Tuesday, May 23rd, 2017

Unregulated drug imports not worth it: Maine’s new drug import bill is too dangerous

Posted on November 04, 2013 in Legally Maine, Perspectives
By Bryan Bonin

A first-in-nation law that allows  prescription drug imports will risk Mainers’ lives, as it puts the drugs beyond the reach of FDA regulations.

Maine has become the first state in the nation to allow individuals to purchase prescription drugs abroad in a new law which passed in June without the signature of Governor LePage. The non-emergency measure went into effect on Oct. 9.
Titled, “An Act to Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” the law permits licensed retail pharmacies in the United Kingdom, Canada, New Zealand and Australia to export prescription drugs to residents of Maine for their personal use through an unlicensed “entity” or intermediary, which could be located anywhere in the world. These imported drugs often come at a much lower price to patients than prescription medicine manufactured and regulated in the United States.

There is no question that prescription medication produced in the United States is expensive; legislators in Augusta have acted too quickly and without appropriate caution in an attempt to reduce drug costs. Pharmaceutical professionals have raised reasonable concerns regarding the safety, privacy and licensure of these transactions.

The purity standards with which drugs are produced and their accurate labeling are heavily regulated in the United States. This new state law, however, shatters our safe and secure drug supply system. Following a “spot check” investigation in 2003, the FDA reported that up to 69 percent of prescription drugs in mail shipments from foreign countries were unsafe, and that Canadian parcels accounted for 80 percent of those. These potentially dangerous products included unapproved drugs, drugs withdrawn from the U.S. market for safety reasons, improperly labeled drugs, and animal drugs not intended for human use.

Apparently, legislators find this to be an acceptable risk to Mainers’ health. It must be understood that just because it’s good enough for Canada, it is not necessarily good enough for Maine.

Although importing prescription drugs prior to this new law was illegal, Maine rep. Sharon Treat, D-Hallowell, stated in a radio interview that it has been successful for many years in Maine.  Though she claimed that, to her knowledge, no unsafe parcels have been imported to Maine, the FDA statistics cannot be misunderstood. It is careless to assume unsafe parcels have not been sent to Maine by mail shipments, simply because there have been no reports.

Maine residents are offered very little protection under this new law. Unlicensed brokers can conceivably operate from anywhere in the world to ship and sell drugs to people in Maine. The law does not require foreign pharmacies or importation facilitators to verify the legitimacy or appropriateness of prescriptions being filled. Therefore, when a medication from an international broker causes harm due to a counterfeit or contaminated prescription drug being shipped to their home, there is no legal protection provided for these patients in Maine. They will not be able to file a complaint against an unlicensed broker with the Maine Board of Pharmacy, as there can be no regulatory or legal recourse against an unlicensed broker.

Under this new law, these imports could even include controlled, addictive prescription drugs such as oxycodone and morphine sulfate. With over 30,000 opiate addicted Mainers already lacking access to appropriate care, risking an increase in addiction levels is irresponsible.  In short, patients’ lives are at risk.In regard to privacy, international mail order brokers are not required to comply with the Health Insurance Portability and Accountability Act, which means they have the freedom to violate and sell your protected health information without any consequences.

Pharmacy practice in Maine is a very closely regulated profession––and for good reason. Patients in Maine rely on counseling from licensed pharmacists to learn drug interactions, to monitor side effects and to receive instructions for use. Beyond that, Maine pharmacists regularly consult directly with prescribing physicians when questions arise about a prescription.

This new law, condoning the importation of mail order prescription drugs, deprives Maine residents of essential functions that Maine pharmacists provide. Instead, a conduit has been carelessly produced to facilitate the entry of counterfeit, adulterated or expired medications into Maine.  Patients’ health and safety must be of higher priority than reducing prescription drug costs.

Bryan Bonin is a senior political science major with a concentration in law.