ER/LA Opioid Analgesics: Applied Pharmacology in the Clinical Setting - Blueprint: General Drug Information for ER/LA Opioid Analgesic Products

REMS 2015 published on September 28, 2015
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Jennifer Bolen, JD
Founder, The Legal Side of Pain and The Pain Lawyer™
A Division of the J. Bolen Group, LLC
Knoxville, Tennessee

Now that you have completed Module V, I would like to go over a couple of suggestions of best practices that you should incorporate into your practice when you prescribe extended-release or long-acting opioids. Here are some critical things that you need to know. You need to know the drugs you are prescribing. You need to understand that patients must be counseled on what happens if there is an adverse event, an adverse event like respiratory depression, what that is like for the patient, what they should do, and even before you get to prescribing the drugs to the patient, you need to ask them about medical history that might make them a bad match for this class of drug.

I also think that it is important for you to consider whether or not the person is an opioid-naive patient in terms of never having these medications before. Is it the right thing for them to receive an extended-release or long-acting opioid? Do they have pain severe enough to warrant around-the-clock dosing, and have they tried these alternative treatments and either failed them or that they are not appropriate for them? Those things you must consider to be able to be in the best practices category. Package inserts and REMS materials for this class of medication will help you set those boundaries and will help you better evaluate your patients, but you have to read the materials to get there. That is what will help you know these drugs.

Well, what if you asked the question I do not prescribe these drugs and these classes, the long-acting opioids, I do not do it very often, and there are many formulations and options to choose from and sometimes it puts you off. Having options is a good thing in medical practice, but it also raises the issue of you understanding these medications before you prescribe them, even though there are quite a few drugs in this particular class, you need to go through and read the materials that the manufacturers put out with each of them. Which patient population and demographics does this drug work best with? Is it something that should be dosed once a day or twice a day? If you do that dosing, how does that work? Does the patient take the medication at night? If they take it at night, do you have to evaluate whether they sleep well? Things like that, that are very clinical in nature, are still important for you to evaluate from a legal perspective because if you have not considered this, then you could have a real problem if somebody looks at your charts and has a claim against you of inappropriate prescribing, or worst yet if some harm comes to a patient. You do not want to be in that position, so it is really important to take a look at these medications. I do not mean to sound like I am scolding you on this. It is not better to be safe than sorry in the sense of just not prescribing. It is best to be safe by understanding what you are prescribing and who you are prescribing it to, and that does take a little bit of a slowdown and several visits to evaluate it. So again, I realize that patients want their medication, they often come in to you on that medication, but you are in charge of that prescription pad and it is your responsibility to make sure that this is a good match of treatment to this patient, and it goes slow and really get to know who you are dealing with.

So, do not forget to click on the tools link here in this module and look for the comprehensive tools that will help you in best practices checklist in general and some of the language that would be important to document and then supply the facts for as you choose your patients for this type of medication. Thank you.

Last modified: September 28, 2015