Research and innovation in personalized medicine are surging. However, adoption of personalized medicine technologies into clinical practice is comparatively slow.

There are a number of significant challenges to the integration of personalized medicine into healthcare practice. The Personalized Medicine Coalition is one organization that has been working to help identify and categorize challenges as well as identify strategies for providers to overcome these challenges.

"One major set of challenges involves recognizing and demonstrating the value that personalized medicine prevention and treatment strategies bring to healthcare," said Daryl Pritchard, senior vice president, science policy, at the Personalized Medicine Coalition.

"A clear value proposition is needed so that providers, at both the individual physician and system level, as well as payers, will provide patients with access to the most effective and efficient diagnostic tests and targeted treatments," he said.

To help overcome this challenge, stakeholders including payers, providers, and the diagnostic and pharmaceutical industries, should discuss health technology assessment processes and agree upon evidence requirements necessary for coverage and clinical implementation, Pritchard said.

Then manufacturers will need to work with providers and payers to develop this needed evidence through studies that are meaningful and will impact practice and reimbursement decisions, he added.

Another major challenge is integrating genomic data into the electronic health record, which still does not happen with any EHR vendor, said Nephi Walton, MD, assistant professor of genomic medicine at Geisinger.

"Even if we could get the lab to transmit the data from the reports directly to the EHR instead of using a PDF, there is literally no place to use it in the EHR," Walton said. "This data particularly around pharmacological variants is critical for decision support, but cannot be used that way because there is no place to store it."

Pritchard and Walton will be speaking on the subject at the HIMSS Precision Medicine Summit, May 17-18, in Washington, D.C.

The management of the often massive amounts of clinical information associated with personalized medicine is challenging to healthcare organizations, Pritchard said.

"Providers will need to include each patient's molecular information, as well as information regarding clinically actionable variants, within electronic health records and ensure that medical, clinical support and outcomes information is interchangeable across various information technology platforms," he said.

"It is also important to develop user-friendly platforms for inputting and accessing personalized medicine data in the clinic; platforms should be a net time-saver for clinicians and should be capable of keeping pace with scientific advancements," he added.

Walton brings up a similar challenge, saying that delivering this information to both the patient and more importantly the provider in a way that they can use it to improve the patient's health is a difficult goal.

"Genetic information is often misinterpreted, this is one of the reasons we have geneticists, but there are not enough geneticists out there to handle what is coming," Walton said. "They can't even handle the volume that is hitting them now."

He added: "It is difficult for geneticists to stay up to date on all the latest information about the management of patient care around genetic variants let alone primary care providers who have not been trained to handle this data or manage genetics patients."

But with the volume of data and patients, however, this has to change, Walton insisted.

"We need to build informatics tools to deliver this information in ways primary care providers can digest it and use it," he said. "Also we need to beef up genetic training in the medical curriculum and expand it to cover every field.

"During my residency training as I rotated through each medical specialty I watched to see how every specialty used genetic testing and I can tell you every specialty is using genetic testing," he explained. "I can also tell you many people are not using the information correctly, particularly when it comes to interpretation of variants, what a negative result means and how to handle variants of unknown significance."

Twitter: @SiwickiHealthIT
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