Virginia Regulatory Town Hall
Agency
Department of Health Professions
 
Board
Board of Medicine
 
chapter
Regulations Governing the Practice of Medicine, Osteopathic Medicine, Podiatry, and Chiropractic [18 VAC 85 ‑ 20]
Action Mixing, diluting or reconstituting sterile drug products by doctors
Stage Emergency/NOIRA
Comment Period Ended on 2/22/2006
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2 comments

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2/11/06  12:00 am
Commenter: Hugh Bryan

modify regulations on mixing, diluting and reconstituting
 
I was involved in the committee that wrote these regulations.  In their present form, they will significantly restrict the ability of physicians to practice medicine WITHOUT any demonstrated improvement in patient care.  At the current time, we have not seen an epidemic of problems related to immediate-use type injections in physician offices.  Regulations should result in improvement in patient safety and outcomes; the emergency regulations result in increased documentation burdens and ultimately in patient expense.  The law requires that regulations be written.  It requires inspections.  The law does not require that every type of mixing have the same requirements for documentation and training.  Immediate-use mixing is low risk and the documentation requirements and the handling requirements should be minimal.
CommentID: 181
 

2/15/06  12:00 am
Commenter: Joseph A. Leming, MD, FAAFP Prime Care Family Practice

Re: Regulations Regarding Mixing / Compounding
 

February 15, 2006

Dear Honored Members of the Board of Medicine:

     I fully support new additional regulations where such will objectively increase patient safety as defined by a reduction in mortality and or morbidity. 

     The regulations as proposed do neither.  Worse, they will either dramatically increase the cost of delivering patient care without merit or they will breed legions of physicians whose daily practice does not comport with these regulations.  This itself is a dangerous precident and again without merit.

     I strongly encourage the Board to set aside the proposed regulations and study the matter further.  I have practiced mixing of Kenalog and Xylocaine (and the like) for more than 20 years and have had no (that would be none) morbidity or mortality.

     Regulations that are or appear "out of step" and without merit likely are.

     I strongly and respectfully request that the Board of Medicine study this matter further and delay the implementation of these onerous and meritless regulations.

     I remain,

Joseph Atkins "Joe" Leming, MD, FAAFP

 

 

 

CommentID: 182