Big Pharma pilots single-page drug info sheetfiled a citizen's petition asking the FDA to reconsider the sheaves of information that typically get stapled to a prescription bag.
Catalina EVP and general counsel Clair DeMatteis told MM&M that the group met with the FDA to show them the problem. Using a recent information leaflet for Pfizer's Celebrex as an example, she noted the small type and that the copy went on for four pages, yet this was just one informational component.
The FDA “agreed with us and they said, ‘You know what? This is a problem,'” DeMatteis recalled. She said the FDA then took it another step in 2010 when it declared that the multiple page information packets were a failure. “Their word,” DeMatteis said, “failure.”The Brookings Group headed up the committee that set out to change things and brought on GlaxoSmithKline, Johnson & Johnson and Pfizer to come up with the best communications strategy. The three firms are now piloting a more user-friendly approach in a California and Michigan. Catalina recruited the drug store chain Rite Aid. DeMatteis said the project required a strong IT component, and Rite Aid's track record suggested it could handle the logistics.
DeMatteis said the all-around collaboration is noteworthy in itself, having brought together three of the largest pharmaceutical companies, the FDA and a consulting company to focus just on patient information. “I don't know that there's a lot of examples of that sort of broad-based collaboration in recent history and it's to the FDA's credit that they've moved forward on this,” she said.
The group proposed a new information leaflet consisting of a one-page document which currently accompanies prescriptions of Pfizer arthritis drug Celebrex, GSK asthma medication Ventolin and J&J HIV drug Prezista throughout the two pilot states. “The new document is simpler. It's newly formatted and it's more consumer friendly for them to understand the drug they're currently taking,” DeMatteis said, adding that the group decided to pilot the program in these states based on their size and diversity. Drugs were chosen based on how many prescriptions were written in those locations. The info sheet is currently available in English.
The company is pooling patient feedback through a combination of phone and online surveys to see if the new format is making a difference. Pharmacists are encouraging patients to give their feedback on whether the document is easy to understand, and DeMatteis said that although the launch is just a week old, they are already seeing an impact. “We are getting people do to exactly what they say you don't do—read the document,” she said after this reporter admitted to tossing the information that comes with prescriptions without reading it.
Results are expected in 10 weeks, with analysis by the end of this year or the start of 2013, and will be used to determine phase two of the program. The first goal would be broader distribution of the one-page info sheets,
DeMatteis said, then expansion into other languages, including Spanish.