Quality assurance of manufacturer-supplied unit dose packages.

This article discusses a quality assurance procedure to prevent defects that have been discovered in unit-of-use packages supplied by manufacturers from being dispensed and administered. Defects are illustrated in Figs. 1 through 8. Defects are classified as one of three types: multiples of number, defects of omission, and unusual defects. Multiples of number are defined as defects in which medication in excess of the intended number of dosage units is in the package. In defects of omission, the package is partially or totally empty. finally, the unusual defects include those not falling in either of the other groups. While the defect of omission is found to be the most common, the defect with the most potential for causing patient harm is the multiple of number type. The manufacturer could lessen the possibility that the multiple of number might cause patient injury by stating the number of dosage units on the package. An ongoing program of inspection of packages at time of opening them is recommended. When defects are discovered, the manufacturer should be promptly notified.