First published 26 August 2015
This editorial has an accompanying comment, Online pharmacies: a consumer perspective.
Online pharmacies have been operating in Australia since the mid 1990s. Community pharmacy is now a mix of traditional pharmacies with little or no online presence, pharmacies that dispense through multiple channels but where physical presence remains the dominant characteristic (substantial number), and pharmacies that are only online. The internet gives access to overseas-based online pharmacies thus allowing a comparison of Australian sites to those overseas.
An Australian pharmacy business must address a number of regulatory and licensing requirements of the jurisdiction and of operational best practice. A prescription is needed for Schedule 4 and Schedule 8 medicines and the importation of controlled substances or products is prohibited.1 The risks to consumers from online pharmacies not complying with these regulations include:
- fake or adulterated products with little therapeutic activity or unknown safety and efficacy
- inappropriate supply of narcotics and other controlled substances
- lack of supervision by a doctor or pharmacist
- lack of appropriate drug information
- failure in supply-chain protocols which may affect the quality of a medicine, e.g. lack of appropriately stored or expired medicines
- unlicensed premises and staff.
Fake or rogue online pharmacies represent a danger to consumer health. In 2014, the US Government Accountability Office estimated that there were 36 000 rogue internet pharmacies. These pharmacies generally supply drugs without a prescription and may or may not employ pharmacists. They are rarely licensed in the jurisdiction where they are located. To all intents and purposes they are not pharmacies and may not even have a shopfront.2
A recent UK study of 113 online pharmacies selling diazepam, fluoxetine and simvastatin found that fewer than 25% were regulated and 80 were willing to sell prescription medicines without a prescription.3 The unregulated sites were more likely to provide safety information (cautions, adverse effects, drug interactions) suggesting that inclusion of some clinical knowledge should not serve as a guarantee of the seller’s provenance. However, the unregulated sites were significantly less likely to provide the contact details of the pharmacy.3
Price tends to dominate the business model of online pharmacies with a focus on the mechanistic, technological and logistical aspects of supply. Most public discussion around online supply in the USA and Europe centres on price, market segmentation and domination, and economies of scale, rather than on the quality use of medicines.4
Anecdotally, both the USA and Australian experiences suggest that online pharmacies are able to offer cheaper medicines. In Australia, this does not include medicines that meet or exceed the consumer copayment as they are subsidised. Some consumers prefer the convenience of mail order, particularly in the rural and remote setting.
All studies and warnings from regulatory agencies emphasise the caution ‘buyer beware’. As the UK Medicines and Healthcare Products Agency advises, ‘Buying medicines online is a risk, many websites operate outside the legal requirements and you have no idea what you are getting and how it will affect you. You are gambling with your health.’5
Overseas online pharmacies appear to not offer the same level of personal contact that is required of Australian pharmacies, whether by standards or guidelines.6 An inspection of six online pharmacies verified by the US National Association of Boards of Pharmacy found no evidence for how consumers could contact the pharmacy for advice about medicines. The Australian situation is markedly different. The Pharmacy Board of Australia emphasises the quality use of medicines and states that:
The Board views the indirect supply of medicines, such as internet and mail-order dispensing, as less than the optimal way of delivering a pharmacy service because communication may be compromised. The Board recognises, however, that there are circumstances where these forms of communication are necessary in, or appropriate to, the patient’s circumstances (e.g. in remote areas).
A pharmacist supplying medicines indirectly to a patient must comply with all relevant State or Territory, and Commonwealth legislation, the Pharmacy Board of Australia’s Guidelines for Dispensing of Medicines, and established practice and quality assurance standards.7
The Australian Therapeutic Goods Administration (TGA) also publishes a warning regarding the potential dangers of online pharmacies (usually overseas) but does not conduct any regulatory review of internet sites.8 The TGA’s position assists consumers in having greater confidence in Australian online pharmacy sites rather than those overseas.
Online ordering of medicines by consumers will remain a feature of the Australian pharmacy landscape, and high operational and professional requirements should ensure that medicines ordered from Australian registered online pharmacies meet Australian standards. Conversely, non-Australian sites offer little in the way of reassurance.
Australian health consumers should be vigilant of online pharmacies and standards and guidelines of the Pharmacy Board of Australia, the Pharmaceutical Society of Australia, and the accreditation requirements of the Quality Care Pharmacy Program need to be maintained. There should be appropriate governance of access to medicines, whether that be through a traditional walk-in pharmacy or via an online transaction.
Bill Kelly is a practitioner member of the Pharmacy Board of Australia and is the executive director of the Australian Friendly Societies Pharmacies Association.
- Therapeutic Goods Administration. Personal importation scheme. Canberra: Department of Health; 2015. www.tga.gov.au/personal-importation-scheme [cited 2015 Aug 12]
- Internet pharmacies: Most rogue sites operate from abroad, and many sell counterfeit drugs. Washington (DC): US Government Accountability Office; 2014. www.gao.gov/products/GAO-14-386T [cited 2015 Aug 12]
- Alwon BM, Solomon G, Hussain F, Wright DJ. A detailed analysis of online pharmacy characteristics to inform safe usage by patients. Int J Clin Pharm 2015;37:148-58.
- Dudley J. The Internet Pharmacy. Presentation from the 46th AESGP Annual Meeting, Dubrovnik 2010. Slideshare.net; 2012. www.slideshare.net/JameswDudley/mail-order-and internet-pharmacy-aesgp-presentation-james-dudley [cited 2015 Aug 12]
- Websites closed in battle against illegal trade in medicines [press release]. London: Medicines and Healthcare Products Regulatory Agency; 2015. www.gov.uk/government/news/websites-closed-in-battle against-illegal-trade-in-medicines [cited 2015 Aug 12]
- The Pharmaceutical Society of Australia. Professional Practice Standards – Version 4 – June 2010. Canberra: Pharmaceutical Society of Australia; 2010. www.psa.org.au/download/standards/professional-practice standards-v4.pdf [cited 2015 Aug 12]
- Pharmacy Board of Australia. Guidelines for dispensing of medicines. Melbourne: Pharmacy Board of Australia; 2010. www.pharmacyboard.gov.au/Codes-Guidelines.aspx [cited 2015 Aug 12]
- Therapeutic Goods Administration. Buying medicines and medical devices over the internet. Canberra: Department of Health; 2015. www.tga.gov.au/community-qa/buying-medicines-and medical-devices-over-internet [cited 2015 Aug 12]