[Submitted electronically to NVP.RFI@hhs.gov]
Re: Request for Information (RFI): Vaccines National Strategic Plan available for public comment
ASHP is pleased to submit feedback to regarding the Vaccines National Strategic Plan (the “Plan”). ASHP represents pharmacists who serve as patient care providers in acute and ambulatory settings, including hospitals, health systems, and clinics. The organization’s more than 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.
ASHP applauds the Plan’s commitment to eliminate vaccine-preventable diseases (VPDs) through safe and effective vaccination. Since the advent of vaccines, the science behind them has steadily improved, but the COVID-19 global pandemic has galvanized innovation in vaccine technology, research, and development like never before. ASHP’s comments will incorporate lessons learned with the novel vaccines against SARS-CoV-2 and reinforce our longstanding advocacy for the pharmacists’ role in supporting public health by increasing patient access to immunizations.
Overall, the Plan’s goals, objectives, and strategies appropriately address the vaccine landscape, addressing the full continuum of vaccine research to safety surveillance. We support the use of the same five broad goals from the 2010 Plan and we commend the decision to segment goal targets into 5- and 10-year plans in order to balance flexibility and innovation with long-term benchmarking. The upcoming deployment of COVID-19 vaccines will provide an opportunity for continuous learning and quality improvement that will be critical to inform the Plan. We encourage regular revision of the Plan to reflect information and knowledge gleaned from those efforts. Below, we offer targeted feedback on aspects of the Plan, as well as some additional suggestions for strengthening vaccine strategies, including incorporating certain elements of ASHP’s Principles for COVID-19 Vaccine Distribution, Allocation, and Mass Immunization.
- Critical Gaps in the Plan’s Goals, Objectives, and Strategies
- Reinforcing Vaccine Trust with Clinicians and Patients: Goal 1 emphasizes innovation in vaccine development and related technologies. We are seeing this innovation firsthand with the COVID-19 vaccine candidates. However, many incorrectly equate innovation in research and development with the elimination of steps in the process. An outreach campaign tailored to healthcare professionals and patients will address any misinformation in the approval process while increasing vaccine confidence.
Further, for Goal 1, Objective 1.1 of the Plan, we suggest adding a strategy that incorporates elements of ASHP’s first principle for vaccines, which reads: The need for vaccine development to advance at an unprecedented rate requires special safeguards to ensure patient safety and instill public trust. Ethical, rigorous, and transparent procedures for informed consent, inclusion of key populations, evidence evaluation for safety and efficacy, and sustained surveillance are critical. Although vaccine candidates will have undergone multiple phases of testing before approval, it is not possible to detect all potential adverse effects and/or additional factors that may affect vaccine effectiveness during pre-marketing clinical trials. Therefore, rigorous post-marketing surveillance is required to monitor the safety and effectiveness of COVID-19 vaccines.
- Bridging the Gap Between Evidence-Based Practice and Routine Clinical Practice: The Plan lacks an overall strategy and framework for a continuous feedback mechanism that connects research, implementation, and quality improvement initiatives. A comprehensive, continuous improvement strategy, leveraging macro- and micro-learning from healthcare systems, will decrease the research-to-practice gap for all of the goals, objectives, and strategies outlined in the Plan.
For Goal 1, Objective 1.2, we recommend adding a new strategy that incorporates elements of ASHP’s principle #5, which reads: Vaccine supply chain capacity and integrity are dependent not only on manufacturing, but also on availability of vaccine components and ancillary resources (e.g., vials, syringes, alcohol swabs), cold chain management, distribution strategies, and storage. To distribute COVID-19 vaccines effectively, storage procedures must be employed to ensure maximum shelf-life capacity and minimize deterioration and waste of what will likely be a constrained supply of vaccine. Another important aspect of judicious vaccine allotment includes the ability to track and monitor vaccine distribution at the organizational, state, federal, and international level. Efforts to track and trace COVID-19 vaccines in a manner that promotes real-time, reliable tracking while minimizing reporting inefficiencies is required.
Finally, we also encourage general improvement in communication among stakeholders and greater consistency in global practice. For Goal 5, Objective 5.3, we suggest adding a new strategy that incorporates elements of our ASHP principle #2, which reads: Despite differences in international, federal, state, and local health policy, regulatory frameworks, and practice models, a concerted effort to ensure widespread global vaccination is necessary to contain COVID-19 and limit continued devastation of public health, economies, and geopolitical relations. Effective communication, collaboration, and coordination with government agencies, public health organizations, regulatory agencies, and health departments are critical to synchronize lines of effort and ensure a successful mass immunization campaign.
- Fully Engaging Clinician Workforce in Immunization: ASHP believes that full engagement of clinicians, particularly pharmacists, will be integral to successfully immunizing against COVID-19 and improving overall rates of immunization for other diseases. Assembling such a workforce will require mobilization of appropriately trained technical staff (e.g., pharmacy technicians) and supervised clinical learners (e.g., pharmacy, nursing, physician assistant, and medical students) to assist with patient screening and referral as well as vaccine preparation and/or administration. We also urge an explicit endorsement of removing barriers that limit clinician participation, including barriers to pharmacist ordering and administering vaccinations in all practice settings.
Specifically, we suggest you review the wording in Goal 4, Objective 4.1.1, which seems to incorrectly classify pharmacies as a “non-healthcare setting.” Further, for the Plan’s Goal 4, Objective 4.1 and Goal 5, Objective 5.3, we recommend incorporating parts of ASHP principles #3 and #4, which read:
- Engage, prepare, and protect the immunizer workforce: A robust, trained workforce of immunizers ready and available to administer COVID-19 vaccines is vital to mass immunization efforts. Assembling such a workforce will require mobilization of traditional and nontraditional immunizers, including appropriately trained and supervised clinical learners such as pharmacy, nursing, physician assistant, and medical students to assist with patient screening and referral as well as vaccine preparation and/or administration. To safely accomplish mass immunization, shortages of personal protective equipment must be mitigated to protect the immunizing workforce and maximize infection control efforts.
- Pharmacists and pharmacy technicians contribute significantly to vaccine awareness and immunization rates through clinical efforts such as patient screening and education, vaccine administration, and accurate reporting of adverse events. The pharmacy workforce should be mobilized nationwide to administer COVID-19 vaccines and as clinical team members in the community. State and federal legal, scope of practice, and reimbursement barriers that prevent or limit pharmacist COVID-19 vaccine administration must be removed.
Finally, to ensure clinician engagement and offer patients maximum flexibility in vaccine access, we suggest adding a new strategy under Goal 4, Objective 4.4 requiring all health plans to cover all FDA-authorized vaccinations under both the medical and pharmacy benefit.
- Identifying and Resolving Potential Errors in Practice: There are unique storage, handling, and administration complexities with each commercially-available vaccine. Errors introduced during each phase of the vaccine use cycle may compromise vaccine safety and efficacy. The logistics in these processes may be more granular than the scope of the Plan — nevertheless, they are an important component to successful vaccination efforts. We recommend working with medication experts and medication safety organizations to identify error-prone processes in vaccine logistics and developing consensus-based safeguards around each.
Specifically, the Plan’s Goal 1, Objective 1.2 could be strengthened by adding a new strategy that incorporates the following ASHP principle: “To distribute vaccines effectively, storage procedures must be employed to ensure maximum shelf-life capacity and minimize deterioration and waste.”
- Developing Consensus-based, National Vaccination Quality Measures: We appreciate the indicators identified to monitor progress and impact of the Plan. These indicators, along with other improvement opportunities may lend themselves as national quality measures worthy of being conceptualized and evaluated. We encourage collaboration with quality measure development organizations to identify meaningful and feasible structural, process, and outcome quality measures for vaccination, including patient-reported outcome measures.
- Utilizing Real-time Interoperable Information Systems: Tracking and reporting of vaccine inventory, vaccine administration, and vaccine safety needs to be interoperable and real-time. A comprehensive approach to vaccine tracking and surveillance is critical for informing all decisions related to the Plan. Leveraging data exchange will enhance the ability to monitor vaccine supply and mitigate shortages, determine vaccination rates and improve community protection from VPDs, and identify safety signals. ASHP is a leader in tracking and reporting medication shortages, including vaccines, and is ready to partner with federal and non-federal stakeholders to bolster efforts to continuously monitor and mitigate threats to vaccine supply. In addition, we advocate for centralized databases for documenting vaccine administration that are accessible to all immunizers and healthcare professionals.
Specifically, for the Plan’s Goal 4, Objective 4.6 and Goal 5, Objective 5.3, we suggest adding new strategies including:
- Identifying solutions for a process for automated perpetual inventory management for use at the local levels and as a means to report amount of vaccine on hand in vaccine finder; and
- Supporting efforts to track and trace vaccines in a manner that promotes real-time, reliable tracking while minimizing reporting inefficiencies is required.
Thank you for your consideration of our comments. We share HHS’s commitment to improving vaccine access for all VPDs, and we look forward to working with you closely as the COVID-19 mass immunization efforts commence. Please do not hesitate to contact me at 301-664-8698 or email@example.com if ASHP can provide any further information or assist the agency in any way.
Jillanne Schulte Wall, J.D.
Senior Director, Health & Regulatory Policy