Outline of the Drug Schedules and the 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 for each Schedule. NAPRA has developed model 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 apply, 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” (the fourth category).
“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 emerges. 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 non-prescription drugs, which were then modified through national consultation.
The National Drug Scheduling Advisory Committee (NDSAC) will meet upon receipt of a submission (on pre-determined dates, up to four times per year) to review applications for scheduling.