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Drug shortages hit a record high in the first quarter of 2024, leaving patients and doctors scrambling for supplies such as ADHD drugs and chemotherapy drugs. And the ongoing struggle to control shortages is now prompting a new call to action.
The American Hospital Association petition to parliament The law is scheduled to be amended in February. Around the same time, the Federal Trade Commission I was demanded to public comment It was part of an investigation into how group purchasing organizations and drug wholesalers are contributing to shortages. The site was flooded with responses from patients looking for medications to treat his ADHD, like Adderall.
“This ADHD drug shortage has seriously affected me for at least the past year. There have been many times when I have not been able to fill my prescriptions. I work in a hospital, and due to my carelessness, People’s lives are at risk.” one patient wrote.
A combination of regulatory and pandemic-related issues are disrupting the supply of ADHD drugs.
Andrew Newhouse, director of clinical pharmacy at Sedgwick University, said the pandemic has allowed doctors to use telemedicine to reach patients remotely, and the Drug Enforcement Administration has eased restrictions on prescribing controlled substances, allowing doctors to meet patients in person. It is said that the drug can be prescribed without an evaluation.
“Demand for Adderall increased 20% from 2020 to 2021, but the DEA has strict rules on maximum production to avoid patient abuse and prevent surplus from falling into the wrong hands.” said Sedgwick. Blog post.
And even though demand soared, the DEA didn’t increase production quotas for the drug until this year.
However, drug manufacturing quotas will only increase by 10%, which may not be enough to resolve shortage concerns, Newhouse said.
The factors driving ADHD drug shortages are unique, and this highlights the major challenges faced by regulatory agencies in addressing overall drug shortages. There is no single cause.
Manufacturing quality issues often result in drug shortages, along with production delays and problems with the flow of necessary raw materials and parts. Shortages can also occur when companies decide to abandon low-cost generic drugs that are no longer worth the time to manufacture or distribute.
For some medicines, a combination of these factors will continue to cause shortages.
“While some shortages may be short-term and related to unexpected seasonal demand, others may be more systemic and suggest more complex drivers of the shortage. ” said Mr. A. November Report from IQVIA.
Stubborn and complex challenges
Drug shortages are nothing new. The supply of various drugs has waxed and waned for decades; Reaching new heights in 2024, causing a significant backlog. There were 323 drug shortages in the first three months of 2024, the highest number since the American Society of Health-System Pharmacists began tracking in 2001.
Medications for ADHD are just one of many that are becoming harder to find.Companies are also struggling to cope Rapid increase in demand About weight loss drugs that are very popular diabetes treatments. Use of these drugs has more than doubled since 2020, according to IQVIA, and as Ozempic exploded in popularity, demand strained the supply chain.
“This, combined with the lack of generic drug options and the existence of only brand-name drugs, has led to the current shortage. Supply of this drug is expected to last until the end of 2024,” Newhouse said. said.
Eli Lilly and Novo Nordisk, companies that make weight-loss drugs, are currently Revitalization of manufacturing industry By building or relocating a new factory, Purchase an existing site.
According to IQVIA, drug shortages are also impacting oncology, but represent a small proportion of the overall volume.
“Due to testing confusion and market withdrawals, there is a significant shortage of older generic chemotherapy drugs, especially platinum-based chemotherapy drugs.Chemotherapy is used as a backbone therapy across multiple indications and is an option for treatment compatibility. “Given the limited availability of chemotherapy, the treatment of cancer patients has been significantly affected and may be delayed due to chemotherapy shortages,” IQVIA reported.
Long-standing problems in the generic drug market also continue to constrain the supply of low-cost drugs such as amoxicillin and albuterol. Companies have little incentive to produce generic drugs because the market incentives to produce generic drugs are low.
“Acorn Pharmaceuticals, historically the leading manufacturer of albuterol, has ceased production, leaving Nephron Pharmaceuticals as the only domestic supplier,” Newhouse said. “Currently, the shortage only affects the liquid used in nebulizer machines and does not affect the production of handheld inhalers.”
Additionally, certain drugs are not economically attractive options, but are essential for patient care.
“Albuterol is an important medicine for millions of Americans who suffer from asthma and COPD,” Newhouse said.
There are also examples of manufacturing quality issues causing product shortages. As a drug ages, the number of companies manufacturing it often declines. As a result, there are fewer production lines available to manufacture them. Production may also be delayed because manufacturers are limited in the amount of raw materials they can produce.
Agency considering next steps
Government officials and agencies are considering ideas to keep critical medicines on shelves.
On April 2, the U.S. Department of Health and Human Services announced: white paper Regarding supply chain issues related to generic sterile injectable drugs used in the inpatient setting. However, this paper proposes a strategy that can be applied to a wider range of drugs.
“HHS requires ‘diversification of supply in terms of redundancy in manufacturing capacity, a balance between domestic and diverse foreign sourcing, and the existence of reliable, efficient, sustainable, and robust manufacturing practices.’ ,” Newhouse said.
The agency detailed the measures it has taken and future efforts to prevent drug shortages.
HHS said it wants Improving monitoring capabilities This is to enable the supply chain to respond quickly when disruption is imminent. To this end, they have also established the new role of Supply Chain Resilience and Shortage Coordinator.
These efforts come in addition to other recent changes.
The CARES Act of 2020 is intended to strengthen FDA’s ability to prevent and reduce drug shortages, Newhouse said.
“This expands the obligation for manufacturers of certain drug products to notify FDA of production discontinuations or interruptions,” Newhouse said. “They will also be required to report the manufacturing volumes of listed human drugs and human biological products. This will help predict potential drug shortages.”
Companies are encouraged to notify FDA if they are at risk of drug shortages.
“Most information about drug shortages is provided to FDA by manufacturers, and FDA works closely with FDA to prevent or reduce the impact of shortages.” F.D.A. I got it. “If a shortage is listed as current in the Drug Shortage Database, FDA is aware of the supply situation and is working with manufacturers on efforts to mitigate supply disruptions. Also, if a shortage is listed as current in the Drug Shortage Database, Regarding pharmaceuticals, we will continue to work with manufacturers to prevent shortages.
But building a more resilient drug supply chain is no easy task and will require continued government intervention, according to the Brookings Institution.
“Our nation’s drug supply chain is not as reliable as we expect, resulting in disruptions to health care and harm to patients,” the recent report said. Brookings Institution Report found. “But little progress will occur unless there are systemic changes to economic dynamics and the misaligned incentives that exist in markets.”
According to the HHS white paper, solutions require a collaborative effort.
“Nonetheless, more effective and durable solutions require additional legal powers and funding to address the root causes of shortages. ,” the report states.
