Harri Ovaskainen
Director for Pharmaceutical Affairs
Finnish Pharmacists Association
Helsinki, Finland

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 create interrelationships between governments, academic institutions, businesses and consumers. Although experts predict that over 380 million people will be online by 2003, approximately 88% of all Internet users are presently situated in industrialized countries (1).

Within this global perspective, industry analysts have projected that Internet pharmacies will generate US$ 1.4 billion in prescription drug sales by 2001 and over US$ 15 billion by 2004. Currently, over 400 businesses dispensing prescription drugs operate on the Internet. 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. Additionally, customers have difficulty knowing whether an Internet pharmacy is a legitimate operation (2).

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. WHO has declared that ordering medical products without the safeguards offered by competent regulation could endanger public health and pose a risk to individual patients (3).

Possible risks of e-commerce pharmaceuticals

Under present conditions, patients can obtain prescription medications over the Internet in several ways. First, in some countries they can request direct delivery of medications if their doctor submits a prescription by telephone or a script attachment. Alternatively, patients can contact their physician over the Internet, request a medication, and have the physician transmit the prescription to the online pharmacy. Compared to the first model, this approach allows the patient’s pharmacist to review the prescription although it bypasses a visit to the physician. Thirdly, consumers can order medications directly over the Internet without seeing a physician or a pharmacist. The latter method is associated with the greatest potential risk to the consumer because it does not require a visit to the physician or review by a pharmacist (4).

The danger for consumers of purchasing medicines in this way cannot be underscored, since they will not be provided with sufficient information allowing them to distinguish between legal on-line pharmacies and illegal commercial sites selling any kind of medical products. 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 (5). 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. 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.

On the other hand, if a patient buys medicines from an illegal commercial site there is a total absence of any quality guarantee covering the medicine. This means that medicines may be counterfeit or substandard or even unapproved new drugs. Illegal websites selling pharmaceuticals do not have counselling services by health-care professionals and they have been identified as selling prescription-only drugs such as antibiotics, toxic chemotherapy regimens or anti-acne drugs that can cause birth defects. These sites also have misleading advertising and information: products are offered as suitable for self-care which, when used in the wrong way, may have serious consequences. Other products are presented as medicines which may not have any proven therapeutic effect.

Some Internet pharmacies offer online prescribing only upon completion of a short questionnaire by the purchaser. Typically, it is claimed that the questionnaire is reviewed by a doctor and the drug is only prescribed if the doctor approves the questionnaire (6), however, this is difficult to verify. To address this concern, the American Medical Association has declared that any health care practitioner who offers a prescription to a patient solely on the basis of an on-line questionnaire without having ever examined the patient has not met the appropriate medical standard of care (7).

Different organizations have warned consumers not to purchase medicines via the Internet. WHO has published a document “Medical products and the Internet: A guide to finding reliable information” (8). 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 (9). 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!” (10). Other related risks are a lack of security for payments, possible disclosure of confidential information, or mishandling of personal data. In Internet transactions, the supplier is processing confidential personal data which includes information on the physical and mental health of individuals.

While ordering routines can technically be handled via the Internet, the issue of physical delivery remains. There are two concerns. One is that delivery does not take place immediately - online pharmacies must also invest in delivery points to be able to guarantee delivery on time. The second concern is safety of delivery whereby packages are sent to homes by mail or by express delivery without the certainty that the customer is actually there and without being able to control exactly what happens to the package at delivery (11). Regular mail delivery does not ensure that packages of pharmaceuticals will arrive undamaged, and in some countries either hot or extremely cold weather may cause changes to the product.

The benefits of e-commerce pharmaceuticals

The greatest benefit for many individuals in obtaining medicines through the Internet is simplicity and convenience. However, it is also easy for a customer to access illegal drug selling sites and order a product simply by providing a credit card number. International regulations require drugs to be declared at the post office to which they are sent, but companies may dispatch packages unmarked.

Legitimate Internet pharmacies usually require patients to register and will offer services such as consultation with a pharmacist by telephone or e-mail. When working well, the legitimate online pharmacies also try to avoid potential drug interactions by asking new patients to complete a form indicating what other medications they are currently taking, giving a medical history, and describing related health conditions. Each patient is provided with a unique personal identifier and confidential patient-specific information is only transmitted following entry of this number. The patient is sometimes offered the opportunity to participate (“opt-in”) in various programmes which the pharmacy offers such as e-mail prescription refill reminders (12).

The Internet offers convenience and privacy for persons buying on-line while providing expanded access to prescription drugs and health care practitioners. Through the Internet, the disabled, the elderly, and patients living in remote areas can easily obtain information, products and services that were previously acquired only with great difficulty. Also, price differences are quite often important. Internet pharmacies are generally 10% lower in the USA despite transportation charges (13).

The challenge for pharmacy regulators is now to develop a regulatory approach that will prevent the dangers described, while leaving unaffected the online innovations that can enhance the appropriate use of medications and improve a patient’s quality of life. A report on the outcomes of several surveys, including an analysis of responses provided by drug regulatory authorities to a WHO questionnaire.

References

1. Forrester Research 1999. http://www.inpharm.com/netfocus/trends/articles_006.html.

2. Oliver, A. J. Internet Pharmacies: Regulation of a Growing Industry. Journal of Law, Medicine and Ethics, 28 (1): 98-101 (2000).

3. Siegel-Itzkovich, J. WHO calls for tighter controls on Internet. British Medical Journal, 314: 1501 (1997).

4. Armstrong, K., Sanford Schwartz, J., Asch, D.A. Direct sale of sildenafil (Viagra) to consumers over the Internet. The New England Journal of Medicine. 341: 1389-1392 (1999).

5. Verified Internet Pharmacy Practice Sites (VIPPS™). A Program of the National Association of Boards of Pharmacy http://vipps.nabp.net/verify.asp

6. Henney, J.E., Shuren, J.E., Nightingale, S.L. et al. Internet purchase of prescription drugs: buyers beware. Annals of Internal Medicine, 131: 861-862 (1999).

7. American Medical Association: Board of Trustees Report 35. Internet prescribing: an interim report. American Medical Association House of Delegates Proceedings, 148^th Annual Meeting. Chicago, 1999.

8. World Health Organization. Medical products and the Internet: A guide to finding reliable information. Geneva 1999 (WHO/EDM/QSM/99.4) http://www.who.int/medicines/library/qsm/who-edm-qsm-99-4/medicines-on-internet-guide.html

9. FDA: Buying Medicines and Medical Products Online. Tips and Warnings for Consumers. Published by FDA http://www.fda.gov/oc/buyonline/default.htm

10. PGEU and CP: The Internet and Medicines: enjoy the Internet but don’t risk your health! Published by PGEU and CP, May 1999. http://www.pgeu.org/02.html, http://www.cpme.be/en/cp_policy_statements.htm

11. Kielgast, P.J., Bonde, J., Molin, H. et al. Pharmacy, pharmacies and Internet. Report and reflections from a study mission commisioned by the Federation Internationale Pharmaceutique. March, 2000.

12. Hazlet, T.K., Bach, M.H.M. The Internet, confidentiality, and the pharmacy.coms. Cambridge Quarterly of Healthcare Ethics, 10: 157-160 (2001).

13. Brushwood, D.B. Responsive regulation of Internet pharmacy practice. Annals of Health Law, 10: 75-103 (2001).