Rhode Island residents can begin ordering prescriptions by mail beginning next month.

01:00 AM EST on Friday, December 31, 2004

BY G. WAYNE MILLER
Journal Staff Writer

PROVIDENCE -- Following an animated final public hearing, the state Health Department yesterday approved regulations allowing the state to license Canadian pharmacies. Rhode Island is the first state to take this step.

Barring a legal challenge, Rhode Island residents will be able to import prescription medications -- through the mail or by private shipper -- starting next month.

Safety and cost dominated the hearing at the Health Department's main auditorium. About 100 people attended, including dozens of older people, pharmacists and representatives of the U.S. drug industry.

Opponents of importation maintain that neither the state nor the federal Food and Drug Administration can guarantee the quality of prescription medications from foreign sources. Proponents say the substantially lower costs of Canadian drugs are a godsend for the poor and elderly.

Secretary of State Matthew A. Brown, a proponent, said he has heard from hundreds of elderly people who cannot afford the higher prices of drugs sold domestically. "They've been forced every week to choose between buying their medications and buying their food," he said, to applause.

"If our country would just give us our pills cheaper," said Irene Santos, president of the local chapter of the Gray Panthers, "we wouldn't have to go to Canada or England or anywhere else." Like other speakers, she blamed higher U.S. prices on the "greed" of drug manufacturers.

"They're not losing any money," Foster resident Patricia Morgan said. "We are."

But Dr. John O'Brien, director of state policy for the Pharmaceutical Research and Manufacturers of America, said that importation could jeopardize a person's health. "These regulations open the door to unsafe, non-FDA approved meds from around the world. We implore you not to move forward. We respectfully request that you make major changes and hold another hearing."

O'Brien also said that a country of some 30 million people cannot serve the medicinal needs of a nation of almost 300 million -- and he predicted that eventually the Canadian government will stop exports. Another speaker cited a story in Wednesday's USAToday in which Canadian Health Minister Ujjal Dosanjh was quoted as saying: "We cannot be the drugstore for the United States."

Many drugs sold in Canada are made in the United States or by U.S.-based companies. Unlike in the United States, Canada has a government-run health-care system for all citizens that includes price controls on prescription drugs.

Others objecting to importation who spoke yesterday included Michael L. Simeone, director of Pharmacy Continuing Education at the University of Rhode Island. Simeone criticized the loss of personal contact a patient has with a pharmacist when buying medicines at the neighborhood drugstore.

"These regulations short-circuit the role the pharmacist plays," Simeone said. The role, he said, is more than bottling pills: it includes monitoring a patient, warning of side effects and helping to prevent drug interactions.

Don Williams, associate director for health-services regulation with the Health Department, attended the hearing but did not speak.

But when it had ended, after almost an hour and a half, he said that he had not heard anything that would necessitate another hearing. Although Williams and others in his department do not agree with the law leading to the new regulations, they have had no choice but to comply with the General Assembly's mandate, Williams has said.

After Williams talked to the department director, Dr. Patricia A. Nolan, the new regulations were filed yesterday afternoon at the secretary of state's office. They will take effect in 20 days.

After meeting with Nolan, Williams said in an interview that the filing does not mean that the department has washed its hands of safety concerns such as counterfeit or contaminated drugs. "We're going to continue to work on the safety issues raised by some of the parties," Williams said.

The new regulations consist of minor amendments to existing rules that already govern the licensing of pharmacies in other states that sell prescription drugs in Rhode Island. In the two-page out-of-state section, the department regulators have twice added the phrase "or province of Canada."

Representatives of the pharmaceutical industry and the Rhode Island Pharmacists Association maintain this hardly constitutes proper oversight.

The new regulations are in violation of a federal law prohibiting the importation of most prescription medications. Some observers expect a legal challenge to the new Rhode Island rules, but it is unclear who would be named as a defendant. If Canada indeed bans such exports, it would be a moot point.