Drug Shortages and Rapid Price Escalation: The Latest on the Crisis
The American health system is now into the seventh year of an unprecedented and unplanned shortage of emergency medications. The root cause is the American manufacturers of intravenous medications, and disputes between those manufacturers and the Federal agencies that oversee drug supply and manufacturing practices (FDA and DEA), over safe manufacturing and quality processes. As a result, during this period prices of all emergency medications have increased dramatically.
For an informative overview of the current situation, please read "Study: EpiPens Should Work At Least A While Past Expiration Dates".
By James J. Augustine, MD, FACEP
Thursday, July 6, 2017
There are now life-threatening problems with medication supplies for EMS providers across all classes of emergency medicines. As of June 26, 2017, there are 69 preparations of 28 emergency care preparations that are in short supply, including most forms of adenosine, atropine, bicarbonate, calcium, dextrose, dopamine, epinephrine, fentanyl, labetalol, magnesium, and lorazepam.
There are an additional 50 large volume intravenous fluid preparations that are not available. The media has featured the hospital shortage of bicarbonate, which affects a wide range of patients.
There has been no media attention to the prices of the medications that are available, but any EMS leader who is responsible for the budget is aware that prices of all medications have increased dramatically.
In response to significant pressure from the emergency community, the FDA has taken two actions: 1) It has approved the sourcing of sodium bicarbonate from an Australian medication manufacturer, a step that mirrors a prior action allowing the importation of normal saline solution from a Norwegian manufacturer in 2014; and 2) More importantly for EMS, the FDA has worked with a manufacturer to extend the expiration dates of some batches of three emergency medicines: atropine, dextrose and epinephrine.
It’s important that EMS leaders understand the details of this extension program, and share and explain the details of the program with any regulatory agencies.
This extension program will assist in the crisis management of the shortage of these three emergency medicines. The program, which could potentially be extended to other medications, will allow emergency providers to safely use the medications that are currently in stock for patient care.
This will result in short term cost savings, because the replacement costs of these medications are going to be significantly higher. (As of June 23, the price of a single 1 mg vial of epinephrine 1:1000, is over $17. This preparation in recent years cost less than $2.00.)
The U.S. Food and Drug Administration is aware of the ongoing shortage situation affecting several injectable drugs, manufactured by Hospira, a Pfizer company, including sodium bicarbonate injection (vials and syringes), dextrose 50% injection (vials and syringes), as well as emergency syringes of other drugs, including epinephrine, calcium chloride and atropine sulfate. Pfizer has reported this shortage is caused by manufacturing, distribution and third party delays …
In addition, certain lots of emergency syringes have had their use dates extended based on stability data provided by Pfizer and reviewed by FDA, so that healthcare professionals can continue to use these specific lots during the shortage. The information about the specific lots with extended use dates is found in these tables.
- Atropine Sulfate Injection, USP 0.1 mg/mL; 5 mL ABBOJECT syringe > (NDC 0409-4910-34)
- Atropine Sulfate Injection, USP 0.1 mg/mL; 10 mL ABBOJECT syringe > (NDC 0409-4911-34)
- Dextrose 50% Injection, USP, 50 mL ABBOJECT Syringe > (NDC 0409-4902-34)
- Epinephrine Injection, USP 0.1 mg/mL; 10 mL ABBOJECT syringe > (NDC 0409-4921-34)
FDA is not requiring or recommending that the identified lots in the referenced tables be relabeled with their new use dates. However, if replacement product becomes available during the extension period, then the agency expects that the lots in the referenced tables will be replaced and properly disposed of as soon as possible.
What Your Agency Can Do
EMS officers and logistics personnel will need to assure the ongoing availability of emergency medications and intravenous fluids. All emergency providers are going to need education on any regional program that involves using medicines beyond printed expiration dates.
The FDA letter suggests not writing the extension information on the drug container, so another way will need to be crafted to allow personnel to understand the extension. However, the printed FDA notification should be available for the clinical providers, so that they completely understand the regulatory changes that are occurring. The EMS agency also needs to maintain a copy of the FDA advisory for their compliance records, and for any EMS regulators who oversee their system.
Develop an Incident Action Plan
It would be wise to have emergency leaders meet and prepare a regional Incident Action Plan. The FDA notification is a good reason to convene a regional meeting of ED leaders, EMS chiefs, and hospital pharmacists to discuss ongoing management strategies.
With that group engaged in planning, a shortage will not cause EMS personnel, or the public, to be surprised. The group will need to consider the budget implications, due to the significant increase in drug prices. It’s also a great management strategy to develop a public messaging process, at the local and regional level.
Communication & Education
If the shortage is causing EMS personnel to use substitute medications or others not in the usual practice, there should be timely communications and extra safety practices implemented to facilitate good patient care. For example, if resuscitation drugs like epinephrine are restricted, all providers must be aware of limitations, substitution of other medications, and dosing changes.
Educational materials need to be available to update the EMS staff, and advise at the point of use about correct dosing, compatibility issues, and side effects. Some EMS systems are printing safety cards for providers to give an immediate visual prompt.
There are other detailed medication management strategies that may be integrated by the regional emergency leadership team to address the issue. For now, clinicians need to be continually updated on shortages. Agencies should rotate medications in an attempt to use those medicines and IV fluids closest to their expiration dates. JEMS will provide updates regarding any future FDA actions related to critical drug shortages.