Cross-Border Internet Pharmacy: Why are they so dangerous? Louise Binder, Chair Canadian Treatment Action Council

Sales data from IMS Health, World Pharmaceutical market summary Production data from Industry Canada Data accessed Sep 30, 2003http://open.imshealth.com/download/dec2002pdf* Canadian Pharmaceutical Supply and Canadian and U.S. Retail Sales (2001) NOTE: Sales data reflect U.S. exchange rate for Trade data reflect current exchange rate, October 2003.

Drug Shortages l Patty Stewart, a New Brunswick woman living with diabetes has experienced shortages first hand. Her health has been put at serious risk due to short supplies of insulin from her local pharmacy. In one instance the last of the pharmacy’s supply was sold to a cross-border American shopper. In addition, due to increasing Internet supply and purchases of many medicines, including insulin, the pharmacy is often short shipped and there aren’t enough medicines to go around. CTAC Press Release, Friday February 27, 2004 l Canadians are facing a shortage of two crucial cancer drugs because of increased cross-border sales by Canadian pharmacies, a Manitoba pharmacy group said yesterday. The drugs, Temodal and Purinethol, are in short supply, which could affect radiation treatments for patients with leukemia and brain tumours, said Michele Fontaine, a Winnipeg pharmacist who specializes in cancer patients and is vice- president of the Coalition for Manitoba Pharmacy. Paul Waldie, Globe and Mail, 13 November 2003

Professional Ethical Practice l The professional ethics of some practices is questionable. For example: remunerating physicians for co-signing prescriptions without having examined the patient; requiring patients to sign a waiver, release or power of attorney to access the services. l According to the Canadian Pharmacists Association, some Internet sites operate illegally and services are not provided by accredited pharmacies. These bypass the comprehensive safety system of drug approval, prescription requirements and pharmacy practice standards. l Additionally, some pharmacies operating an Internet pharmacy service may not be in compliance with medical and pharmacy standards of practice. Purchasing drugs over the Internet bypasses the opportunity for face-to- face consultation with a pharmacist, physician or other health care provider. Internet pharmacies may not have complete profiles of patients’ drugs and allergies, limiting the ability of the pharmacist to monitor drug therapy, including drug interactions and allergies.

The Safety of Imported Drugs is Not Guaranteed Personal use exemptions provide a loophole for both legitimate and illegitimate importation. Simply changing U.S. law to over-ride existing import safety standards or to regulate Canadian commercial activity has no effect in Canada.

Importation of Human Use Drugs for Personal Use Enforcement Directive The personal use exemption unfortunately provides an opportunity for these suppliers to conduct commercial activities, and to evade the submission review process for individual products, and/or the Establishment Licence requirements for importers, by supplying their drug products primarily through the mail to individual Canadians. These activities at times may include violative marketing and advertising activities by means such as the Internet. This has ramifications related to safety because large quantities of products, which have not been reviewed for safety and/or efficacy, and which are of unknown quality, can enter the country and be distributed. The lack of an importer also means no person is responsible for meeting GMP requirements such as appropriate record retention or recall mechanisms. Personally Imported Drugs are of Unknown Quality