While at a conference recently I was looking at information on a new psychiatric medication. Inside the glossy, well-designed pharmaceutical company produced outer envelope was a double sided, folded sheet measuring
20”x 30”. In looking through the tiny-fonted text and tables it was a challenge for me, a psychiatrist, to find the relevant info in the morass.
Cereal boxes, soup cans and packaged foods have a nutrition facts label meant to provide straightforward, easy to digest (sorry, I couldn’t resist!) information for consumers.
In contrast, medications usually come with a sheet of paper that is, in my view, largely indigestible (did it again, sorry), verging on useless.
As a physician my task is to provide patients with information so they can then make informed decisions about their health care. The med insert sheets don’t make that task easier.
Lisa M. Schwartz and Steven Woloshin, two researchers at Dartmouth University have for several years been proposing an alternative idea – the Drug Facts Box (to read their article click here).
“To make such information accessible, we developed the Drug Facts Box: a simple one-page summary of drug benefit and side effect data for a given indication of a drug. The central feature of the box is a data table with the absolute risks of various outcomes with and without the drug. The data are from the FDA review documents, supplemented by high quality systematic reviews.”
Schwartz and Woloshin note that:
” The Drug Facts Box can improve prescription drug communication in multiple ways. It can educate physicians and provide them with an unbiased summary of drug benefit and side effects using the same data the FDA used in the drug approval process. It can educate consumers by filling in important gaps that exist in current informational sources such as drug advertisements and medication guides. Also, it can foster better physician–patient communication by facilitating evidence-based discussions about drugs.”
I think this is a great idea! Sadly the authors conclude with a candid statement that in spite of their work:
“Based in part on the foregoing studies, the FDA’s Risk Communication Advisory Committee and Congress called on the FDA to consider implementing Drug Facts Boxes. Unfortunately, the FDA has said it needs an additional 3–5 y to study the evidence. Given its potential public health impact, physicians and the public should not have to wait that long for better drug information. They should have access now. In fact, the FDA’s own evidence-based user’s communication guide says, “It is imperative to provide patients with numerical estimates of the risks and benefits associated with treatment options.” If the FDA is unable to clearly and succinctly communicate what it knows—and does not know—about the drugs it approves, then it is time for another independent entity to do it for them.”
Not cool FDA, not cool!
PS Wishing you and yours a Happy Holiday season and all the best in the New Year from Kevin, Roman and Shalom at PACTwise.