Background

Keys to preventing transmission of communicable diseases in healthcare settings include prompt recognition and isolation of patients with known or suspected communicable diseases and availability and proper use of personal protective equipment (PPE). ^{Reference Siegel, Rhinehart and Jackson5,6} During the coronavirus disease 2019 (COVID-19) pandemic, enhanced infection prevention strategies were rapidly adopted in healthcare facilities including mask use when in a medical facility; additionally, the use of gloves, gown, eye protection, and an N95 respirator when providing care for all patients with known or suspected COVID-19 was implemented. ^{Reference Weber, Babcock and Hayden7} Rapid isolation of patients and adherence to universal masking have been demonstrated to prevent transmission of severe acute respiratory coronavirus virus 2 in healthcare settings including between healthcare personnel (HCP), from patient-to-HCP, from HCP-to-patients, and from patients-to-HCP. More recently, requiring COVID-19 vaccination as a condition of employment further mitigates the risk of transmission in healthcare and community. ^{Reference Weber, Al-Tawfiq and Babcock8}

Impact of coronavirus disease 2019 on personal protective equipment supply

During the COVID-19 response in 2020, severe shortages of PPE occurred in the United States, especially N95 respirators. ^{4,Reference Ranney, Griffeth and Jha9} To optimize the limited supply of N95 respirators, many healthcare facilities developed strategies and protocols around reuse and extended use. As noted by Cohen and Rogers:

In addition, shortages of antiseptic (eg, alcohol-based hand rubs) and surface disinfectants occurred.

Recommendations for mitigating supply shortages in future pandemics

Key recommendations for mitigating future shortages of PPE in the United States are as follows: (1) incentives for expansion of US domestic productions, (2) increased stockpiles in the Strategic National Stockpile (SNS), and (3) rapid invocation of the Defense Procurement Act to increase supply in future pandemics if there are supply shortages (Table 1). Moreover, increased transparency in the number and type of PPE in the SNS is critically important for healthcare facilities to properly train their HCP on the use of stockpile supplies. This insight is most relevant for N95 respirators to which HCP must be fit-tested prior to use, ventilators for which respiratory therapists must be familiar with maintenance and management, and PPE where doffing sequences can vary depending on the type and institution.

Background

Rapid development of sensitive and specific diagnostic tests, with clinically relevant turnaround times, is crucial to early identification of infected patients to allow proper isolation and use of appropriate PPE by HCP, preserve workforce through return to work of HCP with symptoms suggestive of infection with the pandemic agent, and provide the patient with appropriate therapy.

As noted by Henderson et al:

Shortages of diagnostic tests and associated supplies (ie, nasal swabs, viral transport media, polymerase chain reaction reagents) for COVID-19 persisted for months. ^{Reference Barré-Sinoussi, Chermann and Rey16}

Recommendations for improving diagnostic testing in future pandemics

We endorse and support the recommendations of the Infectious Disease Society of America (IDSA), which provided recent recommendations for “Building Medical Device Supply Chain Resilience: A Healthcare & Public Health Ecosystem-Wide Collaboration.” The IDSA specifically recommended developing “a federally guided supply chain and distribution plan involving all manufacturers of products relevant to diagnostics and pandemic response” (see Table 1 for additional IDSA recommendation). ^{Reference Behnam, Dey, Gambell and Talwar17}

Background

One of the successes of the COVID-19 response has been the rapid development of pharmaceuticals including therapeutic agents and vaccines for the prevention and treatment of COVID-19. ⁴ Both the IDSA and the National Institutes of Health (NIH) have developed and routinely updated evidence-based therapeutic guidelines for prevention and treatment of COVID-19. We strongly support continued recommendations from both IDSA and the NIH and encourage development of similar guidelines for future outbreaks (eg, Mpox).

Impact of coronavirus disease 2019 on therapeutic supplies

Limited supplies, due to manufacturing limitations and an inadequate supply chain for necessary constituents, have impaired widespread use of new therapeutics and vaccines. Therefore, as the federal government rolled out vaccines, Centers for Disease Control and Prevention developed a priority scheme for administration. Similarly, the requirement to adhere to the conditions for use in the Food and Drug Administration (FDA) Emergency Use Authorization (EUA) constrained therapeutic use.

Recommendations for mitigating therapeutic supply shortages in future pandemics

Rapid availability of vaccines and therapeutics for future pandemics requires increased funding for development of vaccines for likely pathogens, rapid review by the FDA with granting of an EUA for therapeutics, and US government purchase and distribution of drugs in an equitable manner (Table 1).

Background

Modern medicine is based in large part on the availability of effective and safe medications. Shortages of drugs negatively affect patient care. Mitigating the impact of drug shortages may increase patient risk by eliminating or altering infection prevention/pharmacy standards.

Impact of coronavirus disease 2019 on drug supply

As described by Shukar and colleagues, “the causes of shortage are multifactorial, including supply issues, demand issues, and regulatory issues. Supply issues consist of manufacturing problems, unavailability of raw materials, logistic problems, and business problems. In contrast, demand issues include just-in-time inventory, higher demand for a product, seasonal demand, and unpredictable demand.” ^{Reference Belisle, Anger and Kanaan23} Although drug shortages in the United States have been a long-standing problem, ^{Reference Shukar, Zahoor and Hayat24} the COVID-19 pandemic has substantially increased the frequency and duration of shortages. ^{Reference Belisle, Anger and Kanaan23}

Recommendations for mitigating drug shortages in future pandemics

Key recommendations for mitigating drug shortages in future outbreaks and pandemics include the following: (1) US government-maintained list of supplies and shortages with information on severity of any shortages, updated at least weekly, (2) transparency of potential supply chain impacts/shortages (eg, shutdown of a factory), and (3) rapid and early FDA action to allow importation and use of non-US-approved pharmaceuticals (Table 1). Guidance on management of drug shortages has been published previously. ^{Reference Belisle, Anger and Kanaan23,Reference Tu, Miller and Forman28–Reference Piatek, Ning and Touchette31}

Ethical distribution of scarce resources

Management of shortages must include ethical values to guide rationing of scarce resources including PPE, therapeutics, and vaccines, both in society and within healthcare facilities. ^{Reference Pulk, Leber and Tran32} Guiding principles include the following: maximizing benefits, treating people equitably, promoting and rewarding instrumental value, and giving priority to persons at highest risk for an adverse outcome. Ethical frameworks for management of drug shortages within) healthcare facilities have been published. ^{Reference Pulk, Leber and Tran32–Reference Berlinger, Wynia and Powell36} At both the national and local levels (including health facilities) experts in ethics and diversity, equity and inclusion must be included in the planning and management of drug shortages.