Collaborative Practice

Question 1

“Collaborative drug therapy management” means:

Answer 1

the cooperative management of a patient’s drug, biological, and device-related health care needs, pursuant to a collaborative practice protocol directed on a voluntary basis by a patient’s physician with the patient’s informed consent, by the patient’s physician and a pharmacist who has signed a collaborative
practice agreement with the physician.

Question 2

“Collaborative practice” means:

Answer 2

that practice of pharmacy whereby one or more
pharmacists have jointly agreed to work in conjunction with one or more physicians for the purpose of collaborative drug therapy management of patients, consistent with the requirements of this subchapter

Question 3

“Collaborative practice protocol” means:

Answer 3

a written document that identifies the collaborative drug therapy management actions that a pharmacist is authorized to perform for a patient and that is developed jointly by the pharmacist and the physician and meets the requirements outlined in N.J.A.C 13:39-13.5.

Question 4

“Informed consent” means:

Answer 4

the written document that is signed by a patient whereby the patient agrees to collaborative drug therapy management by the patient’s physician and a
pharmacist who has entered into a collaborative practice agreement with the physician.

Question 5

“Therapeutic interchange” means:

Answer 5

the substitution and dispensing of a drug chemically

dissimilar from the prescription drug originally prescribed.

Question 6

In order to enter into an agreement to engage in the collaborative drug therapy management of a patient with a physician licensed in this State, a licensed pharmacist shall be:

Answer 6

be pre-approved by the Board to engage in such activity

Question 7

In order to obtain Board approval, a pharmacist shall submit a collaborative practice application and
documentation that establishes that he or she has successfully completed one of the
following::

Answer 7

1) A certificate training program offered by an American Council of Pharmaceutical
Education-approved provider;
2) A post-graduate residency program accredited by the American Society of HealthSystem Pharmacists; or
3) A certification program from the Board of Pharmacy Specialties.

Question 8

A pharmacist granted authorization to engage in collaborative drug therapy management
pursuant to this section shall:

Answer 8

complete a minimum of 10 credits of continuing education every biennial renewal period in each disease(s) or condition(s) covered by the
collaborative practice agreement(s) to which he or she is a party, consistent with the requirements of N.J.A.C. 13:39-3A. However, to the extent that a pharmacist may enter into collaborative practice agreements to treat patients with co-existing, interrelated
conditions or diseases, a pharmacist need only complete a total of 10 credits in the
interrelated conditions or diseases.

Question 9

A pharmacist who engages in collaborative practice with one or more physicians shall
provide the Board, upon request, with:

Answer 9

a signed copy of a collaborative practice
agreement. The collaborative practice agreement shall be consistent with the example contained in N.J.A.C. 13:39-13 Appendix, which is incorporated herein by reference.

Question 10

The written agreement shall:

Answer 10

1) Identify, by name and title, each physician and each pharmacist who is permitted to participate in a patient’s collaborative drug therapy management, including all
covering physicians and/or pharmacists. Each covering physician shall meet the requirements of N.J.A.C. 13:35-6.27(b) and each covering pharmacist shall meet the requirements of N.J.A.C. 13:39-13.3. The agreement shall establish the means by which the physician and/or pharmacist will be notified about covering practitioners for collaborative practice purposes;
2) Specify the functions and responsibilities, including the scope of practice and authority, to be exercised by the pharmacist;
3) Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies;
4) Indicate any diagnosis or types of diseases that are specifically included or excluded;
5) Include copies of all protocols to be used in the collaborative practice;
6) Contain an effective date for the agreement; and
7) Be signed and dated by the physician(s) and pharmacist(s).

Question 11

Any changes, additions, or deletions to the collaborative practice agreement shall be:

Answer 11

submitted to the Board upon request

Question 12

The pharmacist shall:

Answer 12

cooperate with the method established by the physician for monitoring compliance with the agreement and clinical outcomes of the patients.

Question 13

The collaborative practice agreement may be terminated at any time by either the physician or the pharmacist by written documentation. Upon termination of a collaborative practice agreement, the physician and the pharmacist shall provide:

Answer 13

notice of the termination to each individual patient who is undergoing collaborative drug therapy
management. Upon termination of the agreement, the patient’s informed consent for collaborative drug therapy management under the agreement shall be voided.

Question 14

All records relating to a collaborative practice agreement shall be:

Answer 14

maintained in either hard copy or electronic form for a period of not less than 7 years from the date of
termination of the agreement and shall be supplied to the Board upon request.

Question 15

All records shall be:

Answer 15

made available to persons authorized to inspect them under State and Federal statutes and regulations. The oldest 6 years of information shall be maintained
in such a manner, so as to be retrievable and readable within two weeks. The most recent one year of information shall be retrievable and readable within one business day. Records not currently in use need not be stored in the pharmacy, but the storage
facilities shall be secure. Patient records shall be kept confidential.

Question 16

A collaborative practice protocol shall be:

Answer 16

developed for each different type of collaborative drug therapy management authorized by the physician under the collaborative practice agreement and shall identify those activities that may be performed
by the collaborating pharmacist.

Question 17

Each protocol shall:

Answer 17

1) Be jointly developed by the physician and the pharmacist, consistent with standards and practices that are deemed commonly accepted and recognized by national standard-setting organizations, or national or State professional organizations of the
same discipline as the treating physician, and be signed and dated by both the physician and the pharmacist;
2) Be initiated and utilized at the sole discretion of the physician for a specific patient with whom the physician has a bona fide physician-patient relationship
3) Be agreed to by both the physician and the pharmacist with the written informed
consent of the patient, consistent with the requirements of N.J.A.C. 13:39-13.6;
4) Be available at the practice sites of the pharmacist and physician and made available at each site to the patient;
5) Establish the means by which the patient will be advised of the right to elect to participate in and withdraw from the collaborative drug therapy management;
6) Establish when physician notification is required, the physician chart update interval, and an appropriate time frame within which the pharmacist shall notify the physician of any change in dose, duration, or frequency of medication prescribed. Written
notification, by either facsimile or electronic means, shall be provided to the physician no later than 8 hours after any change in prescribed medication is made by the pharmacist;
7) Identify the method and time frame for notification of the physician if an adverse event occurs; and
8) Be reviewed at least once per year by the parties to determine whether the protocol should be renewed, modified, or terminated.

Question 18

Written informed consent shall be obtained from each individual patient participating in collaborative drug therapy management. Both the physician and the pharmacist shall retain a copy of the patient’s written informed consent. The written informed consent
shall:

Answer 18

1) Contain the specific patient’s name;
2) Identify the risks and benefits of collaborative drug therapy management, including
the fact that services provided under collaborative drug therapy management may not
be covered by the patient’s insurance provider;
3) Identify the fact that covering physicians and/or pharmacists may be utilized in the
collaborative drug therapy management of the patient’s care;
4) Identify the patient’s right to elect to participate in and withdraw from the collaborative drug therapy management; and
5) Be signed and dated by the patient.

Question 19

Collaborative drug therapy management shall be:

Answer 19

between a single patient with whom the physician has a bona fide physician-patient relationship, the physician, and the patient’s collaborative practice pharmacist(s) and shall address that patient’s specific condition, disease or diseases

Question 20

Collaborative drug therapy management may include the:

Answer 20

collecting, analyzing, and monitoring of patient data, ordering or performing of laboratory tests based on the standing orders of a physician as set forth in the written collaborative practice protocols, consistent with (c) below; ordering of clinical tests based on the standing orders of a physician as set forth in the written collaborative practice protocols; modifying,
continuing, or discontinuing drug or device therapy; and therapeutic drug monitoring with appropriate modification to dose, dosage regimen, dosage forms, or route of administration.

Question 21

A pharmacist may:

Answer 21

perform laboratory tests that are granted waived status in accordance with the provisions of the “New Jersey Clinical Laboratory Improvement Act,” P.L. 1975, c. 166 (N.J.S.A. 45:9-42.26 et seq.), Department of Health’s rules set forth at N.J.A.C. 8:44, and Department of Health CLIA Program requirements, available at http://www.state.nj.us/health/phel/instruct116.shtml, provided the tests are consistent with the pharmacy practice area or disease state covered by the collaborative practice agreement.

Question 22

The interpretation of clinical or laboratory tests under a written collaborative practice protocol shall be:

Answer 22

performed by a pharmacist only in direct consultation with a physician.

Question 23

Collaborative drug therapy management shall not:

Answer 23

include a therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the consent of the patient’s physician. Written confirmation of the consent, which may be by electronic means, shall be maintained at the pharmacy practice site of the collaborating
pharmacist.

Question 24

Participation in, or withdrawal from, a collaborative practice agreement shall be:

Answer 24

voluntary on the part of a physician and a pharmacist.

Question 25

Participation in, or withdrawal from, collaborative drug therapy management shall be:

Answer 25

voluntary on the part of the individual patient.

Question 26

Any violation of the collaborative practice agreement or protocols on the part of the pharmacist may be:

Answer 26

deemed professional misconduct and may subject the pharmacist to discipline consistent with N.J.S.A. 45:1-21.