Q. How do I set up a collaborative practice protocol with a physician?
John E. Dinardo, R.Ph., J.D.
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A. Modern pharmacy practice has grown professionally to unprecedented levels—from traditional dispensing functions to sophisticated
clinical roles. One important area is collaborative drug therapy management (CDTM), whereby, according to the National Association
of Boards of Pharmacy (NABP), a pharmacist has voluntarily agreed to work with a practitioner under a protocol within which
the pharmacist may perform certain patient care functions authorized by the practitioner under specified conditions and/or
limitations. A collaborative pharmacy practice agreement, signed among one or more pharmacists and one or more practitioners,
provides for collaborative drug therapy management of patients. Drug therapy management implies review of a patient's drug
therapy regimen by a pharmacist for the purpose of evaluating and rendering advice to a practitioner regarding adjustment
of the regimen, with decisions involving drug therapy management made in the best interest of the patient. Such management
may include (1) implementing, modifying, and managing drug therapy according to the terms of the collaborative pharmacy practice
agreement, (2) collecting and reviewing patient histories, (3) obtaining and checking vital signs, (4) ordering and evaluating
the results of laboratory tests directly to drug therapy, when performed in accordance with approved protocols applicable
to the practice setting, and (5) such other patient care services allowed by law.
To participate in CDTM, a pharmacist must adhere to a particular state's requirements for such practice. Although the vast
majority of states have established some level of CDTM, there are many variations and important differences among the states'
pharmacy practice acts. Attributes of state regulations governing CDTM include: (1) types of collaborative practice agreements,
(2) levels of review of approval required, (3) medications included, (4) practice environments, (5) educational requirements/demonstrated
competencies, and (6) other aspects addressed by the state. Some states require a written protocol for each patient; others
require only a general written protocol. Some states limit the type of practice agreement to an administration of injectables
(medications, biologics, and vaccines) protocol, or to an emergency-contraceptive protocol only. Most states do not specify
a limitation.
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The required levels of review of approval also vary from the physician, to the board of pharmacy, to the board of medical
examiners, the facility itself, or various combinations. A few states require no level of review of approval.
While most states allow CDTM in all practice settings, some limit it to the institutional setting. Some states have additional
educational requirements, such as the Pharm.D. degree, specialty certification, disease state management credentialing, accredited
residency credentialing, or minimum clinical experience; some states have no additional requirements. Other aspects addressed
by various states include specific pharmacist duties—initiating and modifying drug therapy, ordering lab tests, changing duration
of therapy, altering drug strengths, modifying or discontinuing drug therapy, monitoring drug therapy, and patient assessment.
It is imperative that the individual pharmacist adhere to his or her state's specific regulations. In general, a pharmacist
would first need to identify a physician who wishes to collaborate with the pharmacist. This could be accomplished in several
ways, either on an individual, institutional, or corporate basis. The physician and pharmacist would then define the various
parameters of the CDTM, based on the state's pharmacy practice act; they would eventually execute a collaborative pharmacy
practice act agreement, specifying the various duties and functions of each practitioner, including the various procedures
necessary for performance. The agreement would also include the patient, since the pharmacist-patient relationship is a key
element of CDTM. The patient would need to consent to the CDTM, thereby complementing and enhancing the patient-physician
relationship and improving overall patient therapy. Moreover, the agreement would also include specific provisions addressing
patient privacy and confidentiality issues.
Obviously, adequate quality assurance is a critical component to the success of any CDTM protocol. Documentation of all activities
related to CDTM needs to be followed according to state regulations and will need to be shared with and made available to
the physician and other providers associated with the protocol, in accordance with HIPAA regulations. Additionally, compliance
with the corporate pharmacy and/or institution's own policies and regulations will be required.
THE AUTHOR practices law in Pennsylvania and has 14 years of experience in pharmacy.
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