Oct. 4, 2022 – How physicians and patients view medication adherence claims in online ads is the subject of a two-part research study announced recently by the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP).

“Patient non-adherence to medication regimes is a well-known challenge in health care,” OPDP stated in the Sept. 23 Federal Register, which also noted that only half of all patients with chronic conditions take their medications as prescribed, a situation that leads to 100,000 preventable deaths and $100 billion in in additional annual medical costs.

According to OPDP, as attention to medication adherence has grown, so have the number of claims and presentations in prescription drug promotion that “focus, either directly or through implication, on a product’s potential to improve adherence to treatment regimens.”

“Nonadherence to prescribed medications is a major cause of morbidity and mortality in our healthcare system, and a finding in the current study that shows a significant impact in improving adherence would be an important affirmation of the effectiveness of direct-to-consumer advertising,” said Coalition for Healthcare Communication Executive Director Jon Bigelow.

One approach that drug companies have been exploring to track medication use is prescription drug use-related software, which can include autoinjectors with Bluetooth built into the cap that sends data to a smartphone or ingestible sensors embedded in pills that send out a signal to a receiver worn by the patient after a pill has been swallowed.

Whether these tracking mechanisms are perceived by patients and physicians as effective at solving the adherence problem is largely unknown, OPDP states. “The focus of the present study is to explore patient and health care provider perceptions of a fictitious prescription drug product that is accompanied by software that is intended to track medication use.”

OPDP’s two key research questions for this study are as follows:

• When prescription drug promotional communications include claims about a product’s ability to track medication use, do these claims influence perceptions about the product’s risks and/or benefits (including its effect on medication adherence)?
• If the promotional claims about the product’s ability to track medication use are accompanied by a disclosure that describes what is known about the effect of medication tracking on medication adherence, does this have an influence on perceptions of the product’s risks and/or benefits (including its effect on medication adherence)?

Variables in the study design include whether the product includes technology that tracks medication use, whether the promotional communication about the drug includes a disclosure describing what is known about the tracking technology’s effect on medication adherence, and what the disclosure communicates about the technology’s effect on medication adherence (positive/no effect/unknown).

OPDP plans to conduct an initial study with 50 consumer and 50 primary care participants who have or treat diabetes. That study will be followed by the main study, which will include 350 participants from each group. Each participant will see one of five versions of a consumer webpage for the fictitious prescription diabetes treatment, and will be asked to respond to a questionnaire that asks about their perception of the product’s benefits, risks and effect on adherence.

“These new studies continue OPDP’s research focus on the impact of various types of messages in DTC advertising,” Bigelow said. “Given that much OPDP research has focused on TV advertising, it is important that the new research will include websites and smartphone apps—key parts of the marketing mix.”

The FDA will accept comments on this OPDP proposed study until Nov. 11, 2022.