Misleading Acetaminophen Liquid Label Could Lead to Overdoses
The labeling and packaging of certain extra-strength acetaminophen liquid products for adults can lead to twofold overdoses. Several labelers, including Walgreens, CVS, Major Pharmaceuticals, Select Brand Dist., Meijer, and EQUATE (Walmart Stores), are currently selling 240 mL bottles of the acetaminophen product with labels that fail to indicate the product strength. Although the label states "500 mg," no volume is listed to help users recognize that the product strength is 500 mg per 15 mL (Figure 1). At the same time, an accompanying dosing cup only has a marking at 30 mL, which measures 1 g of acetaminophen, not 500 mg. Some people might think 500 mg is equal to the 30 mL mark on the dosing cup, and then use 60 mL, or 2 g of acetaminophen per single dose, when they intended to take 1 g.
Information about the proper strength and dose is in the Drug Facts label on the back of the container. However, this isn't visible unless the Drug Facts label is peeled open, and not everyone reads the Drug Facts label, as they should. Similar acetaminophen liquid products for children and infants do list the concentration of the suspension (acetaminophen 160 mg per 5 mL).
ISMP has interacted with the U.S. Food and Drug Administration and the Consumer Healthcare Products Association about the misleading labeling. We think the product should be recalled, given the risk of dosing with up to 8 g per day if used at the suggested frequency of every 6 hours.
Label Improvements Needed for Iron Products
A practitioner reviewing a patient's home medication list learned the patient's daughter had been giving him five tablets of ferrous sulfate daily to equal the 325 mg dose recommended by her father's physician. The ferrous sulfate she had purchased at a pharmacy was only labeled with the amount of elemental iron in each tablet, 65 mg. The label provided no indication that each tablet was equivalent to ferrous sulfate 325 mg. The patient's daughter thought she was supposed to give her father five 65 mg tablets for each 325 mg dose. The patient experienced severe constipation and stopped taking the iron after 2 days but was soon hospitalized for other reasons, where the error was discovered.
This is not a new problem. Longstanding lack of standardization for iron product labeling has led to frequent dispensing and administration errors. A total of 67 reports concerning iron were submitted to the ISMP National Medication Errors Reporting Program between 1998 and 2017. Forty percent of these reports were due to confusing product labeling on both the outer package and individual unit doses.
Providers often order iron based on the salt form (e.g., ferrous sulfate 325 mg daily). Yet the container labels of some iron products express only the amount of elemental iron in each tablet. Other iron products express the amount of iron in salt form on the primary display panel and a differing amount of iron, the elemental form, in the Supplement Facts panel (Figure 2). Over-the-counter iron products are regulated as food supplements, so a Supplement Facts panel appears on the label instead of a Drug Facts panel. Listing the apothecary strength (5 gr) can also lead to confusion. Some iron supplements do not include the amount of iron on the primary display panel and instead list the dose of elemental iron only on the Supplement Facts panel (Figures 3 and 4). In the latter example, one must search under the ingredients section to find that the iron is from ferrous sulfate. ISMP has discussed this issue with the U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition.
Duplicate Oral Anticoagulants
A patient was admitted to a hospital late in 2018 with new-onset atrial flutter and was started on XARELTO (rivaroxaban) 20 mg daily. On discharge, the patient was given a 30-day prescription for Xarelto and educated about what to expect when taking the drug (e.g., side effects). He was seen in the clinic 4 days later, where it was realized the patient did not have prescription insurance coverage until January 1, 2019, leading to issues with prescription affordability. Based on anticipated insurance coverage in 2019, a plan was developed to transition the patient to ELIQUIS (apixaban) 5 mg PO BID after 30 days. The patient was given Xarelto coupons until the new coverage began, and no issues with compliance were foreseen. He and his wife were counseled, and understanding of the plan was confirmed.
The prescription for Eliquis was dated to begin after 30 days and sent electronically to the outpatient pharmacy. However, the pharmacy filled the prescription that same day. The patient picked up the prescription and unfortunately took both Xarelto and Eliquis together, in addition to aspirin and PLAVIX (clopidogrel), which the patient was taking after stents had been placed. Although a duplication alert may have appeared upon processing the prescription in the pharmacy, there may also have been an assumption that the patient was being switched from one anticoagulant to another and knew not to overlap therapies, which was not the case. The patient was later readmitted with gastrointestinal bleeding after taking both Xarelto and Eliquis for 3 days. Three days after discharge, he was readmitted again with a large, bloody pericardial effusion.
Special precautions are needed when prescribing and dispensing high-alert medications in community or ambulatory care. It is critically important for pharmacists to provide patient counseling when anticoagulants are dispensed, especially for new prescriptions, and to ask about the possibility of duplicate therapy. Also, pharmacists should always review the patient's profile to learn if there are active orders for other oral anticoagulants. Directions from prescribers that clearly state when to stop and start each medicine, and directions on prescriptions for when they should be filled (e.g., do not fill before....) would help. Patient counseling at the point-of-sale can reinforce these directions. Home care nurse can also play an integral role in identifying and preventing duplicate therapy by reviewing the patient's medications during a visit.