Atropine Sulfate Ophthalmic Solution Shortage and Its Implications to Hospice Practice

 In Drug Shortage

As of April 20, 2015, the American Society of Health-System Pharmacist (ASHP) has officially announced that there is a shortage of atropine ophthalmic solution.

Atropine was one of the U.S. Food and Drug Administration (FDA) grandfathered medications originally marketed before 1938 which was prior to current requirement of filing a New Drug Application with the FDA.   Many manufacturers could legally produce generic atropine products without filing New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), which made atropine ophthalmic solution a very cost-effective medication in the past.

Since July 2014, Akorn, one of the many generic atropine ophthalmic solution manufacturers, filed an original NDA for atropine ophthalmic solution and obtained FDA approval. This act removed atropine ophthalmic solution from the FDA’s grandfather list. This requires any manufacturers, who wish to continue producing atropine ophthalmic solution to file for an ANDA and obtain FDA approval. This shift in FDA approval status on atropine ophthalmic solution has discouraged the rest of the generic manufacturers from continuing to produce the product and Akorn has become the only atropine ophthalmic solution manufacturer since January 2015. Due to this sudden drop in availability from multiple manufacturers, there has been a shortage of atropine ophthalmic solutions from Akorn, as well as a significant price hike on this medication.

Moving forward, we will expect to see only the Akorn atropine ophthalmic solution products in the market until more generic manufacturers have successfully obtained FDA approval on their ANDA. There is no estimated date on when this will happen.

Here is the current price and shortage status for the Atropine Sulfate 1% Ophthalmic Solution, Akorn:

  • 2ml Bottle, NDC 17478-0215-02 —- AWP $30.74 (~ 1week supply if used 1 gtt QID)
  • 5ml Bottle, NDC 17478-0215-05 —- AWP $58.35 (~ 2 weeks supply if used 1 gtt QID) à shortage
  • 15ml Bottle, NDC 17478-0215-15 —- AWP $95.25 (~ 4 – 6 weeks supply) à back ordered

In a hospice setting, atropine ophthalmic solution was recommended in many hospice formularies and their comfort kits for the use of managing excessive secretions when used orally. Atropine injectable solution was sometimes used orally as well as a substitution when the ophthalmic solution was not available, but there is currently also a shortage of this formulation since February 2015.  Here are some comparable cost-effective alternatives for managing excessive secretions while atropine ophthalmic solution is in shortage (price quoted on 15 day-supply):

  • Hyoscyamine (Levsin) 0.125mg Sublingual tab (0.125mg QID) — AWP $52
  • Glycopyrrolate (Robinul) 1mg tab (1mg TID) — AWP $59
  • Atropine Eye Drop 5ml Bottle (1gtt QID) —- AWP $58 à in shortage

With the current increase in price of atropine ophthalmic solution, the cost of managing excessive secretions routinely is roughly the same amongst atropine ophthalmic solution, hyoscyamine and glycopyrrolate (see above price comparison for 15 days).  However, atropine ophthalmic solution is a less cost-effective option for hospice comfort kits now due to its smallest non-breakable package size being a 2ml bottle (cost $30 per bottle) in comparison to Levsin or Robinul, which can be dispensed in smaller quantity such as 6 tablets ($5 – $8). It is highly recommended for hospices using atropine ophthalmic solution to evaluate the need to substitute atropine with hyoscyamine on their formulary, as well as their comfort kits due to the significant accessibility issues and cost-effective reasons.

 

References:

ASHP Drug Shortage Updates

FDA Drug Shortage Database

 

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