For the first three months of 2024, there were 323 active drug shortages, according to the American Society of Health-System Pharmacists.
Prior to 2022, the last high was in 2014 with 301 active drug shortages. This is also the highest record the trade organization has seen since it started tracking drug shortages in 2001.
Basic drugs are among those in active shortages, such as insulin, drugs specific to type 2 diabetes, standard of care chemotherapy, pain and sedation medications and ADHD medications, according to the American Society of Health-System Pharmacists.
Doctors struggle to find supply
Doctors are trying to help their patients navigate this shortage, as well, which has led to increased anxiety and concern for their patients.
“It has consumed our days,” Dr. Miguel Parilo, of Premier Health’s Bull Family Diabetes Center in Oakwood, said about finding diabetes medication in general.
Parilo may have upwards of 15 to 20 patients a day who need help coming up with an alternative plan if they cannot get access to their regular medication.
Some patients can switch to an alternative, while others may have more difficulty finding a medication that is available, works for them and is covered by their insurance or otherwise affordable.
One of the medicines Parilo’s patients have been having difficulty finding is Humalog, or insulin lispro injection, specifically in the vials, which are generally what patients use when they are using an insulin pump, he said.
The drug company Eli Lilly discontinued its 3-millimeter vial of Humalog, according to the FDA. The drug company warned earlier this year that its alternative 10-millimeter would likely be in short supply through April because of these manufacturing changes, but the shortage has continued into May.
“I never envisioned having a shortage of a medication let alone a handful of medications, and it’s happening from different manufacturers. It’s happening from medicines of different countries of origin, so the reasons for the shortage are unclear and seemingly multifactorial,” Parilo said.
Hours spent calling pharmacies
Carter has spent hours of her time calling pharmacies to try to find her son’s ADHD medicine, which she says does more than help him focus. The medicine, Focalin, helps him function and has improved his quality of life.
“He just could not do anything,” Carter said what it was like for her son before he was diagnosed with ADHD got treatment, saying he was unable to self-regulate or control his emotions without his medicine.
ADHD, or attention-deficit/hyperactivity disorder, is a neurodevelopmental disorder. It exhibits an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development, according to the National Institute of Mental Health.
“Life was so overwhelming that he couldn’t control himself in a lot of different ways, but with medicine...he’s happy. He’s smiling,” Carter said. “He’s able to function as a normal eight-year-old should versus not being able to control the emotions that he has.”
The longest Carter has spent calling multiple pharmacies is more than four hours trying to find Focalin, and her husband has had to leave his job before in order to get to a pharmacy before it closes. She has to start with CVS pharmacies since her family’s insurance requires going through CVS first, which can help her since CVS pharmacies can check within a 20-mile radius for other locations that may have it.
Credit: Nick Graham
Credit: Nick Graham
If she can’t find the medicine at a CVS pharmacy, she has to get permission from her insurance to go through a different pharmacy.
“Once I get out of the CVS network, I then literally have to just start calling pharmacy after pharmacy after pharmacy,” Carter said.
She’s even gotten to the point where she will find a pharmacy that has it in stock, but it will get filled and bought out by someone else before her son’s doctor could send the prescription to that pharmacy for it be filled.
“There have been multiple times that, by the time the physician has seen it and called it in, we’ve lost the supply that they had, so then I have to start back over,” Carter said.
If her son has to go without his medicine, he can start to experience withdrawal symptoms, like severe headaches.
Controlled substances under limits
Drug shortages can occur for many reasons, the FDA says, including manufacturing and quality problems, delays and discontinuations.
New DEA quota changes, along with allocation practices established after opioid legal settlements, are exacerbating shortages of controlled substances, which are 12% of all active shortages and include ADHD medication, according to the American Society of Health-System Pharmacists.
Drug manufacturers aren’t meeting those quotas, the DEA says, saying the companies could have been producing more but chose not to do so.
For amphetamine medications like Adderall, in 2022, manufacturers did not produce the full amount that these limits permitted them to make, according to the DEA and FDA.
Based on DEA’s internal analysis of inventory, manufacturing and sales data submitted by manufacturers of amphetamine products, manufacturers only sold approximately 70% of their allotted quota, according to a joint letter from the Anne M. Milgram, DEA administrator, and Dr. Robert Califf, commissioner for the FDA.
The DEA has also sought more transparency from drug manufacturers, including requiring drug companies submit anticipated production timelines, report monthly on amount of drugs being produced and shipped and report whether those drugs will be used domestically or exported.
Generic drugs in shortage
Generic drugs are less profitable, so drug companies have fewer incentives to make and sell those drugs.
About 70% of the proportion of drugs in a shortage in the U.S. are generic drugs, according to the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing the U.S. pharmaceutical industry.
When something becomes a generic drug, the profit margin continues to shrink and leads to a point where the manufacturer can’t make any money on producing the drug, said Eddie Pauline, president and CEO of the Ohio Life Sciences Association, a trade group representing biotech and other life science industries in Ohio.
“In cases like that, there needs to be some sort of federal or state incentive to make a business case for it,” said Pauline.
About 40% of generic drugs were supplied by one manufacturer, with the median number of manufacturer per drug was two, PhRMA says.
“Given the majority of prescription drug shortages are generic, lawmakers should prioritize public policies that spur infrastructure investments that could increase the resiliency of supply chains for medicines with a long history of drug shortages,” PhRMA said in a statement.
Some point to the insurance companies, many of which won’t cover certain medicines or brands, and/or will require prior authorization, which can be time consuming and prone to errors.
If online submissions for prior authorization are not filled out correctly, sometimes the patient has to go through the process of submitting documents of their insurance carrier and medical records, said Alyssa Overton of Eaton.
“It was really ridiculous, but I’d have to then fill it out by hand and then compile the records and manually fax it,” Overton said about helping others go through the prior authorization process.
Overton has had to go a week without her ADHD medication. Her husband had to go without his medication for about six weeks due to challenges between their insurance carrier and their pharmacy following a data breach at United Healthcare, she said.
Families like the Carters have increasingly been having better luck finding access to the medicines they need, but they’re still waiting for the other shoe to drop again.
“My blood pressure is actually increasing every month,” Carter said. “...I will move mountains for my child. I will, if I have to, sit down on and call every pharmacy. It makes me sad, though, to think of the parents who don’t have the capabilities or won’t.”
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