Skip to main navigationSkip to News Headlines
NJ Division of Consumer Affairs
Global Navigation
Division of Consumer Affairs
The State of New Jersey Office of The Attorney General (Dept. of Law & Public Safety) The State of New Jersey NJ Home Services A to Z Departments/Agencies OAG Frequently Asked Questions
OAG Home
OAG Contact
Division of Consumer Affairs Alerts and Recalls
Division of Consumer Affairs Alerts and Recalls
Office of the Attorney General Homepage Division of Consumer Affairs, Director
Division of Consumer Affairs, Director
Division of Alcoholic Beverage Control
Division of Consumer Affairs
Division of Consumer Affairs Highlights
Division of Consumer Affairs Topics in a A-Z List Format
Office of Consumer Protection (OCP)
New Jersey Bureau of Securities
Office of Weights and Measures
Legalized Games of Chance Control Commission
Alternative Dispute Resolution
Professions and Occupations List
Contact the Division of Consumer Affairs
Division of Consumer Affairs in Spanish
Division of Criminal Justice
Division on Civil Rights
Division of Gaming Enforcement
Division of Highway Traffic Safety
Division of Law
Juvenile Justice Commission
NJ Racing Commission
State Athletic Control Board
Division of NJ State Police
Victims of Crime Compensation Office
Subscribe to Buyer Beware Alerts
OPRA - Open Public Records Act

RULE PROPOSALS
VOLUME 44, ISSUE 6
ISSUE DATE: MARCH 19, 2012
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
BOARD OF PHARMACY


Jointly Reproposed New Rules: N.J.A.C. 13:35-6.27 and 13:39-13

        Collaborative Practice
 
Authorized By: William Roeder, Executive Director, State Board of Medical Examiners and Anthony Rubinaccio, Executive Director, Board of Pharmacy.
Authority: N.J.S.A. 45:14-41; 45:14-48a.(4); 45:14-61; and 45:14-62.
 Calendar Reference: See Summary below for explanation of exception to calendar requirement.
 
Proposal Number: PRN 2012-050.
 Submit comments by May 18, 2012 to:
   William Roeder, Executive Director
   Board of Medical Examiners
   140 East Front Street, 2nd Floor
   P.O. Box 183
   Trenton, NJ 08625
 
and to:
   Anthony Rubinaccio, Executive Director
   Board of Pharmacy
   P.O. Box 45013
   Newark, NJ 07101
 
The joint reproposal of the agencies follows:
 
Summary

The State Board of Medical Examiners and the Board of Pharmacy are jointly reproposing new rules that establish standards of practice for physicians and pharmacists who wish to enter into collaborative practice agreements for the management of patients' drug related therapies. The [page=656] Pharmacy Practice Act, at N.J.S.A. 45:14-41, 48a(4) and 61 through 62, authorizes the Boards to jointly promulgate rules that allow licensed physicians and licensed pharmacists in the State to enter into collaborative practice agreements. These written agreements allow participating physicians and pharmacists to engage in collaborative drug therapy management, defined in the Board of Medical Examiners proposed new rule N.J.A.C. 13:35-6.27, and in the Board of Pharmacy proposed new N.J.A.C. 13:39-13.2, as the cooperative management of a patient's drug, biological, and device-related health care needs.

The proposed new rules were originally proposed in the New Jersey Register on November 16, 2009, at 41 N.J.R. 4176(a). During the public comment period on the original notice of proposal, the Boards received numerous comments on the proposed new rules, the majority of which expressed concern regarding the specific training required of pharmacists to participate in collaborative practice agreements under the proposed new rules. In light of the comments received, the Board of Pharmacy published a notice of pre-proposal soliciting input from members of the regulated community concerning the type of training that should be required of pharmacists to ensure that they may effectively engage in collaborative practice. The notice of pre-proposal was published in the New Jersey Register on July 19, 2010, at 42 N.J.R. 1492(a). In response to the notice of pre-proposal, the Board of Pharmacy received numerous comments, both from practicing pharmacists and from academics engaged in the instruction of future pharmacists that provided the Board of Pharmacy with detailed and useful information concerning pharmacist training.

Upon review of the comments from the notice pre-proposal and those received on the original notice of proposal, the Board of Medical Examiners and the Board of Pharmacy are again proposing new rules, with some modifications to the rules as originally proposed, to allow licensed physicians and licensed pharmacists in the State to enter into collaborative practice agreements.

In response to the original notice of proposal, the Boards received comments from the following:

1. Harvey E. Maldow, R.Ph., M.S., Chief Executive Officer, New Jersey Pharmacists Association;

2. Nicole Henry-Dindial, M.D., President, Union County Medical Society of New Jersey;

3. Scott Mylroie, R.Ph, C.C.P., Joint Board of Consultant Pharmacists;

4. Maria Troncone Leibfried, R.Ph., B.S., Pharm.D, B.C.N.S.P., C.C.P.;

5. Mark Nemhauser, R.Ph., New Jersey Pharmacists Association, National Community Pharmacists Association;

6. Carrie E. Corboy, R.Ph., Pharm.D., C.C.P.;

7. Jinu Andrews, Pharm.D., Clinical Coordinator, Pharmacy, AtlantiCare Regional Medical Center;

8. Francis J. Rodriguez;

9. Paul Rasa, R.Ph., C.C.P., F.A.S.C.P., The Rasa Group;

10. Stephen Brandt, R.Ph., Executive Director, Garden State Pharmacy Owners;

11. Penny Applegate, R.Ph., B.S., C.C.P., A.S.C.P., N.J.A.Ph.A, New Jersey Academy of Consultant Pharmacists;

12. Grace R. Schuyler, Esq., Director, Government Affairs, Rite Aid;

13. Thomas E. Menighan, B.S.Pharm., M.B.A., F.A.Ph.A, Executive Vice President and Chief Executive Officer, American Pharmacists Association;

14. Dana Bland;

15. Lawrence Downs, General Counsel, Medical Society of New Jersey;

16. Robert Adamson, Pharm.D., Director of Public Policy, New Jersey Society of Health System Pharmacists; Corporate Vice President of Clinical Pharmacy Services, Saint Barnabas Health Care System;

17. Debra L. Wentz, Ph.D., Chief Executive Officer, New Jersey Association of Mental Health Agencies, Inc.;

18. Christie R. Boutte, R.Ph., Director, Public Policy, National Association of Chain Drug Stores;

19. Alan Aronovitz; and

20. Gaurav Gangoli, Ernest Mario School of Pharmacy, Rutgers University.

1. COMMENT: Numerous commenters expressed concern about the pharmacist qualifications set forth in N.J.A.C. 13:39-13.3, noting that the rule appears to require pharmacists to meet all the requirements set forth in paragraphs (a)1 through 4 in order to be able to participate in collaborative practice arrangements with physicians. Other commenters objected to the provision in N.J.A.C. 13:39-13.3(a), which would permit a pharmacist with a Doctor of Pharmacy degree to participate in a collaborative practice agreement without added training, but would require a pharmacist with a Bachelor of Science degree to meet the three criteria set out in paragraphs (a)2, 3, and 4 in order to participate in such arrangements. The commenters note that this distinction unfairly discriminates against pharmacists who they believe have the requisite experience, earned through years of practice, to provide quality patient care under a collaborative practice arrangement. Numerous commenters noted that there should be no differentiation in a licensed pharmacist's ability to practice based on the type of degree he or she holds. Other commenters noted that additional training should be required of all pharmacists, irrespective of the degree held, in order to participate in a collaborative practice arrangement. Others, however, noted that no additional training should be required because licensed pharmacists are trained to provide drug therapy management services and routinely provide such services in their day-to-day activities.

Several commenters believe that the new rule's requirements concerning the credentialing or certification pathways for pharmacists to qualify for participation in a collaborative practice arrangement are overly burdensome and too restrictive. Some of the commenters recommended that the Boards amend the new rule to permit a pharmacist to obtain training that is non-disease specific in order to qualify for this type of practice. Other commenters expressed concern about the provision in the new rule permitting a pharmacist to qualify for participation in a collaborative practice arrangement by completing 2,000 hours of experience, noting that the 2,000 hours could be difficult to verify or could be insufficient to properly prepare a pharmacist for the work he or she would undertake as part of a collaborative arrangement with a physician. Other commenters requested that the Boards permit pharmacists to qualify under the new rule by completing various certificate training programs.

RESPONSE: The Board of Pharmacy notes that, as originally proposed, N.J.A.C. 13:39-13.3(a) would permit pharmacists to qualify for collaborative practice privileges by four different pathways. It was never the Board's intention to require a pharmacist to meet the requirements of more than one of the listed pathways in order to participate in a collaborative practice arrangement. The Board is aware that the omission of the conjunctive "or" between each of the four paragraphs in subsection (a) has led to some confusion, but notes that the rule text, as originally proposed, conforms to the codification standards of the New Jersey Administrative Code, and correctly provides that a pharmacist must satisfy one of the four pathways to qualify for this privilege, by containing the conjunctive "or" between the third and fourth paragraphs. However, following a review of the commenters' concerns and the information submitted in response to the notice of pre-proposal, the Board believes that the proposed rule's distinction in scope of practice based on the type of pharmacy degree held by the licensed pharmacist is not warranted. The Board does not believe that possession of a Doctor of Pharmacy degree alone, as provided for in paragraph (a)1 of the original notice of proposal, will adequately prepare a pharmacist to participate in a collaborative practice arrangement. In addition, the Board believes that the certification and credentialing criteria outlined in paragraphs (a)2 and 3 of the original notice of proposal do not adequately capture the type of additional training that the Board believes is necessary to prepare pharmacists to undertake this task. Moreover, the Board is concerned that the fourth pathway, set out in paragraph (a)4 of the original notice of proposal, of 2,000 hours of experience obtained over a two-year period, may be difficult to track given the inherent differences in pharmacy practice settings, and may create confusion.

Therefore, the Board has changed proposed new N.J.A.C. 13:39-13.3(a) on reproposal to provide three distinct pathways for a pharmacist to qualify for approval to participate in a collaborative practice arrangement. A licensed pharmacist, irrespective of the degree that he or she holds, may qualify for Board approval by completing one of the [page=657] following: a certificate training program offered by an American Council of Pharmaceutical Education approved provider; a post-graduate residency program accredited by the American Society of Health-System Pharmacists; or a certification program from the Board of Pharmacy Specialties. The Board believes that each of these three, distinct pathways will provide pharmacists with a thorough and comprehensive foundation to collaboratively provide quality health care services to patients. The Board notes, however, that nothing in the reproposed new rule would preclude a collaborating physician from requiring a pharmacist to obtain additional training beyond that which is provided for in the new rule. Such additional training could be mandated in the individual collaborative practice agreement between the physician and the pharmacist.

The Board notes that in light of the changes that it is proposing to the pharmacist qualification requirements in proposed new N.J.A.C. 13:39-13.3, it has deleted the definitions for the terms "certification" and "credentialing" in proposed new N.J.A.C. 13:39-13.2 on reproposal, as those definitions are no longer necessary.

2. COMMENT: Several commenters expressed support for the new rules believing that they will have a positive impact on patient care.

RESPONSE: The Boards thank the commenters for their support of the originally proposed new rules and believe that the reproposed new rules will likewise have a positive impact upon patient care.

3. COMMENT: Several commenters objected to the physician notification requirement in proposed new N.J.A.C. 13:39-13.5(b)6. The commenters believe that requiring the collaborating physician to be notified within eight hours after a change in prescribed medication is made by the pharmacist is unreasonable. Several commenters noted that a more realistic period for physician notification of such changes would be 24 hours.

RESPONSE: The Board of Pharmacy and the Board of Medical Examiners disagree with the commenters' assertions that requiring written notification be made to the physician within eight hours of a medication change is burdensome. The Boards believe that an eight-hour notification window is reasonable and will help to ensure patient safety. The Boards note, however, that a physician could require notification in less than eight hours if he or she believes that is more appropriate, pursuant to the individual collaborative practice agreement he or she executes with a pharmacist.

4. COMMENT: Several commenters objected to the limitations set forth in N.J.A.C. 13:39-13.7(c), concerning the types of laboratory tests that may be performed by a pharmacist operating under a collaborative practice agreement. The commenters note that the rule's restrictions may delay potentially critical modifications in therapy. The commenters note that a significant number of tests are granted waived status under the Clinical Laboratory Improvement Act (CLIA) and that pharmacists should be permitted to perform such tests under the new rules. The commenters recommend that the rule be amended to delete the specific tests that pharmacists may perform in order to avoid having to amend the rule each time new tests are added to the list of tests granted CLIA waived status. Other commenters suggested that the rule be amended to include other specific tests such as bedside coagulation checks. One commenter suggested that the rule be further amended to clarify that the rule applies only to the tests that pharmacists can perform, rather than order.

RESPONSE: N.J.A.C. 13:39-13.7(c) concerns those tests that may be performed by a pharmacist under a collaborative practice agreement with a physician. The Board of Pharmacy agrees with the commenters' assertion that the list of tests included in new N.J.A.C. 13:39-13.7(c), as originally proposed, may be overly restrictive. The Board has reexamined this issue and believes that such restrictions may work to impede the effective operation of collaborative drug therapy management. The Board notes that the statutory definition of "collaborative drug therapy management" contained in N.J.S.A. 45:14-41 includes the ordering and performing of laboratory tests that are granted waived status in accordance with the provisions of the New Jersey Clinical Laboratory Improvement Act (CLIA). The Board, however, believes that a pharmacist's ability to perform laboratory tests granted CLIA waived status must be guided by the parameters of the specific collaborative practice agreement under which he or she operates. Therefore, on reproposal, N.J.A.C. 13:39-13.7(c) provides that a pharmacist may perform those laboratory tests that are granted waived status under the New Jersey CLIA Act and New Jersey Department of Health and Senior Services' requirements, provided the tests are consistent with the pharmacy practice area or disease state covered by the collaborative practice agreement. This change is also reflected in amendments to the Board of Medical Examiners reproposed rule N.J.A.C. 13:35-6.27(k). The Boards note, however, that a physician may modify this requirement even further by delineating which tests, if any, he or she will authorize a pharmacist to perform under protocols of a specific collaborative practice agreement.

5. COMMENT: One commenter noted that the proposed new rules do not include a requirement for electronic recordkeeping. The commenter believes that collaborative practice agreements and related documents should be included in the Board of Pharmacy's electronic storage requirements.

RESPONSE: N.J.A.C. 13:39-13.4(e), as originally proposed and as reproposed, provides that all records relating to a collaborative practice agreement shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of termination of the agreement. The oldest six years of information must be maintained in such a manner so as to be retrievable and readable within two weeks. The most recent one year of information must be retrievable and readable within one business day.

6. COMMENT: One commenter objected to the proposed new rules, believing they will undermine patient safety. The commenter noted that changes in medication should not be an arbitrary decision and notes that physicians have significantly more training than pharmacists. The commenter believes that the documentation requirements under the new rules will overly burden physicians. The commenter asked who would be liable if a pharmacist notifies a physician within eight hours of a medication change, but the physician does not see the change for 24 hours. The commenter inquired whether the Board of Medical Examiners and the Board of Pharmacy would maintain a list of pharmacists certified by practice specialty. The commenter inquired as to how a physician would know that a pharmacist is properly trained. The commenter also inquired whether the pharmacist has to be within a certain geographic location of the physician and the patient. The commenter also expressed concern that sharing patient records with the pharmacist could result in HIPAA violations because all employees of the pharmacy would have access to the records. The commenter also noted that insurance companies will not cover the costs of tests that are not ordered by physicians, a fact that may be unknown to many patients.

RESPONSE: The Board of Medical Examiners and the Board of Pharmacy disagree with the commenter's assertion that the proposed new rules undermine patient safety. The Boards believe that collaborative drug therapy management instituted pursuant to written practice protocols jointly developed by the physician and the pharmacist will help manage patients' medication-related problems and further patients' well being. The parameters under which a change in medication may be made will be established by the collaborative practice protocols and can be individualized based on the needs of the physician and his or her patients. The Boards believe that when such changes occur, it is reasonable for a pharmacist to provide notification to the physician within eight hours. A physician entering into a collaborative practice agreement with a pharmacist, which is voluntary on the part of both health care providers, must assume responsibility for keeping abreast of medication changes when notification is provided as outlined in the rule or as otherwise required under a particular collaborative practice agreement.

A pharmacist who meets the requirements of the new rules will be provided with authorization from the Board of Pharmacy to engage in collaborative practice. Such authorization may be provided to a physician as evidence of a pharmacist's qualifications. The Boards note that should a physician have a question with respect to the qualifications of a particular pharmacist, he or she may contact the Board of Pharmacy for information. The Boards reiterate, however, that the decision by a physician and a pharmacist to enter into a collaborative practice agreement is a voluntary one. Both the physician and the pharmacist must jointly agree to the parameters of the agreement. The new rules, as originally proposed and as reproposed, do not impose any requirement [page=658] with respect to the geographic location of the pharmacist. The Boards believe that a physician entering into a collaborative practice agreement with a pharmacist for the benefit of the physician's patients would endeavor to ensure that the pharmacist is geographically close to the patients.

Proposed new N.J.A.C. 13:39-13.4(e) requires all patient information accessed under a collaborative practice agreement to be kept confidential. Pharmacies, as health care providers under the Federal Health Insurance Portability and Accountability Act of 1996, are required to comply with the law's privacy protection requirements.

Proposed new N.J.A.C. 13:39-13.6 requires informed written consent to be obtained from each individual patient participating in collaborative drug therapy management. The written informed consent must identify the fact that services provided under collaborative drug therapy management may not be covered by a patient's insurance.

7. COMMENT: Several commenters noted that N.J.A.C. 13:35-6.27(j) and 13:39-13.7(b) provide that collaborative drug therapy management may include modifying, continuing, or discontinuing drug or device therapy. The commenters believe that the rules should be amended to permit pharmacists to also initiate drug therapy under a collaborative practice agreement.

RESPONSE: The commenter's suggested change would be inconsistent with the express statutory requirements of N.J.S.A. 45:14-41. The definition of "collaborative drug therapy management" in N.J.S.A. 45:14-41 does not permit a pharmacist to initiate drug or device therapy. Rather, the act only permits a pharmacist engaging in collaborative drug therapy management to modify, continue, or discontinue drug or device therapy. The Boards, therefore, are precluded from changing the rules as suggested by the commenters.

8. COMMENT: Several commenters recommended that proposed new N.J.A.C. 13:35-6.27(l) and 13:39-13.7(d), which provide that the interpretation of clinical or laboratory tests under a written collaborative practice agreement shall be performed by a pharmacist only in direct consultation with a physician, be amended to remove the interpretation of laboratory tests from the rules' ambit. The commenters believe that whether pharmacists may interpret laboratory tests should be established in the collaborative practice agreement and protocols developed by the physician and pharmacist.

RESPONSE: The amendments suggested by the commenters would be inconsistent with the express statutory requirements of N.J.S.A. 45:14-41. The definition of "collaborative drug therapy management" in N.J.S.A. 45:14-41 expressly provides that the interpretation of clinical or laboratory tests may be performed by a pharmacist only in direct consultation with a physician. The Boards, therefore, are precluded from changing the rules as suggested by the commenters.

9. COMMENT: One commenter requested clarification with respect to the requirement in proposed new N.J.A.C. 13:35-6.27(f)8 and 13:39-13.5(b)8 that collaborative practice protocols be reviewed annually by the physician and the pharmacist. The commenter inquired how such review is to be documented and whether re-execution of the agreement would be necessary. The commenter also asked who is accountable for obtaining the patient's informed consent under the proposed new rules. The commenter noted that examples of the "risks and benefits" of collaborative drug therapy management, which must be delineated in the informed consent document, would be helpful because it is unclear what the risks of such an agreement would be. The commenter also inquired whether the patient should be given a copy of the collaborative practice agreement and the collaborative practice protocols.

RESPONSE: The Boards believe that physicians and pharmacists working under a collaborative practice agreement may determine the type of annual review necessary, and how such review is to be documented, for purposes of complying with the rule. Proposed new N.J.A.C. 13:35-6.27(g) and 13:39-13.6 impose an obligation on both the physician and the pharmacist working under a collaborative practice agreement to obtain the patient's informed consent. The Boards believe that physicians and pharmacists agreeing to collectively manage an individual patient's drug therapy needs are in the best position to know the particular risks and benefits implicated by the provision of such care for that particular patient and, therefore, decline to change the rules to provide examples of risks and benefits. Moreover, the Boards do not believe that it is necessary for physicians and pharmacists to automatically provide copies of the executed collaborative practice agreement and protocols to patients. Physicians and pharmacists are required to maintain copies of collaborative practice protocols at their respective practice sites and to make these documents available to patients upon request under the requirements of proposed new N.J.A.C. 13:35-6.27(f)4 and 13:39-13.5(b)4.

10. COMMENT: One commenter believes that proposed new N.J.A.C. 13:35-6.27(f)7 and 13:39-13.5(b)7, which require collaborative practice protocols to identify the method and time frame for notification of the physician if an adverse event occurs, should be amended to require reporting to the Federal Food and Drug Administration's MedWatch program and/or to the product's manufacturer.

RESPONSE: The Boards' intent in proposing N.J.A.C. 13:35-6.27(f)7 and 13:39-13.5(b)7, is to ensure that physicians and pharmacists agree, in advance of providing joint drug therapy management to a patient, how and when the physician is to be notified of adverse events. The Boards believe that requirements with respect to physician and pharmacist notification to the FDA are outside of the scope of the proposed new rules, which establish the criteria for, and the permissible parameters of, collaborative practice agreements between physicians and pharmacists.

11. COMMENT: One commenter stated that the requirement in N.J.A.C. 13:39-13.3(c), concerning the mandatory 10 credits of continuing education, could cause licensees to exceed the current 30-credit requirement for license renewal. One commenter inquired whether the 10 credits would be in addition to the 30 credits required of all licensees for biennial license renewal.

RESPONSE: New N.J.A.C. 13:39-13.3(c), as originally proposed and as reproposed, provides that a pharmacist granted authorization to engage in collaborative drug therapy management under a collaborative practice agreement must complete a minimum of 10 credits of continuing education every biennial renewal period in the area covered by the collaborative practice agreement. These 10 credits must be taken consistent with the requirements of N.J.A.C. 13:39-3A. Therefore, the 10 credits are included within the 30 credits required of all licensees under N.J.A.C. 13:39-3A.1.

12. COMMENT: One commenter questioned whether N.J.A.C. 13:39-13.4(a) should be amended to require documentation of the Board of Pharmacy's authorization to engage in collaborative practice to be included in the written collaborative practice agreement.

RESPONSE: The Board of Pharmacy does not believe that the commenter's suggested change is necessary. The Board believes that a physician would verify that the pharmacist has obtained Board of Pharmacy authorization prior to entering into a collaborative practice agreement with the pharmacist. The Board notes, however, that nothing in the rule would preclude a physician from requiring a copy of the pharmacist's authorization to be included or otherwise referenced in the collaborative practice agreement.

13. COMMENT: One commenter inquired whether the requirements in N.J.A.C. 13:39-13.7(e) would apply to therapy changes that involve over-the-counter products.

RESPONSE: Proposed new N.J.A.C. 13:39-13.7(e) provides that collaborative drug therapy management does not include therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the patient's physician. The Board of Pharmacy notes that the proposed rule's requirement is based on the express language in N.J.S.A. 45:14-62. The Board also notes that the Pharmacy Practice Act defines "therapeutic interchange" in N.J.S.A. 45:14-41 to mean the substitution and dispensing of a drug chemically dissimilar from the prescription drug originally prescribed. The requirements in N.J.A.C. 13:39-13.7(e), therefore, would not apply to changes that involve over-the-counter products.

14. COMMENT: One commenter inquired whether a pharmacist would have the ability under the proposed new rules to order different laboratory tests and to adjust medication doses based on the results of such tests. The commenter inquired whether the new rules authorize pharmacists to interpret both clinical and laboratory tests and whether the rules would permit a pharmacist to interpret a patient's vital signs. The commenter noted that it may not always be possible for a pharmacist to have direct consultation with the physician. The commenter believes that [page=659] a pharmacist should be permitted to adjust medication dosages for most patients, and only consult with the physician in complicated cases.

RESPONSE: Proposed new N.J.A.C. 13:39-13.7 provides, consistent with the statutory definition of "collaborative drug therapy management" contained in N.J.S.A. 45:14-41, that pharmacists may order and perform laboratory tests that are granted waived status in accordance with the provisions of the New Jersey Clinical Laboratory Improvement Act (CLIA). As noted in the Response to Comment 4 above, the Board of Pharmacy is changing the rule on reproposal to clarify that a pharmacist may perform those laboratory tests that are granted waived status under the New Jersey CLIA Act and Department of Health and Senior Services' requirements, provided the tests are consistent with the pharmacy practice area or disease state covered by the collaborative practice agreement. In addition, N.J.A.C. 13:39-13.7(b) permits a pharmacist to order clinical tests and to engage in therapeutic drug monitoring with appropriate modifications to dose, dosage regimen, dosage forms, or route of administration. A pharmacist's authority with respect to therapeutic interchange, however, is limited by the provisions of N.J.A.C. 13:39-13.7(e). Subsection (e) provides, consistent with the statutory requirements of N.J.S.A. 45:14-62, that therapeutic interchange at the time of dispensing is prohibited without the prior, specific informed consent of the patient and the patient's physician. The Board also notes that with respect to a pharmacist's ability to interpret clinical or laboratory results, N.J.A.C. 13:39-13.7(d) expressly provides, consistent with the definition of "collaborative drug therapy management" in N.J.S.A. 45:14-41, that the interpretation of clinical or laboratory tests may be performed by a pharmacist only in direct consultation with a physician. A pharmacist is required to consult with the physician pursuant to the schedule established under the collaborative practice protocol, except that written notification must be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist under N.J.A.C. 13:39-13.5(a)6.

15. COMMENT: Two commenters objected to the language in the original notice of proposal Summary, which provides that collaborative drug therapy management allows pharmacists to work with physicians to solve a patient's medication-related problems. The commenters recommend deleting the word "solve" and replacing it with the phrase "identify and manage."

RESPONSE: The Board of Medical Examiners and the Board of Pharmacy appreciate the commenters' concern and believe that the suggested language more accurately reflects the pharmacist's role in collaborative drug therapy management. Although the statements that accompany the notice of proposal, such as the Summary, are not binding and serve only to explain the requirements of rule text, the Boards have adjusted the language in the Summary on reproposal to ensure that the referenced statement more accurately reflects the Boards' understanding of the pharmacist's role in managing a patient's medication-related problems.

16. COMMENT: One commenter expressed concern that the proposed new rules would have the unintended effect of limiting the scope of services that can be provided by licensed pharmacists in New Jersey by confusing medication therapy management with collaborative drug therapy management. The commenter believes that if medication therapy management is included within collaborative drug therapy management, pharmacists will be precluded from providing medication therapy management outside of a collaborative practice agreement. The commenter also recommends that all references in the proposed new rules to the services that can be provided through collaborative drug therapy management be amended to refer to a patient's drug, biological, and device-related health care needs for clarity.

RESPONSE: The Board of Pharmacy does not believe that the proposed new rules will create confusion with respect to a pharmacist's ability to engage in medication therapy management if not engaged in a collaborative practice agreement with a physician. The "practice of pharmacy" as defined in N.J.S.A. 45:14-41 includes "managing and monitoring drug therapy." This function is separate and distinct from collaborative drug therapy management, which is also included within the "practice of pharmacy" definition in N.J.S.A. 45:14-14, but which expressly requires the existence of written guidelines or protocols with a licensed physician. Therefore, a pharmacist may practice medication therapy management without having to enter into a collaborative practice agreement with a physician. The Board declines to change the references to the types of services that can be provided as part of a collaborative practice agreement as suggested by the commenter because the Board believes the existing references are clear and unambiguous.

17. COMMENT: One commenter noted that the required disclosure that a pharmacist must provide to patients under N.J.A.C. 13:39-13.6(a)2, advising the patient that services provided under collaborative drug therapy management may not be covered by the patient's insurance provider, may discourage patients from agreeing to participate in the collaborative management of their care. The commenter recommends that the Board discuss the proposed new rules with other State agencies, pharmacy benefits managers, and health care insurers to determine how collaborative practice services can be delivered in a manner that optimizes insurance coverage for the patient, the physician, and the pharmacist. One commenter recommended that the Board of Medical Examiners and the Board of Pharmacy be proactive in helping to ensure that insurance companies permit reimbursement for services provided under a collaborative practice agreement.

RESPONSE: The Boards believe that patients must be advised, prior to agreeing to the management of their care under the protocols of a collaborative practice agreement, about the possibility that such services may not be covered by the patient's insurance provider. The informed consent requirements in proposed new N.J.A.C. 13:35-6.27(g) and 13:39-13.6 are necessary to ensure that patients are presented with this relevant piece of information so that they may make reasoned and informed decisions about their treatment options. The purpose of the proposed new rules is to establish the criteria for, and permissible parameters of, collaborative practice arrangements between physicians and pharmacists. Questions with respect to whether such services will be, or should be, covered by insurance providers are outside of the scope of the Boards' rulemaking authority.

18. COMMENT: One commenter expressed concern over the definition of "credentialing" in N.J.A.C. 13:39-13.2, which limits the awarding of these certificates to academic institutions. The commenter recommends that the definition be amended in order to permit non-governmental agency or association-awarded certificates to qualify a pharmacist for approval to participate in collaborative practice under N.J.A.C. 13:39-13.3.

RESPONSE: The definition of "credentialing" has been deleted from reproposed new N.J.A.C. 13:39-13.2 because the Board of Pharmacy has amended the pathways that may be utilized by pharmacists to obtain approval to participate in collaborative practice with a physician. As reproposed, N.J.A.C. 13:39-13.3 provides that a licensed pharmacist may qualify for Board approval by completing one of the following: a certificate training program offered by an American Council of Pharmaceutical Education (ACPE) approved provider; a post-graduate residency program accredited by the American Society of Health-System Pharmacists (ASHP); or a certification program from the Board of Pharmacy Specialties (BPS).

19. COMMENT: One commenter recommended that the Board amend N.J.A.C. 13:39-13.7(e) to permit a pharmacist to execute a therapeutic interchange upon verbal approval from the physician. The commenter notes that the verbal confirmation could be subsequently documented in the patient record.

RESPONSE: Consistent with current retail pharmacy practice, a physician may determine to make a therapeutic interchange for a particular patient by a verbal authorization to a pharmacist, which is then transcribed by the pharmacist as a new prescription. The proposed new rule is not intended to alter such practice. However, verbal approval from the physician without the subsequent generation of a new prescription for the therapeutic interchange, the Board of Pharmacy believes, would be inconsistent with the express requirements of N.J.S.A. 45:14-62. The act provides that no collaborative drug therapy management shall include therapeutic interchange at the time of dispensing without the prior consent of the patient and the patient's physician, and that written confirmation of this prior consent must be obtained. The Board, therefore, declines to change the rule as suggested by the commenter.

20. COMMENT: One commenter recommended that the jointly proposed new rules be amended to further underscore the importance of [page=660] coordinated care, not only for a patient's single illness, but also for co-occurring disorders.

RESPONSE: Proposed new N.J.A.C. 13:35-6.27(f) and 13:39-13.5 require the physician and the pharmacist to develop collaborative practice protocols that will identify those activities that may be performed by the pharmacist managing a patient's drug therapy under a collaborative practice agreement. Such protocols may specify, if deemed appropriate by the physician, the management of a patient's co-occurring disorders. The Boards, therefore, do not believe that the change suggested by the commenter is necessary.

21. COMMENT: One commenter objected to the requirement imposed under N.J.A.C. 13:39-13.4(e) that pharmacists maintain collaborative practice agreement records for at least seven years, noting that this requirement is inconsistent with existing Board of Pharmacy rules, which require pharmacists to maintain pharmacy records for five years. The commenter recommends that the rule be amended to require such records to be maintained for five years.

RESPONSE: Physicians are required to maintain collaborative practice records for seven years under proposed new N.J.A.C. 13:35-6.27(p), consistent with requirements imposed by the Board of Medical Examiners under its other recordkeeping rules. In order to ensure consistency between the jointly proposed new rules, the Board of Pharmacy believes that it is reasonable to require pharmacists to maintain records relating to the pharmacist's collaborative practice with the physician for the same seven-year period. The Board does not believe that requiring participating pharmacists to maintain such records for an additional two years is overly burdensome. Therefore, the Board declines to change the recordkeeping requirements in N.J.A.C. 13:39-13.4(e) on reproposal as suggested by the commenter.

22. COMMENT: One commenter noted that the proposed new rules are unclear with respect to the regularity with which the patient must be examined by the collaborating physician subsequent to the initiation of a collaborative practice agreement, or that the collaborating physician must have a bona fide relationship with the patient prior to the referral to the pharmacist. In order to ensure that collaborative practice functions as a means to better patient care, and not as a means to reap financial benefit, the commenter urges the Board of Medical Examiners to require that the initiating physician demonstrate a bona fide provider/patient relationship prior to the commencement of collaborative drug therapy management, that the relationship be one of on-going treatment for the specified disease(s), and that there be no business or financial relationship between the collaborating physician and the pharmacist at any point during the collaboration or for a reasonable period of time prior to its initiation.

RESPONSE: The Board of Medical Examiners believes that an underlying physician-patient relationship is a necessary component of collaborative drug therapy management, and that professional practice standards dictate that a physician must have an existing, on-going relationship with a patient prior to the initiation of collaborative drug therapy management for that patient. In order to eliminate any confusion that may exist with respect to this issue, however, the Board of Medical Examiners has changed N.J.A.C. 13:35-6.27 on reproposal to provide that collaborative drug therapy management may be initiated by a physician only for a patient with whom the physician has a bona fide physician-patient relationship. This change is reflected specifically in N.J.A.C. 13:35-6.27(f)2 and (i), and is also reflected in changes to the Board of Pharmacy's reproposed rules N.J.A.C. 13:39-13.5(b)2 and 13.7(a). A "bona fide physician-patient relationship" is defined in reproposed new N.J.A.C. 13:35-6.27(a) to mean a relationship in which the physician has ongoing responsibility for assessment, care, and treatment of the patient's medical condition for which collaborative drug therapy management is utilized. "Ongoing responsibility" means that the physician-patient relationship has existed for at least one year; that the physician has seen and/or assessed the patient on at least four visits; or that the physician assumes responsibility for providing management and care of the patient's condition after conducting a comprehensive medical history and physical examination.

The Board of Medical Examiners does not believe that additional changes to proposed new N.J.A.C. 13:35-6.27 are necessary to address the commenter's concern regarding an underlying business or financial relationship between the collaborating physician and the pharmacist. Existing N.J.A.C. 13:35-6.17 establishes standards concerning a physician's payment or receipt of professional fees and investments, and prohibits the payment or receipt of kickbacks. In addition, the Board of Pharmacy notes that existing N.J.A.C. 13:39-3.10 and 4.17 preclude pharmacists and pharmacies from entering into arrangements with health care practitioners for the purpose of steering patients to or from a specified pharmacy.

23. COMMENT: One commenter recommended that the Boards amend the proposed new rules to clarify that all covering pharmacists and physicians must be "individuals" who meet the requirements in N.J.A.C. 13:35-6.27(b) and 13:39-13.1 and 13.3, in order to protect against the possibility that chain drug stores will employ one or two physicians to serve as collaborating physicians for all the chain's pharmacists, a result which the commenter believes could endanger patients.

RESPONSE: Consistent with the express requirements of the statutory definition of collaborative drug therapy management in N.J.S.A. 45:14-41 and the requirements of N.J.S.A. 45:14-62, the proposed new rules require collaborative drug therapy management to be between an individual physician, his or her patient, and an individual pharmacist. The proposed new rules, however, contemplate that covering physicians and pharmacists may participate in collaborative drug therapy management given the nature of current healthcare practices. The Boards note that N.J.S.A. 45:14-61.b. of the Pharmacy Practice Act acknowledges this reality by authorizing other physicians and pharmacists to participate in a patient's collaborative drug therapy management, by requiring identification of "each physician" and "each pharmacist" permitted to participate under the agreement. Proposed new rules N.J.A.C. 13:35-6.27(c)1 and 13:39-13.4(a)1 require all collaborative practice agreements to identify the name and title of each physician and each pharmacist who will be permitted to participate in the patient's collaborative drug therapy management. The Boards believe that the rules clearly require that covering physicians and pharmacists under the agreement be individual physicians and individual pharmacists. The Boards, however, agree with the commenter that clarification to the rules are necessary to ensure that all such covering physicians and pharmacists meet the threshold requirements for participation in collaborative practice set out in the new rules. Therefore, as reproposed, N.J.A.C. 13:35-6.27(c)1 and 13:39-13.4(a)1 provide that each covering physician and each covering pharmacist listed in the collaborative practice agreement must meet the requirements in N.J.A.C. 13:35-6.27(b) and 13:39-13.3, respectively, in order to participate.

24. COMMENT: One commenter noted that the notice of proposal refers to "chronic diseases," and although the authorizing statute called for the Boards to identify disease states for which authorized laboratory tests may be performed, the proposed new rules are silent with respect to disease states that are appropriate for collaborative drug therapy management. The commenter believes that if the statute calls for the identification of appropriate diseases prior to permitting certain tests to be included in collaborative drug therapy management, then the proposed new rules should specify those diseases.

RESPONSE: The purpose of collaborative practice between physicians and pharmacists and, therefore, the purpose of the proposed new rules, is to maximize patient treatment options. The Boards believe that the identification in the new rules of specific disease states subject to management under collaborative practice arrangements would not further patient care in light of the rapidly evolving nature of disease treatment and management, and pharmacist training. The Boards believe that any limitations as to the disease states that may be collaboratively managed by a physician and a pharmacist will result, in practice, from the type of training currently available for pharmacists and by the specific parameters established by an individual physician as part of the collaborative practice agreement he or she executes with an individual pharmacist.

The following is a summary of new rules which the Boards are reproposing at this time. N.J.A.C. 13:35-6.27(a) and 13:39-13.2 set forth definitions for relevant terms used throughout the reproposed new rules. Reproposed new N.J.A.C. 13:35-6.27(b) and 13:39-13.1 provide that a physician may enter into a collaborative practice agreement with a pharmacist, provided the collaboration that the physician agrees to conduct with the pharmacist is within the scope of the physician's [page=661] practice and the pharmacist is authorized to engage in such activities by the Board of Pharmacy. Board of Pharmacy reproposed new N.J.A.C. 13:39-13.3 requires a pharmacist wishing to participate in a collaborative practice agreement to be pre-approved by the Board of Pharmacy to engage in such activities. In order to obtain Board approval, a pharmacist must submit a collaborative practice application and documentation that establishes that he or she has completed one of the following: a certificate training program offered by an American Council of Pharmaceutical Education-approved provider; a post-graduate residency program accredited by the American Society of Health-System Pharmacists; or a certification program from the Board of Pharmacy Specialties. A pharmacist approved to engage in collaborative drug therapy management must complete a minimum of 10 credits of continuing education every biennial renewal period in the practice area covered by the collaborative practice agreement.

A physician and pharmacist who engage in collaborative practice must submit a signed copy of the agreement upon request to their respective Boards, pursuant to reproposed new N.J.A.C. 13:35-6.27(c) and 13:39-13.4. The signed agreement must, at a minimum, identify each physician and each pharmacist who is permitted to participate in a patient's collaborative drug therapy management, and the functions and responsibilities that may be performed by the pharmacist under the agreement. A sample collaborative practice agreement is proposed to be included as part of both the Board of Medical Examiners and the Board of Pharmacy rules as an appendix to the rules, to provide guidance to physicians and pharmacists as to what information should be included in these agreements. All collaborative practice agreements must be consistent with the sample agreements contained in the Boards' appendices.

Reproposed new N.J.A.C. 13:35-6.27(d) and (e) and 13:39-13.4(b) and (c) require that any changes, additions, or deletions to the agreements must be submitted to a licensee's respective Board upon request, and that a physician establish a method for monitoring compliance with the collaborative practice agreement and the clinical outcomes of the patients.

Reproposed new N.J.A.C. 13:35-6.27(f) and 13:39-13.5 provide that physicians and pharmacists must jointly create collaborative practice protocols for each type of collaborative drug therapy management authorized by the physician under the agreement. These protocols must be consistent with commonly accepted medical standards and practices and must be submitted for review to the Board of Medical Examiners and the Board of Pharmacy upon request. Protocols must be signed and dated by both the physician and the pharmacist. The reproposed new rules provide that the protocols are to be initiated and utilized at the sole discretion of the physician for a specific patient. The protocols must specify when physician notification is required, the physician chart update interval and an appropriate time frame within which the pharmacist must notify the physician of any change in dose, duration, or frequency of medication prescribed. In addition, the protocol must establish requirements concerning physician notification of any adverse event. Copies of the protocols must be available at both the physician and pharmacist practice sites and must be reviewed annually by the physician and the pharmacist.

Reproposed new N.J.A.C. 13:35-6.27(g) and 13:39-13.6 require physicians and pharmacists to obtain a patient's informed consent prior to collaboratively managing the patient's care. The written informed consent document, which must be signed by the patient, must clearly identify the risks and benefits of collaborative drug therapy management. The document must also provide notice to the patient that covering physicians and/or pharmacists may be used in the management of the patient's care and that certain services provided to the patient under collaborative management may not be covered by the patient's insurance.

A collaborative practice agreement may be terminated at any time by either the physician or the pharmacist under reproposed new N.J.A.C. 13:35-6.27(h) and 13:39-13.4(d). The termination must be in writing and all patients who are undergoing collaborative drug therapy management under the agreement must be notified of the termination.

Reproposed new N.J.A.C. 13:35-6.27(i) and (j) and 13:39-13.7(a) and (b) provide that collaborative drug therapy management must address an individual patient's specific condition or disease and specify the functions a pharmacist may perform, which may include the following: collecting, analyzing, and monitoring patient data; ordering or performing certain laboratory tests; ordering clinical tests; 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. Under N.J.A.C. 13:35-6.27(k) and 13:39-13.7(c), a pharmacist may perform only those laboratory tests that are granted waived status in accordance with the New Jersey Clinical Laboratory Improvement Act and under the Department of Health and Senior Services' rules. The tests must be consistent with the pharmacy practice area or disease state covered by the collaborative practice agreement. The interpretation of clinical or laboratory tests may be performed by a pharmacist only in direct consultation with a physician pursuant to reproposed new N.J.A.C. 13:35-6.27(l) and 13:39-13.7(d). Reproposed new N.J.A.C. 13:35-6.27(m) and 13:39-13.7(e) prohibit collaborative drug therapy management from including therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the physician.

Participation in or withdrawal from a collaborative practice agreement is voluntary on the part of the physician, pharmacist, and individual patient pursuant to reproposed new N.J.A.C. 13:35-6.27(n) and (o) and 13:39-13.8. All records relating to a collaborative practice agreement must be maintained by both the physician and the pharmacist in either hard copy or electronic form for no less than seven years from the date of termination of the agreement and must be supplied to the licensee's respective Board upon request under reproposed new N.J.A.C. 13:35-6.27(p) and 13:39-13.4(e). Any violation of the collaborative practice agreement or its protocols on the part of the physician and/or the pharmacist may be deemed professional misconduct and may subject the physician and/or the pharmacist to discipline under reproposed new N.J.A.C. 13:35-6.27(q) and 13:39-13.9.

The Board of Medical Examiners and the Board of Pharmacy have provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.
 
Social Impact

The Board of Medical Examiners and the Board of Pharmacy believe that reproposed new N.J.A.C. 13:35-6.27 and 13:39-13 may have a positive impact upon physicians and pharmacists who wish to engage in collaborative drug therapy management by clearly delineating the parameters within which collaborative practice by these licensees may be conducted. The reproposed new rules may also benefit the patients of physicians and pharmacists engaged in collaborative practice to the extent that the new rules will allow these licensees to work together to more effectively and efficiently manage a patient's drug therapy needs. The Boards believe that collaborative drug therapy management may help to decrease a patient's drug-related problems, such as adverse drug reactions, drug interactions, and over- or under-utilization of medications. Collaborative drug therapy management will help to foster the optimal use of prescription medications, which may result in an overall reduction in the number of physician office visits a patient must make for the management of chronic diseases.
 
Economic Impact

The Board of Medical Examiners and the Board of Pharmacy believe that reproposed new N.J.A.C. 13:35-6.27 and 13:39-13 may have an economic impact upon physicians and pharmacists who wish to engage in collaborative practice to the extent that these licensees may incur administrative costs associated with submitting collaborative practice documentation to their respective Boards. The maintenance of this documentation, in addition to the maintenance of patient records for the time frames specified in the reproposed new rules, may also result in administrative costs for physicians and pharmacists. In addition, pharmacists wishing to engage in collaborative drug therapy management may incur costs associated with meeting the qualifications necessary to obtain Board of Pharmacy approval for participation in collaborative practice.

The reproposed new rules may have an economic impact on patients who agree to have their drug therapy managed by a physician and pharmacist working in collaboration. These patients may experience a [page=662] reduction in their healthcare costs to the extent that proper drug therapy management may decrease the number of physician office visits a patient must make for the management of chronic diseases. Such patients, however, may experience an economic impact as a result of the proposed new rules to the extent that fees that may be charged by a pharmacist for collaborative drug therapy management services provided in connection with collaborative practice may or may not be covered by a patient's insurance provider.
 
Federal Standards Statement

A Federal standards analysis is not required because reproposed new N.J.A.C. 13:35-6.27 and 13:39-13 are governed by N.J.S.A. 45:14-41, 48a.(4), 61, and 62 of the Pharmacy Practice Act. The reproposed new rules are not subject to any Federal requirements or standards.
 
Jobs Impact

The Board of Medical Examiners and the Board of Pharmacy do not believe that reproposed new N.J.A.C. 13:35-6.27 and 13:39-13 will result in the creation or loss of jobs in the State.
 
Agriculture Industry Impact

Reproposed new N.J.A.C. 13:35-6.27 and 13:39-13 will have no impact on the agriculture industry in the State.
 
Regulatory Flexibility Analysis

Currently, the Board of Medical Examiners licenses approximately 32,000 physicians. The Board of Pharmacy licenses approximately 13,800 pharmacists. If licensees of both Boards are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

Reproposed new N.J.A.C. 13:35-6.27 and 13:39-13 will impose various reporting, recordkeeping, and compliance requirements upon licensees of the Board of Medical Examiners and the Board of Pharmacy who choose to enter into collaborative practice agreements. These requirements are discussed in the Summary and Economic Impact statements above.

No additional professional services will be needed to comply with the reproposed new rules. The costs of compliance with the reproposed new rules are discussed in the Economic Impact statement above. The Boards believe that the reproposed new rules should be uniformly applied to all physicians and pharmacists engaging in collaborative practice in order to ensure the health, safety, and welfare of the general public in the provision of drug therapy management services by such licensees. Therefore, no differing compliance requirements for any physicians and/or pharmacists are provided based upon the size of the business.
 
Housing Affordability Impact Anaylsis

The reproposed new rules will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the reproposed rules concern collaborative practice between physicians and pharmacists.
 
Smart Growth Development Impact Analysis

The reproposed new rules will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the reproposed rules concern collaborative practice between physicians and pharmacists.
 
Full text of reproposed new rules follows:
 
CHAPTER 35
BOARD OF MEDICAL EXAMINERS
 
SUBCHAPTER 6.    GENERAL RULES OF PRACTICE
 
13:35-6.27   Standards for collaborative practice for drug therapy management with licensed pharmacists
 
(a) The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
 
"Bona fide physician-patient relationship" means a relationship in which the physician has ongoing responsibility for assessment, care, and treatment of the patient's medical condition for which collaborative drug therapy management is utilized. For purposes of this definition, "ongoing responsibility" means:
 
1. The physician-patient relationship has existed for at least one year;
 
2. The physician has seen and/or assessed the patient on at least four visits; or
 
3. The physician assumes responsibility for providing management and care of the patient's condition after conducting a comprehensive medical history and physical examination.
 
"Collaborative drug therapy management" means the cooperative management of a patient's drug, biological, and device-related health care needs, pursuant to a written 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.
 
"Collaborative practice" means that practice whereby one or more physicians have jointly agreed to work in conjunction with one or more pharmacists for the purpose of collaborative drug therapy management of patients.
 
"Collaborative practice protocol" means 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 set forth at (c) below.
 
"Informed consent" means 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.
 
"Therapeutic interchange" means the substitution and dispensing of a drug chemically dissimilar from the prescription drug originally prescribed.
 
(b) A physician may enter into a collaborative practice agreement with one or more licensed pharmacists, as provided in N.J.S.A. 45:14-61 of the Pharmacy Practice Act, provided the collaboration that the physician agrees to conduct with the pharmacist is within the scope of the physician's practice and the pharmacist is authorized to engage in such activities pursuant to Board of Pharmacy requirements set forth at N.J.A.C. 13:39-13.
 
(c) A physician who engages in collaborative practice with one or more pharmacists shall provide the Board, upon request, with a signed copy of a collaborative practice agreement. The collaborative practice agreement shall be consistent with the example contained in N.J.A.C. 13:35-6.27 Appendix, which is incorporated herein by reference. The written agreement shall:
 
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 (b) above 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, if appropriate, 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).
 
(d) Any changes, additions, or deletions to the collaborative practice agreement shall be submitted to the Board upon request.
 
(e) The physician shall establish a method for monitoring both the compliance with the collaborative practice agreement and the clinical outcomes of the patients.
 
[page=663] (f) Collaborative practice protocols shall be 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. Each protocol shall:
 
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 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 (g) below;
 
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 eight 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.
 
(g) 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:
 
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.
 
(h) 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 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.
 
(i) Collaborative drug therapy management shall be between a single patient with whom the physician has a bona fide physician-patient relationship, the physician, and the pharmacist and shall address that patient's specific condition, disease, or diseases.
 
(j) Collaborative drug therapy management may include the 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 (k) 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.
 
(k) A pharmacist may 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 and Senior Services' rules set forth at N.J.A.C. 8:44, and Department of Health and Senior Services 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.
 
(l) The interpretation of clinical or laboratory tests under a written collaborative practice protocol shall be performed by a pharmacist only in direct consultation with a physician.
 
(m) Collaborative drug therapy management shall not include therapeutic interchange at the time of dispensing without the prior, specific informed consent of the patient and the consent of the patient's physician.
 
(n) Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary on the part of a physician and a pharmacist.
 
(o) Participation in, or withdrawal from, collaborative drug therapy management shall be voluntary on the part of the individual patient.
 
(p) All records relating to a collaborative practice agreement shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of termination of the agreement and shall be supplied to the Board upon request.
 
(q) Any violation of the collaborative practice agreement or protocols on the part of the physician may be deemed professional misconduct and may subject the physician to discipline consistent with N.J.S.A. 45:1-21.
 
Appendix
 
Collaborative Practice Agreement
 
The Pharmacist(s) and Physician(s) listed below are parties to this collaborative practice agreement, through which the pharmacist(s) receives authority, under the supervision of the physician(s) (or covering physician), to perform the functions outlined in accordance with applicable New Jersey statutes and regulations.
 
Physician:
 
Name: _________________________ Title: _______________________
 
Address: ___________________________________________________
 
Phone Number: ________________ License Number: _______________
 
Type of Practice/Specialty: _____________________________________
 
Pharmacist:
 
Name:_____________________________________________________
 
Address: ___________________________________________________
 
Phone Number: __________________ License Number: _____________
 
Qualifications for Collaborative Practice: _________________________
 
Describe the functions and responsibilities, including scope and authority, to be exercised by the pharmacist (attach extra sheets if needed):
 
Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies under this agreement (attach extra sheets if needed):
 
If appropriate, indicate any diagnosis, or types of diseases which are specifically included or excluded under this agreement (attach extra sheets if needed):
 
Attach any protocols to be used in decision making or other activities contemplated under this agreement. This must include a protocol for treating an acute allergic or other adverse reaction related to drug therapy. Each protocol must establish when physician notification is required, the time frame within which the pharmacist must notify the physician of any change in dose, duration or frequency of medication prescribed, and the type of pharmacist documentation required. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist.
 
Physician Signature: __________________ Date: __________________
 
Pharmacist Signature: _________________ Date: __________________
 
[page=664] CHAPTER 39
STATE BOARD OF PHARMACY
 
SUBCHAPTER 13.    COLLABORATIVE PRACTICE
 
13:39-13.1   Purpose and scope
 
The rules in this subchapter establish standards applicable to all pharmacists who seek to engage in collaborative practice with one or more physicians licensed by the Board of Medical Examiners. Only those activities that have been approved by the collaborating physician, consistent with his or her scope of practice, shall be permitted.
 
13:39-13.2   Definitions
 
(a) The following words and terms, as used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise:
 
"Collaborative drug therapy management" means 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.
 
"Collaborative practice" means 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.
 
"Collaborative practice protocol" means 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.
 
"Informed consent" means 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.
 
"Therapeutic interchange" means the substitution and dispensing of a drug chemically dissimilar from the prescription drug originally prescribed.
 
13:39-13.3   Board approval; pharmacist qualifications; continuing education
 
(a) 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 pre-approved by the Board to engage in such activity. 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:
 
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 Health-System Pharmacists; or
 
3. A certification program from the Board of Pharmacy Specialties.
 
(b) The Board shall issue an authorization to engage in collaborative drug therapy management to a pharmacist who, upon application to the Board, demonstrates satisfaction of the requirements of (a) above.
 
(c) A pharmacist granted authorization to engage in collaborative drug therapy management pursuant to this section shall complete a minimum of 10 credits of continuing education every biennial renewal period in the area covered by the collaborative practice agreement to which he or she is a party, consistent with the requirements of N.J.A.C. 13:39-3A.
 
13:39-13.4   Collaborative practice agreement
 
(a) A pharmacist who engages in collaborative practice with one or more physicians shall provide the Board, upon request, with 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. The written agreement shall:
 
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, if appropriate, 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).
 
(b) Any changes, additions, or deletions to the collaborative practice agreement shall be submitted to the Board upon request.
 
(c) The pharmacist shall cooperate with the method established by the physician for monitoring compliance with the agreement and clinical outcomes of the patients.
 
(d) 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 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.
 
(e) All records relating to a collaborative practice agreement shall be maintained in either hard copy or electronic form for a period of not less than seven years from the date of termination of the agreement and shall be supplied to the Board upon request. All records shall be made available to persons authorized to inspect them under State and Federal statutes and regulations. The oldest six 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.
 
13:39-13.5   Collaborative practice protocols
 
(a) A collaborative practice protocol shall be 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.
 
(b) Each protocol shall:
 
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 as defined in N.J.A.C. 13:35-6.27(a);
 
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 [page=665] than eight 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.
 
13:39-13.6   Informed consent for collaborative drug therapy management
 
(a) 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:
 
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.
 
13:39-13.7   Scope of collaborative drug therapy management
 
(a) Collaborative drug therapy management shall be 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.
 
(b) Collaborative drug therapy management may include the 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.
 
(c) A pharmacist may 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 and Senior Services' rules set forth at N.J.A.C. 8:44, and Department of Health and Senior Services 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.
 
(d) The interpretation of clinical or laboratory tests under a written collaborative practice protocol shall be performed by a pharmacist only in direct consultation with a physician.
 
(e) Collaborative drug therapy management shall not include 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.
 
13:39-13.8   Voluntary participation
 
(a) Participation in, or withdrawal from, a collaborative practice agreement shall be voluntary on the part of a physician and a pharmacist.
 
(b) Participation in, or withdrawal from, collaborative drug therapy management shall be voluntary on the part of the individual patient.
 
13:39-13.9   Failure to comply
 
Any violation of the collaborative practice agreement or protocols on the part of the pharmacist may be deemed professional misconduct and may subject the pharmacist to discipline consistent with N.J.S.A. 45:1-21.
 
Appendix
 
Collaborative Practice Agreement
 
The Pharmacist(s) and Physician(s) listed below are parties to this collaborative practice agreement, through which the pharmacist(s) receives authority, under the supervision of the physician(s) (or covering physician), to perform the functions outlined in accordance with applicable New Jersey statutes and regulations.
 
Physician:
 
Name: _________________________ Title: _______________________
 
Address: ___________________________________________________
 
Phone Number: ________________ License Number: _______________
 
Type of Practice/Specialty: _____________________________________
 
Pharmacist:
 
Name: _____________________________________________________
 
Address: ___________________________________________________
 
Phone Number: _________________ License Number: ______________
 
Qualifications for Collaborative Practice: _________________________
 
Describe the functions and responsibilities, including scope and authority, to be exercised by the pharmacist (attach extra sheets if needed):
 
Indicate any restrictions placed on the use of certain types or classes of drugs or drug therapies under this agreement (attach extra sheets if needed):
 
If appropriate, indicate any diagnosis, or types of diseases which are specifically included or excluded under this agreement (attach extra sheets if needed):
 
Attach any protocols to be used in decision making or other activities contemplated under this agreement. This must include a protocol for treating an acute allergic or other adverse reaction related to drug therapy. Each protocol must establish when physician notification is required, the time frame within which the pharmacist must notify the physician of any change in dose, duration or frequency of medication prescribed, and the type of pharmacist documentation required. Written notification, by either facsimile or electronic means, shall be provided to the physician no later than eight hours after any change in prescribed medication is made by the pharmacist.
 
Physician Signature: __________________ Date: __________________
 
Pharmacist Signature: __________________ Date: _________________

 

   
Contact Us | Privacy Notice | Legal Statement | Accessibility Statement
NJ Home Logo
Divisional: DCA Home | Complaint Forms | Proposals | Adoptions | Contact DCA
Departmental: OAG Home | Contact OAG | About OAG | OAG News | OAG FAQs
Statewide: NJ Home | Services A to Z | Departments/Agencies | FAQs
Copyright State of New Jersey
This page is maintained by DCA. Comments/Questions: email

Page last modified: