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?

  • 1 year
  • 4 years
  • 3 years
  • 2 years (correct)
  • What is the purpose of a monthly inventory in pharmacies?

  • To track S8 medicines supplied
  • To record dispensing records
  • To monitor stock levels (correct)
  • To assess compliance with regulations
  • What is the consequence of non-compliance with the Regulations for pharmacists?

  • Restrictions or loss of medicines authorities (correct)
  • Warning letters only
  • Loss of pharmacy license
  • Fine only
  • When must a summary of clinical records of S8 medicines supplied be forwarded to the Department of Health?

    <p>Before the 7th day of the following month</p> Signup and view all the answers

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

    <p>To maintain a record of incoming and outgoing S8 medicines</p> Signup and view all the answers

    What determines how the Act is operationalised?

    <p>The 2016 Medicines &amp; Poisons Regulations</p> Signup and view all the answers

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

    <p>The original and all repeats may be dispensed at one time</p> Signup and view all the answers

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

    <p>Regulation 49</p> Signup and view all the answers

    What should pharmacists strictly adhere to when dispensing medicines?

    <p>The prescriber's instructions for repeat intervals</p> Signup and view all the answers

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

    <p>Their individual profession and any additional training or endorsement</p> Signup and view all the answers

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

    <p>Because it may be requested by the patient alone</p> Signup and view all the answers

    What is the purpose of Structured Administration and Supply Arrangements?

    <p>To regulate the supply of medicines in hospitals and residential settings</p> Signup and view all the answers

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

    <p>Wholesale Licence</p> Signup and view all the answers

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

    <p>Structured Administration and Supply Arrangement</p> 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?

    <p>Schedule 4 or Schedule 8 medicine</p> Signup and view all the answers

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

    <p>They must be appropriately packaged and fully labelled</p> Signup and view all the answers

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

    <p>Purchasing from a registered pharmacy</p> Signup and view all the answers

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

    <p>A valid prescription from an authorised prescriber</p> Signup and view all the answers

    What is the primary format of a valid prescription?

    <p>Handwritten, computer-generated, or electronic</p> Signup and view all the answers

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

    <p>The original and all repeats may be dispensed at one time</p> Signup and view all the answers

    What is the purpose of a medication chart?

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

    What is the restriction on electronic prescriptions?

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

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

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

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

    <p>The authority of health professionals, particularly pharmacists</p> Signup and view all the answers

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

    <p>Their individual profession and additional training or endorsement</p> Signup and view all the answers

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

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

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

    <p>Regulation 49</p> Signup and view all the answers

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

    <p>Because it may lead to misuse or abuse</p> Signup and view all the answers

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

    <p>To outline the authorities of health professionals, particularly pharmacists</p> Signup and view all the answers

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

    <p>Their individual profession and additional training or endorsement</p> Signup and view all the answers

    What information must be included on a handwritten prescription?

    <p>Prescriber's name, address, and telephone number</p> Signup and view all the answers

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

    <p>12 months from the date of issue</p> Signup and view all the answers

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

    <p>Date of birth of the patient</p> Signup and view all the answers

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

    <p>Prescription itself</p> Signup and view all the answers

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

    <p>Not specified</p> Signup and view all the answers

    In what language must handwritten prescriptions be written?

    <p>English only</p> Signup and view all the answers

    Which health professionals can obtain medicines from a pharmaceutical wholesaler?

    <p>All health professionals listed in the table</p> Signup and view all the answers

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

    <p>Can only administer medicines under the instruction of a prescriber</p> Signup and view all the answers

    Which of the following health professionals can dispense medicines?

    <p>All health professionals listed in the table</p> Signup and view all the answers

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

    <p>Can supply, administer, and dispense medicines</p> Signup and view all the answers

    What is the authority of an Endorsed practitioner?

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

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

    <p>Can administer, supply, and dispense medicines to animals</p> Signup and view all the answers

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

    <p>To maintain accurate clinical records</p> Signup and view all the answers

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

    <p>Monthly</p> Signup and view all the answers

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

    <p>They may face restrictions or loss of medicines authorities</p> Signup and view all the answers

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

    <p>5 years</p> Signup and view all the answers

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

    <p>A register of transactions</p> Signup and view all the answers

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

    <p>To monitor compliance with the Regulations</p> Signup and view all the answers

    What is the format of a valid prescription?

    <p>Any of the above or electronic</p> Signup and view all the answers

    What is the authority of pharmacists in Western Australia?

    <p>Specific authorities under Medicines and Poisons Regulations 2016</p> Signup and view all the answers

    What is the purpose of a medication chart?

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

    What determines how the Act is operationalized?

    <p>The Medicines and Poisons Regulations 2016</p> Signup and view all the answers

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

    <p>Specific authorities under Medicines and Poisons Regulations 2016</p> Signup and view all the answers

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

    <p>To regulate the sale, supply, and use of medicines and poisons</p> Signup and view all the answers

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

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

    How long are prescriptions for Schedule 4 medicines valid for?

    <p>Less than 12 months from the date of issue</p> Signup and view all the answers

    What is required for handwritten prescriptions?

    <p>They must be written in English and signed by the prescriber</p> Signup and view all the answers

    What is a requirement for computer-generated prescriptions?

    <p>They must be personally generated by the prescriber</p> Signup and view all the answers

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

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

    How long are prescriptions for Schedule 8 medicines valid for?

    <p>Less than 6 months from the date of issue</p> Signup and view all the answers

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

    <p>The original and all repeats may be dispensed at one time</p> Signup and view all the answers

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

    <p>Their individual profession and any additional training or endorsement</p> Signup and view all the answers

    What should pharmacists strictly adhere to when dispensing medicines?

    <p>The repeat intervals, unless directly instructed to vary</p> Signup and view all the answers

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

    <p>To ensure the safe use of medicines</p> Signup and view all the answers

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

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

    What do Structured Administration and Supply Arrangements facilitate?

    <p>The safe use of medicines in various settings</p> Signup and view all the answers

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

    <p>Pharmacist</p> Signup and view all the answers

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

    <p>Obtain, possess, and administer only</p> Signup and view all the answers

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

    <p>All health professionals</p> Signup and view all the answers

    What is the authority of an Endorsed practitioner regarding medicines?

    <p>Obtain, possess, prescribe, and supply</p> Signup and view all the answers

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

    <p>Under Structured Administration and Supply Agreements</p> Signup and view all the answers

    What is the authority of a Veterinary surgeon regarding medicines?

    <p>Obtain, possess, administer, and supply</p> Signup and view all the answers

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

    <p>A therapeutic product from several substances</p> Signup and view all the answers

    Under what arrangement can a pharmacist administer a flu vaccination?

    <p>Structured Administration and Supply Arrangement (SASA)</p> Signup and view all the answers

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

    <p>The medicine must be packaged and labelled according to regulations</p> Signup and view all the answers

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

    <p>A Schedule 4 or Schedule 8 medicine</p> Signup and view all the answers

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

    <p>A Wholesale Licence</p> Signup and view all the answers

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

    <p>Purchase, possess, administer, supply, or dispense</p> Signup and view all the answers

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

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

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

    <p>To establish uniform labelling requirements for medicines and poisons</p> Signup and view all the answers

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

    <p>All warnings and dosage instructions must be visible</p> Signup and view all the answers

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

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

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

    <p>Labels must be in English and meet uniform standards</p> Signup and view all the answers

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

    <p>All of the above</p> Signup and view all the answers

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

    <p>Species of animal and owner's name</p> Signup and view all the answers

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

    <p>To alert users to potential poisoning hazards</p> Signup and view all the answers

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

    <p>English only</p> Signup and view all the answers

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

    <p>Strength and form of the medicine, and active ingredient names</p> Signup and view all the answers

    What is the requirement for labeling oral retinoids?

    <p>A pregnancy warning</p> Signup and view all the answers

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

    <p>To indicate the medicine is for topical use only</p> Signup and view all the answers

    Which medicines require a sedation warning label?

    <p>Only medicines listed in Appendix K of the SUSMP</p> Signup and view all the answers

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

    <p>To provide cautionary advice for patients</p> Signup and view all the answers

    Where can healthcare professionals find guides on medicines and poisons?

    <p>Health Department of Western Australia website</p> Signup and view all the answers

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

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

    Which poisons can be sold without a licence?

    <p>Schedule 6 poisons</p> Signup and view all the answers

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

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

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

    <p>Labels and containers must comply with the 2016 Poisons Regulations</p> Signup and view all the answers

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

    <p>Because they are already licensed under the Pharmacy Act 2010</p> 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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    Test your knowledge on pharmacists' authority and record-keeping responsibilities for Schedule 2, 3, 4, and 8 medicines. Learn about the requirements for dispensing records, prescription books, and retention periods.

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