Underdosing, Overdosing, and Pill Splitting

Source

Ain’t Misbehavin’
Missing doses and other medication meddling are often no accident. A new study of patient compliance uncovers methods to the madness
Bill Chekan. Pharmaceutical Executive Feb 1, 2007

Primary Premise

While most compliance enhancement interventions have addressed unintentional noncompliance, a new study examines non-adherence that is purposeful and results from a decision the patient has reached through a rational process.

It should be noted that this article, Ain’t Misbehavin’ is not the original report from the study but a commentary about the study,

Study Parameters

The study was an online survey,¹ conducted in 2006 by Harris Interactive for Capsugel, a supplier of capsules for pharmaceutical and nutritional applications. The 1,012 US participants were a representative sample who take at least one pill at least once a day for at least one chronic condition.

“Chronic conditions” included a wide range of disorders, from relatively low severity (e.g., constipation) to life-threatening (e.g., cancer). Most common were “high cholesterol, allergies, cardiovascular concerns, arthritis, gastrointestinal issues, and psychological complaints.”

Results

43 percent of those surveyed reported being intentionally noncompliant at least once in the preceding 3 months.

Interpretations and Recommendations

The author of the article comments that the participants in the study, the criterion for which was taking at least one pill at least once a day for at least one chronic condition, “represent some of pharma’s most highly motivated consumers.”

The author also concludes that “the survey suggests that intentional noncompliance is generally driven by two main needs: to save money or to limit side effects.”

Interspersed throughout the article are examples of possible solutions to the problems raised. For example,

Dose Splitting

Much of the discussion is given over to dose splitting.

“Double-dosage splitters,” are those patients who obtain a prescription for twice the required dosage and then divide the pills in half such each fragment is equivalent to the prescribed amount. Those individuals save money since the medications are retailed at a flat rate per pill rather than per mg dosage and since half the co-pays are eliminated. The article makes a specific note that “most people were informed of this money-saving method by their doctors. And this group scores average or better on income and insurance coverage—these folks are less likely to need to save on meds and yet more likely to do so.”

“Single-dose splitters,” on the other hand, are those who intentionally decrease their dosage by dividing the prescribed dose and then taking that fraction of a dose. Single-dosage splitters are said to be “at the other end of the economic spectrum—poorer and with less access to insurance or drug coverage” and

The article continues,

Mention is also made that “the form of the medication (tablet, capsule, or softgel) appeared to have no influence on noncompliant behaviors. The only exception, understandably, was that double-dose splitting of pills was done exclusively with tablets, as capsules cannot be split.”

Commentary

I selected this article because (1) it specifically addresses intentional noncompliance which, as the author maintains, is addressed in the literature much less often than unintentional noncompliance and (2) it approaches the problem of noncompliance from pharma’s point of view, which I believe provides clinicians like myself a useful perspective on noncompliance as well as insight into the pharmaceutical industry’s thinking.

This shift from my typical perspective may have something to do with my discomfort with the article’s style and organization. The article, as one might expect, is less rigidly organized than a scientific paper. Data-based findings, subjective interpretations of those findings, and recommendations are blended in the same paragraph and, sometimes, the same sentence. Without access to the original study, I found it difficult at times to discern objective findings from the author’s deductions and inferences from that data.

I’m unclear, for example, why “participants [who] were a representative sample who take at least one pill at least once a day for at least one chronic condition” would be said to “represent some of pharma’s most highly motivated consumers,” especially given that studies have repeatedly shown that patients with chronic disorders to be among those most likely to be noncompliant.

Similarly, I was surprised to find the judgment that “the good news is that in general, people who had very serious medical conditions were less likely to be noncompliant,” was immediately followed by “the highest rates of nonadherence were reported by folks with depression or another psychological condition.” If a disorder such as depression, which can be completely debilitating and which carries a relatively high mortality rate isn’t considered a “very serious medical condition,” more information is necessary to support that contention.

When the original data is not accessible, as was the case in this situation,² it becomes the author’s responsibility to provide sufficient data to support conclusions made and to provide information from the study that would weigh against such conclusions. It was useful, for example, to know that the sensitivity level of the study for noncompliance was defined as one or more episodes of intentional noncompliance in the past three months, but given that some of the types of noncompliance discussed (e.g., pill splitting) would seem to occur almost every day, a further breakdown of the frequency of noncompliance is called for.

Nor does it seem likely that a doctor who suggests to a patient that he cut a 200 mg tablet in half to generate the prescribed 100 mg dose, would then label it “noncompliance” when the patient does exactly that. I suggest that would be considered “noncompliance” only from the perspective of the pharmaceutical industry. ³

Were there a Reader Reaction Scale that ranged from “High Approval” to “Utter Disgust,” I would predict that clinicians and health plan administrators would be on the “Approval” pole while pharma representatives would land on the “Disgust” end after reading this paragraph from the article:

The article then goes on

The implication, as I read this paragraph, is that pill splitting is potentially dangerous and steps (e.g., packaging changes) should be taken to stop it.

I would hold that if the central concern is how to address the “drug efficacy and patient health” issues, the appropriate approach, at least from the clinical point of view, would be to first look at the research on the topic to determine if a problem exists and then make recommendations (which might include further research).

If the research indicated that casual pill-splitting resulted in dangerously variant doses, perhaps pill-splitting should be recommended only if an accurate pill-splitting device is used. Or, perhaps those medications should be put into liquid solutions that could be measured into precise doses. In any case, the solution is not automatically forbidding a process because one can imagine it potentially causing a danger. If that were so, then all medications would be forbidden, and the pharmaceutical manufacturers would cease to exist.

The writer reveals another motivation (other than the patient’s health) in this statement: “Most people were informed of this money-saving method by their doctors. And this group scores average or better on income and insurance coverage—these folks are less likely to need to save on meds and yet more likely to do so.”

From, again, my own reading of those lines, the writer appears resentful that those who are saving money by pill-splitting could afford to pay full price.

My point is not that pill-splitting is good or bad but rather than the goals of the stakeholders on this issue are not in alignment. Non-congruent goals are not, per se, a catastrophe – unless the causes of those differences are obscured.

Personally, I believe that by pushing pill-splitting as a cost saving mechanism, health plans and clinicians will inevitably force pharmaceutical companies to move from a flat rate per pill pricing to a fee pro-rated by dose. After all, those health plan newsletters notwithstanding, pill-splitting is not an as economic miracle, producing something from nothing. It’s merely a mechanism for taking advantage of pharma’s traditional pricing structure to shift costs from patients and third party payers to the drug companies in a zero sum game.

On the other hand, I also believe that pharma, by casting their disapproval of pill-splitting as purely altruistic concern for the health of the public free of any taint of protecting profit margins, opens itself to accusations of hypocrisy and evokes animosity that patients and clinicians use to rationalize and justify pill splitting (and similar tactics) as no more than the just desserts of the drug companies.

Long before reading this article, I wondered why the drug companies didn’t send health plans a form letter of this sort:

Of course, maybe I’m being naive and missing the point.

Footnotes

1. That the study was a survey that relied on self-report is significant and deserves more emphasis, especially since the findings ascribe motivations to the participants. Compliance studies based on self-report are notorious breeding grounds for face-saving rationales, whether concocted consciously or unconsciously. [back]
2. I suspect the original study is unavailable because it contains proprietary data, but even if it is accessible, the name of the study was not provided and a search based on the information given in the article turned up no results. [back]
3. This kind of variation in definitions of compliance could also have significant impact on research findings [back]

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