Campania Region (Italy) spontaneous reporting system and preventability assessment through a case-by-case approach: a pilot study on psychotropic drugs.

TY - JOUR

T1 - Campania Region (Italy) spontaneous reporting system and preventability assessment through a case-by-case approach: a pilot study on psychotropic drugs.

AU - Sessa, Maurizio

AU - Rafaniello, Concetta

AU - Sportiello, Liberata

AU - Mascolo, Annamaria

AU - Scavone, Cristina

AU - Maccariello, Alessandra

AU - Iannaccone, Teresa

AU - Fabrazzo, Michele

AU - Berrino, Liberato

AU - Rossi, Francesco

AU - Capuano, Annalisa

PY - 2016/12

Y1 - 2016/12

N2 - OBJECTIVE: We conducted the first pilot Italian study to assess the preventability of adverse drug reactions involving psychotropic drugs reported through spontaneous reporting system from 01/07/2012 to 31/12/2014 in Campania Region. METHODS: Preventability was assessed, case-by-case, using an adapted version of the P-method. The evaluation was performed only for those reports that had, as suspected drug, antipsychotics, mood stabilizers, antidepressants, anxiolytic and/or sedative-hypnotic. RESULTS: Eighty-one cases (19.2%) out of 421 reported during the study period were preventable. In seventy-seven (95.1%) out of 81 preventable cases, the underlying mechanism of the adverse drug reactions was dose-related, in four (4.9%) preventable cases the underlying mechanism of the adverse drug reactions was respectively susceptibility- (1; 1.2%), unknown- (1; 1.2%) and time-related (2; 2.5%). In the 81 preventable cases, 97 critical criteria were detected of which 29/97 (29.9%) related to healthcare professionals' practices, 0/97 (0.0%) to drug quality and 68/97 (70.1%) to patient behaviour. CONCLUSIONS: We proved that it was possible to apply and adapt the P-Method to assess the preventability of the adverse drug reactions involving psychotropic drugs, analysing individual case safety report sent through Campania Region spontaneous reporting system. Information acquired will be used to organize educational activities for both physicians and patients to promote a more appropriate drug use.

AB - OBJECTIVE: We conducted the first pilot Italian study to assess the preventability of adverse drug reactions involving psychotropic drugs reported through spontaneous reporting system from 01/07/2012 to 31/12/2014 in Campania Region. METHODS: Preventability was assessed, case-by-case, using an adapted version of the P-method. The evaluation was performed only for those reports that had, as suspected drug, antipsychotics, mood stabilizers, antidepressants, anxiolytic and/or sedative-hypnotic. RESULTS: Eighty-one cases (19.2%) out of 421 reported during the study period were preventable. In seventy-seven (95.1%) out of 81 preventable cases, the underlying mechanism of the adverse drug reactions was dose-related, in four (4.9%) preventable cases the underlying mechanism of the adverse drug reactions was respectively susceptibility- (1; 1.2%), unknown- (1; 1.2%) and time-related (2; 2.5%). In the 81 preventable cases, 97 critical criteria were detected of which 29/97 (29.9%) related to healthcare professionals' practices, 0/97 (0.0%) to drug quality and 68/97 (70.1%) to patient behaviour. CONCLUSIONS: We proved that it was possible to apply and adapt the P-Method to assess the preventability of the adverse drug reactions involving psychotropic drugs, analysing individual case safety report sent through Campania Region spontaneous reporting system. Information acquired will be used to organize educational activities for both physicians and patients to promote a more appropriate drug use.

U2 - 10.1080/14740338.2016.1221397

DO - 10.1080/14740338.2016.1221397

M3 - Journal article

SN - 1474-0338

VL - 15

SP - 9

EP - 15

JO - Expert Opinion on Drug Safety

JF - Expert Opinion on Drug Safety

IS - sup2

ER -