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Amid ongoing drug shortages, AAP leaders call on HHS to identify solutions

May 3, 2024

The AAP, the American Academy of Child and Adolescent Psychiatry (AACAP) and Children’s Hospital Association (CHA) are calling on federal officials to lead discussions and identify solutions for ongoing shortages of stimulants and other medications that impact child health.

A letter sent by the three organizations to the U.S. Department of Health and Human Services and Drug Enforcement Administration asks the federal government to “convene all relevant stakeholders for a forum to discuss the impact these shortages are having on patients, families and their providers and identify actionable solutions that will alleviate these shortages.”

Drugs in shortage include attention-deficit/hyperactivity disorder (ADHD) medications, oxytocin, Rho(D) immune globulin and standard of care chemotherapy, pain and sedation medications. AAP members have expressed frustrations with the shortages, as well as the discontinuation of other drugs needed to treat children.

“Drug shortages are a serious problem nationally for prescribers and children and their families,” AAP Committee on Drugs Chair J. Routt Reigart, M.D., FAAP, said. “Many of these shortages are for drugs important to the survival and wellness of children.”

Recent studies show there are more active drug shortages in the United States than ever before. According to a study from the University of Utah Drug Information Service and the American Society of Health-System Pharmacists, there were 323 drugs in active shortage during the first three months of 2024. That’s the highest number since tracking began in 2001.

“Shortage of drugs for the treatment of attention deficit disorder (ADD) and ADHD is a particular problem due to the prevalence of these diagnoses,” Dr. Reigart said. “The Centers for Disease Control and Prevention has reported that the latest National Survey of Children’s Health estimates that 6 million children and adolescents between 3 and 17 years of age in the U.S. have these diagnoses. For male children and adolescents in this age group, 13% have been diagnosed and 6% of females. The prevalence and functional impairment of these diagnoses makes the shortages an urgent and critical problem for prescribers and families.”

The letter also addressed the challenges created by the ongoing shortage of these treatments.

“Untreated ADHD can contribute to worsening mental and behavioral health disorders, including mood and substance-use disorders, unintended injuries resulting from ADHD-related impulsivity and long-term impacts on relationships-building, educational achievement and professional success,” the letter said. “Parents and families may also be negatively impacted by the disruption that untreated ADHD can cause in the home, school and work environments.”

Patients and caregivers may have to go to extraordinary lengths to find pharmacies that can fill their prescription and may face challenges with insurance companies for coverage and prior authorization.

The AAP, AACAP and CHA call on federal officials to do more to mitigate shortages so patients and families can see improvements in the availability of stimulant medications at the pharmacy.

In an effort to help families and prescribers navigate shortages of ADHD medication, the AAP has provided guidance on identifying generic alternatives and therapeutic substitutions that may assist those affected. However, Dr. Reigart says these alternatives may not be a solution for all.

“Unfortunately, such substitutions often conflict with formularies requiring unreasonable effort on the part of prescribers to obtain permission to prescribe off-formulary agents,” Dr. Reigart said. “The Committee on Drugs feels that, in the face of such necessary substitutions, prescribing should not be hampered or delayed by onerous prior authorization requirements.”

The AAP also supports the Drug Shortage Prevention Act of 2023. The bipartisan bill before Congress would require drug makers to notify the Food and Drug Administration (FDA) when they see a surge in demand for essential medicines. The FDA has no direct control over drug supplies, but being able to forecast shortages would allow better coordination and planning, which may ease the impact on children and families.

To further help members, the AAP launched a Pediatric Drugs website with information on drug shortages, drug development and drug policy, and education.


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