JUN 15, 2013
By: Ernest P. Gates, Jr, RPh, FASCP, FIACP
N MY VIEW
For pharmacies in the compounding business, quality assurance is a constant battle. And a company’s best defense — against problems such as medication errors, contamination, or potency issues — is a good offense. The pharmacy must always strive to create and maintain a culture of quality to ensure proper procedures, regulatory compliance, patient safety and, ultimately, healthy revenue to support the bottom line.
These principles have always been in force, but they have taken on even greater meaning after last fall’s tragedy at the New England Compounding Center, where contaminated vials of methylprednisolone acetate led to a meningitis outbreak that resulted in over 50 deaths, with hundreds more falling seriously ill.
Compounding pharmacies should waste no time in reviewing their quality assurance programs to ensure that they are up-to-date and effective as they take on today’s challenges.
Keys to quality assurance
Here are six examples of how your compounding pharmacy can maximize quality assurance:
Clean room. Make the clean room the center of your operation. It is common to see clean rooms tucked into a back corner of many pharmacies. However, a clean room can be constructed with large windows and positioned so that it is very visible to customers, yet still isolated against potential contamination. This design maintains a safe, sterile environment and also demonstrates to the public that yours is a transparent organization.
Compliance officer. Employ a full-time compliance officer, or at least have designated quality assurance pharmacy staff to develop and maintain a comprehensive program that involves inspections, monitoring, measurement, and education.
Information exchange. Give the person who occupies this important role ample time to carry out the quality assurance mission. That means creating regular opportunities, such as staff meetings held
weekly or at least monthly, in which employees can exchange information, review quality assurance and patient or physician communication, present operational workflow reports, and assess a
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