The Honorable Lamar Alexander
United States Senate
Committee on Health, Education, Labor & Pensions
428 Dirksen Senate Office Building
Washington, D.C. 20510
Dear Chairman Alexander:
ASHP (The American Society of Health-System Pharmacists) appreciates the opportunity to comment on the Senate Committee on Health, Education, Labor and Pensions (HELP) White Paper “Preparing for the Next Pandemic,” and applauds your efforts in addressing this very important healthcare issue for our country. ASHP is committed to working with you and the Committee to address this pandemic and help find solutions to better assist patients.
ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings. The organization’s nearly 55,000 members include pharmacists, student pharmacists, and pharmacy technicians. For more than 75 years, ASHP has been at the forefront of efforts to improve medication use and enhance patient safety.
Our vision is that medication use will be optimal, safe, and effective for all people all of the time. A primary tenet of that vision includes access to affordable medications needed to save or sustain lives. Addressing the issue of medication safety and the accessibility of prescription drugs is one of ASHP’s highest and longstanding public policy priorities. As such, we were pleased to see that the white paper included recommendations to improve the medical supply chain vulnerabilities of the country. As health system pharmacists, we are clinical experts in the field of medication management and work as part of a health care team to properly prescribe and administer prescription drugs to our patients. In this role, we recognize the critical need to ensure that the Nation’s drug supply chain is uninterrupted and support any policies that would work to achieve this goal. Even slight interruptions in the drug supply chain could lead to delays or prevention of treatment, serious harm to patients, and unnecessary costs to our healthcare system.
1. Protect Our Drug Supply Chain from Shortages:
We appreciate that the Committee addressed the medical supply chain issue in this white paper. We suggest that the Committee consider specific language to address the issue of drug shortages and the drug supply chain. In order to ensure that there is no interruption to the drug supply chain, preparations should be made to increase production of critical drugs and ensure availability of medical devices, including syringes and needles necessary for vaccine administration. We can take concrete steps now to begin shoring up our supply.
In the short term we recommend the following:
- Provide federal funding to create a buffer supply of these critical medications to ensure sufficient supplies are available this fall. Unlike the strategic national stockpile that is held in reserve by the government, a buffer supply will increase inventory on hand in hospitals or their distributors.
- Support development of manufacturing capacity – adding to domestic capacity and improving quality and reliability of international suppliers.
ASHP’s recommendations to address drug shortages over the longer term are as follows:
- Establish incentives to encourage manufacturers to produce drugs in shortage or at risk of shortage: Drugs with fewer than 3 manufacturers are at greatest risk for shortages. FDA should recommend incentives to encourage manufacturers to begin producing drugs that are in shortage.
- Require FDA to publish quality ratings for drug manufacturers and 503B outsourcing facilities preparing copies of drug products under the exemption for products on FDA's shortage list or make public such information that would allow purchasers to assess the relative quality of drug supplies: Drug shortage data indicate that a majority of recent shortages were due to manufacturing quality issues. Hospitals and health systems often make purchasing decisions without access to manufacturing quality data. FDA inspection notices and warning letters describe inspections that are several months old and do not provide timely information of satisfactory resolution of problems identified and do not identify specific products manufactured at that facility. The use of contract manufacturing organizations further obfuscates any connection between an inspection notice or warning letter and a finished dosage form. Healthcare personnel need a mechanism to inform purchasing decisions based on manufacturer quality. FDA should publish manufacturing quality ratings, or make public information that would allow purchasers to compare manufacturing quality when making purchasing decisions. Similar ratings or information should be made public to assess quality of products produced in 503B outsourcing facilities.
- Require the Federal Trade Commission to evaluate the potential for drug product supply chain interruptions when considering manufacturer consolidations. Consolidation in the pharmaceutical industry has disrupted manufacturing lines and created quality issues, resulting in extended duration shortages of critical drug products. To prevent shortages related to mergers and acquisitions, FTC review of proposed consolidations in the pharmaceutical industry should require analysis of potential public health impacts – specifically, the likelihood the transaction will create new and/or exacerbate existing drug shortages.
2. Ensure Medicare and Medicaid Beneficiaries Have Adequate Access to Pharmacist Care
Pharmacists practicing in hospitals, clinics, physician offices, and community settings are trained to treat infectious diseases and can significantly expand access to care if federal barriers are removed. Pharmacists receive a clinically based doctor of pharmacy degree, and many also complete postgraduate residencies and become board certified in areas of specialty care, including infectious disease. Each year, nearly 4,000 pharmacists complete a pharmacy residency and 1,300 complete an additional residency in a clinical specialty. There are currently more than 800 board-certified infectious disease pharmacists nationwide.
In many communities, pharmacists are the most accessible healthcare providers and the first touchpoint of patient engagement with the healthcare system. In fact, 90% of all Americans live within five miles of a community pharmacy. In rural and underserved communities and in communities experiencing physician shortages, pharmacists may be the only healthcare provider that is immediately available to patients.
Many states have recognized the training and expertise of pharmacists as clinicians and clarified their state pharmacy practice laws to authorize pharmacists to provide patient care services that will be essential during the response to COVID-19. These services include ordering and administering immunizations, ordering and interpreting point-of-care tests, and initiating medications, such as antiviral therapies that must be initiated in a limited time from exposure in order to be effective. Some states have also ensured that their residents will have access to these services by clarifying that pharmacists should be reimbursed by health plans, like other providers, when they provide these services.
Forty-nine states and the District of Columbia grant pharmacists the ability to practice collaboratively in some capacity with physicians. The Centers for Medicare & Medicaid Services (CMS) should ensure that its own regulations do not create a barrier to care that is authorized by state pharmacy practice laws.
To ensure that patients can access pharmacist care during a coronavirus outbreak or other public health emergencies, CMS should implement the following policies:
- Clarify Medicare supervision requirements for pharmacists to align with their state scope of practice: To avoid barriers to care for the Medicare population, CMS should provide flexibility in its pharmacist supervision and services requirements so they align with the pharmacy practice law of any state in which a beneficiary is receiving care. This flexibility is necessary to ensure that federal regulations do not prevent pharmacists from providing the same level of care to Medicare beneficiaries that they provide to other patients in the state.
- Clarify Medicare and Medicaid authority to reimburse clinical services provided by pharmacists acting within their state scope of practice: To avoid barriers to care for the Medicare and Medicaid populations, particularly those in rural and underserved communities that are experiencing provider shortages, Congress should clarify that Medicare, Medicare Advantage, and Medicaid plans should reimburse clinical services provided by pharmacists acting within their state’s scope of practice. For example, point-of-care testing plays a critical role in the identification and treatment of infectious diseases. Increasing access to testing may help reduce disease spread and improve outcomes through early detection. Recent studies indicate that pharmacist-provided point-of-care testing can increase early identification of infectious disease, particularly for patients who are not able to see a primary care provider – a group that is likely to grow during a coronavirus outbreak. Further, pharmacist initiation of time-sensitive antiviral therapy can speed care access, improve outcomes and reduce disease spread. Similarly, once a vaccine becomes available, research shows that pharmacists can significantly improve immunization rates. To ensure that Medicare and Medicaid beneficiaries can be diagnosed and treated quickly, CMS should reimburse pharmacists for services related to the treatment of infectious diseases, when they are acting within their scope of practice, just as CMS would for other healthcare providers. Failure to do so will leave Medicare and Medicaid beneficiaries with less access to healthcare services than other patients.
- Clarify Medicare authority to support pharmacy residency programs, including specialized training in infectious disease. Rigorous clinician education, including for pharmacists with specialized training to manage infectious disease medication regimens, is the bedrock of a highly trained workforce that is prepared to manage public health emergencies. Unfortunately, Medicare support for these programs is uncertain.
CMS should clarify that experts in topics such as infectious disease, who serve on the faculty of educational institutions such as medical schools and schools of pharmacy, can provide training to residents in pharmacy and allied health training programs without jeopardizing Medicare funding of programs.
CMS should also clarify that residents in these training programs may participate in clinical rotations at clinical sites operated by other hospitals or health systems, without jeopardizing Medicare funding, if those rotations are appropriate to strengthen resident training in clinical specialties such as infectious disease. CMS should further clarify that specialized pharmacy residency programs operated by hospitals or health systems in clinical specialties, such as infectious disease, are eligible for Medicare funding. The current system of relying on community resources to fund these programs is inadequate to maintain a pipeline of infectious disease experts necessary to manage specialized medication regimens during a medical surge event, such as a COVID-19 outbreak.
3. Provide Resources to Support Clinician Readiness and Resilience
We urge Congress to provide funding to support clinician readiness and resilience during a COVID-19 response. At minimum, these programs should focus on increasing preparedness and enhancing the pipeline of infectious disease and public health experts. For instance, programs should center on the following:
- Infectious disease and emergency preparedness continuing education: Congress should provide funding for immediate development and dissemination of clinician continuing education and certificate training programs on infectious disease and emergency preparedness, including for pharmacists. Such programs should harness the resources and reach of professional organizations, thereby aiding federal and state public health authorities in disaster response.
- Investment in infectious disease and emergency preparedness clinical education: Congress should provide funding to enhance and expand pharmacy, allied health, and medical residency programs and other advanced clinician educational programs focused on infectious disease and emergency preparedness.
- Clinician burnout, well-being, and resilience: Congress should provide funding to combat clinician burnout and to support research regarding clinician resilience and well-being. Public health emergencies can create intense strain on our healthcare system, which extends to our clinicians, including pharmacists. Clinicians already face high levels of burnout, and public health emergencies are likely to exacerbate this, adding to the strain on our healthcare system.
- Clinician and first responder family support: Congress should provide funding to support the families of clinicians, including pharmacists, and first responders during a pandemic or natural disaster. Given the demands placed on clinicians and first responders in these situations, adequate resources should be available for those who are caregivers, to ensure they can access backup or emergency child and elder care, at minimum, so they can focus on providing the best possible care to patients.
- Pharmacy readiness assessment: Congress should provide funding to provide tools for health systems to assess their readiness to respond to medical surge events and resources to address identified gaps, including disruptions to drug supplies, pharmacy staffing, and ongoing hospital operations.
ASHP remains committed to working with Congress to address these issues and appreciates the opportunity to comment on this White paper.
ASHP Vice President, Government Relations