3.4 Advanced Pharmacist Practitioner (APP/APh) & CDTM

Advanced Practice Pharmacist (APh) Designation

California law established the Advanced Practice Pharmacist (APh) designation to recognize pharmacists who have achieved advanced training and clinical experience, enabling them to perform expanded patient care services. The criteria and authority for an APh are detailed in Business and Professions Code (B&P) § 4210 and § 4052.6, with significant regulatory updates regarding the APP title recognition effective Jan 1, 2025. This designation elevates the pharmacist to a higher level of collaborative care, often functioning similarly to mid-level practitioners in specific drug therapy management settings.

Qualifications for APh

To apply for the APh designation, a California-licensed pharmacist must satisfy any two of the following three criteria:

1. Certification: Earn and maintain certification in a relevant area of practice from an organization recognized by the Board (e.g., Board of Pharmacy Specialties (BPS) certification like BCPS, BCOP, BCACP).
2. Residency: Complete a postgraduate residency program earned in the United States through an accredited body (like ASHP), with a significant portion of the residency involving direct patient care with collaborative practice agreements.
3. Clinical Experience: Have provided clinical services to patients for at least one year (defined as at least 1,500 hours) under a collaborative practice agreement or protocol with a physician, APP, or within a health system.

Once a pharmacist satisfies two of these three pillars, they can submit an application to the Board of Pharmacy, complete the necessary paperwork, and receive their APh license. The APh designation must be renewed alongside their standard pharmacist license, typically requiring an additional 10 hours of continuing education (CE) specifically related to their advanced practice area.

Expanded Authority of an APh (B&P § 4052.6)

An Advanced Practice Pharmacist has expanded authority beyond that of a standard licensed pharmacist. While any pharmacist can perform some CDTM in certain settings, an APh operates with a broader scope. An APh may:

1. Perform Patient Assessments: Conduct thorough physical and clinical assessments relevant to the patient's drug therapy.
2. Order and Interpret Tests: Order and interpret drug therapy-related blood tests or other clinical laboratory tests (e.g., ordering a comprehensive metabolic panel to monitor renal function for a patient on specialized antibiotics).
3. Refer Patients: Refer patients to other healthcare providers if the patient's condition warrants care beyond the pharmacist's scope.
4. Initiate, Adjust, and Discontinue Therapy: Participate in the evaluation and management of diseases and health conditions in collaboration with other healthcare providers. Crucially, an APh can initiate, adjust, or discontinue prescription drug therapy, including controlled substances (provided they have a DEA registration and are acting within a collaborative practice agreement).

It is important to note the changes effective Jan 1, 2025, which further solidify the APP title and streamline the collaborative mechanisms between APhs and physicians across various healthcare networks.

Collaborative Drug Therapy Management (CDTM)

Collaborative Drug Therapy Management (CDTM) is a formal practice agreement between one or more pharmacists and one or more physicians. The agreement allows pharmacists to assume responsibility for managing a patient's complex drug therapy regimen.

While an APh has broad authority, non-APh pharmacists can also engage in CDTM under strict protocols in specific settings (such as licensed healthcare facilities, accountable care organizations, or clinics). A CDTM protocol must explicitly state:

• The specific diseases, drugs, or drug categories the pharmacist is authorized to manage.
• The procedures, decision criteria, or plan the pharmacist must follow (e.g., a dosing algorithm for warfarin based on INR results).
• The conditions under which the pharmacist must consult the supervising physician or refer the patient.
• The reporting requirements between the pharmacist and the physician.

Under a CDTM protocol, a pharmacist acts as an extension of the physician's prescriptive authority. If the protocol allows, a pharmacist can modify doses, order necessary lab tests, and authorize refills for chronic medications. This model is highly effective in managing chronic diseases such as diabetes, hypertension, asthma, and anticoagulation therapy, where frequent monitoring and minor medication adjustments are necessary for optimal outcomes. All CDTM protocols must be reviewed and updated regularly (usually annually) to ensure they reflect current clinical guidelines and best practices.

Summary Table of APh and CDTM