“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.

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).

http://www.fda.gov/cder/meeting/medication_guides_200706.htm

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