In recent months, a growing number of public officials here in the Commonwealth and across the country have proposed schemes for city and state governments to import prescription drugs from Canada. While I am pleased that policy-makers are seeking ways to cut prescription drug costs for seniors and the uninsured, the importation of drugs from Canada is bad public policy. It is illegal, unsafe, and short-sighted.
The Food and Drug Administration has clearly stated that the agency cannot safeguard citizens who obtain prescription medications from outside the United States. This is why the FDA has said it is illegal to import prescription drugs from all foreign countries. In fact, the ban was enacted in 1987 because Congress determined that imported drugs “are a health and safety risk to American consumers.”
The US Secretary of Health and Human Services has the legal authority to permit importation, a power reaffirmed in the recent Medicare reform agreement, provided that the department certifies that patient safety will not be compromised. Secretaries from both Democratic and Republican administrations have refused to allow importation because they cannot guarantee the safety of re-imported drugs.
The FDA position has not changed and, until it does, any city that knowingly encourages employees to purchase medication outside of the jurisdiction of the FDA is breaking the law, putting its citizens at risk, and exposing municipal government to great liability. Even the author of a study commissioned by Illinois Gov. Rod Blagojevich favoring the importation of drugs admits that the liability is “extremely high.” Not feeling it safe to pursue importation plans on their own, Illinois officials have asked the FDA to find ways for them to import safely and legally.
Furthermore, these proposals are bad public health policy. Importation undermines the relationship between a patient and his or her doctor and pharmacist. In order for a Canadian pharmacy to fill a prescription, it must be rewritten by a Canadian doctor who has never examined the patient. In Massachusetts, that would be a violation of the state’s Controlled Substance Act.
Community pharmacists are responsible for educating patients about their medication and the condition for which it is prescribed, completely reviewing the patient’s medication history, monitoring drug therapy over time, screening for adverse drug effects, and ensuring that patients take their medication correctly. Any policy that threatens to fragment or reduce these critical components of pharmaceutical care will endanger the health of patients.
When patients obtain their medications from Internet sites and storefronts, they give up a vital link in the health care chain and often give up their rights. Many companies that facilitate Canadian drug imports require customers to sign away their legal rights in the case of any medication-related problems. If this process is so safe, why do these companies require a waiver? No American pharmacy washes its hands of liability; pharmacists here are accountable to the courts, the law, and their patients.
The Massachusetts College of Pharmacy and Health Sciences has a 180-year tradition of preparing its students to become registered pharmacists and respected health care professionals. Since pharmacy is one of this country’s most heavily regulated industries, a fundamental part of their education and training is unwavering compliance with the laws and regulations governing pharmacy practice. Students are taught to respect a system established in this country over 100 years ago to protect consumers and assure patients that the medications they receive are safe and effective. How do I explain to students that they must adhere to the laws, while these importation schemes, Internet sites, and storefront operations are free to flaunt the law and undermine our drug distribution system?
Proponents have said that these efforts are not intended to hurt pharmacists or their patients but are instead a tactic to pressure the pharmaceutical industry. I agree that the price disparity between the US and many foreign countries is problematic. There is clearly a need to bring about more rational pharmaceutical pricing and to end a system that forces American consumers to subsidize drug development for the world. However, I am strongly opposed to compromising the current system of pharmaceutical care and risking the health of patients to achieve short-term gain.
And what gain? The Massachusetts Group Insurance Commission, a state agency responsible for the health coverage of 135,000 public employees and $187 million in prescription drug expenditures, has studied the feasibility of importation and determined that the savings would not outweigh the risks and potential liability. The city of Springfield says it could save millions, but only with nearly 100 percent participation–very unlikely given that most people prefer to continue using their local pharmacy.
There are alternatives. The Massachusetts College of Pharmacy and Health Sciences currently operates MassMedLine, a free hotline (866-633-1617) that provides help for patients who have trouble paying for prescription drugs. Created several years ago by the Legislature, this program currently services over 13,000 citizens from around the Commonwealth. In the past year, MassMedLine obtained more than $7 million in relief for thousands of individuals by referring them to existing programs, discount cards, pharmaceutical industry programs, and, in many cases, by simply recommending more affordable generic drugs. All of MassMedLine’s efforts are legal, use in-state resources, and are proven effective in providing prescription drug cost relief.
The Division of Medical Assistance has determined that the savings from generic drugs exceed 80 percent, on average, roughly the same as that claimed by importation proposals. Many of the most popular generics are not available by Internet or mail order.
With the nation’s attention focused on the new Medicare legislation, the impact of rising prescription drug costs on seniors and those who cannot afford medication is a critical issue. While I applaud political leaders for addressing the issue, I am frustrated that importing foreign drugs is the only solution being considered to address these complex problems.
Buying drugs from unlicensed Internet and foreign pharmacy storefronts is a bad idea. Buying drugs outside the legal authority of the FDA is a worse idea. Encouraging a system that circumvents the patient’s relationship with their community pharmacist is downright dangerous.
Dennis Lyons, RPh, is executive director of the Center for Continuing Professional Development at the Massachusetts College of Pharmacy and Health Sciences.