Several challenges are unique to managing pediatric medical surges, particularly for the healthcare workforce and supply chain. For one, pediatric hospitals require more intensive nursing resources to treat and monitor patients, especially in intensive care and neonatal intensive care units.
 
Additionally, pediatric supply chains can also be more vulnerable to supply chain disruptions, as some critical products have only one supplier or manufacturer capable of producing the necessary pediatric-specific equipment and supplies.

Product Availability

• The repeal of China’s COVID Zero policies have led to a surge in COVID cases. Pharmaceutical companies around the world rely on active pharmaceutical ingredients (APIs) and key starting materials from abroad, including China. Without reliable reporting from China’s economic partners, analysts are keeping a close eye for any warning signs of supply chain disruptions in every sector.
  • The upcoming Lunar New Year holiday may exacerbate disruptions. The holiday lasts from January 21 to 27. Every year, factories are shut down for an extended period to celebrate the Lunar New Year in China and other countries in Asia, and suppliers typically take this into account in their planning and logistics. However, along with the compounding impacts of COVID-19 workforce illness in China, the supply chain may witness additional disruptions this year as production has already been delayed. 
• Amoxicillin
  • Amoxicillin remains in short supply.
    • As of 1/5, states across the nation are still feeling the impacts of an “unprecedented level of respiratory need” as the amoxicillin shortage as well as other over the counter drugs, such as liquid Motrin and Tylenol, remains.
    • The shortages are not only impacting children’s medications but also adult medications which had predated the “tripledemic,” such as NyQuil, DayQuil, and other cold and flu medications. However, the recent surge in respiratory illnesses has inflated the situation.
  • The majority of amoxicillin production facilities are located overseas. Domestic amoxicillin capacity is limited by staffing and active pharmaceutical ingredients (API) constraints, as well as reduction of capacity due to low demand in recent years.
  • The lack of guaranteed demand prior to the respiratory season is driving a lack of surge capacity. Manufacturers of amoxicillin and other antibiotics typically determine production amounts prior to respiratory season based on the amount ordered. Manufacturers typically do not manufacture additional product beyond what is ordered because profit margins for the product are small; it would be a major risk to overproduce and not sell additional product. Contracts that guarantee demand (between manufacturers and government, distributors, and/or providers) may help mitigate shortages for future respiratory seasons.
  • As of 1/5, multiple forms of amoxicillin remain on the FDA and ASHP drug shortage lists. This includes tablets, capsules, and powder for suspension. Providers and patients continue to experience impacts.
  • The American Academy of Pediatrics reported on alternative therapies during the shortage.
• Tamiflu (oseltamivir)
  • On 12/21, HHS/ASPR announced that Tamiflu will be released from the Strategic National Stockpile and other sources to states and territories that request it.
  • Tamiflu and its generic oseltamivir remain in high demand.  As of 1/5, both the oral suspension and capsule formulations of oseltamivir remain on the ASHP shortages list. Oseltamivir is not currently on the FDA shortage list.
    • Other alternative influenza antivirals include Xofluza, Rimantadine, Zanamivir. There are no reported shortages for these drugs. 
  • Updated as of 12/5: FDA’s list of available antiviral medications for the 2022-2023 influenza season. 
  • FDA notes that while certain variations of Tamiflu are unavailable, there are no reported shortages (as of 1/5) among many companies.
• Many over-the-counter pediatric pain relievers (ibuprofen and acetaminophen) are experiencing spot shortages locally. With the exception of ibuprofen oral suspension (prescription only), which is on the ASHP Shortages list, these products are not yet on the ASHP or FDA Drug Shortage lists.
• The two largest pharmacy chains, CVS and Walgreens have started implementing limitations on purchasing children’s pain relief and fever reducing over the counter medicines. CVS purchases are restricted to two items online and in-store, and Walgreens is limiting buys to 6 items online (in-store purchases are not limited).
• The shortages of pediatric pain relievers as well as influenza and other respiratory illness medications will have compounding impacts on the surge in hospitalizations. If parents and caregivers cannot find medication for their sick children, their condition may worsen, and the parents will have no choice but to bring their children to the pediatric hospital or emergency room where we continue to see long wait times for access to healthcare. It is critical to continue mitigating supply chain disruptions around the pediatric drug shortage before hospitalization rates increase further.
• ASHP’s current drug shortages list includes the following drugs that could negatively impact treatment of RSV and other respiratory illnesses:
  • Reverified 1/5: Oseltamivir Oral Suspension and Capsules of various sizes from 5 different companies have been added. Ajanta and Alembic have oseltamivir available to contracted customers. Alvogen has oseltamivir suspension and capsules available. Genentech has Tamiflu presentations available and is reviewing orders. Strides has oseltamivir capsules available. The sizes/formulations that are in shortage will either be released in late December 2022, are on allocation right now, or the company cannot estimate a release date.
    • The CDC has also released an Interim Guidance for Clinicians to Prioritize Antiviral Treatment of Influenza in the Setting of Reduced Availability of Oseltamivir.
  • As of 12/23: Albuterol Inhalation Solutions from Akorn and Nephron Pharmaceuticals Corporation have been added. While both companies have not provided a reason for the shortages, it is safe to assume shortages are being experienced due to the increased use of albuterol inhalers in hospitals to treat COVID-19 patients in respiratory distress.
  • Reverified 1/5: 0.9% Sodium Chloride Small Volume Bags (< 150 mL) of various sizes from six different companies have been added. There are a multitude of reasons for the shortage including increased demand, manufacturing delays, and labor shortages. A number of the companies have supplies on allocation as they work through this shortage while Fresenius Kabi expects a release date of mid-to-late December.
  • Reverified 1/5: 0.9% Sodium Chloride Large Volume Bags of various sizes from five different companies have been added. The majority of companies stated that the reason for the shortage was due to an increase in demand. Additionally, a majority of the companies have product on allocation to their customers while Fresenius Kabi estimates a release date of mid-to-late December for the 250, 500, and 1000 mL bags.
  • Reverified 1/5: Ibuprofen Oral Suspension (Prescription Products Only) from Teva has been added. While no reason for the shortage has been provided, we can assume it is due to or exacerbated by the surge of respiratory illnesses impacting the nation. There has been no estimated resupply date.
  • As of 1/5: Bacteriostatic 0.9% Sodium Chloride Vials of various sizes from Fresenius Kabi and Pfizer remain in shortage. The shortage is likely caused by increased demand, related to the application of sodium chloride for respiratory therapy. Pfizer has 0.9% sodium chloride 10 mL vials on backorder and the company estimates a release date of March 2023. Fresenius Kabi estimates a release date of mid-January 2023 for the 10 mL vials and late-January 2023 for the 30 mL vials.
  • Reverified 1/5: 23.4% Sodium Chloride Injection of various formulations from Fresenius Kabi and Pfizer have been added. Both Fresenius Kabi and Pfizer have said the shortage is due to an increase in demand. Expected resupply dates are from mid-December 2022 to January 2023.
  • Reverified 1/5: Ceftazidime Injection (and its generic name Tazicef) from Pfizer, Sagent, and BBraun have been added. The shortage is due to increased demand, likely due to the fact that ceftazidime is used to treat a wide variety of bacterial infections and providers could be prescribing this drug as a remedy to respiratory symptoms.
  • Reverified 1/5: Rocuronium injection, used during tracheal intubation, is in shortage from several manufacturers due to increased demand and manufacturing delays. Estimated resupply dates vary based on manufacturer. 
• FDA’s drug shortage database lists the following updates regarding drugs that may be related to treating respiratory illness:
  • Reverified on 1/5: Amoxicillin oral powder for suspension is available for current customers from Hikma pharmaceuticals. As of 12/6 most of the amoxicillin oral powder product for suspension from Sandoz is unavailable while some has limited availability. Additionally, as of 12/6, products from Aurobindo and Teva are on allocation.
  • Reverified on 1/5: albuterol sulfate, a bronchodilator for oral inhalation, manufactured by Akorn Pharmaceuticals, remains unavailable and is estimated to be back in stock by Q2 2023. A 5 mL version from Nephron Pharmaceuticals is available.
• FDA’s medical device shortage database lists the following updates regarding medical devices that may be related to treating respiratory illness:
  • As of 10/31: two ventilation-related products are on the FDA medical device shortage list – JOH (Tube Tracheostomy And Tube Cuff) and BTO (Tube, Tracheostomy (with and without Connector).
• Definitions for product shortage vary by organization. Healthcare Ready sources data from multiple organizations that maintain drug shortage lists, including:
  • American Society of Health-System Pharmacists (ASHP), which defines a drug shortage as “a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.”
  • US Food and Drug Administration (FDA), which defines a drug shortage as “a situation where the total supply of all versions of the approved product available at the user level will not meet the current demand, and a registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the user level.”
• On 11/22, the FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 and influenza multiplex test for use in a point-of-care (POC) setting. This will expand the testing kit pool as well as reduce the strain on the testing kit supply chain as two tests are combined into one.
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Treatments for RSV

A monoclonal antibody therapy called palivizumab is available as a precautionary measure to prevent severe RSV illness in certain infants and children at high risk for severe disease during the normal respiratory season. It cannot cure or treat children who are already suffering from severe cases of RSV; it is a preventative treatment.

• On 11/17, AAP updated its guidance: Given the known efficacy of palivizumab along with the unpredictable surge capability of RSV, AAP recommends programmatic consideration of providing more than five consecutive doses of palivizumab depending on the duration of the current RSV surge in a particular region of the country.
• Palivizumab is sold under the brand name Synagis, and is marketed by Sobi in the United States. Sobi purchased US rights to Synagis from AstraZeneca in 2018. Before COVID-19, physicians prescribed Palivizumab more frequently as a preventative measure, yet, this treatment strategy slowed during the pandemic.
• AAP says that it recommends Palivizumab in eligible infants in regions that are experiencing high rates of RSV and that it will release updated guidance as they monitor the seasonal trends.

Workforce Shortages

Workforce shortages continue to impact access to care in hospitals around the country. Additionally, with the current respiratory illnesses beginning to affect more adults across the nation (especially following holiday celebrations) more hospital staff will likely be calling out sick during the Winter season. Resident physicians, doctors, hospitals staff are advocating for increased federal support.
 
The nursing shortage is currently being exacerbated by the rise in hospitalizations amongst the adult and pediatric population. The demand for pediatric nurses is increasing along with the surge of respiratory illnesses; at the same time, fewer nurses are entering the workforce.
 
Ongoing workforce shortages may threaten the ability of facilities to establish a predictable quality of care for patients. Because pediatrics is a specialty practice, there may be additional strain on the workforce with pediatric care experience. Reports indicate that pediatricians are requesting increased federal support as they deal with RSV, COVID-19, and influenza treatment in unison. Physicians state that they can only successfully handle this “tripledemic” with the assistance of a federal emergency declaration and dissemination of support. The Administration for Strategic Preparedness and Response (ASPR), Technical Resources, Assistance Center, and Information Exchange (TRACIE) team has a staffing resources section on their pediatric surge response resources page, which can be found here.
 
Hospitals and other healthcare facilities may need to increase surveillance for respiratory illnesses among staff to reduce the spread and the potential for staff being out sick. Practitioners’ mental health should also be considered and protected. Additional training and support for practitioners that are not used to caring for acute pediatric cases for prolonged periods should be provided whenever possible.