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Were the results of cast due to drug packaging error?
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Abstracts .46 TRACKING, ACCESSING, AND REPORTING ON EDIT QUERIES
Paul B. Connor, M. Marvin Newhouse, and Stephen C. Grubb The Wllmer Ophthalmological Institute The Johns Hopkins University Baltimore, Maryland A system for tracking, accessing, and reporting on edit-system generated queries has been developed for the Collaborative Ocular Melanoma Study (COMS) In the past we have spoken about an edit system that allows custom-written, logical cond~bons and messages whde prowd~ng complex editing capabilities and easy maintenance of edit specM~cat~onfiles However, we have found that w~th more chn~cal centers, more forms, and longer follow-up we need a system w~th sophisticated tracking and reporting capab~ht~es We have ~mplemented a system ~nwhich a umque ~dent~fier~sgenerated and stored along w~th ~nformat~on about each edit query Using this stored ~nformat~onthe system allows correcbon of queried data ~tems using a fast, direct-access algorithm, determ~nabon of the status of edit queries at any point ~nt~me, recording of the source of the error when an edit query ~s resolved, re-editing of records w~thout regenerating prewously confirmed edit queries, automatic regenerabon of outstanding edit queries, and tabulation of errors detected and resolved by form, ~tem, and source of error We present the design features of th~s system and provide examples of ~ts benefits
47 WERE THE RESULTS OF CAST DUE TO DRUG PACKAGING ERROR? Clair Haakenson, Loretta A. Malone, Mary Jo Gillespie, Ruth McBride, and Surena Khatir VA Medlca/ Center A/buquerque, New Mexico The Cardiac Arrhythm~a Suppression Trial (CAST) ~s a double-bhnd, placebo-controlled thai evaluating whether suppression of asymptomat~c or mddly symptomatic arrhythm~as ~s beneficial CAST ~s sponsored by the National Heart, Lung and Blood Insbtute using a Coordlnabng Center ~n Seattle (Umvers~ty of Washington) and a Drug D~stnbut~onCenter (DDC) ~nAlbuquerque (VA Cooperabve Studies Program Chmcal Research Pharmacy Coordinat~ng Center) Three ant~arrhythm~adrugs were chosen for use ~nCAST Active and placebo forms were obtained by the DDC from the manufacturers, repackaged into smaller units, and d~stnbuted to part~c~pabngcenters Recently two of the treatments were dropped, w~th mortahty rates greatly exceeding those of placebo controls Among possible explanations for these dramatic and unexpected results was that a drug packaging error may have occurred either at the manufacturing plants or DDC. To rule out th~s possibility, DDC accountability records, packaging procedures, and samphng programs were carefully examined The following were noted" 1. Quahtabve analys~s of one p~ll from every CAST bottle d~spensed ~n October 1988 (551 bottles) revealed no errors 2 330 bottles selected from drugs returned by parbc~pat~ngcenters and analyzed by manufacturers to test DDC packaging accuracy, revealed no errors 3 All samples analyzed during the study ~n the drug stab~hty program had been found satisfactory 4. Physical inventories and calculated ~nventor~es,frequently compared at DDC, had always balanced 5 DDC receipt records matched those of the manufacturers 6 The DDC and manufacturers observe FDA's Good Manufactunng Practices G~ven these findings, we determined that a packaging error had not occurred in CAST We d~scuss these and other considerations for Coordinating Centers relying on ~ndustry or other groups to perform drug packaging and d~str~but~on.
Abstracts .46 TRACKING, ACCESSING, AND REPORTING ON EDIT QUERIES
Paul B. Connor, M. Marvin Newhouse, and Stephen C. Grubb The Wllmer Ophthalmological Institute The Johns Hopkins University Baltimore, Maryland A system for tracking, accessing, and reporting on edit-system generated queries has been developed for the Collaborative Ocular Melanoma Study (COMS) In the past we have spoken about an edit system that allows custom-written, logical cond~bons and messages whde prowd~ng complex editing capabilities and easy maintenance of edit specM~cat~onfiles However, we have found that w~th more chn~cal centers, more forms, and longer follow-up we need a system w~th sophisticated tracking and reporting capab~ht~es We have ~mplemented a system ~nwhich a umque ~dent~fier~sgenerated and stored along w~th ~nformat~on about each edit query Using this stored ~nformat~onthe system allows correcbon of queried data ~tems using a fast, direct-access algorithm, determ~nabon of the status of edit queries at any point ~nt~me, recording of the source of the error when an edit query ~s resolved, re-editing of records w~thout regenerating prewously confirmed edit queries, automatic regenerabon of outstanding edit queries, and tabulation of errors detected and resolved by form, ~tem, and source of error We present the design features of th~s system and provide examples of ~ts benefits
47 WERE THE RESULTS OF CAST DUE TO DRUG PACKAGING ERROR? Clair Haakenson, Loretta A. Malone, Mary Jo Gillespie, Ruth McBride, and Surena Khatir VA Medlca/ Center A/buquerque, New Mexico The Cardiac Arrhythm~a Suppression Trial (CAST) ~s a double-bhnd, placebo-controlled thai evaluating whether suppression of asymptomat~c or mddly symptomatic arrhythm~as ~s beneficial CAST ~s sponsored by the National Heart, Lung and Blood Insbtute using a Coordlnabng Center ~n Seattle (Umvers~ty of Washington) and a Drug D~stnbut~onCenter (DDC) ~nAlbuquerque (VA Cooperabve Studies Program Chmcal Research Pharmacy Coordinat~ng Center) Three ant~arrhythm~adrugs were chosen for use ~nCAST Active and placebo forms were obtained by the DDC from the manufacturers, repackaged into smaller units, and d~stnbuted to part~c~pabngcenters Recently two of the treatments were dropped, w~th mortahty rates greatly exceeding those of placebo controls Among possible explanations for these dramatic and unexpected results was that a drug packaging error may have occurred either at the manufacturing plants or DDC. To rule out th~s possibility, DDC accountability records, packaging procedures, and samphng programs were carefully examined The following were noted" 1. Quahtabve analys~s of one p~ll from every CAST bottle d~spensed ~n October 1988 (551 bottles) revealed no errors 2 330 bottles selected from drugs returned by parbc~pat~ngcenters and analyzed by manufacturers to test DDC packaging accuracy, revealed no errors 3 All samples analyzed during the study ~n the drug stab~hty program had been found satisfactory 4. Physical inventories and calculated ~nventor~es,frequently compared at DDC, had always balanced 5 DDC receipt records matched those of the manufacturers 6 The DDC and manufacturers observe FDA's Good Manufactunng Practices G~ven these findings, we determined that a packaging error had not occurred in CAST We d~scuss these and other considerations for Coordinating Centers relying on ~ndustry or other groups to perform drug packaging and d~str~but~on.