While Democrats and Republicans both work on the proper legislative response to the 2012 meningitis outbreak, it's critical that lawmakers preserve patient access to customized cures provided by independent community pharmacists through the centuries-old practice of compounding. New, bipartisan House legislation would do just that.
When manufactured drugs aren't an option, independent community pharmacists prepare or "compound" customized medications for patients in accordance with a prescriber's prescription based on the patient's individual needs and under the supervision of the state board of pharmacy. This important practice is widely recognized as medically necessary.
Federal legislation should strike the right balance so that traditional compounding is not hindered, but preserved, while lawmakers ensure proper oversight to prevent another meningitis outbreak, caused by the New England Compounding Center.
Who needs these specialized medications? For starters, those who are allergic to mass-produced drugs; who have difficulty swallowing a pill; or children whose pediatricians prescribe a flavoring to help ensure they take the remedy.
Every day patients rely on compounded medications through their community pharmacy. Here are just a few recent examples:
* An 85-year-old man in otherwise very good health was suffering from rapidly decreasing vision. Soon after starting a customized eye drop medication regimen, his eyesight increased dramatically. Now he can stay in his home and continue to be active and independent.
* A woman on worker's compensation also suffered from a stomach condition that negated the effectiveness of mass-produced pills. Two compounded remedies alleviated her pain and even allowed her to discontinue the use of powerful opioid pain medications, which are prone to abuse and addiction.
* A mother doesn't have to choose between relieving her daughter's discomfort and causing her horrible gastro-intestinal (GI) trauma, because a compounding pharmacist formulated a solution that averted allergies to acetaminophen and ibuprofen. The child wept tears of relief at this life-changing development.
* A man debilitated by chronic pain resumed playing racquetball and other routine activities thanks to two cream formations uniquely made for him.
* A hospice facility became peaceful once again for its residents after a partially paralyzed man could receive his pain relief medication in a way that didn't make him combative.
When the military health care program TRICARE announced plans earlier this year to scale back its coverage of compounded medications, it was met with a flurry of beneficiary complaints that ultimately prompted the agency to postpone any policy change, pending further review. Patients voiced their concerns citing personal experience such as these expressed on the blog of the Military Officers Association of America:
* Taking a compounded testosterone supplement "changed my life for the better and I don't want the FDA taking that away," reported one.
* A retired Army Nurse Corps officer currently working as a Family Nurse Practitioner wrote that compounded medications, when necessary, "may be critical to prevent possible life threatening complications from the main stream prescription medications."
* Another wrote that his GI specialist "sends me to a compounding pharmacy, and I get the medication in the form I need," because commercially it is only available in eye-drop form.
* "I have been using [compounded] bio-identical [hormone replacement therapy] for over two years and they have been excellent in stopping the effects of menopause," added one.
* A husband recalled that "my wife almost died from taking FDA approved medications" due to costly complications arising from manufactured medications prescribed by a series of doctors. Finally, she found her "best course of action" through a compounded medication and at reduced cost.
Success stories like these could be hindered due to some well-intended but overly broad provisions included in S. 959. They subject independent community pharmacies to dramatically expanded oversight by the Food and Drug Administration (FDA), instead of focusing on what caused the meningitis outbreak.
By contrast the Compounding Clarity Act (H.R. 3089), a bipartisan House proposal by Reps. Morgan Griffith (R-Va.), Gene Green (D-Texas) and Diana DeGette (D-Colo.), would strike a more careful balance to preserve patient access to customized medications from community pharmacies and point federal and state regulators in the right direction with all necessary authority.
This is the approach that deserves Congress' support.