Alfageh Basmah H, Abanmy Norah O, Kentab Basma Y, Almohammed Omar A
Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Pharmacoeconomics Research Unit, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
Front Pharmacol. 2024 Jul 31;15:1380231. doi: 10.3389/fphar.2024.1380231. eCollection 2024.
Laws and regulations are needed to regulate the growing online pharmacy (OP) services. The main objective of this work was to provide an overview of the laws and regulations for OP services in the Gulf Cooperation Council (GCC) countries. In addition, the perception of how these laws and regulations in Saudi Arabia (SA) affect the online ordering of medications and health-related products from national and international OPs was explored.
A secondary data collection through emails and a qualitative descriptive analysis was used to gain insight into the OP regulations in the GCC countries. Then, a qualitative study was carried out with semi-structured interviews to investigate the impact of these regulations on the practice and the market from the OP service providers' perspective. The interviews were carried out with a sample of major OP service providers in SA, to represent the GCC countries. During the interviews, multiple open-ended questions were used to explore opinions about the OP regulations and how these regulations affected the practice. The interviews were then transcribed and thematically analysed.
Responses were mainly received from regulators in SA, Bahrain, Oman and United Arab Emirates (UAE). SA and UAE allow for offering of OP services as add-on service for existing community pharmacy, while UAE also allows for standalone OP providers. SA, Bahrain, and Oman allow online ordering of both over-the-counter (OTC) and prescription-only medications (POM) from international OP; a prescription is required for POM and quantities allowed should be no more than 3 months' supply in case of SA and Oman while this was not specified in case of Bahrain. Invoice of purchase was also required for any POM to be released from customs in SA and Bahrain but not in Oman and UAE. Controlled medications were prohibited to be ordered online in SA, UAE, and Bahrain while it was allowed in Oman if the prescription was issued within 6-month, and the quantity dispensed was for 1 month only. Apart from online ordering of medications in these countries, no specific regulations existed to regulate ordering of other health-related products from local or international OPs. Whether Kwait and Qatar have regulations for OP could not be established due to lack of response. Two of the four interviewed representatives of OP service providers in SA were not aware of the existence of specific regulations for OP services. The representatives who were aware of these regulations were satisfied with them and found them beneficial for their business and for the patients at the same time. However, representatives raised concerns regarding the enforcement of regulations on international OP providers.
The existing regulations for online ordering of medications are somewhat comparable between the GCC countries, with no specific regulations for ordering of other health-related products from local or international OPs. In SA, there is limited awareness of the existing regulations for OP services by providers. Nevertheless, the need for detailed regulations on certain aspects of OP services was highlighted, such as regulations for international OPs and importing medications for personal use.
需要法律法规来规范日益增长的在线药房(OP)服务。这项工作的主要目的是概述海湾合作委员会(GCC)国家的OP服务法律法规。此外,还探讨了沙特阿拉伯(SA)的这些法律法规如何影响从国内和国际OP在线订购药品和健康相关产品。
通过电子邮件进行二次数据收集,并采用定性描述性分析来深入了解GCC国家的OP法规。然后,通过半结构化访谈进行定性研究,从OP服务提供商的角度调查这些法规对实践和市场的影响。访谈对象为SA的主要OP服务提供商样本,以代表GCC国家。在访谈过程中,使用了多个开放式问题来探讨对OP法规的看法以及这些法规如何影响实践。访谈内容随后进行转录和主题分析。
主要收到了来自SA、巴林、阿曼和阿拉伯联合酋长国(UAE)监管机构的回复。SA和UAE允许将OP服务作为现有社区药房的附加服务提供,而UAE也允许独立的OP提供商。SA、巴林和阿曼允许从国际OP在线订购非处方药(OTC)和仅凭处方销售的药品(POM);购买POM需要处方,在SA和阿曼,允许的数量不应超过3个月的供应量,而巴林则未对此作出规定。在SA和巴林,任何POM从海关放行都需要购买发票,而在阿曼和UAE则不需要。在SA、UAE和巴林,禁止在线订购管制药品,而在阿曼,如果处方开具时间在6个月内且配药量仅为1个月,则允许在线订购。除了这些国家的药品在线订购外,没有具体法规来规范从本地或国际OP订购其他健康相关产品。由于未收到回复,无法确定科威特和卡塔尔是否有OP法规。SA的四名OP服务提供商受访代表中有两名不知道存在OP服务的具体法规。了解这些法规的代表对其感到满意,并认为它们对其业务和患者都有益。然而,代表们对国际OP提供商法规的执行情况表示担忧。
GCC国家之间现有的药品在线订购法规在一定程度上具有可比性,对于从本地或国际OP订购其他健康相关产品没有具体法规。在SA,提供商对OP服务现有法规的认识有限。尽管如此,仍强调了对OP服务某些方面制定详细法规的必要性,例如对国际OP的法规以及个人使用药品的进口法规。