Working the Hospital Side of S.959
By IACP Member Linda F. McElhiney, PharmD, RPh, FIACP, FASHP, FACA
After attending IACP's 2013 Compounders on Capitol Hill, I spoke to our VP of Government Affairs at Indiana University Health about the proposed S.959 bill, and sent her the information that was provided to the Congressman. Within a few weeks, we had conference calls with the American Hospital Association (AHA), the Children’s Hospital Association (CHA), and members of the Senate HELP Committee to discuss how S.959 was going to have a negative impact upon hospital compounding practices, such as anticipatory or batch compounding, compounding for hospital subsidiaries, compounds as “new drugs,” notification to the FDA for compounded backorder items, and the FDA “Do Not Compound” list. The discussions were very positive and I think that we are gaining support for changes to the S.959 from the various hospital organizations.
About a month ago, the president of the American Society of Health-system Pharmacists (ASHP) urged the entire membership to fully support the passage of S.959 without revisions and to talk to their Congressman. As a fellow of both ASHP and IACP, I was alarmed that ASHP was fully supporting this proposed bill, so I sent an e-mail to ASHP’s Government Affairs department and listed the problems with S.959 that would have a negative impact on hospital compounding. The “hospital exemption” that ASHP helped to write does not exempt hospitals from following all of the regulations that “traditional compounders” must follow; it only exempts hospitals from registering as “compounding manufacturers." Within a couple of hours after that e-mail was sent, I was on a conference call with ASHP’s Government Affairs department, and they are now seriously reviewing how S.959 will impact hospital compounding practices, too.
Last week, to my surprise, Senator Dan Coats’ (IN) legislative aide came to our compounding laboratory at the hospital to get a better understanding about hospital compounding and the impact that S.959 will have upon health-systems. It was a great visit and helped us to present our point-of-view with all of the show-and-tell visuals, such as our quality assurance program, anticipatory/batch compounding process, and examples of unique compounds that we need to prepare for our patients that could potentially be banned by the FDA. The legislative aide seemed very impressed and assured us that she would reinforce our concerns to the Senate HELP Committee and talk with the other Senate staff members.
Sometimes, as a hospital compounding pharmacist, I feel that my comments have fallen on deaf ears. I had no idea that a simple e-mail to a couple of key individuals would have such an impact on gaining support for an important cause. If you think that your opinion doesn’t matter to people with higher authority, think again!!!
IACP greatly appreciates the efforts of IACP Member Linda McElhiney, PharmD, FIACP, FASHP, FACA, to enlighten the profession on how S. 959 will impact patient care in the hospital environment.
Update from Linda McElhiney:
The following people have been selected to serve on a review committee to review and make recommendation on Rule 30 (in the Indiana statutes) Sterile Pharmaceuticals; Preparation and Dispensing. They are:
Sara St. Angelo - State Board of Pharmacy member
Steven Anderson - State Board of Pharmacy member
Angela Ockerman - Professor (teaches compounding) at Butler University
Kara Duncan Weatherman - Professor (teaches nuclear pharmacy) at Purdue University
Linda McElhiney - Indiana University Health
Jeff Jackson - owner of Custom Med and IACP member
Karl Clearwaters - owner of Herbst Pharmacy and IACP member