Model Practice of Pharmacy Act, Part II: Subscribing to a New Practice Model

Health care is changing at a very rapid pace and innovation happens quickly.  Therefore, pharmacy must be ready across all professional domains, especially our legal and regulatory mission, to be able to adapt to this changing health care environment. The profession cannot wait for years for the slow pace of the current system of legislative and regulatory approvals to occur.

This is part II of a three-part series on the Model Practice of Pharmacy Act.  This part describes the need for a new model practice act.

To this end, there exist fundamental differences between the Medical Practice Act (MPA) and the Model Pharmacy Practice Act.  Most importantly, the MPA is proscriptive and the Pharmacy Practice Act (PPA) is prescriptive.  What does this mean?  Proscriptive means forbidding or restricting something.  The MPA allows innovation in practice to occur, but still holds the practitioner to his/her duty to care and treat the patient with the degree of skill, care and diligence expected of a reasonably competent physician.   

This means that a physician can prescribe a drug off label to see if the drug can prevent, relieve, or cure disease.  Oncology is a perfect example of physicians using different agents alone or in combination to potentially cure disease, thereby moving the field forward.  Each off-label change does not require changes to the MPA, unless there is a systematic research approach which means Institutional Review Board approval.  This means that a physician can try a new surgical technique, use a new instrument, or simply change his/her procedure process without waiting for a rewrite of the MPA.

On the other hand, the PPA is a prescriptive document based on the current practice norm or standard.  The PPA allows a pharmacist only to practice within established standards of practice. Innovation to pharmacy practice is therefore restricted.  How many years has it taken to be able to administer immunizations, provide diabetic counseling, or to prescribe hormonal contraceptives?  Change in pharmacy practice is slow, does not promote innovation, and requires convincing many health care professions, elected individuals, and regulators to support the change. This promotes glacial change in practice.

Medicine does not have to do this, which allows innovation in health care to proceed at a much more rapid pace.

Listen to the words of the Federation of State Medical Boards Essentials of State Medical and Osteopathic Practice Act from 2015 states:

1. “The practice of medicine is a privilege granted by people acting through their elected representatives.

2. Offering or undertaking to prescribe, order, give, or administer any drug or medicine for the use of any other person.

3. Offering or undertaking to prevent or to diagnose, correct, and/or treat in any manner or by any means, methods, or devices any disease, illness, pain, wound, fracture, infirmity, defect, or abnormal physical or mental condition or any person, including the management of pregnancy or parturition; offering or undertaking to perform any surgical operation upon any person.

4. Rendering a written or otherwise documented medical opinion concerning the diagnosis or treatment of a patient or the actual rendering of treatment to a patient within a state by a physician located outside the state as a result of transmission of individual patient data by electronic or other means from within a state to such physician or his or her agent.

5. Rendering a determination of medical necessity or a decision affecting the diagnosis and/or treatment of a patient.”

Please note that throughout out the Model MPA, restrictions on practice are minimized, thereby allowing innovation to flourish, to be studied, presented and published, and then adopted into practice without the need to change the MPA. 

If you want change to occur in pharmacy practice, then changes to the PPA must be undertaken.

Read part I of Dr Munger's commentary on the Model Practice of Pharmacy Act.

Read part III of Dr Munger's commentary on the Model Practice of Pharmacy Act.

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