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2/5/2004

Drug Importation Raises Issues for Pharmacists

Cheryl A. Thompson

Faced with large budget deficits, several mayors and governors, particularly those in the Northeast, view drug importation from Canada as a means of cutting expenditures on employees' and retirees' prescription medications. Eventually, these Canadian-purchased medications may be brought to U.S. hospitals and long-term-care settings, where health care professionals must decide whether to permit the use of drugs obtained outside the federally regulated pharmaceutical supply chain.

What pharmacists should bear in mind with an imported drug product, said Dennis G. Lyons, director of government and regulatory affairs at the Massachusetts College of Pharmacy and Health Sciences in Boston, is "more than likely, that medication has come into the country illegally."

FDA, through its "personal importation" policy, allows an individual or the person's physician to bring into the United States a small amount of a drug product sold in another country. But the patient must have a serious condition, an effective treatment for the condition must not be available in the United States, and the companies involved in the distribution of the product must not promote its use to U.S. consumers.

Tempting prices. Advocates of drug importation point to the money that can be saved by buying from a country with controls on wholesale drug prices and a favorable rate of exchange for U.S. dollars.

For nursing-home residents whose care is not covered by Medicaid, Medicare, or long-term-care insurance, the potential to pay less for prescriptions can be tempting.

Nursing-home residents footing 100% of their prescription expenses typically do not pay a discounted price for medications, according to a November 2002 issue brief from the National Health Policy Forum in Washington, D.C.

Lyons said patients' ability to obtain the medications they need is paramount (see sidebar), but FDA's policy cannot be ignored.

Helping Patients Legally Obtain Affordable Medications

MassMedLine, a partnership between the commonwealth of Massachusetts and the private Massachusetts College of Pharmacy and Health Sciences, helps residents who have trouble paying for their prescription medications.

Faculty member Dennis G. Lyons said the pharmacists answering the toll-free hot line steer consumers away from the idea of importation and toward legal means of assistance, such as manufacturers' patient assistance plans, various discount card programs, Medicaid (for those who qualify), and less-expensive alternatives to currently prescribed medications.

A 2003 survey of MassMedLine users indicated that most callers found medication assistance after calling the hot line. Three of five users said they had received at least one free medication from a patient assistance plan when a hot-line worker assisted in filing the application. One of five consumers said that, after calling MassMedLine, he or she obtained a drug discount card. About the same number of consumers said they received suggestions about less-expensive alternatives to their current medications.

Lyons, whose Office of Government and Regulatory Affairs educates legislators and state officials about MassMedLine, said he was pleased with the survey's results.

About half of the program's funding comes from the commonwealth's Executive Office of Elders Affairs, and three eighths comes from federal funding secured by Representative James P. McGovern (D-Massachusetts), Lyons said. The program also receives grants from GlaxoSmithKline and Massachusetts-based Fallon Community Health Plan.

"Why it's a particular concern in a hospital setting or a long-term-care setting is that professional staff in those facilities will then be asked, potentially at least, to administer those [imported] medications," he said. "I believe that there's a significant liability issue involved when they do that."

Hospitals' preparations. About 90 miles west of Boston lies Springfield, which in July 2003 started encouraging the city's employees and retirees to send their prescriptions to a Canadian pharmacy.

The city of 156,000 residents purportedly saved $1 million in the first six months, according to widely circulated reports from Mayor Michael J. Albano, who promoted the program as a cost-saving measure and left office at the end of 2003. Incoming Mayor Charles V. Ryan Jr., in his inaugural speech, said the city was $400 million in debt.

Nancy Wilson, pharmacy director at 588-bed Baystate Medical Center in Springfield, said her department drafted a policy for the hospital to follow in the event a patient brings imported medication to the facility.

Baystate's pharmacy and therapeutics (P&T) committee approved the policy on January 13, she said. Two other committees, which are scheduled to meet by mid-February, must also approve the policy for it to become official, she said.

"As of today, we have not seen any medications from outside of the country," Wilson said when interviewed January 15.

A Baystate policy already requires pharmacists to examine all medications brought by patients to the hospital, she said. Infrequently, patients may be allowed to use a personal supply of medication, she added, but those cases tend to involve drugs not on the formulary.

Robert J. Lewandowski, pharmacy director at 360-bed Mercy Medical Center, also in Springfield, said no patient had, as of January 7, brought imported medication into the facility. But the possibility of such a case was a concern.

"It's on our agenda for the next P&T committee meeting," he said, at which time the medical and pharmacy staffs will discuss the issue and develop a policy.

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) does not have an opinion on the use of imported medications in accredited health care organizations as long as the products were acquired legally, said Darryl S. Rich, an associate director of surveyor management and development.

"The organization decides when it will use medications brought in," he said.

A JCAHO medication management standard, MM.2.40, requires health care organizations to have a policy describing the circumstances for which a personal supply of medications can be used, the process for identifying the products and visually evaluating their integrity, and the manner in which the physician and patient will be informed if the medications are unacceptable for use in the facility.

"If [organizations] choose to say 'we will not accept drugs from a Canadian pharmacy,' then so be it," Rich said.

But JCAHO would object to pharmacies importing the medications from Canada, he said, because that activity is illegal.

Possible problems with importation. Springfield uses CanaRx Services Inc., an Ontario-based company across the CanadaU.S. border from Detroit, Michigan. According to the local Better Business Bureau, the pharmacy started its "online medicines" business in December 2002 and has a street address in Windsor.

Visitors to the Web site can enter a brand or generic name in the search field of the "Medications List" spreadsheet to find the U.S. price of a prescription if facilitated by CanaRx. The spreadsheet also shows the Canadian brand name if different from the U.S. name and indicates whether a generic product is available.

CanaRx does not actually fill the prescriptions. In describing the company's services to FDA officials, CanaRx President G. Anthony Howard said his firm forwards prescriptions to Canada-licensed physicians for rewriting and then sends those prescriptions to Canadian pharmacies for dispensing.

Lyons, from the Massachusetts College of Pharmacy and Health Sciences, said the use of Canadian pharmacies and medications by U.S. consumers could create problems. As an example, he spoke of the proton-pump inhibitor that AstraZeneca markets as Prilosec in the United States and Losec in Canada.

At FDA's request, the company in 1990 had changed the omeprazole brand name in the United States to Prilosec because Losec, the original name, was being mistaken for Lasix, a brand-name diuretic from Aventis. Prilosec capsules bear the brand name on the body of the capsules.

Lyons said the LosecLasix confusion may reappear in the United States if patients' prescription containers of omeprazole are labeled with the former brand name.

Another difference between the two countries is apparent in the CanaRx spreadsheet's entries for levothyroxine. The spreadsheet shows Eltroxin as the generic levothyroxine product, Synthroid as the brand-name product, and Levoxyl as a U.S. product whose Canadian brand name is Synthroid.

FDA does not recognize any levothyroxine product as the generic version of Synthroid, a product of Abbott Laboratories. Levoxyl is the brand-name levothyroxine product by Jones Pharma Inc. Mylan Pharmaceuticals markets the only generic levothyroxine product available in the United States, and FDA considers that product therapeutically equivalent to Unithroid, by Jerome Stevens Pharmaceuticals, Inc.

Eltroxin is manufactured by GlaxoSmithKline in Ontario and marketed in several countries but not the United States.

Canada did not undergo the upheaval in the levothyroxine market that the United States did a few years ago. Health Canada said its 2001 investigation of Synthroid and Eltroxin did not detect problems in the quality of those products and that no immediate action by the regulatory agency was necessary.

A reporter's call to CanaRx was referred to a pharmacist at Eastown Medical Pharmacy, which has the same street address as CanaRx.

Margaret, who did not want her last name used, said a patient who requests brand-name levothyroxine will receive Synthroid, whereas a patient who requests generic levothyroxine will receive Eltroxin, if it is available in the strength needed.

The possible substitution of levothyroxine products by having a prescription filled outside the United States, Lyons said, "is a prime example of why [drug importation] is such a complicated issue."

FDA's actions. To date, FDA has taken legal action against at least one U.S. business, Rx Depot, for helping consumers obtain prescription medications from Canada. A federal judge sided with FDA and shut down Rx Depot's U.S. storefronts in November 2003.

Because CanaRx is a Canadian company, FDA faces a larger challenge in stopping the firm. The agency recently indicated that it may go after cities and states that pursue drug importation.

In January, FDA Commissioner Mark McClellan told the Associated Press that he has not ruled out taking legal action against cities and states that defy the federal ban on importing prescription medications from other countries.

Two months earlier, FDA and Health Canada officials signed an agreement that, in part, calls on Canadian authorities to share with FDA information on Internet pharmacies and facilities that market therapeutic products in the United States.

Possible change in the regulations. Members of Congress, in trying to deal with constituents' concerns about prescription drug prices, passed a law that keeps alive the prospect of the federal government incorporating drug importation into the pharmaceutical supply chain.

The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 calls on the Health and Human Services (HHS) secretary to write regulations permitting pharmacists and wholesalers to import prescription medications from Canada. These regulations are to be written after consultation with the U.S. trade representative and the U.S. Customs commissioner and require extensive documentation by pharmacists and wholesalers who choose to import medications. As of mid-January, Secretary Tommy G. Thompson had not publicly indicated when the regulations would be written.

The law also asks the HHS secretary, in upholding the ban on personal importation of prescription drugs and devices, to focus on cases posing a significant threat to the public health and ignore individuals who import medications for personal use and do so without incurring unreasonable risk.