ArticleSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2025
Assessment of the feasibility of including community pharmacies under the regulation of the saudi food and drug authority.
Article in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
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).
objectivesThis 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. METHODOLOGY: 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.
resultsThe 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.
conclusionThe 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.
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