Table 4.
Risperdal® CONSTA® needle detachments
| Baseline | Follow-up | |||
|---|---|---|---|---|
| N | % | N | % | |
| % of injections | 22 | 0.046% | 14 | 0.033% |
| % of patients | 22 | 0.59% | 14 | 0.45% |
| Location of administration | ||||
| Deltoid | 14 | 63.6% | 7 | 50.0% |
| Gluteal | 2 | 9.1% | 1 | 7.1% |
| Unknown | 6 | 27.3% | 6 | 42.9% |
| Lot number | ||||
| Known | 10 | 7 | ||
| Unknown | 12 | 54.6% | 7 | 50.0% |
| 2nd kit used? | ||||
| Yes | 11 | 50.0% | 4 | 28.6% |
| No/unknown | 11 | 50.0% | 5 | 35.7% |
| 5 | 35.7% | |||
| Detachment timing | ||||
| Before injection | 5 | 22.7% | 4 | 28.6% |
| During injection | 11 | 50.0% | 5 | 35.7% |
| After injection | 0 | 0.0% | 0 | 0.0% |
| Unknown | 6 | 27.3% | 5 | 35.7% |
| Detachment location | ||||
| Needle detached* | 14 | 63.6% | 4 | 28.6% |
| Vial adapter detached | 6 | 27.3% | 5 | 35.7% |
| Both detached | 0 | 0.0% | 0 | 0.0% |
| Unknown | 2 | 9.1% | 5 | 35.7% |
| Dose completeness | ||||
| Full | 2 | 9.1% | 2 | 14.3% |
| Partial | 12 | 54.6% | 4 | 28.6% |
| Missed | 3 | 13.6% | 6 | 42.8% |
| Unknown | 5 | 22.7% | 2 | 14.3% |
| HCP administering dose | ||||
| Medical doctor | 1 | 4.6% | 0 | 0.0% |
| Physician assistant | 0 | 0.0% | 0 | 0.0% |
| Nurse practitioner | 0 | 0.0% | 0 | 0.0% |
| Nurse | 1 | 4.6% | 2 | 14.3% |
| Unknown | 20 | 90.9% | 12 | 85.7% |