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Is A Drug Your Pharmacy Needs On The FDA Shortage List? What Are Your Options?

7 July 2016

Kaitlin Alexander

If you work in pharmacy management, especially at a hospital pharmacy, you may feel as though you're constantly searching for the balance between serving your patients and dealing with the regulatory requirements put forth by the FDA and your state's pharmacy licensing board. This balance is never more challenging to achieve than when one of your patients has been prescribed a drug subject to the FDA's drug shortage list. What will happen if a drug frequently prescribed by your pharmacy becomes subject to a shortage, and what are the options that can allow you to continue to serve your patients? Read on to learn more about the practical effect of FDA shortages on the pharmaceutical supply market.

What will happen if a drug your hospital pharmacy needs becomes subject to a shortage?

When a drug your pharmacy regularly dispenses becomes subject to an FDA shortage, you'll need to evaluate your alternatives. In some cases, patients may be switched to a generic formulary for a period of time until the drug is made more widely available again. However, unlike therapeutic drugs, medically necessary drugs are required in order for patients to function normally, and going from a regular dose of one particular drug to an alternative medication or formulary could leave your patients with some unexpected and unwanted side effects.

For those who go this route, patient education is important. Although most side effects can be relatively mild and will subside within two or three weeks, side effects that persist or interfere with your functioning should be reported by a patient to his or her primary care physician for follow-up and treatment. Your patients will also want to seek emergency help if they develop any reactions that could be attributed to anaphylactic shock, like swollen lips, trouble breathing, or a severe rash. They may sometimes even require an epinephrine injection to diminish this allergic reaction and get back to normal again.

When can you compound these drugs yourself?

Even if your pharmacy isn't registered as an outsourcing facility, you may be able to compound the needed drugs yourself. Pharmacies that aren't registered as outsourcing facilities are required to comply with a number of FDA regulations when producing and marketing a compound drug, including directions for use and limiting the quantity of compounded drugs on hand to those that have already been "spoken for" by patients with valid prescriptions. Depending upon the variety of generic formulations available and the reported side effects of each drug, compounding your own may be the best option for your hospital's patients.

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