Week 2 Flashcards
Australian laws
commonwealth laws
control the quality, safety and efficacy of medicines
Australian laws
state and territory laws
detail more specific provisions for medicine regulation
- individuals, institutions and companies must comply with Commonwealth and state or territory laws
- if there is a conflict between Commonwealth and state/territory legislation, Commonwealth legislation takes precedent
- state/territory legislation: directions for prescription and administration of medicines
Commonwealth Laws
- two acts affecting medicine manufacture and administration: therapeutic goods act (TGA) 1989, Narcotic Drugs Act 1967
1. Therapeutic Goods Act (1989) - provides federal control for standards, manufacture, supply, presentation, registration and availability of therapeutic goods - therapeutic goods: are those used in the prevention, diagnosis, cure or alleviation of a disease, defect or injury in people or animals
- must conform to international students
- must be approved by the TGA before they are released on the market
2. Narcotic Drugs Act 1967 - safeguard against illegal manufacture, supply and use - licensed to manufacture narcotic medications
- specific requirements for security, record-keeping, handling, labelling and storage of narcotics
- failure to do this can lead to revocation of license and criminal prosecution
state or territory laws
- at least one Act and a set of regulations to deal with control of medicines; poisons act, poisons regulations
- the Act: separation of available medicines into broad headings according to; the type, issuing of licenses, general restrictions and conditions, documentation of registers and records
- the Regulations: more specific information; authority to prescribe, labelling of medicines, advertising of medicines, manufacture of medicines, packaging and storage of medicines, supply of medicines and administration of medicines
Drug scheduling
- medicines are divided into categories: schedules: - indicates specific medicines by generic name according to potency, therapeutic use, toxicity, additive and abusive potential, safety and modes of action
- medicines with lower safety risks have less rigid control
- schedules vary slightly between States and Territories: number of schedules, their content and meaning
- uniformity: Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
Schedule 2 (S2)
- “pharmacy medicine”
- available to the public only from pharmacies, where a pharmacist’s advice is available if required
- examples: simple analgesics (large pack), some cough and cold preparations, oral antihistamines (large pack); worm treatments, topical antifungal preparations, etc.
Schedule 3
- “pharmacist-only medicine”
- available to the public only from a pharmacist, but no need for a prescription
- requires professional advice and storage must not be accessible to the public
- examples: some asthma aerosols, topical corticosteroids, glucagon, antivirals for cold sores, adrenaline injections, etc.
schedule 4
- “prescription-only medicine”
- may be used/supplied only under prescription from an authorised provider
- must be stored in a dispensary
- in some Australian states, specially qualified nurses, optometrists and podiatrists may prescribe from a limited range of S4-Prescription only drugs
- examples: most drugs - blood pressure medications, cholesterol-lowering medications, antidepressants, antibiotics, insulins, oral contraceptives, etc.
Schedule 8
- ” controlled drug”
- substances that may produce addiction or dependence
- possession without authority is illegal
- drugs must be stored in a locked cabinet and records kept for 2 to 5 years, depending on state
- examples: opioids such as morphine, methadone and fentanyl, central nervous stimulants such as dexamphetamine, cocaine, ketamine, etc.
Restricted Substances S4
- medicines that require a prescription: includes restricted substances, required drugs, prescription drugs, prescription-only medicines and poisons
A. prescriptions - doctors, dentists, veterinary surgeons, certain groups of nurses, nurse practitioners, optometrists and podiatrists
B. emergencies - doctor: can do verbal orders but must document and sign prescription/medication chart within 24 hours
C. Nurses - aside from nurse practitioners, normally nurses do not have the independent authority to administer restricted substances without a medicine order in the doctor’s handwriting - new medicine charts should be transcribed by the doctor
D. pharmacists - in hospitals, pharmacists are responsible for the storage and recording of restricted substances - records to be maintained for at least 3 years
E. security - stored in locked storage facility to prevent unauthorised access - nurse in charge (or nurse working under their supervision) must carry the keys to the locked storage
remote area care
- where access to doctors is limited, nurses are often responsible for diagnosing illnesses and dispensing medicines
- example: isolated areas of Northern Territory, Queensland, Tasmania and Western Australia
- nurses must apply to the relevant health department for an authority to use their extended powers
Controlled drugs (S8)
includes controlled drugs, prohibited substances and drugs of dependence
A. prescriptions - doctors, dentists or veterinary surgeons
- sone nurse practitioners have the authority if it is in their scope of practice
B. emergencies - nurse may administer a controlled drug when verbally instructed by the doctor
- doctor must document instructions within 24 hours
C. security - must be stored in a locked cupboard (safe bolted to concrete wall or floor) away from other medicines
- nurse in charge of ward (or nurse working under their supervision) is authorised to be in possession of and supply these medicines and has full responsibility of the key i.e. RN and safe always locked
D. ward drug book - nursing staff must maintain a ward register for administration of controlled drugs
- good nursing practice: at change of shift, check the balance of each medicine against the number in register
- requirement to check the balance periodically
- disposal of controlled drugs: some states have specific regulations, others use good practice procedures
common law: duty of care
- health professionals should take reasonable care in preventing harm to people from the negligent handling and administration of medicines
- common law recognises that health professionals (nurses) show a reasonable standard and duty of care
- legal requirement that workplace protocols and policies abide by the law
- compliance with these protocols demonstrates relevant care
- do not assume all hospital protocols, etc. comply with relevant legislation
- duty of care relating to: unclear orders, telephone orders, standing orders
unclear orders
- when a medicine order appears unclear, the nurse should question the prescribing doctor about what was intended
- ask the doctor to write the medicine order more clearly
- during an emergency - if the prescribing doctor is unavailable, consult another doctor
- nurses need to be familiar with: standard doses, adverse reactions, contraindications, drug interactions
- if a discrepancy exists, the medicine order should be questioned
telephone orders
- check the policy at your workplace so you know the correct procedure for taking a telephone order
- doctors must confirm verbal orders in writing as soon as practical
- if administration of a medicine is unreasonable, the nurse must query the telephone order
