6.1 CDTM, Clinical Pharmacy Agreements, MTM & Laboratory Testing

Why this matters

Area 2.2 covers the "conditions under which the pharmacist ... participates in the administration of drugs in the management of patients' therapy." In Oregon, pharmacists manage therapy through several distinct legal channels. Choosing the right one is often the point of an exam question:

Collaborative drug therapy management (OAR 855-115-0315)

CDTM means a pharmacist participates in managing drug therapy under a written protocol. The protocol includes the dosage, frequency, duration and route of administration (OAR 855-006-0005). A CDTM arrangement may be between one practitioner and one pharmacist, or between an organized medical group (a hospital, clinic or group practice) and one or more pharmacists.

The written agreement must contain:

1. The participating pharmacists, identified by name or description.
2. The participating practitioners or group.
3. The principal pharmacist and practitioner responsible for developing, training, administering and assuring the quality of the arrangement.
4. The types of decisions the pharmacist may make. This includes the diseases, drugs or drug categories covered, the methods and decision criteria, documentation and communication procedures, and the circumstances requiring the pharmacist to contact the practitioner.
5. Training and competency requirements.
6. A quality-assurance mechanism with periodic review.
7. The practitioner's authorization of the pharmacist's participation.
8. A requirement that the arrangement be reviewed and updated, or discontinued, at least every two years.

The pharmacist must keep the agreement and records at the pharmacy and make them available to the health licensing boards on request. Prescriptions issued under CDTM must still identify the authorizing practitioner (OAR 855-041-1105). The Board's self-inspection form checks both the agreement elements and the two-year review. Therapeutic substitution outside the agreement is not permitted.

Clinical pharmacy agreements and the practice of clinical pharmacy

ORS 689.005 defines the practice of clinical pharmacy as patient care that optimizes medication therapy, together with the patient's other practitioners. It includes post-diagnostic disease-state management and practice under a clinical pharmacy agreement. A clinical pharmacy agreement is between a pharmacist or pharmacy and a health care organization, a physician (ORS 677.010) or a naturopathic physician. Pharmacists may order and receive lab tests when managing therapy under such an agreement or under CDTM (OAR 855-115-0310(1)(a)).

Medication therapy management (OAR 855-115-0320)

MTM services aim to optimize therapeutic outcomes. They may include:

• Health assessments and medication reviews.
• Medication treatment plans, and selecting or modifying therapy (within the pharmacist's authority).
• Monitoring safety and effectiveness.
• Documenting care and communication with other providers.

MTM and comprehensive medication review are part of the statutory practice of pharmacy. First-year interns may observe MTM but not conduct it (OAR 855-120-0150).

Laboratory testing (OAR 855-115-0310; ORS 689.661)

A pharmacist may order and receive laboratory tests only when:

• Managing therapy under a clinical pharmacy agreement or CDTM.
• Providing a service under the formulary (OAR 855-115-0340) or a protocol (OAR 855-115-0345).
• Operating under an OHA Health Screen Testing Permit (ORS chapter 438).
• Monitoring a therapeutic response or adverse effect of drug therapy.

A pharmacy may itself perform tests whose analytes FDA has cleared under the CLIA regulations, if it holds a CLIA certificate of waiver from HHS (ORS 689.661). A laboratory operated in a drug outlet must have its license displayed (OAR 855-041-1190).

Consulting practice (OAR 855-115-0300)

A pharmacist serving an Oregon-licensed health care facility performs every duty the facility's licensure requires. For correctional facilities, long-term care, community-based care, hospital drug rooms and charitable pharmacies without other state requirements, the consultant provides:

• Policies and procedures for security, storage and distribution.
• Guidance on documenting administration or dispensing.
• Education on request.

Consulting records are kept for three years.

Record retention for clinical services

Under OAR 855-104-0055, clinical pharmacy records are kept seven years. Training records for immunization and for protocol or formulary prescribing are kept six years, or uploaded to the Board's licensing system. Other records are kept three years.

Exam scenario

A hospital-affiliated clinic and four pharmacists sign a CDTM agreement for anticoagulation. It names the principal pharmacist and physician, lists warfarin dose-adjustment criteria, sets an INR level that triggers a call to the physician, requires annual competency checks, and was last reviewed 22 months ago. The pharmacists may adjust warfarin within its criteria. The agreement must be reviewed by the 24-month mark, and each adjustment is documented and kept for seven years. If a pharmacist switched a patient to apixaban, a drug not covered by the agreement, that would be prescribing outside the CDTM arrangement.