Rx & The Law

What Did I Dispense?

by Don R. McGuire, Jr., R.Ph., J.D.
General Counsel
Pharmacists Mutual Insurance Company

One question that pharmacists have when a claim is reported is, “How do we know that the patient didn’t switch the medication themselves?” Unless the pharmacy has very good documentation, we don’t positively know. But, we do know that it’s very unlikely in most cases. The reasons we know this are:

The patient’s access to prescription drugs is limited, so that limits their ability to make the switch. The patient would also need to know the specific generic brands that the store carries to effectively make the switch.
We have observed patterns of medication errors over time and find that look alike/sound alike drugs account for a large part of our claims. So the patient would not only need access to prescription drugs, but also have access to the specific drug of the problematic pair of drugs.
We have also observed that workflow patterns contribute to medication errors and seldom is a drug switched as an isolated, random event. More often than not, there is an explanation for why the switch might have occurred. The incident can be linked to a particular step in the dispensing process where mistakes typically occur.

The patient profile only tells you what should have been dispensed, not what actually went out. Documentation of what was dispensed can be very useful in claims situations. Without this documentation, it is almost impossible to know what was dispensed after a patient has consumed all of the medication. Sometimes inaccurate counts in Schedule II perpetual inventories can verify that the switch occurred. But what about non-controlled drugs? The following example illustrates one solution.

Mrs. Jones suffered from an arrhythmia and was maintained on Coumadin® brand of warfarin. When she presented a new prescription to continue her therapy, it was accidentally filled with Cardura® brand of doxazosin. While investigating the claim, Mrs. Jones became concerned that she had received the wrong drug for the last year. Her previous prescription had been entered correctly and she had it refilled every 30 days for the last year. Various pharmacists and technicians at the pharmacy had processed the refill requests. For Mrs. Jones to have received the incorrect medication for the last year, every person who processed the refills would have had to make the same mistake, i.e., fill her refill with Cardura®, independently, 12 different times. Statistically, this is highly unlikely. However, statistics were not very comforting to Mrs. Jones.

Luckily, the pharmacy had a documentation practice where they recorded both the color and the imprint of the product that was dispensed. It was easy to prove to Mrs. Jones that she had not received the incorrect drug for the last year because the records showed that she had received Coumadin® every month up until the new prescription was filled.

This documentation did not take a lot of time because the staff was not necessarily looking up and double-checking all of the colors and imprints. They were merely observing them and recording them. It was a record of what was going out. However, you would hope that the staff would still question appearances that seemed unusual to them. This practice enabled us to verify what the patient had received long after the contents of the prescription were consumed. This same record would also help to detect if a switch had been made by the patient.

The problem with documentation is that the person documenting receives negative feedback. They document, document, document and most of the time it is never used. Over time, the temptation is to quit doing it. However, documentation, or the lack of it, many times is the critical evidence in a case. The method here was relatively simple and not time-consuming. These are essential criteria for any documentation program. If it takes too much time or is too complex, the negative feedback wins out. The method provided in this article is not the only way to document the actual item dispensed. It is merely the easiest that we have seen. Put your thinking caps on and see what else you can come up with. You won’t be sorry that you’ve taken the time when the need for it arises. Then you won’t have to say, “What did I dispense?”

. See the list from the Institute for Safe Medication Practices; www.ismp.org/Tools/confuseddrugnames.pdf