In a quest to help Nevadans buy lower-priced Canadian prescription drugs from state-approved pharmacies, state officials have come across a foreign obstacle: Canada is just different.
The Nevada State Board of Pharmacy is waiting for an opinion from the Attorney General's Office on the state law's specification that the drugs must be Food and Drug Administration approved, something that isn't a qualification in a country with its own drug requirements and regulating agency.
Lewis Ling, general counsel for the pharmacy board, said the state board is set to approve up to five Canadian pharmacies to sell prescription drugs in Nevada through a state-run Web site, but that all could change depending on Attorney General Brian Sandoval's opinion on the "FDA approved" statute. Nevada's law to make it easier for consumers to buy prescription drugs from Canadian pharmacies went into effect July 1.
One Canadian pharmacist compared the drug licensing process in the two countries to obtaining building permits in different states. The systems are similar, but different and that's enough to cause a delay.
"There are major differences," said Dawn Polley, president and owner of Granville Pharmacy LTD of Vancouver. "This is a big issue and it's hard to know whether it will be resolved."
One big difference is the patents. Once a drug goes off patent and is available in the generic form, Health Canada, the northern version of the FDA, requires pharmacists sell the generic drug first. A brand name is sold only if it's specified in the doctor's prescription.
During the approval process, Nevada inspectors found the five pharmacies that applied to legally sell medicines in the state only had drugs approved by Health Canada and not drugs approved by the FDA.
Ling said he and the other inspectors saw mainly the generic drugs on the shelves on these pharmacies. In some cases the drug is "off patent" in Canada but "on patent" in the Unite States. Ling said because the United States has such a competitive generic market, the U.S. prices often match or are better than the Canadian prices. But then there are the cases when Canada has a generic version that the United States doesn't.
For example, Polley said her pharmacy carries a Merck high cholesterol drug called Zocor and its generic version Simvastatin. The U.S. doesn't carry the generic version. At one Carson City pharmacy, 30 Zocor 20-milligram pills are about $160. At Polley's pharmacy the same pills are $94 and the generic version is $57, which is a savings of about 40 percent.
Polley said Nevada is attempting to license Canadian pharmacies, which is different from what other states she has worked with have done.
"Other states we're working with recommend people to use us, but they don't license us," Polley said.
Ling said Nevada is the only state at the moment attempting to license Canadian pharmacies. Rhode Island's attempt has been bogged down by the FDA legality issue.
Carole Saindon, spokeswoman for Health Canada, said she isn't aware of any Canadian pharmacies licensed in the states. Health Canada approves all the drugs sold in Canada with legislation similar to the United States' Food and Drug Act.
"Many of these drugs sold in Canada are also approved for sale the U.S. by the FDA," she said. "Our systems are parallel in many ways, distinct in others, but for sure you will find that many of the drugs sold in Canada are also sold in the U.S."
Although Nevadans can access Canadian drugs through the Internet, there is no "state approval" stamped on these drugs. Ling has said that the state approval will make the process easier and the Web site will help consumers pick a safe pharmacy.
But most states haven't taken the licensure route, preferring instead to recommend qualifying pharmacies. Eight states, several cities and the District of Columbia operate similar programs in opposition to the Bush administration's stance that prescription drug imports can be unsafe. These states started their programs by governor initiative.
"We inspected the pharmacies and so did our state pharmacy board, so now we have four that we recommend to the people," said Karen Smigielski, spokeswoman for the Minnesota Department of Human Services, which runs a Web site similar to the one Nevada is looking to establish.
She said this Web site was created by the governor's initiative, rather than a law. Consumers cannot order from Minnesota RxConnect. It links buyers to the pharmacy's Web site.
"It excludes medicines from which there is no equivalent approved by the U.S. Food and Drug Administration for sale in the U.S.," Smigielski said.
n Contact reporter Becky Bosshart at firstname.lastname@example.org or 881-1212.