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Commentary

Time to Rethink the Model Practice of Pharmacy


February 03, 2020

mungerOne of the fundamental differences between the Essentials of a State Medical Practice Act (MPA) and the Model Pharmacy Practice Act (PPA) is that the MPA is proscriptive and the Pharmacy Practice Act 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 the duty to care and treatment of the patient with the degree of skill, care and diligence as possessed or expected of a reasonably competent physician.   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 in pharmacy practice is therefore restricted. I believe it is time to rethink the prescriptive nature of the PPA.

The Federation of State Medical Boards Essentials of State Medical and Osteopathic Practice Act from 2015 states following:

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. 

The National Association Boards of Pharmacy Model Pharmacy Act/Rules from 2019 states the Practice of Pharmacy is:

“The ‘Practice of Pharmacy XE "practice of pharmacy" ’ means, but is not limited to, the interpretation, evaluation, Dispensing XE "dispensing" , and/or implementation of Medical Orders, and the initiation and provision of Pharmacist Care XE "pharmacist care"  Services.  The Practice of Pharmacy also includes continually optimizing patient safety and quality of services through effective use of emerging technologies and competency-based training.”1

Pharmacist Care Services are in Appendix 1.  Please note under Pharmacist Care Services a prescriptive listing of care services that a pharmacist can provide—the standard has been set.

The PPA by listing the Pharmacist Care Services stifles innovation.  By the pharmacist starting a new practice role, he/she begins immediately practicing outside of the PPA, thereby placing themselves in legal jeopardy.  This stifles practice! Could practice innovation be undertaken within a collaborative practice agreement?  The answer is yes. However, I have found that physicians are reluctant to try new means or methods that are not their idea. 

It is time for a new paradigm in writing the PPA. I call on the National Association Boards of Pharmacy to draft a Model PPA that is broad in scope, uses advancing discerning verbs that allow innovation in practice, and does not list care services.  This call to evolve regulation of professional practice standards has been made previously based on comparison of word counts between medicine and nursing practice acts to the NABP PPA.3  

There is a US health care crisis of drug misadverturing that requires immediate innovation in pharmacy practice.4 Allowing pharmacist ingenuity to be unleashed can bring about positive changes in drug misadverturing.

Mark A. Munger, PharmD, FCCP, FACC, is a professor of pharmacotherapy and adjunct professor of internal medicine, at the University of Utah, where he also serves as the associate dean of Academic Affairs for the College of Pharmacy.  

References:

  1. Federation of State Medical Boards. Essentials of a State Medical and Osteopathic Practice Act 2015. https://www.fsmb.org/siteassets/advocacy/policies/essentials-of-a-state-medical-and-osteopathic-practice-act.pdf   Accessed 01/2020
  2. National Association of Boards of Pharmacy.  Model Pharmacy Practice Act/Rules. August 2019. https://nabp.pharmacy/publications-reports/resource-documents/model-pharmacy-act-rules/   Accessed 01/2020
  3. Adams AJ.  Transitioning pharmacy to “standard of care” regulation.  Analyzing how pharmacy regulates relative to medicine and nursing. Research in Social and Administrative Pharmacy 2019;15:1230-35.
  4. Medication Errors. https://www.amcp.org/sites/default/files/2019-03/Medication%20Errors.pdf  Accessed 01/2020

Appendix 1

Section 6. Pharmacist Care XE "pharmacist care"  Services. [1]

(a)             Prospective Drug XE "drug"  Utilization Review (DUR)[2] XE "drug regimen review"

                 A Pharmacist shall obtain and review the patient records and medical history for each Prescription Drug Order XE "prescription drug order"  for:

(1)   known allergies;

(2)   rational therapy contraindications;

(3)   reasonable dose, duration of use, and route of Administration, considering age, gender, and other patient factors;

(4)   reasonable directions for use;

(5)   potential or actual adverse Drug XE "drug"  reactions;

(6)   Drug XE "drug" -Drug interactions;

(7)   Drug XE "drug" -food interactions;

(8)   Drug XE "drug" -disease contraindications;

(9)   therapeutic duplication;

(10) proper utilization (including over- or under-utilization), and optimum therapeutic outcomes; and

(11) abuse/misuse.

Upon recognizing any of the above, the Pharmacist shall take appropriate steps to avoid or resolve the problem which shall, if necessary, include consultation with the Practitioner.

(b)            Patient Counseling[3]   

(1)     Upon receipt of a Prescription Drug Order XE "prescription drug order"  and following a review of the patient’s record, a Pharmacist shall personally initiate discussion of matters which will enhance or optimize Drug XE "drug"  therapy with each patient or caregiver of such patient. Such discussion shall be in Person, whenever practicable, or by telephone and shall include appropriate elements of Patient Counseling XE "patient counseling" . Such elements may include the following:

(i)    the name and description of the Drug XE "drug" ;

(ii)   the dosage form, dose, route of Administration, and duration of Drug XE "drug"  therapy;

(iii)   intended use of the Drug XE "drug"  and expected action;

(iv)   special directions and precautions for preparation, Administration, and use by the patient;

(v)   common severe side or adverse effects or interactions and therapeutic contraindications that may be encountered, including their avoidance, and the action required if they occur;

(vi)   techniques for self-monitoring Drug XE "drug"  therapy;

(vii)  proper storage and appropriate disposal method(s) of unwanted or unused medication;

(viii)prescription refill information;

(ix)   action to be taken in the event of a missed dose; and

(x)    Pharmacist comments relevant to the individual’s Drug XE "drug"  therapy, including any other information peculiar to the specific patient or Drug XE "drug" .

(2)   Alternative forms of patient information shall be used to supplement Patient Counseling XE "patient counseling"  when appropriate. Examples include written information leaflets, pictogram labels, video programs, etc.

(3)   Patient Counseling XE "patient counseling" , as described above and defined in this Act, shall not be required for inpatients of a hospital or institution where other licensed health care professionals are authorized to Administer XE "administer"  the Drug XE "drug" (s).

(4)   A Pharmacist shall not be required to counsel a patient or caregiver when the patient or caregiver refuses such consultation.

(c)             Medication Adherence Monitoring Services and Intervention Programs

       Medication Adherence Monitoring Services and Intervention Programs designed to promote improved medication use behaviors, such as compliance and adherence, appropriate monitoring and self-reporting, increased patient knowledge, and improved therapy options, shall comply with established Guidelines for the Appropriate Use and Disclosure of Protected Health Information XE "protected health information"  in Medication Adherence Monitoring Services and Patient Intervention Program XE "patient intervention program" s. (See Appendix D for Guidelines for the Appropriate Use and Disclosure of Protected Health Information in Medication Adherence Monitoring Services and Patient Intervention Programs.)

(d)              Collaborative Pharmacy Practice XE "pharmacy practice, collaborative"

(1)   Collaborative Pharmacy Practice XE "pharmacy practice, collaborative"  Agreement XE "pharmacy practice, collaborative:agreement"

       A Pharmacist planning to engage in Collaborative Pharmacy Practice XE "pharmacy practice, collaborative"  shall have on file at his or her place of practice the written Collaborative Pharmacy Practice Agreement XE "pharmacy practice, collaborative:agreement" . The initial existence and subsequent termination of any such agreement and any additional information the Board XE "board of pharmacy"  may require concerning the Collaborative Pharmacy Practice Agreement, including the agreement itself, shall be made available to the Board XE "board of pharmacy"  for review upon request. The Agreement may allow the Pharmacist, within the Pharmacist’s Scope of Practice Pursuant to the Collaborative Pharmacy Practice Agreement, to conduct  XE "medication therapy management" activities approved by the Practitioner, and as defined by law and by the Rules of the Board XE "board of pharmacy" . The collaboration that the Practitioner agrees to conduct with the Pharmacist must be within the scope of the Practitioner’s current practice. Patients or caregivers shall be advised of such agreement.

(2)   Contents

       The Collaborative Pharmacy Practice XE "pharmacy practice, collaborative"  Agreement XE "pharmacy practice, collaborative:agreement"  shall include:

(i)    identification of the Practitioner(s) and Pharmacist(s) who are parties to the Agreement;

(ii)   the types of  XE "medication therapy management" decisions that the Pharmacist is allowed to make;

 XE "drugs" (iii)  a process for generating any necessary Medical Orders, including prescription orders, required to initiate allowed activities;

(iv) a method for the Practitioner to monitor compliance with the Agreement and clinical outcomes and to intercede where necessary;  

(v)   a description of the Continuous Quality Improvement Program XE "continuous quality improvement program"  used to evaluate effectiveness of patient care and ensure positive patient outcomes;

(vi)   a provision that allows the Practitioner to override a Collaborative Practice decision made by the Pharmacist whenever he or she deems it necessary or appropriate;

(vii)  a provision that allows either party to cancel the Agreement by written notification;

(viii) an effective date;

(ix)  signatures of all collaborating Pharmacists and Practitioners who are party to the Agreement, as well as dates of signing; and

(x)   a procedure for periodic review and renewal within a time frame that is clinically appropriate.

(3)   Amendments to a Collaborative Pharmacy Practice XE "pharmacy practice, collaborative"  Agreement XE "pharmacy practice, collaborative:agreement"  must be documented, signed, and dated.

 XE "pharmacy practice, collaborative"  XE "pharmacy practice, collaborative:agreement" (4)   Documentation of Pharmacist Activities

       Documentation of allowed activities must be kept as part of the patient’s permanent record and be readily available to other health care professionals who are providing care to that patient and who are authorized to receive it. Documentation of allowed activities shall be considered Protected Health Information XE "protected health information" .

(e)               Emergency-Use Dispensing

Prescribing and Dispensing Drugs for emergency-use pursuant to a Pharmacist-issued Prescription[4] and appropriate patient counseling, including but not limited to:

(1)     Opioid overdose reversal agents, such as naloxone;

(2)     Epinephrine;

(3)     Antidote kits; and

(4)     Short-acting beta agonist inhalers.

 


Appendix Footnotes:

[1] Additional Pharmacist Care Services may include, but are not limited to, Patient assessment and evaluation; assessing health plan and medication eligibility and coverage; Administering Drugs, vaccines, or biologicals; performing Peer Review and peer consultations; reviewing, selecting, and developing formularies or plan /practice guidelines; consulting with other health care professionals; providing patient referrals; performing Medication Therapy Management; ordering lab tests; and performing lab tests as provided by State and Federal law.

[2] Pharmacists should be permitted to use computer software, if available, to accomplish this review.

[3]  The intent of this Section is to require that the Pharmacist personally initiate counseling for all new Prescriptions and to exercise his or her professional judgment for refills. Situations may arise, however, where the prescriber specifically indicates that a patient should not be counseled. In such circumstances, it is the responsibility of the Pharmacist to provide the best patient care through appropriate communication with the prescriber and to document the reason(s) for not providing counseling to the patient. 

[4] Pharmacist may prescribe pursuant to specific statewide protocols or standing orders.

 

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