1. Regulations of Online Pharmacy Services

3.  The Internet, first developed as a resource to facilitate communication, has now
grown into a global network of computer systems that link multiple platforms and
creates interrelationships between governments, academic institutions, businesses
and consumers.
 Buying medicines online is common practice across the globe these days. This is
because buyers are preferring to order for medicines through a click of a button
rather than taking a trip to a drug store.
 Within this global perspective, industry analysts have projected that Internet
pharmacies will generate US$ 15 billion in prescription drug sales by 2016 and over
US$ 30 billion by 2022.
 Many of these websites, however, deliver prescription drugs without a valid
prescription, dispense drugs of questionable quality, and fail to provide adequate
independent information to patients on possible adverse reactions and drug
interactions.

12.  Although e-commerce of medicinal products has many
benefits for patients and the pharmaceutical industry, it
remains a concern for regulatory authorities (RAs)
worldwide.
 Regulatory Authorities must safeguard the public from
potential harm posed by illegitimate online pharmacies.
Existing laws may need to be amended, and
enforcement approaches changed, to address the
transnational nature of e-commerce of medicines.

13.  In 1997, the World Health Organization called on its Member States to
tighten controls on the sale of medical products through the Internet.
 WHO was especially concerned that Internet sales may bypass national
drug regulatory authorities, thereby liberating medical products onto the
market which are unapproved, fraudulent, unsafe, or ineffective.
 Legal internet pharmacies must adhere to the laws and regulations of the
specific country in which they are operating.The WHO, as well as the FDA,
has identified the dangers of online pharmacies.
 To gain consumer confidence and make a clearer distinction between legal
and illegal sites, the United States National Association of Boards of
Pharmacy (NABP) has developed the Verified Internet Pharmacy Practice
Sites (VIPPS) programme.
 To be VIPPS certified, a pharmacy must comply with the licensing and
inspection requirements of their State and each State to which they
dispense pharmaceuticals. If the pharmacy has demonstrated to NABP
compliance with VIPPS criteria, it will display the VIPPS hyperlink seal on its
website.

14.  VIPPS criteria include patient rights to privacy, authentication and
security of prescription orders, adherence to a recognized quality
assurance policy, and provision of meaningful consultation between
patients and pharmacists
 National authorities such as the US Food and Drug Administration (FDA)
has published tips and warnings for consumers in the Internet to make
people aware of the dangers of buying medical products online.
 Professional pharmaceutical and medical bodies such as the
Pharmaceutical Group of the European Union (PGEU) and Standing
Committee of European Doctors (CP) have released their own
document “The Internet and Medicines: enjoy the Internet but don‟t risk
your health!”
 At present, regulatory authorities rely on a collection of legal
regulations, international law enforcement operations, and
accreditation programs to address safety concerns related to the e-
commerce of medicinal products.

15. US Legal Restrictions on Online Sales
 Laws regulating the online sales of medicinal products vary from country to
country. In the US, the Ryan Haight Online Pharmacy Consumer Protection
Act of 2008 strictly restricts consumers’ online access to controlled
substances.
 Online pharmacies dealing with controlled substances must register with the
US Drug Enforcement Administration (DEA). Consumers must also complete
an in-person medical examination by a qualified practitioner to obtain a
valid prescription before they can purchase controlled substances.

16. Laws Against Counterfeit Medicines
 The Drug Supply Chain Security Act and the Falsified Medicines Directive (FMD) are
legislative tools used by the US and the European Union, respectively, to address the
dangers of counterfeit medicines.
 By creating an interoperable electronic track-and-trace system, regulatory
authorities aim to prevent counterfeit medicines from entering the legitimate supply
chain.
 To ensure that the supply chain is secure, key supply chain stakeholders such as
manufacturers, repackagers, distributors, and pharmacies must ensure the
authenticity of products at the point of receipt before handing them over to the next
party in line.
 Under Falsified Medicines Directive, EU-based online pharmacies must obtain a
common logo from the national regulatory authorities to display on their
website.Clicking the logo directs the consumer to the pharmacy’s entry on the
regulatory authoritie’s online list of authorized/registered pharmacies, thus verifying
that the pharmacy site is legitimate.

17. International Law
 The MEDICRIME Convention, an initiative of the Council of Europe, is the
first international treaty to criminalize online sales of counterfeit medicinal
products.Individuals engaged in such sales will be prosecuted regardless
of the country where the act was committed.

18. Accreditation Systems
 Accreditation systems can help improve information asymmetry and offer safety
assurance to consumers.For example, these systems provide tools such as accreditation
seals or website checkers that verify the legitimacy of online pharmacies. However, many
consumers are unaware of the existence and purpose of accreditation systems,and some
illegitimate online pharmacies have used fake accreditation seals on their websites to
deceive unsuspecting consumers.

19. The “.pharmacy” Domain
 The “.pharmacy” domain scheme complements national accreditation
systems to verify the legitimacy of online pharmacies. It was launched
by NABP in 2014 to provide consumers worldwide with a way to identify
safe, legitimate, and ethical online pharmacies.
 As the owner of the “.pharmacy” domain, NABP determines which
pharmacies to host on the domain and requires that they demonstrate
legitimacy. Regulatory Authorities may audit NABP periodically to
ensure its reliability and fairness in implementing this scheme.

22. Discussion
 Unfortunately, 66% of countries worldwide do not have laws that explicitly regulate
or prohibit online sales of medicinal products.
 Prescription-only medicines and over-the-counter medicinal products can
therefore be sold on e-commerce platforms by anyone. As a result, regulatory
authorities in these countries are only able to employ the “buyers beware”
approach and hope that consumers will remain vigilant when buying medicinal
products online.
 Regulatory authorities that allow prescription-only medicines online sales can use
an official accreditation system and online registries to direct consumers to
legitimate sites,whereas regulatory authorities that prohibit prescription-only
medicines online sales make it clear that no one is allowed to sell them via e-
commerce.
 Additional restrictions may be imposed. For example, although China allows online
sale of over-the-counter medicines, it prohibits their sales on third-party e-
commerce platforms, including its very own Tmall.com.

23. • most countries criminalize such acts on the basis of counterfeiting and deception
with intent to harm, existing legal frameworks are fundamentally bound by
territorial boundaries.
• To extend jurisdiction beyond their borders or request extradition to prosecute a
suspect, regulatory authorities need a harmonized set of international
agreements, such as treaties or conventions

24. Reasonable precautions private organizations can implement to prevent
illegitimate online pharmacies from conducting illicit activities

25. Conclusion
 E-commerce of medicinal products is expected to become an integral part of
healthcare systems in the future. Increased e-commerce of medicinal products can
bring about advantages such as lower cost, convenience, and consumer privacy.
However, the shift from physical stores to online platforms also presents health risks.
 Many regulatory authorities lack legislation to properly regulate online pharmacies.
Jurisdictional and resource limitations have allowed criminals to escape prosecution.
The lack of legislation to mandate private organizations’ cooperation in investigations
also impacts enforcement efforts negatively.
 Going forward, a proposed strategic and holistic approach may help regulatory
authorities regulate e-commerce of medicinal products more effectively. This strategic
approach—which incorporates a stepwise implementation of industry guidelines,
advisories, and warnings; legislation; and associated enforcement activities—can
address the current risks associated with illegitimate online pharmacies and illegal
medicinal product e-commerce.

27.  1. Ballowe H. The Advantage and Disadvantage of your online pharmacy. Articles Factory. 2010 December 8. Available from: www.articlesfactory.com/articles/health.
 2. Jacobian E. Advantages and Disadvantages of Buying medicines though online pharmacy. Pharma Science.; 2014 November 11. Available from:
https://storify.com/emilyjacobian/advantages-and - disadvantages-of-buying-medicines-t.
 3. Oliver AJ. Internet Pharmacies: Regulation of growing industry. Journal of Law, medicines and ethics. 2000; 28(1): 98-101.
 4. Bargh JA, McKenna KYA, Fitzsimmons GM. Can you see the real me? Activation and expression of the „true self‟ on the internet. Journal of Social Issues. 2002; 58(1): 33-48.
 5. Anand A, Sethi N, Sharon G. Internet Pharmacy: Need to implemented in India. Young Scientist. 2010 January 15. Available from: www.opubs.com/cys.
 6. Priyanka VP, Ashok BK. E-pharmacies regulation in India: Bringining new Dimensions to pharma sector. Pharmaceutical Regulatory Affairs. 2016, 5 (2): 15-21.
 7. Davis S. Advantages, Disadvantages, and Legal issues associated with online pharmacies. The Journal of Education, Community and Values. 2007 January 10. Available from:
http://bcis.pacificu.edu/journal/2007/oldavis.php
 8. Zeman SE. Regulation of online pharmacies: A case for cooperative federalism. Annals of health law.2001; 20(10): 105.
 9. Rice RE, Katz JE. The internet and the health communication: Experiences and expectations. Sage publication.2001; 26-27.
 10. Montengro D. Benefits and Risks of using an online pharmacy. 2009 December 14. Available from: https://www.pharmacychecker.com/benefits-risks-online-pharmacies.asp
 11. Bradford J. Local pharmacy vs. online pharmacy. Soliant Health. 2010 June 9. Available from: http://blog.soliant.com/pharmacy/local-pharmacy-vs-online-pharmacy
 12. Siegel-Itzkovich J. WHO calls for tighter controls on Internet. Medical Journal. 1997; (314): 1501.
 13. Armstrong K, Sanford SJ, Asch DA. Direct sale of sildenafil (Viagra) to consumer over the internet. The New England Journal of Medicine. 1999; (341): 1389-1392.
 14. Verified Internet Pharmacy Practice Sites (VIPPS TM). A program of the National Association of the Boards of pharmacy. 2014 March 3. Available from: http://vipps.nabp.net/verify.asp
 Jain et. al A review on the pros and cons of online pharmacies Journal of Applied Pharmaceutical Research January – March 2017 Volume 5 Issue 1 26
 15. Henney JE, Shuren JE, Nightingale SL.et al. Internet purchase of internet drugs: buyers beware. Annals of Internal Medicine. 1999; (131): 861-862.
 16. American Medical Association: Boards of Trustees Report 35. Internet prescribing: an interim report. American Medical Association House of Delegates Proceedings, 148th annual Meeting.
Chicago, 1999.
 17. World Health Organization. Medical products and the Internet: A guide to finding reliable information. Geneva; 1999 April 4. Available from: http://www.eho.int/medicines/library/qsm/who-
edm-qsm- 99-4/medicines-on-internet guide.html.
 18. FDA. The Possible Danger of Buying Medicines over the Internet. FDA Consumer Health Information. 2010
 November 5. Available from: www.fda.gov/consumer/consumernews.html.
 19. PGEU and CP. The Internet and Medicines: Enjoy the internet but don‟t risk your health. 1999 May. Available from: http://www.pgeu.org/02.html.
 20. Kielgast PJ, Bonde J, Molin H.et al. Pharmacy, Pharmacies and Internet. Report and reflections from a study mission commissioned by the Federation Internationale Pharmaceutique. March,
2000.
 21. FDA. Buying Prescription Medicine online: A consumer safety guide. National Council on Patient Information and Education. 2010 November 5. Available from: www.fda.gov/buyonlineguide.