Biocon Pharma manufactures everolimus in blister cards containing 2.5 mg, 5 mg, 7.5 mg, or 10 mg tablets. This product is used to treat conditions including hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer, and tuberous sclerosis complex-associated renal angiomyolipoma. Each strength is packaged in a carton of four blister cards. Each blister card has seven blisters containing everolimus tablets along with four blisters containing desiccants. The desiccant blisters are labeled with "DESICCANT DO NOT EAT." However, this warning message is only printed on one side of the blister; the other side of the blister contains no wording (Figure 1).
Patients viewing the blank side of the blister may push a desiccant tablet through without realizing it. Although the desiccant tablets look different than the everolimus tablets, these can still be easily mistaken for medication-containing tablets.
That is exactly what happened in a case reported to ISMP. A patient was dispensed everolimus 10 mg tablets. She later called the pharmacist and told them that she had accidentally ingested one of the desiccants instead of a medication tablet. In a second case, a non-English speaking patient was dispensed a carton of everolimus 10 mg tablets. He was confused by the presence of the desiccant blisters. He thought that he may need to take the contents of those blisters. Luckily, he called the pharmacy, and the pharmacist was able to work with the patient to avert an error.
We have previously reported about patients who accidentally ingested desiccant capsules from medication bottles. For example, an elderly patient with poor eyesight nearly asphyxiated when he gagged on a desiccant capsule left in his medication bottle. A literature search confirmed additional cases, some of which required surgery.
Alert pharmacy staff to this blister card packaging issue as your colleagues may never open the carton to see the individual blisters. In the pharmacy computer system and on the cartons, mark these products for mandatory patient education. It is critical that patients know that these blister cards contain desiccants that should not be swallowed or eaten. In fact, it is good practice to warn patients about desiccants whenever manufacturer containers are dispensed.
Now, we are aware of a total of 13 reports related to this issue that have been submitted to ISMP National Medication Errors Reporting Program (ISMP MERP) and the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) since February 1, 2021. Two patients almost ingested the desiccant, including the patient mentioned above. The other 11 patients ingested the desiccant, often for several doses. In two cases, parents administered the desiccants to their children. One mother questioned whether her child's recent erythematous face was related to ingesting the desiccant after discovering she had administered the desiccant to her child at least six times. Another patient took all four desiccants in the blister pack and went to the emergency department for chest pain.
Although at least eight manufacturers provide everolimus tablets in blister packaging, all the reports submitted to FDA and ISMP involve the product from Biocon Pharma, which is the only company that packages desiccants with the tablets in blister cards. The cases frequently involved elderly patients for whom poor vision may have contributed to the confusion. Furthermore, the font size and light tan color of the drug name and dose on the labeled side of the card are difficult to see on the foil blisters. Also, the everolimus product labeling and the information that accompanies the medication dispensed to patients provide NO information about the desiccants and what to do if they are swallowed.
Biocon Pharma told us that the desiccants in everolimus blisters are chemically inert, nontoxic, and nonhazardous, and are not absorbed or digested, and should pass through the body as is. Still, keep in mind that patients swallowing a desiccant tablet may miss a dose of their scheduled cancer or immunosuppressant medication.
Many practitioners will never open the Biocon Pharma everolimus carton to see the individual blister cards, so it is important to alert them to the blister card labeling issue so they are aware of the potential for patients to ingest the desiccant tablets. When educating patients, it is critical to let them know that these blister cards contain desiccants that might be mistaken as tablets. Consider opening the carton to show patients the blister cards. Patients should be warned to never swallow or eat a desiccant.
Confusing Labeling on a Two-Dose Blister
Aprepitant capsules are often administered with dexamethasone and a 5-HT3 antagonist antiemetic like ondansetron to manage moderately or highly emetogenic chemotherapy. On day 1 of the chemotherapy treatment, the aprepitant dose is 125 mg. On days 2 and 3, the dose is 80 mg each day. The 80 mg capsules are available in a single-capsule unit dose package and in a two-dose blister, intended for days 2 and 3 of chemotherapy. However, these two-dose blisters are labeled as 80 mg (Figure 2) and may be confused with the unit dose package, even though the total amount of medication in the package is 160 mg.
In an event reported to ISMP, a nurse initially believed that both capsules (160 mg total) were supposed to be given together for the 80 mg ordered dose. But she checked further and learned that each 80 mg capsule was to be given by itself on days 2 and 3. With the two-dose blister, the package label does not clearly indicate anywhere that there is 80 mg "per capsule" or that the package holds two doses (capsules). This confusion can also happen if patients are taking this medicine at home. Clear labeling about the capsule strength is needed.
Aprepitant is also available in a 40 mg dose for the prevention of postoperative nausea and vomiting. There is also a tri-pack with one 125 mg capsule and two 80 mg capsules.