Tuesday, September 3, 2013

First, do no further harm

As a pharmacist and pharmacy small business owner and a Virginia state delegate, when I think about the tragic 2012 meningitis outbreak, my thoughts and prayers continue to be with those who lost loved ones and friends to this horrific catastrophe. Many of the victims, like Zac Foutz, are still recovering, and I was so glad to read in The Roanoke Times that he is doing better and back on the football field. All of us want to make sure that manufacturers masquerading as pharmacies like the New England Compounding Center are properly overseen by the state and federal governments to avoid future tragedies.

The question is how to do that without harming the millions of patients who rely on local pharmacies for customized medication therapies. When off-the-shelf manufactured drugs aren’t an option, independent community pharmacists prepare or “compound” customized medications for patients in response to a doctor’s prescription based on the patient’s individual needs, such as an allergy or flavoring for a child.

As a pharmacist and small business owner, I can tell you for certain that provisions in a well-intended Senate proposal (S. 959) would hinder the ability of independent pharmacists across the country to compound medications for their patients who might not be able to get these vital prescriptions anywhere else.

Additionally, the measure would require pharmacies to report directly to the Food and Drug Administration when they are compounding medications to alleviate a drug shortage. State boards of pharmacy regulate the practice of pharmacy in each state. During the H1NI outbreak several years ago, when Tamiflu was in short supply, independent pharmacies utilized their compounding expertise to fill the void for countless children. As drug shortages continue to skyrocket with no relief in sight, Congress must make certain that patients receive all necessary medications in a timely manner, not create further delays by adding additional federal bureaucracy.

Furthermore, by allowing the FDA to unilaterally create a “do not compound” list, it could potentially be used to prevent compounding to satisfy doctor’s prescriptions for hormone medications, thyroid preparations, promethazine gels and medications to treat autism, as several examples. Thus, the Senate legislation grants the FDA overly broad authority and impedes patient access to vital medications.

Moreover, the meningitis tragedy was facilitated by the failure of the state board of pharmacy and FDA to coordinate, communicate and take action. The Senate bill erects additional silos between the FDA and state boards of pharmacy when better interaction between the two is necessary. In the case of the New England center, the FDA received more than a dozen complaints but failed to take action.
As an alternative to the Senate bill, I urge you to look at the discussion draft that has been circulated by Rep. Morgan Griffith. His draft maintains state board of pharmacy oversight of traditional compounding pharmacies. State boards of pharmacy have traditionally exercised oversight of this practice and are best suited to continue this role.

His draft also preserves a pharmacy’s ability to compound for multiple patients receiving the same or similar medications at hospitals, physician offices and other health entities, which are additional areas where the Senate bill misses the mark.

State boards of pharmacy have always, and should, retained the oversight role of traditional compounding pharmacies. Our independent pharmacies provide a needed service in compounding medications and have a long history of protecting patient safety. It would be unjust to subject them to additional federal regulatory burdens because of the failings in Massachusetts and at the FDA to properly regulate the New England Compounding Center, and more importantly impede patient access to quality care.

I certainly understand frustration with the amount of time it is taking Congress to consider an appropriate legislative response. Congress should clarify existing FDA authority and make sure that it has a highly functioning team of experts that is focused squarely on any bad actors. What we don’t need to do is to pass a bill that will hinder the ability of local community pharmacies to fully serve their patients in rural areas and throughout Virginia.


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