Regulation of Medicines and Drugs

Regulation of Medicines and Drugs

·        Medicines Act 1981: prescription medicines can only be supplied or possessed on the prescription of a doctor and dispensed in a pharmacy. Maximum amount = 3 months supply (6 months for oral contraceptive)

Regulation of Drugs of Abuse

·  Misuse of Substances Act 1975 defines and regulates controlled drugs - prohibits non-therapeutic use. Mainly Opiates, Ritalin, dexamphetamine and BZDs

·        Prescriptions for opiates and stimulant-controlled drugs must be on a special triplicate form in the Doctors own writing. BZDs don‟t require triplicate form

·        Prescribed for maximum of one month, dispensed in 10 day lots

·        It is illegal to supply a controlled drug for the treatment of maintenance of dependency (except for Gazetted drug clinics)

·        Need good notes to avoid legal recourse (e.g. no automatic repeats)

·        Many injected drugs have been prescribed „legally‟ by doctors and diverted to illicit use (eg sold to dealers)

·        Monitoring of prescription narcotics and abuse prone medicines is carried out by Medicines Control Advisors, reporting to the Medical Officer of Health

·        They can issue a Restriction Notice – which prevents the supply of controlled or specified drugs to a named person – it is then an offence for this person to try and obtain this drugs, and a doctor to prescribe it for them

Classes of drugs

·        Responsibilities of the prescriber:

o   To avoid creating dependence

o   To see that the patient doesn‟t increase the dose, inducing dependence

o   To avoid unwittingly supplying the black market

·        Misuse of Substances Act: 

o   Grades drugs according to harmfulness when misused. Specifies recording, reporting and form filling requirements. Enforced by Customs, Police (where criminal acts) and by Medical Officer of Health in the Ministry of Health 

o   Class A: Possession, prescribing, sale are prohibited – street drugs. Use is an offence (e.g. heroin). Large penalties 

o   Class B: Can only be used for pain. Can only be prescribed for dependency by a gazetted person. Includes morphine, methadone

o   Class C: Controlled drugs which are less hazardous (eg codeine, BDZs, etc)

Clinical Trials

·        Preclinical trials: testing toxicity and potential therapeutic benefit

·        Phase 1: Human pharmacology

·        Phase 2: On patients – focus is safety: dose level and frequency, unwanted effects, treatment duration

·        Phase 3: On more patients – designed to test efficacy not safety

·        Medicines licensed for use 

·        Phase 4: Adverse reaction monitoring – rare effects only show up with widespread general use Þ big responsibility on prescribers to report ADR

MedSafe

·        = NZ Medicines and Medical Devices Safety Authority.  Part of the Ministry of Health.

·        Medicine = any substance … supplied wholly or principally to treat a human for a therapeutic purpose … treating or preventing a disease

·        Medsafe regulates:

o  From production to distribution

o  Access to medicines (eg prescription, restricted, pharmacy only, general sales 

·         Need to regulate to protect public health and to avoid counterfeit or inferior quality medicines