Patient Assessment for Treatment with ER/LA Opioid Analgesia

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

Hi, I am Jennifer Bolen, and I am an attorney who is a legal expert in issues related to controlled substance prescribing. As practitioners, your role in proper prescribing, administering, and dispensing controlled substances is critical to your patients’ health. Safeguarding your patients, their family members, and caregivers against diversion of these agents is also a primary importance. Following each of these six modules, I will provide you with a few key recommendations from a legal perspective that you can incorporate into your practice and help build your toolbox for safeguarding your patients.

Now that you have completed Module I, I would like to provide you just a few reminders of what you should be incorporating into your practice on a daily basis to demonstrate proper documentation and patient assessment. I do believe it is proper to start by identifying common substandard practices that often lead to liability for the prescriber. In the assessment of the patient, a failure to fully assess the patient, including physical examination, is a really big no-no. Also failure to attempt other reasonable treatments or document why they are not appropriate for the patient is really critical, and those that do not do it, again, get marked as substandard. Failure to evaluate risk, and by that the risk relating to a patient’s history of substance abuse, failure to look at family members history of substance abuse, those sort of things, you do not do it, that is a substandard practice. Failure to monitor the patient closely during the initial months of treatment, this is probably one of most important things to remember, but when it is not done, it is very obvious and it can be very devastating if there is harm to the patient. And then finally, failure to properly monitor the patient as you go on and once you kept them in the practice and decided that they are true a candidate for opioids.

Now, let’s look then at best practices and look at things that you can do to demonstrate improvement and show that you are continuing to build that toolbox. The first thing that you should do is learn your state guidelines on pain management and prescribing and even if your state has other types of rules for pain clinic registration operational events, you should look at those as well. You should also take a look at current clinical literature. You need to know where the pain community is going and need to look at what experts across the country are saying should be something that you do when you assess your patients. You really need to take the time to truly assess the patient. Do not leave that to a non-physician provider. “The physician shall” is the language that you see in most of your state guidelines and you really want to take a look at that. If a state says that you should do something, then you might want to consider whether it is best for you to do it as the physician or whether it can be left to a non-physician practitioner. And that is not to minimize a non-physician practitioner role in good assessment practices, but it is to recognize that it is the physician’s responsibility to make these initial assessments and evaluations. Make sure you get prior records from your patient’s earlier providers. If you do not know the doctors, then write a letter and try to get the materials from them. If you do not get the materials, then document that you made the effort, include a copy of the letter in the file, and then move on and reinstitute assessment practices including diagnostic tools and imaging, things like that.

Use proper risk evaluation criteria. This is really important. Many people realize that there are dozens of forms out there to ask risk-related questions of patients. Sometimes they will go to the form that has the least number of questions without fully understanding whether these tools have been validated as statistically relevant to clinical practice. You need to study up on risk evaluation questionnaires and find out which one is best to use in your practice. Ted Jones, who is a pain psychologist, has published a great deal of information and study data in this area, and I would encourage you to look at his materials.

Also perform baseline drug testing. It is important that you incorporate drug testing into your practice and that it be done the right way, that you look to see whether your state materials actually encourage you to test a certain type of drug panel. For example, in the state of Tennessee, a TAC is included in that panel, and there are big arguments about whether you test for it or not, but when you are prescribing opioids, you really need to understand the value of testing a full panel. Use your state prescription drug monitoring program if it is active in your area. Those PMPs were built for you as a tool to check out to see whether your patients are getting medications that would overlap, that they may not have disclosed something to you, and if you do not use it, you are not going to be in a very good position if your files are evaluated by your state licensing board. So a best practice is to use it. Not all states mandate the use of it, but a best practice is to use it. Then you want to carefully document a treatment plan, you want to make sure that your prescribing rationale is clear so that if somebody picks up that chart, they can understand how you arrived at the decision to prescribe the opioid to the patient. You want to create a plan for monitoring that relates to the risk level of the patient and the overall medical condition that they present to you. That may mean you see them more frequently in these earlier months, and I think that is a best practice until you decide whether the opioid is working for them and whether they are going to be responsible in the use of the same. Once you decide that, then you might back off on how frequently you see the patient, whether you are involved as the physician or whether it is okay for a non-physician practitioner to see the patient. Again physician involvement and followup is critical. Do not let these patients go for years without you the physician being involved, that is going to end up marking you as substandard. So, these are some of the best practices ideas for Module I.

Now, some questions here. How thorough does a prescriber-provider opioid agreement need to be? The best recommendation that I can give to you is take a look at what your state materials say in the area of treatment agreement. Copy the language in there. It will often say what the patient’s responsibilities are. It will often say that the patient should agree to the use of one provider-prescriber for controlled substances. It will say that the patient should agree to participate in drug testing if requested or periodically, and that should be in your opioid agreement. There will be other language in there, and you should not confuse that with informed consent because it really is not the same thing. Some states still have their guidelines blended together on treatment agreement and informed consent, but you need to look at carefully the two different concepts, and the different elements of the documentation supporting informed consent relate to the risks that these medications present, the benefits that you anticipate, special issues like drug interaction, not taking them while they drive if that is a situation, not drinking and taking these medications, and also alternative treatments if there are any for the patient. That is what informed consent is about, and the treatment agreement is about boundaries.

When do I need to initiate and document these forms? Well, once you have made a decision to prescribe controlled medications and opioids to the patient, that is when you want to talk about the informed consent issues and then you also want to address the treatment agreement. I think sometimes it is very difficult to show good faith when you simply provide these things in a package for patients before you have ever seen them. It looks like it is just done on a routine basis, and while you may end up prescribing opioids to many of the people in your practice, it is subtle signal set if you wait until you actually have evaluated the patient and made that decision, and you can do these things efficiently. It is just a matter of really thinking about your processes.

Do I have to have the patient’s signature on them? That is one of the important parts of about being in a courtroom. When you have somebody’s signature or initials on documents like that, it is a lot harder for them to say you never did a particular step, and when we use documents like this that tend to be routine in a practice, you want to be able to say that this is your routine, that you absolutely go over these materials with your patient and request that they sign them because they are important and they are part of the foundation of building trust.

Do not forget to click on the tools link in the module where you will find a comprehensive resource of information and forms that you can download and use in your practice today. Thank you very much.

Last modified: September 28, 2015