Medicines and Poisons (WA) Regulations

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Questions and Answers

What is the minimum period for which pharmacists must retain records of S4 medicines?

2 years

What is the purpose of a monthly inventory in pharmacies?

To monitor stock levels

What is the consequence of non-compliance with the Regulations for pharmacists?

Restrictions or loss of medicines authorities

When must a summary of clinical records of S8 medicines supplied be forwarded to the Department of Health?

Before the 7th day of the following month Signup and view all the answers

What is the purpose of a register of transactions for S8 medicines?

To maintain a record of incoming and outgoing S8 medicines Signup and view all the answers

What determines how the Act is operationalised?

The 2016 Medicines & Poisons Regulations Signup and view all the answers

What does 'Reg 24' endorsement on a prescription signify?

The original and all repeats may be dispensed at one time Signup and view all the answers

What is the current regulation number that replaced 'Reg 24' in 2017?

Regulation 49 Signup and view all the answers

What should pharmacists strictly adhere to when dispensing medicines?

The prescriber's instructions for repeat intervals Signup and view all the answers

What is the primary factor in determining a health practitioner's authority to purchase, prescribe, or administer medicines?

Their individual profession and any additional training or endorsement Signup and view all the answers

Why should pharmacists be cautious when varying supply intervals for S8 medicines?

Because it may be requested by the patient alone Signup and view all the answers

What is the purpose of Structured Administration and Supply Arrangements?

To regulate the supply of medicines in hospitals and residential settings Signup and view all the answers

What type of license is required for a pharmacy business to engage in wholesaling activities?

Wholesale Licence Signup and view all the answers

Under what arrangement can a pharmacist administer a Schedule 4 medicine?

Structured Administration and Supply Arrangement Signup and view all the answers

What type of medicine can a pharmacist supply to an authorised professional, such as a doctor, according to the Regulations?

Schedule 4 or Schedule 8 medicine Signup and view all the answers

What is a requirement for medicines dispensed or supplied by a pharmacist?

They must be appropriately packaged and fully labelled Signup and view all the answers

What is a pharmacist's authority to purchase medicines limited to?

Purchasing from a registered pharmacy Signup and view all the answers

What is a requirement for a pharmacist to dispense a Schedule 4 medicine?

A valid prescription from an authorised prescriber Signup and view all the answers

What is the primary format of a valid prescription?

Handwritten, computer-generated, or electronic Signup and view all the answers

What does the endorsement “Reg 24” on a prescription indicate?

The original and all repeats may be dispensed at one time Signup and view all the answers

What is the purpose of a medication chart?

For both patients in hospital at discharge and in residential care facilities Signup and view all the answers

What is the restriction on electronic prescriptions?

They can only be issued on a system approved by the Department of Health Signup and view all the answers

What is a pharmacist's responsibility when varying supply intervals for S8 medicines?

To strictly adhere to the original interval unless directed otherwise by the prescriber Signup and view all the answers

What is the main focus of the Medicines and Poisons Regulations 2016?

The authority of health professionals, particularly pharmacists Signup and view all the answers

What determines the authority of a health practitioner to purchase, prescribe, or administer medicines?

Their individual profession and additional training or endorsement Signup and view all the answers

What is the relationship between the legal requirements of prescriptions and medication charts?

A medication chart is an alternative to a prescription in certain situations Signup and view all the answers

What is the current regulation number that replaced 'Reg 24' in 2017?

Regulation 49 Signup and view all the answers

Why are pharmacists cautioned when varying supply intervals for S8 medicines?

Because it may lead to misuse or abuse Signup and view all the answers

What is the main purpose of the Medicines and Poisons Regulations 2016?

To outline the authorities of health professionals, particularly pharmacists Signup and view all the answers

Under the Medicines and Poisons Regulations, what authorizes health practitioners to undertake activities with medicines?

Their individual profession and additional training or endorsement Signup and view all the answers

What information must be included on a handwritten prescription?

Prescriber's name, address, and telephone number Signup and view all the answers

What is the time limit for a Schedule 4 medicine prescription to be less than?

12 months from the date of issue Signup and view all the answers

What is required for the supply of a Schedule 8 poison medicine?

Date of birth of the patient Signup and view all the answers

What must be personally generated by the prescriber for computer-generated prescriptions?

Prescription itself Signup and view all the answers

How often must a summary of clinical records of S8 medicines be forwarded to the Department of Health?

Not specified Signup and view all the answers

In what language must handwritten prescriptions be written?

English only Signup and view all the answers

Which health professionals can obtain medicines from a pharmaceutical wholesaler?

All health professionals listed in the table Signup and view all the answers

What is the authority of a Paramedic in terms of medicine administration?

Can only administer medicines under the instruction of a prescriber Signup and view all the answers

Which of the following health professionals can dispense medicines?

All health professionals listed in the table Signup and view all the answers

What is the authority of a Podiatrist in terms of medicine supply?

Can supply, administer, and dispense medicines Signup and view all the answers

What is the authority of an Endorsed practitioner?

Has limited authority, but can supply in limited circumstances under certain agreements Signup and view all the answers

What is the authority of a Veterinary surgeon in terms of medicine administration?

Can administer, supply, and dispense medicines to animals Signup and view all the answers

What is the purpose of recording all medicines administered, dispensed, or supplied by pharmacists?

To maintain accurate clinical records Signup and view all the answers

How often must a pharmacist perform an inventory for S8 medicines?

Monthly Signup and view all the answers

What may happen to pharmacists who fail to comply with the Regulations?

They may face restrictions or loss of medicines authorities Signup and view all the answers

What is the minimum period for which pharmacists must retain records of S8 medicines?

5 years Signup and view all the answers

What is required to be maintained for all incoming and outgoing S8 medicines?

A register of transactions Signup and view all the answers

Why may pharmacists be required to participate in routine audit assessments?

To monitor compliance with the Regulations Signup and view all the answers

What is the format of a valid prescription?

Any of the above or electronic Signup and view all the answers

What is the authority of pharmacists in Western Australia?

Specific authorities under Medicines and Poisons Regulations 2016 Signup and view all the answers

What is the purpose of a medication chart?

For both hospital patients at discharge and those in residential care facilities Signup and view all the answers

What determines how the Act is operationalized?

The Medicines and Poisons Regulations 2016 Signup and view all the answers

What is required for the supply of a Schedule 8 poison medicine?

Specific authorities under Medicines and Poisons Regulations 2016 Signup and view all the answers

What is the purpose of the Medicines and Poisons Regulations 2016?

To regulate the sale, supply, and use of medicines and poisons Signup and view all the answers

What information must be included on a prescription for a Schedule 8 poison?

The patient's date of birth and the prescriber's telephone number Signup and view all the answers

How long are prescriptions for Schedule 4 medicines valid for?

Less than 12 months from the date of issue Signup and view all the answers

What is required for handwritten prescriptions?

They must be written in English and signed by the prescriber Signup and view all the answers

What is a requirement for computer-generated prescriptions?

They must be personally generated by the prescriber Signup and view all the answers

What information must be included on a prescription for a medicine that is prescribed for veterinary use?

The species of animal to be treated and the name and address of the person who has the care of the animal Signup and view all the answers

How long are prescriptions for Schedule 8 medicines valid for?

Less than 6 months from the date of issue Signup and view all the answers

What does the endorsement 'Reg 24' on a prescription indicate?

The original and all repeats may be dispensed at one time Signup and view all the answers

What determines a health practitioner's authority to purchase, prescribe, or administer medicines?

Their individual profession and any additional training or endorsement Signup and view all the answers

What should pharmacists strictly adhere to when dispensing medicines?

The repeat intervals, unless directly instructed to vary Signup and view all the answers

What is the primary purpose of the Medicines and Poisons Regulations?

To ensure the safe use of medicines Signup and view all the answers

Why should pharmacists be cautious when varying supply intervals for S8 medicines?

Because it may lead to abuse or misuse of the medicine Signup and view all the answers

What do Structured Administration and Supply Arrangements facilitate?

The safe use of medicines in various settings Signup and view all the answers

Which healthcare professional can obtain, possess, prescribe, supply, and dispense medicines?

Pharmacist Signup and view all the answers

What is the authority of a Nurse/Midwife regarding medicines?

Obtain, possess, and administer only Signup and view all the answers

Which of the following health professionals can administer medicines to patients?

All health professionals Signup and view all the answers

What is the authority of an Endorsed practitioner regarding medicines?

Obtain, possess, prescribe, and supply Signup and view all the answers

Which health professionals can supply medicines to patients in limited circumstances?

Under Structured Administration and Supply Agreements Signup and view all the answers

What is the authority of a Veterinary surgeon regarding medicines?

Obtain, possess, administer, and supply Signup and view all the answers

What can pharmacists manufacture under the Medicines and Poisons Regulations 2016?

A therapeutic product from several substances Signup and view all the answers

Under what arrangement can a pharmacist administer a flu vaccination?

Structured Administration and Supply Arrangement (SASA) Signup and view all the answers

What is a requirement for medicines dispensed or supplied by a pharmacist?

The medicine must be packaged and labelled according to regulations Signup and view all the answers

What can a pharmacist supply to an authorised professional, such as a doctor, according to the Regulations?

A Schedule 4 or Schedule 8 medicine Signup and view all the answers

What is necessary for a pharmacy business to engage in wholesaling activities?

A Wholesale Licence Signup and view all the answers

What can a pharmacist do to a medicine, under the Medicines and Poisons Regulations 2016?

Purchase, possess, administer, supply, or dispense Signup and view all the answers

What is the requirement for labels on poisons intended for consumer use?

The signal heading, safety directions, and the name and address of the manufacturer or distributor Signup and view all the answers

What is the purpose of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)?

To establish uniform labelling requirements for medicines and poisons Signup and view all the answers

What is the requirement for labels on medicines supplied in the manufacturer's original pack?

All warnings and dosage instructions must be visible Signup and view all the answers

What is the requirement for labels on registered pesticides, including home garden products?

The label must be approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA) Signup and view all the answers

What is the requirement for labelling medicines and poisons in Australia?

Labels must be in English and meet uniform standards Signup and view all the answers

What information must be included on labels for dispensed medicines in Australia?

All of the above Signup and view all the answers

What is a requirement for labels on medicines supplied for animal treatment?

Species of animal and owner's name Signup and view all the answers

What is the purpose of the label statement 'KEEP OUT OF REACH OF CHILDREN'?

To alert users to potential poisoning hazards Signup and view all the answers

What is the language requirement for labels on dispensed medicines in Australia?

English only Signup and view all the answers

What information must be included on labels for PBS and RPBS medicines?

Strength and form of the medicine, and active ingredient names Signup and view all the answers

What is the requirement for labeling oral retinoids?

A pregnancy warning Signup and view all the answers

What is the purpose of the “FOR EXTERNAL USE ONLY” or “POISON” label?

To indicate the medicine is for topical use only Signup and view all the answers

Which medicines require a sedation warning label?

Only medicines listed in Appendix K of the SUSMP Signup and view all the answers

What is the purpose of the Pharmacy cautionary advisory label 1 or label 1A?

To provide cautionary advice for patients Signup and view all the answers

Where can healthcare professionals find guides on medicines and poisons?

Health Department of Western Australia website Signup and view all the answers

What is the main purpose of a licence under the Medicines and Poisons Act 2014?

To ensure businesses that sell medicines and poisons by wholesale or retail comply with regulations Signup and view all the answers

Which poisons can be sold without a licence?

Schedule 6 poisons Signup and view all the answers

What is the purpose of a permit for Schedule 7 poisons?

To enable individuals to use Schedule 7 poisons for their work Signup and view all the answers

What is the requirement for labelling and containers of medicines and poisons?

Labels and containers must comply with the 2016 Poisons Regulations Signup and view all the answers

Why do retail pharmacies not need a licence under the Medicines and Poisons Act 2014?

Because they are already licensed under the Pharmacy Act 2010 Signup and view all the answers

Study Notes

Prescriptions and Medication Charts

Prescriptions can be handwritten, computer-generated, or electronic.
Medication charts may be used for patients in hospital at discharge or for supply to patients in a residential care facility.
Electronic prescriptions may only be issued on a system approved by the Department of Health.

Requirements for Prescriptions

Prescriptions must be written in ink, in English, in the prescriber's own handwriting, and signed by the prescriber.
Prescriptions must include the following information:
- Name, address, and telephone number of the prescriber
- Date on which the document is issued
- Name and address of the patient for whom the medicine is prescribed
- Description and quantity, dose, strength, and form of each medicine
- Precise directions for use of each medicine that is to be supplied
- Maximum number of times the medicine may be supplied
- Intervals at which the medicine may be supplied if it is a Schedule 8 poison

Expiry of Prescriptions

Prescriptions must be less than 12 months old from the date of issue for a Schedule 4 (S4) medicine.
Prescriptions must be less than 6 months old for Schedule 8 (S8) medicines.

Authorities for Health Practitioners

Health practitioners are legally authorized to undertake various activities with medicines, such as purchase, prescribe, or administer.
What a practitioner can do is dependent on their individual profession and any additional training or endorsement they hold.

Types of Medicine Authorities

Possible types of medicine authorities include:
- Obtain (also called purchase)
- Possess
- Prescribe
- Administer
- Supply
- Dispense

Authority of Pharmacists

Pharmacists may supply Schedule 2 and Schedule 3 medicines by retail sale, in accordance with their authority.
Pharmacists must make accurate clinical records of all medicines administered, dispensed, or supplied and retain these for at least 2 years for S4 medicines, or 5 years for S8 medicines.
Pharmacists may dispense a Schedule 4 (S4) or Schedule 8 (S8) medicine in accordance with their authority, and on the direction of an authorized prescriber via a valid prescription.

Labels for Poisons and Medicines

Labels for poisons and medicines must be written in English and meet uniform Australian standards on text size, language, and warnings.
Poisons must be labelled in accordance with Part 2 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).
Medicines in Schedule 2 and Schedule 3 should be supplied in the manufacturer's original pack with all warnings and dosage instructions visible.
Pseudoephedrine products must be labelled with the name and address of the supplying pharmacy and the transaction code generated by Project STOP.### Prescription Endorsements
Prescriptions endorsed with "Reg 24" (now "Reg 49" since 2017) allow for the original and all repeats to be dispensed at once.
Repeat intervals must be strictly adhered to, unless directly instructed by the prescriber to vary.

Medicine Authorities

Health practitioners are legally authorized to undertake various activities with medicines, such as purchase, prescribe, administer, or supply, depending on their profession and additional training.
Types of medicine authorities include:
- Obtain (purchase) from a pharmaceutical wholesaler
- Possess (store for later use)
- Prescribe (write a prescription to instruct a pharmacist)
- Administer (give a dose of medicine to a patient)
- Supply (give a quantity of medicine to a patient)
- Dispense (supply a medicine based on a prescription)

Authorities for Different Health Professions

Practitioners with specific authorities include:
- Pharmacists: obtain, possess, administer, supply, and dispense
- Medical practitioners: obtain, possess, administer, supply, and dispense
- Veterinary surgeons: obtain, possess, administer, supply, and dispense
- Dentists: obtain, possess, administer, supply, and dispense
- Nurses/Midwives: obtain, possess, and administer (with some supply authority)
- Optometrists: obtain and possess
- Podiatrists: obtain, possess, administer, supply, and dispense
- Paramedics: obtain and possess
- Aboriginal health practitioners/workers: obtain and possess
- Anaesthetic technicians: obtain, possess, administer, and supply
- Endorsed practitioners: vary depending on profession
- Vessel first aiders: obtain and possess

Pharmacists' Authorities

Pharmacists registered with the Pharmacy Board of Australia have authorities under the Medicines and Poisons Regulations 2016 to:
- Purchase, possess, administer, supply, and dispense medicines
- Manufacture medicines (e.g., combining substances into a therapeutic product)
- Purchase medicines from a registered pharmacy for use, dispensing, or supplying
- Dispense Schedule 4 (S4) or Schedule 8 (S8) medicines with a valid prescription
- Supply S4 or S8 medicines to authorized professionals (e.g., doctors' bag supplies)
- Administer Schedule 4 medicines according to a Structured Administration and Supply Arrangement (e.g., influenza vaccine)

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