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Number of PI change orders.
| PMACS | No PMACS | |
|---|---|---|
| Total number of drugs reported | 61 | 137 |
| Number of drugs with no PI change order | 20 (33%) |
40 (29%) |
| Mean of PI change orders | 2.23 | 2.15 |
| Maximum number of PI change orders | 9 | 9 |
The number of PI change orders for drugs with reexamination reports issued from 2017 to 2019 was compared based on mandatory status of PMACS.
PI, package insert; PMACS, postmarketing all-case surveillance.
