Collaborative Drug Therapy Management (CDTM)

Facilities regulated under article twenty-eight of the public health law, including any diagnostic center, treatment center, or hospital-based outpatient departments (including outpatient clinics), are included. Residential health care facilities, rehabilitation centers and nursing homes are excluded with the exception of nursing homes with an on-site pharmacy staffed by a licensed pharmacist.

The pharmacist must be employed or otherwise affiliated with an eligible facility (see question 1), be currently licensed and registered in NY, and meet the following education and experience requirements:

Pharmacists with a PharmD or MS in Clinical Pharmacy must have:

• A minimum of two years of experience, which must include at least one year of clinical experience in a health facility that involves consultation with physicians with respect to drug therapy.  This experience may also include a residency at a facility involving such consultation.
• Clinical experience must have been completed within the 3 years immediately prior to the pharmacist's submission of his or her application to the Department for approval to participate in CDTM.

Pharmacists with a BS in Pharmacy must have:

• A minimum of three years of experience, within the last seven years, which must include at least one year of clinical experience in a health facility, that involves consultation with physicians with respect to drug therapy.  This experience may also include a residency at a faculty involving such consultation.
• Clinical experience must have been completed within the 3 years immediately prior to the pharmacist's submission of his or her application to the Department for approval to participate in CDTM.

In addition, all pharmacists must meet one of the following:

• Completion of an accredited residency program*; or
• Demonstration of Board Certification status from an accredited body approved by the Department.

For additional clarification, please refer to the Pharmacists Credentials chart.

*Successful completion of a residency program may be used to satisfy the clinical experience requirement.  However, in such cases, successful completion of a residency cannot also be used to satisfy the additional experience requirement and, therefore, board certification would be required.

Yes. Qualified pharmacists may not engage in CDTM without specific approval from SED. Pharmacists must submit Pharmacist Collaborative Drug Therapy Management application form with the required supporting documentation prior to entering into CDTM practice.

For all licensed professionals, unprofessional conduct includes "practicing or offering to practice beyond the scope permitted by law, or accepting and performing professional responsibilities which the licensee knows or has reason to know that he or she is not competent to perform....".

Each patient who is eligible to receive CDTM must be notified:

1. that there is a written agreement between the pharmacist and a voluntarily participating physician in accordance with the policies, procedures, and protocols of the facility;
2. that participation in CDTM is voluntary and that the patient may choose not to participate;
3. that CDTM will not be utilized unless the patient or patient's authorized representative consents, in writing, to such management;
4. that the consent to such management will be noted on the patient's medical record;
5. that the patient or the patient's authorized representative may choose to discontinue CDTM at any time;
6. that, if such management is discontinued, the discontinuance will be promptly noted on the patient's medical record; and
7. that the existence of a written agreement or protocol on CDTM and the patient's consent to such management will be disclosed to the patient's primary care physician and any other treating physician or healthcare provider.
    

Written consent to CDTM must be obtained from the patient or the patient's authorized representative in order for such management to be used with the patient. This written consent may include, but is not limited to, the use of an electronic signature. Written consent must be noted on the patient’s chart. If an electronic signature is used to obtain written consent for CDTM, such consent cannot be incorporated into the general patient consent.  However, if an electronic signature is not used to obtain written consent to CDTM, such consent may be incorporated into the general patient consent.

In accordance with the required written agreement or protocol, a pharmacist may adjust or manage a drug regimen of a patient who is being treated by the participating physician for a specific disease or disease state. Such adjustment or management must be done only pursuant to a patient-specific written order or protocol made by the patient’s physician, and may include adjusting:

1. drug strength;
2. frequency of administration; or
3. route of administration.

The participating pharmacist may not substitute or select a drug which differs from that initially prescribed by the patient’s physician, unless such substitution is expressly authorized in the written order or protocol.

The adjustments must be in accordance with the written agreement or protocol between the participating physician and pharmacist and with the patient-specific written order. If those documents do not require a counter-signature by a collaborating physician, the law does not otherwise require one. The name of the collaborating physician should be provided to the pharmacist dispensing the medication.
 

The pharmacist is required to immediately enter into the patient record any change or changes made to the patient's drug therapy and must use any reasonable means or method established by the facility or the department to notify any of the patient's other treating physicians with whom he or she does not have a written agreement or protocol regarding such changes.

No, not as a routine matter. However, protocols must be made available for review upon request of the Department.

Participating pharmacists may evaluate clinical laboratory tests related to the drug therapy management for the specific disease or disease state specified within the protocol. They may order such clinical laboratory tests, only if specifically authorized by the protocol and only to the extent necessary to discharge their responsibilities under the law.