Buying Drugs from Canada - A Report by the Health Planning Council (October 2004)

Given the rising cost of prescription drugs and interest in buying less expensive drugs from Canadian pharmacies, the Health Planning Council (HPC) Advisory Board has reviewed the role other governmental agencies have taken with regard to providing information to consumers. The HPC Advisory Board decided to make this report available below.

The report provides information about options to help pay for prescription medicine.
It does not provide medical, financial or insurance advice.

Why Canadian?
Many U.S. citizens purchase their medicine online from Canada where prices are often lower due to the cost controls imposed by the Canadian government. People who have high out-of-pocket costs for prescriptions are most likely even to consider purchasing Canadian. These include those with no health insurance, no prescription coverage with their health insurance, or very high co-pays with their prescription insurance.

The savings can be substantial; our survey comparing the ten drugs most frequently used by a Central New York group enrolled in BlueCross/ BlueShield showed savings of 43 - 60%. Not all prescriptions can be filled at Canadian pharmacies or websites. These include controlled substances, medicines that cannot be shipped because they require refrigeration, and drugs that are not available in Canada. Other medicines, such as generic formulations, may not be cheaper through Canadian sources.

Is Buying Drugs from Canadian Pharmacies Legal?
The U.S. Food and Drug Administration (FDA) state that importing drugs into the United States violates the Food, Drug, and Cosmetic Act. (web source). This includes:

• Medicine made in other countries if it is not approved by the FDA or if it does not meet all FDA approval requirements;
• Prescription medicine originally manufactured in the U.S., but distributed in other countries, so its purchase by U.S. residents is considered re-importation.

The FDA has a policy on the personal shipment of drugs that allows its officials to use enforcement discretion under certain circumstances:

1. when the intended use is appropriately identified, such use is not for treatment of a serious condition, and the product is not known to represent a significant health risk; or

2. when a) the intended use is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; b) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; c) the product is considered not to represent an unreasonable risk; and d) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply)and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product, or provides evidence that the product is for the continuation of a treatment begun in a foreign country. (source: RPM Chapter 9, Subchapter, Coverage of Personal Importations)

What Are Other Counties in New York State Doing?
Several counties are trying to help its residents by offering drug card programs that lower the cost of prescription drugs at participating pharmacies or at selected online pharmacies.

Broome, www.broomerx.com, Westchester www.westchesterrx.com , Ulster www.ulsterrx.com, and Chemung counties www.chemungrx.com (perhaps others) have contracted with LibertyCareRx to offer a drug discount card to its residents for use in three different options:

1) selected local (or nationwide) pharmacies;
2) www.drugstore.com (U.S. mail order program); and
3) Liberty Care Canada (Canadian mail order).

According to LibertyCareRx, the discount card which is available for an annual fee of $15 for individuals and $26 for families, saved Westchester residents 26 percent off drug prices at local pharmacies and between 33 and 50 percent off prescription drugs purchased from Canada.

Nassau County has provided for a free prescription drug discount card from AdvancePCS www.nassaurx.advancerx.com that allows users to receive a discount at participating pharmacies or through its mail order program. Their mail order program does not include Canadian pharmacies.

What Are Other States Doing?
Several states, including those below, have opted to provide their residents with information about accessing lower-cost prescription medicine from Canada. All of these sites have disclosure/disclaimer statements.

State of Wisconsin officials visited Canadian pharmacies to evaluate them on a number of criteria. The State sponsors a website www.drugsavings.wi.gov structured similarly to Minnesota RxConnect. The consumer is also able to search for a drug and list the State approved pharmacies that participate. Consumers who are not Wisconsin residents are welcome to order drugs from the website, however the prices quoted on the site are guaranteed for Wisconsin residents only and users of the site are free to contact the pharmacies directly to request pricing information.

State of New Hampshire officials also visited Canadian sites. Their website is entitled, Affordable Healthcare for New Hampshire Residents www.state.nh.us/governor/prescription/prescription.html and offers a direct link to a Canadian pharmacy, along with information about the State's process for selecting pharmacies.
The New Hampshire Dept. of Health and Human Services has identified CanadaDrugs.com (www.canadadrugs.com) as the Canadian pharmacy that meets certain standards including:

• An actual pharmacy, not just a mail order company
  
• Accreditation by the Internet Mail-Order Accreditation Commission
  
• Member in good standing of the North American Pharmacy Accreditation Commission (NAPAC)
  
• Meets and exceeds standards set by other pharmaceutical associations such as Canadian International Pharmacy Association (CIPA)

State of Washington's website www.rx.wa.gov/ offers its consumers links to Canadian pharmacies and provides suggestions on when their use might be appropriate.

What Are Safety Issues to Consider?
Among the questions asked when exploring the issue of purchasing lower priced drugs from Canada is whether the prescription medications obtained from their pharmacies are safe. The FDA posts information on its website www.fda.gov emphasizing its concern with imported drugs.

Many state governments addressed this question by comparing the Canadian pharmaceutical supply and distribution system with that of the U.S. and by making site visits to the physical locations of the website pharmacies.

For example, the Office of Special Advocate for Prescription Drugs of the Illinois Department of Central Management Services focused on safety and efficacy when it examined the feasibility of allowing State employee and retiree beneficiaries to purchase drugs from the provinces of Ontario and Manitoba. Among its key findings:

• The Canadian regulatory system provides equivalent protection for the health and safety of the public as is provided in Illinois.
  
• Both the U.S. and Canada have comparable methods of ensuring safety and efficacy.
  
• The Canadian system for pricing and distribution is less likely to foster drug counterfeiting.
  
• Both the U.S. and Canada have comparable requirements for the warehousing and storage of pharmaceuticals.
  
• Educational requirements and professional regulation of pharmacists in the provinces of Ontario and Manitoba are as rigorous as those of Illinois.

Canadian Regulatory Agencies and Professional Associations.
Health Canada's Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates prescription drugs. It issues a drug identification number (DIN), which is similar to the U.S. national drug code (NDC). The TPD is responsible for evaluating and monitoring the safety, effectiveness, and quality of pharmaceutical drugs.

While voluntary, professional associations such as the IMPAC (Internet and Mail Order Pharmacy Accreditation Commission), NAPAC (North American Pharmacy Accreditation Commission), and CIPA (Canadian International Pharmacy Association) provide a measure of quality assurance to individual Canadian pharmacies. Each province has its own licensing authority which regulates pharmacies and the practice of pharmacy.

How Has the United States Food and Drug Administration Responded?
To date, the FDA's enforcement priorities have not focused on individual consumers. Officials have, however, seized shipments of prescription drugs from Canada. On one occasion, officials stopped a shipment from CanadaRx, which is the main pharmacy for the Canadian Drug Reimportation Program sponsored by the Minnesota Senior Federation. No arrests were made.

The FDA has sent letters to governmental agencies who sponsor programs and websites that facilitate the purchase of Canadian drugs. A sample of organizations which have received these letters follows. The FDA letters are posted on the website at www.fda.gov

FDA Responses to Organizations Promoting Canadian Pharmacies Date 2004 Sponsoring Organization Program/ Action FDA Letter Contents Aug. 20 Mayor of Washington, D.C., Anthony Williams District of Columbia website has link to Minnesota’s RxConnect Concerns about link. Notes deficiencies with Minnesota’s RxConnect selected pharmacies. Aug. 4 Mayor of Boston, Thomas Menino Program for city employees and retirees to purchase drugs from Total Care. Concerns about Total Care Pharmacy of Calgary. July 22, March 18 Governor of Wisconsin, Jim Doyle Website and program. Contracts with Canadian pharmacies to serve citizens of Wisconsin Concerns: about the contracting pharmacies; that the drugs listed have less expensive and safer options domestically; that the State uses a disclaimer June 3 Governor of Illinois, Rod Blagojevich Requests approval of demonstration project for the importation of drugs from Canada Notes it cannot authorize waivers, pilot programs, etc., and references Wisconsin and Minnesota’s websites as illegal. May 24, February 23 Governor of Minnesota, Tim Pawlenty Sponsors a website that facilitates purchasing drugs from select Canadian pharmacies. Encourages state employee participation by elimination of co-pay. Found deficiencies in task force report from State inspection. Notes Canadian pharmacies don’t meet the standards of Minnesota. April 5, Caldwell County (North Carolina) Manager, Bobby White Program facilitating the purchase of Canadian drugs for county employees and dependents. All Canadian drugs purchased by county employees and their dependents will be illegal. Raises possibility of tort liability if a citizen suffers an injury as a result. March 31 Governor of New Hampshire, Craig Benson State program facilitating the purchase of Canadian drugs from select pharmacy. States a problem with their inspection process. Finds that accreditation of pharmacy by IMPAC to have no credibility since these are voluntary bodies with no legal standing. Notes that CanadaDrugs.com has no malpractice insurance and patients must sign a statement of liability.