A Healthesystems publication

Fall 2011

A Case for an Independent Pharmacotherapy Evaluation of Complex Patients

An editorial from the perspective of Dr. Ralph Kendall, PharmD, VP of Clinical Services

Have you ever had a claim that you just didn’t know what to do with? These are the ones that keep you up at night. The case seems to go around in circles with multiple prescribers, all chasing the claimant with more and more medications.

It helps to remember that most often, the first thing someone does when seeing their doctor about a physical complaint is ask the treating physician for a prescription to fix it. Almost 65% of the time, the patient’s complaint involves pain, and almost always, the physician complies with the request.

What tools are available to sort out what is truly an injury-related problem worthy of treatment, and which of these complaints may be brought on by the treatment itself? We sometimes call these iatrogenic problems. As medically defined, an iatrogenic problem could be a side effect, an interaction, or almost any symptom or physical expression caused by the latest drug we’ve added. It could even be an emotional disturbance. The unintended consequences of drug therapy are many and are rarely considered as contributing to poor treatment outcomes.

Additionally, such complaints may be the result of a diagnosis that was missed or a treatment may be masking a symptom rather than correcting the root cause.

One answer to this perplexing problem might be a thorough evaluation of the drug therapy itself. In recent years, the Clinical Services Department of Healthesystems has conducted nearly 7,000 such evaluations. These are called Independent Pharmacotherapy Evaluations (IPEs) and they are tailored for just such claimants. Its important when doing an IPE to use evidence-based guidelines from the peer-reviewed medical literature to compare treatment of the various injury related diagnoses. A strategy can then be suggested to minimize or reduce the impact of a multiple drug regimen. A clinical pharmacist might then prepare a written communication to the prescriber or prescribers for such a case identifying the likely therapeutic problems and offering possible solutions to the often complex issues that are discovered.

The primary question most payers would like answered when doing these reviews is the relationship to injury for each drug in the regimen. When so many medications are used off-label in today’s health care systems, this is sometimes a daunting task. It is imperative to consider both FDA approved uses as well as those indications that are off-label but accepted as good medical practice because of their appearance in official guidelines. But both sides of the treatment issue must be examined. Which medical problems have been accepted as related and compensable as well as which problems are likely to be present, but are untreated. In the return-to-work strategy, neither is neglected.

As mentioned above, “off-label” use can be a confusing issue. Payers are very reluctant to provide coverage for investigational uses of medication. These, however, can be helpful when everything else has been attempted and met with treatment failure. Off-label use is usually contrary to guidelines. This means that a thorough review of the current medical literature is necessary. Sometimes a discussion with the treating physician can explain the evidence supporting such use. Payers are usually disinclined to support such uses when they lack appropriate evidence.

If a little is good, then more must be better ... An excessive dose of medication can do more harm than good. Prescribers sometimes encounter patients who have escalated doses beyond the intended safe treatment range. Some prescribers may have not cautioned the patient concerning the problems of side effect expression and even toxicity. This is common with medications that are available as both an over-the-counter (OTC) medication and a prescription strength drug. This must be safe, its available without a prescription — Acetaminophen, Ibuprofen, and many others are examples. This can result in expression of unwanted side effects and the addition of yet another drug being prescribed.

While we realize that each patient has his or her own sensitivity to medication, a less than therapeutic dose is often worse than no drug at all. In these drug regimen evaluations, it is important to look for subtherapeutic or inadequate doses to help correct a poor clinical outcome. Some medications must be slowly titrated upward to therapeutic levels in order to provide adequate control. This may be done to control expression of an unwanted side effect. But the therapeutic range must still be achieved.

The expression of drug-drug interaction risk is also a commonly missed problem. It most frequently is seen as another reason to prescribe more medication. An example might be the patient who is taking an opioid analgesic plus an antidepressant that modifies one of the metabolizing enzymes. The antidepressant may inhibit the enzyme preventing the opioid analgesic from being metabolized to its active form. This, in turn, prevents the patient from gaining any pain relief. The more drugs a regimen contains the greater the probability that an interaction will be encountered. This is more likely if several drugs are metabolized and excreted through the same pathway (liver or kidney). Likewise, an increased risk will be experienced if the patient has a diminished function through one of these organ systems.

All drugs have side effects. These are more likely to be expressed as doses are increased. We have also observed that if two or more drugs cause the same side effect, that side effect has a greater likelihood of being expressed, even at therapeutic doses. If three drugs in your regimen cause drowsiness, then it is highly likely that you will have drowsiness as a side effect. One reaction that we have observed is the tendency to prescribe a stimulant for these patients. The proper solution may involve simply backing down the dose of one or more of these drugs or changing the timing as well as the dose of medication, rather than adding a stimulant medication. The addition of a stimulant may then cause insomnia resulting in the need for a medication to help sleep.

One of the most critical elements of evaluating a drug regimen is the need to adequately monitor the patient’s response to each drug. It is very helpful to provide the prescriber with a summary of the lab tests and frequency of monitoring each drug that requires monitoring. This alerts the prescriber to the possibility of developing toxicities or the potential of side effects.

By evaluating drug possession rates, we identify how well the patient is able to comply with or adhere to the prescribed directions. This may not assure that the patient is taking the medication according to directions, but it at least suggests that the patient can be compliant because they have the drug in their possession. This can also identify “refill creep” or an “insidious incrementalism” as well. These are situations where the patient has incremented, or self-escalated, the dose without being so directed by the prescriber.

Observing the use of multiple prescribers and even multiple pharmacies can identify those patients who may be using the system to obtain additional supplies of medication for the intent of abuse, or for illicit purposes. Of significant importance is the inclusion of a sample pain management agreement with most IPEs. This provides suggestions to the prescriber about many of the tools available to assess, monitor, and manage patients taking opioid therapies. The agreement provided is suitable for copying and inserting into the patient chart or use elsewhere in the physician’s practice.

Every IPE also includes a feedback form to help evaluate the utility of the information presented. Feedback is used to help structure future IPEs to be of greater educational value to those who help return our injured workers to productive and functional life.

The IPE can be a roadmap towards simplifying the drug regimen. But we must realize that physicians don’t follow such roadmaps all at once. Our intent is that the complex drug regimen is simplified one step at a time, taking first one step – observing the patient’s response – taking the next step, and so forth. Over time, we can arrive at a much simpler solution to the return-to-work issues confronting our patients.

As a clinician, I strongly believe that we have an obligation to interact with all those who play a role in caring for our injured workers. We must use the various systems available to us to identify patients who are at-risk for drug misadventure, analyze the nature of their therapeutic problems, thus leading to meaningful and cost effective suggestions for resolutions to these problems. By providing support in this manner we can enhance the clinical outcomes of our patients, and insure restoration of function and hasten return-to-work.

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