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November 20, 2012

With Relentless Focus, ASHP Helps to Enact Drug Shortages Legislation

Richard Paoletti, M.B.A., R.Ph., FASHP, vice president of operations, Lancaster General Health, Penn., testified about shortages before the U.S. House Energy and Commerce Health Subcommittee in 2011.

The story of how ASHP helped achieve new legislation addressing national drug shortages is one of persistence, a singular focus on a major health care problem, and an all-encompassing commitment to patient safety.

“This is really a story about how, when pharmacists work together, we can change our health care environment to keep patients safe,” said ASHP CEO Paul Abramowitz, Pharm.D., FASHP. “This is a story that shows the power of community and the effectiveness of grassroots advocacy.”

A Growing Problem

Drug shortages have long been a fact of life in many hospital and health-system pharmacy departments. The University of Utah Drug Information Service, which partners with ASHP to provide content for the Society’s Drug Shortage Resource Center, recorded 274 shortages between January 1996 and the end of 2002.

But over the last decade, shortages have been rising exponentially. In 2007, there were 129 recorded shortages. That number jumped to 211 in 2010. Although the reasons for the shortages differ, including manufacturing issues, the discontinuation of drugs deemed unprofitable by the manufacturers, and problems with raw materials, the results have been the same: Pharmacists and other clinicians scrambling to find suitable alternatives, and patients forced to switch medications, experience delays in treatment, or simply go without.

“In 2010, the issue reached a fever pitch,” said Cynthia Reilly, B.S. Pharm, ASHP director of practice development. “We started to experience shortages that weren’t just a challenge for pharmacists. They were having an impact on patient care, and there was an increased potential for harm when both health care practitioners and patients either had to use medications they weren’t familiar with or experience interruptions in therapy.”

As evidence of the detrimental impact of drug shortages mounted, ASHP mobilized, and what followed is a success story of grassroots advocacy.

Gundy Sweet, Pharm.D., clinical professor of medication use policy, University of Michigan, Ann Arbor

In November 2010, ASHP collaborated with the American Society of Anesthesiologists, the American Society of Clinical Oncology (ASCO), and the Institute for Safe Medication Practices (ISMP) to convene a stakeholder summit on drug shortages. According to Bona Benjamin, B.S. Pharm, ASHP director of medication-use quality improvement, the summit was a fact-finding mission.

“We really didn’t know how to attack the issue yet. We couldn’t make recommendations for actions until we knew the reasons for the jump in shortages, so we focused on sharing information,” she said.

For Gundy Sweet, Pharm.D., clinical professor of medication use policy, University of Michigan, Ann Arbor, participating in the summit was an eye-opener.

“The summit provided an opportunity to speak with different stakeholders and to learn about challenges they each face. It helped me to understand the bigger picture,” she said. At the summit, Sweet presented the preliminary results of a study that she and colleagues did as a collaborative effort between ASHP and the University of Michigan that ultimately revealed the labor costs associated with managing drug shortages cost the nation roughly $216 million annually for U.S. hospitals.

Getting the Word Out

The summit marked the start of an ASHP media storm that brought drug shortages into the public eye and created a foundation for clinicians and patients to coalesce in an effort to create change. ASHP members and leaders who are recognized experts on drug shortages, as well as ASHP staff, fielded hundreds of calls from national and trade press.

Erin R. Fox, Pharm.D., FASHP, director, University of Utah Drug Information Service

The unprecedented media attention was a tremendous help to the cause, according to Erin R. Fox, Pharm.D., FASHP, director of the University of Utah’s Drug Information Service. “When an issue becomes high-profile in the media, stakeholders take notice, including patients, manufacturers, and Congress,” she noted.

Joseph M. Hill, ASHP director of federal legislative affairs, agreed. “Once the media got hold of it, the issue took off. The public was hearing of situations where cancer patients were turned away from chemotherapy, and people got scared. The situation now demanded the attention of policy makers and legislators.”

The publicity was a perfect springboard for launching a broad advocacy effort, said Brian M. Meyer, ASHP director of government affairs.

“We built on the media attention and sharpened our focus on the issue,” he said. “That got the attention of several legislators in Congress, and we were able to work with our members in a grassroots effort to educate legislators on the impact that drug shortages were having on patients, their constituents.”

As 2010 drew to a close, ASHP met with Sen. Amy Klobuchar (D-Minn.) to discuss draft legislation. Sen. Klobuchar, along with Sen. Robert P. Casey, Jr., (D-Penn.) later introduced the first drug shortages bill, “The Preserving Access to Life-Saving Medications Act,” in February of 2011. Congressional representatives Diana DeGette (D-Col.) and Thomas Rooney (R-Fla.) soon followed suit with a House version of the bill by the same name.

Pharmacists Speak Up

As 2011 progressed, ASHP members ramped up their grassroots advocacy. The Society’s Legislative Day in September saw participants discussing drug shortages with their senators and representatives and encouraging passage of the bills. Pharmacists drove the message home: Drug shortages must be addressed because patient care is suffering.

In September 2011, ASHP members Richard Paoletti, M.B.A., R.Ph., FASHP, vice president of operations, Lancaster General Health, Pa., and Kevin J. Colgan, R.Ph., M.A., director of pharmacy, Rush University Medical Center, Chicago, testified to the effects of drug shortages on patient care before the U.S. House Energy and Commerce Health Subcommittee.

They discussed delayed treatments and surgeries and changes in therapy, and described how hospital staff must reallocate personnel and resources to contend with shortages. They also pressed for greater transparency in communication between manufacturers and the Food and Drug Administration (FDA) and expressed support for legislation that would require drug manufacturers to report shortages to the FDA.

Meanwhile, ASHP staff and members built on their established relationship with the FDA, and ASHP became known as the go-to source on the issue.

“As our advocacy began to pick up, this opened the door to a bigger relationship with the FDA,” said David R. Witmer, Pharm.D., ASHP chief operating officer. “We became recognized by other organizations and the health care community as the organization that had expertise in this area.”

That recognition stems in no small part from the dedication of the membership, he added. When the FDA announced a public workshop to discuss the causes and impact of drug shortages as well as potential solutions, members such as James M. Hoffman, Pharm.D., medications outcomes and safety officer, St. Jude Children’s Research Hospital, Nashville; Scott Knoer, Pharm.D., M.S., FASHP, chief pharmacy officer, Cleveland Clinic; Ali McBride, Pharm.D., M.S., BCPS, specialty practice pharmacist, hematology/oncology, Ohio State University Medical Center, Columbus; James Stevenson, Pharm.D., chief pharmacy officer, University of Michigan Health System; Fox; and Sweet stepped up to the plate and provided input.

One by one, they provided data, explained how their institutions and many others must juggle resources when stock runs low, and painted a picture of the many ways in which drug shortages are compromising patient care.

Collaboration a Keystone to Success

A month after the FDA workshop, in October 2011, President Barack Obama issued an Executive Order directing the FDA to broaden reporting of potential shortages, speed up regulatory reviews, and increase staffing for its Drug Shortages Program. Although the Executive Order was hailed as a victory, there was still much work to be done.

ASHP continued its interorganizational collaboration by briefing the Susan G. Komen for the Cure, Fight Colorectal Cancer, and the Ovarian National Cancer Alliance in November 2011. In May 2012, ASHP, ISMP, ASCO, and the American Hospital Association placed ads in Politico, a publication that covers Congress, the White House, politics, and lobbying.

ASHP and its members kept up the pressure in Congress, as well, by testifying at hearings held by the House Oversight and Government Reform Subcommittee on Health Care and the Senate Finance Committee. In February 2012, William Greene, Pharm.D., BCPS, FASHP, chief pharmaceutical officer, St. Jude Children’s Research Hospital, Memphis, testified before the U.S. House Energy and Commerce Health Subcommittee. He put a human face on the issue by sharing the story of a five-year-old patient with a brain tumor who suffered thiamine deficiency because of a shortage of a multivitamin solution.

In May 2012, the House and Senate incorporated the bills addressing drug shortages into their respective versions of legislation reauthorizing PDUFA. They reconciled their PDUFA legislation in June, and the final version was passed unanimously in the Senate and by a margin of 92-4 in the House of Representatives.

The lack of partisanship in this process demonstrates the universal importance of the issue and the ability of all who advocated on the grassroots level to separate it from the politics of an otherwise gridlocked Congress, said Meyer.

“The drug shortages issue was not couched in terms of health care reform, but in the availability of medical treatment for patients,” he said. “Whether you’re talking about pediatrics, emergency medicine, oncology, or another specialty, this touches everyone’s life. It automatically cuts across partisan lines.”

Finally, in July of 2012, 20 months after the stakeholder summit, the President signed the Food and Drug Safety Innovation Act (Title X of Public Law 112-144 addresses drug shortages).

What’s Next?

The Executive Order of last October, the reauthorization of PDUFA, and the laws and regulations outlined in 24 pages of Title X are victories for patient care. But that doesn’t mean the end of drug shortages—or an end to the need for advocacy on behalf of patient care and the profession of pharmacy, according to Reilly.

“We haven’t checked it off as a done issue. We’re going to continue to monitor drug shortages and look for places where we can have an influence,” she said.

Joseph M. Hill, ASHP director of federal legislative affairs

Hill points to the need to support the FDA’s efforts. “We face serious fiscal challenges as a nation. The FDA’s mission is crucial to public health, and we want to make sure their budget remains intact. That is something we’ll have to continue to work on.”

But ASHP staff can’t do it alone. If the drug shortage issue reveals anything, it’s that clinicians can have a tremendous impact on shaping health care law.

“A key piece to the success on this was our members’ willingness to get involved, contact their legislators, and educate them on the issues,” said Meyer. “We hope to build on the credibility our members have established on behalf of the profession, and build on the relationships they have with their legislators not only for continued work on drug shortages, but for other issues going forward.”

–By Terri D’Arrigo

ASHP’s New PhORCAS™ System Streamlines Residency Application Process

Filed under: Current Issue,Feature Stories — Tags: , , , — Kathy Biesecker @ 2:35 pm


With the October launch of its Pharmacy Online Residency Centralized Application Service™ (PhORCAS™), ASHP has pushed aside the typically cumbersome, paper-laden residency application process to make room for a more efficient and convenient alternative.

“The residency application process has been slow and labor-intensive,” said Kate Farthing, Pharm.D., BCPS, pharmacy clinical specialist, quality and patient safety, at Legacy Good Samaritan Medical Center in Portland, Ore. Dr. Farthing, who is a former residency program director, also served on the PhORCAS design team. “Our goal was to streamline the entire process for both applicants and residency programs.”

With PhORCAS, applicants can submit and track their applications—and all supporting material—through a single website. Similarly, residency program administrators can receive and organize those applications through their electronic portal.

All residency programs that are registered with the National Matching Service (NMS) and have a unique NMS number are eligible to participate in PhORCAS. To date, all of the approximately 1,500 residency programs in the ASHP accreditation process recruiting for positions in the 2013 match are committed to using PhORCAS.

More Pharmacy Students Seeking Residencies

Janet Teeters, M.S.

PhORCAS emerged in response to the dramatic increase in the number of residency applications over the last few years, as pharmacy students seek a competitive edge in an uncertain job market. In 2011, more than 4,000 applicants applied for 3,000 residency positions through the ASHP Resident Matching Program, according to Janet Teeters, M.S., director of ASHP Accreditation Services.

“It’s a capacity issue,” she said. “Some residency programs receive more than 200 applications. How do you possibly process that amount manually?” In fact, the influx has created administrative overload as programs struggle to keep pace.

“Imagine that you are heading up a residency program, and your staff has to collate and coordinate all of the pieces of an application into one file for each candidate,” said Dr. Farthing. “You may receive 50 to 100 or more applications over a short period of time, each application has eight to 10 supporting documents, and they all arrive by mail at different times. This creates a major burden for programs seeking the best candidates.”

Applicants have felt the crunch, too, as some residency programs began imposing tighter submission deadlines to compensate for the surge in application volume. According to Teeters, deadlines used to fall in February. But as programs tried to maintain control over the paperwork, many began bumping their deadlines up to earlyJanuary.

“Considering that most applicants don’t decide which programs they’ll apply to until after ASHP’s Midyear Clinical Meeting in early December, that’s a lot of pressure to get everything together and mailed out in time,” said Teeters.

Providing a Little Peace of Mind

PhORCAS is intended to put an end to all of that. Applicants gather and submit every component of every application electronically, including transcripts, recommendation letters, and program-specific supplemental information. They can easily track the status of their applications online at any time, precluding the need to bombard residency programs with anxious phone calls and emails wondering what has been received.

Residency programs spend an inordinate time responding to such inquiries from applicants, noted Dr. Farthing, adding that “there won’t be a need for that anymore because both sides can see the same information in real time.”

PhORCAS also allows residency programs to organize large numbers of candidates and sort them by predetermined criteria, which helps them to isolate candidates who are good matches for their particular programs.

And although most of the application material is standardized under PhORCAS, the system still allows residency programs to customize their submission requirements to accommodate variations such as application dates, supplemental materials, and the specifics required in an applicant’s statement of intent. Reference letter writers must use a standardized reference form, but they can opt to write and upload personalized recommendation letters as well.

“Residency programs can continue to follow their own processes the same way that they always have,” said Teeters. “We’re not replacing any part of that or asking them give up any of the individuality.”

Jenny VanAmburgh, Pharm.D.

“From my standpoint as a residency director, the process will be much more manageable,” said Jenny VanAmburgh, Pharm.D., associate clinical professor and assistant dean for academic affairs at Northeastern University, Boston. “All the information I need will be easily accessible.”

Cost, Time Savings Built In 

The cost for applicants to use PhORCAS is $75 for the first four applications and $25 for each additional application. That’s comparable to the pre-PhORCAS application process, according to Teeters. She added that applicants stand a lot to gain from the new system, including:

  • The ability to compile a single online submission, which PhORCAS disseminates to every residency program chosen by the applicant,
  • The need for just one set of academic transcripts, regardless of how many residency programs the student applies to, and
  • A reduction in the time and expenses associated with making dozens of paper copies and arranging postage or overnight delivery for every application.
  • Time savings, not having to call or email the sites to see if their materials have arrived.

“PhORCAS is very adaptive and intuitive,” said Han Feng, a fourth-year pharmacy student at Shenandoah University in Winchester, Va., who was among several students enlisted by ASHP to evaluate the system before its launch.

“I think students will like being able to tailor their applications to specific programs and do everything from home,” Feng said. “The system looks and feels very similar to PharmCAS—the system used for applying to pharmacy school programs—but it’s more flexible.”

Froedtert Health Expands Roles of Pharmacy Technicians

Filed under: Current Issue,Feature Stories — Tags: , , , , , — Kathy Biesecker @ 2:32 pm

Katherine Dogs, CPhT, interviews a patient about his medications.

When Tyler Van Schyndel, Pharm.D., was choosing his pharmacy residency project in 2011, he wanted one that would leave a lasting mark. He chose well. His pilot study demonstrated that pharmacy technicians could efficiently and accurately collect medication histories in the emergency department (ED) of Froedtert Health,Milwaukee.

Dr. Van Schyndel’s work was so compelling that the hospital eventually adopted the practice as standard procedure in and beyond the ED.

“I saw a greater role for pharmacy technicians as something that could benefit the hospital,” said Dr. Van Schyndel, who conducted the project while a first-year pharmacy resident at Froedtert. “I also knew that ASHP’s Pharmacy Practice Model Initiative (PPMI) was a priority there, and that a big part of it is expanding roles for technicians.” (Dr. Van Schyndel is currently a second-year resident in critical care medicine at the University of Wisconsin Hospital and Clinics Pharmacy Services, Madison.)

Rectifying Inefficiencies

Prior to the study, pharmacists conducted most medication histories after patients were admitted. That meant physicians frequently wrote initial medication orders before seeing a patient’s most up-to-date and accurate medication information. Because of this system, pharmacists would have to contact the prescribing physician to sort out discrepancies due to medication list changes that occurred after pharmacists met with patients on the floor to complete the medication reconciliation.

“From the standpoint of accuracy and medication safety, it was very important to obtain those medication histories as soon as patients came through the door,” added Jordan Dow, Pharm.D., M.S., Froedtert’s manager of medication utilization and Dr. Van Schyndel’s residency project preceptor.

Prior to the study, only 10 percent of medication histories were completed before admission orders were written. During the pilot, 98 percent of patient medication lists were updated prior to admission orders being written.

In the pilot study, one experienced technician was trained to conduct medication histories, gathering medication histories in the pre-admission testing clinic while being shadowed by a pharmacist. That was followed by three weeks of medication history taking in the ED, again under a pharmacist’s supervision.

Dr. Van Schyndel measured the technician’s efficiency and accuracy: The technician completed more than 13 histories daily, and pharmacist verification identified an average of 0.3 discrepancies per history. He also estimated that widespread use of technicians to take medication histories—rather than pharmacists or nurses—would save the hospital more than $110,000. It was clear to Dr. Van Schyndel that this was a cost-efficient way to arm physicians with the most accurate drug information about a patient before any drug orders were written.

“It’s safer for patients, requires less work redoing medication reconciliation on the floor, and requires far less time going back and forth with the physician to correct discrepancies,” he said.

Roles Shift to Benefit Patients

Dr. Van Schyndel presented his findings to the pharmacy department to justify re-allocating pharmacy technicians for medication history collection. That shift would become even more important after the hospital completed its planned transition to computerized prescription order entry (CPOE) in August 2012. Once that occurred, the primary role of technicians—transcribing prescribers’ written medication orders into the electronic medical record—would become obsolete. (Froedtert did complete its transition to CPOE on schedule last summer.)

“We needed to figure out how to best use the substantial amount of technician time that was freed up while simultaneously enabling pharmacists to perform higher-level functions, such as more direct patient care,” said Dr. Dow.

The hospital agreed. Pharmacy technicians now collect medication histories at the two major patient admission points: the ED and the pre-admission clinic, which are the gateways for about 75 percent of all admissions. A few histories are still collected on the inpatient side.

Dr. Dow emphasized that pharmacists remain accountable for the technicians’ performance and check their work before signing off on it. Four pharmacy technicians have so far been trained to conduct medication histories. Two more are in training to increase the pool of qualified technicians and avoid issues of insufficient staffing.

“The pilot study demonstrated the value of this technician-led service—both on paper and in practice—to our inpatient pharmacists as well as to our physicians and nursing colleagues in these areas, and it paved the way to roll out the initiative hospital-wide,” said Dr. Dow.

The change also represented a significant culture change for the pharmacy department. Pharmacists were concerned about allowing technicians to interact at such a high level with patients, but the technicians’ performance allayed their fears.

“After the study, the team completely supported the new arrangement,” said Dr. Dow, “and have even asked for more of the same.”

November 5, 2012

Reflections on the NECC Compounding Tragedy

Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP

I, LIKE MOST OF YOU, CONTINUE TO FOLLOW the news out of Framingham, Mass., as more is learned about the operations at the New England Compounding Center (NECC).

What investigators are finding—unsatisfactory conditions, shipping of product before the results of sterility testing were known, and inattention to other known safeguards—deeply upsets me. These types of practices are totally unacceptable anywhere, at any time. The patients who relied on these medications deserved much better, and our sympathies go out to all of the affected patients and their families. But condolences cannot begin to replace their losses. Enhanced safeguards must be put into place so that this does not happen again.

Having said this, however, it’s important to note that I am also concerned that compounding by pharmacists—a practice that is essential to patient care—may be broadly called into question. Compounding and pharmacy are inextricably linked.

From preparing a topical cream to the complex processes involved in preparing sterile products, compounding happens every day in every hospital and health system. What happened at NECC does not reflect the professionalism and commitment to patients provided by pharmacists throughout the country. We cannot allow what happened there to shape the public perception of a critical element of patient care.

ASHP has a long history of pushing for the highest standards for compounding and sterile product preparation in hospitals. In the early 1990s, we began publishing practice recommendations in AJHP. We published the “ASHP Technical Assistance Bulletin on Quality Assurance for Pharmacy-Prepared Sterile Products (TAB)” in 1993. The TAB established the three-tier risk assessment structure that was later adapted by USP for use in the <797> standards for sterile compounding. Our guidelines on outsourcing sterile compounding services urge pharmacy departments to conduct due diligence when outsourcing compounding services.

It is essential for the safety of all patients that all pharmacies that compound medications, regardless of the setting, adhere to the very highest standards. In addition, state boards of pharmacy will need additional resources to provide strict oversight of compounding pharmacies and provide more transparency.  And when companies cross the line from compounding to manufacturing, there needs to be enhanced coordination between state boards and the U.S. Food and Drug Administration (FDA) to ensure that the necessary regulatory scrutiny is applied.

We know the important role that compounding plays in patient care, but we have a fair amount of work to do to restore the public’s trust after this tragic event. As hospital and health-system pharmacists, we have always taken the lead in medication safety in our practice settings, ensuring that our patients can always depend upon us. ASHP pledges to work diligently to restore that trust and to help prevent a tragic and unfortunate event like this from ever happening again.

November 4, 2012

ASHP, UNC Eshelman Partner to Offer UNC Pharmacy Grand Rounds

Filed under: ASHP News,InfoCentral — Kathy Biesecker @ 5:39 pm

A new continuing education (CE) series of monthly webcast and on-demand offerings sponsored by ASHP and the University of North Carolina Eshelman School of Pharmacy, Chapel Hill, will feature nationally recognized leaders in progressive pharmacy practice, education, and research. The subscription series launches in January. Subscriptions to UNC Pharmacy Grand Rounds are available at both the individual and hospital level.

A one-year subscription provides 12 hours of live CE per learner on current topics. If learners cannot attend the live webcast, archives of broadcasts will be available. Continuing Professional Education (CPE) certificates may be processed online immediately, and CE is reported directly to CPE Monitor.

The 2013 calendar year includes topics such as pharmacogenomics, cardiology, administration, nephrology, psychiatry, women’s health, endocrinology, critical care, geriatrics, oncology, infectious diseases, and general medicine. All live webcasts are broadcast at noon EST on the second Tuesday of the month.

While the series is ideal for small and mid-size health systems with limited resources to conduct monthly CE activities, health systems of any size will benefit. In addition to providing education to their staff on current topics, managers will have the ability to monitor participation and progress of their learners online. Click here for a complete description of topics and subscription details such as webcast schedule.

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