Compliance Monitoring in Chronic Pain Management

Douglas L. Gourlay

Howard A. Heit

The pain management practitioner faces several challenges in the safe and effective management of chronic pain. One of these relates to the important issue of monitoring compliance with a previously agreed-on course of therapy. Unfortunately, in today’s medicolegal climate, the need for clinicians to take steps to reduce the risk of diversion and misuse of controlled substances has become apparent. Although the debate continues as to what degree prescribers contribute to the overall source of controlled substance that reaches the street,¹^,²^,³^,⁴ there should be no debate about the prescriber’s responsibility to ensure a decreased need for these drugs by addressing demand reduction strategies in all susceptible individuals. All pain patients are not potential diverters: All aberrant behavior does not represent drug addiction or misuse.⁵ However, we tend to adopt a more casual attitude toward prescription drugs, including opioids, despite the fact that there is a disturbing trend toward prescription drug abuse by adolescents and others who have found their family medicine chests a ready supply of abusable drugs.⁴^,⁶ Whether this is because of an implicit sense of safety associated with prescription products or due to a simple comparison with typical illicit drugs of abuse found on the street is unclear. In fact, there has been a marked increase in counterfeit drugs on the street, typically adulterated with potent opioids such as fentanyl and carfentanil. In many cases, the first exposure to these drugs results in a fatal outcome. The emergence of naloxone rescue protocols in so many cities in North America is a testament to this growing problem.⁷^,⁸

How Communication Influences Compliance Assessment

Clinicians have less control over how our prescriptions are used than we would like to believe. In fact, there are three dimensions to consider when examining the prescription of any controlled substance.

The first is “what the patient is told to do.” Obviously, a prescriber must inform and document the instructions around the prescription of any medication, especially controlled substances. To this end, a physician might reasonably be held to account for a bad outcome in the context of medication use if the only documented instructions to the patient were “Use as directed.” Treatment compliance assumes that the clinician is clear about how the patient was instructed and that the patient clearly understood these instructions. In the author’s opinion, this is rarely the case.

The second is “what the patient is telling the prescriber he is doing.” Communication between patient and prescriber is key not only to ensuring the best possible treatment outcomes but also in identifying possible miscommunications between prescriber and patient around treatment plans, especially with opioids. So, the patient who is advised to take medications in a “three-times-daily fashion” might remain clinically unstable—until the prescriber finds out that the patient is actually taking medications at 0900h, 1000h, and 1100h, respectively. Clearly, the prescriber and the patient are not on the same page around the dosing interval of this medication. Again, assessment of treatment requires careful communication.

But the final possibility is “what the patient might be doing with the medication, in a worst-case scenario.” Take for example the patient who is becoming obviously impaired during the first week of a recent prescription refill. Although the patient never run out of medications early (over the course of a 1-month prescription), he may be overusing his medications during the initial phase of the prescription, only to struggle on toward the end of the month because he has literally “borrowed from tomorrow to pay for today” in his dosing schedule.⁹ Simply asking what is the most medication he has had to use in 24 hours will help to get a better understanding of how the medication is actually being used.

In the aforementioned examples, the clinician is clearly responsible for the instructions given to the patient and to some extent is responsible for clarifying those instructions if necessary based on what the patient tells the clinician he or she is doing. In the third case, however, the patient alone must be held responsible for any adverse outcomes based on what he is actually doing if this information is withheld from the prescriber.

A considerable effort has been expended in teaching clinicians how to initiate pharmacotherapy (“entrance strategy”), but unfortunately, there has not been an equal effort expended in teaching the technique of terminating these medications (“exit strategy”),¹⁰^,¹¹ some of which may have considerable withdrawal syndromes associated with their rapid taper or abrupt discontinuation. No matter how selective we appear to be in offering opioid trials to “low-risk” patient populations, prescribers will always need to (1) assess the opioid trial as either successful/failed and (2) have a defensible, rational, and compassionate exit strategy.¹²

For the purposes of this chapter, compliance monitoring may be defined as those steps taken by a prescriber to ensure that treatment plans are adhered to and prescribed medications are appropriately used. Many factors contribute to a patient’s failure to adhere to an agreed-on treatment plan.¹³ To expect 100% adherence, even when controlled substances are involved, is to ignore this fact.¹³

Compliance monitoring should begin with an individual assessment of risk. As outlined in Chapter 59, it is unwise to assume that you can assess risk, with any degree of certainty, at the first visit. Risk assessment and management is best performed over time. Treatment agreements, interval and contingency prescribing, pill counts, prescription monitoring programs (PMP), and urine drug testing (UDT) can all play important parts in helping to manage risk and so improve outcomes.¹⁴^,¹⁵^,¹⁶^,¹⁷

The fact is we have little evidence to support this practice.¹⁸ Beyond this, there is little evidence to support the notion that risk evaluation and mitigation strategies (REMS) accomplish any of their stated goals. In fact, the recent push toward abuse-deterrent/abuse-resistant has also been without scientific or clinical support of efficacy.¹⁹ Only time will tell if these approaches have a meaningful and positive impact on the problem of prescription drug abuse in America. In the authors’ opinion, placing too much confidence in the ability of clever delivery systems to prevent aberrant drug-taking behavior in the high-risk patient population may cause us to revisit many of the same problems we have had to deal with over the
past 25 years. As with the diabetic patient who self-reports optimum glycemic control at a follow-up visit, the clinician still performs a glycated hemoglobin (HgBA₁C) test (which is a measure of glycemic control over time) as an objective measure of treatment success.⁹^,²⁰ Because hyperglycemia is not illegal, there is little prejudice created in the clinician’s mind when the objective test is at odds with the patient’s self-report. Just as with HgBA₁C, the clinician can use a discordant UDT result to motivate change on the part of the patient and to monitor healthy changes already made.

For the most part, monitoring efforts should be based on the initial then subsequent assessments of risk over time. In this regard, frequency of drug testing might reasonably be expected to be greater in an identified “high-risk” patient population compared to a “low-risk” population. In fact, even in high-risk populations, UDT can be overused. Medically necessary testing must be tailored to the patient.

A variety of tools have been developed to aid the clinician with this important task.²¹^,²²^,²³^,²⁴^,²⁵^,²⁶ Regardless of the tool used, the result is only an estimate of the risk of the patient engaging in aberrant behavior. High risk is not an absolute contraindication for the prescribing of controlled substances but might cause a prudent clinician to seek formal consultation with or referral to other appropriate health care professionals who have sufficient experience and resources to manage these often challenging cases.¹⁴ It is important to remember that having a legitimate reason for prescribing a controlled substance does not in itself make it appropriate to do so.

Interpreting Aberrant Behavior

Even with the most reasonable treatment plan, a patient’s ability to comply is based on a multitude of potentially conflicting factors. When a patient fails to comply, the treating clinician needs to have an approach that allows the patient and prescriber to adequately address these issues. Not all aberrant behavior represents abuse, addiction, or criminal intent.⁹ Similarly, what may seem like reasonable treatment goals for any given patient may be more difficult for some patients to comply with than others, even in the context of a previously signed treatment agreement. When a patient steps out of previously defined limits and boundaries, the clinician should examine the context of this behavior.

It is often surprising for clinicians to realize that some aberrant behavior can be iatrogenic in nature. Unreasonably set limits or demands on a patient can cause even the lowest risk patients to “step out of bounds.” However, in some cases, this behavior can be framed in the context of a “Golden Moment” where the patient may begin to see things for the way they are rather than the way he or she wished they were. In this way, both clinician and patient can improve their level of communication that is inherent in all positive therapeutic relationships. Rather than simply dismissing the patient for breaking the treatment agreement, which can perpetuate the patient’s revolving-door approach to health care, both parties become better educated to move forward in a strengthened therapeutic relationship based on mutual trust and honesty. This approach best serves the mutual interests of patient, practitioner, and the community in which they live.

Some patients, however, are not ready to make these changes; they may need to seek care elsewhere. It is important to remember that it is generally better for a patient to abandon a reasonable and prudent course of therapy offered by a knowledgeable practitioner than it is for that patient to be dismissed from the practice. Although it may be necessary and appropriate to discontinue the prescription of controlled substances such as the opioid class of medication, this should rarely be equivalent to dismissal from care, although a drug-seeking patient may interpret the two as being the same. From a medical legal perspective, it is usually better to “abandon the molecule” rather than be perceived as having abandoned the patient.

POTENTIAL TREATMENT TRAPS IN COMPLIANCE MONITORING

Borrowing from Tomorrow to Pay for Today

For most patients, problematic prescription drug use does not involve misuse or diversion. For those patients who do exhibit aberrant behavior such as running out of medications early, the most common problem relates to simply taking more than prescribed. The concept of borrowing from tomorrow to pay for today is something that many patients can relate to.⁵ In these circumstances, prescribing multiple prescriptions for smaller quantities of medications, to be dispensed by the pharmacist on an interval basis, can assist the patient with treatment adherence. In many states, regulations now allow for appropriately dated prescriptions to be written and filled sequentially by a pharmacist (“Do not fill until”).¹⁷ Patients who need more oversight than weekly medication pickup should likely be referred on for more formal assessment of potential comorbid conditions such as substance use disorders or other significant psychopathology.

Avoiding Excessive Pill Loads

In the management of chronic pain, medications must be carefully titrated to their optimum dose. Traditional teaching for a trial of opioid therapy suggests using immediate-release medications to establish drug responsiveness followed by conversion to sustained-release medication, typically in a two-or three-times-daily dosing schedule with a suitable amount of immediate-release medication for breakthrough pain management. More recent guidelines from the Centers for Disease Control and Prevention have suggested that, where possible, immediate-release medications are to be used over their sustained-release counterparts.²⁷ Although the addiction literature continues to suggest that from the perspective of abuse/addiction risk, patients are likely to do better on sustainedrelease or truly long-acting (e.g., methadone/buprenorphine) opioids for the long-term treatment of chronic pain, there are no recent long-term perspective studies in the literature to confirm this important clinical point.²⁸^,²⁹^,³⁰^,³¹

By definition, a successful trial is one in which the patient is clearly improved either in terms of pain relief, functional restoration, or ideally both. Properly chosen patients may do well with this approach. Some, however, improve initially but lack the sustainable relief seen with truly opioid-responsive pain. In these cases, there is often seen a gradual dose escalation with diminishing returns as the side effect profile begins to overtake the therapeutic effect. For some patients, efficacy is measured by the subtle cognitive effects transiently seen with a new drug or drug dose rather than the marked reduction in pain scores and improved function typically seen with treatment-responsive pain. Unfortunately, tolerance to these effects can develop quickly, leading to significant dose escalation. Sometimes, to reduce drug use, the prescriber provides the patient with smaller dose tablets in the hopes the patient will be able to titrate the dose down, reducing the overall dose taken and so the adverse effects often seen with higher medication levels.

For example, a patient who is using 80 mg of controlledrelease oxycodone in an every-8-hours dosing schedule may request 20-mg tablets rather than the 80-mg tablets, indicating that the patient often feels he or she does not need to take the entire dose to keep the pain under control. To reduce the total daily dose, the 80-mg tablets are changed to 20-mg tablets. In this case now, instead of receiving 3 tablets per day,²¹ tablets per week, the patient receives 12 tablets per day (to be used “as directed” in a three-times-daily divided dose). This is a total of
84 tablets per week. In a monthly prescription, this amounts to 336 tablets. Although some patients may achieve the desired goal of dose reduction, others will ultimately begin to redistribute the controlled-release drug, often taking the medication more frequently during the day than the agreed-on 8-hour interval. With such large quantities of tablets available, borrowing from tomorrow to pay for today can become a problem.⁵ In such cases when patients have asked for smaller unit doses as described earlier, it can be revealing to ask the patient to bring in extra medications at the next visit. It is a minority of patients who can comply with this request, indicating that they use the medication up eventually. In these cases, closer inquiry may show that the duration of action for the modified-release drug is only 3 or 4 hours, necessitating six or more dosing intervals per day to achieve “stability.” Clearly, the use of a modifiedrelease medication in the same fashion as an immediate-release preparation is inappropriate. In a sense, the patient can be legitimately advised that the “clever delivery system” has failed them. In these cases, the answer is not to dose more frequently with the controlled-release preparation but rather to consider rotating to another modified-release system or to a truly long-acting medication such as methadone or buprenorphine.

Using Pill Load Limits to Modify Behavior

Many practitioners use the time between visits as a guide to how many unit doses any given prescription will need. So, if a prescription is written for 3 tablets daily and the follow-up appointment is in 30 days, many clinicians would write the script for 90 tablets (possibly adding 2 or 3 days’ worth to cover for exigent circumstances). For most, writing a prescription for less than 100 tablets is quite reasonable. In some cases, that same 30-day interval will require many more than 100 tablets. As an example, a person might use 10 hydrocodone/acetaminophen tablets per day. In this case, a 1-month supply would require you to write for 300 tablets. Practically, this would mean the patient would have to fill prescriptions on a 10-day interval (to allow for unit dose limits of 100 or fewer tablets per prescription). This is both inconvenient for the patient as well as costlier due to co-pays for filling multiple scripts.

This may also present an opportunity for the patient to consider tapering the daily dose of medication used and so allowing for more time between prescriptions filled. At least one recent guideline has indicated that individual prescriptions for excessive numbers of tablets or milligrams of drug will trigger an investigation by the appropriate regulatory body.³²

Compliance Monitoring Tips and Traps

There is some literature examining compliance failures and aberrant behaviors, but most seem to examine this from a patient perspective. Physicians have rarely been taught to consider their own role in the patient behaviors that they are struggling with.

Take for example the patient who is demonstrating aberrant behavior including symptom magnification and drug-seeking behaviors. Many clinicians can identify this as abnormal, either at the conscious or gut levels, and act accordingly. Few have ever considered the possibility that this may be iatrogenic in etiology.

If a patient believes that the ongoing prescription of medications is “contingent” on the doctor believing that he or she “still needs” these drugs, the patient is likely to behave in a way that he or she believes will result in continuation of the status quo. However, if the prescriber has caused the patient to believe (either consciously or unconsciously) that he or she is uncomfortable with these prescriptions and at some point will ultimately stop writing prescriptions for them, the behavior can be seen in a totally different light. It should not be a surprise that when the patient sees that today is not the day to begin the feared taper or worse simple discontinuation of the drugs on which the patient has at least become physically dependent that the demeanor changes almost magically. Yes, it is clearly abnormal behavior, but it is not entirely clear what this behavior means. As a general rule, it is easier to identify abnormal behavior than it is to accurately interpret what it means. In the context of abnormal behavior, there can be a variety of “correct” responses: The one absolutely incorrect thing to do is to simply ignore it.¹⁷

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