This column was prepared by the Institute for Safe Medication Practices (ISMP), an Emergency Care Research Institute affiliate.
Alpha-gal syndrome is a potentially life-threatening allergic condition that can occur after a patient has been bitten by a tick. It is named for a molecule, galactose-alpha-1,3-galactose, which is found in most mammals, but not humans. Symptoms may then occur after the patient eats red meat or is exposed to other products made from mammals, such as gelatin or dairy products. A hospital reported that a patient with alpha-gal syndrome received beef broth with their food tray despite a special diet order in the electronic health record (EHR) stating that the patient cannot have beef or pork products. During an event investigation, the hospital identified deficiencies in the EHR that included how drug-food allergies do not cross over into the diet restrictions, as well as not having a mechanism to screen for inactive ingredients in medications and vaccines (eg, gelatin, glycerin, magnesium stearate, bovine extract) or animal-derived products (eg, monoclonal antibodies, heparin, certain antivenoms), which may be contraindicated for patients with alpha-gal syndrome (see “Products That May Contain Alpha-gal”).
ISMP discussed a similar concern with inactive ingredients in its April 2022 newsletter article, “Hidden Pork Content in Colace Capsules.” Some medications, including the Colace® brand of docusate sodium, have gelatin capsules sourced from pigs, but product labeling does not state that. People with food allergies or those who want to avoid animal products need to know the origin of the ingredients contained in their medications. ISMP “contacted Avrio Health, the manufacturer of the brand product Colace, and confirmed that the gelatin used is sourced from pigs, which is not specified in the labeling. It appears that, under current regulations, the product label is not required to detail the animal source of the gelatin.”
Safe Practice Recommendations
There is a good chance that staff may be unaware of alpha-gal syndrome and how patients with this condition may react to certain medications and inactive ingredients. Refer staff to resources such as the Centers for Disease Control and Prevention website. Consider building an alert to notify practitioners when you become aware of a patient with food allergies, or someone known to have alpha-gal syndrome.
Evaluate your EHR and/or pharmacy dispensing systems’ functionality to determine if an alert would fire if a patient with alpha-gal syndrome had a documented allergy to an animal-derived product or an inactive ingredient known to trigger this allergy. During transitions of care, specifically ask patients about any reactions they have had from foods, medications, or inactive ingredients, and document the details of the reaction in the EHR and/or pharmacy dispensing system. If patients have concerns about the inactive ingredients contained in a medication, the pharmacy should review the package/label and prescribing information or contact the manufacturer for more information.
Additional resources include the following: What medications are contraindicated with an alpha-gal allergy? What mammal by-products could be listed as inactive ingredients on the package insert (i.e. magnesium stearate, gelatin)? (InpharmD.com) and “Alpha-gal Syndrome” (VEGANMED.org).