Pharmacy Info To Consumers Is Lacking: FDA
7 CommentsBy Ed Silverman // December 16th, 2008 // 2:03 pm
The FDA released a study today showing that the printed sheets distributed along with prescriptions by pharmacies fails to consistently offer “easy to read, understandable information” about the use and risks of medicines.
The study, Expert and Consumer Evaluation of Consumer Medication Information, showed that 94 percent of consumers received the handouts with new prescriptions, only about 75 percent of the info met the minimum criteria for usefulness as defined by a panel of stakeholders. In 1996, Congress called for 95 percent of all new prescriptions to be accompanied by useful CMI by 2006, the FDA notes.
“The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, in a statement. “Because the congressional goals have not been met, the FDA intends to seek public comment on initiatives that can be used to meet the goals…We need to work with pharmacy operators, drug manufacturers, health care professionals, and consumers to come up with a sensible, comprehensive and more effective solution.”
To be useful, the FDA says the handouts should include scientifically accurate, unbiased info in an understandable and legible format. The handouts should also specify: the name of a drug and its uses; how to monitor for improvement in the condition being treated; contraindications; symptoms of serious or frequent adverse reactions and how to respond and other general info, according to the FDA.
What else will the FDA do? Early next year, the FDA Risk Communication Advisory Committee will hold a public meeting to discuss the findings and the agency has created a web site to receive public comment on the study and solicit feedback to find better ways to provide useful info.
The FDA regulates prescription drug labeling written for health care professionals and Medication Guides and Patient Package Inserts written for consumers, but the agency says it does not review or approve CMI leaflets. Instead, the FDA says its role, “as set forth by Congress, has been to encourage the private sector to provide this information, supply the companies with the necessary guidance and evaluate the private sector’s progress.” (See this chart for comparisons).
The FDA-sponsored study was conducted by the National Association of Boards of Pharmacy through a subcontract with researchers at the University of Florida, College of Pharmacy. Shoppers trained to simulate patients visited pharmacies randomly selected throughout the US, according to the FDA statement. The shoppers gave pharmacists prescriptions for two commonly prescribed drugs, metformin and lisinopril, and collected the CMI provided with the prescriptions. “Expert and consumer panels evaluated the quantity and quality of this information,” the FDA statement says.
There were some improvements shown by the new study when compared to a similar evaluation of CMI in 2001, which found that 89 percent of patients received written information when their new prescriptions were filled, but only about 50 percent of the CMI met minimal criteria for usefulness.
pharmavet
Not only are these sheets incomprehensible, but some pharmacies tack on a “pharmacist counseling fee” for stuffing the packages.
Larry Sasich
Hi Ed,
I am in Saudi Arabia right now and have just started to read the report. I represented Public Citizen on the steering Committee when the voluntary criteria, called the Keystone criteria, where originally developed.
The evaluators for this report and the earlier reports did not follow the Keystone criteria as intended and should be headed “Pharmacy and the Private Sector Failed Again.” This issue has been going on since 1979 when FDA Commissioner Gere Goyan proposed the mandatory distribution FDA approved writen drug information for consumers that was consistent with a drug’s professional product label.
1. Only leaflets meeting all of the minimal voluntary criteria would count towards the distribution goal. If you look at Table 3 on page 14 of the report for metformin the percentage of leaflets meeting 80% to 100% of the criteria was 0.6%. Being as optomistic as possible less than 1% of the metformin leaflets should be counted toward the quantity goal.
2. The operational defination for Scientifically Accurate was consistent with a drug’s professional product label. My feeling is that the FDA and NLM created the DailyMed Web site knowing that consumers were not receiving Scientifcally Accurate information.
3. The reported stated that errors of omission were not counted (page 8). This goes directly to the issue of scientific accuracy.
As is always the case only regulations with strong oversight provisions will solve problems for consumers that the free market can’t.
My proof reader is not here and hope this is not too messey.
Best,
Larry
Larry D. Sasich, Pharm.D, MPH, FASHP
Chairman, Department of Pharmacy Practice
LECOM School of Pharmacy
Erie, PA 16505
Phone: 814-866-8467
E-mail: lsasich@lecom.edu
Consultant, Saudi Food and Drug Authority
Riyadh, Saudi Arabia
+966-1-275-9222
lsasich@sfda.gov.sa
emjeff
Well, maybe, but have you read the official labeling of any marketed drug? It’s horrible. I think it’s pretty ironic that the agency responsible for the useless and incomprehensible gibberish known as “drug labeling” sees fit to criticize other’s attempts at educating the consumer.
laurie
Been there done that.They had a public hearing on this two years ago in Maryland, which I attended and spoke, when all of this was investigated, recommendations made…….and NO changes made.
Maybe if the FDA actually took some action based on recommendations they could stop having hearing after hearing for the same thing.
laurie
Here’s the transcript of that meeting
http://www.fda.gov/cder/meeting/medication_guides_200706.htm
Justice in Michigan
The last time FDA tried to simplify/improve labeling - I believe including what pts get - it served as an opportunity to insert the now famous/infamous “preemption preamble.”
Of course, I understand the logic that - if you are not going to include _everything- - companies should be held liable for what is _appropriately_ moved to page 2. The question is the definition of “appropriately,” and whether page 2 is still there somewhere. As we know, the sheets we get from pharmacies go out of their way to declare their incompleteness (again, understandably).
harry
from 1997 FDA website Janet Woodcock …interesting
“Finally, in my opinion, effective communication is linked to drug safety. If we can get the information about potential or actual problems with drugs out to doctors, patients, and those people who need it, then drugs are going to be safer. If people are in the dark, then misuse of drugs will occur more frequently. We are working toward improving prescription drug labeling and improving over-the-counter drug labeling.
Most people cannot have missed the increased prominence of direct-to-consumer advertising recently. In addition, there’s a private, ongoing, voluntary process to have consumer information available at the pharmacy for prescription drugs. So when consumers fill their prescriptions, they will receive information sheets. This process is being monitored by the FDA to ensure that it happens adequately. This is a very important issue for drug safety: that consumers get adequate information on how to use their drugs and that the information they get is correct.