Glucagon label contributes to confusion. Some people with diabetes keep a glucagon kit in their homes. Glucagon is a medicine used to treat low blood glucose (BG) when the person is unable to eat or drink enough carbohydrates. If the BG is extremely low, the person may be confused or they may become unconscious. There are a number of kits available so, it is important users learn to use the kit before an emergency happens. Some kits, such as Lilly's GLUCAGON EMERGENCY KIT, contain a vial of glucagon powder, a syringe with liquid to dissolve the powder, and instructions on how to prepare and give the medicine. However, as described in the event below, the instructions included in the kit are not clear, even to doctors or nurses.
A nurse gave orange juice to a patient with a low BG, but it did not raise the BG much so he gave the patient a dose of glucagon. When the patient's BG was checked 30 minutes later, the BG was still low. Orange juice was given again, but 20 minutes later, the patient's BG remained low. Another glucagon injection was given, which finally started to raise the BG. The patient was able to eat and drink more carbohydrates until the BG returned to normal.
Later, the nurse who gave the glucagon injections mentioned that he had measured the dose in "units" using a regular insulin syringe (not the syringe included in the kit). The label on Lilly's Glucagon Emergency Kit (Figure 1) and vial states the dose is "1 mg (1 unit)." The nurse was new and had never administered glucagon. He did not realize that "1 unit," in this case, meant a full mg as indicated by the marking on the syringe contained in the kit. The patient had received only 1/100 of the required dose. Apparently, the nurse became confused when he saw "1 unit" and used an insulin syringe to measure each dose.
Although the likelihood of a similar error occurring again is small, we asked Lilly to look at the product labeling to consider whether the dose in units is needed. According to Lilly's Glucagon Emergency Kit directions, the syringe that contains the diluent is to be used to withdraw the dose (to the 1 mg mark on the syringe) and then also inject it. It is important to learn how to use and give the glucagon with the exact product that is available in the home, because they are different. For example, GLUCAGEN HYPOKIT (glucagon), distributed by Novo Nordisk, lists the dose only in mg (1 mg) on the primary display panel. Have patients and family members review any handouts, videos, or package information included with the glucagon. If they receive Lilly's Glucagon Emergency Kit (Figure 1), the directions state the syringe (containing the liquid to dissolve the powder) is to be used to withdraw the dose (to the 1 mg mark on the syringe) and then also to inject it. Instructions can be found here: http://pi.lilly.com/us/rglucagon-ppi.pdf.
Vancomycin injection for oral use given IM. We recently received a report from a long-term care (LTC) pharmacy that discovered administration errors at two of its facilities. The pharmacy had received orders for vancomycin 125 mg orally every 6 hours to treat Clostridium difficile-associated diarrhea for residents at these facilities. Vancomycin is available in capsule form for oral use. However, the powder in vials of vancomycin injection can also be reconstituted with sterile water to make an oral solution. Due to the high cost of VANCOCIN brand capsules and problems obtaining specific vancomycin products, the pharmacy elected to send the LTC facilities a supply of vials of the injectable form of vancomycin powder along with diluent for the nurses to reconstitute the powder to make an oral solution. The vials and diluent were provided in two separate bags, along with directions for mixing and storing the oral solution, and the volume of solution to administer for each 125 mg dose. The nurses at both facilities were unfamiliar with the practice of using injectable vancomycin for oral administration. Although the nurses reconstituted the powdered drug correctly, they administered each dose intramuscularly (IM). The error was discovered when the director of nursing at one LTC facility mentioned to a consultant pharmacist that she was concerned the medication had not been provided in capsule form and needed to be reconstituted by nurses at the facility. One patient received five IM doses of the drug before the error was detected. This resident experienced pain at the administration sites when the drug was injected (IM administration of the drug is not advised).
Unfortunately, parenteral vancomycin (IM or IV) does not treat a C. difficile infection in the bowel. This put the residents at risk for worsening infection, and the duration of oral therapy had to be extended to cover the missed treatment. It is also worth noting that parenteral vancomycin has been inappropriately prescribed for this purpose, and oral vancomycin has been prescribed or otherwise used erroneously to treat a systemic infection in other patients.
For the treatment of C. difficile diarrhea, oral metroNIDAZOLE may be a viable alternative if the patient is experiencing their first episode and it is not a resistant case. If oral vancomycin is needed, and vancomycin injection will be reconstituted for oral use, pharmacists should prepare the solution in the pharmacy and provide each individual dose in an oral syringe, marked "FOR ORAL USE ONLY." Dispensing medications in the most ready-to-administer form should be the prevailing practice for all pharmacies that provide medications in hospitals, LTC facilities, and for use in patient homes.
Positive change, negative consequence. Given the long list of products that use a suffix to describe the drug release rate (e.g., XL, SR, XR) and the lack of standardization as to their exact meaning, it's nice to have it spelled out on the manufacturer's label. But this can lead to unintended consequences. In the following case, specification of "once daily" on a label was misunderstood. A renal transplant patient had been taking oral tacrolimus 3 mg every 12 hours. For convenience, this was converted to a once-daily tacrolimus product, ASTAGRAF XL (Figure 2). The patient was told to take 6 mg orally once daily, and blood levels were measured after a week of therapy. The trough level was undetectable and it was learned the patient had been taking 1 mg daily instead of 6 mg daily. When asked why, the patient stated she was following directions on the bottle. She'd been given the sealed manufacturer's bottle of Astagraf XL that was labeled 1 mg once daily, which she thought was the dose and frequency. Contributing to the error, the pharmacy label was not directly attached to the bottle but to an outside carton that contained multiple bottles. Also, the prescription for the once daily medication was called into the pharmacy, so the patient did not receive written instructions. Besides properly labeling containers dispensed to patients and educating them about how to take the medicine, this error also points out that positioning "once daily" so close to the strength on the label can cause confusion. We mentioned this to the US Food and Drug Administration for their consideration.