OTC Painkiller Labels Don't Properly Inform Caregivers

Most caregivers cannot make informed decisions about OTC painkillers based on information provided in the products’ labels and inserts, according to findings published in Patient Education & Counseling.

Researchers from the University of Cape Town in South Africa conducted a survey to assess whether caregivers make informed decisions regarding their children’s use of OTC painkillers.

Between December 2012 and January 2013, 60 caregivers from different socioeconomic groups and nationalities who were part of 5 mothers’ groups were surveyed. The questionnaires for caregivers were comprised of 87 questions, while 7 pharmacists completed surveys made up of 50 questions.

All 7 pharmacists reported that labels are always included with OTC painkillers packaged in a box, which was confirmed by 90% of caregivers indicating that they always receive labels.

Concerning inserts, 5 of the pharmacists said they were sometimes included with OTC painkillers. However, more than two-thirds of caregivers (69.5%) reported always receiving inserts when buying OTC painkillers, and only 27% said they sometimes received inserts. The remaining 3.4% reported never receiving inserts.

Roughly half of the pharmacists (57%) reported never providing Patient Information Leaflets (PILs) with OTC painkillers, which aligned with the 61% of caregivers who said they never received such PILs. Surprisingly, most pharmacists mistakenly believed that the insert was only for health care professionals and the PILs for the public.

Most notably, 43% of pharmacists felt the information provided with OTC painkillers was ineffective in preventing overdose among children. A few of the reasons behind the pharmacists’ perceived ineffectiveness of OTC information included “need lots of verbal communication between caregivers and patients in relationship of trust,” “not enough info stuck on the actual bottle,” and “not enough time with them.”

“Pharmacists are respected by the general population and so they have a responsibility to make sure they are passing on information that can be understood and implemented, as well as making sure that every person is given advice on OTC medication,” study co-author Hanna-Andrea Rother, PhD, told Pharmacy Times. “…It would be beneficial if pharmacists received more training on how to provide information in plain English but still (comply) with medical advice.”

The researchers voiced concern after discovering that 10% of survey respondents could not determine at what age a child could receive acetaminophen. Furthermore, 10% gave an incorrect dosage after reading the OTC drug’s insert label, and 3% gave an incorrect dosage after reading its PIL. Three responders reported that their children became sick after taking acetaminophen; however, they attributed the illness to an allergic reaction and not an overdose.

“It is important to note that the label is the most accessible source of information to consumers purchasing from shops, yet the label did not have explicit dosage instructions for children,” the authors concluded. “This should, at a minimum, be a requirement for all labels on OTC medications.”