A study released today by the U.S. Food and Drug Administration found that the 
printed consumer medication information (CMI) voluntarily provided with new 
prescriptions by retail pharmacies does not consistently provide easy-to-read, 
understandable information about the use and risks of medications. The study, 
Expert and Consumer Evaluation of Consumer Medication Information, showed that 
while most consumers (94 percent) received CMI with new prescriptions, only 
about 75 percent of this information 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 current voluntary system has failed to provide consumers with the quality 
information they need in order to use medicines effectively and safely," said Janet 
Woodcock, M.D., director of the FDA's Center for Drug Evaluation and 
Research. "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."

CMI has been defined as being useful if it includes scientifically accurate, unbiased 
information that is presented in an understandable and legible format. Specifically, 
CMI should include the drug name and uses, how to monitor for improvement in 
the condition being treated, contraindications (situations when the medicine 
should not be used), symptoms of serious or frequent adverse reactions and what 
to do, and certain general information, including statements encouraging patients 
to talk to their health care professional.  

"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," said Woodcock. 

In early 2009, the FDA Risk Communication Advisory Committee will hold a public 
meeting to discuss the study's findings. In addition, the FDA has created a Web 
site to receive public comment on the study and solicit feedback on the best ways 
to provide useful prescription information to consumers. 

The FDA regulates prescription drug labeling written for health care professionals 
and Medication Guides and Patient Package Inserts written for consumers, but the 
agency does not review or approve CMI leaflets. The agency's 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. 

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 United States. The shoppers gave the 
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.

There were some improvements shown by the new study when compared to a 
similar evaluation of CMI in 2001, Evaluation of Written Prescription Information 
Provided in Community Pharmacies, 2001. That study revealed 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.   

For information: 
Expert and Consumer Evaluation of Consumer Medication Information, 2008 

Comments on a study examining the impact on consumer comprehension of 
inclusion of a toll-free number to report side effects in direct-to-consumer (DTC) 
prescription drug television advertisements are being sought by FDA. The study 
will examine the placement of the toll-free statement and the length of time the 
statement is presented on-screen in a DTC television advertisement for a 
prescription drug. Federal Register Pre-Publication Notice

More and more U.S. children are being given drugs to fight chronic conditions such 
as asthma and hyperactivity, according to a study published on Monday.  From 
2002 to 2005 prescriptions for medicines to treat type-2 diabetes doubled, asthma 
medications rose by more than 46 percent, medicines for attention-deficit 
hyperactivity disorder increased by more than 40 percent and prescriptions for 
cholesterol-lowering drugs were up by 15 percent. The study was conducted by 
Emily Cox of Express Scripts Inc. in St. Louis, a manager of pharmacy insurance 
benefit plans, Dr. Donna Halloran of the Pediatric Research Institute in St. Louis, 
and Douglas Mager of the Kansas Health Institute in Topeka.

In a report published in the November issue of Pediatrics, they said the increases 
could mean that chronic conditions are on the rise.  But they said the trend could 
also reflect other factors such as changes in the way doctors prescribe drugs and 
better screening that identifies more chronic conditions.

In addition, the team said federal programs that encouraged research on pediatric 
drugs resulted in "increased data on safety and efficacy in children (that) likely 
provided physicians with a greater degree of confidence to prescribe (such drugs)."

Half of U.S. doctors report using placebos several times a month, according to a 
study published in the British Medical Journal (BMJ).  However, nearly 70% of 
those that use placebos described the treatment to their patients as "a potentially 
beneficial medicine not typically used for your condition." Only 5% of doctors 
explicitly called it a placebo treatment. Most doctors used actual medicines as a 
placebo treatment: 41% used painkillers, 38% used vitamins, 13% used 
antibiotics, 13% used sedatives, 3% used saline injections and 2% used sugar pills.

A record number of deaths and serious injuries associated with drug therapy were
reported to the U.S. Food and Drug Administration (FDA) in the first quarter of 
2008. Serious injuries associated with drug therapy reached a total of 20,745 new 
cases; reported deaths totaled 4824 cases, a 2.6 fold increase from the previous 
quarter.

In addition, varenicline (Chantix, Champix), an aid to stopping smoking, accounted
for more reported serious injuries than any other prescription drug for a second 
quarter, a total of 1001 new cases, including 50 additional deaths. Varenicline was 
the subject of a previous Quarter Watch special report1 and a separate FDA Public 
Health Alert about psychiatric side effects. Ranked second in reported serious 
injuries was heparin, a drug that helps prevent injury from blood clots. Heparin was 
the subject of a major product recall after a potentially lethal contaminant was 
identified and traced to suppliers in China. In the first quarter of 2008, the FDA 
received reports of 779 cases of serious injury in which heparin was the principal 
suspect drug.

 These findings come from a program being developed by the Institute for Safe
Medication Practices (ISMP) to improve patient safety through increasing our
understanding of how and why drug-related injuries and medication errors occur. 
The results come from analyzing new adverse drug events reports submitted to 
the FDA. The agency releases computer excerpts of these reports for research 
use after personalidentifying information has been removed.