From Our 2011 Archives

Report: Some Drugs Sold Without Safety Information

Consumer Reports Says Some Pharmacies Don't Include Medication Guides With Prescriptions

By Kathleen Doheny
WebMD Health News

Reviewed by Laura J. Martin, MD

June 28, 2011-- Drug labels often lack crucial safety warnings, according to a new investigation by Consumer Reports. In addition, some pharmacies don't include medication guides required for some drugs by the federal government, the magazine reported.

Even within large chain stores, the drug information given is inconsistent, the researchers found.

"Our small spot check reveals major differences among the warnings on the bottle and among the patient information material," says Lisa Gill, prescription drug editor for Consumer Reports Health. "It's shocking that the FDA medication guide was not included in four of the five prescription bags."

"Consumers need to be ever vigilant, especially when you consider how many medication errors there are," she says. About 1.5 million preventable medication errors occur each year, according to Consumer Reports. About one-third of those occur outside of hospitals.

The new report follows a Supreme Court decision last week ruling that consumers cannot sue makers of generic drugs under state law for allegations of inadequate warnings. The ruling was necessary, the justices said, because state law has to yield to federal law. Some state laws require changes or updates as new information about drug risks are discovered, which might happen years after name-brand drugs have come on the market but soon after generics do. However, federal law requires warning labels on brand and generic drugs to be identical.

Missing Medication Guides

The investigation focused on two topics. The researchers looked at whether drugstores provided a federally mandated medication guide required for certain medicines. They also looked at information given to consumers -- on drug labels, warning stickers, and printed information -- to see if it varied from store to store.

The investigators filled a prescription for warfarin. It is a blood thinner and a commonly prescribed drug.

They went to pharmacies in these stores:

  • Costco
  • CVS
  • Target
  • Walgreens
  • Walmart

Four of five pharmacies did not provide the federally mandated medication guide required. It is required for warfarin and more than 130 other drugs.

"Costco got it right," Gill tells WebMD.

When Consumer Reports asked representatives from the other four stores what went wrong, it heard from Target and CVS that the information is automatically printed out but it somehow didn't make it to the consumer.

"Walmart and Walgreens did not respond" to calls from Consumer Reports, Gill says.

When the researchers looked at the information provided, they found it varied from store to store, and even from the same store.

  • Target had four clear warnings.
  • Walgreens had four warning stickers.
  • CVS has three warning stickers.
  • Costco had two.
  • Walmart had none. (On two later visits, Walmart had three warnings each.)

All the pharmacies did provide their own patient materials, Gill says. However, they differed from the guide approved by the FDA for warfarin. They also had conflicting information about alcohol. Two stores advised customers to limit or avoid alcohol. But the FDA guide recommends not drinking alcohol at all when on the drug, according to Consumer Reports.

Also, sometimes the font size used in printed material was so small it was difficult to read. Medical jargon was another problem.

Part of the problem, according to Consumer Reports, is that there is no nationwide standard, similar to the Nutrition Facts labels on food packages or the Drug Facts labels on over-the-counter medication. Instead, each state pharmacy board sets the rules, the report says.

Need for Standardized Handouts

The findings are concerning, says Allen J. Vaida, PharmD, executive vice-president of the Institute for Safe Medication Practices, an advocacy group. He reviewed the findings for WebMD.

''What is most surprising is that four of the five failed to provide the mandated medication guide for something like warfarin," he tells WebMD.

The inconsistency found is also a concern, he says. Even within the same store, there were differences, he notes. "You would think they would at least have that standardized," he says.

Stephen Schatz, a spokesman for the National Association of Drug Stores, did not comment directly on the study. But he said the organization just sent a letter to the FDA, urging it to implement a single patient medication information (PMI) document for prescription medicines dispensed at pharmacies.

The single PMI would take the place of the several different types of information now required, he says, including the MedGuides, Patient Package Inserts, and Consumer Medication Information. The aim is to make the information more accurate, complete, and easy to understand.

Consumer Tips

The investigation points to the importance of talking to your pharmacist, especially if you get a drug that is new to you, Vaida tells WebMD.

The push by some pharmacies for speed, promising a prescription will be ready in minutes, is not a good trend, he says.

Among questions to ask the pharmacist, he says, are the exact and best times to take a medication. "If you have a medication and the directions say take twice a day, you may take it at 9 and 3. [But] maybe it should be 9 and 9."

Other ways to stay safe, according to Consumer Reports:

  • Ask about any food, other medications, vitamins, or supplements that should be avoided when taking the medication.
  • Ask whether you can drink alcohol or other beverages while taking the medication.
  • Ask about common side effects and rare ones.
  • Read the patient information sheets provided.
  • Know when you are to stop the medication if it is not meant for long-term use.

SOURCES: Lisa Gill, prescription drug editor, Consumer Reports Health.Allen J. Vaida, Pharm D, executive vice president, Institute for Safe Medication Practices.Consumer Reports, August, 2011.Stephen Schatz, spokesman, National Association of Drug Stores. ©2011 WebMD, LLC. All Rights Reserved.