Drug reimportation dilemma: Drug safety vs. access

If drug reimportation is the answer, then what's the question? For patients, it's easy: How can I get affordable drugs? But for physicians, it's more complicated.

The drive toward importation of U.S.-manufactured drugs back across the border has left many doctors asking themselves whether it's more important that their patients are able to pay for their prescriptions or that their drugs are safe.

"It may be a penny-wise approach to get the patient the medicine right now because there's no other way they're likely to afford it, but it may prove to be a pound-foolish approach as we see problems emerging with the quality of the products," said Richard Roberts, MD, professor of family medicine at the University of Wisconsin.

"Reimportation seems like an easy answer, but I think it's an answer that, over time, will be fraught with difficulties," he said.

Among those difficulties is the potential for reimportation to swell the already existing flow of counterfeit drugs into the United States. "We are concerned because when patients go outside the country to purchase their drugs, there is no way for physicians to be certain that the drugs we prescribe for them are the drugs they are going to receive," AMA Trustee Rebecca J. Patchin, MD, testified at a May listening session held by the federal Task Force on Drug Importation.

Safety concerns also have motivated the Food and Drug Administration to oppose past attempts to legalize reimportation.

"When it comes to buying drugs absent our existing regulatory procedures, the FDA has consistently concluded that it is unable to endorse a buyer-beware approach," John Taylor, FDA associate commissioner for regulatory affairs, testified at a May Senate hearing on reimportation.

Despite the concerns of organized medicine and federal agencies, a movement is growing in Congress to allow reimportation. At last count lawmakers had introduced three new pieces of legislation this year alone. More and more policy-makers are lining up to support those measures.

"Politically it's a popular position to hold," said Rep. Ron Paul, MD (R, Texas). "You don't get any points for prohibition. You get points when you say, 'Yes, I would like to help patients.' "

From his perspective as a former practicing physician, he has seen little evidence that safety is an insurmountable problem, Dr. Paul said.

"In a free society, you do assume that people take upon themselves some responsibilities," he said. Knowing the risks, patients should have the right to buy drugs from wherever they want.

Problems go deep

Counterfeit drugs might just be the most obvious problem physicians confront when patients decide to get drugs from Canada or Mexico.

While U.S. distribution of pharmaceuticals is not perfect, it contains many complex protections to help ensure that patients not only get the medications they are prescribed but also get them in the right dose and potency. Reimportation does an end-run around many of those safeguards.

"Generally, I would not object to a patient's request to obtain a drug from Canada or any other legitimate or verifiable source, but the problem that I have encountered is that this is a cheese with many holes," said Bernd Wollschlaeger, MD, medical director of Aventura Family Health Center in North Miami Beach, Fla.

Patients have brought into Dr. Wollschlaeger's office boxes of insulin ordered over the Internet, presumably from Canada and apparently shipped without proper storage or transportation.

"There was no dry ice, there was no cooling, there was no demonstrable chain of custody where I could see that this drug was only on the road for a limited period of time," he said.

Many other red flags pop up when patients bring reimported drugs into their physicians' offices for inspection. "People have come in to me, showing me bottles with a big grin on their face, saying, 'Hey, look, I got this from Canada and it was cheaper.' Then you look at the bottle, and country of origin is not specified," said Richard Blum, MD, medical director of United Cerebral Palsy of Suffolk County, New York.

Dr. Blum, who sits on several pharmacy boards, also recounted patients bringing in pills that he could easily crush between his fingers, a sure sign that the drug was of very poor quality.

"Since it doesn't have to meet [U.S. Pharmacopeia] standards of quality, dissolution and manufacture, it's basically caveat emptor," he said. But patients don't understand that. "They think everyone has the same standards."

Some drugs, such as warfarin, have narrow therapeutic indexes, so that even if a lab test certifies that it has active ingredients, the pills could have an undetermined potency, causing too much blood thinning or too little for clinical purposes.

These concerns raise the issue of whether reimported drugs are really cheaper or if they might cost thousands of dollars in avoidable hospitalization costs when patients are harmed by fake or damaged medication, Dr. Blum said.

And it's not just uncertainty about the quality of reimported drugs that has physicians worried. Safeguards built into the U.S. distribution system are lost when drugs are reimported.

For example, if the FDA recalls a drug, doctors and pharmacies are notified and can contact patients. Similarly, many health plans work in cooperation with pharmacies to track the prescriptions patients are filling, so they can let physicians know if adverse interactions between medications might occur.

What's the alternative?

So is it better that patients stay within the protective mechanisms of the current system, even when that means they cannot afford their medications?

"If it's a difference between her getting the drug, if you will, on a bootleg basis, and taking it versus not taking it, philosophically I might disagree with how she acquired it but, you know, I'd actually rather have her take the drug," said Raymond J. Lanzafame, MD, associate professor of surgery at the University of Rochester and director of the Laser Center-RGH in Rochester, N.Y.

Dr. Lanzafame is especially sensitive to the barriers patients face in the U.S. market. "In my own case, I'm in my early 50s, and so that means I'm in the 'consumer' phase of my health care career," he said. "Every time I go to get a prescription refilled, the co-pays change and the tiers change ... and I am only on a couple of meds. That can be unwieldy, particularly for people on a fixed income."

Reimportation isn't a solution to high-priced drugs; it's simply trading the devil you know for the one you don't, said Ronald P. Bangasser, MD, president of the California Medical Assn.

"I don't know that I can say that I have been sure that patients have gotten medicines that haven't worked and caused them to be hospitalized," he said. "I do know for sure that if the patients haven't gotten the medicine at times, that has caused them to be readmitted to the hospital."

Drug makers might have themselves to blame, in part, for the current situation, physicians said. Direct-to-consumer advertising has ensured that patients identify with brand-name drugs first and that they perceive generics as subpar.

"[Marketing] folks have discovered that the consumer can now walk into the physician's office and say, 'I want this brand,' " Dr. Lanzafame said. "The plus is that for some of these conditions, at least it will bring the patient to the door to be able to discuss the condition. But on the other hand, let's not kids ourselves, that stuff is being put out on the airwaves because it sells drugs."

The combination of brand-name snobbery, healthy doses of media attention and a copious amount of Internet advertising seems to have convinced the public that reimportation is as good a way as any to get medications, and on the cheap.

Even patients in Dr. Blum's private practice, many with seven-figure bank accounts, turn to Canada for low-cost drugs. "People want the product, but they don't want to pay for it," he said. But people do seem willing to pay for "cosmeceuticals." This is encouraging drug companies to invest in lifestyle, rather than life-saving, drugs.

That trend helps explain why there have been four new erectile dysfunction drugs, but no new antibiotics in the past five years; vials of Botox are flying off the shelf, while cancer treatments stagnate; and several weight-control medications are on the horizon, but no heart drugs, he said.

A safe system needed

Most physicians have some patients who get drugs from Canada or Mexico. Many more patients might be doing so without telling their doctor, Dr. Bangasser said.

"We know that this is being done," he said. "I'm just concerned about how it's being done right now, with patients just hoping they're getting the right stuff."

That recognition has many physicians calling for the federal government to implement a system to ensure some minimal safety standards for drugs shipped from over the border.

"We have people in Southern California who drive down and get [drugs] now, by the bus load," Dr. Bangasser said. "We'd like to see a better system of cooperation between our government ... and the Canadian government or others to make sure the medications they get are appropriate."

The AMA has called for any system of reimportation to be overseen by the FDA and to include strict standards not only for what drugs would qualify but also for the manufacturing facilities, labeling and packaging, and the tracking of chains of custody. "Admittedly, these requirements would demand significant federal resources, but if we are to allow drug importation, these measures are necessary," Dr. Patchin said.

But can reimportation ever replace the corner pharmacy? "For those of us who do any kind of e-purchasing, you're always a little nervous as the consumer as to whether you're going to get sent you what you expected to get," Dr. Roberts said. "We find it a little bit comforting to be able to look somebody in the eye as they hand you your package of pills or whatever and know they will still be there next week if you have a problem."