1. Cohen, Michael R. ScD, MS, RPH

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Aspirin use can be surprisingly risky

In the third quarter of 2016, aspirin ranked first among all drugs monitored by QuarterWatch for reported serious injuries to patients age 75 and older, and fourth among all drugs in reported serious injuries to U.S. patients of all ages. QuarterWatch, the publication of an independent surveillance program conducted by the Institute for Safe Medication Practices (ISMP), monitors adverse drug events reported to the FDA by manufacturers, healthcare professionals, and the public. The ranking for aspirin remained high even when vague reports, consumer reports, and reports without appropriate investigation of patient deaths were excluded.


Investigation revealed that most reports of serious injuries involved patients who were taking a combination of aspirin (mostly low-dose) and an anticoagulant, most notably rivaroxaban, warfarin, apixaban, and enoxaparin. Details to determine the appropriateness of the dual therapy weren't provided in the reports. Overall, aspirin was the primary suspect drug in 2,134 reported cases during the third quarter of 2016, including 169 deaths and 1,137 gastrointestinal hemorrhages.


The risks of combining aspirin with other drugs that inhibit coagulation are high. ISMP recommends that the FDA sponsor a reanalysis of the extensive clinical trials data on anticoagulants with a goal of identifying and guiding the appropriate use of dual antiplatelet therapy.


The QuarterWatch report with references is available at



On a tear

Propofol is an I.V. sedative-hypnotic used to induce and maintain anesthesia or sedation. A redesigned bottle of Actavis propofol 1,000 mg/100 mL (10 mg/mL) has a label designed to be peeled down to create a hanger, which is used to hang the bottle on an I.V. pole. Previously, Actavis had provided plastic hangers to put around the bottle to hang the infusion. Unfortunately, when peeling down the redesigned label to create the hanger, part of the label with the drug name and concentration is torn off, as shown above. The new design also makes it difficult to attach the patient-specific label. In addition, the label is upside down and difficult to read once the bottle is hung.

Figure. When the lab... - Click to enlarge in new windowFigure. When the label is peeled down to create a hanger, part of the drug name and concentration is torn away.

ISMP has contacted the FDA and the manufacturer about these problems. Until the issue is remedied, facilities should consider purchasing propofol in 1,000 mg/100 mL bottles from a manufacturer that provides plastic hangers. Plastic bottle hangers can also be purchased separately for bottles of various sizes.



Education is a must

A patient with cancer was prescribed a 7-day infusion of fluorouracil, a nucleoside metabolic inhibitor, administered at home via an ambulatory elastomeric infusion pump. For unknown reasons, the entire infusion was administered in about 4 days. The patient was very sleepy for the next 2 days and had "terrible diarrhea," according to family caregivers. Even though the infusion was complete, the family waited until the patient's scheduled appointment 4 days later to report the mishap. The patient was hospitalized and treated with I.V. hydration. Why the antidote uridine triacetate wasn't administered isn't clear. Taken orally, uridine triacetate blocks cell damage and cell death caused by fluorouracil chemotherapy. The patient was discharged after 7 days of hospitalization.


This incident points to the need to educate patients with ambulatory infusion pumps about specific details regarding how the pump works, what to expect over the course of the treatment, infusion rates, how long the infusion should last, how much should be left in the container each day, and the need to immediately report any incident to their healthcare team, especially if the container empties faster than anticipated. Patients and families must also be educated about signs and symptoms of adverse drug reactions, including overdose and toxicity, and they should also be warned that these signs and symptoms may not be immediately apparent. Dangerous treatment delays can occur because patients may be asymptomatic in the first few hours and days after an overdose. Rapid identification of an overdose allows prompt treatment with an antidote, if available, to minimize serious adverse reactions and the risk of a harmful or fatal outcome.