Recent years have seen increased regulation of medical professions in response to public demands for quality care, improved access to care, and cost controls. In 1990, the National Association of Boards of Pharmacy decided that the pharmacy profession should "take control of its own destiny and elevate the practice of pharmacy to the standards of care that it had aspired to for almost 30 years," said Carmen A. Catizone, NABP executive director, in his annual report.
One result of this decision is NABP's revision of the Model State Pharmacy Practice Act, completed in April and presented "hot off the press" at the group's 88th annual meeting in Salt Lake City in May.
NABP president David E. Holmstrom told members the goal for revising the model act was to develop the best possible resource for helping the state boards of pharmacy shape their state pharmacy acts "to provide effective rules for safeguarding public health." According to Holmstrom, federal laws and regulations pertaining to the practice of pharmacy have often been modeled after NABP's position or language from its model act.
The impetus for revising the model act, which had remained the same since the mid-1970s, came in 1990 with the passage of the Omnibus Budget Reconciliation Act. Of particular interest to NABP were the drug utilization review and patient counseling provisions.
NABP organized a task force to develop model regulations that states could use to comply with OBRA '90 DUR and patient counseling requirements. According to Catizone, "the model act presented an excellent opportunity to revise the regulation of pharmacy practice and move away from the stereotypical pharmacist/practitioner, whose responsibilities to the patient encompass only the dispensing of medications and devices."
Unlike the smooth salt flats bordering the NABP meeting's host city, the road to completing the revisions was fraught with obstacles. The committee received huge volumes of input from state boards of pharmacy and major national pharmacy organizations, filled with conflicting concerns and recommendations. The model act met with strong resistance from pharmacists who believed that DUR and patient counseling should be regulated by the profession itself, not the state boards. Some were concerned that NABP's regulations would eliminate pharmacists' professional discretion, while others worried that complying with the regulations would cause an economic catastrophe.
Frank Z. Wickham, NABP executive committee member, described the revision process and explained the model act's provisions. He stressed that "what we have developed here is a model in which we have attempted to cover all areas of expanding practice, which, in conjunction with all valuable comments we received, was developed as a result of looking at pharmacists' professional activities in a variety of practice settings from around the United States."
The committee's first stop was to solicit comments on the previous version of the act from all major pharmacy professional organizations, the pharmaceutical industry, and the state boards of pharmacy. NABP staff reviewed the comments for appropriate incorporation into the model act and made the first round of revisions. Drafts were again distributed for comment and then fine-tuned by the review committee. "The result," said Wickham, "is the document we present to you today."
A new definition of the practice of pharmacy was developed to reflect the changes the profession is experiencing. This new definition provides the foundation on which the rest of the model act and rules are based, and reads as follows:
"The 'Practice of Pharmacy' means the interpretation, evaluation, and dispensing of prescription drug orders in the patient's best interest; participation in drug and device selection, drug administration, drug regimen reviews and drug or drug-related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmaceutical care; and the responsibility for compounding and labeling of drugs and devices (except labeling by a manufacturer, repackager, or distributor of nonprescription drugs and commercially packaged legend drugs and devices); proper and safe storage of drugs and devices and maintenance of proper records for them. …