As we have said before, labeling is risky business.
This point was driven home again a few weeks ago when Pfizer recalled 1 million packets of birth control pills after discovering a packaging error.
In a statement, Pfizer explained that some blister packs of Lo/Ovral-28 and its generic equivalent could contain an inexact count of active ingredient tablets and that the tablets may be out of sequence (packs come with 21 active tablets and seven sugar pills to regulate menstruation).
While the this episode didn't relate to language or translation, it still serves as a powerful reminder of the importance of quality in drug and device packaging - and the risks associated with a lack of quality.
The Lo/Ovral-28 problem prompted the New York Times to ask:
"What if you end up pregnant because of the packaging mix-up? Is Pfizer offering to cover the cost of the pregnancy or terminating the pregnancy? Or to pay for other health-related costs, like the cost of buying another form of birth control?"And, looking into the future, Pharmalot is predicting a "Pfizer generation".
It will take years to determine whether or not Pfizer has any financial liability for unwanted pregnancies. The potential exposure is huge. And even if actual liability is small, getting to that decision will involve long and expensive legal maneuvers.
Medical translation providers should take this opportunity to test their procedures for QA and QC - and review their professional liability insurance!
[Thanks to Mary Shillue for the heads-up!]
For more on quality processes and risk management in medical translation, take a look at the following:
- Quality matters, or: Is risk a four-letter word?
- Customized medical translation is the wave of the future
- Why translators need editors
ForeignExchange's METRiQ quality system provides medical device and pharmaceutical companies with measurable, known quality for packaging, labeling, and IFUs. To learn more, contact ForeignExchange Translations.