In June 2010, Massachusetts promulgated regulations governing the implementation of collaborative drug therapy management (CDTM), which enables credentialed pharmacists to have protocolized prescriptive authority under a supervising physician. Once the regulations became operational at the state level, Brigham and Women’s Hospital (BWH) in Boston prioritized the implementation of this exciting development. This collaboration enables pharmacists to practice at the top of their licenses while providing excellent patient care in a cost-efficient manner. In order to attain these goals, we sought to develop and implement a regulatory compliant CDTM policy in our hospital setting.
Drivers for Program Implementation
To begin this program, we had to create a framework that could facilitate proper monitoring and management. We determined it would be best to first focus on a single service in order to perfect the processes of clinical protocol development and implementation, define performance metrics, and obtain documented referral and patient consent. After reviewing the potential services, we found that our ambulatory care services—specifically outpatient anticoagulation management—provided the most appropriate setting for initial implementation. By starting in one outpatient care area with a defined focus, we were able to troubleshoot the rollout and apply the key lessons learned to further growth.
Naturally, the main driver for any new health care program should be based on improving patient outcomes. CDTM allows specialty-trained pharmacists to focus their knowledge and expertise on the pharmacotherapy of specific disease states. Thus, this specialized care has the potential to improve adherence to guidelines and reduce hospital admissions, readmissions, and emergency department visits.1 Pharmacist interaction also reduces the burden on physicians to manage drug therapy, allowing them to shift their focus to diagnosis and management of patients with a higher level of acuity.2 Furthermore, this process enables physicians to see a greater volume of patients, because credentialed pharmacists can manage patients with chronic diseases that are relatively stable.
Establishing Clinical Protocols
In response to, and with close consideration of the regulations governing CDTM as enacted by the Massachusetts Boards of Medicine and Pharmacy and the Department of Public Health, BWH leadership created a policy to authorize credentialed pharmacists to practice CDTM beginning with our ambulatory protocols. The policy and clinical protocols establish criteria for clinician credentials, subject matter expertise, quality review, and other requirements for pharmacists and physicians to practice CDTM.
This regulatory compliant policy has been in place for over a year now, allowing credentialed pharmacists to practice as mid-level practitioners without requiring physician co-signatures on orders or prescriptions. Moving forward, pharmacist and physician content experts are developing additional clinical protocols based upon the best medical evidence available. Each clinical protocol requires approval by the hospital’s P&T Committee, which is also responsible for reviewing periodic performance metrics for the quality assurance of pharmacy practice.
To date, we have 12 credentialed pharmacists practicing CDTM at BWH and our policy governs CDTM for hypertension, dyslipidemia, Type II diabetes, anticoagulation, chronic pain, and outpatient antimicrobial infusion protocols.
Regulatory Requirements and Scope
Under the auspice of the CDTM policy, all authorized pharmacists shall:
The collaborative practice agreement should include, but not be limited to: the collection and review of a patient’s medication history and relevant disease state history, the monitoring and recording of vital signs, and assisting the supervising physician or physician designee with documenting clinical interventions, ordering and interpreting select laboratory tests, ordering medications, and instructing and counseling patients on the use of prescribed drug therapy.
An authorized pharmacist may not diagnose, order medications outside of what is in the written protocol, provide anesthesia or procedural sedation, or perform procedures involving ionizing radiation. Furthermore, authorized pharmacists shall not be utilized as sole medical personnel in charge of emergency services, outpatient services, or any other clinical service where licensed physicians are not readily available. Lastly, authorized pharmacists may not order radiology tests.
Adoption Tips and Results
Key to the success of such a project is identification of physician and nursing champions, as well as engaging mid-level practitioner and professional credentialing leadership. At BWH, the draft CDTM policy was reviewed by the Office of General Counsel to assure regulatory compliance, and key pharmacy, nursing, and physician leaders provided valuable input. The policy also was reviewed and approved by the P&T Committee and the Medical Executive Committee prior to adoption.
Early collaboration with mid-level credentialing leadership is recommended to help define the steps required for the credentialing process. We created a pharmacy department credentialing committee to help manage pharmacist CDTM credentialing. The committee is responsible for reviewing candidates and if appropriate, recommending approval of the candidate’s credentialing application. Additionally, the committee will ensure that the pharmacist is maintaining all regulatory requirements to maintain credentialed status.
We recommend piloting the initial clinical protocol in an established area of clinical practice to gain support, develop quality criteria, and collect pre- and postimplementation patient outcome data. Clinical protocols should be created by experts of the clinical content and supported by literature and national guidelines. In addition, the institution should seek to refine and implement a standard process for documenting clinical services in the medical record. The greatest benefit may be found by initiating this work with departments and patients using high-risk medications.
Due to a lack of local experience with this type of program (BWH being among the first in Massachusetts to enact CDTM), our initial attempts at establishing the framework were challenging. For other facilities considering CDTM implementation, we recommend collaboration on a statewide level between institutions and health care systems to share best practices and successes.
Program Reception and Reaction
Since inception, those involved in the program continue to be motivated by the process, and have become the champions of establishing their respective clinical protocols. Our pharmacists have taken ownership of this process as well and have received significant support of clinical supervisors in guiding the protocols through the administrative approval process.
The most recently approved practice area is outpatient parenteral antimicrobial therapies. Alongside two infectious disease pharmacists, the main champion was one of our attending infectious disease physicians, who was particularly keen to establish the program and enroll patients in order to better manage antimicrobial therapy. The role this physician played was instrumental for politically navigating the approval of this specific program and gaining support for CDTM practice throughout the institution. Thus far, this program has been well received by all practice areas.
Extending the Program
Our short-term goal is to expand chronic disease state management in the ambulatory setting. The overall goal is to maximize the number of patients exposed to this collaborative practice. By continuing to expand, we hope to create a model that will lure more pharmacists to practice at the top of their license.
As a robust health care system, we would ideally like to place a credentialed pharmacist in every area of practice. We run on-campus clinics, but we also have clinics throughout Boston. Expanding into the inpatient setting is another goal, particularly for practices that utilize certain high-risk medications, such as aminoglycosides and anticoagulants.
We are aware of the tendency for patients to veer off track from appropriate therapy once discharged, potentially leading to high readmissions. Our goal as a health care institution is to reduce the readmission rate for identified patients with chronic disease states. A program such as CDTM, along with other readmission rate reduction strategies, can decrease the overall cost of patient care, while simultaneously giving our pharmacists an opportunity to exercise the full extent of their competence and expertise.
The authors represent the department of pharmacy† and clinical compliance and risk management‡ at Brigham and Women’s Hospital in Boston, Massachusetts.
Paul M. Szumita, PharmD, BCPS, is a clinical pharmacy practice manager at Brigham and Women’s Hospital (BWH) in Boston. He also is an adjunct assistant professor of pharmacy at three colleges and serves as the program director for BWH’s PGY2 critical care pharmacy residency training program.
Julie K. Atay, PharmD, MBA, BCPS, CACP, is the anticoagulation services manager at BWH where she plays an active role in inpatient and outpatient anticoagulation management, clinical research, and guideline and policy development related to anticoagulants.
Lina Matta, PharmD, BCPS, is a clinical pharmacy practice manager at BWH and is actively involved in developing and managing clinical programs focused on optimal pharmacotherapy and enhancing the role of the pharmacist in improving patient outcomes. Lina also serves as a coordinator for the pharmacy residency training program and is a member of the leadership team on the BWH P&T Committee.
David Seaver, RPh, JD, is a risk manager at BWH and is licensed to practice both pharmacy and law in Massachusetts. He is the Legislative Committee Chair for the Massachusetts Society of Health-System Pharmacists and has testified on a number of legislative and regulatory matters before the Massachusetts legislature and Board of Pharmacy including the Collaborative Drug Therapy Management law.
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