Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.

TY - JOUR

T1 - Campania preventability assessment committee: a focus on the preventability of the contrast media adverse drug reactions.

AU - Sessa, Maurizio

AU - Rossi, Claudia

AU - Rafaniello, Concetta

AU - Mascolo, Annamaria

AU - Cimmaruta, Daniela

AU - Scavone, Cristina

AU - Fiorentino, Sonia

AU - Grassi, Enrico

AU - Reginelli, Alfonso

AU - Rotondo, Antonio

AU - Sportiello, Liberata

PY - 2016/12/1

Y1 - 2016/12/1

N2 - OBJECTIVE: The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. METHOD: All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach. RESULTS: From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment. CONCLUSIONS: Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.

AB - OBJECTIVE: The current study aims to assess the preventability of the contrast media adverse drug reactions reported through the Campania spontaneous reporting system, identifying the possible limitations emerged in this type of evaluation. METHOD: All the individual case safety reports validated by the Campania Pharmacovigilance Regional Centre from July 2012 to September 2015 were screened to select those that reported contrast media as suspected drug. Campania Preventability Assessment Committee, in collaboration with clinicians specialized in Radiology, assessed the preventability according to the P-Method, through a case-by-case approach. RESULTS: From July 2012 to September 2015, 13798 cases were inserted by pharmacovigilance managers in the Italian Pharmacovigilance Network database (in the geographical contest of the Campania Region), of which 67 reported contrast media as suspected drug. Five preventable cases were found. The most reported causes for preventability were the inappropriate drug use for the case clinical conditions and the absence of the preventive measure administrated prior to the contrast media administration. Several limitations were found in the evaluation of the critical criteria for the preventability assessment. CONCLUSIONS: Educational initiatives will be organized directly to the healthcare professionals involved in the contrast media administration, to promote an appropriate use of the contrast media.

U2 - 10.1080/14740338.2016.1226280

DO - 10.1080/14740338.2016.1226280

M3 - Journal article

SN - 1474-0338

VL - 15

SP - 51

EP - 59

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

IS - sup2

ER -