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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

April 3, 2020

ASHP Update on COVID-19

Dear Colleagues,

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

WEDNESDAY EVENING I had the opportunity to participate on a director of pharmacy roundtable call with members of the New York State Council of Health-System Pharmacists. On the call, the current situation on the ground and lessons learned regarding the COVID-19 pandemic were shared by New York City pharmacy leaders. These individuals and their teams are true healthcare heroes. They are dealing with patient care situations that are beyond compare. Patient care needs have required an increase of propofol, fentanyl, and midazolam utilization by 400-600% in the past 14 days as they manage the demands of the intensive care unit and ventilated patients. One healthcare system shared that three weeks ago, it had 18 COVID-19 positive patients. As of Wednesday, they had 1,100.

We have all watched and listened to reports from New York, New Jersey, and other COVID-19 epicenters responding to this national pandemic. Listening firsthand to the heroic efforts of pharmacists on the front lines underscores the urgent need to proactively provide data to our health system, local, state, and national leaders on the pharmacy staff resources and drug supply needed to meet the needs of our COVID-19 patients. These extraordinary times will require remarkable coordination and responsiveness among our industry partners and government agencies.

ASHP has put the full weight of our advocacy efforts toward resolving these issues. This week, ASHP and the American Hospital Association, the American Medical Association, the Association of Clinical Oncology, and the American Society of Anesthesiologists, sent a letter to the Drug Enforcement Administration (DEA) requesting an immediate increase in controlled substances (CII) annual production quota allocations to manufacturers and 503B outsourcing facilities to increase the supply of opioids critical to COVID-19 patients on ventilators. ASHP’s letter notes the tightening CII supply and the need to increase production of fentanyl, hydromorphone, and other supportive CIIs as quickly as possible to avoid exacerbating existing shortages. ASHP will continue to work with the DEA, the Food and Drug Administration, manufacturers, and distributors to provide hospitals with the CIIs and other medications that are in short supply and critically needed to treat patients during the COVID-19 response.

Yesterday we sent a letter to Vice President Mike Pence, imploring him to encourage agencies to coordinate their efforts to increase manufacturing capacity for critical medications, including opioids, sedatives, and paralytics, to the greatest extent possible.

A colleague in New York expressed that a “tsunami” of drug shortages is coming as more hospitals and health systems struggle to manage the exponential rise in patient load. It is ASHP’s number-one priority to keep this issue at the forefront of public attention, and we will activate all of our partners and resources to help ensure you have the medications your patients need.

Launch of New Free Service: ASHP CareerPharm Rapid Connect

ASHP has been working on many fronts to assist you, our members, and all healthcare professionals to combat the COVID-19 pandemic. We continue to create new resources to support your valuable work on the front lines of patient care.

As the impact of the pandemic escalates, we are hearing from healthcare organizations nationwide that pharmacy departments are struggling to keep pace with the demands of the growing COVID-19 patient population. In response, I am pleased to share that ASHP has quickly developed and launched a new free service, ASHP CareerPharm Rapid Connect, to help healthcare organizations connect with pharmacists who can provide critical services including surge support with temporary onsite staffing, remote medication order review, remote clinical pharmacy specialist services, and other staffing needs. ASHP’s CareerPharm Rapid Connect also will help organizations connect with pharmacy technicians. We hope this free service will provide opportunities for hospitals, health systems, and others to fill a growing demand for pharmacy personnel during this urgent time of need.

PPE Shortages

In addition to the troubling issue of drug shortages related to COVID-19 patient care, ASHP members and other healthcare providers continue to face shortages of personal protective equipment (PPE). As I noted in last week’s blog, we are continuously surveying our members to understand the real-time impact of this issue. According to our most recent survey results, 58% of respondents whose organizations perform sterile compounding reported the need to reuse masks, and 42% reported a major or moderate disruption in the availability of medical masks. This is a substantial increase from the first survey, where 15% of respondents indicated disruptions in their supplies. We will continue to survey this situation and provide you with updates in the weeks ahead.

Given the data, ASHP is advocating for increased production and supply of PPE to ensure pharmacy personnel and other healthcare providers have adequate protection from exposure. We also continue to advance ASHP’s policymaker recommendations that address shortages of PPE for pharmacists and drug shortages to Congress, HHS, and the Vice President’s COVID-19 Task Force. Over 5,000 ASHP members have contacted their members of Congress to share those recommendations. If you haven’t yet, please consider reaching out to your members of Congress to ensure your concerns are heard.

We also created a dedicated section on ASHP’s COVID-19 Resource Center with the latest sterile compounding and PPE guidance and health policy statements. Resources include additional tools that ASHP created to support your needs as well as guidance from others, including the United States Pharmacopeia Compounding Expert Committee’s recommendations in response to shortages of garb and PPE for sterile compounding.

In addition, we continue to work on creating tools and resources to protect and assist you, our members, and all healthcare professionals as you work on the front lines of patient care. Today, we released our newest recommendations for pharmacists and pharmacy technicians on ways to prevent exposure to COVID-19 while in the workplace as well as recommendations on how to protect your family and friends to reduce exposure at home. Given the rapidly evolving guidance and recommendations supporting this effort, we will be updating these materials regularly.

Extending the Reach and Impact of the ASHP Community

ASHP supports our members by serving as a professional home and facilitating a sense of community. During this challenging time, we’ve expanded that community to include and support the interprofessional teams that are working together to treat patients in the face of unprecedented challenges.

In this spirit, you may recall that a few weeks ago, we opened access to our evidence-based online resources and tools on ashp.org, making them widely available to all pharmacists and the broader healthcare community. It gives us great satisfaction to know that members and non-members alike are using and sharing many of our important COVID-19 resources. More than 32,000 professionals have taken advantage of our free offering of ASHP’s Critical Care Pharmacy Specialty Review Course, Practice Exam, and Core Therapeutic Modules package, including more than 24,000 who are not currently ASHP members.

ASHP will continuously offer credible, trusted resources and share best practices, advice, and experiences from those on the front lines across the country. We recently launched a daily COVID-19 podcast on our @ASHPOfficial podcast channel with episodes featuring ASHP members and pharmacy practice leaders who discuss the evolving clinical, operational, and leadership challenges surrounding the COVID-19 pandemic. In the latest podcast episode, nationally recognized drug shortage expert Erin R. Fox and ASHP experts share the most recent information on drug shortages related to COVID-19 and the impact the recent relief bill passed by federal legislators will have on managing the supply chain. I encourage you to subscribe to @ASHPOfficial to receive this free, timely content.

As a reminder, we also recently established a COVID-19 Connect Community that ASHP members — and all healthcare providers — can use to ask questions, receive answers, share experiences, post resources, receive updates, and learn best practices related to COVID-19. Since it was launched less than two weeks ago, this active community has grown to more than 51,000 members and has generated nearly 500 discussions. It’s a wealth of real-time, real-life information. Please join and participate if you haven’t already.

Summer Meetings

Finally, I’d like to address our decision announced earlier this week to cancel the Summer Meetings in June. Our top priority is the safety of our meeting participants and staff, and supporting your patients’ needs. We are working on a plan to deliver many of the important activities from the Summer Meetings virtually, including educational programming and the House of Delegates. We’ll share the details as they become available.

In the meantime, please take care of yourself and your families. Be assured that we will continue to work tirelessly on your behalf. Thank you for everything you do for your patients and the profession.

Sincerely,

Paul

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