PP2 Poisons Regulations Part 1 2020 PDF

WA Medicines & Poisons Regulations – Part 1 Andrew Stafford Acknowledgement: Shelley Appleton WARNING This material has been reproduced and communicated to you by or on behalf of Curtin University in accordance with section 113P of the Copyright Act 1968 (the Act) The material in this communication...

WA Medicines & Poisons Regulations – Part 1 Andrew Stafford Acknowledgement: Shelley Appleton WARNING This material has been reproduced and communicated to you by or on behalf of Curtin University in accordance with section 113P of the Copyright Act 1968 (the Act) The material in this communication may be subject to copyright under the Act. Any further reproduction or communication of this material by you may be the subject of copyright protection under the Act. Do not remove this notice. Learning objectives By viewing this lecture, you should be able to ◼ List the legal requirements of prescriptions ◼ Describe the legal requirements for medication charts ◼ Outline the specific authorities of health professionals, particularly pharmacists, in Western Australia Medicines and Poisons Regulations 2016 ◼ Topics covered ◼ Requirements of prescriptions ◼ Authorities for health practitioners working with medicines ◼ Types of medicine authorities ◼ Authority of pharmacists ◼ Licences and permits ◼ Poisons regulation – sale, supply & use of poisons ◼ Poisons regulation – drugs of addiction Requirements for prescriptions ◼ Form of prescription ◼ Valid prescriptions may be handwritten, computer generated or electronic. A medication chart may be used for patients in hospital at discharge or for supply to patient in a residential care facility. ◼ Electronic prescriptions may only be issued on a system approved by the Department of Health. Handwritten prescriptions, must be written in ink, in English, in the prescribers own handwriting and signed by the prescriber. Computer generated prescriptions must be personally generated by the prescriber and signed https://ww2.health.wa.gov.au/Articles/N_R/Requirements-forprescriptions-in-Western-Australia Requirements for prescriptions (cont) ◼ Prescriptions must include the following information: ◼ ◼ ◼ ◼ ◼ ◼ ◼ ◼ ◼ the name, address and telephone number of the prescriber; the date on which the document is issued; the name and address of the patient for whom the medicine is prescribed or, in the case of 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; if the document is for the supply of a medicine that is a Schedule 8 poison and is not for veterinary use — the date of birth of the patient; a description and the quantity, dose, strength and form of each medicine that is to be supplied; precise directions for use of each medicine that is to be supplied; if the document provides for the medicine to be supplied on more than one occasion — the maximum number of times it may be supplied; if the document is for the supply of a medicine that is a Schedule 8 poison on more than one occasion — the intervals at which it may be supplied; If a document, it should be signed by a prescriber https://ww2.health.wa.gov.au/Articles/N_R/Requirements-forprescriptions-in-Western-Australia Requirements for prescriptions (cont) ◼ Expiry of prescriptions: Prescriptions must be less than 12 months old from the date of issue for a Schedule 4 (S4) medicine and less than 6 months old for Schedule 8 (S8) medicines. A prescription for a S8 medicine may not include a S4 medicine. These should be written on separate documents. ◼ Veterinary prescriptions: must be marked as for veterinary or animal use only. ◼ Interstate prescriptions: can be dispensed in Western Australia if they meet WA requirements. Special rules apply to restricted S8 medicines https://ww2.health.wa.gov.au/Articles/N_R/Requirements-forprescriptions-in-Western-Australia Requirements for prescriptions (cont) ◼ Invalid prescriptions: Prescriptions that are not valid cannot be made valid by addition of information by the pharmacist. For invalid prescriptions, the pharmacist should either: ◼ Return the prescription for correction; ◼ Cancel the prescription and request a new prescription; or Take an instruction for emergency supply, dispense, and await the written confirmation (as below). ◼ ◼ Schedule 8 prescriptions: The pharmacist must be satisfied as to the authenticity of the prescription, identity of the person presenting the prescription, and bona fides of the prescriber. Unless the prescription is electronically prescribed, has been checked using a prescription exchange scanning barcode, or the patient is well known and has had the items prescribed previously, the pharmacist should contact the prescriber to confirm the authenticity of the script. Prescriptions determined to not be genuine, must be cancelled and retained. The Department of Health must be notified of all forged prescriptions. ◼ Schedule 8 prescriptions: After the original dispensing of a Schedule 8 prescription, any authorised repeats must be retained at the pharmacy. ◼ https://ww2.health.wa.gov.au/Articles/N_R/Requirements-forprescriptions-in-Western-Australia Schedule 4 Schedule 8 Dispensing medicines ◼ Upon dispensing the following information should be marked on the prescription (or recoded in an electronic prescribing system): ◼ ◼ ◼ ◼ prescription reference number; quantity dispensed; date dispensed; and name and address of pharmacy. ◼ Prescriptions should be marked as cancelled when all authorised supplies and repeats have been exhausted. Prescriptions marked with instructions for “limited dispensing” or “staged supply” at daily or weekly intervals, may only dispensed in accordance with these instructions. ◼ Pharmacists must make a record of the supply in the patient’s clinical record (i.e. the pharmacy electronic dispensing system). The records must include the date supplied, quantity supplied and prescription reference number. https://ww2.health.wa.gov.au/~/media/Files/Corporate/general%20documents/medicines%20and%20poisons/Word/Dispensingprescriptions.doc Dispensing medicines (cont) Dispensing repeats ◼ the prescription authorises repeat supply, the pharmacist must prepare and provide a duplicate of the prescription to the patient. This document must include the number of times the script has already been dispensed. ◼ Prescriptions endorsed with “Reg 24” mean that the original and all repeats may be dispensed at one time. ◼ ◼ Regulation 24 refers to Commonwealth PBS rules and is not a WA restriction; from 2017 “Regulation 24” became “Regulation 49” Repeat intervals, where indicated must be strictly adhered to, unless there is direct instruction received from the prescriber to vary these. Pharmacists are cautioned against varying supply intervals for S8 medicines, particularly on the request of the patient alone. Hospital & Residential Medication Charts ◼ ◼ ◼ Structured Administration and Supply Arrangements ◼ ◼ ◼ ◼ ◼ ◼ ◼ Medicine authority for different health practitioners ◼ Under the Medicines and Poisons Regulations, health practitioners are legally authorised to undertake various activities things 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 (e.g. endorsed health practitioners) https://ww2.health.wa.gov.au/Articles/N_R/Requirements-forprescriptions-in-Western-Australia Authorities ◼ ◼ ◼ ◼ ◼ ◼ Types of medicine authorities Possible types of medicines authorities include: ◼ obtain (also called purchase) – legally buy medicines from a pharmaceutical wholesaler ◼ possess – store a medicine for later use ◼ prescribe – write a prescription to instruct a pharmacist to dispense a medicine ◼ administer – administer a dose of a medicine to a patient when instructed by prescriber ◼ supply – when a prescriber gives a quantity of medicine to a patient to take ◼ dispense – when a pharmacist supplies on the instruction of a prescription Types of authorities for different health professions Practitioner type Obtain Possess Administer Supply Dispense Pharmacist Y Y Y Y Y Medical practitioner Y Y Y Y Y Veterinary surgeon Y Y Y Y Y Dentist Y Y Y Y Y Nurse/Midwife Y Y Optometrist Y Y Podiatrist Y Y Y Y Y Y Paramedic Y Y Aboriginal health practitioner/worker Y Y Anaesthetic technician Y Y Y Y Endorsed practitioner* Vessel first aider Y Y *Nurse, Midwife, Optometrist, Podiatrist Some professions can also supply in limited circumstances under Structured Administration and Supply Agreements. For clarity, some restricted authorities are not listed here. https://ww2.health.wa.gov.au/Articles/A_E/Authorities-forhealth-practitioners-working-with-medicines Prescribe Authority of pharmacists ◼ Pharmacists, registered with the Pharmacy Board of Australia, have various authorities under the Medicines and Poisons Regulations 2016 to purchase, possess, administer (in accordance with SASA on flu vaccinations), supply and dispense in accordance with the Regulations ◼ Pharmacists can also manufacture a medicine, which may include taking several substances and turning this into therapeutic product. ◼ Purchasing medicines: Pharmacists may purchase medicines to use, dispense or supply from a registered pharmacy. Authority of pharmacists (cont) ◼ Supply and prescription: ◼ ◼ ◼ ◼ ◼ Pharmacists may dispense a Schedule 4 (S4) or Schedule 8 (S8) medicine in accordance with their authority, and on the direction of an authorised prescriber via a valid prescription. A pharmacist may supply a S4 or S8 to an authorised professional (e.g. doctors bag supplies), according to the Regulations. Wholesaling activities are not permitted unless the pharmacy business also holds a Wholesale Licence. A pharmacist may administer a Schedule 4 medicine in accordance with a Structured Administration and Supply Arrangement (e.g. influenza vaccine). Any medicine dispensed or supplied must be appropriately packaged and fully labelled according to regulations. Pharmacists may supply Schedule 2 and Schedule 3 medicines by retail sale, in accordance with their authority Authority of pharmacists (cont) ◼ Recording ◼ ◼ ◼ Pharmacists must make accurate clinical records (e.g. dispensing records / “prescription book”) of all medicines administered, dispensed or supplied and retain these for at least 2 years for S4 medicines, or 5 years for S8 medicines. All records must be available to be produced if demanded by an authorised officer of the Department of Health. A register of transactions, kept in an approved manner and form, must be maintained for all incoming and outgoing S8 medicines. A monthly inventory must be also performed. When S8 medicines are supplied, a summary of clinical records of S8 medicines supplied for the month must be forwarded to the Department of Health, before the seventh day of the following month. Authority of pharmacists (cont) ◼ Compliance assessment ◼ Pharmacies and pharmacists may be required to participate in routine audit assessments to monitor compliance with these requirements. ◼ Non-compliance with the Regulations may result in regulatory actions such as restrictions or loss of medicines authorities, notification to the Pharmacy Board of Australia, and/or prosecution under the legislation. Key points ◼ The 2016 Medicines & Poisons Regulations determine how the Act is operationalised ◼ Details include requirements for ◼ Prescriptions and charting ◼ Dispensing ◼ Authorities Key references ◼ ◼ ◼ ◼