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May 15, 2020

ASHP Launches New Section of Pharmacy Educators and Continues to Advocate for Pharmacists During the COVID-19 Pandemic

Dear Colleagues,

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

AS YOU KNOW, ASHP staff and members have been working tirelessly during the COVID-19 pandemic to support our members and all healthcare providers to enhance the safe use of medications, deliver quality care, and enhance patient outcomes. This work has served as continued reinforcement of our long-standing commitment to supporting pharmacists across the continuum of care and elevating the vital role that pharmacists play as patient care providers. In our 78-year history, we have continually supported heightened standards and training for pharmacy professionals regardless of practice setting.

In this vein, I am pleased to share that the ASHP Board of Directors has approved the creation of a new membership section that will further strengthen and significantly enhance ASHP’s leadership in the preparation and training of the pharmacy workforce. The new ASHP Section of Pharmacy Educators will provide a unique and distinct membership home and leadership voice within ASHP for pharmacy school faculty, deans, and preceptors who are involved in the training of pharmacists.

The COVID-19 pandemic has shown how quickly healthcare and the pharmacy profession can change, and how critical education and training are to meet evolving patient care demands. Building on our existing world-class educational offerings and professional development expertise, ASHP is well-positioned to support educators in all settings, preparing the next generation of practitioners to provide the highest level of interprofessional patient care in highly dynamic and complex environments. This new section will play a key role in ensuring we can provide our educators with an even greater voice as we work together to face the immense healthcare challenges of today and tomorrow.

ASHP President-elect Tom Johnson will appoint an executive committee in August to lead the section’s work, and the committee will begin meeting virtually this fall. ASHP members interested in serving on the section’s leadership should submit an application by July 24.

Support for Pharmacy Residents

Over the past several weeks, I have shared information on ASHP’s efforts to support residents and our accredited residency programs facing uncertainty during the COVID-19 pandemic. Many members and residency programs tell us about ongoing issues, including the potential impact of licensing exam cancellations prompted by stay-at-home orders and social distancing requirements as well as financial challenges faced by their hospitals and health systems. In response to these concerns, on Monday, ASHP’s Commission on Credentialing and Board of Directors approved an extension of the licensure requirement for residents until January 1, 2021. This action, for the 2020–21 residency year only, temporarily waives the requirement that residents be licensed for two-thirds of the residency year (e.g., a July 1 residency start normally requires licensure by November 1). Our Accreditation Services team, through our partners at the National Association of Boards of Pharmacy, continues to monitor pandemic-related effects on residencies and will take any necessary future actions to alleviate burdens caused by delays in testing or licensure. In the meantime, ASHP will do everything it can to ensure the maximum amount of flexibility to our accredited programs during these extremely challenging times. If programs or others have questions, please reach out to Janet Silvester, vice president of Accreditation Services, or Stephen Ford, director of Residency Accreditation Services, for assistance.

Taking ASHP Meetings Virtual

The impact of COVID-19 has extended beyond our hospitals and health systems and challenged us to think differently when “business as usual” is no longer possible. Public health and safety measures are likely to remain in place in some form for months to come. In response to this changing landscape, ASHP announced on Wednesday that we will be moving three important fall events to virtual forums.

Policy Week, which includes our annual Legislative Day on Capitol Hill, will become a virtual experience in September. ASHP’s National Pharmacy Preceptors Conference and Conference for Pharmacy Leaders will take place in October as virtual events. Watch for forthcoming programming details and registration information about these valuable meetings. We remain committed to leveraging technology solutions to deliver the dynamic, high-quality educational content and professional development experiences our members expect from us.

One of the first ASHP events affected by COVID-19 was our Summer Meetings & Exhibition, initially planned for the first week of June in Seattle. Instead of gathering there, we are offering a free series of educational “Summer Sessions” at the end of June, featuring select content from the ASHP 2020 Summer Meetings as well as sessions on the latest COVID-19 updates. These sessions will be open to all practitioners, regardless of ASHP membership status. Continuing education credits will be available to participants. Stay tuned to ASHP’s NewsLink, social media channels, and other communications for additional information about these Summer Sessions.

Remdesivir Resources and Advocacy

Since my last blog, there has been promising news on the efficacy of remdesivir as a treatment for COVID-19. Last week, the Food and Drug Administration (FDA) issued an emergency use authorization for remdesivir to speed access to the investigational antiviral — the first to show promise against SARS-CoV-2 infection. Subsequently, a remdesivir monograph was published in AHFS Drug Information. As a reminder, ASHP has opened access to AHFS DI to all healthcare professionals for a limited time with the username ahfs@ashp.org and password “covid-19.”

Our AHFS drug information staff continue to update ASHP’s Assessment of Evidence for COVID-19-Related Treatments. The document outlines evidence about remdesivir, supportive therapies, and other medications used to treat patients with COVID-19. SafeMedication.com, ASHP’s consumer-friendly medication information resource, is an excellent place for patients to learn more about remdesivir.

We also held a live webinar this week describing the early use of remdesivir for COVID-19 patients. The second part of the webinar series, scheduled for May 20, will share clinical experiences in using remdesivir and a discussion of clinical trial results by the Nebraska Medical Center–Nebraska Medicine pharmacy team. Recorded versions of ASHP’s COVID-19 webinars are available for those unable to attend the live sessions.

While remdesivir shows promise in early studies, access to medication is of great concern to pharmacists across the country. Last week, I sent a letter to Vice President Mike Pence urging the administration to make public its process for determining which hospitals will receive allocations of remdesivir, communicate information about the allocations to all hospitals, and provide information on the timeline and details for the commercial availability and distribution of remdesivir. We also asked the administration to coordinate with the FDA and the Department of Health and Human Services (HHS) to allow hospitals the flexibility to reallocate product to meet changing needs.

Our letter was extensively quoted in an Associated Press article picked up by The New York Times — a testament to ASHP’s commitment to being a voice for our profession and leading national efforts to optimize medication use, improve patient safety, and advance clinical pharmacy practice.

At the urging of ASHP and others, last weekend, HHS announced that state health departments will distribute remdesivir to appropriate hospitals in their states. HHS noted that “state and local health departments have the greatest insight into community-level needs in the COVID-19 response, including appropriate distribution of a treatment in limited supply.” We encourage ASHP members who need remdesivir for their patients to contact their state health departments.

ASHP’s Promise to Support the Essential Role of Pharmacists

I wanted to highlight ASHP’s advocacy on behalf of the vital role pharmacists play in the COVID-19 response. Last week, Rep. Carolyn Maloney introduced the Student Loan Forgiveness for Frontline Health Workers Act (H.R. 6720). Unfortunately, pharmacists are not specifically identified as healthcare workers in this important legislation. ASHP, in collaboration with other pharmacy organizations, wrote to Rep. Maloney and urged her to include pharmacists in the loan forgiveness program. We look forward to working closely with Rep. Maloney’s office to support that effort.

Finally, in my last blog, I discussed a letter that I sent to the chief executive officer of Novo Nordisk responding to their advertisements, which omitted pharmacists from a list of individuals, including nurses, doctors, researchers, and other essential workers, who were acknowledged for their caring efforts on the front lines of the COVID-19 response.

I requested that pharmacists be explicitly recognized as healthcare providers and noted for the essential role they are playing, in addition to doctors, nurses, communities, and essential workers. I was pleased to quickly receive a response from Novo Nordisk’s leadership, acknowledging the vital role of pharmacists and agreeing to specifically highlight pharmacists in a new version of the advertisement, which has already been in print.

In closing, I want to reassure our members that ASHP will continue to work across multiple fronts to represent your perspectives and needs as we collectively navigate the ongoing pandemic response so you can provide the best care possible for your patients. Providing you with the latest information and new resources on our COVID-19 Resource Center remains a top priority. Please watch our weekly NewsLink emails to learn about new and updated resources and live webinars, and continue to connect with your peers on our COVID-19 Connect Community. You can also subscribe to @ASHPOfficial to receive content from our daily podcasts.

Thank you for being a member of ASHP and for everything that you do for your patients and our profession.

Sincerely,

Paul

April 8, 2019

ASHP Is Taking Government Relations and Advocacy to the Next Level

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

I am happy to announce our plans to further strengthen ASHP’s government relations activities in Congress, federal agencies, the White House, and the states. Further, to enhance our advocacy initiatives and communications regarding our government relations efforts.

To that extent, we have made some important strategic changes to ASHP’s government relations area. First, we have added a Vice President of Government Relations to our Senior Leadership Team who will also complement our exceptional Government Relations staff. We announced last week that we have hired Tom Kraus, M.H.S., J.D., as ASHP’s new Vice President of the Government Relations Office. Tom is a leader with incredible experience. He has a sincere passion for improving the health and well-being of patients, and he understands that pharmacists play a critical role as patient care providers — and can do even more.

Tom is a former Food and Drug Administration (FDA) Chief of Staff and FDA Associate Commissioner. He also served on the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee as Staff Director, working under Senators Kennedy and Harkin. During his time on the HELP Committee, he was instrumental in the passage of key legislation, including FDA drug and food safety reforms and user fee legislation, the American Recovery and Reinvestment Act, and the Affordable Care Act. While at the FDA, he was a top advisor to the FDA Commissioner, a key leader among FDA’s over 14,000 employees, and FDA’s main liaison and advocate to Congress.

Tom has also served as a health policy, management, and life sciences senior executive for Ernst & Young, McKinsey & Company, Avalere Health, and, most recently, the Boston Consulting Group. In these roles, he engaged with virtually every major component of U.S. healthcare, including agencies within the Department of Health and Human Services, state agencies, the pharmaceutical industry, health insurance companies, and many others. Tom earned a Bachelor of Science in Biology from the University of Michigan, a Master of Health Science in Health Finance and Management from Johns Hopkins University, and a Juris Doctor from Georgetown University Law Center.

Tom will be joining the ASHP team later this month, and we are looking forward to introducing you to him at the ASHP Summer Meetings in Boston.

Secondly, ASHP has also hired Doug Huynh, J.D., as our new federal lobbyist and primary legislative advocate on Capitol Hill. Doug comes to ASHP with extensive experience from the Society of Interventional Radiology, where he worked for 12 years as Director of Government and Policy Affairs. Doug also served as a lawyer and lobbyist in a number of other healthcare-related organizations. He has an in-depth understanding of the healthcare landscape and the issues that impact pharmacists, physicians, healthcare organizations, and other providers, as well as excellent relationships on Capitol Hill and a strong knowledge of the political process. Doug graduated from Virginia Commonwealth University with degrees in Communications and Political Science, and he earned his law degree from Quinnipiac University. Doug joined our team earlier this month, and we also look forward to introducing you to him at the ASHP Summer Meetings in Boston.

We are confident that these important enhancements to our already strong Government Relations team will be of great value to ASHP members and their patients, and will help us further advance pharmacy practice by better educating policymakers and other important healthcare stakeholders. We look forward to sharing more about the many new things we will be doing through ASHP’s enhanced government relations and advocacy program.

Thank you for being a member of ASHP, and for everything that you do for your patients.

Sincerely,

 

Paul

February 27, 2017

ASHP Continues Working on Solutions to Rising Drug Prices

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

RISING DRUG PRICES have affected virtually every segment of healthcare. From consumers to hospitals to third-party payers, all have been forced to make difficult decisions regarding healthcare choices. Patients and ASHP members’ organizations are feeling the impact of escalating drug prices, as is the entire healthcare system. ASHP is well aware of this alarming trend and is diligently working with a wide array of stakeholders and bipartisan policymakers to explore practical and sustainable solutions.

This problem is about public health and the downstream effects that high drug costs have on the health of patients and the ability of our healthcare institutions to care for them. For example, we know that when patients face higher costs they are more likely to not fill their prescriptions and may even ration their medications. Nonadherence often leads to more expensive therapies or hospital stays due to complications resulting from untreated or undertreated conditions. Payers have also had to make difficult choices in the face of spiraling drug costs, including challenging formulary decisions. Hospitals and health systems may be forced to make difficult decisions to offset rapidly rising drug costs.

Even generic drugs widely used to manage the cost burden on individual patients and our hospitals and clinics are now experiencing dramatic price increases. Instead of a robust marketplace flush with competition that drives prices lower, sometimes there appears to be little or no competition, resulting in a single company producing a generic product. Without competition, manufacturers can raise their prices as high as the market will bear. In 2016, a study commissioned by the American Hospital Association and the Federation of American Hospitals noted that drug spending increased 8.5% in 2015, while inflation increased only 0.7%. This trend cannot be sustained. The study provided an example of one hospital where “the price increases for just four common drugs, which ranged between 479 and 1,261 percent, cost the same amount as the salaries of 55 full-time nurses.” Unfortunately, while this may be an extreme example, the typical drug price increases in a hospital or health system place a heavy burden on the healthcare team and its organization to ensure their patients have access to medication therapies.

In 2016, ASHP joined the Steering Committee of the Campaign for Sustainable Rx Pricing (CSRxP), a coalition consisting of physicians, consumers, payers, hospitals, health systems, and patient advocacy groups. We believe that CSRxP, as a coalition of nationally prominent organizations, has the best chance of effecting change at the national level regarding drug price increases. With ASHP’s input, CSRxP developed a policy platform that seeks to address this problem through market-based solutions, focusing particularly on competition, value, and transparency. ASHP and other members of the Steering Committee have begun conducting joint meetings with congressional staff to discuss bipartisan policy solutions. CSRxP has also been implementing an ongoing media strategy to call attention to drug pricing and place this issue on the national agenda.

Efforts to address the problem through legislation are already underway. For example, S. 297 and H.R. 749 would require the Food and Drug Administration (FDA) to expedite approval of an Abbreviated New Drug Application (ANDA) when a drug is in short supply or little or no competition exists. Another bill, S. 124, would prohibit brand companies from paying generic manufacturers to delay introduction of a generic version, otherwise known as “pay for delay.” ASHP believes these are steps in the right direction, but more can and should be done to promote competition and limit marketplace manipulation through pay-for-delay or restricted distribution.

Also under consideration in Congress is legislation (S. 92, S. 183) that would allow drugs to be imported from other countries, such as Canada, where prices are significantly lower. This approach, however, is not one that ASHP supports, due to safety concerns over the origin of the drug and the disconnect of the pharmacist-patient relationship. Another policy option would be to allow the government to negotiate drug prices directly with manufacturers for drugs covered by Medicare Part D. However, this legislation (S. 348, H.R. 242, S. 41) does not have bipartisan support.

Finally, the Prescription Drug User Fee Act (PDUFA) is up for reauthorization this year and may serve as a legislative vehicle to address this problem. This reauthorization is considered must-pass legislation, and we have already begun discussions with key congressional staff about the policy goals of CSRxP and their potential fit within PDUFA.

ASHP remains an active leader in CSRxP and will continue pushing for solutions to the problem of rising prescription drug prices. As the only national pharmacy organization on the Steering Committee, we will continue to work collaboratively with our partners to provide the perspective of our members and to help ensure that affordable medications are accessible to those who need them.

Thank you for all that you do on behalf of your patients and for being members of ASHP.

Paul

# # #

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

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 1, 2011

ASHP Applauds Presidential Executive Order on Drug Shortages

Filed under: Uncategorized — Tags: , , , , , , — Kathy Biesecker @ 11:51 am

ASHP applauds President Obama for signing an executive order Oct. 31, 2011, taking action on the public health crisis of prescription drug shortages. The President’s order directs the Food and Drug Administration (FDA) to broaden reporting of potential shortages, expedite regulatory reviews, and increases staffing resources for the FDA’s Drug Shortages Program.

The President also expressed support for bipartisan legislation that would require drug manufacturers to notify the FDA six months ahead of a potential shortage so that the FDA can help facilitate increased product availability from other manufacturers.

ASHP has advocated strongly in support of this legislation together with the American Hospital Association and co-conveners of a drug shortages summit last year. “The President’s leadership to address this public health crisis is an encouraging signal that we might fix the problems that are causing patients to go without life-saving drugs,” said Henri R. Manasse, Jr., Ph.D., Sc.D. “ASHP has been working hard to focus public attention on this national health crisis and we applaud President Obama for taking action today.”

The Executive Order reflects actions that ASHP has been advocating for some time, including requiring reporting of expected shortages and attention to the secondary market. “We hope this action today will help Congress move forward with the bipartisan legislation (H.R. 2245 and S. 296) as soon as possible,” said Manasse.

ASHP has also been advocating for increased FDA funding to address this and other issues through its work with the Alliance for a Stronger FDA,. “The FDA has been working hard to address drug shortage for some time, but needs more people and more funding to address the broad-based issues that cause drug shortages,” added Manasse.

ASHP reports 232 shortages in 2011 on its drug shortages resource center,  which tracks shortages and provides information about alternative treatment options.

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