ASHP InterSections ASHP InterSections

April 9, 2020

Important Wins on the Advocacy Front in the Fight Against COVID-19

Dear Colleagues,

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

AS THE IMPACT OF THE COVID-19 PANDEMIC CONTINUES TO ESCALATE ACROSS THE COUNTRY, there is increased urgency to ensure that frontline pharmacists, pharmacy technicians, and our healthcare partners have the medications and equipment they need to successfully treat their patients. ASHP continues to spearhead multiple advocacy efforts that support your ability to provide the best care possible for those in need.

Mitigating shortages of critical medications like propofol, fentanyl, midazolam, paralytics, and others remains a high priority. We continue to engage with relevant federal agencies to improve access to medications. I am pleased to report that the Drug Enforcement Administration (DEA) and the Food and Drug Administration (FDA) have taken critical actions in direct response to ASHP’s advocacy efforts.

ASHP, in coordination with the American Medical Association, the American Hospital Association, the Association for Clinical Oncology, and the American Society of Anesthesiologists, sent a letter last week to the DEA requesting an immediate increase in the annual production quota allocations for Schedule II controlled substances. This would enable manufacturers and 503B outsourcing facilities to increase the supply of opioids critical to the care of COVID-19 patients on ventilators. As a direct result of this collaborative advocacy effort, the DEA announced yesterday that it is taking immediate actions to address this critical issue. These actions include increasing the annual production quota for controlled substances, including fentanyl, morphine, and hydromorphone, that are used for the treatment of mechanically ventilated COVID-19 patients, and increasing the amount of ketamine, diazepam, and other controlled substances that can be imported into the United States.

We also sent a letter to the FDA advocating for regulatory flexibility in compounding drugs in shortage and compounding in hospitals. ASHP’s advocacy efforts, including significant staff engagement on the issue, directly triggered the FDA to clarify existing compounding guidance, including the removal of the one-mile radius requirement for hospitals compounding medications. FDA’s quick action to reduce regulatory hurdles for health systems is an important step to help clarify compounding guidance during this crisis.

ASHP will continue to advocate for additional compounding flexibility, including the expansion of FDA’s drug shortage list to include products ASHP has identified as in shortage. We will also continue to seek 503B outsourcing facility flexibility, particularly for hospital-owned or affiliated 503B operations, to help ensure they can meet hospitals’ medication needs.

Yesterday, we were pleased to see that the Department of Health and Human Services (HHS) authorized pharmacists to order and administer COVID-19 tests pursuant to the Public Readiness and Emergency Preparedness (PREP) Act. The authorization is responsive to the joint COVID-19 recommendations we created with other national organizations. While this authorization does not address pharmacist reimbursement, we are encouraged to see HHS providing pharmacists with a greater role in supporting the COVID-19 response, and we continue to work on that issue.

We also continue to actively advocate for Congress to recognize pharmacists as providers in the Medicare program to further support the COVID-19 response and beyond. Yesterday, ASHP and 11 other national organizations sent a letter requesting that Congress immediately support legislation that would establish pharmacists as providers in Medicare Part B on an emergency basis to provide COVID-19 and flu testing. This authority is an important step in being able to rapidly expand access to testing across our country to support the national response to this crisis. We also see this as a step toward expanded recognition of pharmacists by payers, including Medicare.

Finally, ASHP is also working with our members and other stakeholders to gain access to medications from the Strategic National Stockpile (SNS). Most recently, we joined with several organizations to request that FEMA immediately release all available quantities of a number of critical drugs from the SNS to the New York and New Jersey Departments of Health to address urgent patient care needs. We are also working to support other state affiliates and members across the country with these important requests.

ASHP and its government relations team will continue to work tirelessly with our collaborating partners to ensure that U.S. regulatory authorities are responding to the current needs of pharmacists and healthcare providers.

While our collective attention is on the needs of frontline practitioners, I wanted to take an opportunity to highlight some positive news about the newest members of our profession. ASHP’s 2020 Residency Match concluded this week, and I want to congratulate the 5,269 future pharmacists who matched with 2,551 PGY1 and PGY2 pharmacy residency programs across the country. This number represents a 46% increase in the number of available positions over the past five years – a remarkable rate of growth. I am pleased that our accredited residency programs have demonstrated an outstanding commitment to training during the pandemic. While managing multiple critical priorities, these programs continued to interview applicants virtually. This undoubtedly will be a unique time during which to begin a residency program regardless of its focus. ASHP is committed to ensuring that these young practitioners and their programs have the needed resources to successfully conduct critically important resident training this year and beyond.

In the same vein, please know that ASHP stands ready to offer you and your healthcare colleagues that same level of steadfast support. In addition to advocating to give you access to critical medications, ASHP continues to update and create new resources and tools that can be found on our COVID-19 Resource Center. We have also opened access to many evidence-based online resources and tools on ashp.org, making them widely available to all pharmacists and the broader healthcare community.

Over the last few weeks, I have heard countless stories from members and others about the challenges they are facing, but I’ve also heard many stories of hope and heroism. I, and David Chen, ASHP assistant vice president for Pharmacy Leadership and Planning, have listened in on calls from pharmacy leaders at major health systems in New York City, the pandemic’s current epicenter. We are incredibly impressed by how these leaders have shared their information and experiences and how they support each other and their frontline staff. This is a tremendous example of how peer-to-peer connection and communication can aid in the pandemic response. Their experiences and willingness to share their stories will undoubtedly help others in responding to COVID-19 in facilities across the country. We applaud them for these efforts.

Please also know that ASHP is here to support your well-being, which should remain a priority for all healthcare personnel during this challenging time. Please make sure that you are taking care of yourself and your family.

“ASHP has our backs.” These are the words of a member who recently reached out to us. This really resonated with me, and I can assure you that we will continue to work across all fronts, leveraging our talented staff, our valued partners, and our amazing members to provide you with the information, connections, and resources you need today and in the future.

Thank you for everything you do for your patients and the profession.

Sincerely,

Paul

June 1, 2010

In Support of Collaborative Practice

Henri R. Manasse, Jr., Ph.D., Sc.D.

Henri R. Manasse, Jr., Ph.D., Sc.D.

IN THIS ERA OF HEALTH CARE REFORM, advanced pharmacy practice, and enhanced public focus on medication safety and efficacy, you might think that health care professionals would be on the same page in our approaches to team-based, quality patient care. Unfortunately, in the case of the American Medical Association (AMA), you would be wrong.

The AMA recently released its “Scope of Practice [SOP] Data Series: Pharmacists.” This members-only document seeks to define, describe, and prescribe the scope of pharmacy practice. And it does so using erroneous information, false statements, and pure errors of fact about pharmacists’ education, training, and scopes of practice.

It is a troubling look into the way that the AMA perceives today’s pharmacist—a point of view that is clearly out of the mainstream of contemporary practice. The SOP is devoid of what prominent national boards and regulatory bodies such as the Institute of Medicine, the National Quality Forum, the American Board of Internal Medicine, and many others are saying about the importance of collaborative care.

It is clear from the document that the AMA is concerned about the way that medication therapy management (MTM) and collaborative practice agreements are evolving. Pharmacists in hospitals and health systems and nurse practitioners are moving into areas of practice traditionally handled by physicians. But it is an evolution created by need. Drug misadventures are a reality.

With more than 18,000 FDA-approved chemical entities and dosage forms on the market and a practice model that allows any physician to prescribe any medication at any time, there has never been a more urgent need for medication experts. Pharmacists who practice in hospitals and health systems are those experts.

The current state of practice, including a greater demand for pharmacists’ clinical skills and a growing number of new practitioners seeking pharmacy residencies, further bears out the need for pharmacists’ medication management services in the context of team-based care.

Instead, even though collaborative drug therapy management is currently authorized in 45 states, the AMA has chosen to use their policy document to raise fears in the reader that pharmacists aren’t competent to conduct MTM.

ASHP will not passively stand by and allow this publication to go unanswered. I recently sent a letter to AMA Executive Vice President and Chief Executive Officer Michael D. Maves, M.D., M.B.A., in which I laid out the inaccuracies and untrue representations in the SOP and asked the AMA to retract the document or, at minimum, correct it.

In this new world of patient care, it will take every health profession working together to ensure that patients receive the safest, most effective care. Pharmacists are a critical component of that care delivery model, and ASHP continually stands at the ready to promote the importance of collaborative practice.

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