Sheldon S. Sones, RPh, FASCP: Behind many national recalls is often a facility like yours that participated in the FDA’s MedWatch program. Just a few weeks ago, at two separate facilities in Massachusetts, I was alerted to “floaters” or “coring” that appeared in propofol 20 ml. vials manufactured by a prominent company.
I feel it is the pharmacy consultant’s responsibility, as part of his or her services to you, to coordinate the facility’s response and file an FDA MedWatch report. The FDA then assimilates these reports and may or may not initiate a recall. Your taking this initiative may well save untoward events in other facilities as you participate in this important process. FDA is voluntary and reporting does not necessarily identify the facility, but when it does, one should seek the administrator’s and medical director’s concurrence in advance. Additionally. I would note that a valid inquiry from any overseer would be to confirm your participation in MedWatch.
To learn more about the FDA’s MedWatch Program go to www.fda.gov/medwatch.
Note: This article comes from a recent edition of Pharm-ASC, a weekly e-mail publication by Sheldon S. Sones, RPh, FASCP, a Newington, Conn.-based consultant, pharmacist and safe medication officer serving more than 100 ASCs in the Northeast. Learn more at www.sheldonsones.com.
