Fight More than Crime

After listening to the California State Board of Pharmacy discuss electronic pedigrees last month, I’ve been thinking a lot about patient safety. The board is urging item serialization to fight counterfeit drugs, and the entire healthcare industry is debating just how to pull it off.

Serialization can bring more visibility to the drug supply chain, illuminating those grayer areas where counterfeiters have been able to operate. But there are other threats to patient safety in need of solutions, too. And they may be more prevalent than counterfeit drugs. Administration errors are made in hospitals and nursing homes, and they even occur in retail pharmacies.

Two members of our magazine staff, for instance, have loved ones whose prescription drugs have been filled incorrectly. One member’s son had been given the incorrect drug after a pharmacy technician mistook another drug with a similarly spelled name for the prescribed one. The pharmacy did have a bar code system in place, but the code didn’t scan, and the pharmacist ignored it, my colleague reports.

Also, a staff member’s cat was mistakenly given a significantly higher dose than prescribed, owing to a pharmacy error.

While both the son and the cat suffered only temporarily, they were still at risk. These mistakes were detected only after their behaviors had changed. What if our colleagues hadn’t paid close attention?

Dosing errors also occur at hospitals and alternate-care facilities. A family member of mine has recently been admitted to a convalescent hospital. While the caregivers appear to be thoughtful and considerate, they are very very busy, so they do slip. Drug administration is often a few hours late. Drugs are dispensed from central carts into unmarked paper cups and then carried to patient rooms. I have yet to see a bar code scanner in the entire facility. I worry, because nurses and their certified assistants on their way to administer drugs frequently get distracted by other patients in need. The staff—which always seems skeleton—has to remain vigilant despite the stress. Their work is hard, and it is critical. Yet, much of it seems left up to luck.

I would like to believe that technology can solve these problems. RFID and bar codes for autoidentification as well as some of the more sophisticated unit-of-use containers, like One World Manufacturing’s NextBottle and Tyco Healthcare’s narcotics-delivery system, hold promise. But in addition to a technology change, we also need a philosophy change.

I would like to think that the just-enacted FDA Amendments Act of 2007 will make a difference, especially when it comes to counterfeiting, with its emphasis on “promising technologies” in Section 505D on Pharmaceutical Security. Use of track-and-trace and authentication technologies are urged.

But then I come across more-general discussions of patient safety, like the debuting Drug Safety Newsletter from FDA, and see very little mention of packaging and labeling.

Med-E.R.R.S. and the Institute for Safe Medication Practices (ISMP) offer some hope. The two groups will be sponsoring the teleconference, “Spotlight on Medication Safety: Designing Safe Packaging and Labels.”

Counterfeit drugs are a threat and must be addressed. But so are errors at the hands of healthcare professionals. Patient safety initiatives should fight against both counterfeits and medical errors. Packaging and labeling play key roles, because weaknesses in either leave drugs vulnerable both to error and to crime.

Daphne Allen


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