Table 1. Generic Substitution Scoring Scheme for Small-Molecule Drugs.
| Variable | Pointsa |
|---|---|
| Duty to substitute | |
| Yes | 0 |
| No | 1 |
| Patient notification | |
| Not required independent of packaging | 0 |
| Required independent of packaging | 1 |
| Patient consent | |
| Not required | 0 |
| Opportunity for refusal noted | 0.5 |
| Required | 1 |
| Liability for substitution vs not substituting | |
| No greater risk | 0 |
| Not specified | 0.5 |
| Possibly greater risk | 1 |
| Total possible points | 4 |
a
Possible range of scores is 0 to 4 (with a maximum of 1 point for each of the 4 variables); lower scores reflect a regulatory framework more favorable to substitution.