Find out whether patients take any imported medications

Pharmacists can often recommend generic alternatives to patients in an effort to reduce costs. The problem occurs when generic drugs do not exist for the prescribed products.

This drives costs up and forces the uninsured and those who don’t receive coverage for all medications to look for cheaper alternative sources, says Susan Winckler, RPh, JD, vice president of policy and communications and staff counsel for the American Pharmacists Association. Those alternative sources tend to be in the form of imported medications.

Imported medications are a scary prospect for pharmacists. They cannot accurately check for drug interactions when patients order prescriptions from foreign sources. They also cannot verify whether the drug is the correct strength or made from the correct ingredients. This poses a serious threat to a patient’s health.

“One [pharmacist] described it as working in the dark,” said Winckler.

Drug importation made headlines recently when Springfield, MA, reimbursed city employees who purchased medication from Canada, and leaders in California, Illinois, and Iowa considered similar programs. State and local governments have considered drug importation programs to reduce costs to their insurance plans, in turn reducing the burden on taxpayers, who foot the bill for government employees’ health insurance.

In addition, at press time Congress is negotiating a Medicare reform bill with a provision that would allow Americans to import drugs from nearly 25 countries.

Consumers do not receive pedigree papers for the prescription drugs they purchase. Pedigree papers outline the drug’s sales and shipment history. Without these papers, it is impossible to tell where a drug has been or whether it was shipped and stored properly, says Marv Shepherd, PhD, professor of pharmacy administration at the University of Texas at Austin.

This is a problem for pharmacists and consumers when drugs are imported. Consumers do not know whether the drug they are taking is correct and will help them, and pharmacists cannot perform an accurate interaction check because they can only base the check against FDA standards, which imported drugs do not usually meet, Winckler says. “They’re pretty limited in the checks they can do,” Winckler says of pharmacists. “It’s important to understand that it may not be the same product you get in the United States.”

Most of the drugs consumers purchased from Canada are for chronic care, such as arthritis or other ailments, Winckler says. If consumers need urgent acute treatment for an illness and go to a local pharmacy or hospital to fill a prescription, they should tell the pharmacist that they receive medications from Canada.

A recent FDA inspection of packages at Miami, New York, San Francisco, and Carson, CA, mail facilities turned up 1,019 imported drug products that violated FDA standards. Of those drugs, 16% were from Canada, 14% from India, and 13.8% from Thailand. The remainder were from other countries.

TIP: Pharmacists do not normally ask patients whether they use drugs from Canada, but they should always have patients identify all medications they use, including over-the-counter medications and herbal supplements, says Kathleen Cantwell, director of federal legislative affairs and government affairs counsel at the American Society of Health-System Pharmacists. This can help the pharmacist conduct a more accurate interaction check.

Proponents of the Medicare reform bill call the prescription drug importation process “reimportation.” That is not what happens, Winckler says. Although it seems as simple as a U.S. manufacturer making and shipping drugs to Canada, and then Americans purchasing them from Canadian vendors, it’s not that cut and dried.

The FDA maintains strict regulations over manufacturing, labeling, and shipping, among other things. If a drug is manufactured in what the FDA considers substandard facilities, the drug may not be of the same quality as drugs made in the United States.

American drug companies manufacture and label medications to Canadian standards, meaning some drugs are of a different strength or form than they would be in the United States.

Whereas the FDA could require something to be a capsule in the United States, Canadian regulation could require the same drug to be tablet form, says Winckler.

Such drugs do not comply with FDA standards because of labeling and other differences. They are considered illegal, Winckler says. FDA-approved drugs must have labels that explain, in English, proper use, dosage, and potential side effects. Many unapproved drugs are not labeled in English or omit information about side effects or safe use.

The FDA has not prosecuted individual consumers because they might not know they are breaking the law, Winckler says.

The FDA has acted against companies that facilitate drug importation, including warning CanaRx Services, Inc., of Detroit—the company that provides prescription drugs for Springfield, MA, and its importation program—to stop violating U.S. law. If companies do not respond and comply, the FDA can take legal action, including seizing property and seeking injunctions to stop importation activities, according to the FDA.

Some companies simply ship medications from another country through Canada and into the United States. Health Canada, the Canadian equivalent of the U.S. Department of Health and Human Services, only regulates drugs sold in Canada. It does not approve those imported with the intent to export to other nations, increasing the risk that Americans could receive counterfeit or defective drugs, Shepherd says.

Nearly 60% of all counterfeit medications do not have the active ingredients to make the drug work as it should, which can lead to further complications or death because the disease remains untreated, Shepherd says.

Yet drug importation appeals to many legislators because Canadian controls reduce drug prices, which looks good to someone trying to save money, he says. “Someone’s going to get hurt,” Shepherd says. “As a legislator, you’re trying to correct your budget and finances at the expense of the lives of other people.”

If the Medicare reform bill passes and allows consumers to import drugs, U.S. pharmacies would not be able to compete with the international prices and would see more business go overseas, Winckler says.

The government might have to allow pharmacies to purchase drugs overseas and maintain two inventories, one of which would be imports for those who cannot afford the higher prices.

In another scenario, the prescription drug benefit provision of the Medicare reform bill could reduce the importation need. Seniors might be able to afford more drugs in the United States, allowing them to purchase drugs domestically instead. The U.S. government should sit down with pharmaceutical manufacturers and negotiate some type of price concessions, such as an inflation index or a plan not raise prices multiple times a year, he says.