How learning about the FDA drug shortage could help your child’s care

Having a sick child is hard enough, but a current drug shortage is threatening to complicate matters even more for many families with chronically ill children.

“There is a supply problem with many drugs in this country right now, and it’s getting worse,” says Kathleen Gura, PharmD, BCNSP of Children’s Hospital Boston’s Department of Pharmacy. “Last year we had about 200 drugs in short supply, we’re already up to 211 this year, and that number may grow.”

Drug shortages are nothing new; in the past few decades several medications have dipped to very low supply levels, complicating care for many patients. But the problem with the current shortage is the fact that many different medications are becoming scarce at the same time, creating several shortages simultaneously.

Kathleen Gura, PharmD, BCNSP

The root of these drug shortages is layered, but it essentially comes down to a problem where pharmaceutical profits are dropping while their production costs increase.

As more and more companies produce generic drugs, profits drop throughout the drug industry. At the same time, the Food and Drug Admiration (FDA) is imposing stricter safety and cleanliness standards on drug-manufacturing plants. As a result companies are earning less money from the medications they make while their production costs grow to stay ahead of FDA standards. Many companies are finding the profits from some drugs no longer justify their production costs and are reducing shipping numbers, or discontinuing brands all together.

When this happens it’s not uncommon to have one or two companies end up as the sole providers of drugs that once had several manufactures.

“One or two plants may close and all of the sudden you have a last man standing situation,” says Gura. “When that happens some of the companies left are not going to be able to keep up with the demand.”

Fortunately for pediatric hospitals, infants and toddlers require much smaller dosages than larger patients, so supply concerns may not occur as quickly as they would in an adult hospital.  Pediatric hospitals are also good about sharing information about drug supply problems with one and another, which can often help prevent drug shortages before they occur.

“We very closely monitor drug shortages going on in other parts of the country and then look at how it would affect us if happened here,” Gura says. “Because we have access to that information we’re able to start looking for alternatives early. It helps to be proactive instead of reactive.”

Doctors may not always be aware of medicine shortages, so communication with drug prescribers is vital. If you hear about a potential shortage, please let them know.

To address drug shortages that directly affect Children’s, Gura says the hospital has several programs in place, and in every case communication is a vital component.  Since the scarcity started, Children’s has increased its contact with drug vendors and prescribers, which have been useful in identifying trends that may indicate a potential shortage.

If a drug shortage is expected, then the Department of Pharmacy makes recommendations to prescribers about exploring other treatment options or lowering dosages without compromising care. The department can also act as an advocate for patients who are worried about drug availability, and can help point parents in the right direction if a medication their child needs is in low supply.

And while Children’s may be doing everything it can to stay ahead of shortages, communication is a two way street. It’s not safe to assume your child’s clinician knows about drug supply shortages, so parents need to talk openly and often with their doctors and drug suppliers, and relay that information to Children’s whenever possible.

“Sometimes parents learn about these things before we do, so we appreciate when people alert us to information they may have about drug shortages,” says Gura. “Also, parents need to plan ahead. Never wait for your child to run out of medication before ordering more, always be conscious of your supply and what your child’s needs are.”

One of the more serious side effects of the drug shortage has been the rise in a “grey market” for selling drugs. Unscrupulous buyers are buying drugs that are in short supply, and then selling them back to the hospitals or online at inflated prices. Not only does this increase cost for everyone, it creates a drug market with far fewer safety standards in place to ensure the safety and quality of the drugs given to children.

“Parents should always discuss the situation with their physician or nurse practitioner anytime a prescribed medication is in danger of being in low supply,” Gura says. “This way they can work with a trusted pharmacist to determine therapeutic alternatives, and avoid the use of grey market drugs.”