Drugs Scheduling Coursework Materials

DRUGS SCHEDULLING Efficacy of listed complementary medicines • • Low risk, listed complementary medicines may only carry indications and claims for the symptomatic relief of conditions (other than serious disease, disorders or conditions), health maintenance, health enhancement, risk reduction Sponsors must certify they hold evidence to support indications and claims made in relation to listable goods → must be sufficient to substantiate that the indications and claims are true, valid and not misleading Drug development • • • • • • • Pharmaceutical industry is worth worldwide more than $250 billion/year Cost of developing a new drug can be $200-500 million Drug companies need 1-2 new drugs every 3-4 years to remain financially viable Investment in research and development of drugs is considered risky On average it takes more than 10 years to bring a newly discovered active compound to market Every manufacturer must apply to TGA for inclusion of their product to ARTG TGA assesses chemistry/toxicologic data from in vitro & in vivo tests + sometimes does own tests Clinical trials • • For drugs which will be registered, human clinical trials must demonstrate safety and efficacy Clinical trials collect also information about adverse drug reactions Clinical trial phases • • • • Phase 1 – small number of healthy human volunteers (~20-80) to determine safety and tolerability Phase 2 – small number of patients (normally 100-300) to determine efficacy (compared with existing drugs or placebo) and detailed dosage information Phase 3 – randomised double blinded trial (compared to established theraphy/placebo) Phase 4 – obligatory post marketing surveillance to detect any rare or long-term adverse effects Drug scheduling – Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) Unscheduled Available for general sale in supermarkets, grocery stores, health food stores Schedule 2 Pharmacy medicine • Stored on open shelves in pharmacies, no advice needed from pharmacist Schedule 3 Schedule 4 Schedule 5 Schedule 6 Schedule 7 Schedule 8 Schedule 9 • Substances and preparations for therapeutic use (aspirin, paracetamol) Pharmacist only medicine • Stored behind the pharmacist’s counter • Can only be purchased after speaking to a pharmacist to make sure they are appropriate and safe for the individual e.g. pseudoepinerphrine Prescription only medicine • Must be prescribed by an authorised healthcare professional Caution • Have low toxicity or a low concentration and low to moderate hazard - can cause only minor adverse effects to human being in normal use Poison • Moderate to high toxicity – maybe death/injury if ingested, inhaled, contact with skin or eyes Dangerous poison • Have high to extremely high toxicity; Can cause death or severe injury at low exposures; Require special precautions in their manufacture, handling, or use • May require special regulations restricting their availability, possession or use Are too hazardous for domestic use, or use by untrained persons Controlled drug (possession without authority = illegal) • High potential for abuse and addiction e.g. morphine, methadone, methylphenidate • Must be prescribed by an authorised healthcare professional who may need an S8 permit to prescribe these medicines Prohibited substance • Substance and preparations may only be used for research purposes → permits for research uses on humans must be approved by a recognized ethics committee on human research (cannabis, mescaline, psilocybin) • Sale, distribution, use, manufacture of substances without permit is illegal