Global e-pharmacy regulations: protocol for a scoping review
Creators: name: Panda, Sushree Nibedita
name: Goodman, Catherine
name: Satheesh, Gautam
name: Devaki Nambiar
name: Nandakumar, Krishna
Publisher: name: OSF Registries
Year: 2023
Subjects: subject: Medicine and Health Sciences
subject: distance sale
subject: drugs
subject: e-pharmacy
subject: legislation
subject: medicines
subject: online pharmacy
subject: online sales
subject: regulations

description: Review team: Gautam Satheesh, Sushree Nibedita Panda, Krishna Nandakumar, Abdul Salam, and Devaki Nambiar. (The review team will receive inputs from collaborators at the London School of Hygiene &amp; Tropical Medicine (Catherine Goodman and Benjamin Palafox) and Strathmore Business School (Sammy Masibo and Frank Wafula). Funding: Health Systems Research Initiative (UK MRC, FCDO, Wellcome Trust) Background About 2 billion people globally have no access to essential medicines. (1) With online medicine purchase being simple, quick, convenient, and more accessible, particularly for the elderly, the disabled, and those living in rural areas, e-pharmacies present potential opportunities to improve the overall access situation. The global e-pharmacy market is currently growing at a rapid rate; in 2021, it was valued at USD 52 billion and is expected to reach USD 250 billion by 2030, with emerging markets like India growing at the fastest rate. (2) This rapid expansion, especially in many low- and middle-income countries (LMICs), has been largely uncontrolled and carries significant risks, including sale of prescription-only medicines (POMs) without prescription, inadequate information provision to patients, lack of data privacy, and consumer fraud. (3) Most high-income countries (HICs) have regulatory frameworks governing e-pharmacies that mitigate these risks. Additionally, some HICs have mandatory and/or voluntary verification systems in place to identify legitimate e-pharmacies, e.g., ‘EU common logo’, ‘LegitScript certification’, etc. Yet, HICs too have been facing several e-pharmacy-related challenges for years. The major threat in HICs is posed by the plethora of illegal or rogue e-pharmacies—often closely resembling legitimate providers—that operate locally or internationally without licensure, sell counterfeit products, and fail to comply with drug/patient safety laws and regulations. (3) A 2016 report by the Center for Safe Internet Pharmacies stated that 96% of such e-pharmacies did not comply with the relevant laws of countries within which they operate. (4) Other regulatory challenges faced by HICs include the lack of consensus on regulatory models, lack of regulatory capacity, regulating sales across borders, and risks of over-regulation. (3) The situation is potentially more dire in LMICs, many of which currently lack regulations specific to e-pharmacy. In fact many LMICs continue to struggle to ensure regulatory compliance even for brick-and mortar pharmacies, which often operate without qualified personnel, sell POMs rampantly without prescription, provide clinically inappropriate medicines, and do not provide adequate information to patients. (3, 5) Countries with established e-pharmacy regulations may offer several lessons for LMICs in understanding regulatory approaches, identifying best practices, and addressing potential challenges to regulatory compliance. These lessons can be tailored contextually to fit the regulatory and legal environment in LMICs and inform their regulatory process. Previous relevant reviews and reports Based on expert consultations and web searches, we identified five relevant reports/guides. LegitScript—a compliance and monitoring firm that focuses on healthcare product merchants including e-pharmacies—issued two reports in 2016, one focusing on shipping regulations for various countries and the other (in collaboration with Visa.inc), presenting a manual for acquirers, i.e., financial institutions which have boarded or plan to board an internet pharmacy service (6, 7). In 2019, Hock et al. published an online report summarizing the national and international laws, accreditation systems, and approaches to control online medicines sales of selected countries in the OECD and Asia. (8) In 2022, Baker Mackenzie provided an overview of telemedicine and telehealth legal frameworks in nine Asia-pacific countries (9). The most recent report is by SALIENT Advisory, which assessed the status of e-pharmacy regulations across 15 African countries and 4 other countries. (10) In academic literature, only three peer-reviewed studies have focused on e-pharmacy regulations. Miller et al. (2021) described the regulatory systems in Kenya, Nigeria, and India, while they were in development. (3) Rojas-Cortes et al. in 2023 explored regulations in four Latin American countries and recommended strategies for strengthening them. (11) Finally, the review by Sabrina et al. (2021) focused majorly on telemedicine regulations in 5 Asian countries, with a minor focus on tele-pharmacy. (12) Thus, gaps remain in the existing literature. Several of the reviews are now quite out of date, given the rapidly changing e-pharmacy and regulatory landscape, and there is no review covering countries in all global regions, and covering all aspects of e-pharmacy regulation in depth. We aim to undertake a multi-country review of e-pharmacy-related regulations covering all global regions. As our goal is to identify lessons for LMICs developing their own regulatory systems, we have purposively selected a sample of countries from across the globe with established e-pharmacy regulations, to answer the following review questions: 1. What are the regulations relevant to each domain of e-pharmacy (registration, sale/distribution of medicines, classes/categories of drugs sold, quality of drugs, monitoring, data privacy, advertising, e-commerce, tele-health etc.)? 2. How do regulations and regulatory frameworks compare across country and region? 3. What are the common and/or recommended regulatory approaches that may be relevant to or adopted by low- and middle-income countries? Methods The focus of this scoping review includes regulatory, legislative approaches including voluntary accreditation or guidelines at the international, federal, state/province, or municipal levels that relate directly or indirectly to e-pharmacies. The scoping review will be guided by the Joanna Briggs Institute approach to the conduct of scoping reviews. (13) Country selection The context for this review is global and will include legal approaches and government policies from various countries. We will include countries which have established regulations for e-pharmacy, as of June 2023. We will aim to achieve maximum variation of geographic regions (World Health Organization classification) and income groups (World Bank classification). From each WHO region, we will sample at least one country, based on geographical variation and variability of relevant regulations. Following review of relevant literature and expert consultation, we selected 13 countries: Americas (PAHO): United States, Brazil Europe (EU): United Kingdom, Germany, Ireland Southeast Asia (SEARO): Indonesia Western Pacific (WPRO): Singapore, Australia (with few focus states), Japan Africa (AFRO): Ghana, South Africa, Kenya Eastern Mediterranean (EMRO): United Arab Emirates Inclusion criteria • Latest available, currently active official regulatory and legislative documents (directives, acts, policies) issued by an independent country or group of independent countries or relevant regional organization, including official publications of appointed national committees. • Guidelines and documents pertaining to voluntary systems, in the selected countries. For e.g., LegitScript or Verified Internet Pharmacy Practice Sites (VIPPS) in the USA. Exclusion criteria • Documents with no specific reference to e-pharmacies or online sale of medicines. • Advisories or guidance for consumers. • Draft documents or proposed bills that are yet to be enforced. • Documents authored by expert groups as part of official consultative processes leading up to formulation of guidelines or policies. Search strategy and sources For each country of interest, we will search the official government and regulatory websites (e.g., USFDA, EMA etc.) for regulations and legal documents, without any restrictions to document type, language, or date of issue. We will then perform site searches on Google and Google Scholar using appropriate search strings (e.g., “Site:.gov “online pharmacy”) to yield potentially relevant results. Additionally, we will review the reference lists and cross references in national legislation to identify other relevant laws. Finally, key informants from the selected countries will be consulted to ensure that we have identified all the relevant documents for each country. Selection of regulatory documents and data extraction A pilot review of four regulatory documents will be conducted to test the inclusion criteria, evaluate the assessment tool, and finalize the guidance on selecting and extracting data (See Appendix). Following the pilot, the identified documents will be screened independently and in duplicate by the reviewers (KN, SNP, and GS). Data from each document will be extracted by one reviewer and verified by a second reviewer. Non-English texts, if possible, will be translated using online tools. Any disagreements in screening and data extraction will be resolved through discussion between the two reviewers , and if they cannot reach consensus, other team members (DN and AS) will be consulted. All extracted data will be stored in Microsoft Excel. Data extraction tool We developed a data extraction template to adequately capture the information provided in the identified documents, which will be evaluated in the pilot. [See Table 2] The minimum data to be extracted from a given document will include the title of the document, issuing authority, year of issue, country, regulatory domain, enforcement, and subject of legislation. Study data will be collected and managed using REDCap electronic data capture tools hosted at The George Institute for Global Health, India. (14, 15) References 1. Ozawa S, Shankar R, Leopold C, Orubu S. . Access to medicines through health systems in low- and middle-income countries. Health Policy Plan 2019;34(Supplement_3):iii1-iii3. 2. Grand View Research. ePharmacy Market Size, Share &amp; Trends Analysis Report, 2022–2030 [Internet]. 2022. Available from: https://www.grandviewresearch.com/industry-analysis/epharmacies-market 3. Miller R, Wafula F, Onoka CA, et al. When technology precedes regulation: the challenges and opportunities of e-pharmacy in low-income and middle-income countries. BMJ Glob Health. 2021;6(5):e005405. 4. LegitScript. The Internet Pharmacy Market in 2016: Trends, Challenges, and Opportunities. 2016. Available from: http://safemedsonline.org/wp-content/uploads/2016/01/The-Internet-Pharmacy-Market-in-2016.pdf 5. Satheesh G, Puthean S, Chaudhary V. E-pharmacies in India: can they improve the pharmaceutical service delivery? J Glob Health. 2019;10:010301. 6. Visa Inc. Online Pharmacy Guide for Acquirers. 2016. Available from: https://bd.visa.com/content/dam/VCOM/global/support-legal/documents/online-pharmacy-guide-for-acquirers-vbs-18-apr-2016.pdf 7. LegitScript. Internet Pharmacy Policy Guide. 2016. Available from: https://www.legitscript.com/wp-content/uploads/2016/06/Country_by_Country_-_Internet_Pharmacy_Regulations_-_3-23-15.pdf 8. Hock SC, Lee MMX, Chan LW. Regulating Online Pharmacies &amp; Medicinal Product E-Commerce. 2019. International Society for Pharmaceutical Engineering. Available from: https://ispe.org/pharmaceutical-engineering/november-december-2019/regulating-online-pharmacies-medicinal-product-e 9. Baker McKenzie. Telemedicine and Telehealth Legal Framework Overview. 2022. Available from: https://www.bakermckenzie.com/-/media/files/insight/topics/healthcare-life-sciences/baker-mckenzie-telemedicine-and-telehealth-legal-f.pdf?sc_lang=en&amp;hash=BAE0C28E4145CA80515B9E5D5F35F97A 10. SALIENT Advisory. Online Pharmacy in Africa: Landscape of Online Pharmacy Regulations. 2023. Available from: https://www.salientadvisory.com/2022/11/23/online-pharmacy-in-africa-supporting-pharmaceutical-regulatory-agencies-to-advance-access/ 11. Rojas-Cortés R, Gorordo M, Vahos J, et al. Regulación de la venta de productos médicos por Internet: experiencias y estrategias para Latinoamérica [Regulation of the online sale of medical products: experiences and strategies for Latin America]. Rev Panam Salud Publica. 2023;47:e81. 12. Intan Sabrina M, Defi IR. Telemedicine Guidelines in South East Asia-A Scoping Review. Front Neurol. 2021;11:581649 13. Peters MDJ, Marnie C, Tricco AC, et al. Updated methodological guidance for the conduct of scoping reviews. JBI Evid Synth. 2020;18(10):2119-2126. 14. PA Harris, R Taylor, R Thielke, et al. Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81. 15. PA Harris, R Taylor, BL Minor, et al. The REDCap consortium: Building an international community of software partners, J Biomed Inform. 2019