Web app for self-prescription of statins 96% concordant with physician reviewers
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A web application to help individuals self-prescribe statin therapy demonstrated 96% agreement with subsequent physician judgment, according to research published in the Journal of the American College of Cardiology.
The goal of this investigation was to assess the ability of a web-based app to accurately discern patients who would benefit from statin therapy; therefore, improving access to preventive therapies.
“There have been five efforts to bring statins over-the-counter, and they were well intentioned, but they failed pretty badly. None of them received FDA approval,” Steven E. Nissen, MD, MACC, chief academic officer of the Sydell and Arnold Miller Family Heart, Vascular & Thoracic Institute and Lewis and Patricia Dickey Chair in Cardiovascular Medicine at Cleveland Clinic, told Healio. “I publicly opposed each of the prior efforts to take statins over-the-counter. I did so because the studies showed that as many as half of the people who actually self-selected to take over-the-counter statins were ineligible due to their risk being too low or too high, or to have a contrary indication, which of course is risky.
“For this analysis, we mimicked how the web application would work in the real world, and got a 96% accuracy,” said Nissen, who is also a Cardiology Today Editorial Board Member. “If you go to a primary care doctor and that doctor uses their own judgment to decide whether you should get a statin or not, they probably wouldn’t be 96% accurate. This might be as good if not better than one could get from seeing a physician one-on-one. This is a very high level of accuracy, and it ought to settle the question with skeptics. Skeptics, like me, who were not in favor of prior efforts.”
For the study, 500 participants completed an at-home web app that evaluated the appropriateness of treatment with rosuvastatin 5 mg. The web app was programmed using the 2018 cholesterol treatment guidelines from the American Heart Association, American College of Cardiology and 10 other societies on moderate-intensity statin use as well as the warnings and precautions for rosuvastatin. The primary endpoint was the proportion of participants whose self-selected eligibility for nonprescription rosuvastatin was concordant with clinician assessment.
Nissen said rosuvastatin 5 mg was chosen due to its safety and efficacy profile.
Researchers included 83 participants with a Rapid Estimate of Adult Literacy in Medicine (REALM) test score of less than 61, corresponding to a seventh or eighth grade education.
During the self-assessment, participants responded to questions related to medical history, medication use, total cholesterol, HDL, LDL, triglycerides, BP and, if needed, waist circumference, high-sensitivity C-reactive protein and coronary artery calcium score. Based on the participant’s responses, online statin eligibility assessment concluded with one of three possible outcomes: “OK to use,” “not right for you” or “ask a doctor.”
According to the study, respondents were deemed ineligible for therapy with rosuvastatin 5 mg if their assessed risk was less than 5% or greater than 20%; a risk greater than 5% and less than 7.5% without additional risk factors; or if they had a contraindication to rosuvastatin. The results of the web app assessment were not revealed to participants.
Concordance with physician judgement
Nissen and colleagues reported that the web app self-selection for rosuvastatin therapy was concordant with clinician selection in 96.2% of participants (95% CI, 94.1-97.7). Among the cohort, 4.6% were deemed appropriate (“OK to use”) and 91.6% were deemed inappropriate for treatment (“not right for you”).
According to the study, discordance was attributed to incorrect self-selection in three cases, incorrect rejection in 14 cases and an incorrect “ask a doctor” outcome in two cases.
Nissen said the high level of statin ineligibility that was observed was due to the trial’s all-comer enrollment design.
“No program will be 100% accurate. The FDA has said it wants to see 90% or greater accuracy. If you think about other over-the-counter medications, the accuracy is probably not 90%, but, for this group of drugs, we sought to achieve a program that could get to that 90% level of accuracy,” Nissen said. “We got 96%, we were very pleased and we’re going to now go on and do another study of about 1,000 patients to verify that we’re getting the right people on statin therapy.”
‘Before we leap’ to self-directed care
In a related editorial, Neha J. Pagidipati, MD, MPH, assistant professor of medicine at Duke University School of Medicine and member of the Duke Clinical Research Institute, and Eric D. Peterson, MD, MPH, Adelyn and Edmund M. Hoffman Distinguished Chair in Medical Science at University of Texas Southwestern Medical Center, wrote there are factors to consider when looking at technology-assisted self-selection for drug therapies.
“Before we leap into this new world of technology-aided self-directed care, however, we need both optimized digital decision-aids and larger implementation studies. Although Nissen et al found that patients were reasonable at reporting their health histories, the accuracy, completeness and ease of collection of health information could be improved if the tools had been digitally integrated with the participants’ electronic medical record,” Pagidipati and Peterson wrote. “Future implementation studies should also assess for adverse effects resulting from using self-guided patient decision aids (such as overuse, safety concerns, and patient anxiety),” they wrote. “Although such studies will take resources, the potential upside gained from better cardiovascular prevention could be enormous. The time has come for us to learn how to safely empower patients to self-prescribe preventive therapies.”
References:
- Grundy SM, et al. Circulation. 2018;doi:10.1161/CIR.0000000000000625.
- Pagidipati NJ, et al. J Am Coll Cardiol. 2021;doi:10.1016/j.jacc.2021.07.020.
For more information:
Steven E. Nissen, MD, MACC, can be reached at nissens@ccf.org.
Perspective
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In the past, companies went to the FDA and tried to make statins an over-the-counter drug, but the FDA backed off on it. In that sense, this study is encouraging. This app is not a bad idea, and it would simplify getting these drugs to people who need them. We've talked a lot about how can we simplify the health care system and how do we make it less expensive. I like the idea of putting a nurse clinician in the pharmacy for a small charge to keep people out of the ED. Urgent care centers are trying to do the same thing, but they're not necessarily as cheap. I've been very impressed with our nurse clinicians.
I'm in favor of all kinds of ways to make things simpler and less expensive because we have the most expensive health care system in the world and we're not getting enough for our money. This is another example of how we can we make the system simpler and less expensive and still be safe.
Using this app, I'd worry a little bit about people making mistakes. On the other hand, statins are so safe. They're certainly safer than aspirin and I believe that it's perfectly okay to make certain statins nonprescription. However, my solution would be not to worry about having patients fill out a computer app. I would put lower-dose statins right next to the aspirin and let people buy it themselves. The pharmacies would love it because they'd make more money on the over-the-counter statins than they would on the prescription statins.
Another thing to consider is the education levels of the patients using these apps. As we've discovered when we do telemedicine, many of our older patients are not very good with a computer and they would probably have a very hard time with something like this app. However, among college-educated individuals and younger people who were born with a computer in their right hand, it's not a bad idea.
I would put the questions at a third-grade education level, but I would still worry that there might be mistakes. This study didn't show many mistakes and with statins, I wouldn't worry so much, but I'd be more uneasy with some of the other drugs, like certain antibiotics, where you can have a very serious and anaphylactic reaction. Certain drugs would be very safe, but others you'd have to think long and hard about.
Increasing access to lower-dose statins, however, is not a bad idea, because the risk for side effects is minimal. People taking statins sometimes report having cramps. But studies have shown that just as many people in the placebo group had cramps and muscle aches as the statin group. There is a small percentage who get serious muscle injury, but it’s a very small subgroup.
Many of pharmacies are now hiring nurse clinicians who patients can talk to. I like that idea a little better because the nurse clinician can make sure they get to the bottom of what people are telling them, as opposed to letting patients just hit buttons on the computer.
There might be other drugs, like lower-dose beta-blockers, that I might be willing to put out there for patients to get without a prescription or after talking to the nurse clinician in the pharmacy.
Our EDs are clogged with people who shouldn't be there. Patients might have a little fever or it's Saturday and their doctor is not in the office, and they go to the ED. It's an extraordinarily wasteful way to do health care. Even if you just go in with a sore throat, the ED bill is still thousands of dollars, which is ridiculous. You should pay $25 to the nurse clinician at the local pharmacy, they'll look at you and if they see anything, then they'll send you to the ED.
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