What do Right to Try Laws Mean for EHR Vendors?

I recently received an email from the Goldwater Institute which outlined the passing of “right to try” laws across the country. For those not familiar with this, right to try laws basically gives a terminally ill patient the option to try a drug that’s currently in clinical trials, but isn’t yet approved for public use. There are a lot more intricacies to the law, but you get the idea. Here’s the details of which states have passed it or are working on right to try laws:

Right To Try has passed in:
Alabama, Arizona, Arkansas, Colorado, Florida, Illinois, Indiana, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, North Carolina, North Dakota, Oklahoma, Oregon, South Dakota, Tennessee, Texas, Utah, Virginia, and Wyoming

The bill is still under active consideration and could pass this year in:
California, Pennsylvania, Wisconsin, and the District of Columbia

Right To Try has also been introduced in:
Connecticut, Delaware, Georgia, Hawaii, Kansas, Kentucky, Maine, New Hampshire, New Jersey, New York, Ohio, Rhode Island, West Virginia

With 24 states having passed a right to try law, that’s almost a majority of states. As I see this unfold, I wonder what it means for EHR vendors. My guess is that most of the right to try paperwork is still done on paperwork and EHR vendors have almost nothing to do with it. I wonder if that’s the best thing. Should EHR vendors facilitate things like right to try?

One challenge with getting EHR vendors involved is that no EHR vendor wants to implement a regulation that’s essentially different in 50 states (or at least different in 24 states today). I’m sure there are some legal and political reasons why these laws are being passed by states. I have to imagine it has to do with our dysfunctional government in Washington. However, a state by state path to right to try means no EHR vendor will consider implementing a streamlines application process. It’s just too complex and won’t add enough value to their users.

It’s too bad that a national right to try law can’t be passed. Then, I could see an EHR vendor streamlining the application process. They could integrate a database of current clinical trials so that they could make doctors aware of what clinical trials are available and could be considered for their patient in this situation. I guess this piece is possible on a state by state basis, but it certainly wouldn’t be as elegant as one national standard.

As it stands, I don’t see any EHR vendor really building out this functionality on a state by state basis. Maybe that means it’s a great opportunity for a startup company. Then, they can integrate the functionality into the EHR using an EHR’s API (once those finally happen).

About the author

John Lynn

John Lynn

John Lynn is the Founder of the HealthcareScene.com, a network of leading Healthcare IT resources. The flagship blog, Healthcare IT Today, contains over 13,000 articles with over half of the articles written by John. These EMR and Healthcare IT related articles have been viewed over 20 million times.

John manages Healthcare IT Central, the leading career Health IT job board. He also organizes the first of its kind conference and community focused on healthcare marketing, Healthcare and IT Marketing Conference, and a healthcare IT conference, EXPO.health, focused on practical healthcare IT innovation. John is an advisor to multiple healthcare IT companies. John is highly involved in social media, and in addition to his blogs can be found on Twitter: @techguy.

5 Comments

  • Hi John,

    This is an interesting issue. I have been writing for the pharmaceutical industry for 20 years and when a patient is terminally ill (especially true with cancer) usually doctors can try drugs “off-label” ie not FDA-approved for that particular condition.

    I like the idea of including it in an EHR because that would be a great way for us to collect DATA (!) on how the drugs work so it could facilitate FDA decisions about future approvals. How could an EHR collect data with different laws? Maybe checkboxes for:

    1. “right to try” state
    2. health plan medical exception
    3. drug company clinical trial
    4. etc

    That would allow companies to know the pathway by which unapproved drug has been introduced to the patient.

    Beyond that, the rest of the data could be collected the same as any other treatment. But it would identify the drug as “experimental” or its use as “experimental” upfront so the data could be partitioned for analysis by the drug company and the FDA.

    These are just some thoughts. People who are more involved in the use of unapproved, clinical trial, or off-label drugs as well as EHR vendors will have more informed input. I just wanted to get the ball rolling on this discussion.

    Thank you for writing about this subject.

    Peggy

  • Peggy,
    As I’ve researched right to try laws, I guess the FDA has almost always approved
    requests to use drugs off label. However, the process to get the FDA to approve it requires months of approval and I saw one estimate of 100 hours of work. When you’re dying, that time is precious and could be the difference in living. So, that’s why the right to try laws are so valuable.

    I think you describe a lot of what’s possible if it was tied to the EHR. I talked about the front end side of things where the doctor finds an opportunity to use a drug that’s in clinical trials, but like you mentioned it could also help in tracking how these early drug administrations do with a right to try patient.

    Thanks for adding to the conversation.

  • Ideally this would be handled by Superscripts and First Databank (and other systems tracking FDA approved drugs). They already must track all the various state laws, especially as it pertains to EPCS. The more complicated part is where the drugs are ordered from and how – another reason Superscripts would be the natural facilitator.

    Without support from Surescripts and the medication tracking systems I would imagine most EHRs would allow these drugs to be manually entered and saved to a favorites list. If so, they should also be able to include in the description/notes the states and circumstances that allow it as well as the ordering process for each drug. Because the drugs would not be from the medication database the EHR could not perform the usual drug-drug and other checks. So this would not be ideal but it should work.

  • Catherine,
    Very interesting suggestion. I think they are positioned to take this on. I’ll be interested to see if they think it’s worth their time. I know each of them has some major projects on their plate now.

  • It is interesting to hear how this might work from a practical perspective. Thank you, Catherine. From the perspective of the value proposition of treatments, I would think that it would ultimately be worth somebody’s effort to track efficacy and outcomes of experimental utilization. Again, thank you John for calling attention to this.

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