09+L03

=PEL Core Topics - Law=

//understanding procedures relating to drugs of addiction ( //Controlled Substances Act 1984//)//


 * Written prescriptions**

(1) A prescriber who writes a prescription for the supply of a drug must— (b) date the prescription with the date on which the prescription is written and sign the prescription; and (c) include on the prescription— (i) his or her professional name, address and telephone number; and (ii) — (A) the full name and address of the person for whom the prescription is intended; or (B) where the prescription is intended for an animal—the species of animal for which it is intended, the name and address of the owner of the animal and the name (if any) of the animal; and (iii) where the prescriber is a dentist—the words "For dental treatment only"; and (iv) where the prescriber is a veterinary surgeon—the words "For animal treatment only"; and (v) where the prescriber is a surgical podiatrist—the words "For podiatric treatment only"; and (d) specify— (i) the name, dose form and (if relevant) the route of administration of the drug being prescribed; and (ii) where applicable—the strength of the drug; and (iii) the dose of the drug to be administered to the person for whom, or the animal for which, it is prescribed; and (iv) the frequency at which the drug is to be administered; and (v) the total amount of the drug to be supplied each time the prescription is dispensed; and (vi) the total number of times the drug may be dispensed; and

(e) if the prescription is for a drug of dependence for human use, comply with the following additional requirements: (i) include on the prescription— (A) the date of birth of the person for whom the prescription is intended; and (B) where the prescriber is acting under a section 18A authority—the authority number; and (ii) express the total amount of the drug to be specified under subparagraph (d)(v) in both words and numerals; and (iii) keep a record of the details required to be included and specified under this regulation.

(2) If the prescriber is prescribing an above average strength or potentially dangerous dose of the drug, he or she must— (a) underline the statement of the dose of the drug in the prescription; and (b) sign his or her initials alongside the underlined portion of the prescription referred to in paragraph (a) (1) A pharmacist or medical practitioner who dispenses a prescription for a drug— (a) must endorse on the prescription— (i) his or her name, business name and business address; and (ii) the date on which the drug is dispensed; and (iii) the unique identifier applicable to the drug; and (b) must, on the day on which the drug is dispensed, record— (i) the unique identifier applicable to the drug dispensed on the prescription; and (ii) his or her name as the dispenser; and (iii) the date; and (iv) the trade name or the approved name of the drug, or, if it does not have either a trade or approved name, its ingredients; and (v) — (A) the full name and address of the person for whose use the drug is dispensed; or (B) where the drug is intended for an animal—the species of animal for which it is intended, the name and address of the owner of the animal and the name (if any) of the animal; and (vi) the form, strength and quantity of the dispensed drug; and (vii) the directions given for the safe and proper use of the dispensed drug; and (viii) the name, address and business telephone number of the person who prescribed the drug; and (ix) the number of times the prescription may be dispensed and (where the prescription so specifies) the intervals at which the drug may be dispensed; and (c) if the prescription is for a schedule 4 poison and does not specify the number of times the drug is to be dispensed, must— (i) dispense it once only pursuant to that prescription; and (ii) endorse on the prescription "CANCELLED"; and (iii) unless it is for any reason forwarded to the Department or the Minister, retain the original or duplicate prescription (as the case may be) for at least one year and have it readily available for inspection during that period; and (d) if the prescription specifies the number of times and the intervals at which the drug may be dispensed—must not dispense the drug more times than the number specified or at intervals less than those specified; and (da) if the prescription specifies the number of times but not the intervals at which the drug may be dispensed—must not dispense the drug more frequently than he or she considers appropriate; and (e) in the case of a prescription for a drug of dependence, must, each time the drug is dispensed, except where the drug is fully dispensed, forward a copy of the prescription to the CEO no later than the 7th day of the month following the month in which the drug was so dispensed or such later date as the CEO may, on application by the pharmacist or medical practitioner, authorise; and (f) where a prescription is fully dispensed, must— (i) on the day on which the prescription is fully dispensed, endorse on the prescription "CANCELLED"; and (ii) — (A) in the case of a prescription for a drug of dependence, forward it to the CEO no later than the 7th day of the month following the month in which the drug was so dispensed or  such later date as the CEO may, on application by the pharmacist or medical practitioner, authorise; (B) in any other case, retain the original or duplicate prescription (as the case may be), for at least two years and have it readily available for inspection during that period. Maximum penalty: $5 000. (1a) A pharmacist in charge of a pharmacy at which no drugs of dependence are dispensed for a period of 30 consecutive days must, no later than the 7th day of the month following the month during which the 30th day of that period falls, notify the CEO of that fact in writing. Maximum penalty: $5 000. (2) If a prescription has been issued in duplicate and the original is retained by the pharmacist or medical practitioner, it is sufficient compliance with this regulation if the required information is marked on the duplicate prescription. (3) Despite subregulation (1)(d), if a pharmacist or medical practitioner is satisfied that a person— (a) has lost a previously dispensed supply of a drug; or (b) will, through absence from the State or otherwise, find it unduly difficult to have future supplies of a drug dispensed as needed, he or she may (but is not obliged to) dispense a prescription for the person at an interval earlier than that specified on the prescription. (4) If, pursuant to subregulation (3), a pharmacist or medical practitioner dispenses a drug of dependence at an earlier interval than that specified on the prescription, the pharmacist or practitioner must notify the prescriber of that fact in writing. (5) A pharmacist or medical practitioner must not dispense a prescription for a drug— (a) if the prescription— (i) is presented or otherwise sought to be dispensed— (A) in the case of a drug of dependence—more than 6 months after the date on which it was written; or (B) in any other case—more than 12 months after the date on which it was written; or  (ii) has been cancelled; or   (iii) is partly or wholly illegible; or  (iv) does not comply with the Act or regulations; or  (b) if there are reasonable grounds for suspecting that the prescription has been altered, forged or obtained by false pretences; or  (c) unless— (i) in the case of a prescription that is to be dispensed for the first or only time—an original prescription is presented; or (ii) in the case of a prescription that is to be dispensed for the second or subsequent time— (A) the original prescription and a written record (whether made on the prescription or on a separately attached repeat authorisation) of the number of times the drug has been dispensed are presented; or (B) a duplicate or copy of the prescription and a written record (made both on the duplicate or copy (as the case may be) and on a separately attached repeat authorisation) of the number of times the drug has been dispensed are presented; or (d) if the prescription has been transmitted electronically—unless the prescription is able to be dispensed by the pharmacist or medical practitioner in accordance with the terms of an exemption under subregulation (6a). Maximum penalty: $5 000. (6) A pharmacist or medical practitioner must not, in respect of a drug of dependence— (a) dispense more than 2 days' supply of the drug unless at least one of the following applies: (i) the person for whose use the drug is prescribed is known to the pharmacist or practitioner; or (ii) the pharmacist or practitioner recognises the signature on the prescription as that of the prescriber who purportedly gave the prescription; or  (iii) the pharmacist or practitioner has verified with the prescriber who purportedly gave the prescription that the prescription was in fact given by that prescriber; or  (b) hand over the dispensed drug until— (i) the person for whose use the drug is dispensed has signed and dated the prescription and, unless the person is known to the pharmacist or practitioner, has produced satisfactory evidence of his or her identity; or (ii) an agent acting on behalf of the person for whose use the drug is intended has signed and dated the prescription and, unless the agent is known to the pharmacist or medical practitioner, has produced satisfactory evidence of his or her identity.
 * Dispensing prescriptions **

Resources
[|Controlled Substances (Poisons) Regulations 1996]