With physicians and families around the country frustrated by shortages of some prescription medications and access issues, the AAP is supporting legislation and meeting with government agencies to advocate for efforts to minimize disruptions.
For months, providers have dealt with shortages of some medications for attention deficit/hyperactivity disorder (ADHD), a situation that may have been exacerbated by the COVID-19 pandemic. Oncologists also have reported shortages of drugs to treat cancer in children. Additionally, families and pediatricians have expressed frustration over the limited supplies of the respiratory syncytial virus (RSV) immunization nirsevimab (Beyfortus), after it received approval from the Centers for Disease Control and Prevention (CDC) last summer. Sanofi is expanding its nirsevimab manufacturing network and rolling out a new reservation program for the 2024-’25 season in an effort to address supply issues seen after last year’s launch.
“It’s like playing a game of Whac-A-Mole every month to help families find the medication they need,” said Seth D. Kaplan, M.D., FAAP, vice president of the AAP Texas Chapter. “We have had to put a lot of the responsibility of this on the families.”
A pediatrician at a small practice in Frisco, Texas, Dr. Kaplan says shortages often lead to “uncompensated care” as staff spend more time trying to locate drugs for patients.
“We never even got commercial Beyfortus because, by the time we found out that commercial payers would pay us enough to cover costs, we couldn’t order any,” Dr. Kaplan said. “We’ve only had it available for Vaccines for Children (VFC) patients, and we’ve been afraid to borrow from VFC for private patients because we have no guarantee we will be able to get private stock to pay back to VFC.”
Beyond the nirsevimab shortage, the biggest issues Dr. Kaplan has seen are with stimulants for ADHD, including Focalin, Metadate, Concerta, Adderall XR and Vyvanse. Because of the unpredictability of stock and no noticeable pattern to the shortages, the task of finding medicine often falls on patients and families.
“We’ve had so many families upset with us that we couldn’t tell them where supply would be available, but we have no access to that information and live in a large enough area that there are dozens of pharmacies they are trying to get medicine from.”
Since providers have to prescribe via Electronic Prescriptions for Controlled Substances and check the Prescription Monitoring Program, it often is easier for patients to tell doctors where to send a particular prescription, Dr. Kaplan said.
“Our EHR (electronic health record) has recently provided some tools that make this much easier,” Dr. Kaplan said. “But when the parents call pharmacies and they say they do have supply they need, they are told that is true at that moment but might not be 30 minutes later. So parents call the office or message us via the portal and say they need the script at that moment, something we are not always able to accomplish in real time.”
Mary Beth Miotto, M.D., M.P.H., FAAP, a pediatrician with Mattapan Community Health Center in Boston and president of the AAP Massachusetts Chapter, said pediatricians in her state have expressed frustration with the impacts of shortages of essential medications, particularly during the winter respiratory season. Dr. Miotto and her peers prepared for months for the rollout of nirsevimab and said they were “disappointed” by the limited supply.
“When we received word from CDC networks that additional supplies would be released in January, there was a mix of guarded optimism and hesitancy,” Dr. Miotto said. “Most pediatricians are afraid of promising this lifesaving preventive therapeutic to parents yet again, only to be let down another time. Many of us have seen our youngest patients go through a difficult RSV season. Many of us have admitted infants who were eligible for nirsevimab to the PICU with severe RSV bronchiolitis.”
Government response
In a statement provided to AAP News, Food and Drug Administration (FDA) officials said the agency does not manufacture drugs and cannot require companies to make a drug. The FDA said it does work closely with manufacturers and others in the supply chain to “understand, mitigate and prevent or reduce the impact of intermittent or reduced availability of certain products.”
“Manufacturing quality issues are the major reason for drug shortages,” the statement said. “However, there have been other reasons such as production delays at the manufacturer and delays companies have experienced receiving raw materials and components from suppliers. FDA cannot order manufacturers to make more products or address shortages by telling them how to distribute.”
The FDA, however, can expedite reviews of new production lines and material sources to increase production and publish information if data are available that could support use of a drug after its labeled expiration date.
The FDA also can facilitate temporary importation of medicines approved abroad after careful review of information about the product and the facility where it is made. It has done so recently by temporarily allowing importation of an antibiotic that can be used to treat pregnant women with syphilis and babies with congenital syphilis while there is a shortage of Bicillin L-A (penicillin G benzathine injectable suspension).
Last year, the bipartisan Drug Shortage Prevention Act was introduced, which would require manufacturers to notify the FDA if they experience six consecutive weeks of an increase in product demand to minimize drug shortages and improve the FDA’s predictive ability and responsiveness. The AAP supports the legislation, one of a number of proposals put forward in an attempt to address the problem.
Access issues
In addition to shortages, the discontinuation of the corticosteroid inhaler Flovent HFA (fluticasone propionate inhalation aerosol) caused concern among pediatricians as generic fluticasone HFA and Asmanex HFA are the only drugs that can be administered to children effectively when utilizing a spacer. However, many private payers and Medicaid plans that covered Flovent have not been covering the generic or Asmanex.
In January, AAP President Benjamin D. Hoffman, M.D., FAAP, sent a letter to payers urging them to cover the alternative medications and remove unnecessary prior authorizations. The AAP also has been having frequent discussions with the U.S. Department of Health and Human Services about this issue and shared with the Centers for Medicare & Medicaid Services concerns from specific states about inadequate Medicaid coverage of suitable options for children.
Dr. Miotto said the additional administrative burdens are causing burnout even among the most experienced asthma care pediatricians.
“The timing of the discontinuation of brand name fluticasone and changes in asthma therapeutic coverage feels like a bad joke right in the middle of the respiratory season,” Dr. Miotto said. “Our chapter is partnering with our state Department of Public Health and Medicaid leaders to assist prescribers and raise parent awareness of the need for prescription changes, but pediatricians are frustrated and fear an upcoming surge in asthma hospitalizations.”
As advocacy efforts continue, pediatricians worry about long-term effects these additional burdens may place on families and providers alike.
“I worry some families will just give up and go without medication due to all of these complications,” Dr. Kaplan said.
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