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Code of Practice for Poisons Permits for Medical Treatment Poisons Act 1964 Updated August 2013 Contents 1. Introduction ......................................................................................................................... 1 2. General requirements ........................................................................................................ 2 3. Administrative responsibilities of the permit holder ....................................................... 2 4. Site personnel ..................................................................................................................... 3 5. Range of medications......................................................................................................... 3 6. Storage requirements ......................................................................................................... 3 7. Record keeping requirements ........................................................................................... 4 8. Disposal or destruction of Schedule 4 and Schedule 8 poisons .................................... 5 8.1 Schedule 4 poisons ....................................................................................................... 5 8.2 Schedule 8 poisons ....................................................................................................... 5 Further information .................................................................................................................... 6 1. Introduction The Poisons Act 1964 authorises the Chief Executive Officer of Health (or their delegate) to issue a poisons permit to purchase and use medicines for health services. There is a poisons permit for first aid treatment and a poisons permit for medical treatment. This Code of Practice sets out the responsibilities in regard to poisons permits for medical treatment. The issuing of a poisons permit for medical treatment is not intended to replace the treatment of ongoing or chronic health conditions by an employee’s usual medical practitioner or other health care provider. The access to scheduled medicines provided by a poisons permit for medical treatment is intended to improve access to scheduled medicines in the event of injuries sustained on-site, other medical emergencies and for health conditions which, if untreated, would preclude an employee being considered ‘fit for work’ or which need urgent management. The permit is issued so that medicines in Schedules 2, 3, 4 and (if authorised) 8 can be purchased for the sites listed on the permit. The poisons permit is not required for provision of medical services per se. 1 2. General requirements 2.1 A medical practitioner can hold a poisons permit on behalf of their medical practice or occupational health company, authorising the purchase of medicines for medical treatment. 2.2 The medical practice/occupational health company must be able to provide a medical service or advice 24 hours a day, seven days a week to each site listed on the permit. 2.3 The permit holder is responsible for compliance with all conditions included on the permit. Some of the responsibilities may be delegated, in writing, to another person within the medical practice/occupational health company or to another person in a contractual relationship with the permit holder. However, any delegated responsibilities must be within the skills, knowledge and scope of practice of the person to whom the responsibility is delegated. The permit holder always retains primary responsibility for complying with the Poisons Act 1964, Poisons Regulations 1965 and any conditions imposed on the permit by the Chief Executive Officer of Health. 3. Administrative responsibilities of the permit holder 3.1 The permit holder must ensure their medical practice/occupational health company is the only provider of medical authorisation to the site or sites named on the permit. An exception would be in an emergency where the normal method of communication could not be used. 3.2 A medical practitioner employed by the medical practice/occupational health company must authorise the administration* of all medicines on the sites named on the permit. This is to be achieved by: telephoned authorisation for each administration of medication on site the provision of clinical protocols, signed by a medical practitioner of the medical practice/occupational health company to the site, which authorises designated personnel on site to administer doses of certain medicines without reference to a medical practitioner on each occasion or a combination of the above. *Please note the Poisons legislation does not authorise supply of prescription medicines (Schedule 4 and Schedule 8 medicines) to employees for later use (dispensing) by anyone other than a pharmacist, an authorised prescriber or someone under their direct personal supervision. ‘Personal supervision’ is defined in the Poisons Regulations 1965 as ‘close and continuous control requiring the actual presence of the person exercising the supervision’. All dispensed prescription medicines must be labeled in accordance with the Poisons Regulations 1965. 3.3 Medicines in Schedule 2 (pharmacy only) or Schedule 3 (pharmacist only) may be supplied to an employee provided a medical practitioner employed by the medical practice/occupational health company has either provided individual telephone authorisation or a clinical protocol that authorises the supply of these medicines. 2 Schedule 2 and 3 medicines must only be supplied in the original manufacturer’s pack with all warnings and dosing information intact. 3.4 The permit holder is to be accountable for all medicines purchased for each site named on the permit. 3.5 All changes to details included on the permit must be advised in writing to the Western Australian Department of Health, Pharmaceutical Services Branch as soon as possible. Changes include addition or deletion of a site address. 3.6 When the permit holder wishes to relinquish the responsibilities of being permit holder, they are to advise the Department in writing. The site cannot be transferred to a different poisons permit without the express permission of the Department, when an amended permit will be issued in the name of the new permit holder. 3.7 When a site address is to be deleted from a permit, the permit holder is to advise the Department in writing, within 24 hours, of the disposal process for all medicines on that site that were purchased under the authority of has the permit holder. 3.8 When requested by the Department, the permit holder will provide a report, within seven days, of all medicines used at each site, in accordance with the request. 3.9 A poisons permit issued under the Poisons Act 1964, does not absolve the permit holder of any responsibility required under other legislation in operation within Western Australia. 4. Site personnel 4.1 All personnel at each site named on the permit, who have access to medicines should provide to the permit holder photo ID in addition to either: For a Registered Nurse: evidence of their current registration through the Australian Health Practitioner Regulation Agency as a registered nurse. For all other personnel: a recent (within the previous three years) national police clearance. 5. Range of medicines 5.1 The permit holder is responsible for which medicines will be held on each site named on the permit. 5.2 The permit holder is to ensure there is a suitable system in place for authorising the purchase of medicines for each site and to ensure the medicines are received, handled, stored, used and recorded appropriately at each site. This permit does not allow the permit holder to purchase the medicines from a wholesaler then on-supply these medicines to the site(s). 6. Storage requirements 6.1 All medicines must be stored securely. The medicines must only be accessible to those personnel on site who have been authorised by the permit holder. 3 6.2 Schedule 8 drugs are to be stored on site in compliance with Poisons Regulation 56 and Appendix M. Should the Permit Holder believe that these storage requirements for Schedule 8 drugs are unsuitable, there is provision in the Poisons Regulations 1965 for a submission to be made to the Delegate of the Chief Executive Officer of Health to store Schedule 8 medicines in a different manner, such as in a smaller safe. 6.3 The key to the Schedule 8 storage safe must be held by a person on site nominated by the permit holder. 6.4 All medicines should be stored on site at the temperature recommended by the manufacturer. 6.5 The permit holder is to ensure that each site has a written procedure to: check for expired stock ensure that any medicine which is subject to a consumer level recall by the manufacturer is able to be identified, and the requirements of the recall implemented dispose of those medicines which have passed their expiry date or have deteriorated to the extent that they are unsuitable for administration. (For disposal see Section 8) 7. Record keeping requirements 7.1 All medicines administered are to be recorded in the employee’s medical history notes by the person administering the medicine. The record must contain the following detail: the patient’s name name and dose of the medicine directions for use route of administration amount used date and time medical practitioner’s name or protocol reference name of person administering the medicine. 7.2 The permit holder is to ensure that a sequential record of medical advice given to each site is retained at the medical practice/occupational health company. The record is to contain the following detail: the date and time of the advice the patient’s name the name and dose of the medicine the directions for use including route of administration name of person to whom the advice is given and who will administer the medicine medical practitioner’s name and signature. 7.3 A Register of Drugs of Addiction is required to be kept for all Schedule 8 transactions and the details to be completed for each entry are specified in Poisons Regulation 44. The Register approved for use in patient care areas in Western Australia is designated HA14. 7.4 A separate page of the Register shall be used for each formulation, strength and pack size of each Schedule 8 medicine, so that the balance on hand at any time in respect of each Schedule 8 medicine will be clearly apparent. 4 7.5 Alterations, obliterations or cancellations are not to be made in any Register, but any mistake made in an entry may be corrected by a marginal or footnote, initialed and dated. 7.6 An inventory of all Schedule 8 poisons must be carried out and documented in the Register at least once a month or whenever the on-site person responsible for the Schedule 8 medicines changes. Any discrepancies between the actual quantity of drug and the total in the Register should be immediately investigated and if it becomes apparent that Schedule 8 medicines have been lost or stolen, the WA Police must be notified immediately. Discrepancies that remain unresolved after 24 hours of detection must be notified, in writing, to the Pharmaceutical Services Branch, WA Department of Health. 7.7 All records which include Schedule 4 medicines, must be retained for two years. 7.8 All records which include Schedule 8 medicines, must be retained for seven years. 8. Destruction and disposal of Schedule 4 and Schedule 8 medicines 8.1 Schedule 4 medicines Schedule 4 medicines may only be supplied to authorised persons for disposal. The Department has issued a number of poisons permits to companies for the collection and destruction of Schedule 4 medicines by incineration. Community pharmacies which participate in the Return of Unwanted Medicines (RUM) Program may be approached to accept out of date or unwanted Schedule 4 medicines. 8.2 Schedule 8 medicines Schedule 8 poisons may be destroyed by: a medical practitioner and a director of nursing a medical practitioner and a pharmacist a pharmacist and a director of nursing or two pharmacists. One of these people must be witness to the other. A record of the destruction must be kept and both must sign and date the relevant entry in the Register of Drugs of Addiction (the Register) at the time of destruction. A registered nurse or other ‘on site’ authorised person could adopt one of two methods: Write the unwanted poisons out of the Register and negotiate with a community pharmacist to accept and destroy the Schedule 8 poisons, (the Register should be signed by the people being witness, or a receipt received from the community pharmacist). or Write the unwanted poisons out of the Register and take them to the permit holder to arrange for destruction. 5 Further Information Further information may be obtained from: Pharmaceutical Services Branch Department of Health PO Box 8172 PERTH Business Centre WA 6849 Telephone: (08) 9222 6883 Facsimile: (08) 9222 2463 Website: www.health.wa.gov.au/poisons Email: [email protected] Poisons Act 1964 and Poisons Regulations 1965 are available at: www.slp.wa.gov.au 6 This document can be made available in alternative formats on request for a person with a disability. © Department of Health 2013