PP2 Poisons Regulations Part 2 2020_Updated Labelling.pdf

WA Medicines & Poisons Regulations – Part 2 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 2 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 ◼ Describe the various licences and permits issued under the 2016 Poisons Regulations ◼ Discuss the requirements for labelling and containers as mandated by the 2016 Poisons Regulations Medicines & Poisons Regulations 2016 Topics covered ◼ Licences and permits ◼ Licence types ◼ Permit types ◼ Containers for poisons ◼ Containers for medicines ◼ Labels for poisons and medicines Licences and permits ◼ Businesses that sell medicines and poisons by wholesale or retail require a licence under the Medicines and Poisons Act 2014. ◼ Poisons in Schedule 5 (labelled “Caution”) and Schedule 6 (labelled “Poison”) can be sold without a licence. Retail pharmacies do not need a licence because they are already licensed under the Pharmacy Act 2010. ◼ Those wanting to use Schedule 7 poisons (also known as Dangerous Poisons) for their work will usually need a permit to be able to purchase these poisons. There are some exceptions – for example, farmers and pastoralists can purchase most registered agricultural pesticides in Schedule 7 for use on their property without requiring a permit. Licences and permits (cont) ◼ Those using medicines and poisons in research and educational settings will also need a permit to be able to purchase these substances. ◼ Permits allow purchase of the substances listed on the permit from a licensed supplier and storage at the premises listed on the permit. Permits do not allow resale and will be issued for a specified use. Permits may be issued for a single chemical, such as hydrofluoric acid for cleaning stainless steel welds, or for a range of substances, such as all medicines in Schedules 2, 3, 4 and 8 at a hospital. Licence types ◼ Wholesaler’s/manufacturer’s licence ◼ ◼ Indent licence ◼ ◼ Allows the business to sell medicines or poisons via a third party. Those holding an indent licence do not physically handle the medicines or poisons. Licensees need the skills to assess whether their clients are authorised to purchase medicines or poisons. Schedule 7 retail licence ◼ ◼ Allows the business to manufacture and/or sell medicines and poisons by wholesale to authorised purchasers, such as businesses with a permit. Allows the business to sell Schedule 7 poisons to those authorised to purchase them. Most Schedule 7 retail licences are issued for supply of agricultural chemicals. Schedule 2 retail licence ◼ Allows businesses located in rural and remote areas to sell Schedule 2 medicines, which would normally only be available for consumers to purchase from pharmacies. These licences will be issued where the business is more than 25 km from the nearest community pharmacy Permit types ◼ Health service permit ◼ ◼ Government permit ◼ ◼ For purchase of medicines by health services such as medical practices, private hospitals and businesses providing health care to remote worksites. There are also permits for public hospitals and other public sector agencies providing health services. For purchase of medicines or poisons by government departments for operational work or research and education. Industrial permit ◼ For purchase of poisons by businesses for industrial type uses. These permits are mainly issued for Schedule 7 poisons such as hydrofluoric acid, chlorine gas and cyanide. Permit types (cont) ◼ Research/education permit ◼ ◼ Stockfeed manufacture permit ◼ ◼ For purchase of medicines or poisons for education or research, such as at a school or university. Allows stockfeed manufacturers to purchase antibiotics to mix into stockfeed, on the order of a veterinary surgeon. Veterinary practice permit ◼ For purchase of veterinary drugs by veterinary clinics and hospitals. Mobile vets also require this type of permit. Permit types (cont) ◼ ◼ Pharmaceutical samples permit ◼ Allows representatives of pharmaceutical companies to store and carry samples and provide them to authorised health professionals, such as medical practitioners. ◼ Subject to the condition that the permit holder must comply with the following requirements in relation to the transport and storage of pharmaceutical samples — a) samples must be stored at the specified premises except when the permit holder is carrying them in a vehicle in the course of the permit holder’s business; b) the samples must be stored at the specified premises in a locked cabinet or refrigerator; c) not more than 100 samples of any single medicine or samples of not more than 5 different medicines may be stored at the specified premises at any one time; d) not more than 25 samples of any single medicine or samples of not more than 5 different medicines may be carried in a vehicle at any one time. e) Records must be kept for 2 years “Pharmaceutical sample” ◼ means a sample package — (a) that contains a medicine that is a Schedule 2, 3 or 4 poison; and (b) that is — (i) up to one- third of the size of the smallest trade pack of the medicine; or (ii) if it is not practical to produce a pack that is one-third of the size of the smallest trade pack of the medicine — the smallest trade pack of the medicine. Containers for poisons ◼ Poisons must be stored, supplied and transported in containers that comply with Part 2 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) ◼ A feature of containers for poisons is the presence of tactile identification. For Schedule 6 poisons this comprises the word “poison” and ribs on the side of the container or the word “poison” embossed on the shoulder of the container. ◼ The SUSMP includes a list of Schedule 5 and Schedule 6 poisons that require child resistant closures and detailed information about the packaging of particular poisons, such as naphthalene (moth balls). ◼ Poison containers must be readily distinguishable from containers used for food and drink. ◼ Registered pesticides will be supplied in packaging approved by the Australian Pesticides and Veterinary Medicines Authority. Containers for medicines ◼ Wherever possible, medicines should be supplied to patients in the manufacturer’s original packaging. This is particularly important for Schedule 2 and Schedule 3 medicines where the manufacturer’s packaging includes warnings and dosing instructions. ◼ If a part-pack must be supplied, a health professional must not supply in a paper or plastic bag, envelope or a cardboard box unless the medicine is also strip or blister packaged. Where the manufacturer’s original pack includes a child resistant closure (CRC), the medicine should also be supplied to patients with a CRC in place. Labels for poisons & medicines ◼ All medicines and poisons containers must be labelled so as to clearly identify the contents. This is important to prevent inadvertent consumption and poisoning. Labels must meet uniform Australian standards on text size, language and warnings. Labels for poisons ◼ Poisons must be labelled in accordance with Part 2 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). ◼ The SUSMP stipulates that labels must be in English and there are also rules about the size and visibility of the words printed on labels. ◼ Poisons for use by consumers must be labelled with the appropriate signal heading (“Caution” for Schedule 5 and Poison for Schedule 6), the words “Keep out of reach of children”, the names, strength and quantity of the poisons in the product, relevant first aid and safety directions and the name and street address of the manufacturer or distributor in Australia. Certain poisons will require additional information on their labels. ◼ Registered pesticides, including home garden products, will have labels approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Labels for over the counter medicines ◼ 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 Labels for dispensed medicines ◼ Prescription medicines and controlled drugs supplied to patients by both pharmacists and prescribers (including veterinary surgeons) must be labelled in accordance with Appendix L of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). ◼ Labels must be in English and include the following information: ◼ ◼ ◼ ◼ ◼ ◼ ◼ ◼ “KEEP OUT OF REACH OF CHILDREN” (in red on a white background) generic or brand name of the medicine NOTE: The Australian Government mandated that from 1st February 2021, prescribers must include strength and form of the medicine the active ingredient names when preparing prescriptions for Pharmaceutical Benefits Scheme directions for use (PBS) and Repatriation PBS (RPBS) medicines. Pharmacist should dispense PBS and RPBS total quantity in the container medicines by active ingredient or generic name patient name name, address and telephone number of the supplying pharmacy/ prescriber date of supply Labels for dispensed medicines (cont) ◼ Pharmacists must also include the prescription reference number corresponding to the record made in their dispensing system. ◼ Where the medicine is supplied for an animal, the species of animal and the name of the animal’s owner must be on the label as well as the words “FOR ANIMAL TREATMENT ONLY”. ◼ Where the medicine is for topical use, the words “FOR EXTERNAL USE ONLY” or “POISON” must be added (in red on a white background). ◼ Some medicines also require additional label warnings. For example, oral retinoids must have warnings about becoming pregnant. ◼ Sedation warnings ◼ ◼ Medicines listed in Appendix K of the SUSMP must be labelled with a sedation warning when supplied to patients. Pharmacy cautionary advisory label 1 or label 1A should be used. Medicines for use only within a hospital or health care facility (for example, for administration to inpatients) do not require this additional label. Conclusions ◼ The Poisons Regulations 2016 detail the permits and licences required for obtaining poisons in Western Australia ◼ This legislation also describes the requirements for containers and labelling of these substances ◼ Pharmacists have a professional responsibility to be aware of this legislation, and changes to it References ◼ Health Department of Western Australia: Medicines and Poisons Guides for Health Professionals: http://ww2.health.wa.gov.au/Health-for/Healthprofessionals/Medicines-and-poisons ◼ Hattingh L, Low J and Forrester K. Australian Pharmacy Law and Practice 2nd edn. Sydney: Mosby/Elsevier;2012. ◼ Western Australia Medicines Poisons Act 2014: https://www.legislation.wa.gov.au/legislation/statutes.nsf/ main_mrtitle_13171_subsidiary.html ◼ Medicines and Poisons Regulations 2016: https://www.legislation.wa.gov.au/legislation/statutes.nsf/ main_mrtitle_13861_homepage.html