Outline of the Schedules and Scheduling Process
The national model consists of three schedules or four categories:
Schedule I, Schedule II, Schedule III and Unscheduled, with specific conditions for sale expected for each. NAPRA has developed National Standards of Practice for pharmacists corresponding to the level of professional intervention and advice necessary for the safe and effective use of these drugs by consumers, according to each Schedule.
The model for making drug scheduling recommendations embodies a "cascading principle" in which a drug is first assessed using the factors for Schedule I. Should sufficient factors pertain, the drug remains in that Schedule. If not, the drug is assessed against the Schedule II factors, and if warranted, subsequently against the Schedule III factors. Should the drug not meet the factors for any schedule, it becomes "unscheduled".
"Factors" rather than "criteria" are considered to be more appropriate assessment tools as they are contingent, conditional and dependent. A process using factors allows judgment by reviewers to find the best fit and facilitates a re-evaluation process of scheduled drugs when new knowledge or practice experience emerge. The factors were initially adapted from established standards for prescription drugs, proposed guidelines for drugs monitored by pharmacists, and the World Health Organization's guidelines for nonprescription drugs, then modified through national consultation.