Clinician Guide to the ER/LA Opioid Analgesics - Blueprint: Specific Drug Information for ER/LA Opioid 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 VI, I would like to provide you with just a few reminders of what you should be incorporating into your practice on a daily basis to demonstrate good faith prescribing of extended-release and long-acting opioids.

It is really important that you understand that the label for each of the products in this drug class signals the type of information that you need to know in understanding the best patient population for the drug, how the drug should be prescribed, how you initiate dosing of the medication, and then how you titrate it up or titrate it down, how you adjust medication, and things like that, how you discontinue medication and how you dispose of medication. There is some important language in the label that you need to consider and somehow work into your documentation to signal that this is a right patient match as far as your concern in terms of the legitimate medical purpose for the use of the drug, and the language is follows: The patient must be one who has pain severe enough to warrant around-the-clock dosing with this medication and that you have either tried alternative treatments and the patient has failed them, or that those alternative treatments are not appropriate for the patient. So just putting this language in your documentation is not good enough. That would be boilerplate or template, but from a legal perspective, you would want to include the specific facts to each individual as to why they qualify for this medication, and that would be done initially as you set your initial treatment plan and then as you continue with this. It is important that you signal your rationale for starting to prescribe these medications and continuing to prescribe the medications, and you also want to remember that your state has specific rules or guidelines that they want you to follow if you are prescribing controlled medication opioids to patients on a chronic basis. And there are things that we have covered, thought of, and heard of in these different modules, but what you want to understand is that you must assess the patient carefully. You must do that physical exam and that risk assessment and document that you have done it, looked at the results, and then have a plan for stratifying the patient in terms of how frequently you will see them, what type of goals they have in the treatment, how these medications play that role, how they help them achieve the goals, and then the boundaries related to the use of the medication so that it is safe, so that they store them appropriately, so that they tell you if they are experiencing adverse events, so that they can communicate other types of problems if they get new medication from a different provider that might not be a controlled substance. Things like that are really critical in continuing treatments with these patients. You want to make sure you have the right documentation. You want to make sure you are doing your initial risk evaluation through drug testing and the check of the prescription drug monitoring program, and you also want to carefully, carefully talk with the patient about their responsibilities through your treatment agreement but also face to face so that they understand when you might choose to discontinue a drug because they have chosen not to use it safely or they have chosen to do something illegal that could harm others. Those are tough issues to discuss, but your patients will respect you if you bring them up and really say I care about you as an individual and I want you to understand how serious it is that we take these drugs appropriately and use them as the manufacturer has intended. You want to plan for your frequent monitoring and you want to be as a physician involved in follow-up care. Do not just see that patient one time, give them an extended-release or long-acting medication and then push them off to a non-physician practitioner. That can really get both of you as practitioners into trouble and can end up seriously harming an individual, and from a legal perspective, that is a very bad place to be. So take care, understand the label, understand what the manufacturer has put together as part of a tool kit to help you understand each drug and then go to tool kit items as you bring your prescription pad out and think about using a drug in this class with a patient.

So do not forget to click on the tools link at the end of this module, and you will find some materials that will help guide you in making these changes in your practice. I realize it might seem like an overwhelming burden, but this can be done much like these presentations and modules in steps just thinking out the practice protocols, and you can prescribe these drugs safely to appropriate patients. Good luck and thank you.

Last modified: September 28, 2015