02/03/13
In an excellent piece published in
the BNA Pharmaceutical Law
and Industry Report, “Confounded in Compounding Apothecaries: The
Critical Need for Confining State Pharmacy Boards to
Self-Regulation,” William G. Schiffbauer takes a close
look at state pharmacy boards and the conflicts of interest and other problems
that have arisen in connection with recent expansions of their
activities.
He finds that pharmacy boards, mostly
made up of pharmacists, have strayed from their core mission of
“self-regulating” pharmacists – that is maintaining the competence of
professional pharmacists and identifying and disciplining problem pharmacists.
An example of inappropriate pharmacy board regulatory activity is the
regulation of compounding pharmacies such as the New England Compounding Center
whose negligence is reported to have caused 44 deaths and sickened 678 people in
19 states. Schiffbauer notes that it took 25 deaths and 344 injuries to “move”
the Massachusetts Board of Pharmacy to adopt emergency regulations – long after
the facts were known and after similar tragedies had already occurred.
According to Schiffbauer, compounding pharmacies act more as pharmaceutical
manufacturers than as local pharmacists, and pharmacy boards have neither the
resources nor the competence to regulate pharmaceutical manufacturing
processes.
Continue Reading here
No comments:
Post a Comment