Gordon Schiff, M.D., Director of Clinical Quality Research and Improvement at Cook County Hospital in Chicago, was also concerned about medication errors when he sought funding from the U.S. Pharmacopeia and the ASHP Foundation for a simple, straightforward study entitled “SODId (Solid Oral Dose Identification) Study: Current Practice of Pharmacists and Physicians.”
The idea behind the study was to conduct a simple field test of how well pharmacists and physicians could identify common – but unpackaged – medications. His team randomly selected 50 pharmacists and 50 physicians to test their ability to identify 3 commonly prescribed medications. Only half of the pharmacists and less than half of the physicians could correctly identify all three medications.
“According to a survey we conducted, the need to identify a medication outside of its bottle arises at least once a month or more,” says Schiff. “More than half of physicians and pharmacists are faced with this situation at least once a week. Patients make use of weekly pill organizers and forget what is in them. A patient is admitted to the ER in a coma and can’t tell you what the medications in his pocket are. Or a patient is given a new generic version of his medication that looks different from the last version he took. He can’t tell if this is an error, so he stops taking the medicine.”
Current FDA regulations allow pharmaceutical manufacturers to develop and assign identification codes of their own choosing to the medications they make. The result is a dizzying array of similar medications with very different codes, and even more problematic, very different medications with very similar codes. “This is a basic patient safety and protection issue,” says Schiff. “The solution is a universal, standardized medication code imprint system.”
Very little data on the subject exists, so Schiff felt driven to fill the void. “We tried to make our study as easy for participants as possible,” he explains. “We used three common drugs on the formularies of three institutions, and we didn’t throw any curve balls. We gave them as much time as they needed in their natural work settings with identification resources at their fingertips. They were not able to make simple identifications.”
“I hope that this study will provide some more convincing and compelling evidence that we have a problem,” states Schiff. “What’s so important to me is that establishing a universal system would be a very easy, inexpensive solution to preventing adverse drug events.”
Schiff acknowledges that there remain questions about how to implement the system and who would facilitate or regulate it once established. But with a long phase-in period, he believes that a global system allowing identification of solid dosage forms regardless of the country of origin is possible. “With all the hundreds of thousands of medication doses being shuffled around from pharmacy counters to bottles to medication containers to mouths, it is inevitable that we need a way to identify them,” he says. “I hope that some disastrous adverse event does not have to happen before a change is made.”