Pharmaceutical Services Branch information bulletin Supplying Schedule 3 medicines Who should read this bulletin? Supply This information is intended as a guide for pharmacists supplying over-the-counter Schedule 3 (S3) medicines. S3 medicines are used to treat medical conditions where the consumer is able to self-identify ailments and symptoms, but verification and counselling by a pharmacist is required. Schedule 3 medicines S3 medicines (Pharmacist Only Medicines) are defined as: ‘Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.’ In Western Australia, S3 medicines are those specified in Schedule 3 of the Standard for the Uniform Schedule of Medicines and Poisons (SUSMP), see: www.tga.gov.au/industry/schedulingpoisons-standard.htm S3 medicines are those which are substantially safe with pharmacist intervention to ensure quality use, but may still cause harm if used inappropriately. Legal restrictions Only a pharmacist is authorised to supply S3 medicines by retail sale. A S3 medicine can only be supplied from a pharmacy once a therapeutic need has been established: directly by a pharmacist or by a pharmacist intern under the personal supervision of the pharmacist. Legislation requires a S3 medicine to be supplied in person and true therapeutic need to be established. Dialogue with the consumer is needed to reinforce or expand on safe medicine use. Pharmacist involvement is necessary to: select the most appropriate treatment identify and manage adverse effects and interactions ensure symptoms of serious conditions are not masked or diagnosis delayed monitor safe use if recommended by another health professional reduce the risk of dependency, misuse, abuse or illicit use. The Pharmacy Board of Australia provides guidance on best practice for S3 medicine supply: www.pharmacyboard.gov.au/CodesGuidelines.aspx Pharmacist interaction must extend beyond simple questions to ensure that a real therapeutic need is established. Supply of multiple quantities at one time is not acceptable, without exceptional reasons and where these are documented. The Pharmaceutical Society of Australia practice standards provide guidance on individual S3 items (requires login): www.psa.org.au/supportingpractice/professional-practice- standards/pharmacist-only-medicines-s3protocols Appendix J items S3 items in Appendix J include hydrocortisone, hydrocortisone acetate, and pseudoephedrine. Appendix J items must not be stored in the retail area of the pharmacy. A record of the sale must be made in the dispensing system (prescription book) of: the date supplied purchaser/patient name and address quantity supplied a unique identifying number. These records must be kept for two years. The product must be labelled with the name and address of the pharmacy and the assigned unique identifying number. Pseudoephedrine Before supplying pseudoephedrine, the pharmacist must also confirm the identity of the purchaser by sighting photographic identification. This is not required if the purchaser is known to the pharmacist. Regardless of identification requirements, all pseudoephedrine sales must be labelled and information on the transaction recorded. An approved system must be used to record the required Appendix J information. The only system currently approved in WA is Project StopTM. This system is important to review previous supply history, prevent diversion and to be able to support quality use of medicine in individual patients. injector for the emergency treatment of anaphylaxis. In 2012, salbutamol in inhaler form to treat acute asthma was added. The intention of these amendments is to provide the ability for schools to keep life saving medicines on hand, to treat children under their care, in an emergency. Pharmacists may supply these items to a school where a specific patient and a therapeutic need are not identified. The supply must be related to the official activities of the school and only for the medicines and delivery forms mentioned. Pharmacists should exercise professional judgement regarding verification of requests, quantities supplied, and counselling offered. Pharmacists may wish to direct purchasers to clinical or workplace resources on correct emergency management of these conditions, such as: www.asthmafoundation.org.au www.allergy.org.au Other restrictions S3 medicines must be stored in the pharmacy in a way that prevents any physical access by the public. All S3 medicines must be packaged and labelled according to the requirements of the SUSMP. In Western Australia, S3 medicines may only be advertised in bona fide health practitioner trade journals. Only those listed in Appendix H of the SUSMP may be advertised directly to consumers. Salbutamol and adrenaline More information In 2009, the Poisons legislation was amended to allow schools, kindergartens and childcare services to purchase, store and administer adrenaline in an auto For more information on S3 medicines supply, contact the Pharmaceutical Services Branch on (08) 9222 6883 (Monday – Friday, 8.30am – 4.30pm) or at poisons@health.wa.gov.au