Balancing Policy, Safety, and Digital Care in Medication Use: Jody L. Green, PhD

Recent survey data from among 21,000 adults reveal that 62.3% of the US population uses at least 1 medication weekly, signaling a heavy reliance on both clinical and self-guided health management. A standout finding of this research is the near parity between over-the-counter (OTC) and prescription use (46.0% and 46.3%, respectively). For health care policy makers, this prevalence estimate and others are vital for regulatory science, pharmacoeconomic modeling, and postmarketing safety monitoring. Safety monitoring is particularly critical, as 16.3% of adults now take 5 or more medications weekly, increasing the potential for dangerous drug interactions.

In this interview with The American Journal of Managed Care^® (AJMC^®), lead study author Jody L. Green, PhD, chief scientific officer at Uprise Health, emphasizes, “Health care is not an either-or proposition. It is a continuum in which consumers combine self-care and clinician-guided treatment to meet their needs.” That continuum, she says, is heavily influenced by regulatory decisions.

Green also highlights that the digital integration of health records serves as a crucial safeguard in this environment, allowing for systematic checks for contraindications and improved care coordination for an aging population managing multiple chronic conditions, and that understanding the underlying drivers of medication choice—the “why” behind the data—remains the next frontier for improving medication adherence and safety protocols.

This interview has been lightly edited for clarity.

AJMC: Your data show nearly identical past-7-day prevalence for OTC and prescription medication use. What do you believe is the most important policy or public health implication of this near parity?

Green: This mix certainly underscores an important reality: Health care is not an either-or proposition. It is a continuum in which consumers combine self-care and clinician-guided treatment to meet their needs. Each comes with different trade-offs between access and cost. The increase in utilization of medications that have gone through the Rx-to-OTC switch would suggest this process is a critical policy, assuming the benefit-risk evaluation is appropriate.

AJMC: With 16.3% of adults reporting use of 5 or more medications and 3.3% reporting 10 or more in a single week, how should policy makers and clinicians interpret your findings in the context of medication safety and care coordination?

Green: I think the American population is pretty invested in their health. I know even for my kids and my parents, seeing the different ends of the spectrum, there seems to be just more interest in being healthy and taking charge of your own medical status. And so the digital integration—we talk about the implication for policy makers and clinicians—the digital integration of health records is so important in keeping patients safe when treated for multiple conditions, especially as the population ages. These systems really allow for systemic checks, systematic checks for contraindications, other considerations for care coordination, and then, of course, patient education is key, just empowering the individual to stay vigilant with their medication safety.

AJMC: You note that the top 3 medications have remained unchanged for close to 25 years, since the Slone Survey, while others shifted substantially in rank, such as pseudoephedrine and several prescription-to-OTC switches. To what extent do you believe regulatory decisions vs broader clinical trends are driving these changes?

Green: It is difficult to measure direct causality; however, the temporal relationships between the utilization before and after an Rx-to-OTC switch suggest these types of regulatory decisions are impactful. The broader clinical trends are still reliant upon regulatory decisions and product approvals, considering all medications in our study were approved for OTC and/or prescription use.

AJMC: Given the recent FDA rule outlining additional conditions for nonprescription use, how might your medication-specific prevalence data inform modeling of public health impact or benefit-risk assessments for future OTC switches?

Green: Our study focused on medication utilization and is limited in that we did not perform any benefit-risk assessment. With the recent FDA rule outlining additional conditions for nonprescription use, it will be important to measure pre- and postapproval utilization, as well as measures of benefit and risk. Access is a measure of benefit but should be weighed in relation to risk for any medication when studying the larger public health benefit.

AJMC: Medication use was higher among women (66.6%) than men (57.3%), yet age-related increases were similar across sexes. Can you speak to the factors that may have contributed to the differences you saw between women and men in your study?

Green: I think we all understand that as you get older, you have more conditions, whether it be aches and pains or something more serious, like cardiovascular disease or diabetes, and while our study did not investigate the reasons for the differences between the sexes, other work that’s been published has noted things such as health literacy [and] willingness to seek care, which I think, from personal experience, might see a difference between men and women in that regard. Then, of course, [there are] basic biological differences in certain disease states. Certainly, that has been studied in diabetes and cardiovascular areas, where we do obviously identify differences between men and women in susceptibility to some of these chronic diseases in particular. Personally, I think the differences in our data between men and women are likely a mixture of these factors and possibly more, but that certainly is an interesting area of continued study.

AJMC: You took several steps to improve recall accuracy, including a 7-day recall window and prompted reporting. What do you see as the most important remaining gaps in national medication surveillance?

Green: I think some of the questions you’ve asked here, such as why are there differences or why are Americans taking just as many OTC products as prescription medications in any given week, and digging into that next layer of the onion, as they say, to understand the underlying drivers in terms of choice of medication [and] medication adherence is another large area of interest and concern for clinicians who are trying to manage, particularly, chronic care disease. This study really focused on the utilization, but that next layer of why and how to—and then, of course, if we know why, we then know how to influence these decisions in terms of compliance, adherence, and safety—that really, I think, will be the next step in translating these data into some impactful public health messages.

I would say in addition to that, the other really exciting part of this research is, when the Slone study was done 25 or 30 years ago, it was random digit dialing. Of course, we don't do that today, for cost and just [because] the whole phone environment landscape is different than landlines of the past. Understanding the online surveys and online research really can be done in a methodologically sound way and be used to get to a large number of individuals in a shorter period of time, so that it’s quicker from data collection to translational research to really making an impact with your findings. Employing these digital data collections, not even just online surveys, but now we have wearables and all kinds of other cool electronic data collection and electronic patient-reported outcomes—we really need to capitalize on this. I think it’s an exciting time to apply that methodology in a sound manner to really advance the research in this area.

The other advantage to this type of research is setting a baseline and being able to measure impacts of regulatory decisions. The previous study, which is similar but not exactly the same, was done decades ago. A lot has happened in the regulatory space and in the US market of available products. Now, I feel like it’s really great we have this baseline, so the next Rx-to-OTC switch or any of the medications that follow it—nonprescriptions with conditions—will have at least a way to measure, at least, the impact on utilization and access to these medications.