Opportunities for Collaboration in Clinical Pharmacy Services

Take-Home Points

• Pharmacists have specialized clinical and advanced training that enables them to monitor and adjust drug therapy while working in collaborative relationships with physicians and patients.
• Although hospitals have used clinical pharmacists for years, recent legislation enacted in several states now enables community pharmacists to provide clinical services through collaborative protocols with physicians.
• Most community collaborative protocols between a physician and a pharmacist are narrow in scope, limiting pharmacist clinical services to specified patients and disease states.
• Clinical services include some or all medication monitoring, adjusting doses and regimens, and possibly changing prescriptions.
• Most collaborative protocols require specific record keeping and communication between physician and pharmacist.
• Legislation differs in each state regarding the disease states that may be managed, the nature of the services to be provided, the wording of the protocol and need for registration, and the setting in which the services can be provided (ie, retail, hospital, clinic, etc.).¹
• Opportunities exist for enhancing customer relations and increasing revenue by billing for services through Medicaid or medication therapy management (MTM) through Medicare Part D in some state programs.
• Adequate training, a private area for patient consultations, a system for documenting patient and physician interactions, and extra support to cover drug distribution activities while the pharmacist is counseling are all necessary for pharmacist clinical services to be successful.

Thirty years ago, a pharmacist’s primary role was safeguarding and distributing medications. The term “clinical pharmacy” first entered the hospital pharmacist lexicon in the mid-1980s; pharmacists, typically in the hospital setting, would interact with physicians and make recommendations on drug regimens to avoid adverse drug reactions or interactions, in addition to enforcing the formulary. Other services included making recommendations to the physician regarding:

• Dose adjustments for patients with renal or hepatic failure
• Modifying route of administration
• Monitoring patients for adverse drug events
• Selecting cost-effective medications
• Converting intravenous doses to equivalent oral doses
• Recommending therapeutic substitutions from nonformulary orders to formulary medications

Over time, the job description of the clinical pharmacist was differentiated from that of the staff pharmacist, and as the relationship between pharmacist and physician developed, doctors began asking the pharmacist to go beyond offering advice and to initiate changes to the drug and dosage regimens in response to patients’ signs and symptoms. Although hospitals had the legal flexibility to allow such practices, initially a physician was generally required to countersign each order. In time, hospitals approved blanket protocols that gave pharmacists direct authority to make these changes without prior or subsequent approval by a doctor. In the retail or community setting, however, pharmacists were not allowed to modify any regimen without a prescription by a physician. Prior to making a change, pharmacists were required to call the physician to ask for a new prescription.

Today, as collaboration between pharmacists and physicians has grown and education and training of pharmacists has improved, a new model is being explored throughout the country: the community pharmacist as clinical provider of services in the community setting. This article explores the trends, nature of such services, and opportunities available as more states are enacting legislation to facilitate greater collaboration between pharmacists and physicians than took place in the past.

The Evolution of Pharmacy Education

The education and experience a pharmacist gains during school and after graduation includes much more clinical training than it did 30 years ago. Accredited pharmacy schools in the United States have gradually phased out the bachelor of science (BS) degree in pharmacy and now only offer a doctor of pharmacy (PharmD) degree. Hospitals now also offer 1- and 2-year general and specialized post-PharmD residencies in various areas of hospital pharmacy clinical programs. In addition, some hospitals have started placing pharmacists in outpatient clinics where they can assist in managing a patient's chronic disease, such as asthma, hypertension, and hypercholesterolemia. These outpatient services are provided as either part of a multidisciplinary term including pharmacists, physicians, and nurses, or under the supervision of a physician.

In 1990, some states passed legislation under which pharmacists could provide clinical services in the hospital setting under specific protocols considered to be prescribing but that were “dependent” on a licensed prescriber. Washington, one of the first states to offer such a protocol, allowed pharmacists to provide defined services to patients of specified physicians. Although the protocols sound restrictive, specific services could be anything the physician wanted done by a qualified and trained pharmacist. Examples of more unusual services include monitoring and modifying parenteral nutrition, adjusting doses of lidocaine for patients receiving lidocaine infusions, and initiating and modifying opioid regimens for patients needing patient-controlled analgesia after surgery.

The Community Clinical Pharmacist

The newest term used when discussing collaboration between pharmacists and physicians in the retail arena is “community clinical pharmacist (CCP).” Not that the idea of a pharmacist working in collaboration with a physician for retail patients is new; pharmacists have often called physicians to discuss medications, doses, and regimens when they encountered potential drug interactions or intolerable adverse effects. What makes the role of CCPs different is their ability to directly adjust a patient’s medication regimen without contacting the physician. The CCP service allows pharmacists to assist in the care of patients/customers in the community and prescribe therapies for patients in acute situations to reduce urgent care and emergency department visits.

The rules regarding the role and responsibilities of a CCP differ in each state, depending on specific legislation. The list below was collected from the allowable protocols and regulations of numerous states.^2-4 Depending on the state, a pharmacist can do some or all of the following:

• Specify or limit the disease states the pharmacist can assist in managing
• Determine whether the pharmacist can administer medications
• Determine the setting in which the pharmacist may render clinical services (ie, community, hospital, or clinic)
• Specify additional training needed beyond the degree, both initially and as ongoing continuing education
• Require communication with a physician and documentation of their services
• Specify whether the physician needs to countersign after each medication adjustment.
• Determine whether a pharmacist may do each of the following: (a) initiate, (b) modify regimen, and/or (c) discontinue a medication
• Require ordering and interpreting tests to monitor drug safety and efficacy
• Indicate whether the protocol is limited to specifically identified patients of the physician

Most states require that a majority of services be rendered pursuant to a collaborative relationship with a physician who is also seeing that patient. Some states, such as California, make exceptions for services such as administration of vaccinations, prescription of nicotine replacements, and initiation or furnishing of hormonal replacements.

At least 36 states authorize pharmacist clinical services in any setting as set out in a written protocol. Some protocols are specific to certain disease states, while others limit services to vaccinations, smoking -cessation counseling, and provision of emergency contraception. Twenty-one states require pharmacists, and in some cases, physicians, to submit the written protocol to the Board of Pharmacy or Medicine.

As a result of the wide variance between states regarding the nature of services allowed, the nature of the protocol, and the disease states covered, each setting needs to refer to the specific rules in the state in which the pharmacist will practice to determine the extent to which clinical pharmacy services can be provided under protocol. For example, in North Carolina, clinical pharmacist practitioners (CPPs) provide drug therapy management (including controlled substances) under the direction or supervision of a licensed physician who has provided written instructions for a patient and disease-specific drug therapy. The instructions may include ordering, changing, or substituting therapies or ordering tests. Any changes to the protocol must be approved by the pharmacy and medical boards. The supervising physician must be readily available for consultation with the CPP and will review and countersign each order written by the CPP within 7 days. The written CPP agreement must be specific with regard to the physician, the pharmacist, the patient, and the disease; specify the predetermined drug therapy, which shall include the diagnosis and product selection by the patient's physician; and include any modifications which may be permitted and the dosage forms, dosage schedules, and tests which may be ordered.³

In Washington state, pharmacists who wish to be certified as CPPs must complete 20 hours of self-paced training to learn how to identify illness, rule out complications, and prescribe therapies. CPP training also includes instruction on developing a business and marketing plan, documentation, ethical considerations, and practical points. Each of the 14 clinical modules provides a comprehensive review of a disease state, the differential diagnosis to rule out other causes of symptoms, and treatment recommendations. The certified CPP can complete one or all the clinical modules, or pick the ones that best fit their practice setting.²

The Asheville Project

Studies have shown that drug therapy monitoring, counseling, and educational services provided by community pharmacists contribute to improved health outcomes for patients with chronic conditions such as hypertension, diabetes, and hyperlipidemia.¹ One of the more famous studies showing the success of the clinical community pharmacist is The Asheville Project.

The Asheville Project was a North Carolina state-sponsored project that allowed pharmacists to provide education and counseling to state employees with specific chronic health problems After the patients were provided with intensive education through the Mission-St. Joseph’s Diabetes and Health Education Center, they were teamed with community pharmacists for a medication review and patient education. There were numerous positive outcomes from this project, including fewer sick days, improvement in diabetes monitoring parameters, and lower health care costs.⁵

One of the more complex and difficult aspects of providing clinical services is whether the pharmacy can be paid for the services provided. There are many examples of pharmacists using physician codes to bill commercial insurance companies and having varying degrees of success at getting reimbursement. Some states have conducted major projects evaluating whether outcomes improve when pharmacists are reimbursed. Mississippi was the first state to seek and gain Medicaid approval to pay pharmacists for their clinical services in 1998. A similar waiver and plan was implemented in Ohio in 2012.

Payments for pharmacy services provided through state Medicaid programs vary from state to state. The most commonly reimbursed services in the 15 states that provide Medicaid compensation for direct patient care include smoking cessation, counseling, and other preventive services.⁶ Under Medicare Part B, pharmacists are not included in the statutory definition of “providers” and cannot directly bill for patient care services. In contrast, Medicare Part D does reimburse for MTM services when provided under contract with the sponsor of a prescription drug plan. Qualified MTM services include medication review but not chronic disease management. MTM does not require a formal collaborative agreement between a pharmacist and a physician, and it can be provided without dispensing a medication.

Clinical Services in the Pharmacy

To make clinical services a success, community pharmacies need to ensure that pharmacists are afforded the time to provide patient care services, not just dispense products to patients. This may require additional staff and training of existing staff. Community pharmacists should move to a technician-driven, pharmacist-managed dispensing process. Investment in technology may also be required, such as purchasing a state-of-the-art pill counter or a robot for automated dispensing. Community pharmacies should also look into what is allowed under state board of pharmacy rules with regard to technicians being able to verify the work of another technician without requiring a pharmacist verification.

Community pharmacists also need to think about where they will counsel patients during the dispensing process and if that space provides some level of privacy. The space should allow for an intimate discussion where the patient does not feel rushed or concerned about privacy. The CCP will need to document any drug therapy problems found during the dispensing process when pharmacists are performing clinical services, along with an action taken. Electronic or hard-copy records or charts should be kept for all patients and should include all interventions and recommendations the pharmacists make.⁷

Conclusion

The nature of pharmacy services has been steadily changing as new models of care and new reimbursement programs have emerged. New legislation in many states provides opportunities for personal and professional growth for individual pharmacists and pharmacies that want to offer more to their customers than simply filling prescriptions. Pharmacists need to grow their collaborative practice in the community setting by partnering with care groups and physicians, and savvy pharmacy owners will see this as an opportunity for both customer and revenue growth, while improving the quality of patient care.

Lorne Basskin, PharmD, is a consultant for hospitals and hospital systems in formulary development and management and drug use policy. He has written and presented numerous research projects on clinical pharmacy services, pharmacoeconomics, and outcomes research. After serving as director of clinical services and director of pharmacy services at a Florida hospital, he developed and served in a national pharmacist position and as director, clinical and information services, both at a large for-profit hospital corporation. He is an adjunct professor at Brown University School of Public Health in Providence, Rhode Island.

References

• Centers for Disease Control and Prevention: Division for Heart Disease and Stroke Prevention. Select features of state pharmacist collaborative practice laws. cdc.gov/dhdsp/pubs/policy_resources.htm. Published December 2013. Updated July 16, 2015. Accessed October 6, 2015.
• Clinical community pharmacist. Washington State Pharmacist Association website. wsparx.org/?page=CCP. Accessed October 10, 2015.
• North Carolina Administrative Code. Board of Pharmacy—Pharmacy Rules. 21 NCAC 46. 3101. Section .3100—Clinical Pharmacist Practitioner. North Carolina Board of Pharmacy website. www.ncbop.org/LawsRules/Rules.pdf. Updated November 2015.
• McBane SE, Dopp AL, Abe A, et al; American College of Clinical Pharmacy. Collaborative drug therapy management and comprehensive medication management - 2015. Pharmacotherapy. 2015;35(4):e39-e50. doi: 10.1002/phar.1563.
• The Asheville Project. theashevilleproject.net. Accessed October 10, 2015.
• Isasi F, Krofah E. The expanding role of pharmacists in a transformed health care system. National Governor’s Association website. nga.org/files/live/sites/NGA/files/pdf/2015/1501TheExpandingRoleOfPharmacists.pdf. Published January 13, 2015. Accessed October 7, 2015.
• Pai AK. Integration of a clinical community pharmacist position: emphasis on workflow design. J Am Pharm Assoc (2003). 2005;45(3):400-403.