Part 5Special provisions relating to drugs of dependence

Part 5—Special provisions relating to drugs of dependence 36—Interpretation (1) In this Part, unless the contrary intention appears— health service pharmacy means a pharmacy that is part of a health service facility; order means an order other than a prescription; supplier means— (a) a pharmacist; or (b) a person licensed under the Act to manufacture, sell by wholesale or supply drugs of dependence; ward of a health service facility means a ward, clinic, unit, operating theatre or any other section of a health service facility in which persons receive medical or dental treatment. (2) For the purposes of this Part— (a) a reference to the administration of a drug is, if the drug is administered continuously over an extended period (for example, by means of an intravenous drip or pump) a reference to the commencement of administration by that means; and (b) the registered health practitioner principally responsible for the treatment of a person is the practitioner having, for the time being, the greatest input in the determination of the course of treatment of the person. 37—Special restrictions on prescription or supply of drugs of dependence by registered health practitioners and veterinary surgeons (1) A person must not prescribe or supply a drug of dependence for use by his or her spouse, domestic partner, parent, grandparent, child, grandchild, brother or sister unless— (a) the prescription or supply is authorised by the Minister; or (b) the prescription or supply is in circumstances of a verifiable emergency. (2) A registered health practitioner must not prescribe or supply a drug of dependence for use by himself or herself unless the prescription or supply is in circumstances of a verifiable emergency. (3) Subregulation (1) does not apply to the supply of a drug of dependence by a pharmacist if the pharmacist is dispensing a prescription for the drug. (4) A veterinary surgeon must not prescribe, sell or supply a drug of dependence for an animal without having first examined the animal unless the prescription, sale or supply is in circumstances of a verifiable emergency. 38—Restriction on prescribing or supplying S2, S3 or S4 poisons containing S8 poisons A prescriber must not prescribe or supply for use by a person who the prescriber knows or has reasonable cause to believe is dependent on drugs— (a) an S2 poison or S3 poison that contains a poison listed in Schedule 8 of the Uniform Poisons Standard; or (b) an S4 poison that contains a poison listed in Schedule 8 of the Uniform Poisons Standard, for the purpose of maintaining or treating the person's dependence unless the prescriber prescribes or supplies the drug in accordance with an authority granted by the Minister. 39—Records to be kept by manufacturers of drugs of dependence A person who manufactures a drug of dependence must— (a) record the following details immediately after the drug is manufactured: (i) the date of manufacture; (ii) the trade name or the approved name of the drug or, if it does not have either a trade or approved name, its ingredients; (iii) the amount and, if applicable, the strength of the drug manufactured; (iv) the total amount of the drug now on the premises on which the drug was manufactured; and (b) sign and date the record immediately after the record is made. 40—Records to be kept by sellers and suppliers of drugs of dependence (1) A supplier who sells or supplies a drug of dependence must comply with the following provisions: (a) the supplier must, immediately after selling or supplying the drug— (i) make a record in electronic form of— (A) his or her name and business address; and (B) the name and address of the person to whom the drug was sold or supplied; and (C) the date on which the drug was sold or supplied; and (D) the trade or approved name of the drug or, if the drug does not have either a trade or approved name, the ingredients in the drug; and (E) the amount and, if applicable, the strength of the drug; and (F) if the drug was sold or supplied on order—the invoice number (if any) for the sale or supply of the drug; (ii) make a record of the total amount of the drug now in stock on the premises from which the drug was sold or supplied and sign the record; (b) if the drug is sold or supplied in accordance with an order, the supplier must, as soon as practicable after selling or supplying the drug, cancel the order by writing "CANCELLED" on the order or, if the order was given by fax endorsed with the name and address of a single pharmacy that may sell or supply the drug, on the faxed copy of the order; (c) the supplier must transmit the record referred to in paragraph (a)(i) electronically to the Chief Executive so that it is received no later than the 7th day of the month following the month in which the drug was sold or supplied or such later date as the Chief Executive may, on application by the supplier, authorise. (1a) A supplier who sells or supplies a drug of dependence on an order must— (a) retain the original order or a copy of the order for a period of at least 2 years; and (b) keep it readily available for inspection by an authorised officer; and (c) on request by an authorised officer—send a copy of the order to the authorised officer. (2) Subregulation (1)(c) does not apply to— (a) persons licensed under the Act to manufacture drugs of dependence or sell drugs of dependence by wholesale; or (b) pharmacies (including health service pharmacies) in respect of the supply of drugs of dependence to a health service facility. (3) A person who makes a record under subregulation (1) must ensure that the record is kept at all times on the premises from which the drug was supplied. (4) A supplier must not supply a drug of dependence in accordance with an order— (a) unless the supplier has reasonable cause to believe that the person who ordered the drug is lawfully authorised to do so; and (b) unless the person receiving the drug— (i) provides the supplier with a signed and dated receipt for the drug; and (ii) is known to the supplier or produces satisfactory evidence of his or her identity. (5) If a drug of dependence is authorised or required by the law of any place to be carried aboard a ship, a person must not supply that drug for carriage aboard a ship unless he or she has received a written order for the drug from the master or medical officer of the ship. (6) The Minister may exempt a supplier, or a class of suppliers, from this regulation, or specified provisions of this regulation, if satisfied that the supplier, or class of suppliers, has adequate arrangements for the keeping of records. 41—Records to be kept by suppliers of drugs of dependence who receive such drugs (1) If a supplier of drugs of dependence receives such a drug, or a person receives a drug of dependence from a supplier on order, the person receiving the drug must— (a) give to the person who provided the drug a signed and dated receipt for the drug; and (b) record the following details and sign the record: (i) the name and address of the person who provided the drug; (ii) the name and address of the person who took delivery of the drug; (iii) the date on which the drug was received; (iv) the trade or approved name of the drug or, if the drug does not have either a trade or approved name, the ingredients in the drug; (v) the amount and, if applicable, the strength of the drug; (vi) if the drug was provided on order—the invoice number (if any) for the supply of the drug; (vii) the total amount of the drug now in stock on the premises at which the drug was received. (2) A person who makes a record under this regulation must ensure that the record is kept at all times on the premises at which the drug was received. (3) The Minister may exempt a person, or class of persons, from this regulation, or specified provisions of this regulation, if satisfied that the person, or class of persons, has adequate arrangements for the keeping of records and the security of drugs of dependence. 42—Supply or administration of drugs of dependence by registered health practitioner (1) A registered health practitioner who supplies a drug of dependence for use by a person, or who administers a drug of dependence to a person, must, immediately after the drug is so supplied or administered, record the following details and sign the record: (a) his or her name; (b) the full name and address (or, in the case of a patient in a ward of a health service facility, the location of the ward) of the person to whom the drug is supplied or administered; (c) in the case of the supply of the drug to a person acting on behalf of the person for whose use the drug is intended, the full name and address of the person for whose use the drug is intended; (d) the trade name or approved name of the drug or, if it does not have either a trade or approved name, its ingredients; (e) the amount and, if applicable, the strength of the drug supplied or administered; (f) the date; (g) the time at which the drug was supplied or administered; (h) the amount of the drug (if any) now remaining— (i) in stock on the premises at which the drug is supplied or administered; or (ii) otherwise in the possession of the practitioner. (2) Subregulation (1) does not apply to a pharmacist. (3) If an error is discovered in a record made for the purposes of subregulation (1), the person authorised to make the record must correct it in the following way: (a) it must not be deleted, whited out with correction fluid or erased; (b) it must be ruled out or otherwise marked so as to still be clearly legible after it has been so ruled out or marked; (c) a footnote or margin note reference must be made alongside the error; (d) the footnote or margin note must— (i) be made on the same page as the page on which the error occurs; (ii) contain the correct information and the date of the correction; (iii) be endorsed with the name and signature of the person making the correction. (4) The Minister may exempt a registered health practitioner, or class of registered health practitioners, from this regulation, or specified provisions of this regulation, if satisfied that the registered health practitioner, or class of registered health practitioners, has adequate arrangements for the keeping of records. 43—Sale, supply or administration of drugs of dependence by veterinary surgeon A veterinary surgeon who sells or supplies a drug of dependence for an animal or administers such a drug to an animal must, on the day on which the drug is so sold, supplied or administered, record the following details and sign the record: (a) his or her name; (b) the species of animal for which the drug is sold, supplied or administered, the name and address of the owner of the animal and the name (if any) of the animal; (c) the trade name or approved name of the drug or, if it does not have either a trade or approved name, its ingredients; (d) the amount and, if applicable, the strength of the drug sold, supplied or administered; (e) the date; (f) the time at which the drug was sold, supplied or administered; (g) the amount of the drug (if any) now remaining— (i) in stock on the premises at which the drug is sold, supplied or administered; or (ii) otherwise in the possession of the veterinary surgeon. 44—Additional requirements for administration of drugs of dependence in health service facility (1) The administration of a drug of dependence to a person in a health service facility must be carried out in accordance with the following additional provisions: (a) the registered health practitioner principally responsible for the treatment of the person while in the health service facility, or a registered nurse or a midwife acting in accordance with a standing order prepared or endorsed by the health service facility and approved by the Minister must— (i) ensure that the prescribed instructions in respect of the drug are entered in the person's medication record; and (ii) endorse the relevant entries with his or her name and signature and the date of the making of the entries; (b) the drug must be administered to the person by a registered health practitioner in accordance with all instructions in the person's medication record; (c) the drug must not be administered to the person unless the administration is witnessed by a registered health practitioner, or, if a registered health practitioner is not reasonably available, by some other responsible person; (d) the registered health practitioner who administers the drug must, immediately after doing so, ensure that the name and signature of the person who witnessed the administration of the drug is recorded; (e) if a registered health practitioner gives prescribed instructions by telephone as to the administration of a drug of dependence to a person in a health service facility— (i) the practitioner must give the instructions to— (A) a registered health practitioner who is authorised to administer drugs of dependence; and (B) another responsible person employed at the health service facility; and (ii) the practitioner to whom the instructions are given must, immediately after receiving the instructions by that method, ensure that the following information is recorded in the person's medication record and sign the record: (A) his or her full name; (B) the prescribed instructions in respect of the drug; (C) the words "by telephone"; (D) the date on which the telephone instructions were given; (E) the name of the registered health practitioner who gave the telephone instructions; (F) the name and signature of the other person to whom the instructions were given in accordance with subparagraph (i); and (iii) the practitioner who gave the instructions must, within 48 hours of giving the instructions by that method, endorse the relevant entries in the medication record with his or her signature and the date. (2) The designated nurse or designated midwife for a ward of a health service facility for a particular shift must ensure that the following additional record‑keeping requirements are met in respect of drugs of dependence in the ward: (a) all relevant records required to be kept under these regulations in respect of those drugs must be kept in the ward; (b) all drugs of dependence must be counted at the end of the shift and— (i) if the balance in respect of a particular drug is found to be correct, the word "correct", the time and date and the nurse's or midwife's name and signature must be recorded alongside the entry for the drug; and (ii) if the balance in respect of a particular drug is found to be incorrect— (A) the word "incorrect", a brief explanation of the discrepancy, if known, the time and date and the nurse's or midwife's name and signature must be recorded alongside the entry for the drug; and (B) the Director of Nursing or manager of the health service facility, and the health service facility pharmacist, if any, must be notified, as soon as practicable, that an incorrect amount of drugs is stored in the ward; (c) the drugs count and records made under paragraph (b)— (i) must be witnessed by the designated nurse or designated midwife for the ward for the next shift and endorsed with his or her name and signature; or (ii) must, if the next shift does not commence immediately after the previous shift— (A) be witnessed by a nurse or midwife working on the same shift as the nurse or midwife who made the entry and be endorsed with the name and signature of the witnessing nurse or midwife; and (B) be checked by the designated nurse or designated midwife for the ward for the next shift at the commencement of that shift and be endorsed with his or her name and signature. (3) The Director of Nursing or, if there is no Director of Nursing, the manager of a health service facility must ensure that for each shift for each ward of the health service facility a nurse or midwife is designated as having responsibility for record keeping under subregulation (2). (4) The nurse or midwife designated under subregulation (3) must be a nurse or midwife present on the ward during the shift and may only be an enrolled nurse if no registered nurse or midwife will be present. (5) The manager of a health service facility must take all reasonable steps to ensure that— (a) all drugs of dependence delivered to the health service facility or a ward of the health service facility are received by a registered health practitioner employed at the health service facility or, if such a practitioner is not reasonably available, by some other responsible person; and (b) an accurate and up‑to‑date balance of stocks of all drugs of dependence in each ward of the health service facility is maintained at all times; and (c) the requirements of this regulation are complied with. (5a) The Minister may exempt a health service facility, or class of health service facilities, from this regulation, or specified provisions of this regulation, if satisfied that the health service facility, or class of health service facilities, has adequate arrangements for the administration of drugs of dependence. (6) In this regulation— designated midwife for a ward of a health service facility for a shift means a midwife designated under subregulation (3) as having responsibility for record keeping under subregulation (2) for the ward for the shift; designated nurse for a ward of a health service facility for a shift means a nurse designated under subregulation (3) as having responsibility for record keeping under subregulation (2) for the ward for the shift; health service pharmacist means the pharmacist in charge of a health service pharmacy; prescribed instructions, in respect of a drug, means the form and strength of the drug and the route, frequency and duration of administration of the drug. 44A—Special provisions relating to the supply and administration of certain drugs of dependence (1) A drug of dependence to which this regulation applies may only be supplied or administered to a person for whom it has been prescribed— (a) by the medical practitioner who prescribed the drug of dependence for the person; and (b) at a prescribed health service facility; and (c) in accordance with an approved treatment protocol. (2) A person who supplies or administers a drug in contravention of subregulation (1) commits an offence. (3) This regulation applies in relation to the following drugs of dependence: (a) N,α‑dimethyl‑3,4‑(methylenedioxy)phenylethylamine (MDMA); (b) Psilocybine (Psilocybin). approved treatment protocol means a treatment protocol which has been approved by an ethics committee; ethics committee has the same meaning as in the Commonwealth Act; prescribed health service facility means— (a) an approved treatment centre or authorised community mental health facility (both within the meaning of the Mental Health Act 2009); or (b) any other health service facility, or health service facility of a class, determined by the Minister by notice in the Gazette to be a prescribed health service facility for the purposes of this regulation. 45—Destruction of drugs of dependence (1) Subject to this regulation or any order of a court, a person must not destroy a drug of dependence unless— (a) the destruction is witnessed by another person, being— (i) an authorised officer; or (ii) a police officer; or (iii) a registered health practitioner; or (iv) a veterinary surgeon; or (v) a person who has been authorised in writing by the Chief Executive of the SA Ambulance Service to administer drugs of dependence; and (b) the person destroying the drug ensures that the following information is recorded in respect of the drug immediately after its destruction: (i) the full names and the signatures of the person and the witness to the destruction; (ii) the trade name or approved name of the drug or, if it did not have either a trade or approved name, its ingredients; (iii) the amount and, if applicable, the strength of the drug; (iv) the date and time of the destruction; (v) the amount of the drug (if any) now remaining in stock on the premises at which the destroyed drug was stored. (2) This regulation does not apply to the destruction of a drug of dependence by— (a) a person for whose use the drug was lawfully prescribed or supplied; or (b) a police officer or an authorised officer.