Implications of the Maine drug-import law

January 10, 2014

Some of the medications coming into Maine will originate in countries where oversight of the pharmaceutical production process is lax or nil. Are the possible consequences worth the probable savings?

The state of Maine, one of the most rural and conservative states in the Union, took a step recently that none of the other, more urban and progressive states has yet done. To help its citizens lower their healthcare costs, Maine has gone rogue, passing a law to allow for the importation of pharmaceuticals from outside the United States. Some estimates suggest that importing medications from Canada will save the state between $3 million and $5 million annually in direct outlays.1

Importing drugs from the country next door might seem to be a wise move, but it raises a slew of issues that regulators, consumer advocates, and pharmacists must consider.

While the cost of drugs in the United States is among the highest in the world, the Food and Drug Administration (FDA) is stringent when it comes to consumer safety. In 2013 alone, a host of drugs were recalled for various reasons, all with the ultimate goal of keeping people safe.2

It should be noted that medications coming into Maine will come not only from countries such as Canada and the United Kingdom, where oversight and quality controls are robust, but from other countries that do not hold themselves to such high standards. Since FDA has no control over prescription drugs brought in from other countries, it is rendered defenseless to validate the true contents and safety of products purchased online and shipped internationally.

Oversight role of FDA

Counterfeit drugs are a worldwide problem. According to the World Health Organization (WHO), as much as 70% of the medications imported into developing and developed nations are counterfeit and have been responsible for thousands of deaths.3 The United States has avoided this problem, for the most part, thanks to the work of FDA.

For noncompounding pharmacists, FDA is a backstop for legal liability. The drugs that U.S. pharmacists dispense have something akin to the full faith and credit of the United States behind them: The inspections performed ensure that the product sold is of the highest quality. If and when there is a problem, FDA can quickly mobilize to remove drugs from shelves, enter production facilities to track down problems, and fine companies to ensure compliance with its rules. Drugs that flow across pharmacy counters and into the hands of patients have the assurance of FDA inspections and oversight.

For imported drugs, products ordered from websites and shipped directly to consumers, this is not the case. Since there is no federal oversight or control on imported medications, it’s difficult for pharmacists to do their jobs and protect patients.

A large part of a pharmacist’s job is to monitor for drug interactions between multiple prescriptions. Medications imported from low-cost, low-regulatory jurisdictions may not have the same level of efficacy or accurate dosages either on their labels or in their composites. As a result, dangerous interactions may take place. If and when they do, who will be responsible? Who will be liable, and who will ensure that drugs being produced are at the highest level of quality?

A growing problem

Even when FDA has exercised the greatest degree of oversight possible, the United States has seen a growing problem with the import of counterfeit drugs.

For example, in 2007-2008, 149 Americans died after using a contaminated version of the blood-thinner heparin, which had been legally imported into the United States from China.4

In 2011, Genentech, a division of Roche, reported a massive influx of counterfeit Avastin being imported and sold in the United States. The Associated Press quoted Genentech spokeswoman Charlotte Arnold as saying, "We're still analyzing what it is. We know it doesn't contain the active ingredient in Avastin.”5

In 2012, The Wall Street Journal reported that authorities had identified a supply chain that may have enabled the fake cancer drugs to reach U.S. clinics.6

In Maine, the assumption is that the majority of imported pharmaceuticals will come from Canada, a country with tight controls on the production and distribution of medications. While Canada is a good source of medication, it does not have a stellar track record when it comes to exporting drugs to the United States.

New dangers

Fewer and fewer primary care physicians are in practice today. In Maine alone, roughly 530 primary care physicians treat a population of just over than 1.3 million people.7 That means each doctor is responsible for the frontline health of 2,500 people.

These doctors simply don’t have the time to follow up with each and every patient to ensure that they are taking their medications properly. Therefore, by default, this responsibility is shifting to the pharmacist, whose role has never been more critical.

This can be a dangerous development, not because pharmacists are not equipped to help patients understand their medications, dosages, times/days for use, etc., but because in a new environment where patients can purchase drugs online, patient oversight is moving beyond the reach of trained professionals.

Furthermore, the costs related to physician oversight and mitigation of problems that may arise from cross-border drug importing have not been accounting for.

For example, most type I diabetics must either wear an insulin pump or self-inject on a regular basis. If the insulin they’re taking has not been shipped and stored at the proper temperature, a significant adverse reaction might take place. So what patients may perceive as a way to save money - order medications online - might ultimately put their health and lives at risk. This in turn may result in a spike in healthcare costs related to increased unscheduled doctor visits, including, under extreme circumstances, visits to the emergency room.

More than meds

Pharmacists do more than just dispense medications to patients. Pharmacists play an integral role in the U.S. healthcare delivery system. Patients ask them for guidance on the use and effectiveness of certain medications. Often they are the first ones to hear about negative drug reactions. They have significant responsibility in ensuring patient health.

The new Maine law creates a major barrier to maintaining this vital relationship between pharmacist and patient. Already, we have seen the negative impact that mail order and online pharmacies have had on patient health; the new laws in Maine have the potential to further damage the patient/pharmacist relationship.

There is no question that effective ways should be sought to reduce the cost of medications to patients in the United States. However, these approaches should be developed within the regulatory framework of agencies such as FDA, which can work with the healthcare community to develop safe solutions that address Americans’ need for lower-cost medications.

 

References

1. The Partnership at Drugfree.org, “Maine becomes first state to allow prescription drug purchases from abroad,” 10/23/2013. Accessed 12/17/13.

2. FDA, Drug Recalls. Accessed 11/13/2013.

3. Toscano P. “The dangerous world of counterfeit prescription drugs,” USA Today, 10/7/2011. Accessed 12/17/2013.

4. Bate, R, Mooney L,Milligan J. “Dangerous substandard medicines: An increasing global problem,” American Enterprise Institute, 7/6/2011. Accessed 12/17/2013.

5.“Roche warns of counterfeit Avastin in U.S.,” USA Today, 2/14/2012. Accessed 12/17/2013.

6.Drug distributor is tied to imports of fake Avastin."  Extract accessed at FirstWordPharma.com, 12/17/2013.

7. Agency for Healthcare Research and Quality. “The Number of Practicing Primary Care Physicians in the United States, as of October 2011.” Accessed 12-17-2013.

Philip E. Gaucher Jr. is founder and CEO of VeriMed (www.VeriMed.com), a company that develops technologies to create a safer, more transparent supply chain for controlled substances.