The article summarises the important steps toward online medication safety, and the potential role of pharmacists in facilitating the safe use of medications obtained from the internet
András Fittler PharmD PhD
Lajos Botz PharmD PhD
Department of Pharmaceutics and Central Clinical Pharmacy
University of Pécs, Hungary
Email: [email protected]
The internet has revolutionised communication, everyday life, commerce and also healthcare during the past decades. The majority of European households now have internet access and millions can reach online services on their mobile devices away from work or home. A popular use of the Internet is to find medical information, and many rely on it as a basic health information resource.(1) Internet commerce provides the opportunity to purchase various goods, and medicines are not an exception.(2) Internet, or online pharmacies sell pharmaceuticals, including prescription medications. According to a recent systematic review and our previous studies, it is estimated that nearly 6% of the general population is buying drugs online.(2) Unfortunately the majority of online drug sellers violate safe pharmaceutical practices and laws. Numerous websites sell medicines without valid medical prescriptions and possibly distribute substandard, illegal, unapproved or counterfeit drugs.(3)
It is likely that a customer/patient will encounter a potentially dangerous website because the number of online pharmacies operating illegally is enormous, easily outnumbering legitimate sellers.(4) According to the LegitScript Internet pharmacy certification standards, only 0.7% of 36,000 active Internet pharmacies are classified as legitimate.(5) Illegal internet medicine distributors can pose a great health risk because online customers are often not aware that drugs purchased from these sources might not have the rigorous pharmaceutical quality required of conventional retail pharmacies.(6) The difficulty of determining the legitimacy of a website is another crucial problem, especially if it is a foreign internet pharmacy. Because of these numerous contributing factors, the growth of unregulated drug markets and the spread of counterfeit medications is becoming a serious public health risk,(7) consequently causing a financial burden because of ineffective drug treatments, adverse events, incorrect active ingredients, or loss of confidence in the health system.(4)
Effective regulation is required
Ordering medicines from the internet can possibly be convenient and economical for patients. Online pharmacies can provide further benefits to customers, for example, privacy, fast and free access to information, comparison of drug prices, and access to medicines that are not available because of drug shortages. These positive features are undeniable in cases of legitimate and regulated online pharmacies, where patients can take advantage of the opportunity without significantly endangering their safety. Although the benefits seem obvious and are widely advertised on most websites, customers might not understand that the lack of face-to-face consultation with a healthcare professional can have unfavourable consequences. On the other hand, obtaining prescription-only drugs via the internet (which is technically illegal in most European countries), or without a valid medical prescription is potentially unsafe in many cases.
Dangers include the lack of meaningful interaction with healthcare professionals (physician and/or pharmacist), misdiagnosis, inappropriate use or dosage of a medicine, abuse of controlled drugs, no personal data protection, and delays in delivery/non-delivery. Such dangers are further exacerbated when medicines are purchased from unlicensed and illegal websites delivering products with unknown origins and potentially substandard or counterfeit medications.(8)
Because internet pharmacies are accessible to global consumers, they may have a global effect. Therefore, an international approach is required with respect to the regulation of online medical trade. Above all healthcare professionals should deliberately take part in prevention and patient education regarding this issue in their everyday activities.
Internationally harmonised regulation in the EU
Low quality, fake and potentially unsafe drugs can reach patients or customers either by the infiltration of such medicines in the legitimate supply chain, or by purchasing drugs from illegal distributors, such as fraudulent online pharmacies. So far, only a small number of counterfeit medicines have reached the legitimate pharmaceutical supply chain in Europe, but as online trade is difficult to regulate and falsifications become more sophisticated, online resources and illegal distribution of medications can pose a significant threat. Wide availability of the internet, e-commerce and the free movement of products has facilitated the development of online drug markets, especially illegal drug sellers. Today the online ordering and mail delivery of medicines is probably one of the most important potential sources of substandard, fake and counterfeit medicines in developed countries.
A new legislation (directive 2011/62/EU) on falsified medicines based on the 2008 proposal by the European Commission has been published. It is now applicable and was made national law in member states in January 2013.(9) The directive introduces stricter measures to ensure the safe trade of medicines, such as: (i) an obligatory authenticity feature on the outer packaging of medicinal products; (ii) a common European logo of legally-operating online pharmacies/retailers clearly displayed on every page of the website; (iii) tougher control and inspection of the producers of active pharmaceutical ingredients; and (iv), stricter record-keeping requirements for wholesale distributors.
Accreditation and verification
Urgent steps are required to combat the unregulated online sale of medicines and to protect people purchasing drugs from the internet. Introduction of internationally accepted security logos and publicly accessible, centralised registers of officially licensed mail-order pharmacies is one potential solution. Worldwide governmental and professional bodies are currently developing national and internationally harmonised regulations and focusing on public campaigns regarding the dangers of online medicines. Several professional organisations have developed an accreditation/verification system for websites to improve patient safety by distinguishing reliable operations from illegal ones.
The HON code certification is an international ethical standard aiming to offer quality health information. The Royal Pharmaceutical Society of Great Britain has developed an internet pharmacy logo to aid members of the public in identifying who is operating an internet site from a registered pharmacy premises. Similarly, a security logo of the German Register of Mail Order Pharmacies is displayed on trusted online pharmacies in Germany. In the US, the National Association of Boards of Pharmacy has set up the requirements for the Verified Internet Pharmacy Practice Sites accreditation programme. A limitation of these accreditation programmes is that involvement is voluntary and is ignored by rogue sites. Furthermore, accreditation logos can also be misleading because illegal operators can easily display fake seals or verification logos.
Public campaigns, consumer education and enforcement
Another effective method to draw patients’ attention to the dangers of illegal online resources of medicines is the provision of public information outlining the complexity of the problem. It is likely that most people are not fully aware of the lack of adequate enforcement against illegal operators, criminal elements in global drug supply chains, high incidence of counterfeit products, and public health risks. The World Health Organization (WHO) has established an International Medical Products Anti Counterfeiting Task Force, drawing the attention of patients and health professionals to the dangers of counterfeit medicines. The World Health Professions Alliance, representing dentists, nurses, pharmacists, physical therapists and physicians, has developed the ‘Be Aware Toolkit’, helping healthcare professionals to identify and report counterfeit medicines.
In the US, the Food and Drug Administration promotes the ‘BeSafeRx – Know Your Online Pharmacy’ campaign educating consumers and health care professionals about the health risks of buying prescription medicine through fake online pharmacies. Operation Pangea, coordinated by Interpol, is an annual international action tackling the online sale of counterfeit and illicit medicines and highlighting the dangers of buying medicines online. By joining forces (customs, health regulators, national police and the private sector) Operation Pangea V has contributed to the shutdown of more than 18,000 illegal websites, and the confiscation of 3.75 million illicit pills valued at US $10.5 million in the year 2012.
Role of hospital pharmacists
Based on the results of our previous questionnaire among hospital patients, many individuals are willing to buy their drugs from the web and probably most of them are not fully aware of the risks associated with online medications or other similar health-related products. Owing to the potential direct (for example, impurities, wrong dosage, drug interactions) and indirect (for example, lack of professional information, unmanaged disease(s), adverse effects) dangers of online medications, pharmacists and hospital pharmacists should give advice to patients regarding internet-based pharmacies and the dangers of counterfeit medicines. Pharmacists should: (i) help prevent health hazards by providing information to patients and colleges; (ii) inspect and report any suspicious medications; and (ii), provide advice on how to evaluate online distributors and differentiate illegal medication suppliers.
Prevention and raising awareness in patients, doctors and nurses on the potential health hazards of illegal online pharmacies is a crucial tool in safeguarding patients. Patients should be advised to purchase their medicines only from qualified pharmacists and from reliable online sources. It should also be noted that patients might take supplementary products (for example, herbal remedies, food supplements), which are also available on the internet, alongside their prescribed or over-the-counter drugs.
Adapting information leaflets of international organisations, or preparing or making available such online brochures to patients (for example, see www.who.int/impact/en/) are easy and feasible solutions. Education campaign materials or videos may be incorporated in a designated webpage on patient safety (for example, see the European Commission Public Health website at http://ec.europa.eu/health/human-use/videos/index_en.htm, or the Center for Safe Internet Pharmacies website at
www.safemedsonline.org/).
Patient health records may not include details of all medicines, herbal remedies, vitamins and food supplements that were obtained from online sources; clinicians must therefore be encouraged to ask their patients where they obtained their medicines. Including specific questions during patient history taking, for example, such as: “Where was the product procured?” could yield valuable information about the origins of a patient’s medications.
Pharmacists could also inspect the medications their patients acquired online and screen for suspicious products. If counterfeit medicines are suspected or detected, pharmacists should ask patients to bring in their medicines. If it is proved to be substandard or counterfeit, patients should be ordered to cease therapy, and the suspicious drug must be replaced immediately. The falsified drug should be reported to the relevant authority or the Pharmaceutical Society of the given country. Alternatively the WHO Rapid Alert System website can also be used (an electronic reporting form is provided at www.counterfeitmedalert.info), but the reports can also be submitted by other email or fax to the Pharmaceuticals Unit Western Pacific Regional Office.
Conclusions
Some patients might insist on buying medicines from the internet. When evaluating online drug suppliers, two important aspects must be considered: danger signs and safeguards of patient safety on websites. A typical warning sign is if no valid medical prescription is required for prescription-only medicines or if no contact information is available on the website. Further warning signs can be suspicious disclaimers exempting the pharmacy and its employees from any liability. Similarly if the online text is illegible, contains numerous grammatical mistakes or if customers are constantly redirected to other websites, low quality service is indicated. Independent third party certifications (verification seals, logos) are typical safeguards of patient safety, although their validity should be analysed by clicking through to verify that it links to the correct webpage of the professional organisation.
It can be reassuring if the geographical location and the telephone number of the pharmacy are declared on the website. On legally practicing pharmacy websites, patients should have the option to consult with healthcare professionals (physician, pharmacist) and find detailed product information (dosing, side effects, storage) about the requested medication. Following receipt of the medicine from the online pharmacy, a number of other techniques can identify substandard or counterfeit medicines. The country of origin, the packaging of the drugs, the contents of the patient information leaflet can easily also be evaluated by pharmacists.
Key points
- Potentially unsafe drugs can reach patients or customers either by the infiltration of such medicines in the legitimate supply chain, or by purchasing drugs from illegal distributors, such as fraudulent online pharmacies.
- Many individuals are willing to buy their drugs from the web and probably most of them are not fully aware of the risks associated with online medications.
- Including specific questions during patient history taking, could yield valuable information about the origins of a patient’s medications.
- Patients should be advised to purchase their medicines only from qualified pharmacists and from reliable online sources.
References
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- Orizio G et al. Quality of online pharmacies and websites selling prescription drugs: A systematic review. J Med Internet Res 2011;13(3).
- Levaggi R et al. Marketing and pricing strategies of online pharmacies. Health Policy 2009;92(2-3):187–96.
- Liang BA, Mackey TK. Sexual medicine: Online risks to health – the problem of counterfeit drugs. Nat Rev Urol 2012;9(9):480–2.
- LegitScript.com. LegitScript. May 2013. www.legitscript.com/ (accessed 9 August 2013).
- Fittler A, Bosze G, Botz L. Attitude of patients and customers toward on-line purchase of drugs – a Hungarian survey by community pharmacies. Orv Hetil 2010;151(48):1983–90.
- Mackey TK, Liang BA. The global counterfeit drug trade: patient safety and public health risks. J Pharm Sci 2011;100(11):4571–9.
- Fittler A et al. Behaviour analysis of patients who purchase medicines on the internet: can hospital pharmacists facilitate online medication safety? Eur J Hosp Pharm 2013;20(1):8–12.
- 2011/62/EU: the ‘Falsified Medicines Directive. http://ec.europa.eu/health/human-use/falsified_medicines/index_en.htm (accessed 9 August 2013).
