Managing Therapy with ER/LA Opioids

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 III, I would like to provide you with just a few reminders and suggestions of what you should do in your practice on a daily basis and to share with you some of the best practices tips. Again, starting with substandard clinical practice is a good way to try to understand what you should be doing. If you are going to modify treatment and periodically review the patient’s needs, if you do not do that in a timely fashion, that would be considered substandard. What is a timely fashion? Well waiting 6 months to see the patient again would be not appropriate, especially if you initiated extended-release or long-acting opioids. You need to see the patient frequently enough, especially early in the treatment plan, to make sure that these medications are working for them, that they are taking them appropriately, and that they are not engaged in anything that would lead to their harm or the harm of another person. It would be substandard to leave followup in the early phases to a non-physician practitioner. They can be involved in the treatment of these patients and absolutely should, but to leave it totally to them early on would be a bad thing to do, and it could end up being labeled substandard by a licensing board. One of the things that you have to be careful about in modifying treatment is any kind of rapid increase in medication without justification. If somebody has increased pain on the medication that you have given them, then you have to consider whether it is appropriate to adjust that medication up, whether you might want to add in a different medication, whether something else needs to be done like a procedure or another diagnostic type test. If you do not consider these things, that would be labeled substandard. You need to document your rationale here clearly, and when people do not, an expert witness who is a clinician is going to sit there and say, “I don’t understand why this person modified the treatment the way that they did,” and that could end up being a recommendation to your licensing board to suspend or revoke a license. Nobody wants that. Do not ignore the results of drug tests or prescription drug monitoring, database information, third-party reports, and if you ignore things like that, it certainly will be labeled as a substandard practice. You cannot just set aside results of use of illegal drugs and say, “Oh, it’s no big deal.” You have to consider this very carefully because you are the one that has chosen to prescribe the controlled medications to this patient. You also want to never ever, ever fail to assess the patient for the things that are now referred to as the 5As, and as you will see on this chart here, you have to really answer the question, “Do opioids remain indicated in the patient’s care and is the patient going to be responsible as we move on with this medication?” You have to look at their activity. Are they reaching activity goals on this medication? Have they moved from the couch to getting up and getting a little exercise? Are they getting good analgesia and pain relief? If they are always a 10 every time they come into your practice, is that because they want more medications or is it because their condition really justifies it? You have to make that clear in your medical record. You have to look at affect in a patient. That is the new or fifth A component, and the Federation of State Medical Boards has published a little bit more of it on its model guidelines, and you will notice that several states are starting to pick up on this. Affect deals with mood and other parts of the patient’s mental health as they relate to using these medications, as it relates to how they are improving social life. It goes well beyond that, but take a look at that and do not ignore it. Adverse events, has the patient had any adverse events while using this medication? Are the side effects too much? Are there sleep issues where this medication could present a real problem? Have you even checked in and used a tool like STOP-Bang or Snore Score to see whether or not this patient might be a candidate for a sleep evaluation related to potential sleep apnea or other clinical conditions? And finally, is there any aberrant behavior? Using the drug test information, third-party reports, prescription drug monitoring database information, very, very critical, and it is not to say that you need to drug test your patients every time. That is not going to be borne out by medical necessity, but you need to have a plan for that, and that plan is part of periodic review.

So, again, you want to look back and see what your state materials suggest in terms of how frequently you see your patient. As you look at the slide on the screen there, you want to find out whether or not they require you to see a patient at least every 3 months or every 2 months. Some states actually state that in their materials. Others leave it more open-ended. You want to look at the clinical guidelines and see what is recommended for the different risk levels that patients have stratified out to. Low-risk patients, maybe they can go 2 to 3 months in between visits, not necessarily at the beginning of treatment, but once you have identified a solid treatment plan for the patient. Higher-risk people probably need to be seen quite frequently, and that is what the clinical materials support. You need to have a risk management tool kit, we will talk a little bit more about that in a minute, and then, you need to seek out education that helps you show that your periodic review in modifying treatment is done in good faith.

If you live in a state that has a prescription drug monitoring program, are you required to access this program? Your state materials will tell you whether that is the case, and states are changing the requirements right now. Many of them are moving to a required access. Others leave it more open-ended. It is a good thing to use the prescription drug monitoring material and document it in the medical record. Do you have to document those findings? You should. The way that you would do it would be that you check the program and if the patient is either complying with the one physician-prescriber or practitioner-prescriber rule, or that they are getting medications from multiple clinicians and you need to justify why that is. In other words, was there an emergency treatment necessary? Did they get medication from a dentist? You need to make sure that your documentation shows that. Is it the responsibility of a pharmacist to do this? The pharmacist has a responsibility to log the dispensing of the medication from any prescription issued to them. That is their end of the deal, but it is not their end of the deal to document and evaluate whether it is appropriate unless the state has made it the case, and in some cases, the pharmacists have that duty clearly to not fill a prescription if they have looked at the PMP and see that the patient is getting multiple controlled substances from different clinicians. They need to talk about that with those clinicians as well, and many states have provided an exception to make it clear under HIPAA that it is okay to do so. Again, read your state materials.

Do I have to obtain a drug test on all of my patients? Most state licensing boards right now would consider drug testing is part of the standard of care in this area, especially when you are prescribing extended-release or long-acting medications. So, yes, you need to make that part of your platform. How often you do it, what drug test panels you use, some states will guide that, other states, again, more open-ended. So go look at the clinical materials and see what is being recommended, and then put that in a notebook to show that this is what you followed and what used in your guidance, and you will find that most of the clinical materials from the major organizations out there are very clear in what they suggest that you do.

If you obtain drug testing on all your high-risk patients, is that considered good practice? If you limit it only to high-risk patients, that would not be good clinical practice. You want to have it for all of your patients, and the frequency of it will be tied to the risk of the patient, and then you want to use some targeted random testing on everybody to make sure that they are using the medications appropriately and that they are not using substances that would interfere or cause them harm.

If you do not have a formal policy on this in your office, is that a problem? More states that have pain clinic registration acts or laws actually require a drug testing policy. Very easy to create one. You should have one even if you are in a state that does not require it. Why? Because it helps you set boundaries, and anything that helps you set boundaries within your practice will then flow over to your patients, and when you do that, that really builds a platform for trust.

So do not forget to click on the tools link here at the end of this module. You are going to find a comprehensive set of information and resources that you can download and use immediately in your practice. Always give consideration to them as it relates to your state requirements. Do not wait. Thank you.

Last modified: September 28, 2015