By John Carruthers, staff writer, June 01, 2012
Despite Medicare Part D, created by the Medicare Modernization Act of 2003 to provide drug coverage within the program, the price of prescription drugs remains a sticking point for many patients. Many Web-savvy patients have at the very least investigated the possibility of obtaining cheaper prescription medications from Canada — whether ordering online through a pharmacy or traveling across the border themselves. This can put dermatologists in an awkward position, both as unwitting legal advisors and as physicians dedicated to the best course of treatment for patients.
Importation from Canada
The issue of patients buying drugs from pharmacies outside the U.S. took center stage in the early 2000s when a group of Midwestern governors, led by former Illinois Gov. Rod Blagojevich (D), encouraged their constituents to buy their drugs north of the border and lobbied the federal government to change the importation laws in the name of financial savings. At the time, Blagojevich claimed publicly that Illinois would shave $91 million off of the state’s $1.8 billion annual drug bill by obtaining prescription drugs from Canada for the state’s retirees and state employees, who alone accounted for $340 million in annual prescription drug spending. The interest was bipartisan: Minnesota Gov. Tim Pawlenty (R) proposed a plan to allow patients to buy U.S.-made prescriptions online directly from Canadian pharmacies.
But nearly a decade later, the practice remains illegal (see sidebar, page 34), and the Food and Drug Administration (FDA) continues to advise against the personal importation of drugs from foreign sources. The Rx Price Watch, a report put out in March 2012 by the public policy arm of the AARP, found that retail prices for a set of Medicare drugs used most often by Medicare beneficiaries had grown at double the rate of inflation from 2005 to 2009. [pagebreak]
“I practice in Buffalo, and you can drive 10 minutes across the border and be in Canada. So drug importation is somewhat of an issue here, and it really boils down to cost. Medicine is very expensive here in comparison, and some patients can’t afford the cost,” dermatologist Robert Kalb, MD, said. “I’ve heard patients ask about getting medication in Canada. The trouble is that they can’t honor my prescription there. Some of the patients will have physicians there who will re-write the prescription to allow them to get it filled.” Online pharmacies in Canada, however, may accept American prescriptions.
Patients who do manage to get prescriptions filled north of the border, according to dermatologist Mary Maloney, MD, chair of the American Academy of Dermatology’s Regulatory Policy Committee, run the risk of having the drugs confiscated, though usually not much else.
“The FDA and the government still consider the importation of drugs from other countries to be illegal,” Dr. Maloney said. “And so while patients will not be charged as such, the drugs will be impounded. What it comes down to is that patients will try to bring drugs over for personal use, and they may be able to get some of them through customs, and some of them will get picked up and confiscated.”
Dr. Kalb said that the relatively small percentage of patients who still actively seek drugs from Canada usually do so because of two things — cost concerns and a local connection.
“Most of the patients who do this have a tie to Canada — a friend who lives there, a relative they can contact — when they bring it up to their physician. Some of the more expensive medicines cost patients $30 in Canada versus $300 here, and that’s why it’s such a big issue for them,” Dr. Kalb said. “As a general rule, it’s a small percentage of patients. It has to do with logistics, because it’s not the easiest thing to do, especially if you follow the letter of the law.”[pagebreak]
Safety and patient care
The safety risk of drug importation is the most-cited argument against relaxing importation laws, an argument that has rankled Canadian health officials and that critics, including former Iowa governor Tom Vilsack (D), have decried as a scare tactic. But when considering importation, especially from the even more grey area of online pharmacies, there are serious safety concerns, according to Nicolas P. Terry, JD, Hall Render Professor of Law at Indiana University’s Robert H. McKinley School of Law.
“I would certainly not recommend drug importation to anyone. If a patient says to their physician that it’s what they’re doing, I would recommend pointing out the risks involved. We do not for sure know the origins of those drugs, how they have been kept, how they have been shipped. It would be always preferable to work through normal, legal, U.S. sources,” Terry said. “I don’t think that doctors should start giving legal advice to their patients, so the legality of it isn’t necessarily for the doctor to discuss except perhaps for noting that there are questions about it. The doctor should work within their own sphere of expertise and talk about the drug distribution chain, the safety concerns and whether patients can be confident in it or not.”
One effective tactic, Terry said, involves spelling out the prescription benefits already available to patients, rather than continuing to highlight the extra-legal nature of importation.
“There are various strategies that patients can and do use to lower the cost of drugs in this country. If they have private insurance, for example, ordering a 90-day supply rather than a 30-day through the insurance’s benefits manager is likely to bring considerable cost savings,” Terry said. “If patients can’t do that, look to see if different employer-supplied insurance options [such as switching from a PPO to an HMO plan or vice versa] will have different deductible rates on drug plans. There are also mail-order pharmacies in this country that are legal and will provide a break in price.”
The National Association of Boards of Pharmacy (NABP), he said, runs a program called Verified Internet Pharmacy Practice Sites (VIPPS) for consumers seeking to purchase mail-order drugs through reputable U.S. sources [see sidebar, right]. This, the group says, is a vital service, as only 3 percent of the 9,600 sites the NABP has reviewed appear to comply with appropriate laws and practice standards.[pagebreak]
Exceptions and scope
Under certain circumstances, the FDA has, in the past, relaxed its blanket opposition to drug importation. According to its official policy, the FDA will not object to personal importation of a three-month or less supply of drugs that the FDA has not approved, providing the situation meets these criteria:
- The drug is used for a serious condition for which there is no effective treatment in the U.S.
- There is no promotion of the drug to U.S. residents.
- The drug is considered by the FDA as not posing “an unreasonable risk.”
- The individual verifies in writing that it is for his or her own use and provides contact information for the doctor providing treatment.
- The product is for the continuation of a course of treatment begun in a foreign country.
In addition, Dr. Maloney said, during times of shortage, the FDA has been known to assist in securing imported drugs for patients in need while the supply recovers.
“The FDA actually helped us with psoralens. There was a manufacturing shortage in 2010 because of a lack of raw materials. People who were on phototherapy couldn’t get psoralen, and many of them had to discontinue their treatment,” Dr. Maloney said. “The FDA was very helpful in identifying supplies from overseas and allowing the importation during that time. It really kept a lot of people getting their treatment. The government will help facilitate the importation of certain drugs in rare cases.” For instance, in 2012 the FDA has allowed the importation of methotrexate manufactured in Australia and approved in Canada to stave off a U.S. shortage of the drug, a vital cancer and psoriasis treatment.
Given the hesitancy of patients and some physicians to speak about the issue of importation, and the nature of disreputable Internet pharmacy sites, the exact scope of the drug importation issue is difficult to quantify, and thus call regulatory attention toward. The debate over imported drugs continues, but an FDA pilot program referred to on the agency’s public information site hinted at the scope of personal importation. During a five-week period in 2009, the FDA and Customs and Border Protection examined 1,908 packages of drugs from 19 countries of origin that were sorted through a mail-processing facility in Carson, Calif. Of those examined, 721 were detained as in violation of the Federal Food, Drug, and Cosmetic Act.
Groups stress safety issues
Drug importation efforts by governors such as those detailed in the article above have receded from the news, but patient and consumer groups continue to petition for a solution to rising drug prices. Both medical groups and government agencies with an interest in the topic stress that patient safety must be valued above all before changes to the system are considered.
American Medical Association
“Our AMA will:
(1) support the legalized importation of prescription drug products by wholesalers and pharmacies only if:
(a) all drug products are Food and Drug Administration (FDA)-approved and meet all other FDA regulatory requirements, pursuant to United States laws and regulations;
(b) the drug distribution chain is closed,’ and all drug products are subject to reliable, electronic’ track and trace technology; and
(c) the Congress grants necessary additional authority and resources to the FDA to ensure the authenticity and integrity of prescription drugs that are imported;
(2) oppose personal importation of prescription drugs via the Internet until patient safety can be assured;
(3) review the recommendations of the forthcoming report of the Department of Health and Human Services (HHS) Task Force on Drug Importation and, as appropriate, revise its position on whether or how patient safety can be assured under legalized drug importation; and
(4) educate its members regarding the risks and benefits associated with drug importation and reimportation efforts.”
AMA House of Delegates policy adopted in 2004
National Association of Boards of Pharmacy
“While the price of prescription drugs obviously is of concern to U.S. patients, it should not be the driving force behind their importation. The practice of importing drugs from foreign jurisdictions is illegal and has been made so to support the overriding purpose of the law, namely the protection of the public health and welfare. Until there is equity in the pricing of prescription medications, it may be impossible to completely stop U.S. patients from obtaining medications from Canada, Mexico, and other countries ... As regulatory authorities in the U.S. and other countries grapple with this important issue, educating the American public on the danger and illegality of purchasing prescription medications abroad is a necessary component of any solution to the problem.”
“Position Paper on the Importation of Foreign Drugs,” 2003
In the article to the left, Nicolas P. Terry, JD, Hall Render Professor of Law at Indiana University’s Robert H. McKinley School of Law, suggests online pahrmacies as a potential solution for patients facing high prescription drug costs. The following is a list of online pharmacies accredited under the Verified Internet Pharmacy Practice Sites (VIPPS) program by the National Association of Boards of Pharmacy.
Open to the public
BioPlus Specialty Pharmacy Services www.bioplusrx.com
BioScrip Pharmacy Services, Inc. www.bioscrip.com
Diabetic Care Services & Pharmacy www.diabeticcareservices.com
Drugs Depot www.drugsdepot.com
DrugSource, Inc. www.drugsourceinc.com
HomeMed Pharmacy, LLC www.planthefam.com
K Mart www.kmart.com/pharmacy
Liberty Medical Supply, Inc. www.libertymedical.com
MedfusionRX, LLC www.medfusionrx.com
Ridgeway Pharmacy, Ltd. www.ridgewayrx.com
Aetna Rx Home Delivery www.aetna.com/aetnarxhomedelivery
Cigna Home Delivery Pharmacy www.teldrug.com
Express Scripts www.express-scripts.com
Medco Health Solutions, Inc. www.medco.com
OptumRx, Inc. www.prescriptionsolutions.com
PBM Plus Mail Service Pharmacy www.pbmplus.com
Prime Therapeutics, LLC www.primetherapeutics.com
Rx Direct, Inc. www.rxdirect.com
United States Pharmaceutical Group, LLC www.nationshealth.com
WellDyne Rx www.welldynerx.com