Treating Patients with ER/LA Opioid Analgesics: Initiating, Modifying, and Discontinuing Therapy

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 II, I would like to provide you with just a few reminders of what you should be incorporating into your practice on a daily basis as it relates to your responsibilities for prescribing extended-release or long-acting opioids.

Let’s start with some common substandard practices in initiating treatment in patients using opioids. It would be substandard to write a prescription to a patient for controlled substances without having a real good assessment of them, including a risk assessment. You need to slow down in the beginning and really think about why you are prescribing the medication to the patient and then do some testing and some questioning to see whether or not they are going to be responsible patients and you will not know that right away, but those who do not slow down will be labeled as substandard. Do not ever prescribe to patients without getting the proper documentation of their past history, performing the physical exam, and again doing a proper risk assessment using either a questionnaire or learning how to ask the questions to the patients. Also do not prescribe without a solid treatment plan. You know when you initiate treatment with extended release or long-acting opioids, you really should be doing an opioid trial, and your documentation should show that. A trial means that you are basically going slowly to see if this is going to work with the patient so that means that you do not give the top of the label or over the label without explaining why you thought that that was appropriate for the patient. If you do that as a matter of habit with your patients then your practices could be labeled substandard and so that is why the FDA, the REMS materials that are out there are really trying to say hey let’s take a careful look when we initiate treatment to make sure we are doing the right thing for patient selection. Also, failing to recognize the challenges that are associated with patients receiving opioids including whether or not any of their family members are also on pain management treatment. You need to talk about these things with your patient and you cannot just do that all in one visit, so again, slow down and maybe hold your decision to prescribe until after the first visit and you have had a chance to really reflect on the patient case. If you want to go forward and prescribe on the first visit, then make sure you have clearly documented your rationale. And do not ever skip the informed consent process. Patients have a right to this information. It is an ethical precept for you and so you want to go over those risks and benefits of these medications very carefully. If you do not, informed consent, when there is harm that is going be a big problem.

I think that it is important that you understand that these obligations that are put out there and the requirements that are guided clinically come from general practice standards. They come from professional societies and state licensing board materials, and then we do have a developing body of evidence-based materials that you need to look to so that if you are thinking of a Venn diagram with each of the three things I just described you want to be in the middle where you have pulled information from each of those areas and put them into practice protocols and really think about them as you prescribe for this patient population. As matter of additional best practices, a checklist would be easy, past records, a complete history to include a pain specific history, a physical exam and that does mean touching the patient in an appropriate focused evaluation and describing that this was done, treatment plan and your goals, drug testing and a prescription drug monitoring program, database check, a proper risk assessment using again like a SOAPP-R and an ORT using the brief risk interview by Dr. Ted Jones, things like that documented in your file and then scored and used to stratify patient risk… very, very important. Informed consent and treatment agreement, periodic review and monitoring protocols so that the patient and you know how often they are going to be seen, when drug testing could happen, those sort of things. And finally, do not ever forget consultations and referrals, if a patient’s needs are beyond the scope of your practice you have a duty to refer them to somebody that can help them, and that does not mean you lose your patient, it just means that you are getting the appropriate help for them, and that is a best practice. Failure to do those things could label you as substandard.

Do not forget to click on the tools link in this module where you will find some comprehensive resource information and forms that you can download and use in your practices today. Do not forget about it. Thank you.

Last modified: September 28, 2015