Dealing With Drug Shortages
Dealing with drug shortages in some capacity has become an everyday occurrence in many pharmacies. In fact, the number of new drug shortages per year grew until 2011. It’s trended downward since then, likely due to federal initiatives intended to mitigate this crisis. Drug shortages are a burden for the healthcare system and for patients. They are time-consuming, can increase healthcare costs, and also increase the risk for medication errors. Sometimes patients can’t get needed therapies when certain drugs are in shortage. It has become increasingly important for pharmacists and pharmacy technicians to have tools, or efficient strategies, for dealing with drug shortages.
Robin Hatch comes in with this Rx for Thyrolar-1 one tablet orally every day. She’s been getting this Rx for years. As it happens, you do not have Thyrolar-1 or an equivalent in stock. The last time you tried to order it, it was unavailable from the wholesaler.
What is a drug shortage?
The Food and Drug Administration (FDA) defines a drug shortage as a time when the total available supply of all versions of an approved product doesn’t meet the current demand, and a registered alternative manufacturer is not able to meet the current and/or projected demands for the potentially medically necessary use. To pharmacies, it simply means that despite ordering adequate amounts of a drug, you can’t get enough to fill all the prescriptions or orders you get.
Why do drug shortages happen?
Drug shortages can happen for a variety of reasons, including recall of drug products because of contamination, manufacturing issues (e.g., questionable quality control), drug discontinuations, unavailability of raw materials needed to produce a drug, and ripple effects from shortages of other similar products. Drug shortages have even been caused by natural disasters, when a drug manufacturing plant has been damaged and cannot produce its usual supply. In 2015, manufacturing issues were the largest known cause of drug shortages, accounting for almost 25%. In 2017, hurricanes that impacted Puerto Rico lead to shortages of many meds, including some IV bags. (Note that about 10% of the meds prescribed in the U.S. are manufactured in Puerto Rico.)
An example of a drug shortage caused by a recall was the shortage of docusate oral liquid in the U.S., in 2016. This product was contaminated with bacteria, and outbreaks of infection were identified in a number of U.S. states.
An example of a drug shortage caused by discontinuation was the shortage of tromethamine solution in the U.S., which also occurred in 2016. This injectable med is used to treat patients in the hospital setting whose blood becomes too acidic due to problems such as after cardiac arrest. Fortunately, the preferred treatment for this condition is actually injectable sodium bicarbonate. However, an advantage of tromethamine was that it’s sodium-free, which could be good in patients with high sodium levels. And unfortunately, injectable sodium bicarbonate has also been in shortage from time to time.
Examples of drug shortages caused by a ripple effect are the recent shortages of a number of IV antibiotics. When an antibiotic such as ceftazidime is in shortage, other antibiotics that can treat the same types of infections (e.g., cefepime, cefotaxime) will be used to take up the slack, and hospitals may order larger quantities than usual. This can lead to “secondary shortages.”
What are some more examples of drugs that are currently in short supply?
In the U.S., there’s a lot of focus on shortages of hospital drugs. These have consistently included drugs like injectable epinephrine, which is used for resuscitation of patients in code situations or cardiac arrest; propofol, which is used to sedate patients when they’re in surgery or intubated in critical care; and injectable furosemide, which is used to help patients get rid of fluid build-up in the body so that their hearts and lungs can work normally. There have also been shortages of some chemotherapy drugs, such as cytarabine and doxorubicin, which have caused treatment delays for some patients. Shortages of electrolyte solutions such as calcium salts have been troublesome for compounding parenteral nutrition. Even IV fluids such as normal saline have been in shortage at times. All of these shortages are serious, and could result in less than optimal patient care or in some cases, patient harm.
You ask the pharmacist why Thyrolar is short, and what you should tell Ms. Hatch. He says that its manufacturer does not have it available right now, and it’s not clear when and if it will be available again. It’s an old drug, and there are a number of other options available. He says that he will take a minute and speak with Ms. Hatch.
What strategies can I use to help prevent problems during drug shortages?
Monitor drug shortage lists. These can help you anticipate shortages that might affect your pharmacy, and also help you know when a drug shortage is expected to resolve. The FDA has a list that includes medically necessary drugs that are in shortage at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm. They have mobile apps that might be useful for keeping very close tabs on shortages. The American Society of Health-System Pharmacists (ASHP) has a more inclusive list at http://www.ashp.org/shortages. Here you can find current and resolved shortages, as well as drug products that are no longer commercially available. In Canada, you can access https://www.drugshortagescanada.ca/ to get details about current shortages.
Sometimes, pharmacy listservs will have information on drug shortages, and you can get automatic email updates if you subscribe online to some. Ask your pharmacist if you need help finding one to follow. In addition, your pharmacy may put out information such as email updates or newsletters about current shortages that are causing problems, which can be especially useful if you can’t access other online resources at your workplace.
If you work in the hospital, also keep lines of communication open with your purchasing agent and your administrators to find out about potential drug shortages. This way, you can start thinking about how a shortage might affect your work area, and start to consider ways to help handle the shortage.
Try to find out why the shortage is happening. This might affect your game plan. For example, you might be able to order a different strength of a drug if just one strength is short because of a discontinuation. Or you might need to order an alternative drug if all strengths are short because of a manufacturing issue.
In the hospital setting, administrators might be making recommendations on how to handle shortages. However, your input is valuable, since you are able to keep your finger on the pulse of what’s happening on the front lines of patient care.
Keep close tabs on your stock. It’s important to know what is coming in and going out of the pharmacy. One of the big complaints about shortages is that they can happen with almost no notice at all. One day, a drug simply won’t come in from the wholesaler. Just because you ordered a drug doesn’t mean you’ll receive it.
Check how much of a drug your pharmacy is using. This information will help your pharmacy plan how to handle a specific shortage.
Also, when you check your stock, make sure to note expiration dates of drugs that are in shortage. Use the ones that have the shortest expiration first, to avoid wasting any valuable doses. In the hospital setting, if your practice area doesn’t move a drug very quickly, contact someone in charge to see if you can trade your short-dated drug for one with a longer expiration. That way, a practice area that uses the drug more frequently can use the short-dated drug before it expires.
For drugs that are short, try to contact your supplier to get more details about product availability. Ask about limits placed on the amount you can order, and when/if the drug is expected to be available again.
Order sufficient supplies of alternatives. Having alternatives on hand can help ensure that patients can be treated appropriately and avoid gaps in treatment. You may be lucky enough to get a product in if you simply order a different generic or brand of what you need. (In the retail setting, this might require you to take additional steps such as contacting insurers to get “dispense as written” or “override” codes.) Or, you may have to get a different product, such as a different strength or dosage form.
As mentioned, certain strengths of injectable epinephrine have been short, and other strengths that have been available have been used in their place. (Although, it has been important to use strategies to help prevent dangerous mix-ups and errors with different products.) Another example of an alternative is bumetanide, which is an option if the diuretic furosemide is unavailable. If bumetanide is available and furosemide is not available, it will be important to try to stock enough bumetanide to take up the slack for furosemide.
Avoid hoarding drugs. Ordering excessive amounts of a drug product for your pharmacy, or even hoarding it in your hospital pharmacy satellite, can prevent patients who need the drug from getting it by creating “artificial shortages.” Plus, hoarding can increase pharmacy costs. Instead, follow your pharmacy’s guidance on how much drug you should stock, such as by running usage reports to find out how much you will need. If you have no guidance, try to estimate how much of the drug you will actually need over a certain period of time instead of ordering all that you can get. (Of course, all that you can get may be less than what you need in the case of a drug shortage.)
Communicate with other pharmacy staff, nurses, prescribers, and even patients. This can help save valuable time and avoid confusion for everyone. You might need to let prescribers know that a particular drug is temporarily unavailable, and what alternatives you have available. Or in the hospital setting, you might need to let nurses know a different strength of a drug is being stocked instead of what’s usually used, or that a drug that’s in shortage is being dispensed from the pharmacy instead of being stocked in automated dispensing cabinets.
In some cases, you might be able to contact another pharmacy to see if they have the med a patient needs, if you don’t have it. If a drug is unavailable and a patient must be switched to another treatment, share our letter to notify prescribers, Suggestion to Switch Medication, with your pharmacist.
Anticipate errors. As mentioned, your pharmacy may have to order alternate products during a shortage that are made by different manufacturers, and have different appearances, strengths, package sizes, etc. Try to see where errors might happen, and suggest safeguards to prevent them. Watch for labels or packaging that might lead to confusion. For example, the label for a product that you are using in place of a drug that is short might look too similar to a completely different product that’s usually stocked in your pharmacy. This could easily lead to mix-ups. Or stocking a different strength of a product, say a 2 mg/mL concentration, might confuse nurses who are accustomed to always seeing a 1 mg/mL concentration of a certain drug. This could lead to overdose of a patient. Consider measures such as recommending computer alerts, adding special labels, or using shelf tags to avoid these types of problems.
Another activity that could lead to errors is when prepping individual doses of injectable meds in the pharmacy to prevent wastage of meds in bulk vials. This requires drawing up individual doses of meds into syringes. Ensure the labeling of these preps include the total dose in the container, as well as the concentration of the med. This is similar to what FDA requires for labeling of injectable drugs. Be sure an appropriate beyond-use date is also included on the label. For example, you wouldn’t want to use the manufacturer’s expiration date. Instead, you’d likely have a shorter date depending on whether the doses are drawn up from a single- or multidose vial.
Support your pharmacy’s “go-to” person for managing drug shortages. Some pharmacies have one person who coordinates everything surrounding drug shortages. Make sure to communicate effectively with this person, following any kind of guidance that’s put into place. Also, give this person feedback on what’s working and what’s not. The intensity of drug shortages that we’ve seen the last few years is greater than ever before, and we’re still learning better ways to help reduce the impact on patient care.
The pharmacist speaks with Ms. Hatch. She says that Thyrolar has worked for her for many years. She is open to another drug therapy, but she says that she still has some of her Thyrolar left from her last Rx. She says that she will come in next week and check on the status of the supply of Thyrolar. If it’s still not available, she’ll talk with her prescriber at her next appointment about other therapies that might work to treat her thyroid condition.
Project Leader in preparation of this technician tutorial (320882): Stacy A. Hester, R.Ph., BCPS, Associate Editor; last modified November 2017.
Cite this document as follows: Technician Tutorial, Dealing With Drug Shortages. Pharmacist’s Letter/Pharmacy Technician’s Letter. August 2016.