Current through all regulations passed and filed through September 16, 2024
(A) A practitioner
may elect to manage the drug therapy of an established patient by entering into
a consult agreement with a pharmacist. The agreement is subject, but not
limited to, the following standards:
(1) The
primary practitioner must ensure that the managing pharmacist
has access to the patient's medical record, the medical record is accurate, and
that while transferring the medical record, the primary
practitioner ensures the confidentiality of the
medical record.
(2) The
practitioner must have an ongoing
practitioner-patient relationship with the patient
whose drug therapy is being managed, including an initial assessment and
diagnosis by the practitioner prior to the commencement of the consult
agreement.
(3) With the exception
of inpatient management of patient care at an institutional facility as defined
in agency 4729 of the Administrative Code, the practitioner, prior to a pharmacist managing the
patient's drug therapy, shall communicate the content of the proposed consult
agreement to each patient whose drug therapy is managed under the agreement, in
such a manner that the patient or the patient's representative understands
scope and role of the managing pharmacist, which includes the following:
(a) That a pharmacist may be utilized in the
management of the patient's care;
(b) That the patient or an individual
authorized to act on behalf of a patient has the right to elect to participate
in and to withdraw from the consult agreement.
(c) Consent may be obtained as part of the
patient's initial consent to treatment.
(4) The diagnosis by the
practitioner must be within the
practitioner's scope of practice.
(5) The practitioner
shall meet the minimal and prevailing standards of care.
(6) The practitioner
must ensure that the pharmacist managing the patient's drug therapy has the
requisite training, and experience related to the particular diagnosis for
which the drug therapy is prescribed. Practitioners
practicing at institutional or ambulatory outpatient facilities may meet
this requirement through institutional credentialing standards or
policies.
(7) The
practitioner shall review the records of all services
provided to the patient under the consult agreement.
(B) Quality assurance mechanisms. The
following quality assurance mechanisms shall be implemented to verify
information contained within the consult agreement, and ensure the managing
pharmacist's actions are authorized and meet the standards listed in paragraphs
(A) and (B) of this rule:
(1) Verification of
ongoing practitioner-patient relationship. A
practitioner-patient relationship can be established
by detailing criteria set forth in paragraph (A)(2) of this rule, within the
consult agreement.
(2) Verification
that practitioner diagnosis is within the
practitioner's scope of practice. Establishing that a
diagnosis is within the practitioner's scope of practice may be established by
detailing the criteria set forth in paragraph (A)(4) of this rule, within the
consult agreement.
(3) Verification
that pharmacist's training and experience is related to the drug therapy.
Establishing that a pharmacist's requisite training and experience with a
particular drug therapy is related to the diagnosis for which the drug therapy
is prescribed, may be established by detailing the criteria set forth in
paragraph (A)(6) of this rule, within the consult agreement.
(C) Continuous quality improvement
program. The following should be included in the development of a continuous
quality improvement program in order to evaluate the effectiveness of patient
care and ensure positive patient outcomes:
(1)
Notifications to primary practitioner. The managing pharmacist must notify the
primary practitioner of the following situations regarding any
pharmacist authorized to manage drug therapy under the agreement:
(a) A pharmacist has had their pharmacist
license revoked, suspended, or denied by the state board of pharmacy;
(b) If prescribing controlled substances, a
pharmacist has failed to renew their controlled substance prescriber
registration;
(c) If prescribing
controlled substances, a pharmacist fails to obtain or maintain a valid D.E.A.
registration;
(D) Overriding decisions of managing
pharmacist. Any authorized practitioner identified under the consult agreement
may override any decision, change, modification, evaluation or other action by
any pharmacist acting pursuant to consult agreement or under the direction of
the managing pharmacist, that was made with respect to the management of the
patient's drug therapy under the consult agreement.