Will pharmacy regulations be based on outcomes?

NABP surveying state pharmacy boards

Basing state pharmacy regulation on patient outcomes instead of departmental systems could be in the profession’s future, according to early results of a survey developed by the National Association of Boards of Pharmacy (NABP). To date, state pharmacy boards have reacted positively to the notion, and the Florida board has begun steps to institute an outcomes-based set of standards.

Along with providing a more clinical and patient-centered approach at a time when the profession is seeking to be more clinically oriented, an outcomes-based system could better identify exactly how pharmacist-run clinics succeed, which could expand those programs to other disease states.

"We think it’s critical for the boards of pharmacy to be involved in quality of care issues and to look at patient outcomes," says NABP executive director Carmen Catizone. How far individual state boards want to go will be shown when a detailed survey by the national board task force is compiled. The survey will ask boards for regulation suggestions in areas such as the implementation of continuous quality improvement (CQI) programs like those used by other outcomes-based regulators in health care. The survey also asks state boards to consider their role in enforcing any new types of standards and to ensure that the current oversight of pharmacy systems won’t be completely lost in any changes.

If the survey ends in consensus for an outcomes approach, NABP will incorporate recommendations on how to approach one into its Model Practice Act. Ultimately, however, only individual state boards can adopt and enforce changes.

What are the benefits?

Right now, state board oversight is built around department standards more than patient outcomes. For example, standards concerning the use of up-to-date dispensing systems, equipment, technician job descriptions, or even filing systems are stressed. An outcomes-based program could use patient sampling to try to establish standards for medication errors, compliance, or contraindication problems leading to hospitalization as an outcomes-based criteria.

Another benefit of an outcomes-based program is that clinical pharmacists, especially those who directly handle drugs under a collaborative practice agreement, clearly would be under the regulatory authorization of a state pharmacy board in times of litigation. Currently, pharmacists can be scrutinized by medical boards because state pharmacy boards don’t have clear authority to police their own in cases of drug delivery.

Litigation or, more specifically, how to avoid confidentiality problems in cases of litigation, has delayed temporarily the implementation of an outcomes-based approach by the Florida Board of Pharmacy.

Deciding to change and then considering three areas of outcomes — medication errors, peer-review evaluation, or consumer surveys — the Florida board will focus on medication errors and convene a CQI committee. The committee would be charged with reviewing dispensing errors and drug interactions, among other factors, which it would use to frame an outcomes-based program.

But a legal opinion that the committee’s patient records would not be confidential or protected from litigation without a specific act of the Florida legislature has delayed the process while continuing to add to its interest as a test case.

[For additional information, contact the NABP at (847) 698-6227.]