What to know about home testing and monitoring devices

Abstract

The home testing market continues to expand, offering a wide array of products that are user friendly and comprehensive. Many areas are seeing growth, particularly with the rise of new technologies and wearables. As use of home testing and monitoring kits becomes increasingly common, what do pharmacists need to know? Home tests are typically available as strips, cups, dip cards, cassettes, and more recently, digital monitoring devices (wearables). Blood, urine, and saliva are the primary testing media. Forces driving the growth in home diagnostics include increased public interest in health and preventive medicine; reduced health care costs, because patients can avoid unnecessary visits to health care providers and seek earlier treatment for a medical condition; reduced access and availability of health care resources; increased number of available tests; and important advances in technology that have led to simplified, accurate tests that can be easily performed at home. Home testing and monitoring kits are designed to detect the presence or absence of a medical or physiological condition and to monitor disease therapy. Recent growth in this market has been in the area of preventive health. Individuals with a family history of certain conditions such as hypertension and diabetes are now using wearables and other devices to take a proactive approach to wellness and prevention. Others who are interested in monitoring certain aspects of their health are also using wearables to obtain more personalized, individualized information to guide lifestyle and health decisions. FDA requires that home tests perform as well as their professional-use equivalent. However, individuals must use these products properly to achieve accurate results. For FDA to approve a direct-to-consumer test, consumers need to be able to get an accurate result from the test and interpret it in the way it's supposed to be interpreted. The test must be able to be used as intended, and results must be easy to decode. And ultimately, the test's benefits must outweigh its risks. FDA maintains a site that provides information on approved OTC medical devices for home use. Home test kits are available to aid in detecting the following conditions: pregnancy, female fertility, male fertility, colorectal cancer (fecal occult blood tests), high cholesterol, UTIs, HIV, hepatitis C, and misuse of drugs. With the variety of diagnostic and monitoring products available, deciding which test to recommend to a patient can be challenging. The major product variables to consider include test complexity, ease of reading results, presence of a control, and cost. As health care providers, when recommending a test or device, it is important to think through the following potential variables: ▪Is testing appropriate for the patient?▪What is the patient's ability to accurately conduct the test? Interpret the results? Take appropriate actions based on the results?▪What happens if the test strip turns a specific color for a positive result but the user is colorblind?▪Is a “negative” result good or bad? Is a “positive” result good or bad?▪When should the user contact their physician?▪What if a patient misinterprets their results?▪What are the potential ways in which the test results could have been interfered with?▪Is there liability? Where/when does the manufacturer's responsibility begin and end?▪What if patients take action based on a result that leads to a negative outcome such as using an unapproved therapy or seeking care from an unorthodox source? The future of home testing and diagnostics will get more complex, and more data will be in patients’ hands. This will likely lead to some patients feeling more empowered, others more confused, and many wanting guidance from an expert. Pharmacists can and should be this expert to provide advice, recommendations, and referrals where appropriate. Daniel L. Krinsky, RPh, MS, owner, EduCare4U, LLC; and co-owner, PGx101, Stow, OH. For more information, please see APhA's Handbook of Nonprescription Drugs, 19th Edition, available in print or online to subscribers of Pharmacy Library at www.pharmacist.com.