FDA to introduce regulations for prescription medication adherence products
Digital tools that remind patients to take medications on time and in the correct doses will be considered for regulation as a part of the drug review procedure.
Medication adherence is a difficult goal to achieve even for those who are critically ill. There are several reasons why patients find it difficult to take prescription medicines on time. Common barriers include financial constraints, not believing the medicine is going to cure them, and confusion on how and when to take multiple medications and complex doses.
FDA Commissioner Dr. Scott Gottlieb announced that the agency is working on regulation of digital tools that help the care providers to track, monitor and evaluate the patient’s progress of taking prescription medicines. They want to set up a framework that will review such digital healthcare tools as a part of the drug review procedure.
All kinds of digital products such as mobile phone apps, PC software, tools that use facial recognition and mobile phone cameras to track progress of critically-ill patients and monitor side-effects are considered for regulation by the Food and Drug Administration Authority.
Gottlieb recently said at the 2018 Health Datapalooza conference,”There’s a wide variety of ways in which apps and software can enhance healthcare, and our mission at the FDA is to apply our regulations under a balanced, risk-based framework.”
This regulation of digital adherence apps will help both the patients and the caregivers, who at present are hesitant to use anything that hasn’t been marked approved.
“Clinicians and health systems are often hesitant to use these tools without knowing their validity and limitations,” said Ryan Shaw, an associate professor at the Duke University School of Nursing. “The FDA’s move to regulate digital health tools will help accelerate their use in care delivery.”
It must be noted the recently President Donald Trump approved a hike in the funding for FDA. The agency is thus planning its own initiatives and investments for the upcoming years. In 2016, the agency received a citizen petition sent by the Clinical Decision Support Coalition that comprises of pharmaceutical companies that also manufacture digital devices, software companies and healthcare providers.
Today’s pharma companies are working hand-in-hand with medical healthcare technology companies that are working on creating tools for greater medication adherence. According to the Clinical Decision Support Coalition, almost 50% of the total number of prescriptions issued in the United States are not adhered to.
People find it a daunting task to take medicine on time even when they are aware that the medication is essential for them to live and also overall improve their quality of life.
Such innovation in the healthcare industry is the need of the hour especially at a time when the world is reeling under the increasing threat of terminal diseases.
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