How to Manage Drug Shortages and Expired Pharmaceuticals
Arthur Hsieh // May 13, 2014
EMS providers use a variety of prescribed medications when caring for their patients in the prehospital arena. Pharmaceuticals range from basic medications such as oxygen and oral glucose, to more complex drugs that can be lifesaving.
For many decades these medications were plentiful and in seemingly endless supply. However, in the past decade national drug shortages have affected EMS systems significantly, causing field providers and system administrators to consider multiple alternative methods of maintaining, administering and obtaining prehospital medications.
Breaking down the issue
EMS medications are prescribed by a physician and are delivered by field providers under medical protocols. These and other medications are regulated by the U.S. Food and Drug Administration (FDA), which dictates the conditions that medications are created, manufactured and distributed. These regulations are designed to protect the health and welfare of the American public1.
Many of the medications delivered in the prehospital field are inexpensive to manufacture. Ironically, this may be one of the reasons why these drugs are in short supply, as poor profitability is a major consideration in manufacturing. In turn, this results in fewer companies making the medications, resulting in decreasing volume production. Other factors include quality control issues that delay manufacturer, as well as delays caused by drug component shortages2.
The Obama administration and the FDA have worked with groups affected by the pharmaceutical shortages and have implemented several regulations that have slowed the problem3. However, problems with prehospital drug availability continue to exist. The FDA maintains a list of medications that are, or will be in short supply.
There are several approaches that can be implemented to reduce the impact of drug shortages on prehospital care. Some of these solutions can be immediately implemented; others will take both administrative and regulatory changes in order to be used.
EMS providers and supervisors can implement a few workarounds almost immediately. For example, make sure that medications with the earliest expiration dates are used first. While this seems elementary, physically moving the next-expiring medications to the front of the shelf or placing them all together in the jump bag is a good way to make sure they are used first. The point is, be proactive with expiration dates and anticipate when you will need to swap medications out.
Next, review the minimum medication stocking levels within the jump bags and on the unit itself. It may be that carrying 10 prefilled syringes of epinephrine in the unit's storage area may really be excessive, and that carrying five may be adequate. The medication stockpile might then be better distributed across the ambulance fleet. This has the added potential benefit of using the medications before the expiration date.
Also consider the use of multidose vials. Single-use prefills are convenient, but more expensive and contribute to medication wasting if you don't use the entire amount. A multidose vial may be less convenient, but allows the field provider to draw up precise amounts of medication and retain the remainder for another patient encounter.
EMS system medical directors can consider changes in protocols or medication doses. Physicians and clinical protocol workgroups should research current knowledge about clinical treatments and consider flexibility in dosing regiments, or eliminating certain medications altogether.
Consider using equivalent medications. While there have been intermittent issues with similar medications such as fentanyl and morphine sulfate, there may be reasonable availability of other medications such as versed, valium or Ativan.
Such changes may entail working closely with local and state regulatory bodies to ensure consensus on standards of care. Fortunately, most officials are fully aware of the situation and want to work on finding solutions to the issue.
Recognize that changes such as the ones just mentioned will require a significant amount of training to ensure patient safety is not compromised. For example, ALS providers may need to practice a few drug calculations when drawing up a weight-dependent dosage of medication. Alternative medications will have different dosages and dosing intervals. Even alternative forms of the same medication may come in different packaging, making it more difficult to recognize, or easier to be confused with another drug. Making changes to daily practice requires effort to make them go seamlessly.
It may be possible to establish medication exchanges among service providers as well as hospitals. If agencies knew what was available through other services within their region, it may be more straightforward to find scare medications. Similar relations may be established with hospitals. Hospitals tend to buy in larger quantities and may have more of the scarce medications available. It's critical to explore the medical-legal issues associated with such sharing or purchasing arrangements; keep everyone within the loop.
Using expired medications
Several states have instituted a "hands off" approach to using expired medications in prehospital treatment. It is well known that many medications do not lose their efficacy when they expire. Expiration dates are set by the manufacturer and are based on a variety of parameters, including how the drugs are stored.
However, short of laboratory testing, there is no sure way of knowing when a drug becomes inactive. Given the variable temperature swings that exist in many ambulances, it is not clear whether to safely assume that a medication is still usable after its expiration date.
System stakeholders, physicians, and pharmaceutical experts should work closely to adopt a plan that balances patient safety, the need for treatment and making medications available for immediate use.
Are compounding pharmacies an option?
A compounding pharmacy is one that has been approved to make, or compound medications upon request. These orders can often be filled quickly, resulting in short turnaround times. Such medications may come in forms and packaging that field providers may not be familiar with; in-service training will be critical to ensure safe usage of such formulations.
You will also need to ensure that local and state regulations permit the use of compounded medications as a substitute for the original. Again, given the shortage of prehospital drugs, there will be a desire to ensure that such medications are available for life saving situations.
It does not appear that drug shortages will disappear any time soon; in fact, many suspect it will only get worse. EMS agencies and field providers will need to think outside the drug box and come up with creative, innovative ways to ensure that their patients will receive the right drug at the right time.
1. US Food and Drug Administration. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm192695.htm. Retrieved 5 May 2014.
2. US Food and Drug Administration. Frequently asked questions about drug shortages. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm050796.htm. Retrieved 5 May 2014.
3. Association of State and Territorial Health Officials. Coping with and Mitigating the Effects of Shortages of Emergency Medications. http://www.ems.gov/pdf/2013/ASTHO_Shortages_of_Emergency_Meds.pdf. Retrieved 6 May 2014.