2003N-0324 - Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
FDA Comment Number : EC1
Submitter : Mr. Richard Alter Date & Time: 06/10/2004 05:06:51
Organization : Meridian Pharmacy
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
I believe that although the intent of the legislation is good, the outcomes can be poor! There a number of reasons for this statement:
1) There is a plethora of information currently existing (by State and Federal Mandate)on prescription vials. This information leads back to the dispensing pharmacy. The Pharmacy (and pharmacist)has the patient profile, and can better screen the patient for "true" Adverse events.
2) The extra warning label will also "inspire" additional unnecessary cause of concern about their medications.
I believe the current system works fine in addressing Adverse Events.