Table 3 Comparison between PIs of the local and imported products by word counting of 20 criteria
Variable | Local | Imported | P valuea | Fold difference in medians |
|---|---|---|---|---|
Median [Q1-Q3] | Median [Q1-Q3] | |||
Inactive ingredients (excipients) | 0.00 [0.00–0.00] | 33.50 [20.00–58.50] | 0.000 | >33.50 |
Therapeutic class | 0.00 [0.00–4.00] | 5 [3.5–9.00] | 0.016 | >5.00 |
Indications | 14.00 [10.00–20.00] | 25.00 [18.50–37.00] | 0.023 | 1.78 |
Drug dose | 0.00 [0.00–0.00] | 0.00 [0.00–108.5] | 0.401 | – |
Missing dose | 30.00 [15.00–34.70] | 30.00 [26.00–34.50] | 0.797 | 1.00 |
Maximum dose | 0.00 [0.00–0.00] | 0.00 [0.00–0.00] | 0.898 | – |
Directions for use | 37.00 [20.00–43.00] | 33.00 [24.00–71.00] | 0.365 | 1.12 |
Overdose and management | 45.70 [38.00–71.00] | 62.50 [44.00–80.00] | 0.365 | 1.37 |
Warning and precautions | 49.00 [36.00–173.00] | 161.50 [117.50–322.00] | 0.010 | 2.29 |
Effect on ability to drive and use machines | 0.00 [0.00–20.50] | 42.00 [33.00–47.00] | 0.002 | >42.00 |
Contraindications | 28.33 [9.00–60.50] | 89.00 [66.00–126.5] | 0.000 | 3.14 |
Adverse drug reactions | 66.00 [62.00–97.00] | 334.00 [235.50–448.50] | 0.000 | 5.06 |
Drug-drug interactions | 57.70 [49.00–73.00] | 151.00 [109.00–304.00] | 0.001 | 2.62 |
Drug-food interactions | 0.00 [0.00–13.00] | 23.00 [12.00–35.00] | 0.001 | >23.00 |
Pregnancy considerations | 16.70 [12.00–25.00] | 25.00 [20.00–71.00] | 0.010 | 1.50 |
Lactation considerations | 13.00 [8.00–15.70] | 16.00 [9.00–21.50] | 0.116 | 1.23 |
Pediatric considerations | 13.00 [6.70–55.00] | 62.00 [39.50–72.50] | 0.019 | 4.77 |
Possibility of tablet splitting | 0.00 [0.00–0.00] | 7.00 [4.50–12.00] | 0.000 | >7.00 |
Possibility of crushing and mixing with food or beverages | 5.00 [1.50–5.00] | 5.00 [3.00–7.00] | 0.270 | 1.00 |
Storage | 22.00 [15.00–35.00] | 55.50 [47.50–59.00] | 0.000 | 2.52 |