Monday, December 15, 2014

Third Question of the Day December 15, 2014 How odd is it that the American Medical Association (AMA)'s recently joined in with ICAP, PCCA and others to fix the DQSA in light of AMA's previous position (see article below) and in light of the Texas State Board of Pharmacy and the Texas Pharmacy Association opposing laws that would allow pharmacies to operate in physician's offices? Looks like the AMA would have been smarter and at least negotiated support for it to share in the profits by allowing them to have pharmacies in the doctor's offices? Does this again suggest that for compounders and the organizations that represent them that it is all about the money and them keeping the profit for themselves? Why or why not? Oh wait if all states allowed pharmacies to be located and operated within a physician's office would the need for office use compounding supplied by compounding pharmacies be reduced??


  1. AMA meeting: Compounding pharmacies need more oversight  

    www.amednews.com/article/20130701/house/.../...

    American Medical News
    Jul 1, 2013 - Compounded drugs are essential for many ophthalmology practices, says Sam Solish, MD, chair of Advocacy
    Limited Physician Dispensing
    As noted in previous articles of Texas Pharmacy Today, on Wednesday, July 2, the Texas State Board of Pharmacy held a stakeholders’ work group to get additional feedback on a concept developed by Allergan, Inc., that would allow physicians to dispense.  The manufacturing company had asked the TSBP to develop proposed rules establishing a new license category for pharmacies to be located and operated within a physician’s office.  Under this proposed pharmacy license, physicians would have limited authority to dispense cosmetic or aesthetic pharmaceuticals.
    Prior to yesterday’s stakeholders’ meeting, TPA had submitted a letter to TSBP voicing the Association’s concerns and requesting that the agency defer action on Allergan’s request pending additional information and further evaluation.  As a result of our May 23 letter along with concerns expressed by other pharmacy groups as well as Allergan, the agency scheduled this stakeholders’ meeting to discuss the issue.
    Participating in this meeting were representatives from pharmacy organizations including TPA, AIP, TrueCare, TPBC, TSHP, TFDS and NACDS; Allergan and other manufacturers’; the legislative offices of Senator Charles Schwertner, R.Ph., M.D. (R-Georgetown) and Representative John Zerwas, M.D. (R- Houston); attorneys; and TSBP Board members Jeannie Waggoner, Dennis Weisner, Chris Dembny as well as Executive Director Gay Dodson and key staff.
    As you know, TPA had already met on several occasions with Allergan, and expressed our concern regarding their proposal.  Although the concept is significantly different from legislation that TPA opposed and helped secure a veto in 2013, there still are issues of concern that need to be addressed including health safety and financial protections for the patient.  Additionally, there is an inherent financial conflict of interest for prescribers to also dispense.  And finally, physicians who dispense should meet the same requirements that pharmacists do when dispensing the same “aesthetic pharmaceuticals.”
    Still, considering the parameters incorporated in the Allergan proposal, it may be beneficial to have regulatory negotiations within the pharmacy agency rather than risking passage of a much more problematic legislative concept.  By the way, 45 states allow for physician dispensing of cosmetic or aesthetic pharmaceuticals.  And only 19 of those states have pharmacy board oversight.  In the other 26 states, the issue is handled by the medical board.

    Senator Schwertner recently weighed-in by submitting a letter to the agency with the following “suggestions:”

    "I write today to express my significant concerns with a possible new class of pharmacy license to be discussed by the Texas State Board of Pharmacy (“Board”) on July 2. The creation of a new pharmacy license to allow for physician dispensing of medications is a departure from our existing license classifications; pharmacists have a long-standing role in this state as the dispenser of medications. Accordingly, any decision to allow physician dispensing is a policy decision that is best left to the Texas Legislature."
    and 
    "I strongly encourage the Board to not move forward with the creation of this new classification of pharmacy license. If you have any questions or would like to visit with me about this issue and my concerns, I am happy to meet with you or any Board member."
    However, in past Texas legislative sessions, bills have been filed to allow physician to dispense “aesthetic pharmaceuticals.”  With each year, support for physician dispensing has grown in the legislature to the point that the bill actually passed in 2013 only to be vetoed by Governor Rick Perry.
    Many of the same issues noted above resurfaced during the meeting.  No decisions were made.  The agency will determine its next step, if any, at its formal meeting on August 4.  It is unlikely that the Allergan request moves forward.  Never the less, on July 30, the TPA Board again will discuss this proposal and will develop additional comments to TSPB prior to their August meeting.
  2. quotation from here



  3. Texas State Board of Pharmacy Votes Against Class I Pharmacy In Physicians' Office

    Tuesday, November 04, 2014   (0 Comments
    Posted by: Brom Hoban 
  4. Physicians' Office

  5. Last May, the Texas State Board of Pharmacy (TSBP) listened to a presentation from a company named Allergan, regarding their rule-making request to establish a new category of pharmacy that would be operated within a physician’s office—referred to as a “Class I” pharmacy. In this new type of pharmacy, pharmacists located in a physician's office would dispense cosmetic or aesthetic pharmaceuticals.

    TPA opposed the proposal: Last August, TPA’s President-Elect Rene Garza, Pharm.D. and PharmPAC Chair Christopher Alvarado, Pharm.D. testified during a TSBP meeting and expressed opposition to both the creation of this new pharmacy category and to providing limited authority for physicians to dispense cosmetic or aesthetic pharmaceuticals.

    Today, the Texas State Board of Pharmacy voted unanimously to not create a Class I Pharmacy in a physician’s office, instead leaving this issue to be addressed by the Texas Legislature.

    TPA will continue to monitor the issue.

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