Eye on Ethics

When black and white become gray

By Sue Bliss, R.Ph., M.B.A.

Q: The profit margin at the pharmacy you manage is sliding. Insurance reimbursements drop, while patients drive to Canada or Mexico to stock up on cheap drugs. An acquaintance says he has a new way to obtain drugs at a lower cost. What do you do about his offer?  

A: Internet drug "reimportation" outlets are erupting all over the United States like a fast-spreading fungus. Opening overnight in storefronts or on Web sites, outlets transmit prescriptions to Canada, where they may be rewritten by a Canadian physician, filled at a Canadian pharmacy, and shipped to the U.S. patient. This eliminates connections among the patient, a U.S. pharmacist, and Food & Drug Administration-approved drugs that have been shipped from the maker to a licensed wholesaler for U.S. distribution.

The federal government itself is deeply conflicted about reimportation. A bill loosening restrictions on reimportation is working through Congress, fracturing party lines and directly violating standards of the embattled FDA. The agency's current interpretation of reimportation allows individuals to obtain only small amounts of prescription drugs for their own use.

The roots of the conflict are money, and the more serious issues of safety and liability. Drug pricing varies widely by volume and type of buyer. Manufacturers will not watch quietly as U.S. patients stampede to buy pharmaceuticals at contract prices negotiated by private or public insurance systems in other nations. American consumers are blithely unaware of the legal protection they lose by importing drugs from foreign countries for themselves: Neither the country of origin, nor the United States, nor the corner pharmacist is liable for any drug misadventure that ensues.

Legal responsibility for drugs marketed within each country extends only to citizens of that country using the drug within its borders. Each nation sets its own standards for drug safety, and may allow marketing or indications of drugs that are not considered safe by the FDA. Phenylbutazone and chloramphenicol are available in Latin America, and the U.S. patient may appreciate the FDA's protection only in hindsight, after permanent injury.

Pharmacists, who are always liable for the quality of drugs they dispense, are also at risk as counterfeit drugs surface. The counterfeit market recently targeted two heavily advertised drugs, a cholesterol-lowering agent and erythropoietin. Manufacturers are considering embedding microchips in drug package design; this technology could track a prescription drug package much like a stray dog may be tracked back to its owner.

Why is this necessary? Who will pay the cost, if the public receives bogus or even dangerous drugs? Who will die? Who will be sued?

The frightening case of the Kansas City pharmacist convicted of watering down chemotherapy drugs exposed a ring of individuals who purchased returned or outdated drugs and resold them, a form of drug diversion known as the "gray" market. Those who legally distribute drugs can be tempted to divert drugs for profit, but even those trying to beat the cost of medication may inadvertently open the market to further fraud. Bootlegged drugs appear at flea markets close (or not close) to our Northern or Southern borders. Drugs bouncing from nation to nation, from repackager to redistributor enough times, may be impossible to track. Worthless or even dangerous products may reach the patient's hands.

Erosion of quality in the drug supply chain is a slope that drops more steeply when the weight of public demand is not counterbalanced by the wisdom and experience of pharmacists, who literally hold the line against nonsensical use of drug products every day.

How can we protect our patients, ourselves, and the drug supply chain? Here are some suggestions:

• Work with our patients' physicians, to ensure that each patient receives the most cost-effective medications and appropriate education about their use.

• Add a new warning to our counseling procedure, that we cannot guarantee the quality of drugs purchased outside the highly regulated U.S. drug chain, and we cannot be liable for misadventures from their use.

• Report any breach in the drug supply chain that we become aware of to the FDA or our state board of pharmacy.

• Steer clear of any "too-good-to-be-true" drug pricing that appears on the horizon.

The AUTHOR has practiced long-term care and community pharmacy in Oregon for more than a decade and has served on numerous professional and community boards.

Sue Bliss. When black and white become gray.

Drug Topics

Sep. 1, 2003;147:51.