Sertraline liquid oral concentrate is produced in a 20-mg/mL concentration. The solution must be diluted before use to make the preparation more palatable. Direct administration of the concentrated, undiluted solution is astringent and may numb the mouth and tongue for at least a day, even if the mouth is rinsed extensively.

The Institute for Safe Medication Practices (ISMP) recently received a report of a young child who received the undiluted concentrate. The instructions on the prescription and pharmacy labels did not direct the caregiver to dilute the solution before administration. As we often hear at ISMP, the caregiver threw away the patient information sheet and product carton that contained information about the need to dilute the product. At the time of the report, it was not known whether the patient’s caregiver received education from either the prescriber or the pharmacist on how to prepare and administer a dose of the solution. The child experienced discomfort and numbness and became distressed from the untoward effects of receiving the solution undiluted.

To administer sertraline oral concentrate safely, it must be diluted immediately before administration. Caregivers, health care practitioners, and patients must use the manufacturer-provided dispensing device to measure the required amount of solution. The solution should then be mixed with 4 oz (½ cup or about 120 mL) of ginger ale, lemonade, lemon/lime soda, orange juice, or water only. Other liquids should not be used to dilute this medication. It is important to inform caregivers and patients that a slight haze may appear after mixing, which is normal. Most commercially available sertraline products include a warning to dilute before use on the main panel of the manufacturer’s carton and bottle (figure). The manufacturer cartons and container labels also include mixing instructions on the side panels. However, an informal poll of community and long-term-care (LTC) pharmacist colleagues found that they were not familiar with the product or the need to dilute it before administration. Prescribers also may not know of this step and provide dosing instructions for only the actual milligram or milliliter amount of sertraline oral concentrate to administer.



To reduce the risk of errors, educate prescribers and pharmacy staff about the need to dilute sertraline oral concentrate before administration. Use the teach-back method to educate caregivers and patients on how to prepare and administer the medication. This type of education should be mandatory in community pharmacies. Ensure that caregivers and patients have explicit instructions, beyond those found on the manufacturer labels, on how to properly dilute the oral concentrate, including the acceptable diluents to use. Be sure that important mixing instructions and warnings on manufacturer labels are not covered by the pharmacy-applied label. In LTC facilities, make sure that directions for dilution are in the order and appear on the medication administration record. For products dispensed to both LTC facilities and patients, consider applying an auxiliary label warning that the product must be diluted.
 
Michael J. Gaunt, PharmD, is a medication safety analyst and the editor of ISMP Medication Safety Alert! Community/ Ambulatory Care Edition.