The Drug Shortage Crisis

Contributor: Collin Lee

UPDATE: The FDA announced that it will let methotrexate and doxorubicin supply in from Europe to prevent a shortage in the United States.

Drug shortages have become a BIG, BIG, BIG problem. In the past five years, the number of drug shortages in the United States has quadrupled. There were 220 different shortages in 2011. Compare that to just 56 shortages back in 2006. Many of the drugs currently on the shortage list are injectable medications that are crucial to patient care. For instance, many pharmacies will soon run out of the potentially life-saving chemotherapy drug methotrexate. Imagine the heartache of patients and loved ones when they are told there is no drug left to give them. To make it worse, these shortages aren’t going to end anytime soon.

What’s Causing All These Drug Shortages?
Many of the medications on the shortage list are generic medications. Pharmacies receive these medications at a very low price compared to their brand name counterparts, and these medications do not provide big profit margins for the manufacturer. Therefore, manufacturers are choosing to stop making the generic medication and instead use their facilities to manufacturer drugs that will bring in more money. There are no FDA or governmental laws or rules to prevent this from happening. Unfortunately, the remaining manufacturers who make the generic medication can’t keep up with the demand.

Also, over the past few years the FDA has closed several of the generic manufacturing plants due to concerns related to their manufacturing practices. In some cases, the plant closed was the only one producing the particular medication. Medication that is already out on the market may be recalled by the FDA, depleting supply within a couple hours and leaving doctors, pharmacists and patients scrambling to find alternative treatments.

Another problem is that the number of medications approved for sale each year is increasing, but the number of manufacturing sites making these medications has not grown to scale. This means that the amount of time the manufacturer uses its plants to produce a single medication diminishes, resulting in decreased supply.

In some cases there can be a shortage of the raw material that is used to make the medication. Most of these materials are provided from countries outside of the United States and the supply is outside of the manufacturer’s control.

An Atmosphere of Panic
These shortages create an atmosphere of panic….not just for patients but for pharmacists as well. Our worst fear is to have to tell a patient we can’t provide a medication that has been proven to help and in some cases cure. Often, there are alternative medications that are just as good, but sometimes the alternative may not be the best fit for the patient, or it may not be covered under his insurance. Adding to the problem even more, pharmacies begin purchasing the shortage medication or alternative medication in larger-than-usual supply in order to build up stockpiles and ensure treatment for their patients. This in turn results in a shortage of the alternative medication. It becomes a vicious cycle

Being forced to use alternative medications, often within a very short period of time, puts patients at risk for medication errors. Healthcare professionals may not be familiar with the side effects, dosing or contraindications of the alternative medication. Sadly, there have been reported deaths and adverse outcomes associated with these medication changes. These deaths aren’t a result of incompetent healthcare workers, but rather a set of circumstances outside of their control.

How to Protect Yourself
One way to protect yourself against medication shortages is to visit the American Society of Health-System Pharmacists website at www.ASHP.org. Type in “drug shortages” in the search box and select the Drug Shortages Resource Center. From there, click on Current Shortages. If you see one of your medications on the list, click on the medication name for detailed, up-to-date, information on the shortage. Contact your local pharmacy to see if they still have supply on hand and if they are anticipating running out before more supply becomes available or before your refill is due. Note that sometimes a drug may be on the shortage list but there is enough supply on the market to keep up with overall demand.

If you need injectable medications such as methotrexate or other chemotherapy agents on the list, contact your physician immediately so he or she can work ahead of time to secure a supply or at least be ready to discuss the benefits/risks of an alternative drug regimen with you before your next scheduled dose. Being informed ahead of time will give you time to digest new information and hopefully minimize any undue risks, stress or worry.

Has a drug shortage affect you or a loved one? Leave a comment and tell us about it.

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