A few weeks ago I received an e-mail from a reader asking me what my thoughts are on patients who import their prescription medicines from other countries. I gave a brief reply to him, but thought it was a topic that I should probably address here in a full blog post.
It’s an important issue. As I’ve written about numerous times, prescription drugs are a major part of many medical treatments today, and they can be expensive. Prescription drug prices in foreign countries are often much less expensive than in the U.S. For example, a story by students in the Walter Cronkite School of Journalism at Arizona State University reported the following:
Three years ago, Gail Lang, 70, was… diagnosed with tardive dyskinesia, a difficult-to-treat neurological disorder.
Tardive dyskinesia has no known cure, but medications can diminish its symptoms, Bob Lang said. She was prescribed Xenazine, a drug which would stop her body shaking and bring her relief.
But there was one big problem: It cost $9,000 for a 30-day supply of the drug, $112,000 a year.
While Medicare in 2010 offered coverage of most drug expenses over $4,550, Bob Lang said that when he went into Walgreens to buy his wife’s medication, he was told his plan would not cover it.
According to a National Academy of Sciences study, 13.6 percent of government prescription drug insurance plans do not cover Xenazine because it is an orphan drug, which means it is only prescribed for rare diseases. Lang said he did not know why the insurance did not cover his wife’s medicine but he checked back with another pharmacist for the price of Xenazine and got the same high price, which means it was not simply an error of the pharmacy.
Currently, only one manufacturer in the U.S. formulates Xenazine.
…following advice from his wife’s aunt, Lang went online and found Planet Drugs Direct — one of 77 online Canadian pharmacies approved by the Canadian International Pharmacy Association.
By ordering the prescription through a Canadian pharmacy, the Langs only spend $1,776 a year for Xenazine.
This particular story is fairly atypical in terms of the size of the savings, but it does illustrate the point fairly well. Importing prescription drugs from foreign countries can result in big savings, often 50% or more.
So, should self-pay patients consider buying drugs overseas? Although the potential savings can be considerable, my answer is no. There are two main problems that, for the most part, lead me to conclude that the potential savings just aren’t worth the other costs.
The first problem is pretty easy to explain – it’s illegal, at least in most circumstances. Here’s what the FDA has to say about personal importation of prescription drugs:
Is it legal for me to personally import drugs?
In most circumstances, it is illegal for individuals to import drugs into the United States for personal use. This is because drugs from other countries that are available for purchase by individuals often have not been approved by FDA for use and sale in the United States. For example, if a drug is approved by Health Canada (FDA’s counterpart in Canada) but has not been approved by FDA, it is an unapproved drug in the United States and, therefore, illegal to import. FDA cannot ensure the safety and effectiveness of drugs that it has not approved.
There are a handful of exceptions where the FDA will allow importation, including if “the drug is for use for a serious condition for which effective treatment is not available in the United States” and “the drug is considered not to represent an unreasonable risk.” In these cases the person bringing the drug into the country must also confirm in writing the medicine is for personal use and also demonstrate the drugs are being taken under the direction of a physician or that they are part of treatment that started in a foreign country.
I should mention up front I’m not a big fan of the FDA’s stated reason here why personal drug importation illegal. I’m of the opinion that, if Canada or the U.K. or Germany has approved a drug for people to use and a U.S. citizen and their doctor think that drug best suits the patient’s needs, then they should be able to get it.
But that’s a political and public policy issue, which I generally try to avoid getting into here. The other two main reasons generally given by supporters of the ban on drug importation have much more legitimacy in my opinion.
First, and I’ll only touch on it briefly because it’s also a political, public policy, and economic issue, is that the reason prescription drugs overseas are typically so much less expensive than in the U.S. is that other countries impose price controls on drugs. I won’t run you through the economic case against price controls, I’ll just note that it’s widely accepted by nearly every economist that imposing price controls typically causes more harm than good. In this particular case that harm is, in my opinion, being inflicted at least in part on U.S. consumers who have to pay higher drug prices to make up for reduced revenue from foreign sales.
The second main reason for supporting the ban on importation of prescription drugs is far easier to explain: safety. Simply put, the U.S. has a pretty safe and secure prescription drug system (which is not to say perfect), and buying medicines from overseas, particularly over the internet, eliminates a lot of the protections that the FDA does provide.
Consider this story from Maine, where the state legislature in 2013 legalized prescription drug importation (don’t ask how it is a state can permit, or at least thinks it can permit, something federal law directly prohibits – that’s probably a whole day’s worth of legal reading I don’t want to inflict on my readers):
The president of the Maine Pharmacy Association has filed a complaint with state regulators alleging that a Canadian company broke state law by selling him generic drugs from prescriptions that were filled in India, Turkey and Mauritius.
… Kenneth “Mac” McCall… says that Maine law requires the company, Canada Drug Center, to sell Maine consumers only drugs that are made or processed in Canada…
McCall said his curiosity was piqued when he noticed a newspaper ad for lower-priced prescription drugs in November, not long after the law took effect to allow retail pharmacies in Canada, the United Kingdom, Australia and New Zealand to sell drugs to Mainers.
The newspaper ad offered consumers less expensive, generic forms of popular prescription drugs such as Celebrex (an anti-inflammatory used to treat arthritis), Nexium (to treat heartburn) and Advair (a steroid used to treat asthma, emphysema and chronic obstructive pulmonary disorder).
“Are you still paying too much for your medications?” the ad asked. The company selling the drugs was not identified, but there was a toll-free number, which McCall called.
He was directed to a website, CanadaDrugCenter.com, where he ordered three medications: Cobix, the generic equal of Celebrex; Izra, the generic version of Nexium; and Clopivas, the generic equivalent of the popular blood thinner Plavix.
When McCall’s order arrived, the labels showed that the drugs had been manufactured not in Canada but in India, and that the prescriptions had been filled in Turkey, India and Mauritius, an island in the Indian Ocean off the coast of Madagascar.
McCall clearly has a vested interest here, but that doesn’t change the fact that people who probably thought they were buying prescription medicines from Canada (with a fairly robust drug safety system as well) instead would wind up with drugs from countries where protections for patients are somewhat less stringent.
The dangers of getting drugs from outside of the protected U.S. system are fairly significant. Here is an excerpt from a news story in the Globe and Mail just a few weeks ago:
French customs said on Thursday that they had seized a stash of 10 tonnes of fake aspirin and erectile dysfunction and diarrhea drugs from China in what they billed as the European Union’s biggest-ever seizure of counterfeit medicine…
The fake aspirin and anti-diarrhea drugs contained no active ingredient other than sugar, while the fake erectile dysfunction drugs did contain an active ingredient but dosed differently than the original product, the official said.
…shipments as big as the latest case are exceptional. In 96 per cent of cases, counterfeit drugs crossed borders in modest postal packets, and the drugs seized are mainly fake drugs for erectile dysfunction, the customs official said.
“We’re talking about people who don’t dare to go to the pharmacy, who order the drugs online at attractive prices but have no idea what they’re getting,” he said.
Viagra or aspirin that contain only sugar may not be a major health risk, but it can get pretty serious with other drugs:
Vials of the cancer drug Herceptin probably stolen in Italy have been tampered with and reintroduced into the medicine supply chain, the European Medicines Agency said.
Counterfeit drugs have been identified in the U.K., Finland and Germany, Roche (ROG) Holding AG, the Swiss maker of Herceptin, said in an e-mailed statement. There have been no reports of any harm to patients from the fakes, the EMA said in a separate statement today. Roche is recalling suspect vials as a precaution, the agency said.
Herceptin, used to treat breast cancer, is among Roche’s best-selling products, with sales of 6.1 billion Swiss francs ($6.9 billion) in 2013. An analysis of one of the stolen vials showed it doesn’t contain trastuzumab, the active ingredient in Herceptin, Roche said. Other vials were shown to have been diluted.
“This is the first time a product suspected of being counterfeited has entered the official drug distribution chain in Finland,” the Finnish Medicines Agency said in a statement on its website.
None of this is to suggest that the U.S. drug market is wholly without problems either, as this report from the Partnership for Safe Medicines documents:
Since 2007, 16 physicians and drug distributors have been prosecuted for the purchase or sale of non-FDA approved cancer treatments and the FDA is currently conducting more investigations. Since 2011, the FDA has notified more than 100 medical practices in 29 states that they may have purchased counterfeit cancer medications which were distributed by a fake online Canadian pharmacy. In total, the FDA has sent more than 1000 letters across all therapeutic areas to professionals who may have bought medications from known counterfeit drug sellers. The tested counterfeit cancer medication contained no active ingredients, only saline and acetone. Illegal distributors make a profit selling drugs that are illegally imported, expired, stolen, damaged by bad handling or outright counterfeits. Doctors purchasing these discounted drugs generate a profit for themselves by billing insurance, Medicare and patients at the same price they would for legitimate treatments…
The full report cites nearly 20 recent cases in which counterfeit, adulterated, or unapproved drugs were introduced into the U.S. system, many of them involving illegal importation by unscrupulous doctors, pharmacists, or medical suppliers.
I have often said that the point of saving money as a self-pay patient isn’t to save money, it’s to get the medical care you need at the best price possible. ‘Saving’ money by importing prescription drugs from other countries seems like an unacceptable risk given the dangers involved, especially when there are many other alternatives, including prescription drug discount cards, patient assistance programs, generics, and shopping around for the best price on drugs.