The Wall Street Journal reported in its December 17, 2008 issue results of a study sponsored by federal regulators that found pharmacies too often fail to provide consumers with important drug safety information in the printed materials stapled to or inserted in the bags containing filled prescriptions for customers. Pharmacies were also criticized by the FDA for the wide variance in the amount of information provided and the insertions of distracting, promotional messages about unrelated, commercial products, based on the findings. For example, about two-thirds of the leaflets lacked general dosing information, while two out of five failed to give dosing instructions specific to the patient. Only a small fraction of materials instructed the patient to stop use immediately if harmful side effects occurred.
The study was conducted by the National Association of Boards of Pharmacy and University of Florida's College of Pharmacy. Informational materials were analyzed by researchers for a common blood pressure medication and a widely prescribed drug for diabetes, sampled from 365 randomly selected pharmacies across 41 states. Researchers essentially posing as patients obtained product from the retail outlet. In market research terms, the tactic is referred to as "secret shoppers" because their true identity is not revealed to the unsuspecting retailer.
While some blame was placed by the study's authors on companies furnishing safety data to pharmacies, chief blame was placed squarely on the pharmacy companies themselves for their corporate editing: namely; the exclusion of content from preprinted literature prepared for distribution to their retail customers. U.S. pharmacies dispense nearly four billion prescriptions each year, the article noted. While there was noted improvement over an earlier 2001 study, researchers considered the sampled materials to have still failed in meeting basic safety needs of the consumer.
In covering the story, additional blame was assigned to the government for the FDA's lack of establishing and communicating standards. Unfortunately, the FDA does not have the same authority to regulate the content of pharmacy-provided leaflets that it has over labels and packaging inserts provided by the pharmaceutical companies. In its wisdom, Congress passed a law in 1995 preventing the FDA from setting specific standards for pharmacy literature, requiring the FDA to only monitor "usefulness of the information."
All of this is a longwinded way of saying that the patient-provider relationship remains as vitally important as ever. In the current environment, no patient can expect to be entirely safeguarded by printed literature from the pharmacy or the pharmaceutical manufacturer. Doctors need to help frame the expectations of the patient regarding likely or possible side effects and equip their patients with the knowledge tools to segregate possible harmful or dangerous side effects from others when taking a new medication.
Of course, the buck stops with the patient's responsibility for oneself. When having a new prescription filled, a patient should insure that safety information is readily available with the drug when first obtained and that it is understandable, including instructions on when and how to take the drug. If not, stop and ask the pharmacist for clarification or additional information before leaving the retail counter. If uncertainty or confusion remains, call the prescribing physician's office right away for details.
Consumers are also encouraged to seek multiple sources of information for a complete and consistent picture of what their expectations might be. NAFC's web site and printed public education brochures contains information about the most frequently encountered side effects of medications such as those for overactive bladder (OAB) and enlarged prostate (BPH).
An example can be found at http://nafc.org/uploads///pdf/OAB%20Medications5.23.08.pdf Such information can also help protect a consumer against an error in how a prescription has been written or filled. But even NAFC can't offer the whole story by itself.
While there is more that the retail pharmacy sector can do to improve its safety performance, every link in the chain has a role to play. Remember yours.
Published On: December 19, 2008