When patients want to buy meds online

What advice do you give that will help them, while still protecting yourself? What alternatives can you offer?

Have your patients been getting strange e-mails like this one:

Need not over the counter Meds? Dr. will help you get Meds Meds you need for great deal All Meds that you have heard about Visit to see all Meds you wanted No papers needed to get any Meds Any Meds granted without papers needed Meds that will help more than over counter

According to the National Association of Boards of Pharmacy, there are about 500 Internet sites that can be traced back to legitimate American pharmacies and 50 to 75 to legitimate Canadian pharmacies. But that leaves untold numbers of rogue sites—like the one that sent the e-mail above—that pose a potential danger to your patients.

Last year, according to a survey by JupiterResearch, a company specializing in business and technology market research, between 2 and 4 million adults purchased their meds online from foreign pharmacies or from rogue sources. Some of these are hard deals to turn down, especially for patients on maintenance drugs who are spending six times as much for their medicines as their offering price on the Internet.

What do you say when a patient asks you for advice about buying drugs from an Internet source? What's your liability if someone develops problems from drugs purchased online? We talked to the experts to find out.

About the sites

There are three distinct categories of Internet sites that your patients should know about. First are the reputable companies administered by pharmacy benefit management companies or created by established American pharmaceutical distributors such as CVS or Walgreens. These sites require patients to present a prescription from their regular doctor.

Ordering online from such sites can save patients money: Typically the sites charge two-thirds what a local drugstore charges. These legitimate sites also are convenient for patients who have difficulty getting to a pharmacy. And some health plans require subscribers to order maintenance drugs online or by mail.

Into the second category fall the Web sites that represent legitimate Canadian pharmacies. You write a script, the patient sends it by mail to the address at the Web site, a Canadian pharmacist rewrites the script, then verifies it with you. The script is then sent to a Canadian licensed pharmacy where it is filled and shipped.

The appeal of these sites is their deep discounts. "My patients save hundreds of dollars by ordering from Canada," says Steven Gitler, an FP in Cherry Hill, NJ. "The service is excellent, and the meds are perfectly safe. It's a good alternative to the high prices in this country." FP Donald Cohagan from Bentonville, AR, agrees. "I actively advise my patients to buy meds online from Canada and have never had a problem."

(Of course, you have to warn patients that foreign-made drugs cannot be sold legally in this country because they haven't passed muster with the FDA and that mailed packages may be denied entry. New legislation on reimportation is being debated in Congress as we go to press.)

Other doctors are wary of Canadian Web sites because a large number of them are bogus. These sites fall into the third category—the rogue sites. Some dispense drugs based on a pro forma questionnaire completed online. A doctor then writes a script based on the responses. Other sites require no prescriptions at all. These sites are especially popular among patients who order meds like Viagra and are looking to avoid an embarrassing conversation with their doctor about sexual problems.

Aside from the obvious problem that patients are being prescribed drugs without first being examined by a physician, these rogue sites pose other safety concerns. In many cases, the drugs aren't pure, or they're counterfeits (see "Inferior drugs from Canada?").

Good doctor-patient communication is the key to avoiding the adverse consequences of inferior meds. Ask where your patients are getting their drugs. Tell them about a service offered by the National Association of Boards of Pharmacy (www.nabp.net/vipps) that helps users determine whether a site is a licensed pharmacy in good standing. The association awards a "VIPPS" designation to qualified sites.

What's your liability?

If a patient suffers an adverse reaction from a drug bought over the Internet, could you be liable? "It comes down to the level of your involvement," cautions Wayne J. Miller, a healthcare attorney with the Compliance Law Group in Woodland Hills, CA. "If a patient isn't presenting a script from you, then you have little involvement in the process, and your potential liability is very low." But your involvement ratchets up if you expressly sanction or condone buying from the Internet.

"You may be asked for a recommendation for a reliable Canadian pharmacy or another Web site offering drugs over the Internet," says Miller. "You want your patient to comply with your therapy, and you know he's having trouble paying for it, so you're in a quandary." But if you offer specific advice and assistance, that puts you at risk. You're, perhaps unwittingly, getting involved in the process.

"One liability problem with Canadian sources is the issue of the intermediate doctor. When a Canadian doctor rewrites your script, he's not seeing the patient. The American physician may be considered guilty of aiding and abetting because he's helping that Canadian doctor prescribe drugs without seeing the patient."

How can you avoid that? Limit your involvement when it comes to Internet pharmaceutical purchases. Serve only as an information resource for your patients. Give them information from the FDA about the risks of getting drugs through the Internet, then let them make informed decisions.

But what should you do when the phone call comes from a Canadian pharmacist to verify your script? "You're within your legal rights to make sure the script is the one you wrote and that the pharmacist is interpreting it correctly," says Miller.

Miller suggests that you have some documents ready to give to patients, such as the "FDA Consumer Safety Alert" in this issue's Clip and Copy, and a letter that states your position on Internet drug sales. In that letter, state that you don't advocate going to the Web for drugs and that your only involvement will be to confirm a script if a pharmacist calls for safety's sake. State that you're not guaranteeing the quality or appropriateness of any drugs obtained that way.

No one's been sued yet for malpractice over an Internet drug issue, according to Miller, but he says it's only a matter of time. "It won't happen until there's a clear case where a doctor crossed the line to become an advocate of a pharmacy site. And then it will turn on whether and to what degree the patient perceived that he was advised to go that route.

Offer alternatives

What alternatives can you offer patients looking to save money? Some doctors give as many coupons and free samples as they can. Others refer patients to programs sponsored by states and by major drug manufacturers that offer free or discounted drugs. Applicants generally must be within 300 percent of the poverty guidelines—for a couple, that's an income of $38,000 a year.

"These programs are a well-kept secret," says Pat McKercher, director of the Center for Medication Use, Policy, & Economics at the University of Michigan. "The problem is, the patients who need them most find them difficult to penetrate." One source of help can be found at a Web site sponsored by the Pharmaceutical Research and Manufacturers of America (www.helpingpatients.org). The site simplifies the application process by allowing patients to complete a single application, and then matching the patient to a program that meshes with their qualifications. Patients no longer have to find and fill out forms for each program.

Information is in both Spanish and English, and there's also a large-print version. More than 400 brand name meds are represented at the site, although quantities of some may be limited.

Inferior drugs from Canada?

A recent FDA analysis of three commonly prescribed drugs purchased from a Web site posing as Canadian showed that so-called "Canadian generics" were fake, substandard, and potentially dangerous.

FDA investigators purchased three commonly prescribed drugs—Ambien, Lipitor, and Viagra—in "generic form" from a Web site that had been sending promotional spam e-mails like the one at the beginning of this article. None of the three products has an FDA-approved generic version.

"The test results of our analyses offer proof positive that buying prescription drugs online from unknown foreign sources can be a risky business," says FDA Acting Commissioner Lester M. Crawford. "As was the case here, even where a Web site looks legitimate, the FDA has clear evidence that the Web site is dispensing misbranded drugs that are not the same quality as those approved by the FDA for sale in the United States.

"Consumers who believe they are getting equivalent products from reputable sources are being misled and putting their health at risk." The drugs discovered in the blitz were the wrong strength, didn't dissolve properly, or contained contaminants. In the case of Lipitor, the online purchaser specified that he was taking erythromycin (contraindicated for Lipitor) and he was sent the cholesterol-lowering medication anyway despite potentially dangerous drug interactions.

The FDA's test results are summarized at www.fda.gov/importeddrugs/chart071304.html. Additional information about buying drugs online is available at www.fda.gov/oc/buyonline/default.htm.

 

Dorothy Pennachio. When patients want to buy meds online. Medical Economics Sep. 3, 2004;81:47.