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Pharmacist scope of practice expansion

Michael J. Romano, R.Ph.

By C. Lyn Fitzgerald

The state, in the biggest change in pharmacy law since 1961, is in the final phases of expanding the scope of what pharmacists can do in collaboration with physicians, including managing drug therapy in an institutional setting and administering injectable medications at the retail level. At the same time, retail pharmacy chains are expanding their patient services and are poised to open primary care centers staffed by nurse practitioners (NPs).

Experts say this expansion in health care delivery options is simply an effort to meet a critical need in a system dogged by poor compliance, inadequate access and soaring costs, and that pharmacists and pharmacies are the perfect conduits for such an endeavor because of their accessibility – with an estimated 250 million people visiting a pharmacy every week.

Local advocates say the pharmacist and pharmacy expansions represent more efficient and patient-centered health care that grants long-overdue recognition of the pharmacist as a more complete clinical partner in care. Physicians, anxious that a transfer of care might mean fragmentation and a possible erosion of care quality, believe that the changes are positive so long as there is collaboration and effective communication between them and the pharmacy providers. All agree if these new developments are instituted properly, the patient stands to benefit most.

New Pharmacist Roles in Institutions

While the current regulatory definition of pharmacy practice in Pa. focuses on preparing, compounding and dispensing drugs and devices, a new law expected to be implemented this spring significantly expands the role that pharmacists play as health care providers. Act 102, the Pennsylvania Collaborative Drug Therapy Management Law, amends the Pharmacy Act of 1961 and permits pharmacists, under a written agreement – or protocol – with a licensed physician to administer drugs and manage drug therapy in an institutional setting.

An institution is defined in the Act as: extended care facilities, nursing homes, nursing care facilities, convalescent homes, resident care facilities, hospitals or another place which offers medical treatment to patients who require food, board and overnight sleeping facilities and care. Institutional settings under the Act do not include offices used primarily for private or group practice by health care practitioners.

The Act permits several duties under “managing drug therapy,” including:

· Adjusting a drug regimen.

· Adjusting drug strength.

· Adjusting frequency of administration or route.

· Administering drugs.

· Ordering laboratory tests.

· Ordering and performing other diagnostic tests necessary in the management of drug therapy, consistent with the testing standards of the institution.

Some Pa. pharmacists working in institutions are already afforded limited authorization to manage drug therapy. Under the Medical Practice Act of 1985, physicians are authorized “to delegate duties to health care practitioners,” while the Osteopathic Medical Practice Act “authorizes services and acts rendered by allied medical persons under the supervision, direction or control of a licensed physician.” Act 102 codifies the new duties under pharmacy regulation, removing a licensure roadblock to pharmacists performing clinical activities proactively.

Under today’s institutional policy and procedures (protocols), a pharmacist may only suggest ordering a test or suggest adjusting a medication, and a physician must then give an order before the execution occurs. For example, University of Pittsburgh Medical Center (UPMC) protocol allows pharmacists to perform tasks such as therapeutic interchanges and suggesting dosing adjustments, according to Terence Starz, M.D., a rheumatologist at the University of Pittsburgh Medical Center (UPMC) and president-elect of the Allegheny County Medical Society.

Once the Act 102 regulations are finalized, institutional protocols will be free to permit pharmacists to act more independently, so long as it is within the authority spelled out in the agreement between physician and pharmacist, according to Michael J. Romano R.Ph., Chairman of the Pennsylvania State Board of Pharmacy.

This change in Pa.’s Pharmacy Act, touts Romano, “finally recognizes Pennsylvania pharmacists for their clinical expertise in the monitoring and management of drug therapy in an institution,” and adds Pa. to the 40 states that already allow collaborative drug therapy management agreements.

While protocol specifications are currently governed by the policies of individual institutions, Act 102 standardizes rules governing an institutional protocol – which it defines as “a written document that describes the nature and scope of the drug therapy management to be carried out by the pharmacist,” to be derived and managed by a committee of medical staff in an institution, such as a pharmacy and therapy committee.

The new rules mandate not only that there be a written agreement between licensed physicians and pharmacists, but also what must be included in such agreements. The agreements must be effective for a period not to exceed two years from the date of execution and must contain, among other requirements, a provision that drug therapy regimens be initiated by a licensed physician, and a provision detailing expedient physician notification (not to exceed 72 hours) when there are any changes in dose, duration or frequency of medication prescribed. Other requirements for the agreements include, but are not limited to:

· A statement identifying the types of drug therapy management decisions that the pharmacist is authorized to make, including a statement of the ailments or diseases involved within the physician’s scope of practice, and types of drug therapy management authorized.

· A statement of the tasks the pharmacist shall follow in the course of exercising drug therapy management authority, including the method for documenting decisions made, and a plan for communication or feedback to the authorizing physician concerning specific decisions made. Documentation of each intervention must occur within 72 hours in the patient medical record and must also be recorded in the pharmacist’s records.

· The signatures of the licensed physicians and licensed pharmacists who are entering into the written protocol, and the dates signed.

Additionally, the protocol must be within the scope of the licensed physician’s current practice. A physician cannot delegate above and beyond what he or she is licensed to do, says Romano.

New Pharmacist Roles in Retail Setting

The second new provision in the Act gives pharmacists working in a retail environment the authority to administer to persons over the age of 18 injectable medications, biologicals and immunizations, such as adult flu and pneumonia vaccines, as well as travel related vaccines – all under a written agreement, or protocol, with a licensed physician. Rules within the Act govern things such as record-keeping and prescribing physician notification, and do not permit a pharmacist to delegate the administration of injectable medications to another person.

The written agreement or protocol is valid for a time period not to exceed two years and must contain many of the provisions listed under the rules for managing drug therapy, as well as the following:

· The identification of the medication, biological or immunization, which may be administered.

· The identity of the patient or groups of patients to receive the authorized injectable medication, biological or immunization.

· The identity of the authorized routes and sites of administration allowed.

· A provision establishing a course of action the pharmacist shall follow to address emergency situations including adverse reactions, anaphylactic reactions and accidental needle sticks.

· A provision establishing a length of time the pharmacist shall observe an individual for adverse events following an injection.

· The identity of the location at which the pharmacist may administer the authorized medication, biological or immunization.

The order from a licensed prescriber must be written, received electronically or if received orally be reduced to writing, and contain the identity of the licensed prescriber issuing the order and the patient to receive the injection; the medication, immunization or vaccine, and dose to be administered; the date of the original order and the date or schedule of each subsequent administration, if any.

Whether managing drug therapy in an institutional setting or administering injections in a pharmacy, a pharmacist must have a written collaborative agreement with a physician, whose order or prescription still drives the care, and who retains veto power over the agreement at any time. In an institution, for example, an attending physician may chose to not participate in an institution’s protocol simply by requesting that such protocol not be applied to his or her patient.

Refinements and Rationale

While Act 102 was signed into law in 2002, the lengthy regulatory process is soon to be concluded. But there was another roadblock early on. “Being the first state to institute such changes is nothing to brag about,” says Carol E. Rose, M.D., an anesthesiologist at UPMC. Rose, who was president of the Pennsylvania Medical Society (PMS) at the time the regulation was first being considered, says that the PMS was not originally in favor of the proposed changes. “It was important to the PMS that participation be voluntary (by all parties), and that the relationship be formalized by a protocol, so that the care given by the pharmacist be essentially an extension of the physician’s care – not the independent practice of medicine by a pharmacist,” she says.

The PMS insisted that care be driven by a physician order or a referral from a physician, and that pharmacists have specific education requirements, including training in current guidelines and recommendations for cardio-pulmonary resuscitation, and for administrating injectable medications, biologicals and immunizations.

The regulation originally proposed expanding pharmacists’ drug therapy management capability to all pharmacy settings, including retail, but the PMS insisted that the expansion be limited to an institutional setting only, according to Coleen Kayden R.Ph., a Lancaster County pharmacist and past president of the Pennsylvania Pharmacist Association (PPA).

Kayden says the PMS was willing to hold up the entire regulation unless the authorization was limited to institutions, while the final version reflects a compromise so that the immunization piece would go through. Even with the compromise, Kayden believes the immunization authority is a huge success for Pa. pharmacists, as 37 states already allow pharmacist to administer vaccines. “It marks a move for our state’s pharmacists from a dispensatory mode to a more professional mode,” she says.

The PMS says it views an expanded practice of pharmacy as a positive development, as long as it remains within the scope defined in the regulation. The American Academy of Family Physicians, in its 2001 pharmacist position paper, said it supports physician-pharmacist collaboration, so long as the physician remains recognized as the “best trained to arrive at a diagnosis, in taking medical history and in doing examination.” The American College of Physicians – American Society of Internal Medicine (ACP-ASIM) says it supports the use of pharmacists as immunization information sources, hosts of immunization sites, and immunizers, as well.

According to the Alliance for Pharmaceutical Care (APC), research supports pharmacists as immunizers, especially when it comes to two vaccine-preventable diseases: pneumonia and influenza. APC, a consortium of ten national pharmaceutical organizations working to expand the scope of pharmacy practice through state legislation, writes that there are 20 “key” studies and demonstration projects that show evidence of the value of the pharmacist in an expanded clinical role. A 2000 study appearing in the International Journal of Pharmacy Practice, for example, showed that pharmacists providing flu and pneumonia immunizations increased vaccination rates in high-risk patients by 74 percent. According to the Centers for Disease Control (CDC), seasonal influenza killed 36,000 Americans in 2003 with pneumonia accounting for another 65,000 deaths that same year.

Implementation

Pa. members of the National Community Pharmacists Association (NCPA), an organization that represents pharmacists staffing nearly 25,000 independent pharmacies, are eagerly awaiting authorization to provide immunizations, according to Doug Hoey, R.Ph., the association’s chief operating officer. Immunizations, he says, will be an additional “niche” independent pharmacists can use when competing with the larger chains.

Chain pharmacies are planning to implement immunizations as well. “Immunization will be a priority for Rite Aid,” once the Act 102 regulations are passed, says Jody Cook, spokesperson for the Rite Aid Corporation. Dan Haron Brooks, Eckerd’s senior vice president of pharmacy, says his company is committed to a Pa. rollout as soon as allowed, and notes that Eckerd immunized close to 15,000 people last year in Massachusetts and Georgia alone. Eckerd has 1,854 stores across the country, 285 of which are located in Pa., while Rite Aid has approximately 3,400 stores, 349 in Pa.

Retail pharmacies have already begun expanding patient care offerings in Pa. Rite Aid, in partnership with University of Pittsburgh School of Pharmacy, has opened four “Rite Care” pharmacies in the Pittsburgh area this past summer, offering medication therapy management services (MTM). The sites are staffed by specially trained pharmacists who identify patients’ medication-based concerns and needs, and communicate them to the patient and his or her physician, says Patricia Dowley Kroboth, Ph.D., Dean, University of Pittsburgh School of Pharmacy. The intended patient is anyone who has a chronic disease, especially those who take multiple medications, she adds.

According to Kroboth, the Rite Care venture is not a result of the impending Act 102 regulations, but operates in accordance with federal regulation, meeting MTM requirements in the Medicare Modernization Act of 2003. Cook touts the Rite Care project as Rite Aid’s way of ensuring that their customers get the best results from their medications.

Pharmacies are expanding primary care services even further, as nurse practitioner-staffed primary care centers are popping up in chain pharmacies elsewhere in the country. The centers, which offer pharmacy-like hours including evenings and weekends, are independently owned and operated by companies such as MinuteClinic, which is currently partnered with CVS, and Conshohocken-based Take Care Health Systems (Take Care), which has partnered with Rite Aid, Osco and Eckerd. NPs at the centers provide diagnosis and treatment for common illnesses such as strep throat and ear, eye, sinus bladder and bronchial infections, as well as vaccinations and screenings. According to Take Care documents, the visits typically take 10-15 minutes and no appointment is necessary.

A supervising physician is always on call at Take Care and MinuteClinic centers, and physicians are compensated for things such as chart reviews. Moreover, patients with illnesses outside the scope of services offered at the center are referred to their physician or, if critical, to an emergency room. If a patient doesn’t have a primary care physician, a list of local physicians is provided.

“Our centers are not meant as a replacement for primary care,” says Regina Baime, M.D., an internist and Chief Medical Officer of Take Care. Instead, she says, Take Care takes a “team-based approach with other key health care providers, in order to function as a much-needed complement to care.”

At present there are no pharmacy-based centers in Pa., but that may change soon. “We are very motivated to enter Pa.,” says James Woodburn, M.D., chief medical officer of Minneapolis-based MinuteClinic, whose company plans to have centers in 10 markets with nearly 100 locations by the end of the year. Woodburn asserts that the consumer focus of the pharmacy-based center model is the reason for their success. Take Care, which opened its first center last year in Portland, has plans to open 1,300 centers by 2007, but has no immediate plans for Pa.

“The Take Care model foreshadows the emergence of a more efficient health care system,” according to David Nash, M.D., chairman of the Department of Health Policy at Jefferson Medical College, Thomas Jefferson University, and chairman, National Medical Advisory Board for Take Care. Research that illustrates a health care system in need of change, says Nash, includes a 2004 New England Journal of Medicine study of 12 large U.S. communities in which just over half (54.9 percent) of their residents were receiving the care they needed, and a Center for Studying Health System Changes report that utilization of emergency departments for nonurgent or semi-urgent care has intensified over the past two years.

The NP-staffed centers provide access to affordable high-quality care, not only for those within the system, but for those individuals “who need it most,” says Nash, including a growing number of underinsured and uninsured. Take Care’s low cost per visit is attractive to those concerned about being able to afford care, says Baime, noting that the average cost of care at a Take Care center is between $48 and $68, compared to the average cost for a routine doctor’s visit of over $100, and more that $300 at an ER.

Pa. insurers are receptive to paying for the pharmacy-based services. Highmark, the state’s largest health insurer, already contracts with independent certified NPs. According to a Highmark spokesperson, “Theoretically, if a group of CRNPs arranged to provide basic medical services in a retail store and then billed Highmark – we would reimburse.”

Quality Concerns

Scope of practice expansions by pharmacists and pharmacies shunt care to non-physicians, raising concerns about erosion of care quality. Continuity of care by a patient’s physician remains a concern. Any transfer of care involves some risk, particularly regarding possible breakdowns in communication, says Kate Kelly, Pharm.D., medication safety analyst at the Institute for Safe Medication Practices (ISMP). Protocols must provide for effective documentation and communication of care both ways, says Kelly.

Pharmacists, or in the case of the primary care centers – NPs – must have access to all essential patient information including complete medication history, comorbid conditions and patient allergies. Physicians must be notified about any care that has been provided or any changes in therapy in a timely manner, Kelly explains. The ISMP supports the new Act 102 pharmacy regulations, and Kelly believes that its rules for participation and protocol provide for effective communication.

The new regulations require pharmacists who are party to a written agreement or protocol to obtain and maintain professional liability coverage in the minimum amount of $1 million per occurrence or claims made – a requirement that Romano says acknowledges the risks of medical mishaps inherent to health care.

Advocates for the NP-staffed pharmacy centers say the processes in place at the centers ensure quality care that is communicated effectively. MinuteClinic and Take Care both use electronic medical records (EMRs) to track patients and their care, while NPs utilize a software program embedded in the EMR that provides evidence-based clinical practice guidelines that guides diagnosis and treatment. “The Take Care NPs are supported by standardized protocols that I am confident will ensure quality care,” says Nash. Take Care is also working to ensure effective communication by implementing a system in which primary care physicians and patients can securely access EMR encounter information online, according to Baime. “This electronic backbone decreases the chance of a failed handoff,” adds Nash.

Some physicians remain wary of the changes. Clinical guidelines are effective tools, says Starz, but nothing can replace the experience of a medically-trained physician on site. Starz explains that diagnosis is not cut and dry and that he worries that larger health issues, masked as simple ailments, will be missed by NPs working alone.

Paul W. Dishart, M.D., an internist and family physician in the Pittsburgh area concurs. “Who’s going to orchestrate patients’ health care needs,” he asks. Dishart believes immunizing pharmacists and NPs working independently, even with a physician on call, will result in a fragmentation of medical care. Doctors should be the ones in control of patient care, he says.

Physician Impacts

Physicians are also anxious about what primary care offerings at pharmacies will mean to their business and profession. Skeptical about who will be utilizing the centers, some physicians worry that it will be their patients, not the uninsured, who seek care at pharmacies. Dishart says he fears that some patients will go to the pharmacy for care instead of maintaining an ongoing relationship with a family physician. “It’s like a nurse in a box,” says Dishart. “It’s convenient and cheap, but at what cost? We’re already losing docs in Pa.,” he adds.

According to data provided by MinuteClinic, only nine percent of patients seen in 2004 were without insurance. Woodburn acknowledges a potential loss of volume by primary care physicians, but notes that the much of the care provided at his clinics is on evenings and weekends. Starz, on the other hand, does not believe Pa. physicians will suffer economic or professional damage. “Patients know and respect the role of the physician. That perception won’t disappear overnight,” he says. Furthermore, he contends that there aren’t enough doctors and there is enough business to go around. “The competition is good. We all need to find the most effective ways to deliver care,” says Starz.

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