Chapter 151

Lowell Anderson

Originally published in the "Minnesota Pharmacist," the journal of the Minnesota Pharmacists Association

Last fall I reported to you an initiative of the Center for Leading Healthcare Change to examine our Practice Act (Chapter 151), and make recommendations to the profession and the Board of Pharmacy for changes. The goal of the twelve member committee is to recommend to the profession ways to change the Act that would allow pharmacist practitioners to more effectively and efficiently address the health needs of Minnesotans.

Well, the Working Group on the Minnesota Pharmacy Practice Act has finally completed its recommendations. It took a year and a half to complete, and we believe that if it results in changes to the Practice Act it can significantly effect the ways in which Minnesota pharmacists provide needed services.

As previously noted, our practice act originated in 1927 (along with the practice acts for horseshoers, embalmers, attorneys, physicians and surgeons and others). A significant rewrite occurred in 1937. The 1937 Act is the foundation for pharmacy practice today. Otherwise, 1937 was remarkable as well: Amelia Earhart disappeared, the Hindenburg went up in flames and F.Scott Fitzgerald was still writing!

Both the Board and the profession (as well as others) have periodically sought to amend the Act in efforts to provide for a practice that recognizes contemporary abilities of the pharmacist as well as the needs of the consumer and patient. But those efforts have only built on the concept of practice as it was envisioned in 1937.

As the Working Group studied Chapter 151 we focused on elements that impede practice innovation, limit participation in emerging delivery systems and maintenance of safe distribution and clinical practices. Ultimately, pharmacists, as with any other educated and licensed practitioner, should be allowed to practice at the top of their education.

Let me share a few examples of our recommendations:

The entire Act rests substantially on the definitions. Starting with the most basic: What is a pharmacist?

The Working Group believed that the definition of “Pharmacist” should clearly state that practice is not tied to the location from which a pharmacist provides a service. Clearly, contemporary societal needs for pharmacists’ services extend to facilities and residences other than a licensed pharmacy.

Therefore, we recommend that the language in the current Act be changed from the current language: “The term "pharmacist" means an individual with a currently valid license issued by the Board of Pharmacy to practice pharmacy.”

Our recommendation is that it be changed to: “Pharmacist” means an individual currently licensed by this State to engage in the Practice of Pharmacy. A Pharmacist may engage in the Practice of Pharmacy, as defined in this Chapter, within or outside of a licensed Pharmacy, as defined in the Rules of the Board.

Ok, so the term “pharmacy practice” is used. What does that mean? The current definition is quite prescriptive: "Practice of pharmacy" means: (abbreviated)
Interpretation and evaluation of prescription drug orders; compounding, labeling, and dispensing; participation in clinical interpretations and monitoring of drug therapy for assurance of safe and effective use of drugs; participation in drug and therapeutic device selection; drug administration for first dosage and medical emergencies; drug regimen reviews; and drug or drug-related research; participates in immunizations; participation in the practice of managing drug therapy and modifying drug therapy according to a written protocol; participation in the storage of drugs and the maintenance of records; responsibility for participation in patient counseling on therapeutic values, content, hazards, and uses of drugs and devices; and offering or performing those acts, services, operations, or transactions necessary in the conduct, operation, management, and control of a pharmacy.

We looked at this description of practice and considered that the focus of pharmacy practice is changing from primarily a dispensing function to primarily a clinical-services function. Therefore, the definition should reflect the clinical training and competencies of the pharmacist. The definition should reflect the need for the pharmacist to oversee the management of the product distribution function, but the focus should be the on the service side.

Further, the definition of practice should allow for innovation and full participation in emerging delivery systems. E.g., accountable-care organizations (ACOs), health homes

Even though the process of collaborative practice is currently defined, functionally it will most likely change, as ACOs and health homes become a standard for delivery of services. There is strong possibility that these new entities will be given authority to define collaborative practice to reflect the needs of the populations for which they are responsible. Therefore, these entities will obviate the need for statute or rule to prescribe the manner in which an agreement will be reached and function.

Our recommendation for a replacement definition is:
“Practice of pharmacy” means the practice in which a pharmacist accepts responsibility for a consumer’s drug or medicine-related needs, which may include but not be limited to: 
(1) the management of drug or medicines-related consumer and patient needs, which may include but is not limited to
(a) modify, initiate, and discontinue medications,
(b) order and collect information to inform medication management,
(c) document appropriately
(2) the control, dispensing, preparation, and compounding of drugs or medicines
(3) collaboration with other practitioners in the management of the care of a consumer or patient
(4) administration of drugs or medicines
It is unlawful for any person to practice pharmacy as defined in subdivision 27 in this state unless the person holds a valid license issued according to this chapter.
We also added a definition of “collaborative practice”:
“Collaborative Practice” means a pharmacist and other practitioner(s) practicing together within the framework of their respective professional scopes of practice. This collaborative agreement reflects both independent and cooperative decision making and is based on the preparation and ability of each participant.

Pharmacy technicians will be increasingly important to a competent and sustainable practice as the cost-control initiatives of health reform come into play. It was particularly perplexing that the current Statute restricting a technician from using any professional judgment -- not just the judgment of a pharmacist, but even the judgment that a competent technician can exhibit

The current language defines technician: 
The term "pharmacy technician" means a person not licensed as a pharmacist or a pharmacist intern, who assists the pharmacist in the preparation and dispensing of medicines by performing computer entry of prescription data and other manipulative tasks. A pharmacy technician shall not perform tasks specifically reserved to a licensed pharmacist or requiring professional judgment.

As long as the Statute explicitly states that the technician is not to enter into professional judgments restricted to pharmacists the elaboration in sentence one serves no purpose as it does not fully describe the capabilities of a technician. There is also a need for defining accountability. In situations where there are multiple pharmacists present, which pharmacist is accountable?

Technicians also appear in the body of the Act. In that discussion the Working Group said §151.102 is restrictive in the extreme and does not recognize the value and contribution of a properly trained technician. Neither does it recognize the ability of the pharmacist to manage the staff. It is the recommendation of the Working Group to incorporate the principles of accountable to the pharmacist and restricted from making decisions that require the professional judgments of a pharmacist, thereby recognizing that a properly trained technician makes professional judgments. Further, the number of trained and credentialed technicians working in a pharmacy should not be subject to arbitrary ratios, but rather be left to the professional judgment of the pharmacist.

Our recommendation in the definition of a Technician is: 
The term "pharmacy technician" means a person not licensed as a pharmacist or a pharmacist intern who is registered with the Board as a Technician, who assists the a pharmacist and is accountable to a pharmacist. in the preparation and dispensing of medications by performing computer entry of prescription data and other manipulative tasks. A pharmacy technician shall not perform tasks specifically reserved to a licensed pharmacist or requiring professional judgment of a pharmacist.

We encourage you to read the entire report in the belief that it is an important review of the Practice Act by members of the profession. Whether, or not, it results in positive changes will be up to the profession and the Board – and, ultimately the legislature. For the profession to succeed in changing the Practice Act will require all of the Minnesota professional associations and the Board working together, as well as individual pharmacists. We recognize there is a lot of word smithing between now and a bill being presented to the legislature. In the meantime we need to agree in concept on changes and the need for change.

It is my belief that true and lasting reform of the health system must begin at the interface of the practitioner and the person who uses the services – consumer and patient. To force change on either the provider or the consumer is inefficient because legislated changes generally ignore the market and cultural forces that truly govern much of the way we individually use health-care services. We believe that this report can begin the discussion among those responsible for patient care.

Lowell J. Anderson, D.Sc., FAPhA, practiced in community pharmacy for most of his career. He is a former president of MPhA, Mn Board of Pharmacy and APhA. In addition he has held positions in the Accrediting Council on Pharmacy Education, National Association of Board of Pharmacy and the United States Pharmacopeia. Currently he is Co-director of the Center for Leading Healthcare Change, University of Minnesota and co-editor of the International Pharmacy Journal. He is a Remington Medalist.