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With Relentless Focus, ASHP Helps to Enact Drug Shortages Legislation

Member, Staff Advocacy Create Major Win for Pharmacy, Patients

Nov 20, 2012

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

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