FDA TO EXAMINE SELF-SCREENING TO TREAT DISEASE

Health apps, pharmacy kiosks could help patients determine medications

Written by
Gary Robbins
12:01 a.m., March 19, 2012
Updated 7:33 p.m. , March 18, 2012

The public’s huge and growing use of the Internet and other technologies to get health information has the U.S. Food and Drug Administration asking a provocative question:

Should the agency stop requiring prescriptions for certain drugs that are used to treat diseases and conditions that people can diagnose by themselves, or with a bit of help?

The FDA says the idea represents a possible “new paradigm” in health care, and that it will hold public hearings on the matter Thursday and Friday in Washington, D.C. The testimony will focus on drugs commonly prescribed for high cholesterol, high blood pressure, migraine headaches and asthma. The agency also may explore easier access to diabetes treatments.

The “FDA is aware that industry is developing new technologies that consumers could use to self-screen for a particular disease or condition and determine whether a particular medication is appropriate for them,” the agency said in the Federal Register.

It said people might be able to perform screening by doing such things as answering a series of questions presented on kiosks in pharmacies, or on websites. The FDA also could require that the nonprescription drugs be sold in a pharmacy, and that a consumer consult a pharmacist, rather than simply turn to the Internet.

The Internet has become especially popular among people searching for health information. WebMD.com draws about 16 million unique visitors a month, roughly as many as Southwest Airlines and the White Pages. The site’s features include drug reviews and tips about how to spot an onset of hypertension and other diseases.

People are increasingly turning to health apps available on tablet computers and mobile phones. The apps help people monitor everything from their blood pressure to how well they respond to an aspirin regimen. Consumers can attach blood pressure monitors to iPhones and iPads to more easily record and monitor data.

At some Rite Aid pharmacies, “wellness ambassadors” roam the aisles with iPads, looking up product information for customers. And health kiosks are becoming increasingly interactive, doing such things as measuring blood oxygen and blood glucose. Some of the kiosks, such as the one produced by Ideal Life of Toronto, can electronically send the information to clinicians, or to a person’s friends or family.

“There’s growing demand for these kiosks, and I think you’ll soon see that they’ll be able to connect people live to doctors and nurses,” said Scott Flacks, marketing director of Ideal Life.

Health websites vary in quality and accuracy, and self-screening can require a lot of self-education. There are downsides to not seeing a doctor, say health officials. But for some, self-screening also carries appeal.

“We’re seeing the democratization of information that used to be narrowly held by doctors,” said Joseph Smith, chief medical officer at the West Wireless Health Institute in La Jolla.

“I can see taking tests for things like cholesterol and choosing an appropriate drug. There are some risks, but they’re well-known and you can always see a doctor. We need to be looking for ways to reduce health care costs. This could be a start.”

Larry Smarr, a UC San Diego physicist-futurist who is a big proponent of self-monitoring, says, “Consumers will be provided with a greatly increasing set of additional information about their bodies and medical options regardless of what the FDA does. This is driven by rapidly decreasing costs in medical tests and the growth of social networks.”

Andrew Lucks advises caution, especially when it comes to choosing medications to treat hypertension.

“I don’t think it is as easy as it sounds,” said Lucks, a cardiologist at Scripps Health. “There are several different types of antihypertensive medications out there and different classes are used to treat different types of patients.

“In addition, some of these medications, when started, can have effects on kidney function and electrolytes that need to be monitored with blood tests. This could be a potential danger-pitfall if left to the pharmacist or the patient alone.”

The FDA seems to envision a larger role for pharmacists. In announcing this week’s hearings, the agency said, “Some diseases or conditions might require confirmation of a diagnosis or routine monitoring using a diagnostic test (e.g., a blog test for cholesterol levels or liver function) that could be available in a pharmacy. A pharmacist, or consumer, could then use the results to determine whether use of a certain drug product is appropriate.”

The National Community Pharmacists Association sees more limited involvement.

“Yes, this could eliminate the need for a physician visit for certain meds that may have been prescription prior to this change,” said Ronna Hauser, NCPA’s vice president of policy and regulatory affairs.

“However, there may be circumstances when a patient might need a physician visit and diagnosis and original prescription to start therapy but could continue on that therapy with pharmacist refill authorization capabilities.”

The larger question may turn out to be whether the public can sift through and make sense of the extraordinary amount of information they can get about their own health and available medicines.

“Some of the nonmedical public will be able to process information and help themselves but not all will be good at it,” said Charles Daniels, pharmacist-in-chief for the UC San Diego Health System.

“This is an age of health care based upon expert best practices and evidence of outcomes. Clinical experience in diagnosis and treatment can’t be replaced, but very smart devices built around that experience make sense. The FDA will have a big challenge determining if the devices can do their job and provide the right advice to users.”

FDA TO EXAMINE SELF-SCREENING TO TREAT DISEASE | UTSanDiego.com