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September 23, 2011

ASHP Driving National Effort to Manage Drug Shortages Crisis

DURING HIS LONG CAREER AS A PHARMACIST, RICHARD CARVOTTA, R.PH., M.B.A., has never experienced anything quite like the prescription drug shortages currently plaguing hospitals and health systems across the U.S. “I’ve been a director for 27 years, and the past year has been the worst I’ve ever experienced,” said Carvotta, director of pharmacy for St. John’s Hospitals in Oxnard and Camarillo, Calif. “The challenges presented to hospitals are immense.”

The results of two national surveys released at an ASHP Capitol Hill press briefing in July—one from ASHP and the University of Michigan Health System and one from the American Hospital Association (AHA)—attach some hard numbers to the scarcity:

• In 2010, there were 211 drug shortages, the highest number recorded in a single year. By comparison, 224 shortages were reported over the six-and-a-half-year period from January 1996 to June 2002.

Eighty-two percent of hospitals delayed patient treatment as a result of a drug shortage.

• Annual labor costs associated with managing shortages total an estimated $216 million nationally.

• Shortages of three drugs affected over 80 percent of health systems (dextrose, epinephrine, and succinylcholine injections).

• 99.5 percent of hospitals reported at least one shortage in the past six months, and 78 percent implemented rationing or restrictions for drugs in short supplyi.

The most obvious fallout from drug shortages are postponed treatment and less-than-ideal patient care, which results from either lack of good alternative therapies or, when alternatives are available, use of drugs that may have more side effects or be less effective.

Drug shortages also contribute to medication errors, because clinicians suddenly find themselves working with unfamiliar substitutes, or with strengths or dosage forms they ordinarily do not use. In a 2010 survey of more than 1,800 health care practitioners conducted by the Institute for Safe Medication Practices, 35 percent of respondents said that their facility experienced near-miss errors caused by a drug shortage in the previous year; about one in four reported actual errorsii.

A Public Health Crisis

Erin R. Fox, Pharm.D.

“The current situation is nothing short of a health care crisis,” said Erin R. Fox, Pharm.D., manager of the Drug Information Service at the University of Utah Hospitals & Clinics, Salt Lake City. “What makes the current batch of shortages even more difficult is that these are chemotherapy products and, in many cases, there are no alternatives. Patients are having their treatments delayed and may have their chance for a best outcome destroyed because of these shortages.”

Among the assorted reasons given for the shortages are industry consolidation; production stoppages related to noncompliance with good manufacturing practices; voluntary recalls or holds placed on production due to quality problems; interruptions in raw material acquisitions; limited manufacturing capacity in the face of increased demand; and manufacturers’ decisions to halt production of low-profit drugs.

Chemotherapy agents (for which there are few therapeutic alternatives), antimicrobials, and analgesics have been particularly hard hit.

Helping ASHP members manage drug shortages has become a top priority for ASHP. At the heart of the organization’s multifaceted strategy to help hospitals cope with the problem is its Drug Shortages Resource Center (the most frequently visited section of ASHP’s website). The center, created in 2001, disseminates detailed information on the status of current and resolved drug shortages, including expected resupply dates. This information is also shared with the Food and Drug Administration (FDA).

“Awareness of this issue is so great across the country that we don’t miss much,” said Cynthia Reilly, B.S.Pharm., ASHP’s director of practice development, whose team manages the ASHP resource center. “ASHP members play a critical role because their reports are often the first indication that a shortage is occurring.”

 A Legislative Solution?

ASHP is pressing for legislation that would give the FDA greater authority to manage shortages. A bill introduced in the House of Representatives in June requires all manufacturers of prescription drugs, including biologic agents, to notify the FDA of any discontinuance, interruption, or adjustment in the manufacture of a drug that may result in a shortage. Penalties for noncompliance run up to $10,000 per day, with a $1.8 million cap.

The bill requires the FDA to publish information related to manufacturing problems and shortages on its website.

Currently, FDA regulations require only that sole-source drug manufacturers send a six-month notice of an anticipated supply disruption. A similar bill introduced in the Senate in February does not yet include monetary penalties.

Joseph Hill

According to Joseph Hill, ASHP director of federal legislative affairs, ASHP is working closely with the sponsors of the bills in both chambers (Reps. Diana DeGette and Tom Rooney, and Sens. Amy Klobuchar and Robert Casey) and will continue to encourage bipartisan support.

“The intent of both bills is to create an early warning system so that the FDA can plan ahead when a shortage is looming,” said Hill. The added time would give the FDA an opportunity to work with other manufacturers to ramp up production of drugs about to go into short supply. (The agency does not, however, have authority to compel a manufacturer to increase production of a medically necessary product.)

In 2011, the FDA claimed to have averted 38 shortages the previous year when it was alerted in advance.

Given the highly contentious mood in Congress these days, it’s hard to say when either bill will move forward, but Hill is guardedly optimistic. The Senate recently formed a bipartisan working group to explore solutions to drug shortages. “Congress is not doing much bipartisan work these days, so I think this is significant,” said Hill. He anticipates some movement in the House of Representatives this fall.Missing Health Care Tools

Legislation is only one step toward a comprehensive solution to a complex and multifactor problem, said Bona Benjamin, B.S.Pharm., ASHP’s director of medication-use quality improvement. “There’s a large landscape of moving parts involved, and we need feasible solutions that won’t have unintended consequences, such as creating inequities in the marketplace,” she said. “We have to ensure that manufacturers of critically needed drugs continue to produce them.”

Benjamin works closely with the FDA and the University of Utah Drug Information Service to find innovative solutions to shortages, such as cobbling together comparable therapies from more plentiful drugs, and ensuring that clinicians receive all the necessary information they need to administer alternatives safely. “Health care workers are in the profession to help people get and stay well,” she added, “and drugs are an essential tool to achieve that goal. Right now we’re missing many of our fundamental tools.”

Carvotta, the pharmacy director, makes it clear just how high the stakes are: “Drug shortages have created a new world for hospital pharmacy, and we need to be creative and resourceful in coming up with alternatives,” he said. “But the time it takes to do this is absorbed by existing staff, and the productivity gurus have no idea about the work effort that is involved.”

Fox said that she loses a lot of sleep over the issue of shortages. “I talk to so many patients who can’t get their treatments,” she said. “I also talk to so many pharmacists who are worried about medication errors due to the high rate of shortages. It is an absolute nightmare for both patients and pharmacists.”

 i “Impact of Drug Shortages on U.S. Health Systems,” R. Kaakeh, B. Sweet, C. Reilly, C. Bush, S. DeLoach, B. Higgins, A. Clark, and J. Stevenson; AJHP, October 2011;


 Editor’s Note: For more information about drug shortages, read the accompanying interview with Erin R. Fox, Pharm.D., manager of the Drug Information Service at the University of Utah Hospitals & Clinics, Salt Lake City.  


Enacting Collaborative Drug Therapy Management Legislation

Gloria Sachdev, Pharm.D.

GLORIA SACHDEV, PHARM.D., calls her seven-month odyssey to win passage of an Indiana state law that expands collaborative drug therapy management (CDTM) for pharmacists a “wonderful eye-opening experience.” She would also prefer never to endure anything like it again.

“I’m trained as a clinician, and I’m used to moving quickly from Point A to Point B,” said Sachdev, clinical assistant professor of primary care at Purdue University, West Lafayette, Ind., and adjunct assistant professor in the School of Medicine at Indiana University. Until recently, Sachdev was also legislative chair for the Indiana Pharmacist’s Alliance (IPA).

“This ‘process’—and I use that term loosely—was like nothing I’ve ever experienced,” she said. “Things just kind of happened and then changed 180 degrees at the last second.”

Starting with the Grassroots

It all began in fall 2010, when the IPA’s Legislative Committee drafted a bill to permit Indiana pharmacists to adjust drug therapy per physician-signed protocol in any practice setting, as long as the pharmacist is under a physician’s direct supervision. At the time, Indiana allowed CDTM only in hospitals and long-term care facilities. (Currently, 48 states permit some degree of CDTM.)

Indiana State Capitol Building, Indianapolis

In January 2011, Rep. Steve Davisson, who happens to be a pharmacist, introduced the bill in the House. Sachdev learned that the bill first needed a hearing and a vote in the House Public Health Committee.

If passed there, the bill would proceed to the House floor, where it would have to pass two additional hearings. If it passed in the House, the bill would then float to the Senate, where it would proceed through a similar sequence. If the bill passed the Senate, it would proceed on to the General Assembly for a final vote. But first, the bill needed a House Public Health Committee hearing, or the bill would die. And it didn’t look like this first step was going to happen.

The IPA mounted a huge grassroots effort aimed at the committee chair: Physicians, hospital faculty, pharmacists, payers, and students wrote and called the committee chair, urging her to grant a hearing. Time was running out, and for a legislature embroiled in heated issues, the CDTM legislation was small fry.

But the grassroots effort paid off, and a hearing was scheduled for February 21, the last day of the committee’s schedule. Yet Sachdev was told the committee would likely not vote and instead push the bill into summer session—and almost certain demise. But the committee did vote, 11–0 in favor. “The whole thing took 10 minutes,” said Sachdev. “We were stunned and excited.” What happened next would also leave her stunned, though not so excited.

Back and Forth, and Back Again

Within hours, all but two of the 40 House Democrats bugged out for Illinois to thwart Republican efforts to pass anti-union legislation. None of the Democratic committee members had signed the bill. It died.

The Indiana House, in session

During the five-week Democratic boycott, the IPA’s lobbyist, along with Indiana Sen. Ron Grooms (the other pharmacist in the legislature), devised a strategy to resurrect the bill in the Senate as an amendment to another bill. After weeks more of legislative contortions, they worked something out. In the meantime, Sachdev undertook the critical task of getting the politically powerful Indiana State Medical Association (ISMA) to reverse its opposition to the bill.

“They were not a warm and fuzzy crowd,” Sachdev said. “About 50 people peppered me with questions for 20 minutes. I was smiling but nobody was smiling back.”

She succeeded. Briefly. Two days after coming out in favor of the bill, the group reversed its decision. Negotiations and several more ISMA flip-flops continued for two weeks and into the night before a hard-won Senate hearing (also held on the last day of its schedule). In the end, the group supported the bill.

Finally, on April 29th, the last day of the 2011 legislative session, the bill passed both houses—barely. A week later, the governor signed it into law, effective July 1. Sachdev calls it “the most important piece of state pharmacy legislation passed in over a decade.”

 ASHP Offers a Helping Hand

Along the way, Sachdev got some help from ASHP and other pharmacy organizations, such as strategy ideas and links to pharmacists who had enacted legislative change in their own states, as well as guidelines for preparing informational handouts for legislators.

“Our role is to support members and affiliates as a resource,” said Karen Noonan, ASHP’s director of state affairs and grassroots advocacy. “Advocacy is most effective and powerful if ASHP members tell their stories directly to legislators.”

In looking back over the legislative see-saw she encountered, Sachdev offered a few pieces of advice for colleagues attempting to pass CDTM legislation (or any pharmacy-related legislation):

•  Don’t underestimate the power of grassroots activism.

•  Enlist help from stakeholders beyond the pharmacy profession.

•  Engage your state’s medical association, which is not always in touch with frontline care issues but is often politically powerful.

•  Use pharmacists and other health care experts to build your case early on, then hand the baton to your lobbyists and give them whatever they need.

•  Invite legislators to visit pharmacy practices early in their session, when they’re less busy.

•  Don’t celebrate until the ink dries on the governor’s signature.   

24/7 Care via Remote Order Entry

The new remote order entry system at LSU ensures that medication reach patients in a timely manner.

THE JOINT COMMISSION AND ASHP strongly recommend that, when feasible, hospitals provide 24-hour pharmacy review of medication orders. But for the many hospitals nationwide that close their pharmacy departments at night, orders must wait until the following day to be reviewed, long after a drug has been administered. The delay leads to inefficiency and an increased risk of medication errors.

“It becomes a retrospective, not a prospective or concurrent, review,” said Michael Dorman, M.S., R.Ph., inpatient pharmacy director at Earl K. Long Medical Center in Baton Rouge, La., part of Louisiana State University (LSU) Health Care Services. In addition, pharmacists at facilities without 24-hour pharmacies might spend half of the next day entering orders from the previous night. “It becomes chaotic, because you have to clear the queue of overnight orders, then take care of new ones,” he said. “So, mornings were very hectic.”

That all stopped with the advent of a new remote order entry system in the LSU Health Care Services health system that ensures around-the-clock pharmacist involvement in the medication administration process. Now, when pharmacists come on duty in the morning, their queue is clear.

Making the Most Efficient Use of Staff

Three of LSU’s five outlying hospitals currently use remote order entry, with a fourth scheduled to join the system soon. The 24-hour pharmacy at Earl K. Long serves as the clearinghouse for all remote orders.

Michael Dorman, M.S., R.Ph., inpatient pharmacy director, Earl K. Long Medical Center

It works like this: At closing time for the pharmacies at each rural hospital, the remote order entry system activates automatically. All medication orders are scanned and diverted to the 24-hour pharmacy at Earl K. Long, where they are reviewed and entered into the pharmacy information system for the originating hospital. After the order has been reviewed and approved, the medication can be retrieved from an automated medication dispensing machine located on the originating hospital’s nursing unit.

 The next morning, a pharmacist at the originating hospital double-checks the overnight orders for accuracy and electronically signs off to complete the process. Urgent situations in which a delay in drug administration would harm the patient, as well as orders controlled by a licensed independent practitioner, are not subject to the remote order entry protocol.

“Overall, this is an innovative way to get the job done. It frees us up from having to employ a pharmacist here overnight and makes the most efficient use of our available staff,” said Todd Fricker, R.Ph., a staff pharmacist at Lallie Kemp Regional Medical Center. The 25-bed hospital in Independence, La., was the first in the LSU system to use remote order entry when the system went live in May 2009. “There’s no break in service continuity between shift changes, and it expedites order processing,” he said.

A Flexible System

In 2010, the number of remote orders averaged 5,675 per month, or 28 percent of all orders entered at Earl. K. Long, according to Dorman. The increase in workflow there necessitated the addition of two overnight pharmacists, each working seven days on and seven days off. Even with the addition of staff, Dorman estimates that LSU Health Care saves nearly $541,000 annually, because remote order entry obviated the need for similar staff increases at the outlying hospitals.

“We’re essentially doing the same amount of work with two pharmacists that six pharmacists would typically perform,” he said.

At the same time, remote order entry puts nurses in closer touch with pharmacists, according to Danny Jackson, Pharm.D., system pharmacy director for LSU Health Care. “There’s quite a bit of interaction between pharmacists at Earl K. Long and nurse supervisors at the rural hospitals,” he said.

The fact that the LSU Health Care pharmacy information system was already standardized across all facilities (with all hospitals sharing the same computer server) made implementing the remote order entry system easier. With it, pharmacists can log in from any location and call up records of any patient within the LSU system.

Pharmacist Vanessa Pourciau utilizes the LSU remote order entry system.

“If you’re about to embark on remote order entry, the more the host and remote location systems are matched with regard to formulary, protocol, and processes, the smoother things will go,” said Jackson. “It’s a lot easier than having to go back and standardize things after the fact.”

He added that LSU has not yet determined the impact of remote order entry on medication error rates, because a number of performance improvement projects, such as bar-code medication administration, were implemented throughout the LSU system in a short time span. “It’s difficult to isolate the impact of each one,” Jackson said.

“Right now, we’re collecting data to compare pharmacy entry errors at the remote location [Earl K. Long] versus the home locations to see if any patterns or issues show up,” he said.

Pharmacists Answer Call to Serve in Wake of Storms

The Tuscaloosa, Ala., tornado in April of this year came within a block of DCH Regional Medical Center.

NONE OF THE PATIENTS WORE SHOES. Yet they would have to cross rain-soaked hallways strewn with broken glass, shards of concrete, and twisted pieces of metal to reach the stairwells. Tim Holding, Pharm.D., remembers wanting to give his shoes away, but he needed them to carry patients over the debris and help the ambulatory patients walk down six floors.

Just a couple of hours earlier, Holding, a staff pharmacist at St. John’s Mercy Hospital in Joplin, Mo., was worried that the coming thunderstorm would pelt his car with hail, now that the parking garage had been torn down. From a south-facing patio, he watched the black wall of clouds approaching and heard the sirens go off. Holding went back in. Moments later, “Execute Code Gray” blared from hospital loudspeakers: Staff on the units would have to physically move or otherwise protect patients.

Pharmacy’s Location a Blessing

Holding was back in the pharmacy working on a vancomycin consult when the tornado’s 200-mile-per-hour winds made a direct hit. Ceiling tiles shook loose and dust filled the room, but the pharmacy’s central location protected it from the worst. “I always complain that hospital pharmacies are in the middle of the hospital, and we never have a view,” he said. “This one time I was glad that we didn’t.”

Patient-care rooms in St. John's Mercy Hospital in Joplin, Mo., were demolished in the EF5 tornado that hit the city in May.

Less than a minute later, Holding opened the door onto the ruins. Main and backup generators had been wrenched from their foundations, and it took Holding and some pharmacy technicians 15 minutes to find a working flashlight before they could venture into the darkened and treacherous hallways.

Word reached Holding that patients were trapped on the sixth floor, so he and a technician headed up. In one corner room, the south and west exterior walls were simply gone, and Holding could see three rooms down to the east. The bed, still containing an elderly woman, had spun completely around, but she was unharmed. “If patients couldn’t walk, we used mattresses, wheelchairs, any means possible to get them down,” Holding said.

Later, at a temporary dispensary set up a block away, the formulary dwindled to the point where Holding had to tell physicians what their options were. A makeshift hospital went up inside the town’s Memorial Hall a mile away. It has since been replaced by a modular system next to St. John’s.

That day, six people at the hospital were killed and several more died of their injuries. Overall, more than 150 people lost their lives and thousands were injured in the terrifying storm. The massive tornado’s power was enough to deform the hospital’s steel supporting beams. St. John’s will be demolished and rebuilt.

“For more than a month afterwards,” Holding said, “I thought about it pretty constantly—what I should have done, where I should have been.”

Doing Whatever It Takes

The EF5 tornado that destroyed much of Joplin on May 22, 2011, was among the worst in an exceptionally destructive and deadly year for the storms. On April 14, a tornado turned one caregiver into a victim. U.S. Public Health Service (USPS) LCDR Brian Johnston, D.Ph., facility director and chief pharmacist at the Choctaw Nation Health Clinic in Atoka, Okla., was at home and in the midst of a live chat session for an ASHP Foundation Leadership Academy capstone course when tennis-ball-size hail started falling. The twister was his house minutes later. Johnston, his wife, one of his two daughters (the other was out of town), and their puppy hunkered under a mattress in the laundry room as the winds ripped their house apart.

The family walked out unscathed. For the next eight-and-a-half weeks, weeks, Johnston and his family lived in a motel room, then a rented house 30 miles from home while waiting for their house to be rebuilt. A September move-in is planned. “We’re slowly getting our lives back on track,” Johnston said.

Johnston has been on the other end of disasters as well. In September 2004, as a USPS lieutenant, Johnston was deployed to Florida to care for victims of the “hurricane train” that ravaged much of the state that year.

“It was, hands down, the best thing I’ve ever done in my job,” he said. “I had my clinical area of expertise, but if they said, ‘Hey, go haul some oxygen bottles’ or ‘Give this guy a bath’ or ‘Change bedding,’ I didn’t care.”

The Desire to Help People

Tim Martin, Pharm.D., director of pharmacy at DCH Regional Medical Center in Tuscaloosa, Ala., understands the sentiment. On April 29, Martin was at work when a 1.5-mile-wide funnel swept within blocks of the hospital. Immediately after the storm passed, the casualties began descending on the largely undamaged facility. Forty-three people were killed and thousands injured in Tuscaloosa alone.

“In the emergency department, we saw 800 people in six hours,” said Martin. “What I did in there had nothing to do with medication distribution or therapeutic decisions. I did whatever was needed. Your instincts kick in, and I think those are the same instincts that bring many people into the pharmacy profession: You want to help people, and the hour presented itself when we were able to do that.”

Editor’s Note: For more personal storm stories told in pharmacists’ own words, go to “In There Own Words.”

Cleveland Clinic Hospitals Lead Way on Quality-of-Care Measures

STARTING IN OCTOBER 2012, Medicare will reimburse hospitals based on quality-of-care measures, including how closely hospitals follow best clinical practices and how satisfied patients are with their care. “All institutions now have a heightened awareness of the need to perform better because of Medicare’s pay-for-performance reimbursement that’s coming,” said Michael Hoying, R.Ph., M.S., director of pharmacy for Fairview-Lutheran Hospitals, part of the Cleveland Clinic Hospital System. A New Opportunity for Pharmacists  Among the factors that Medicare will consider in its incentive calculus will be drug-related process-of-care measures for patients with congestive heart failure (CHF)—specifically, the percentage of patients with CHF evaluated for left ventricular systolic (LVS) function and the percent of CHF patients with LVS dysfunction who received an ACE inhibitor or an AR blocker. A year ago, Fairview-Lutheran’s respective scores for this patient population hovered around 93 percent and 86 percent, both below national averages.

Michael Hoying, R.Ph., M.S.

Hoying recognized an opportunity for pharmacists to improve the scores and reach organizational goals of 100 percent compliance. “The pharmacy was not consistently involved with heart failure measures, and we saw that we could do a better job of identifying patients who needed their CHF core measures reviewed.”

In August 2010, Fairview-Lutheran’s night-shift pharmacist began a nightly review of a computer-generated data pool, looking for all patients admitted to the hospital that day with a primary or secondary diagnosis of CHF. For patients with CHF whose most recent echocardiograms showed ejection fractions of less than 40 percent and who had received either an ACE inhibitor or AR blocker, the treatment is documented in the electronic medical record (EMR).For those who had not received drug therapy, the pharmacist checks the EMR to determine if there are valid reasons for why it has not been ordered. If none are found, the patient’s record moves to a follow-up list. Patients for whom a new echocardiogram had been ordered are also placed on the follow-up list.The next morning, a pharmacist reviews the follow-up list and obtains either a medication order for appropriate treatment or documentation of a medication variance. A cardiology nurse practitioner who is part of the daily clinical staff coordinates the final resolution to ensure that the core measures have been met.

“Where we faltered in the past was documenting why an ACE inhibitor wasn’t on board,” said Hoying. “That’s where the pharmacists have really filled a role and made sure that there’s either a good reason why the therapy wasn’t ordered, or have tracked down the physician to get the order if there’s no reason why the patient shouldn’t be receiving the drug.”

Over the next few months, the number of CHF patients screened monthly quadrupled. Fairview-Lutheran reached—and has maintained—100 percent compliance with core CHF measures by the last quarter of 2010.

“At first, managing the list was a little overwhelming,” noted Erin Barnett, Pharm.D., clinical specialist II at Fairview-Lutheran, “but soon we were able to easily integrate the new procedures.”

Connecting Patients and Pharmacists

Last March, Hoying turned to another factor that will weigh heavily in the Medicare incentive calculations: the Hospital Consumer Assessment of Health Care Providers and Systems (HCAHPS) survey. HCAHPS is the first national, standardized, publicly reported survey of patients’ perceptions of their hospital care. The results will count for 30 percent of the Medicare reimbursement score. For the two survey questions about how well patients were informed about new medicines during their stay, Fairview-Lutheran scored poorly.

Hoying initiated a pilot program on one 36-bed unit that increased the number of direct encounters between pharmacists and patients. The goal: improving communications about new drugs.

Prior to pharmacist involvement, overall communication about medications for the unit ranked in the 17th percentile among comparably sized hospitals. For describing what a new medicine was for, it ranked in the 55th percentile, and for describing possible side effects, it ranked near the bottom, in the 2nd percentile.

By the second quarter of 2011, the unit had jumped to the 96th percentile for overall communication about medications, and to the 99th and 90th percentiles, respectively, for the other two measures.

“We’ve had a huge impact,” said Hoying. “I plan to use the data to make the case for greater resources and to start a residency program, which would allow us to expand our coverage to other units.” He’s already added two pharmacists to his staff.

“The story at Fairview-Lutheran demonstrates how pharmacists can really improve patient outcomes as well as their hospital’s ranking,” said David Chen, R.Ph., M.B.A., director of ASHP’s Pharmacy Practice Sections and Section of Pharmacy Practice Managers. “This shows how much they can make a difference.”

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Creating an Anticoagulation Service in a Community Pharmacy

Filed under: Provider Status,What Worked for Me — Tags: , , , , , , , — jmilford @ 11:05 am

From left, Michah Hata, Pharm.D., and Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, FCPhA

THE MEDICAL LITERATURE is filled with examples of how anticoagulation services managed by pharmacists help reduce the number of anticoagulation-related emergency room visits and hospitalizations. This, in turn, results in significant cost savings1.

Typically, these types of clinics only occur within health systems or medical group practices. But as pharmacy faculty members, I and my colleague, Micah Hata, wondered if this collaborative practice model could be implemented in a community pharmacy.

Overcoming Challenges

So, we worked with a community pharmacist owner in Arcadia, Calif., to add patient care services to his pharmacy. The pharmacy has a private area that can be used as a treatment room to provide patient confidentiality.

We faced a number of major challenges with this project, including:

• Physicians’ resistance to a community pharmacist managing their patients’ warfarin therapy,

• Patient concern about the pharmacists’ capability to manage a therapy that posed significant risk, and

• Payers’ lack of familiarity with community pharmacists’ billing under the major medical plans for services as well as pharmacist-managed medication therapy.

The first task in implementing such a service was to find a licensed physician to medically approve our warfarin management protocol. The second step was to obtain an FDA “Clinical Laboratory Improvement Amendments Waived” testing laboratory certificate so that the pharmacy could officially be recognized as a licensed laboratory. Both tasks were completed by the end of June 2009.

We then faxed a letter along with our physician referral form to the offices of four doctors in our community. The letter detailed the services we would be providing. Within two weeks, the four physicians began to refer patients to our clinic.

Two years later, we have 25 physicians who regularly refer their patients to us. The interesting thing is that we have never marketed to any physicians other than the original four. Therefore, the network of referring physicians has been developed by word-of-mouth among physicians and patients.

A Success Story

Patients have easily accepted pharmacists as providers of direct patient care services, including anticoagulation services. In fact, they have all commented on how much they prefer the pharmacy-based services. We currently have 71 active patients who utilize our services, many of whom have been with us since our debut.

Success in obtaining reimbursement from the patient’s insurance company has been the major challenge. Pharmacists were not listed as approved providers in the original Medicare Act. As a result, we cannot bill Medicare via Palmetto, Medicare’s intermediary claims processor. On the other hand, if the patient has a PPO as either a primary or secondary payer to Medicare, then we can bill the private payer.

One major payer in California initially refused to accept our claims because it had never seen pharmacists bill the major medical plan. Over time, we worked with this payer and responded to every question. We circumvented its refusal to acknowledge pharmacists as providers by starting a group practice, which the payer was willing to accept as a provider in its network.

We were finally informed that we are now listed as a provider in the payer’s network and now receive reimbursement. There are a number of other payers we are billing and from whom we receive reimbursement. Medicare Part B continues to be a problem, and we plan to inform our patients that reimbursement from Medicare is not available.

The best outcome of this new venture is that none of our patients have had problems with adverse events that necessitated a trip to the ER or admission to the hospital as a result of their anticoagulation therapy. In fact, we are now also receiving referrals for the collaborative management of diabetes Type II patients as part of our medication therapy management approach.

It’s clear from our experience that pharmacist-managed direct patient care services can be implemented in a community pharmacy.

By Roger S. Klotz, R.Ph., BCNSP, FASCP, FACA, FCPhA,  and Micah Hata, Pharm.D. Both authors are assistant professors at Western University of Health Sciences, Pomona, Cal.

1 Comparison of “Two Different Models of Anticoagulation Management Services with Usual Medical Care,” Rudd, KM, Dier,  JG; Pharmacotherapy, April 2010; 30(4): 330–338.

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