BETHESDA, MD 01 Mar 2016—At Marion General Hospital in Indiana, an increase in the cost of one component of the facility's gastrointestinal (GI) "cocktail" prompted a review of the usefulness of that medication and an evidence-based change to the compounded admixture.
Clinical pharmacist Elaine Greene, clinical programs facilitator, said emergency department (ED) physicians at the 99-bed not-for-profit hospital had been ordering GI cocktails that consisted of a compounded mixture of viscous lidocaine, an antacid, and Donnatal elixir.
Donnatal contains phenobarbital, hyoscyamine sulfate, atropine sulfate, and scopolamine hydrobromide. The product is marketed by Concordia Pharmaceuticals Inc., a West Indies–based subsidiary of Concordia Healthcare Corp. of Ontario, Canada. Concordia acquired the Donnatal product line in 2014 from Revive Pharmaceuticals (formerly PBM Pharmaceuticals) of Charlottesville, Virginia.
Greene said that after a noticeable increase in the price of Donnatal, she looked for scientific literature about the effectiveness of GI cocktails. She wasn't surprised by what she discovered.
"A couple of articles . . . seemed to imply that there was not a lot of benefit beyond the antacid," Greene said.
She said the ED physicians, when presented with the research findings, opted to retain the antacid and the lidocaine but remove the Donnatal from the GI cocktail recipe.
"Not all institutions use Donnatal in their GI cocktails," said Nicole Harger, clinical specialist in emergency medicine at the University of Cincinnati Medical Center. She said the medical center's GI cocktail consists of a liquid antacid and lidocaine.
Harger said it makes good clinical sense to "run the GI cocktail, whether or not it includes Donnatal, through your pharmacy and therapeutics committee, just to ensure the effectiveness, safety, and bioavailability" of the admixture.
That language echoes a 2010 statement on GI cocktails from ASHP's Council on Therapeutics, which also emphasized that FDA has declared as "questionable" the effectiveness of the combination of ingredients in Donnatal.
Donnatal is one of more than 3400 so-called "DESI" drugs—products that entered the U.S. market between 1938 and 1962 and were designated as safe by FDA but have not been evaluated for efficacy.
FDA in 2006 launched an initiative to identify DESI drugs and bring them into regulatory compliance or remove them from the market. The agency in 2014 awarded a five-year contract to perform a legal review of DESI drugs and identify an approach to finalizing their status.
The labeling for Donnatal states that the product is "possibly" effective as an adjunctive therapy for irritable bowel syndrome and acute enterocolitis and may be useful as an adjunctive therapy for duodenal ulcer.
Despite its small size, Green's hospital reports that it averages about 50,000 ED visits annually. Greene estimated that it would have cost the hospital "about $9,000 a year" to keep Donnatal in the GI cocktail.
But she said cost was just one factor in the decision to reevaluate the GI cocktail formulation.
A bigger problem, she said, is when ED physicians use the cocktail to determine whether a patient's abdominal or chest pain results from a GI problem or a myocardial infarction (MI).
"If a patient does have indigestion, this is certainly going to take care of it. But I wouldn't want to rely on it to diagnose an MI," Greene said of the GI cocktail. "That's not good science."
Harger said the use of GI cocktails in cardiac evaluations dates back many years.
"However, it's been shown in the literature that that's probably not a good strategy, particularly with more advanced testing technologies available," she said.
And she said there are reports in the medical literature about patients whose pain resolved after treatment with a GI cocktail but who were later found to have had a cardiac event.
"I think it's such a historically used thing, and it seems so harmless, more or less, that it's not a big target" for review, Harger said of the cocktails. "I don't think they're harmless."
Greene said the inability to purge GI cocktails from the hospital's formulary stems from physicians' habits and preferences.
"Doctors like them," she explained. "There is a fine line that we have to work when we're working with physicians."
She said physicians' preferences also drive some of the hospital's use of compounded oral rinses.
"We've made adjustments to 'Miles magic mixture' and all those mouth 'swishes' . . . to make sure we have a formulation that at least is representative of something that might have some efficacy," Greene said.