6.4 Collaborative Drug Therapy Management (§6801-a) & Non-Patient-Specific Orders
Key Takeaways
- Collaborative Drug Therapy Management under Education Law §6801-a is patient-specific and requires the collaborating physician to be employed by or affiliated with the same facility as the pharmacist; it does not authorize nurse practitioners as collaborating prescribers.
- Pharmacists qualify for CDTM through a PharmD/MS-in-Clinical-Pharmacy path (2 years' experience, including 1 year of clinical facility consultation) or a BS-in-Pharmacy path (3 of the last 7 years' experience, including 1 year in a clinical facility setting), plus written patient consent before services begin.
- Non-patient-specific orders under 8 NYCRR §63.9 (implementing Education Law §§6527, 6801, and 6909) are population-level, may be issued by either a physician or a certified nurse practitioner, and authorize pharmacists to administer immunizations or dispense self-administered hormonal contraceptives after Board-approved training.
- If the DOH Commissioner determines there is an outbreak of disease or an imminent threat of one, the Commissioner may issue a non-patient-specific regimen applicable statewide under 8 NYCRR §63.9(a)(1)(b)(ii) — the model used for New York's statewide naloxone standing order under PHL §3309.
- The MPJE tests the distinction sharply: CDTM is patient-specific, physician-only, and PharmD-qualification-driven, while non-patient-specific orders are population-level, physician-or-NP-issued, and activity-specific-training-driven.
Collaborative Drug Therapy Management — Education Law §6801-a
Collaborative Drug Therapy Management (CDTM) is defined by Education Law §6801-a as "the performance of clinical services by a pharmacist relating to the review, evaluation and management of drug therapy" for a patient being treated by a physician for a specific disease or associated disease states. CDTM operates under a written agreement or protocol with a voluntarily participating physician, consistent with the policies, procedures, and protocols of the facility where the care is delivered.
Two structural limits matter most for the exam. First, CDTM under §6801-a is patient-specific, not a population-level standing order — it is built around an individual patient's treatment relationship with a physician. Second, it is institutionally bounded: the participating physician must be employed by or affiliated with the same facility as the collaborating pharmacist. §6801-a does not extend collaborating-prescriber status to nurse practitioners, and it does not authorize a community pharmacist to enter a CDTM protocol with an unaffiliated outside physician.
Pharmacist eligibility to practice CDTM follows one of two paths:
- A Doctor of Pharmacy (PharmD) or Master of Science in Clinical Pharmacy, current unrestricted New York licensure, and a minimum of 2 years' experience, including at least 1 year of clinical health-facility consultation with physicians regarding medication therapy; or
- A Bachelor of Science in Pharmacy, with a minimum of 3 years' experience within the preceding 7 years, including at least 1 year in a clinical health-facility setting.
Permissible clinical actions under a CDTM protocol include adjusting or managing an existing drug regimen — strength, frequency, or route of administration — but not substituting a different drug unless the protocol expressly authorizes it; ordering disease-related laboratory tests when the protocol specifically authorizes it; and performing routine monitoring functions such as vital-sign assessment. Written patient consent is mandatory before CDTM services begin, and participation remains voluntary for the pharmacist, the physician, and the patient. §6801-a has historically operated as a demonstration program subject to periodic legislative reauthorization rather than a permanent grant of authority, so candidates should confirm current reauthorization status rather than assume it never expires.
A Different Authority: Non-Patient-Specific Orders — 8 NYCRR §63.9
The MPJE regularly tests whether candidates can distinguish §6801-a CDTM from a separate, broader authority: non-patient-specific orders, authorized under Education Law §§6527, 6801, and 6909 and implemented at 8 NYCRR §63.9. Where CDTM is patient-specific and physician-only, non-patient-specific orders are population-level and may be issued by either a New York-licensed physician or a New York-certified nurse practitioner with a practice site in the state.
New York recognizes two pharmacist activities under non-patient-specific orders: administering immunizations, and dispensing self-administered hormonal contraceptives (FDA-approved oral contraceptives, contraceptive vaginal rings, and contraceptive patches used to prevent pregnancy), each requiring the pharmacist to complete Board-approved training first. A non-patient-specific order authorizes one or more certified pharmacists — named individually, or identified through employment or contract with an entity legally authorized to provide pharmacy services — to act on a defined group of individuals for a prescribed period, rather than for a single named patient. For immunizations specifically, adults 18 and older may receive the full range of ACIP-aligned vaccines under a non-patient-specific order, while patients ages 2 through 18 are limited to influenza vaccine only.
Statewide Orders During an Outbreak
8 NYCRR §63.9(a)(1)(b)(ii) gives the DOH Commissioner a further, escalated tool: if the Commissioner determines that there is an outbreak of disease, or an imminent threat of an outbreak of disease, the Commissioner may personally issue a non-patient-specific regimen applicable statewide — replacing the need for an individual physician or nurse practitioner order at every practice site. The working, real-world example of this authority in action is the naloxone standing order under PHL §3309: the DOH Commissioner issues and periodically renews a statewide standing order (the most recent renewal runs from February 12, 2026 through February 12, 2028) that lets every pharmacist registered and in good standing with the New York Board of Pharmacy dispense the opioid antagonist naloxone to anyone who requests it — including people at risk of overdose and third parties positioned to assist them — without any patient-specific prescription at all.
The Distinction the Exam Wants You to Draw
| Feature | CDTM — §6801-a | Non-Patient-Specific Order — Part 63 |
|---|---|---|
| Patient specificity | Patient-specific; built on an existing physician-patient relationship | Population-level; covers a defined group, not one named patient |
| Who may issue/collaborate | Physician employed by or affiliated with the same facility as the pharmacist | Physician OR nurse practitioner licensed/certified in New York |
| Pharmacist qualification | PharmD/MS + 2 yrs (1 yr clinical) or BS + 3 of last 7 yrs (1 yr clinical) | Board-approved training in the specific activity (e.g., immunization certification) |
| Typical clinical scope | Adjusting an existing drug regimen, ordering authorized labs, routine monitoring | Administering immunizations; dispensing self-administered hormonal contraceptives |
| Statewide escalation | Not applicable | DOH Commissioner may issue a statewide order during a disease outbreak or imminent threat |
Scenario
A community pharmacist without a PharmD and without documented clinical-facility experience wants to independently titrate a patient's antihypertensive regimen under a protocol signed by a physician who has no affiliation with the pharmacist's employer. This fails §6801-a on two grounds — pharmacist qualification and the same-facility physician requirement — regardless of how well-documented the protocol is. Contrast that with the same pharmacist administering an influenza vaccination to a 10-year-old under a non-patient-specific order signed by a certified nurse practitioner: that is lawful under Part 63, provided the pharmacist holds the required immunization certification.
Under Education Law §6801-a, who may serve as the physician collaborating with a pharmacist under a Collaborative Drug Therapy Management (CDTM) protocol?
A pharmacist holds a Bachelor of Science in Pharmacy and wants to qualify to practice Collaborative Drug Therapy Management under §6801-a. What experience must this pharmacist show?
Which statement correctly distinguishes a non-patient-specific order under 8 NYCRR §63.9 from Collaborative Drug Therapy Management under §6801-a?
The DOH Commissioner determines there is an imminent threat of a disease outbreak in New York. Under 8 NYCRR §63.9(a)(1)(b)(ii), what may the Commissioner do?