Trends in Collaborative Drug Therapy Management

Karen E. Koch, PharmD

Disclosures
In This Article

States' Experiences

Procuring CDTM recognition has been difficult for some states. A list of objections to CDTM that states have encountered, and their rebuttals, is compiled in Table 3 and discussed in the following description of some states' experiences. Finally, strategies suggested for successful CDTM legislation are summarized in Table 4.

California

California was the first state in which pharmacists officially expanded their roles. In 1972, the Health Manpower Pilot Projects initiated cross-training students of allied health professions beyond their legal scope of practice.[7] Five years later, California Assembly Bill 717 provided prescriptive authority to those involved in the initial Manpower Pilot Projects. These projects were very successful, and in 1981 the state passed legislation that would allow pharmacists in acute and intermediate health care facilities the following privileges: to adjust dosages pursuant to a prescriber's authorization; to order laboratory tests; to perform physical assessments; and to administer medications.

The legislature reviewed and expanded the pharmacy practice act in 1983, thereby permitting pharmacists to initiate therapy, and again in 1994, when it expanded practice sites to include ambulatory care clinics. In the spring of 1998, the legislature passed Senate Bill 1596, which permits payment for nondispensing activities.

Washington

In 1979, Washington was the first state to enable pharmacists to prescribe under protocol. Although the original legislation has not been changed, the board of pharmacy expanded the implementing regulations several times to clarify the number and types of protocols and to expand from hospital settings to ambulatory clinics and to retail pharmacies. Each protocol and pharmacist must be registered with the pharmacy board. A particular protocol (eg, pediatric immunization) filed by a chain of drug stores may cover numerous pharmacists working throughout the state.[30] At the same time, a hospital with progressive pharmacy services may have 10 to 20 different clinical protocols on file with the state board of pharmacy. As the hospital certifies pharmacists, their names are submitted to the board's list of practitioners.

Pharmacists in Washington state have been successful and continue to push the envelope of collaborative practice.[22,23,27,28,30,31] For example, they were the first to pursue Drug Enforcement Administration registration, and pharmacists at Valley Hospital (Renton, Wash) provide conscious sedation under protocol.[26] In the spring of 1998, retail pharmacists received national attention when they began providing emergency contraception pills under protocol.[32]

Oregon

Oregon was the third state to recognize collaborative practice. In 1980, the attorney general's ruling of the pharmacy practice act permitted pharmacists to enter into collaborative agreements via protocols or case by case. All medications and all settings were included and no level of approval or review was required.

Although they have successfully collaborated with physicians since 1980, pharmacists were uncomfortable with the tenuous status of the attorney general's ruling and wanted to secure their position via a legislative statute. They faced opposition from members of the medical society, who felt comfortable with collaborative practice in a hospital setting but not in an ambulatory one. When the pharmacists pointed out that it would not change what was already taking place in ambulatory settings for almost 20 years, the medical association relented, and in 1998 the Oregon board of pharmacy revised the regulations implementing the pharmacy practice act.

Mississippi

In 1980, Mississippi passed legislation stating that pharmacists have the authority to conduct protocol-based prescribing in institutional settings. The practice act was revised in 1994 by further defining the institutional protocols. Later that year, however, the state pharmacy board was approached by pharmacists who wanted to start an anticoagulation clinic. Since the clinic was an extension of a well-established acute care clinical pharmacy program, the board permitted it to operate under the institution's collaborative practice authority. The pharmacists were able to monitor anticoagulation status, consult with patients, and adjust therapy but not generate prescriptions.

Pharmacists initiated their clinic, but they wanted to amend the pharmacy practice act so that they could have prescribing privileges similar to those allowed the state's nurse practitioners. They met with representatives of the Mississippi Society of Health-Systems Pharmacists, the Mississippi Pharmacists Association, and the University of Mississippi School of Pharmacy. This group came to a consensus on what collaborative practice should be in the state, and they developed a white paper which they forwarded to the state's board of pharmacy. The executive director of the state pharmacy board was supportive of expanding collaborative practice to ambulatory sites and worked to build political support with legislators, the medical board, the nursing board, public health officials, and PhRMA. Meanwhile, the anticoagulation clinic was managing more than 400 patients and was able to supply letters of support from numerous physicians. The legislature passed the bill in February 1995. The pharmacy board wrote the regulations in August, a public hearing on them was held in November, and the amended regulations became effective in January 1996.

Florida

Florida was the fifth state to provide prescriptive authority, but it took an entirely different approach. In 1986, it created a third class of drugs -- a formulary of about 50 legend drugs from which pharmacists can prescribe to patients. A panel regulates these agents and places several restrictions on them: no prescribing to pregnant or nursing mothers, drug supplies limited to 34 days, and no refills. This independent prescribing privilege has been underutilized,[33,34] and Florida pharmacists have been attempting to pass legislation that would permit them to create protocol-based dependent prescribing. This was opposed by PhRMA and several medical groups, the latter of which claim that collaborative prescribing would interfere in the physician-patient relationship and that it is beyond the scope of pharmacists' education and training.

In the 1999 spring session, the Florida legislature approved a bill with an amendment that established a CDTM task force. This 15-member task force, with representatives from pharmacy, medical, nursing, and manufacturing groups, will thoroughly examine CDTM, inside and outside Florida, and determine its efficacy in improving health care outcomes of patients.

New Mexico

In 1993, New Mexico was the ninth state to pass legislation that provided pharmacists with collaborative management abilities. Legislators also took a new approach, but it was in sharp contrast to Florida's concerns about dependent authority. They created a new category of pharmacist -- the "pharmacist clinician." These pharmacists have physical assessment training, which is similar to that of physician assistants. They must complete a 60-hour pharmacy board-approved physical assessment course, followed by 9 months of supervised clinical experience involving physical assessment skills. These pharmacist clinicians are able to register with the Drug Enforcement Administration and use all agents in all settings to monitor, assess, prescribe, and modify therapy.

This approach was successful because New Mexico has long had pharmacists working collaboratively in the Indian Health Service. These pharmacists are granted more independent assessment and management responsibilities than CDTM pharmacists in other states, and they are much needed in the medically underserved communities of this rural state.

Other States

Other states with unique features in their collaborative practice acts include Michigan (1991). It specifically excludes anabolic steroids, and it requires pharmacists to include the name of the delegating physician on the prescription.

North Dakota (1995) requires protocol approval by both the Board of Pharmacy and the Board of Medical Examiners, and a physician can have collaborative agreements with not more than three eligible pharmacists. The pharmacist must have an advanced degree or training and has to notify the physician whenever he or she initiates or modifies therapy.

In contrast to North Dakota, Texas (1995) requires only that the protocol be available to the pharmacy board, but not necessarily filed with it. It is emphasized that collaborative agreements are between individual practitioners, pharmacists and physicians, and not a group of practitioners and a facility.

Arkansas (1997) requires only physician review of the protocol.The state also recognizes that pharmacists who complete diabetes mellitus training are eligible for insurance company reimbursement.

Legislation recently approved in Ohio (1998) is fairly restrictive. It allows the pharmacist to monitor and modify therapy but not to practice therapeutic substitution. Ohio also requires the patient or caregiver to sign the consultation agreement along with the physician and pharmacist.

South Carolina appears to be more liberal. Its legislature does not require protocols, and it has changed the way it refers to CDTM by deleting the term "collaborative" and replacing it with "drug therapy management."

Some states' regulations are very limited; for example, Vermont's pharmacy board regulations state "pharmacists may adjust medication doses if the order is part of a medication or dosing protocol that has been approved by the medical staff of the institution; this section should not be construed as giving prescribing privileges to pharmacists."

The Federal Government

The federal government has always been progressive with promoting the capabilities of pharmacists in its employ. The government has not been encumbered by the competing interests of medical societies and the pharmaceutical industry. As a result, it has addressed the growing need for nonphysician members on the health care team by expanding the responsibilities of highly skilled pharmacists, nurses, and physician assistants.

A federally employed pharmacist must be licensed in at a least one state, although the pharmacist's scope and practice may then be broadened or limited by the policies of his or her employment site. In 1995, the undersecretary for health approved prescribing authority for midlevel practitioners.[35] These "clinical pharmacy specialists" must meet one of the following qualifications: master's or PharmD degee, accredited residency, specialty board certified, or equivalent experience. In the Reno, Nev, Veterans Affairs Hospital, pharmacists have been independently prescribing medications and ordering laboratory and radiology tests for more than a decade[36]; whereas in the new West Palm Beach, Fla, Veterans Affairs hospital, clinical pharmacy specialists supervise the work and cosign the orders of the pharmacists in the anticoagulation clinic.[37]

The US Armed Forces have also promoted pharmacists' services. Navy pharmacists are now direct care providers in a number of ambulatory care clinics (anticoagulation, dyslipidemia, HIV, pain management, and antiemesis). By managing these medically stable patients, the pharmacists have freed up the physicians' time for more seriously ill patients.[38] The Army has institutionally credentialed prescribers who use physical assessment skills and knowledge of disease to manage patients with diabetes, hypertension, asthma, hyperlipidemia, and certain psychiatric disorders.[27]

In February 1999, the federal government recognized the practitioner status of non-federally employed pharmacists through the Health Care Financing Administration's (HCFA) inclusion of pharmacists as "certified providers" of diabetes self-management training services. Under the proposed rule (HCFA-3002-P), Medicare beneficiaries with diabetes would receive up to 10 hours of initial outpatient training within a 12-month period with an annual follow-up of a single 1-hour session.

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