110) to P4 statements regarding regulatory reform.</p><p><strong>Conclusion: </strong>The study reveals strong sector-wide preference among pharmaceutical professionals for transitioning community pharmacy regulation to SFDA, driven by dissatisfaction with current MOH oversight. This consensus across all professional categories and experience levels indicates practitioners' expectations that SFDA regulation would enhance pharmaceutical service quality and regulatory effectiveness in Saudi Arabia.</p>","PeriodicalId":49257,"journal":{"name":"Saudi Pharmaceutical Journal","volume":"33 5","pages":"36"},"PeriodicalIF":4.3,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12491131/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145208003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}