An online pharmacy is an internet-based vendor that sells medicines and includes both legitimate and illegitimate pharmacies. Independent Internet-only sites, online branches of “brick-and-mortar” pharmacies, and sites representing partnership among pharmacies fall under the purview on “online pharmacies.”[1] Contemporary times are witnessing a surge in E-commerce, including online shopping, and this includes the sale of prescription and nonprescription medicines as well. The concept of online pharmacies and online sale of medicines has been in vogue worldwide for more than two decades. An estimated 2986 online pharmacies were operating globally in the year 2008,[2] the numbers of which would have risen as of today. Indian consumers too have begun using these online services in the recent times. Laws for E-commerce are ill-defined and subject to varied interpretations.[3] Various laws such as the Information Technology Act, 2000; the Drug and Cosmetics Act, 1940; Drugs and Cosmetic Rules, 1945; Pharmacy Act, 1948; and the Indian Medical Act, 1956, govern the online pharmacies in India. Many of these, including the Drugs and Magic Remedies Act, under which drug advertisements are regulated, were written when use of computers and the internet was not as prevalent as it is now. Laws do exist for online pharmacy stores in India. As per the Indian laws, medicines can be sold only by a registered pharmacy that has a retail license and a registered pharmacist on payroll. A prescription for medicines ordered is mandatory, except for sale of over-the-counter products. Orders for medicines can be taken only from areas where the pharmacy retail license applies. All the medicines must be verified and certified by the registered pharmacist before delivery. However, there is an ambiguity regarding shipping of medicines from one state to another and whether a pharmacy is allowed to collect money before delivery of medicines. Exporting medicines India directly to the customers is highly regulated. Furthermore, no provision exists to recognize the prescription written by a doctor who is not registered in India. Schedule X medicines cannot be sold to customer without prescription. It is imperative to maintain customer records including name of the patient, doctor, and address for every Schedule H and Schedule X medicines sold by the pharmacy. Selling medicines to minors (under age 18), selling banned drugs, and selling medicines at a cost higher than the maximum retail price are prohibited. Additional technolegal requirements related to privacy, diligence to cyber laws, data protection, and internet advertising are required to be complied with, by these pharmacies.
Why are online pharmacies popular? Online pharmacies offer better pricing than offline stores, with increased access, lower transaction and product costs, convenience and greater anonymity for consumers. They offer accessibility to people with limited mobility and people in remote areas. These provide medialerts (personalized medicine reminder service), discounts, doorstep delivery within a short time, and validation of prescription through licensed pharmacists. Information about substitutes and adverse effects is also available on these sites. Consumers believe (perhaps rightly) that the medicines they receive from online pharmacies are comparable to medicines sold in the “brick-and-mortar pharmacies.” Notwithstanding their popularity, these pharmacies enjoy a fair share of controversies. The controversies gained media attention after the anthrax cases in 2001 which saw people ordering ciprofloxacin without a prescription.[4] Use of “cyber doctors,” the dispensing of drugs without prescriptions, and the import of prescription medications are just the tip of the iceberg. “Cyber actors” evaluate patients through questionnaires and checklists and prescribe medication based on this communication. These online consultations forgo the detailed patient evaluation and physical evaluation that is considered necessary before providing treatment. It obviously promotes self-medication. Patients who obtain these medications may suffer drug–drug interactions and adverse effects, about which they may have no/inadequate prior warning or counseling.
While online pharmacies could be a boon for consumers, these have acquired a not-so-commendable reputation due to various reasons, the primary of which is the unregulated manner of functioning. The scope of services offered by the online pharmacies is not limited to India alone. As per an estimate, there are between 30,000 and 50,000 online pharmacies operating in the USA. Most are based far from the jurisdiction of US officials, in Russia, China, India, or Turkey.[4] The Alliance for Safe Online Pharmacies, a nonprofit organization focuses on raising consumer awareness about online pharmacies, states that several of these selling to American consumers are illegitimate.[5] Off-shore buyers can obtain prescription drugs such as antidepressants, antianxiety medications, antihypertensives, medical termination of pregnancy kits, weight loss pills, and sildenafil citrate containing products easily. Fatality and severe adverse reactions due to consumption of diet pills, counterfeit medicines, formulations contaminated with lead and other heavy metals, wrong medicines or dose dispensed online without a prescription, and illegal use of medicines which are known to be habit forming have been reported. Most of these reports originate from the West, but we might witness similar reports from India as well, considering the growing use of online pharmacies in the country. Often, the source country from where the medicines are shipped is different from those claimed by the website, a practice that is considered fraudulent and illegal. In addition, illegal websites may disappear without trace, at a slightest hint of a regulatory action. Consumers seeking overseas options to purchase medicines also pose a threat to the pharmaceutical industry and pharmacists of the respective country. A fall out of this is a lobbying that made it seems as if all cheaper medications purchased from international sources are substandard, illegal, or counterfeit, which is not entirely true. Online pharmacies reduce transactional costs and the costs of obtaining pharmaceuticals through a more efficient centralized order-processing system. The reduced procurement and transactional costs are passed onto consumers in the form of lower prices. The anonymity offered by the internet encourages patients to seek information about medicines that they would otherwise avoid asking their physician or at an offline pharmacy. Legitimate sites have appropriate technology to ensure security although the use of “cookies” to collect information about visitors and lack of secure web technology are inherent risks to anonymity.
A lack of oversight, dud medicines, sugar pills, expired, adulterated, and contaminated medicines pose a real risk for patients. Lack of monitoring encourages fraudulent practices such as sending incorrect dosages or generic variants when the physician has prescribed a brand name. Government and regulatory agencies and courts of law have tried to address these controversies, but the interventions have not been able to keep pace with the rapid growth and onslaught of the “rogue” internet pharmacies. The US Food and Drug Administration (FDA) with INTERPOL and 200 law enforcement agencies around the world conducted a global action against online pharmacies, in the year 2014, wherein 237 people were arrested and more than 10,600 illicit websites were shut down.[6] The Pharmaceutical Crime Program supported by major pharmaceutical companies in 2013 helped crack down on illicit sites.[6] Reputed sites such as the Microsoft, Yahoo, and Google permit only online pharmacies accredited through Verified Internet Pharmacy Practice Sites (VIPPS) program to advertise in the U.S. The credit card companies including VISA decline payments to online pharmacies that are not VIPPS-certified. In India too, the Maharashtra FDA have approached the Drugs Controller General of India to curb the illegal online sale of medicines.[7]
Role of Consumers
Consumer awareness is the key to curb such fraudulent practices; consumers need to be educated about the need to verify the authenticity of the service provider as well as the product and to avoid sites that sell drugs without a legal prescription. Good online pharmacies have well-defined safety and quality benchmarks, uncomplicated privacy and security policies, a verifiable physical address and licensed pharmacist on roll. Clinicians should familiarize themselves with a few reputable and legitimate online pharmacies that they may recommend to their patients. A mutual awareness of online purchase of medicines by the patient is necessary for better patient management and avoidance of the consequences of self-medication. We need to reflect on the consumers' interests and inclinations for online pharmacies to enhance a symbiotic the physician-pharmacist-patient relationship. These measures coupled with adequate monitoring from regulators can help the consumer reap rich benefits of these pharmacies, sans the inherent risks involved.
References
- 1.Fung CH, Woo HE, Asch SM. Controversies and legal issues of prescribing and dispensing medications using the Internet. Mayo Clin Proc. 2004;79:188–94. doi: 10.4065/79.2.188. [DOI] [PubMed] [Google Scholar]
- 2.Lax Regulation Sees India Becoming a Haven for Illegal Online Pharmacies. [Last accessed on 2016 Oct 20]. Available from: http://www.livemint.com/Home-Page/NFIWys7sX5w4TX7RzrqrKI/Lax-regulation-sees-India-becoming-a-haven-for-illegal-onlin.html .
- 3.Electronic Trading of Medical Drugs in India. [Last accessed on 2016 Oct 20]. Available from: http://www.ecommercelawsinindia.blogspot.in/2012/03/electronic-trading-of-medical-drugs-in.html .
- 4.Expanded Reporting: Anthrax: Study Finds Outbreak of Cipro Web Sites Followed Mailattacks. Med Lett CDC & FDA. 2002 Oct 13; [Google Scholar]
- 5.Amy Nordum. US Patients Turn to Online Pharmacies for Cheap Meds, but Drug Companies Say the Sites Endanger Consumers. [Last accessed on 2016 Oct 15]. Available from: http://www.ibtimes.com/us-patients-turnonline-pharmacies-cheap-meds-drug-companies-say-sites-endanger-1932079 .
- 6.INTERPOL and Pharmaceutical Industry Launch Global Initiative to Combat Fake Medicines. [Last accessed on 2016 Oct 20]. Available from: https://www.interpol.int/News-and-media/News/2013/PR031 .
- 7.Maharashtra FDA Approaches DCGI for Regulating Illegal Online Pharmacies Operating in India. In E-Retailing Laws and Regulations in India. [Last accessed on 2016 Oct 20]. Available from: http://www.ptlb.in/ecommerce/?p=272 .