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What price must we pay for safety?
Excessive cost of EPINEPHrine auto-injectors leads to error-prone use of ampuls or vials and unprepared consumers
August 11, 2016

A series of recent events reported to ISMP has intensified our previously documented concerns about very serious errors with EPINEPHrine (www.ismp.org/sc?id=2780) that have occurred after healthcare providers felt compelled to replace cost-prohibitive EPIPEN (EPINEPHrine injection) auto-injectors or a generic EPINEPHrine auto-injector with ampuls and/or vials. When a severe hypersensitivity reaction occurs, the EpiPen or a generic auto-injector can help ensure that lifesaving EPINEPHrine is available quickly and is administered in the correct dose and by the correct route of administration. The device automatically delivers a premeasured dose of EPINEPHrine —0.3 mg for adults and 0.15 mg for children—intramuscularly (IM) or subcutaneously. But due to an ongoing series of price hikes, some healthcare providers have decided to use a much less costly alternative— EPINEPHrine ampuls and/or vials. Although cheaper, this method introduces a much higher risk of errors. As borne out by the ISMP National Medication Errors Reporting Program (ISMP MERP), the presence of a vial or ampul of EPINEPHrine invites dosing errors and accidental intravenous (IV) administration to a patient with an IV access catheter or IV administration set. Some errors have resulted in fatalities.

Recent errors

All of the recent events reported to ISMP involved administration of 1 mg of EPINEPHrine by the IV route after switching from EpiPens to EPINEPHrine ampuls and/or vials. For example, one hospital reported three errors in the past 6 months in which the entire contents of the 1 mg/mL vial of EPINEPHrine was administered IV, when 0.3 mg IM should have been administered. In another hospital, a patient who was experiencing an anaphylactic reaction to FERRLECIT (ferric gluconate) was also given EPINEPHrine 1 mg IV when the correct dose and route was 0.3 mg IM. The patient required admission to a critical care unit for close monitoring.

Available EPINEPHrine auto-injectors

Mylan’s EpiPen is the most frequently prescribed EPINEPHrine auto-injector, generating more than 3.6 million outpatient prescriptions last year.1 Several rival products joined the market only to fall by the wayside. EpiPen’s strongest competitor, Sanofi’s AUVI-Q, was removed from the market in October 2015 due to concerns about inaccurate delivery of the dose. A generic EPINEPHrine auto-injector by Impax (labeled as Lineage Therapeutics, which Impax acquired) generated less than 200,000 prescriptions last year,2 largely because prescribers are much more familiar with EpiPen. Also, the Impax product cannot be substituted as a therapeutic equivalent for EpiPen because the US Food and Drug Administration (FDA) has determined that there is insufficient data showing that the generic auto-injector is therapeutically equivalent. (The Impax product is not AB rated in the Orange Book.) The Impax auto-injector is not covered by some insurances, and purchasing groups have had difficulty negotiating contracts with the company. Thus, EpiPen essentially has a virtual monopoly on the market, contributing to ongoing price hikes over the years. 

High cost of EpiPens and other auto-injectors

According to pricing data provided in standard drug databases, the retail price of EpiPens, after adjustment for inflation, has increased by more than 450% since 2004,1 going from about $50 per pen in 2004 to more than $300 per pen in 2016.2 The price increases are among the biggest of any top-selling brand drug.3 Since two doses are often needed for severe allergic reactions, Mylan began providing two EpiPens per package (2-Pak) while discontinuing packages with a single pen. Some healthcare providers have reported paying up to $900 for the EpiPen 2-Pak. By comparison, a 2-pack of EpiPens sold by Meda in France3 and Spain costs about $85 (called “Altellus” in Spain). Price increases are not due to higher costs of the raw materials; a typical adult dose of EPINEPHrine packaged in a vial or ampul costs less than $2. EpiPen price increases have also driven up the cost for alternative EPINEPHrine auto-injectors. The Impax product also carries a hefty price tag, with each twin pack costing between $300 and $500.

Dangerous and unethical pricing practices

We believe the excessive pricing of EpiPen and the generic auto-injector poses a serious threat to patient safety. Financially, the consumers’ ability to obtain and administer EPINEPHrine safely and efficiently during critical allergic responses is unduly impacted, placing adults and children with a history of serious allergies at significant risk if they can’t afford an auto-injector, even with insurance and company cost-savings cards that can reduce the cost of a 2-pack by up to $100.4 Consumers are also relying on expired EPINEPHrine auto-injectors or hoping a single device will provide enough protection for multiple siblings or other family members. And, as detailed above, the high cost of EpiPen and the generic auto-injector has led healthcare providers to resort to the use of affordable alternatives that increase the risk of potentially deadly errors that would be much less likely with the auto-injectors.

Although we can’t say with certainty how many healthcare providers have switched or are switching to EPINEPHrine ampuls and/or vials (despite recommendations from various professional organizations to use the auto-injectors), we can’t fault them. For healthcare providers that use EPINEPHrine auto-injectors and store them in numerous locations throughout their organization, hundreds of thousands of dollars may be needed annually to stock these devices and replace them when they expire. (Mylan does not offer credit or replacement for expired EpiPens.) The pricing of EpiPens and alternative auto-injectors is unethical and socially irresponsible, and it’s reminiscent of the price gouging that was occurring with the gray market for drugs in short supply.

Anaphylaxis kits and simulation training

If your organization has made the difficult decision to replace EPINEPHrine auto-injectors with ampuls and/or vials, please consider providing patient care areas with an anaphylaxis kit rather than stocking the ampuls and/or vials separately. The kit should contain a 1 mL vial or ampul of EPINEPHrine 1 mg/mL, a syringe, and any other needed supplies (e.g., alcohol wipe, needle), along with clear directions regarding measurement of the correct dose and administration by the correct route. Simulation training using the kit is highly recommended to ensure practitioners are comfortable with and understand how to prepare and administer EPINEPHrine from a vial or ampul.

References

  1. Swetlitz I. High price of EpiPens spurs consumers, EMTs to resort to syringes for allergic reactions. STAT. July 6, 2016. www.ismp.org/sc?id=2781
  2. Miller M. There’s absolutely no reason why an EpiPen should cost $300. Slate: Money Box. July 8, 2016; updated July 15, 2016. www.ismp.org/sc?id=2782
  3. Koons C, Langreth R. How marketing turned the EpiPen into a billion-dollar business. Bloomberg Businessweek. September 23, 2015. www.ismp.org/sc?id=2783
  4.  Rubenfire A. Lack of competition leads to EpiPen pricing woes. Modern Healthcare. March 28, 2016.
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