Friday, July 5, 2013

Pharmaceutical Compounding Quality and Accountability Act

There is a bill working its way through the US Senate, Senate Bill 959, the “Pharmaceutical Compounding Quality and Accountability Act”, which was written in response to the deaths of 53 people who died as a result of fungal contamination of a compounded injectable steroid late last year. Dr. Vaughan is here today to talk about the US Senate’s response to this tragedy.

Anchor: How did this tragedy ever happen?

Dr. V: Contamination is always a potential problem when making pharmaceuticals. The New England Compounding Center (NECC) did not follow proper protocols for testing for sterility of the injectable steroid. 53 people died and over 700 others are still being treated for their infection.

Anchor: How does Senate Bill 959 address this?

Dr. V: Everyone expected the Bill to require extra regulation and inspection of compounding pharmacies. As a physician who orders from compounding pharmacies, just like the local hospital, we have already had to make changes tracking every component of every IV for an individual patient.

Anchor: What kinds of patients use a compounded prescription?

Dr. V: If a child cannot swallow a pill or is sensitive to a component of a pill, a compounding pharmacist can prepare that medication as a liquid. Many make special preparations for pets. My patients prefer getting bio-identical hormone replacement therapy (BHRT) from compounders. Men with low testosterone get it in creams that are much more concentrated than those advertised on TV. Women use creams, pills, troches, or pellets. Compounding gives greater choice in strength and method of delivery. It’s more personalized

Anchor: What will be the impact if this bill passes?

Dr. V: In its current form, it will deny patients medications and nutrients that are life giving and lifesaving. I encourage anyone interested in this to do research on the web. Make your own decision. Then let your representatives know how you feel. If you are on compounded prescriptions, do it now. I want to do everything possible to avoid another disaster like last year. Even so, I think S.959 gives the FDA too much authority to ban the most common BHRT treatments used by millions of women and men. They tried to do this in 2008 with the female hormone estriol but did not have the authority to enforce its actions. S.959 gives them full authority to ban commonly used BHRT. I’ll be talking about this and Andropause next Wednesday, July 10th at 6:00 PM at my office. Go to my website for details.

Anchor: Thanks Dr. V. She’ll be back....

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