Hello, I’m Dr Jeff Kingsley. Welcome to another edition of Riding in Cars With Researchers. Today I’m going to talk to patients and researchers about patient management in research trials.
I have a patient right now who just called me 30 minutes ago. She was in a research trial for chronic pain for a while, maybe a year. She was in that trial with me and she did beautifully. She was so happy. She went from being on multiple pills and patches per day to being on one injection per month. Absolutely outstanding results. She was thrilled. I had a wonderful time in the study. Now the study is over and now she has to go back onto the medicines that she was on before the research trial, which is fine. She understood that upfront. She understood that she can’t immediately stay on this, which is another post that I’ve created for you. She’s obviously not worse off. She just simply has to go back to what she was on before. She can’t continue to get the benefits that she was receiving in this trial until this medication gets FDA approval. Now she’s finished the trial, I write prescriptions for her to go back on her previous medicines and the insurance company denies filling her prescriptions. Why? Well, because the insurance company doesn’t know anything about research and so from their perspective, this patient went off of all of her chronic pain medicines a year ago and is now spontaneously going back on full doses of all of these medicines, so from their perspective, they’re saying, wait, this makes no sense.
We need proof from a pain medicine specialist that you belong on these medicines. We need all sorts of things before we can fill these prescriptions now. That’s unfortunate. We are contacting the insurance company. We’re getting everything fixed. She’ll be fine. She’ll get back on her medicines. The reason I bring it up for our topic today is that it’s important for you to think proactively. Now, this all this almost never happens. I’ve had plenty of other patients that finished the very same trial and their insurance company said nothing but as an investigator, and as a patient, think about this. When you’re doing research trials, both as an Investigator and a patient, be proactive. As a patient, ask…. “is there going to be any issue with me getting back on my other medications? Can we contact the insurance company proactively? Can you write me the prescriptions in advance of the end of the trial so that I can go to the pharmacy and just ensure that there’s going to be a seamless transition?”
Physicians, 99% of patients have no issue whatsoever when finishing a research trial, but if you can do a little something extra to protect the one percent, isn’t it worthwhile? Think about it as always.
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