Emerphed: The Role of Pre-Filled Ephedrine for Emergencies in the Operating Room

The pharmacy department is generally responsible for making prepared syringes to be distributed prior to procedures.

Ephedrine is a critical medication needed for hypotensive emergencies in patients in the operating room. The pharmacy department is generally responsible for making prepared syringes to be distributed prior to procedures.

If during a surgery a patient becomes hypotensive, the prepared syringes will be administered to the patient. An alternative to the pharmacy-prepared ephedrine syringes are ampules, which then must be drawn up during an emergency. In the United States, the FDA has approved ephedrine sulfate (Emerphed), a pre-filled syringe ready to use while under anesthesia (Stewart, 2020).

This pre-filled dosage form will reduce the need for hospital pharmacy departments to prepare syringes, disposal of unused and/or expired syringes, and possible errors from drawing up the incorrect dose in the event of using ampules during emergencies. Anesthetists routinely draw up ephedrine from the ampules, but since they are only used in the event of an emergency, the product is still routinely unused and discarded (Vipond, 2000, p. 303).

As such, ephedrine is among the top 6 medications associated with the most waste. In this article, we review the newly approved pre-filled syringe ephedrine sulfate and its potential role in the operating room.

FDA-Approved Emerphed

Emerphed (ephedrine sulfate) is a sympathomimetic amine that acts directly on alpha- and beta-adrenergic receptors as an agonist and indirectly causes the release of norepinephrine that has been FDA-approved for use in the operating room (Nexus Pharmaceutical Inc, 2020).

For the treatment of clinically emergent hypotension, the initial recommended dose of 5 mg to 10 mg is administered by intravenous bolus (Nexus Pharmaceutical Inc, 2020). The pre-filled syringe contains 50 mg/10 mL ephedrine sulfate and is a clear, colorless solution that is stored at room temperature (Nexus Pharmaceutical Inc, 2020).

Cost of Pre-Filled Syringes

The cost of ephedrine sulfate versus the usual prepared syringe is an important consideration for the pharmacy department in deciding whether to purchase it for use in the operating room. A few European countries have noticed the pre-filled syringes cost more than twice the cost of ampules. However, the pre-filled syringes do reduce the number of drugs an anesthetist must draw up and may reduce administration errors through clear labeling and concentration of the drug (Wikner, 2001, p. 712).

In a study, the authors reported that the cost of ampules was 68.59 euros at 1.43 euros per ampule. If the new syringes were used, there was a 62% usage increase totaling 111.00 euros at 3.00 euros per ampule; however, the waste of the unused ampules could eliminate any cost savings (Wikner, 2001, p. 712). In a Scandinavian study, the overall administration of standard ephedrine syringes in the hospital was estimated to be 52.8%, indicating a moderate amount of wasted standard syringes (47.2) (Armoiry, 2016, p. 920).

A hospital will need to evaluate the quantity of surgical procedures undergoing anesthesia at their institution in order to decide whether the cost will be a significant factor in determining inclusion of ephedrine sulfate on their formulary. Given that the use of the ampule is approximately half the cost of the pre-filled syringe (Armoiry, 2016, p. 920 and Weinger, 2001, abstract), if cost were the only consideration, it may make sense for institutions to continue using the least expensive product.

However, the propensity for drug errors (eg, wrong concentration, wrong dose) and the amount of product being used may both be lowered by the use of the pre-filled syringe (Wikner, 2001, p. 712, Armoiry, 2016, p. 920).

Conclusion

In the operating room, ephedrine is an essential medication for emergency use. The FDA-approved ephedrine sulfate can help facilitate immediate action when needed. The pharmacy will spend less time having to make the prepared syringes and checking for the short expiration dates. Additionally, possible errors can be decreased such as drawing up the wrong medication and/or concentration.

The cost of ephedrine sulfate may not be as significant when considering the amount being wasted with unused prepared syringes and short expiration dates. In the United States, there is insufficient information on ephedrine use during emergencies in operating rooms.

Once the anesthesiology department becomes more familiar with ephedrine sulfate, a hospital can assess to see whether this will help reduce errors, waste, and costs. Considerations can be made on possible inclusion in the hospital formulary, as some hospitals may have a high volume of surgeries being performed.

References

1. Stewart, J., 2020. Nexus Pharmaceuticals, Inc. Announces Approval Of Emerphed™ (Ephedrine Sulfate) Injection, The First And Only FDA-Approved, Ready-To-Use Ephedrine Injection (50 Mg/10 Ml Vial) - Nexus Pharmaceuticals. Nexus Pharmaceuticals. Available at: http://www.nexuspharma.net/ emerphed-ephedrine-sulfate-injection-approval. Accessed 14 May 2020.

2. Emerphed. [package insert]. Lincolnshire, IL: Nexus Pharmaceuticals Inc.; 2020.

3. Wikner, M. A., & Tighe, S. Q. (2001). Pre-filled ephedrine syringes. Anaesthesia, 56(7), 712. doi:10.1046/j.1365-2044.2001.02137-34.x

4. Vipond, A., & de Mello, W. (2000). Drugs used in anaesthetic emergencies: current practice and a cost analysis of prefilled syringes. Anaesthesia, 55(3), 303-304. doi:10.1046/ j.1365-2044.2000.01352.x

5. Armoiry, X., Carry, P. Y., Lehot, J. J., Michel, C., Aulagner, G., & Piriou, V. (2016). Estimated economic impact of pre-filled ephedrine syringes in the operating room. Acta Anaesthesiol Scand, 60(7), 917-924. doi:10.1111/aas.12718

6. Weinger, M. B. (2001). Drug wastage contributes significantly to the cost of routine anesthesia care. J Clin Anesth, 13(7), 491-497. doi:10.1016/s0952-8180(01)00317-8.