COVER STORY

LET'S COLLABORATE

Here's how to get more R.Ph.s to use their prescriptive authority, allowed in most states but lagging in practice

Magaly Rodriguez de Bittner, Pharm.D., CDE, has to know geography as well as pharmacy. As the coordinator for Giant Brands' diabetes education program, she works at grocery store pharmacies in Delaware, Maryland, New Jersey, and Virginia. Giant offers the same pharmacy-based diabetes education program in 160 stores, but the pharmacist's role is different in each state.

"Virginia lets pharmacists manage drug therapy by protocol with physicians," Rodriguez de Bittner explained. "I can perform clean waste tests, such as finger sticks, in the store. A mile away in Maryland, I cannot do testing at the store, but the patient can. The patient has to stick his or her own finger in front of me. The different practice acts make it difficult to institute collaborative drug therapy management chainwide. It is very confusing."

The American Pharmacists Association is just as confused. APhA counts 45 states that allow some sort of collaborative drug therapy management (CDTM). ASHP counts 39 and four pending (see table). Either way, each state has its own version of collaborative practice and collaborative practice protocols (CPPs).

List of states by statutory and regulatory authority

Equally unclear is how many pharmacists, pharmacies, and practice settings are involved in CDTM. "You may see things in statute and regulation, but that does not mean it is being implemented widely," cautioned Janet Haebler, M.S.N., R.N., senior associate director, Practice and Governmental Affairs Program, for the New York State Nurses Association. NYSNA has been battling New York pharmacy organizations over CDTM for years (see "A battle over turf" box). But CDTM has been slow to spread, even in states that have approved the practice and implemented regulations.

"Collaborative practice is a concept that states are empowering and accepting," said National Association of Boards of Pharmacy executive director Carmen Catizone. "It is accepted well but not implemented well."

Catizone sees three major barriers to CDTM. To start with, pharmacists in many states are not sure what type of collaborative practice is allowed. Once R.Ph.s find out what they can do, he said, they have to find prescribers with whom they can sign protocols and collaborate. Then they have to figure out how to get paid. "You can set up all these collaborative relationships, but it's still hard to get paid," he cautioned. "Patients have to see the value of these relationships and demand the services if CDTM is going to succeed."

Getting started

Most states explicitly authorize CDTM in their pharmacy practice act, noted Susan Winckler, APhA VP for policy and advocacy. Most states borrow from model acts created by APhA and NABP. And most states have made substantial changes to model language in order to meet local political needs.

Some states allow CDTM in all practice settings, some only in hospitals, some in nursing homes but not ambulatory care clinics, and some in ambulatory care but not long-term care. Some states base CDTM on where the patient is located. Other states regulate based on the pharmacist's setting.

Some states allow R.Ph.s to administer immunizations but not to modify drug therapy. Some allow the opposite. Some allow R.Ph.s to begin drug therapy but not to end it, some to end but not to begin. Some states allow pharmacists to immunize children but not adults. Some allow no immunizations.

Adding to the confusion are states that are silent on collaborative practice. That can give pharmacy boards more flexibility to regulate CDTM, prohibit the practice entirely, or allow de facto collaboration as long as no one objects.

Whether CDTM comes by way of legislation or regulation, state boards and state associations need to take the lead in helping pharmacists understand their own flavor of CDTM. "New law is great, but it doesn't mean much unless pharmacists act," Winckler said. "Pharmacists aren't always clear on what they are allowed to do. When presented with a road map, they are interested. But the profession, the associations, and the boards have to provide that guidance. Not knowing where you can go can be discouraging for pharmacists who want to expand their practice."

Pharmacists in Washington hit that great question mark in the road more than two decades ago. The state amended its practice act in 1979 to allow pharmacists to initiate and modify drug therapy under written protocol with a prescriber, said Rod Shafer, CEO of the Washington State Pharmacy Association (WSPA). A 1994 revision allows pharmacists to administer drug therapy, including immunizations. "It seemed like the right thing to do at the time," he said. "Physicians just didn't see collaborative practice as a threat. Everybody was fat and happy. If we had to do this today, we'd have to fight some of the same turf issues you see in states like New York."

But amending the practice act and adopting regulations to implement CDTM weren't enough. For the first few years, Washington pharmacists largely ignored CPPs. "Nobody knew what protocols were or how to use them, especially in the community setting," explained Don Downing, pharmacy director at Takopid Health Center in Tacoma and associate clinical professor at the University of Washington School of Pharmacy in Seattle.

"It was easier in the hospital, where collaborative agreements were just an extension of standing orders, which everybody was already comfortable with," said Downing. "In the community, pharmacists were worried about what regulations they might bump up against. We were reluctant to step forward and try something new."

The initial push for CPPs didn't even come from pharmacists, Downing said. It came from dentists who asked pharmacists to take care of adjusting fluoride refills for pediatric patients based on age. Success with dental refills encouraged pharmacists to venture into medical refill protocols. CPPs got a boost in the late 1980s and early 1990s as the board of pharmacy opened its protocol files. That let pharmacists use existing CPPs as templates for their own programs.

The biggest jump in CPPs came in the late 1990s. WSPA, the state board of pharmacy, and Washington's two pharmacy schools joined forces to promote collaborative practice. The three groups reworked continuing education courses into turnkey collaborative practice programs. The main elements include formal education and certification; a selection of template protocols based on successful CPPs; a list of prescribers ready to work with pharmacists; a how-to manual; and preapproved payment options, including private pay, state Medicaid, sample Medicare assignment forms, and a growing list of third-party programs.

"Collaborative practice increased exponentially with the three pillars of pharmacy behind it," Downing said. "You need turnkey programs, and you have to hold a lot of pharmacists' hands. But once they do the first few patients, they're eager to jump in. You have to set up the support systems, and you have to educate pharmacists very carefully."

Most pharmacists see collaborative practice and discover two immediate fears, Downing explained. They worry about personal responsibility for patient outcomes and about liability insurance. "It's one thing to fill a script for warfarin," he said. "It's something else to take responsibility for that patient's outcome. Most pharmacist education and experience is passive. You are ancillary to somebody else—the physician. Taking on that responsibility yourself is a hurdle that needs to be addressed up front. It is absolutely critical to implementing collaborative practice."

Insurance is a non-issue, Downing continued. In 20-plus years of experience, he said, Washington pharmacists and physicians have not faced a single lawsuit based on collaborative practice. CPPs have not affected liability insurance rates because there has been no negative experience.

That is almost true, said Ken Baker, VP and general counsel for Pharmacists Mutual Insurance Co. His firm has seen a handful of liability claims based on collaborative practice, he said, but no cases in which the pharmacist made an error in judgment. In reality, he said, collaborative practice increases the practitioner's liability exposure because more independent judgments are being made. But the increased exposure has not translated into increased claims. That means no change in rates for pharmacists who sign CPPs.

"Our liability insurance coverage already includes collaborative practice in states where it is included as part of the practice of pharmacy," Baker said. "But other companies may not recognize collaborative practice as part of the practice of pharmacy. If you are going to engage in the activity, you have to be clear that it is allowed in your state and that it is covered in your insurance policy."

Finding collaborators

The next step is finding prescribers who are willing to collaborate. Sometimes it comes with the job. In Colorado, Kaiser Permanente has about 100 pharmacists working under CPPs, up from five in 1992. Many were hired specifically for collaborative practice, said Kaiser Permanente Colorado Region clinical pharmacy services director Kent Nelson.

They are initiating, administering, and monitoring drug therapy in primary care, cardiac care, anti-coagulation therapy, international travel, medication triage, and other specialties, even though Colorado has no CDTM statute. "We are acting under the state medical act, which allows physicians to delegate prescribing authority," Nelson explained. Kaiser's key is to hire pharmacists with advanced clinical training.

Physicians draw distinctions within their own profession based on board certification and other professional standards, Nelson noted. It is natural to recognize certification from the Board of Pharmaceutical Specialties (BPS) certification, advanced residencies, and other specialized training in other professions.

When Nelson started Kaiser's first pharmacy-based nephrology service, he hired an R.Ph. with a nephrology residency. Nothing else would do. "The advanced training requirements are absolutely nonnegotiable," he said. "If we don't have the qualified people, we don't do the program. If we didn't have those stringent requirements, I'm not sure we'd have the same degree of cooperation from the medical staff."

Cooperative prescribers can be harder to find in the retail world. When a drug chain is involved, Rodriguez de Bittner said, all the R.Ph. has to do is follow the certification or training standards set by the state. The chain typically handles details such as marketing, finding prescribers, and drawing up the CPP.

Independent pharmacists are on their own. That can be either a burden or an advantage, said Les Krenk, owner of Maui Clinic Pharmacy in Hawaii and president-elect of the Hawaii Pharmacists Association.

In some cases, board-required training and certification courses include prescriber referrals. That is particularly true in high-profile services such as smoking cessation and emergency contraception, he said. For the pharmacist-entrepreneur, he said, the door is wide open. Pharmacists who are certified diabetes educators (CDEs) have an easy time finding physician partners.

"Physicians who see a lot of diabetics see the benefits of collaborative practice," Krenk explained. "The physician knows that I know more about diabetes and diabetes treatment. And the physician knows that I have more time and better economics to deal with the patient. He has five minutes with the patient and five minutes to do his notes, I have 30 minutes with the patient. That doesn't take a lot of convincing."

Another pharmacist who engages in collaborative practice is Michael Cinque in Philadelphia. As a pharmacy owner, he joined forces with three other independents to form ExcelleRx in 1996. The company now manages medications for about 25,000 hospice, organ transplant, and pain patients in three dozen states. ExcelleRx employs about 50 clinical pharmacists at centers in Philadelphia, Memphis, and Tempe, Ariz. They don't evaluate patients, Cinque said, they evaluate medication therapy based on nursing evaluations, lab reports, medication profiles, and current best practices.

Depending on state requirements, ExcelleRx pharmacists either recommend therapeutic changes or modify therapy themselves. About 99% of recommendations are accepted by physicians, Cinque added.

Use of Web-based forms and services make communication among pharmacist, prescriber, and nurse faster, easier, and less prone to errors than traditional paper charts and handwritten orders, Cinque added. "Technology is the great equalizer," he said. "The real issue in a collaborative practice model is communication. The total focus on drugs and drug therapy management is what sets pharmacists apart. When you communicate that message, prescribers are open to collaboration."

Follow the money

ExcelleRx doesn't worry about payment. The company works on a per-diem fee from hospice and other care organizations.

In Hawaii, Krenk has also found reliable payment mechanisms. Local Blue Cross Blue Shield programs pay pharmacists for diabetes education. He also gets a 10% boost in Rx volume from diabetes referrals. More important, he sells an average of one glucose meter every day. That is up from one a quarter before becoming a CDE. "We don't have to look to our internal customers for growth," he said. "We're getting referrals from cooperating physicians. Collaborative practice is a growth market for any pharmacist willing to go for it."

But getting paid for collaborative practice doesn't have to mean building a national company or going after time-consuming certification. Pharmacists and pharmacy chains in many states are doing well with relatively straightforward services such as immunizations, smoking cessation, and emergency contraception.

The common key, WSPA's Shafer said, is consumer demand. Most Washington pharmacies charge AWP plus around $10 for immunizations, he said. For influenza, that translates to about $15 per patient. Other common immunizations include pneumonia, hepatitis B, diphtheria-tetanus, and travel products.

Washington pharmacists administered about 200,000 immunizations in 2002, Shafer said. Nearly all were paid in cash. "The service has to be useful and somebody has to be willing to pay for it," he said. "The financial side has to be put on the table when you consider collaborative practice. You have to see an adequate return on your investment."

So far, Washington's business model seems to be working. Nearly 1,000 CPPs have been filed, Shafer said. Most are for high-demand services, including immunizations; EC; and, most recently, smoking cessation.

Collaborative practice began among independents, but chains have also joined the game. Fred Meyer, Walgreens, and Rite Aid, the major chains in Washington, all participate in collaborative practice. "Chains are not the most innovative thinkers," Shafer said. "But once you clear the road, they'll run right over you to implement a program. They have the space, the people, and the marketing resources to make it happen."

Fred Gebhart

Watch your back

Legislative movement on collaborative practice isn't always forward. Alaska pharmacists are battling an attack on collaborative practice protocol (CPP) regulations approved in 2002. The issue? Emergency contraception (EC).

"One of our state senators wants to get us out of the EC business," explained Terry Babb, president-elect of the Alaska Pharmacist's Association. "The only way he could do it was a bill to blow up the whole idea of collaborative practice. The problem is that collaborative practice is being used in a lot of areas, not just EC."

Collaborative drug therapy management has been the standard in Alaska since the state amended its pharmacy practice act in 1996. Pharmacists promptly began signing CPPs for immunization and for therapy monitoring for anticoagulation, alcohol dependence, and other problems. Outside Alaska's few urban areas, Babb noted, R.Ph.s are typically the only healthcare professionals available on a regular basis.

Immunizations and drug therapy monitoring created little controversy, Babb continued. Problems began when Alaska pharmacists started pushing for regulations to formalize existing protocols and clear the way for EC protocols.

The state pharmacy board adopted CPP regulations last year. "The law had finally caught up with the way we practice pharmacy in the state," Babb said. "Now we are very concerned about patient safety if collaborative practice goes away."

CPP is still the law in Alaska. But the bill has another chance for passage this fall. "We have a serious fight on our hands," Babb said. "It is embarrassing as a profession to be at risk to take a huge step backwards. I worry that we will be setting a precedent for other states as well."

A battle over turf

Creating collaborative practice can be a slow process. Hospital pharmacists in Pennsylvania spent eight years striving to obtain this expanded right, finally winning approval earlier this year. New York pharmacists have been fighting since the early 1990s.

Nursing home physicians and hospitals like the idea, said Craig Burridge, executive director of the Pharmacists Society of the State of New York. But statewide physician and nursing associations remain opposed. "It's a very political issue," he said. "We're talking about managing the drugs a patient is taking, not diagnosing. The nurses aren't willing to make that distinction."

The New York State Nurses Association (NYSNA) readily admits that hospital pharmacists in New York are doing what would be collaborative practice in other states. Pharmacists are rounding with physicians and nurses, educating patients on drug therapy, and making recommendations on drug therapy changes. The nurses' group doesn't want pharmacists to turn those therapeutic recommendations into therapeutic decisions that are now restricted to physicians and nurse practitioners.

"For 30 years, I have valued collaboration and consultation with pharmacists," said Janet Haebler, M.S.N., R.N., NYSNA's senior associate director, Practice and Governmental Affairs Program. "Their expertise is incredible. But if you adjust drug dosing, you have to be able to diagnose. We want to see that authority remain with one person to avoid potential confusion."

Burridge said the lack of collaborative drug therapy management is exacerbating New York's R.Ph. shortage. About 25% of N.Y. pharmacy grads practice elsewhere, he said. Three times as many N.Y. pharmacists reciprocate licensure out of state as out-of-state R.Ph.s reciprocate into New York.

"If you have a Pharm.D., you are not going to practice in a restrictive state like New York," Burridge said. "You're going to go to another state with a broader scope of practice where you can actually do all the clinical things you learned in pharmacy school."

Sharing the pain

Pharmacy associations have to navigate the idiosyncrasies of state pharmacy practice acts every year at the National Conference of State Legislatures. The Alliance for Pharmaceutical Care, a group of 10 national pharmacy groups, runs one of the largest booths at NCSL.

Pharmacists offer legislators and other attendees free screening for cholesterol, diabetes, respiratory and cardiovascular diseases, osteoporosis, and body fat analysis. The idea is to introduce legislators to ways pharmacists can improve healthcare quality and decrease costs. But pharmacists are often restricted to talking instead of doing. In many states, the alliance has to hire independent laboratory providers to conduct tests that pharmacists routinely run and order under CDTM.

"We point out that the people providing these great services are pharmacists—or could be pharmacists if the state practice act and regulations allowed us to perform to our training," said Les Krenk, president of the Hawaii Pharmacists Association and regular APC volunteer. "The idea is that legislators personally experience pharmacy services and carry the message home."

 

Fred Gebhart. Cover Story: LET'S COLLABORATE. Drug Topics Sep. 1, 2003;147:58.