Topical Analgesics and Burns
The U.S. Food and Drug Administration (FDA) told healthcare professionals and the public that certain over-the-counter topical products for relief of mild muscle and joint pain have been reported to cause rare cases of serious skin injuries, ranging from first- to third-degree chemical burns (http://www.ismp.org/sc?id=99). A case recently submitted to the Institute for Safe Medicine Practices (ISMP) illustrates the problem. After application of an icy hot medicated patch (menthol 5%) over the sternum, a patient was seen in a hospital emergency department with a burn measuring 9 cm by 5.5 cm (Figure 1). Fortunately, the degree of injury was not severe, and the patient is now fine. The products generally contain menthol, methyl salicylate, or capsaicin. Injuries have ranged from mild-to-severe chemical burns with use of such brand-name products as Icy Hot, Bengay, Capzasin, Flexall, and Mentholatum. With only 40 or so reports, apparently the problem is not all that common, but there is no way to predict who will have this kind of reaction. In many cases, severe burning and blistering occurred within 24 hours after just one application. Some patients had complications serious enough to require hospitalization. An ISMP consumer Web site article discusses adverse events from topical products, along with a "Top 10 List" of safety tips. This can be viewed at: http://www.ismp.org/sc?id=103.
Serious Adverse Drug Reaction
The FDA notified parents, caregivers, and healthcare providers not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants born before 37 weeks gestation. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue. The agency is aware of 15 cases of NEC in patients fed SimplyThick for varying amounts of time, leading to two deaths. The product had been mixed with breast milk or infant formula. Illnesses have been reported from at least four different medical centers around the country. The product is available from distributors and local pharmacies in packets of individual servings and in 64-ounce dispenser bottles. Healthcare providers should avoid administering the product to premature infants and advise parents and caregivers accordingly. For details, visit: http://www.ismp.org/sc?k=ucm256257.
A Child Harmed From Potassium Chloride Error
A few years ago a child was admitted to the hospital after receiving an intravenous push dose of concentrated potassium chloride as an outpatient. The child was receiving parenteral nutrition (PN) at home. In response to lab results showing hypokalemia, the child's physician wanted potassium chloride added to the PN. Instead of making new solutions, the home care pharmacy sent several syringes containing potassium chloride concentrate to the house for the child's mother to add to the PN. However, the mother placed these syringes with a supply of sodium chloride syringes and later used them to flush the child's IV line. The patient suffered cardiopulmonary arrest but was resuscitated and transported by ambulance to a hospital. The child had severe hypoxic ischemic encephalopathy. She did begin to recognize her family, although we do not know if she suffered any long-lasting deficits. Certain drugs like heparin and insulin may need to be added to the PN in the home immediately before administration because of stability issues. However, potassium chloride concentrate should never be sent to a patient's home for addition to a PN bag. Although it is more costly, it is safest to make new solutions or bring the patient's PN bags back to the pharmacy for additional electrolytes. When initiating PN in the home, it is better to send only a 2- to 3-day supply at first, since electrolyte adjustments are more likely during the first week. Make sure patient education materials for home administration of PN are standardized between the home infusion pharmacy, home health agencies, and local hospitals.