FV22 PILOT RESULTS OF IMPLEMENTATION OF SOP TO REQUEST FOLLOW UP INFORMATION: DRUG SAFETY DEPARTMENT OF PFIZER SPAIN EXPERIENCE AFTER STANDARDIZATION OF THE REQUESTS FOR FURTHER INFORMATION

摘要

Objectives: In order to improve the quality of notifications, Pfizer implemented a new Standard Operating Procedure (SOP) to standardize the collection of information for the reports, regarding the seriousness, expectedness and source of the cases. We have reviewed the number of follow ups (FU) in order to establish if there has been an increase on them.Methods: The Pfizer Spain drug safety database was analyzed, comparing the reports included in a first period from July 2003 to December 2004 (prior to the SOP implementation) and the reports included in a second period from January 2005 to June 2006 (after the previous mentioned implementation). The total number of FU received to complete the information of the initial cases was compared, and the available information of the reports after the implementation was examined.Results: A total of 4830 cases were notified: 2326 (1413 initials, 913 FU) on the first and 2506 (1432 initials, 1074 FU) on the second period. During the first period the reported initials, FU and the% of the total were respectively, regarding the source: health professionals (HP) 617, 158 (20.3%); health authorities (HA) 134, 12 (8.2%); clinical trials (CT) 662, 743 (52.9%); and the expedited cases 166, 94 (36.2%). On the second period the reported cases were HP: 662, 265 (28.9%); HA: 220, 13 (5.6%); CT: 550, 796 (59.1%); and expedited cases 158, 136(86.1%).Conclusions: An increase on the FU that complete the initial information of the cases is observed. This increase mainly is observed in HP and clinical trial cases, but not in the notifications received from health authorities, probably because the request is done to the health authorities, instead of directly to the HP. Regarding the expedited cases notified to regulatory, an important increase in the FU is observed, which proves that the SOP is more effective with these cases. Moreover, if we take in consideration that after the SOP implementation a high number of reported cases have the required information, we consider that thisSOP enhances the information (enough to perform a correct case causality evaluation), and this will improve the quality of the reports.