By Donnie Vinson, MD
If you are not aware, the vision of the Anesthesia Patient Safety Foundation is as follows: “That no one shall be harmed by anesthesia care.” With this in mind, no aspect of anesthesia occupies a more important place in the safe management of our patients than the accurate administration of medications. Many of you may already be familiar with or experienced the use of a new formulation of phenylephrine and a new formulation of ephedrine. These two recently FDA-approved formulations potentially help mitigate risks associated with calculation and compounding errors and unsafe injection practices. Provided below is some basic information on each for your clinical consideration.
Biorphen (Eton Pharmaceuticals) is the first and only FDA-approved, ready-to-use formulation of phenylephrine. Biorphen can be quickly administered without compounding and is supplied in an ampule containing 500 mcg/5 ml; the ready-to-use formulation of 100 mcg/cc is unlike the concentrated phenylephrine (10 mg/cc vial, which is equal to 10,000 mcg/cc) that must dilute to a solution of 100 mcg/cc before use. As costs vary from region to region and by supplier, remember that the “new” kid on the block typically costs a few dollars more than the common form (maybe or maybe not). However, a few dollars more is nothing to compare to the increased margin of safety produced by its lack of need for further dilution. Herein lies the opportunity for improving patient safety. The current 10 mg/cc vial remains one of the rare drugs in our Anesthesia carts that requires dilution (and double dilution at that), and it has the potential for lethal outcome if used without proper dilution. As Dr. Sutton stated a year ago in a prior edition of this newsletter, “As many of you may know, a particular pet peeve of mine is Phenylephrine 10 mg, a likely lethal dose that can be easily mistaken for an Atropine or Robinul vial. Please secure this drug and require intentionality for its use.”
Biorphen MUST NOT BE DILUTED before administration; “DO NOT DILUTE” is in bold print in the Package Insert and on both the vial and the carton. The formulation is a clear and colorless solution, available in type 1 one-point cut, clear, colorless glass, 5 ml single-dose ampule containing 5 ml of solution for injection. It is indicated for patients with clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. The shelf life is 3 years, and the formulation is sulfite and preservative-free. Remember, phenylephrine can precipitate angina in patients with a history of angina, exacerbate heart failure, and cause severe bradycardia. Phenylephrine is a direct-acting sympathomimetic amine that functions as an alpha-1 adrenergic agonist. SAFETY OFFERING: Ready-to-use 100 mcg/cc formulation with no dilution!
Emerphed (Nexus Pharmaceuticals) is FDA-approved and is the first and only premixed ephedrine in a ready-to-use 50 mg/10 ml vial. This ephedrine sulfate formulation does not need compounding, dilution, or mixing. Like Biorphen above, Emerphed MUST NOT BE DILUTED before administration; in this case, “Premixed formulation – Do not dilute” is found in red print on both the vial and the carton, as well as a similar declaration in the Package Insert. The formulation is a clear, colorless solution available as a single-dose vial that contains 50 mg/10 ml ephedrine sulfate; each ml contains ephedrine sulfate 5 mg, 0.9% NaCl, in water for injection. The shelf life is reported to be two years. Emerphed is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia. Remember, ephedrine is a sympathomimetic amine that directly acts as an agonist at alpha- and beta-adrenergic receptors and indirectly causes the release of norepinephrine from sympathetic neurons. SAFETY OFFERING: Ready-to-use 5 mg/cc formulation with no dilution!
I present these two medications for your awareness and review. I have no ties to these pharmaceutical companies; as an aside, my father is a retired Pharmacist who worked for Abbott Laboratories for 27 ½ years. I simply would like to promote these for their potential to minimize harm due to human error; with no need for compounding, dilution, or mixing, there is an associated reduction in the potential for preparation error. The ready-to-use formulations also enhance the time needed to deliver the drug to the patient for the desired treatment of hypotension. You may consider ordering these new formulations going forward as you order to replace your existing formulations. In all of our actions, constantly think “patient safety”!
