Table 1.
Pharmacovigilance Activity per Category | Number of questions per category | Pooled number of YES answers per category | Pooled number of NO answers per category | Pooled number of answers YES + NO | Percentage of YES/total |
---|---|---|---|---|---|
Organizational Structure relating to PV | 12 | 259 | 149 | 408 | 63% |
AEFI collection from passive reporting | 8 | 171 | 101 | 272 | 63% |
AEFI collection from active reporting | 9 | 198 | 108 | 306 | 65% |
Management of AEFI | 5 | 132 | 38 | 170 | 78% |
Management of Aggregate Reporting | 5 | 118 | 52 | 170 | 69% |
Safety Database System | 9 | 124 | 182 | 306 | 41% |
PV Quality Management System | 8 | 207 | 65 | 272 | 76% |
Safety Signal and Risk Management, and Communication | 8 | 160 | 112 | 272 | 59% |
Safety Data Exchange Agreements | 3 | 73 | 29 | 102 | 72% |
Total | 67 | 1442 | 836 | 2278 | 63% |
This table displays the survey results of the nine PV key activities assessed: The first column indicates the nine different PV key categories; the second column shows the number of questions per category; the third column, the total number of YES responses reported per category, indicating that the respective activities and processes are performed (without any further specification on the level of implementation); the forth column, the total number of NO responses reported per category, indicating that the respective activities/processes are not performed; the fifth column shows the total number of all responses (YES and NO) per category; and the sixth column displays the percentage of YES responses per category.