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HCPC symposium presentation hints at “science based” data from retrospective patient studies
For just about as long as the Healthcare Compliance Packaging Council (HCPC; Alexandria, VA) has been around (which is since 1990), its packaging and materials members have been making the case that improved medication adherence justifies the generally higher cost of compliance packaging. The point is intuitively obvious—when patients can look at a “calendarized” blister card and see that Thursday’s dosage has already been taken, or Wednesday’s had been overlooked, they have an easy way to monitor their compliance with a drug regimen. But, with the well-known exception of the 28-day cycle of birth control pills, compliance packaging is only occasionally in widespread use in the US.
In a presentation at this year’s HCPC Symposium, now titled RxAdherence (see item below), Dr. Ted Lithgow, president of MeadWestvaco Healthcare (Richmond, VA), gave some tantalizing hints at how his company is addressing this issue with rigorous data. The bulk of the study is under embargo until published “soon” in the peer-reviewed journal, Clinical Therapeutics. But Lithgow’s description of its general scope is of interest not only for putting some numbers on the packaging/adherence question, but also how they went about gathering the data.
According to Lithgow, the study will show a “statistically significant” improvement in adherence by patients using compliance packaging as compared to conventional pharmacist-dispensed vials, specifically a 9-to-17-day increase in “length of therapy” (a measure of the duration of compliance for a given prescription) overall, and as much as an 80-day increase in days covered over the course of a year. (Measuring how “persistant” a patient is in maintaining therapy is itself a complicated calculation, with a variety of metrics.) These data come out of a retrospective study of 3.1 million patients, over the period 2006-2009, obtaining prescriptions for a combined enalapril/lisinopril regimen (ACE inhibitors for hypertension), who filled their prescriptions at Walmart, a client of MeadWestvaco’s that is using the company’s Shellpak clamshell package. In-depth analysis of patients, prescriptions filled and packaging format used will establish these data points, as well as others, in the coming publication, says Lithgow.
“We’ve done meta-analysis of previous studies of compliance packaging,” Lithgow said, “but many of them do not approach the rigor of a well-controlled, randomized clinical trial. These new data, we believe, will make the point in a rigorous manner. Compliance packaging might not cause the biggest change in adherence for a given patient group, but it is a method that is 100% scalable, touching all patients of a specific medication.” He added that there is a growing awareness at FDA and in healthcare systems that poor adherence is technically a type of medication error, and as this is recognized, more attention will be paid to correcting it.