Poor adherence to medication is a growing issue across the country. The New England Healthcare Institute estimates the current cost of drug-related morbidity, including poor adherence, to be as much as $290 billion annually in avoidable medical spending, 13 percent of total U.S. healthcare spending. Research also shows that half of all patients in the U.S. do not take their medicines as prescribed, a dismal level of adherence which has held steady over the past three decades. Poor adherence leads to worsening of disease, serious and avoidable health risks, increased hospitalizations and even death.
Within the study, the use of Shellpak demonstrated improvement in the adjusted estimates of refill persistence and adherence as measured by length of therapy and proportion of days covered with medication. The proprietary packaging features a child-resistant and senior-friendly outer plastic shell that protects medication tablets packaged in a 30-day calendar blister card similar to packaging long used for birth control pills. The calendar feature helps patients track medication usage, helping reduce dosing errors such as overdosage and missed doses, and refill timing. The large, flat blistercard and package surface allows for dosing instructions and patient education to be printed in large, readable font. Shellpak can also be customized to provide differentiation for each medication enclosed.
"We know there are many factors affecting medication adherence, and we know that the most successful solutions will involve multiple components," said study co-author Lenn Murrelle, MSPH, PhD, and principal founder of Venebio, a life sciences research consultancy. "What's exciting about this study is that medication packaging alone was found to have a positive effect on medication refill behavior. This says to us that packagng without any additional communications or instructions to either pharmacists or patients can play an important role in helping patients take their medication as directed."
The retrospective analysis used pharmacy dispensing data from Walmart for 3.1 million individuals filling prescriptions for the generic cardiovascular medications lisinopril or enalapril, either alone or in combination with hydrochlorothiazide.
Results revealed the Shellpak refill persistence benefit was especially pronounced among certain subgroups.
• New medication users had an average length of therapy increase of 9 days over a year.
• Ongoing medication users had an average length of therapy increase of 5 days over a year.
• Persons taking fixed-dose combination formulations, or 2 medications in a single tablet experienced an average 17-day increase in length of therapy for new users and 12 days for ongoing medication users.
In addition, the study revealed that Shellpak users overall were more likely to reach "full refill adherence" - at least 80 percent of days covered with medication in a year - than vial users, with the greatest effect observed in new medication users. However, full refill adherence (PDC greater than or equal to 80 percent) was more likely in Shellpak users regardless of their baseline level of adherence.
• PDC greater than or equal to 80 percent was more likely reached by using Shellpak in those with the lowest level of baseline adherence, by 20 percent in new medication users and 23 percent in ongoing users.
• Individuals with a middle level of adherence at baseline had a 15 percent greater likelihood of reaching full adherence with Shellpak for new users and 8 percent for ongoing users.
• In the group with the highest level of baseline adherence, Shellpak users were 11 percent more likely to reach full adherence for new medication users and 5 percent for ongoing users.
"This publication is the first, large-scale pharmacoepidemiologic analysis of medication packaging, and the results are exciting and significant," said Ted Lithgow, PhD, president and chief science officer, MWV Healthcare. "We believe smarter packaging serves a purpose beyond simply containing and protecting the physical integrity of a pharmaceutical, and this robust data provides compelling scientific evidence for Shellpak as a now-proven solution to help drive better patient adherence. We will continue to work with the medical, pharmacy and pharmaceutical communities, and regulators to consider these data and to further investigate the effects of packaging on medication adherence."
About the Study
This was a two-year, retrospective cohort study of 325,361 new and ongoing users of the oral angiotensin converting enzyme inhibitors (ACEI) lisinopril or enalapril - commonly prescribed for the treatment of hypertension and congestive heart failure - designed to assess the real world effectiveness of a new calendar packaging technology on prescription refill adherence and persistence for daily, self-administered, long-term medication use. Eligible users comprised two packaging cohorts, Shellpak (282,605 lisinopril users (86.9 percent)) and vial (42,756 enalapril users (13.1 percent)), and ACEI user groups: 76.321 new users (23.5 percent) and 249,040 prevalent ongoing ACEI users (75.5 percent).
To assess the impact of Shellpak on refill behavior, measures of refill adherence and persistence in the baseline year before and follow-up year after the packaging switch were compared in the 325,361 adults aged 18-75 years who filled 30- or 90-day prescriptions in both the baseline and follow-up years. These individuals had adherence and persistence data available both before and after the packaging switch to Shellpak. Researchers used linear and logistic regression and propensity score matching to assess the impact of calendar blister packaging on refill adherence, using medication possession ratio (MPR) and proportion of days covered (PDC), and persistence using length of therapy (LOT).
The study was designed, conducted, analyzed and reported in accordance with the Good Research Comparative Effectiveness (GRACE) principles and Guidelines for Good Pharmacoepidemiology Practice. The Walmart pharmacy dispensing data were de-identified in accordance with HIPAA guidelines.
Source: MeadWestvaco Corp.