Change in Rx Label Design Has No Effect on Patient Medication Use, Safety or Health
Researchers at Brigham and Women's Hospital in Boston conducted a study to see if an improved label design for prescription drugs—launched nationwide by Target Corp. in May 2005—influenced patients' adherence to essential medications, safety and health outcomes for specific chronic diseases.
Study results were published in and reported by peer-reviewed journals. (See the Bibliography.)
- Investigators found no statistically significant effect from the labeling intervention on any of the measured outcomes: medication adherence, outpatient physician or emergency room visits, or hospitalizations for patients with chronic diseases.
The Robert Wood Johnson Foundation (RWJF) provided $312,817 in support of this unsolicited project from November 2006 to October 2008.
In a 2004 publication, the Institute of Medicine reported that about half of all Americans have difficulty understanding and using health information—possibly because of difficulty reading prescription drug labels, with their small print and poor presentation. In May 2005, a national chain pharmacy—Target Corp.—implemented a new label design featuring larger font sizes, more space for instructions and warnings, a logical sequence and a color-coded system so family members could better identify which medications were theirs.
Research presented by the grantee organization to RWJF showed that among patients with chronic medical conditions, non-adherence was linked to worse health outcomes and more frequent hospitalizations, according to the project researchers at the Division of Pharmacoepidemiology and Pharmacoeconomics of Brigham and Women's Hospital at Harvard University. A number of studies had evaluated how label design influences readability and comprehension, but little research existed on whether label design influences medication-taking behavior and health outcomes of patients with specific chronic diseases.
According to RWJF's 2005 Annual Report, "[t]he Pioneer Portfolio supports innovative projects that can lead to fundamental breakthroughs in the health and health care of Americans. We seek to invest in high-return ideas that could have major impact in the future, even though the probability that projects will lead to such breakthroughs is uncertain.
"In 2005, the Pioneer Portfolio pursued this objective through a mix of projects aimed at helping us think more precisely about the trends and strategies that may define the future of health and health care.
"Our immediate focus is to develop a strategic approach that will attract new ideas and breakthrough innovations. Our longer-term objective is to assess and steer our investments toward projects that are most likely to result in breakthrough advances in health and health care."
At the time RWJF issued this grant in 2005, the Institute of Medicine had recently reported that approximately half of all Americans have difficulty understanding and using health information.
RWJF funded this project to assess whether Target's improved prescription drug label design would influence medication-taking behavior and patient outcomes.
The researchers evaluated whether an improved prescription drug label design—Target ClearRx—influenced patients' medication-taking behavior, safety and health outcomes. They:
- Compared behaviors and outcomes among Target pharmacy clients between May 2004 and May 2006—a year before and after the new label's implementation in May 2005.
- Compared behaviors and health outcomes of Target clients with a control group of patients who filled their prescriptions at other pharmacies, focusing specifically on:
- Patients aged 18–65 who filled a prescription for a drug to treat one of nine chronic diseases, including diabetes, depression, hypertension, coronary artery disease and asthma, among others.
- New users of chronic-disease medication versus patients who had started treatment prior to the new label. The researchers theorized that the improved label might have the greatest effect when patients initiated therapy, as opposed to refilling a prescription they were already accustomed to taking.
The study sample—23,745 Target pharmacy users and 162,368 matched non-Target pharmacy users—was derived from beneficiaries commercially insured by either Blue Cross Blue Shield of Minnesota or Blue Cross Blue Shield of New Jersey. To ensure patient confidentiality, all traceable personal identifiers were removed from the data before analysis. Study tools included:
- A calculation of days covered based on pharmacy claims refill data to measure medication adherence.
- Statistical analyses to evaluate the new-user and repeat-user behaviors and outcomes.
- Diagnosis codes from medical claims to identify outpatient visits, emergency room assessments and hospitalizations to measure outcomes and health safety for the nine chronic diseases.
The researchers planned to study three patient populations—the poor, elderly and the commercially insured—but ended up studying only commercially insured patients because:
- They could not find data sources sufficient to evaluate the effects of the Target label on Medicaid and Medicare patients in Pennsylvania or New Jersey—the two original sample states.
- Claims for elderly patients included in the databases turned out to be unusable because the implementation of Medicare Part D—prescription drug coverage—coincided with the study period. Most of the seniors' claims were lost after January 1, 2006 when Part D began.
- In an article in the Journal of General Internal Medicine in May 2009, the researchers reported no effect from the labeling intervention on medication adherence.
- In an article published in Medical Care in September 2009, the researchers found a small but statistically insignificant reduction in rates of emergency room visits or hospitalizations for patients with chronic diseases who used the Target label and were new medication users. No effect was seen in previous users.
- The study underscored the challenges of measuring the effects of health literacy interventions on actual health services use or health outcomes because:
- Study instruments might not catch nuances of behaviors such as timing of administration or administration on an empty or full stomach as directed.
- The researchers were unable to study Medicaid or uninsured patients, populations that often exhibit lower health literacy. Studying these patients would be a more effective means of assessing the effectiveness of the interventions.
- The negative findings can point stakeholders toward realistic expectations as they work to develop labeling standards for prescription drugs.
- The results also highlight the need to encourage better doctor-patient and pharmacist-patient communication about medications.
AFTER THE GRANT
After the grant, the project director was invited to present the study's findings at:
- The Institute of Medicine and American College of Physicians Foundation annual health literacy meeting in Washington on November 19, 2008.
- A panel meeting of the United States Pharmacopeia (USP) in Rockville, Md., December 15–16, 2008 to develop minimum standards for prescription drug labels and to discuss the best methods to measure labeling improvement.
The researchers published their findings in peer-reviewed journals. The study results received coverage in the medical media. (See the Bibliography.)
The research provided a foundation for them to conduct an Agency for Healthcare Research and Quality-funded randomized controlled trial of improved prescription drug labels in low health-literacy populations.
GRANT DETAILS & CONTACT INFORMATION
Studying the effect of improved prescription drug label design on medication adherence and patient safety
Brigham and Women's Hospital (Boston, MA)
Dates: November 2006 to October 2008
William H. Shrank, M.D., M.S.H.S.
(Current as of date of this report; as provided by grantee organization; not verified by RWJF; items not available from RWJF.)
Avorn J and Shrank WH. "Communicating Drug Benefits and Risks Effectively: There Must Be a Better Way." Annals of Internal Medicine, 150(8): 563–564, April 21, 2009. Available online.
Elliott VS. "Simpler Drug Packaging Doesn't Improve Patient Compliance." American Medical News, March 30, 2009. Available online.
Shrank WH, Gleason PP, Canning C, Walters C, Heaton AH, Jan S, Patrick A, Brookhart MA, Schneeweiss S, Solomon DH, Avorn J and Choudhry NK. "Can Improved Prescription Medication Labeling Influence Adherence to Chronic Medications? An Evaluation of the Target Pharmacy Label." Journal of General Internal Medicine, 24(5): 570–578, May 2009. Abstract available online.
Shrank WH, Patrick A, Gleason PP, Canning C, Walters C, Heaton AH, Jan S, Brookhart MA, Schneeweiss S, Solomon DH, Wolf MS, Avorn J and Choudhry NK. "An Evaluation of the Relationship Between the Implementation of a Newly Designed Prescription Drug Label at Target Pharmacies and Health Outcomes." Medical Care, 47(9): 1031–1035, 2009. Abstract available online.
Report prepared by: Pamela Lister
Reviewed by: Janet Heroux
Reviewed by: Marian Bass
Program Officer: Claire B. Gibbons