New FDA rules require that the information sheets accompanying prescription drugs be clear and direct — at least more so than they currently are.
The sheets, which the industry refers to as labels, will highlight vital information that docs need to know to prescribe a drug safely, including warnings, recent changes to the label, how to use the drug and what the dose the drug follows. There will also be a section specifying what doctors should tell patients about the drug.
Because the labels will be less obtuse than they currently are, FDA officials expect that drug advertising will change dramatically. Presumably if you can’t be obscure in one place, it isn’t allowed in the other either.
The new information will be integrated into the electronic label that drug companies are required to submit to the FDA. The expectation is that this will make detailed drug information more accessible to the public.
This could be a big step in the right direction.
DrugBank is an all-in-one resource for patients and healthcare providers alike to look up detailed chemical, pharmaceutical, medical and molecular biological information on nearly 4,100 drugs. I looked up a couple common headache drugs and am impressed with the results: Topamax, Vicodin (which brings up results for acetaminophen since it is one component of Vicodin) and Imitrex. It also links to popular drug sites, including Drugs.com and RX List, for when readers want more information.
FDA now requires drug companies to submit electronically prescription drug information to the agency. The idea is to give health care providers and the public easier access to the information found in inserts included with prescription meds. In practice, this will likely mean that the hard-to-read package inserts will be exactly the same but searchable online.
Insert information will be available via the National Library of Medicine‘s DailyMed. To be confused by government jargon and too much detail, see FDA’s press release. (FYI, FDA refers to the information as labels.)
(Via Kaiser Network‘s Daily Health Policy Report; FDA To Announce New Requirement That Drug Makers Submit Digital Labels for Medications)
How many different warning labels do your prescription meds have? Except for laughing at the ridiculous graphics or the dire predictions, I don’t pay much attention to them. But labels aren’t a laughing matter for many people in the US according to a study covered in today’s New York Times.
With tiny print and obscure language on other written warnings distributed with meds, many people rely on the stickers for instruction. Yet the stickers’ messages aren’t standardized or very informative. So they are hard to understand, inconsistent and, most important, open to interpretation. The graphic included in the story shows some of these misunderstandings.
Hardest hit are patients with a 6th grade or lower reading level. Considering that 50% of adults in the US can’t read an 8th grade level book, package inserts are useless for too many people. In fact, 46% of American adults can’t understand the label of their prescription meds.
The labels can be problematic for readers at every level. The study found that the “‘FOR EXTERNAL USE ONLY’ sticker stumped 25 percent of even those who could read every word, and misled 90 percent of the adults in the lowest literacy group.”
These stickers aren’t standardized and haven’t been seen as important forms of patient education. Clearly that’s a mistake that needs to be reconsidered.
Did you know that October is Talk About Prescriptions Month? Neither did I until I read it on About.com’s headache page. This year’s theme is the 3 Rs of prescriptions: risk, respect and responsibility. With the daily cocktail of preventives and buffet of abortives that people with headache take, this article is a good reminder of what we need to ask and know about our meds.
And to add to the list of ways to keep drug information, scanning the copious leaflets, pamphlets, fact sheets and boxes to your computer and saving them as jpegs is a low-paper way to go.