Safety Signals Using Proportional Reporting Ratios from Company and Regulatory Authority Databases
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Safety Signals Using Proportional Reporting Ratios From Company and Regulatory Authority Databases Andrrei Czarnecki, MD, PLD, DSc Global Product Safety, Eli Lilk ti Co. U ! v Research Centre, Windlesham. Surrey, UK
Simon Vorr, MB BS, FFPH, FFPM Global Product Safety, Eli Ld!v 0 Co. L i l y Research Centre. U'indlesham. Surrey, UK
Databases hdd by regUatory agencies and by pharmaceutical conzprmiesmay be used to detect safety si&. We compand the utility of a company safctv databme with thmejhm two Iatge regulatgr authority databa9cs in assessing potential safetr signah in d e r to understand haw the diflmt sma may be used. Pmportid reporting rntios (PRRS) wem calculatedjhm the company database for historid evcnts that had led to changes in prescribing infcmation (PI) and were compand to PRRs calculated in exter-
Key Words Pharmacovigilance d a f abases: Proportional reporting ratio: Adverse reaction
Dr. Andrzej Czarnecki. Global Product Safetv. EI; l
Lir~
,
L i r Research ~
Cen t re. Windlesham , Surrey, UK GU20 6 P H (email: czarnecki-andrzej@ lillv,com),
I NTRODUCTI 0 N Proportional reporting ratios (PRRs) are being used increasingly to compare the rate of adverse - . drug reactions for specific drugs with similar reactions for all drugs in a safetv database. The roots of PRRs go back more than 35 years, and the original work by Patwary using 2 x 2 tables to examine the rate of new reports received for a particular drug was acknowledged by Evans (1) and more recently by Moore (2). Evans and colleagues (3) have moved the concept forward with a description of how PRRs can be used by a regulatory agency in signal detection. Debate is ongoing about the utility of PRRs compared to other tools such as reporting odds ratios (4) and Bayesian methods, such as Bayesian confidence neural network analysis, which is used by the Uppsala Monitoring Centre (5.6). Roux et al. (7) compared 10 methods of data mining and concluded that several different methods provide good results. It is becoming accepted that PRRs are, at the very least, a useful tool in detecting signals (8).The data necessary to calculate PRRs can come from a variety of sources, but large computerized safety databases are the most convenient, and automated signal detection tools are likely to be used more frequently in the v
nal databam (the US Food and Drug Adminisination Fmdm aflnfonnation database and the UK Adverse Dncg Reactions On-line Information Ticking databaw). Fw mast events then wts a,greaatt between d of the databases. Fw some dected historical events we have shown that ifa company database is Iatge enoughandawidemngeofthenputican?as is covered then thew is insignijicant d i f m c e between PRRs mladatedjhm the mpany database and l q e r external databam.
future. Pharmaceutical companies hold databases containing spontaneous reports that are sent to them directly or from regulatory agencies and also from clinical trial safety reports. Despite substantial underreporting of spontaneous reports, PRRs have proved to be a useful signal de
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