Ohio Administrative Code Title 4729:1 - Licensing and Consult Agreements
What are “Consult Agreements” under Ohio Law (ORC & OAC)
The concept of a consult agreement is set out principally in:
Ohio Revised Code (ORC) § 4729.39 — “Consult agreement with physicians.”
Ohio Administrative Code (OAC) Chapter 4729:1‑6 — Consult Agreements with Physicians (Rules like 4729:1‑6‑01, 4729:1‑6‑02, 4729:1‑6‑03) which flesh out how consult agreements are to be structured and operated.
In broad terms: a consult agreement allows a pharmacist to manage certain aspects of a patient’s drug therapy under a written agreement with a prescribing practitioner (physician or certain other practitioners as authorized) for specified diagnoses, under defined conditions. The managing pharmacist is given limited authority as defined in the agreement and the law, to adjust therapy, order certain tests, etc., but only as allowed by the agreement.
Key Statutory Requirements (ORC § 4729.39) for Consult Agreements
Here are some of the statutory constraints / requirements (ORC) that the OAC rules must implement:
Who may enter into them
Pharmacists may enter consult agreements with physicians. Also with physician assistants, clinical nurse specialists, certified nurse‑midwives, or certified nurse practitioners, but only when those non‑physician practitioners are authorized (via supervision, collaboration, etc.).
Prerequisites
Practitioner must have an ongoing practitioner‑patient relationship for each patient whose drug therapy is to be managed.
The diagnosis for which the patient has drug therapy must be within the scope of practice of the practitioner.
Pharmacist must have training/experience related to that diagnosis.
What the pharmacist may do under a consult agreement (but only to the extent the agreement allows, and subject to rules)
Modify drug therapy: adjust dose, strength, route, frequency, discontinuation, duration, maybe add a drug.
Order and evaluate lab/diagnostic tests related to the drug therapy. But not to make diagnosis.
Procedural requirements
The agreement must be in writing (or, if verbally entered, immediately reduced to writing).
It must specify the diagnoses/diseases managed, whether primary or comorbid; drugs/drug categories; criteria / plans / decision protocol; tests permitted; documentation; QA / record‑keeping; communication between pharmacist and practitioner; override rights; training/experience criteria; effective and expiration dates.
Duration
Valid for up to two years, and may be renewed if conditions are still satisfied.
Limitations & liability
A consult agreement only applies to those patients and prescriptions for which the practitioner is part of the agreement. Cannot manage drug therapy prescribed by a practitioner not party to the agreement.
There are statutory liability protections: the law says that, under certain circumstances, a pharmacist acting in accordance with a consult agreement is not liable in damages “for injury or loss … allegedly arising from the change” of a drug under that agreement, and similarly for a practitioner, unless the practitioner specifically authorized the change. But that protection is limited (e.g., it does not protect in respect of actions beyond what the agreement permits or in areas not covered by the statute).
Key Rules in OAC Title 4729:1‑6 (Consult Agreements) – Details
The rules under OAC 4729:1‑6 expand and implement the statutory framework. Some highlights:
Rule 4729:1‑6‑01 defines terms: what is a “managing pharmacist,” what is “communication,” “positive identification,” etc.
Rule 4729:1‑6‑02 sets out the detailed requirements for a consult agreement (identification, diseases managed, drug categories, decision criteria, tests, record keeping, communication, quality assurance, training, effective dates).
It also requires that consult agreements and associated actions be documented, records retained for at least three years, and that agreements shall be “confidential patient records” subject to confidentiality rules.
The rules also lay out how the managing pharmacist may act (order tests, adjust, etc.), including the requirement to comply with prescription rules, and include conditions about how prescriptions or orders are to be documented (including identification of managing pharmacist, etc.).
What the Rules Do Not Allow / Clear Limitations
A managing pharmacist under a consult agreement cannot make diagnoses. That remains with the practitioner.
The pharmacist cannot manage drug therapy for a patient whose prescribing practitioner is not part of the consult agreement
There may be categories of drugs or diseases for which consult agreements are not permitted, depending on rules that the boards adopt.
Liability / Legal Risk
The statute (ORC § 4729.39) provides some immunity from civil damages for a pharmacist who acts in accordance with the consult agreement regarding a change in drug therapy (as authorized), and for a practitioner if they authorized the change.
But this protection is not absolute. If a pharmacist acts outside what the consult agreement authorizes, or makes unauthorized changes, or violates other regulatory or legal duty, then the protections likely will not apply.
Also, if the consult agreement fails to meet the statutory / rule requirements (e.g. lacks required elements, is not valid, has expired, or is not signed properly), that may expose both pharmacist and practitioner to discipline or liability.
Case Law / Reported Judicial Interpretations
Despite a fairly detailed regulatory regime, I did not find reported Ohio appellate court decisions (at least in the accessible sources) that focus narrowly on consult agreement disputes (e.g. liability under § 4729.39, or disputes over validity of consult agreements under rule 4729:1‑6). That does not mean there are none, but none were found in my search.
There are analogous principles in case law concerning standard of care, scope of practice, delegation, and liability for professional acts. For example:
If a pharmacist acts outside their scope as defined by law, they may be liable in tort for negligence (even beyond administrative discipline).
The requirement of an ongoing practitioner‑patient relationship means that entering into a consult agreement without such a relationship may expose both parties to legal risk.
Courts may look at whether documentation and agreement terms were followed strictly (e.g. whether the managing pharmacist had the prescribed authority, whether decisions were documented, whether communication requirements were met) when deciding issues of liability.
Because no specific case was located, parties relying on consult agreements should treat all the details carefully, maintain thorough records, ensure all required signatures, amendments, and renewals are in place; and ensure that the extent of the authority given is unambiguous.
Practical Implications / Best Practices
Because the rules are specific and carry legal and liability implications, these are some good practices to follow:
Ensure the agreement meets all required elements under Rule 4729:1‑6‑02 (diagnoses, drug categories, decision criteria, communication plan, override provision, QA mechanism, training criteria, etc.). If any element is missing, the agreement may be invalid or expose participants to disciplinary action or liability.
Training & credentialing: Make sure the managing pharmacist has training and experience for the diagnoses/diseases managed under the agreement.
Documentation & records: Maintain accurate, retrievable records for each patient managed under the consult agreement, and keep them for the required period (at least three years) as per the rules. Record all actions, communications, prescriptions/orders, etc.
Renewal & duration: Track the two‑year expiration, renew properly, ensure amendments signed by appropriate parties, ensure that all parties are properly licensed.
Communication & override: The practitioner must be allowed to override managing pharmacist decisions; communication must happen regularly as specified; reports submitted as required.
Stay within scope: Pharmacists must act only within what the consult agreement (and the law) authorizes. E.g. cannot prescribe controlled substances unless permitted by agreement and relevant regulatory registration; cannot make diagnoses.
Patient consent and disclosure: Inform the patient of the consult agreement, the scope, what is managed, the responsibilities, etc.
Liability protection: Be aware of both the protection offered by § 4729.39 for acting under a valid agreement, and the limits: protection doesn’t extend to acts outside the agreement, negligence, or failure to comply with the statute or rules.
What Remains Unsettled / Weak Areas (Possible Legal Controversies)
Because case law is scarce, some questions remain:
How courts will treat “overlapping authority”: what happens if a consult agreement gives a managing pharmacist power over drug therapy in some areas, but a practitioner also intervenes or disagrees?
When is the “ongoing practitioner‑patient relationship” satisfied? What if the patient hasn't seen the practitioner recently? Is tele‑medicine sufficient? Courts might differ.
How broadly do the statutes’ immunity provisions protect pharmacists and practitioners in practice? E.g. is professional malpractice insurance affected, or how documentation and oversight are evaluated in civil suits?
Whether some consult agreements might be challenged as being beyond the pharmacist's scope if the disease/diagnosis is too complex or outside usual training.
Regulatory compliance is crucial; courts will likely give deference to the Board’s determinations if rules are followed.
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