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ASHP Submits Letter on the Proposed Rules on Consult Agreements

State Medical Board of Ohio

February 8, 2019

Andrew P. Schachat, M.D.
State Medical Board of Ohio
30 E. Broad Street, 3rd Floor
Columbus, OH 43215

Subject: Letter Regarding the Proposed Rules on Consult Agreements for Pharmacist Management of a Patient’s Drug Therapy (4731-35-01 and 4731-35-02)

Dear Dr. Schachat:

On behalf of ASHP (American Society of Health-System Pharmacists), I am writing to express our concerns over the proposed rules on consult agreements for pharmacist management of a patient’s drug therapy (4731-35-01 and 4731-35-02) and to request that the State Medical Board of Ohio consider changes to its proposed rules.

ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s nearly 50,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.

ASHP is concerned that the proposed rules severely diminish the scope and role of the pharmacist in managing a patient’s medication therapy under the provisions of a consult agreement. The diminished scope of practice will have significant negative impact on patients by limiting patient access to the care of medication experts and burdening physicians with onerous administrative requirements to manage these consult agreements. We recommend the following changes to the proposed rules:

4731-35-01 — Consult Agreements

  • Removal of Section A-1-i — Requirement for physician approval prior to adjustment to the dose of a controlled substance.
    • Given the current national opioid crisis, limitations on the ability of pharmacists to manage controlled substances could exacerbate the problem of opioid overuse by preventing pharmacists from adjusting doses down or discontinuing opioids that are no longer needed for the patient.

4731-35-02 — Standards for Managing Drug Therapy

  • Modification of section A-3 — The language concerning physician communication with the patient is excessive and could discourage patients from allowing a pharmacist to participate in their care through a consult agreement. We recommend that sub bullet (d) be removed from the rules.
  • Removal of section A-6 — The requirement that the authorizing physician ensure that the managing pharmacist’s training and experience are adequate is an excessive burden on the physician. In order to be licensed in Ohio, pharmacists are extensively trained in pharmacology and pharmacotherapy in pharmacy school and through the process of continuing education, further scrutiny of this training and experience by the authorizing physician is redundant and over burdensome.
  • Clarification of section A-7 — The term “prompt review” is subjective as written and should be more clearly defined.
  • Modification of section B-1 —The responsibility of defining the extent and scope of the pharmacist on the physician is unclear in this section. We recommend rewording this section to outline that the scope of practice for the managing pharmacist is defined by the policy/procedure established in the consult agreement.
  • Modification of section C-4-a — We recommend removal of the requirement for a pharmacist to notify a primary physician prior to any action. This requirement goes against the spirit and purpose of the consult agreement. It is an extra layer of regulation that is extremely onerous on the physician as well as the managing pharmacist, and it could discourage physicians from entering into consult agreements with pharmacists. This rule will negatively impact patients’ access to the necessary care they could receive from a pharmacist to manage their medications under a consult agreement. As the medication experts, pharmacists are qualified to perform these actions under a consult agreement. This rule will decrease both access to and quality of care.
  • Modification of section D-1 — We recommend removal of the requirement for the primary physician and managing pharmacist to hold regular meetings. Meetings held between physicians and pharmacists under a consult agreement should be held as needed on a case-by-case basis, directed by either the physician or pharmacist.

Patients receive better care when pharmacists are able to fully and efficiently work with physicians and other providers on the healthcare team. These proposed rules as written will limit the many current positive and beneficial collaborations between physicians and pharmacists in the state of Ohio, and will not be in the best interest of the patients that we all, as members of the interdisciplinary healthcare team, are seeking to serve.

We appreciate the opportunity to offer our comments on the proposed rules. If you have any questions regarding this letter, or if we can be of any assistance, please contact Nicholas Gentile, Director of State Grassroots Advocacy and Political Action, at [email protected] or 301-664-8687.


Kasey K. Thompson, Pharm.D., M.S., M.B.A.
Chief Operating Officer & Senior Vice President for Policy and Planning