Poisons Amendment Regulations (No. 2) 2008 (WA)
7 November 2008 GOVERNMENT GAZETTE, WA 4805 HE301*
Poisons Act 1964
Poisons Amendment Regulations (No. 2) 2008
Made by the Governor in Executive Council.
1. Citation
These regulations are the Poisons Amendment Regulations
(No. 2) 2008.2. Commencement
These regulations come into operation as follows —
(a) regulations 1 and 2— on the day on which these regulations are published in the Gazette; (b) the rest of the regulations — on the day after that day. 3. The regulations amended
The amendments in these regulations are to the Poisons
Regulations 1965.4. Regulation 2 amended
(2) A prescription is issued electronically if it is issued under regulation 37(1A) or 51(1A).
(1) Regulation 2 is amended as follows:
(a)
by inserting before "In these regulations" the subregulation designation "(1)";
(b) by inserting in the appropriate alphabetical position 44
"approved electronic prescribing system" means a system of electronic prescribing approved by the CEO under regulation 32B;
(2) At the end of regulation 2 the following subregulation is
inserted —
44
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5. Part 4A inserted
After Part 4 the following Part is inserted -Part 4A - Electronic prescribing systems
32A. Terms used in this Part (1) In this Part and Appendix K -
"access code", of an individual, means a password orother means by which the individual gains access
to a system of electronic prescribing;
"inappropriate use", in relation to a system of
electronic prescribing, includes using the system in a way that is not in accordance with the procedures that control access to and use of the system;
"system identifier", of an individual, means the code by which the identity of the individual is recorded by a system of electronic prescribing.
(2) For the purposes of this Part, an entry is made in a
system of electronic prescribing if—
(a) a prescription is issued, amended or cancelled via the system; or (b) a poison is dispensed in accordance with a prescription issued via the system; or (c) information is otherwise entered into or retrieved from the system in relation to - (i) issuing, amending or cancelling a prescription via the system; or
(ii) dispensing a poison in accordance with a prescription issued via the system.
32B. Approval of electronic prescribing systems
(1) The CEO may approve a system of electronic
prescribing if satisfied that the system -
(a) is sufficiently secure; and (b) is designed so that, to the extent practicable - (i) for any particular poison - only persons authorised to prescribe that poison can use the system to prescribe the poison; and
(ii) pharmaceutical chemist authorised to
for any particular poison - only a under the direct personal supervision of the pharmaceutical chemist, can use the system to dispense the poison; and
7 November 2008 GOVERNMENT GAZETTE, WA 4807 (iii) a poison dispensed in accordance with a prescription issued via the system is dispensed for the person for whom it was prescribed; and
(iv) a poison dispensed to a person in accordance with a prescription issued via the system is the poison prescribed for the person;
and
(c)
complies substantially with the criteria in Appendix K; and
(d)
complies with any other criteria the CEO thinks relevant.
(2) A reference in subregulation (1)(b) to a person
authorised to prescribe or dispense a particular poison
is a reference to a person authorised to do so underthe Act.
(3) Before being satisfied that a system of electronic
prescribing is sufficiently secure, the CEO must be
satisfied that, to the extent practicable -
(a) personal information relating to prescribers, chemists is protected; and
(b)
access to and use of the system is controlled by appropriate procedures; and
(c)
only persons permitted to have access to the system according to those procedures can have access to the system; and
(d) every occurrence of-
(i) a prescription being issued or amended
via the system; and (ii) a poison being dispensed in accordance with a prescription issued via the system,
is recorded by the system in a way that cannot
be amended or erased.
(4) Subregulation (3) does not limit the matters that the
CEO may take into account for the purposes of subregulation (1)(a).
(5)
The CEO may approve a component of a system of electronic prescribing if satisfied as to the matters in subregulation (1) in relation to the component, to the extent relevant to the component.
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32C. System administrators A system of electronic prescribing is not approved while there is no individual who is designated as the administrator of the system by the CEO.
321) . Offence provisions (1) A person must not access an approved electronic
prescribing system unless the person -
(a)
is permitted to have access to the system according to the procedures that control access to the system; and
(b) gained access according to those procedures. Penalty: a fine of $5 000.
(2) A person who has an access code for an approved
electronic prescribing system must not -
(a)
reveal the person's access code to another person; or
(b)
otherwise allow another person to have access to the system unless to do so is in accordance with the procedures that control access to the system.
Penalty: a fine of $5 000.
(3) A person must not make inappropriate use of an
approved electronic prescribing system.
Penalty: a fine of $5 000.
(4) An administrator of an approved electronic prescribing
system must ensure that -
(a)
a person who is permitted to have access to the system in accordance with the procedures that control access to the system is not given more
than one access code; and
(b)
each person who is responsible to the administrator for the operation and control of the system does not make inappropriate use of the system.
Penalty: a fine of $5 000.
32E. Miscellaneous rules (1) In any proceedings under this Act or the Misuse of
Drugs Act 1981, if it is proved that the system
identifier of a person has been recorded in the system
in respect of an entry, then, in the absence of proof to
the contrary, that person is to be taken to have made
the entry.
7 November 2008 GOVERNMENT GAZETTE, WA 4809 (2) Despite anything else in this Part, the administrator
must make all records of the system available, on
request, to a person authorised under section 52A of
the Act.
6. Regulation 36 amended
(1) Regulation 36(1)(b) is amended by deleting "holder of a
prescription written" and inserting instead -"
person (or an agent of the person) in respect of whom a prescription for the poison was issued
(2) Regulation 36(3) is amended as follows: (a) in paragraph (a) by deleting "thereon" and inserting
instead -
66 by it ";
(b) in paragraph (a) by deleting all of the paragraph from and including "prescription shall" in the second place where it occurs and inserting instead -
44
dispenser shall -
(i) in the case of a prescription that is not issued electronically - stamp or mark the prescription to show clearly the date
upon which it is dispensed and the name and address of the pharmacy at which it is dispensed; and
(ii) in the case of a prescription that is issued electronically - indicate the date upon which it is dispensed and the name
by the approved electronic prescribing and address of the pharmacy at which it is dispensed using the means provided system;
(c) in paragraph (b) by deleting "thereon, shall write in ink, stamp or mark in legible letters across such prescription the word "cancelled";" and inserting instead -
by it, shall -
(i) in the case of a prescription that is not
issued electronically - write in ink,
stamp or mark in legible letters across
the prescription the word "cancelled";
and
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(ii) in the case of a prescription that is issued electronically - cancel the prescription using the means provided
by the approved electronic prescribing
system;
(d)
in paragraph (d)(i) by deleting "marked "cancelled";" and inserting instead -
cancelled; ";
(e) in paragraph (e) by inserting after "defaced" -
or appears to have been altered ";
(f) in paragraph (f) by deleting "to whom" and inserting instead - 46 given
(g)
in paragraph (0 by deleting "is presented shall retain the prescription and" and inserting instead -
shall ";
(h) in paragraph (0 by deleting "prescription." and inserting instead - 46
prescription, and, in the case of a prescription
that was not issued electronically, retain it.
7. Regulation 37 amended
(1) Regulation 37(1) is amended as follows:
(a) by deleting paragraphs (a), (b) and (ba) and inserting
instead -
46
(a) it shall include -
(i) the name and address of the prescriber; and (ii) the name and address of the patient; and (iii) the name and quantity of the substance;
and(iv) directions for use (if necessary); and (v) the date on which it is issued; and (vi) the maximum number of times it may
be repeated, if any, and (where
applicable) the intervals at which it may
be repeated;and
(b) it shall be issued in a manner provided for in
subregulation (1A) or (113); and
7 November 2008 GOVERNMENT GAZETTE, WA 4811
(b) in paragraph (c) by deleting "written" in both places where it occurs and inserting instead - 66
issued ";
(c)
in paragraph (c) by deleting "be marked as such" and inserting instead -
indicate that
(d)
in paragraph (c) by deleting "be marked", in the second place where it occurs, and inserting instead -
include the words ";
(e) in paragraph (d) by deleting "by underlining that part of the prescription and initialling the same in margin;" and inserting instead - "
by -
(i) in the case of a prescription that is not issued electronically - underlining that part of the prescription and initialling the same in the margin; and
(ii) in the case of a prescription that is issued electronically - the means provided by the approved electronic
prescribing system;
(2) After regulation 37(1) the following subregulations are
inserted -
(1A) A prescription that is issued electronically shall be
issued via an approved electronic prescribing system.(1B) A prescription that is not issued electronically shall be
either -
(a) written in ink in the prescriber's own handwriting; or (b) processed on a computer program that - (i) complies with the criteria specified in Appendix L; or
(ii) is recommended by the Poisons writing by the CEO.
The prescription shall be signed by the prescriber in his or her own handwriting.
8. Regulation 42 amended
Regulation 42(2) is amended as follows:(a) by deleting "to whom" and inserting instead -
46
in respect of whom ";
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(b) by deleting "has been given" and inserting instead -
46 is issued ".
9. Regulation 44 amended
(1) Regulation 44(1) is amended, in the definition of "authorised
person", by deleting "from" and inserting instead -issued by ".
(2) Regulation 44(3)(d) is amended by deleting "wrote" and
inserting instead -issued
10. Regulation 44A amended
Regulation 44A(1) is amended by deleting "from" and inserting instead -
issued by
11. Regulation 51 amended
(1) Regulation 51(l) is repealed and the following subregulations
are inserted instead -
"
(1) A prescription for the supply of a drug of addiction
shall comply with the following conditions -
(a) it shall include -
(i) the name and address of the prescriber;
and(ii) the name, address and date of birth of
the patient or, in the case of a
prescription for veterinary use, the name
and address of the person having thecare of the animal for which the prescription is intended; and (iii) the description and quantity of the drug
to be dispensed; and(iv) precise directions for the use of the
drug, including the dose to be taken or
administered and the frequency with
which the dose is to be taken or
administered; and(v) the date when it was written; and
(vi) if the drug is to be dispensed more than
once under the prescription - the maximum number of times it may be repeated and the intervals at which it may be dispensed;
7 November 2008 GOVERNMENT GAZETTE, WA 4813 (b) it shall not prescribe more than one drug of addiction, or any other substance, but may prescribe the same drug in more than one form;
(c) if issued by a dentist - it shall include the
words "for dental treatment only" and if issued
by a veterinary surgeon - it shall include thewords "for animal treatment only";
(d) if it prescribes an unusual dose it shall indicate
that such a dose was intended by -
(i) in the case of a prescription that is not issued electronically - that part of the prescription being underlined and
initialled by the prescriber in the
margin; and(ii) in the case of a prescription that is issued electronically - the means provided by the approved electronic
prescribing system;
(e) it shall be issued in a manner provided for in
subregulation (1A) or (1B).
(1A) A prescription that is issued electronically shall be
issued via an approved electronic prescribing system.(1B) A prescription that is not issued electronically shall be
either -
(a) written in ink in the prescriber's own handwriting; or (b) processed on a computer program that - (i) complies with the criteria specified in Appendix L; or
(ii) is recommended by the Poisons Advisory Committee and approved in
writing by the CEO. The prescription shall be signed by the prescriber in his or her own handwriting.
(2) Regulation 51(2) is amended by inserting after "his" in both
places where it occurs -
44 or her ".
12. Regulation 52 amended
(1) Regulation 52(3) is amended as follows: (a) in paragraph (a)(ii) and (iii) by deleting "signed" and inserting instead -
issued ";
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(b) in paragraph (b) by deleting "on" in both places where it
occurs and inserting instead -
44 by ";
(c) in paragraph (ba) by deleting subparagraphs (i) and (ii)
and inserting instead -
44
(i) in the case of a prescription that is not issued electronically - sign the prescription clearly in ink using his or her usual signature and clearly indicate the date on which the drug is dispensed; and
(ii) in the case of a prescription that is issued electronically - indicate that the drug of addiction was dispensed and the date on which it was dispensed using the means provided by the approved electronic prescribing system;
(d) in paragraph (bb) by deleting "shall stamp or otherwise
mark the prescription clearly in ink with the name and
address of the dispensary;" and inserting instead -
44
shall —
(i) in the case of a prescription that is not issued electronically - stamp or otherwise mark the prescription clearly in ink with the name and address of the dispensary; and
(ii) in the case of a prescription that is issued electronically - provide, in relation to the prescription, the name
and address of the dispensary using the means provided by the approved
electronic prescribing system;
(e) in paragraph (d) by deleting "presentation of the
prescription" and inserting instead -
44
a particular occasion ";
(f) in paragraph (d) by deleting "dispensed, note on the
prescription clearly in ink the amount dispensed and the
date on which it was dispensed;" and insertinginstead -
"
dispensed -
(i) in the case of a prescription that is not
issued electronically - note on the
prescription clearly in ink the amount
7 November 2008 GOVERNMENT GAZETTE, WA 4815 dispensed and the date on which it was
dispensed; and(ii) in the case of a prescription that is issued electronically - indicate, in relation to the prescription, the amount
dispensed and the date on which it was dispensed using the means provided by the approved electronic prescribing
system;
(g)
in paragraph (e)(i) by deleting "mark the prescription with" and inserting instead -
indicate, in relation to the prescription,
(h)
in paragraph (e)(ii) by deleting "subject to subregulation (7), retain" and inserting instead
44
in the case of a prescription that is not issued electronically - retain, subject to subregulation (7),
(i) in paragraph (0 by inserting before "the dispenser
44
in the case of a prescription that is not issued
electronically -
IF
(j) by inserting after paragraph (f) - (fa) in the case of a prescription that is issued
electronically - the dispenser shall indicate
that the prescription is cancelled using themeans provided by the approved electronic
conditions in paragraph (f) are met; prescribing system if one or more of the
(k)
in paragraph (h)(ii), by deleting "full" in both places where it occurs;
(1) in paragraph (h)(viii), by inserting before "a note" -
44
in the case of a prescription that is not
issued electronically -
(2) Regulation 52(3a) is amended by inserting after
"subregulation (3)(a)(iii)," -
46
if the prescription is not issued electronically, ".
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(3) Regulation 52(4) is amended by deleting "prescription marked
"cancelled" or that is more than 6 months old." and inserting
instead -
M.
prescription -
(a) that is more than 6 months old; or (b) that-
(i) in the case of a prescription that is not issued electronically - is marked "cancelled"; or
(ii) in the case of a prescription that is issued electronically - is cancelled using the means provided by the approved electronic prescribing system.
(4) Regulation 52(5) is amended by inserting after "which
appears" -
44
to have been altered or ".
(5) Regulation 52(6) is repealed and the following subregulation is
inserted instead -(6) If a pharmaceutical chemist is presented with or accesses a prescription which he or she suspects of
being false in any particular he or she shall -
(a)
in the case of a prescription that is not issued electronically - retain possession of the prescription for such reasonable period of time as will enable him or her to satisfy the requirements of paragraph (b); and
(b) in any case - make enquiries concerning the
genuineness of the prescription, the identity of the person who issued it and the bona fides of the person wishing to have the drug dispensed under it.
(6) Regulation 52(6a) is amended by deleting all of the
subregulation from and including "regulations" and inserting
instead -
regulations, he or she shall -
(a) in the case of a prescription that is not issued
electronically -
(i) mark on the prescription "cancelled",
the address of the dispensary and, in his or her own handwriting, the date and his or her usual signature; and
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(ii) forward the prescription to the CEO; and
(iii) inform the CEO of the relevant circumstances and the reasons for his or her refusal to dispense the drug of addiction under the prescription;
and
(b) in the case of a prescription that is issued
electronically -
(i) cancel the prescription using the means prescribing system; and
(ii) inform the CEO that the prescription has his or her refusal to dispense the drug of addiction under the prescription.
(7) Regulation 52(7) is amended by inserting after "prescription" -
that is not issued electronically ".
13. Regulation 53 amended
(1) Regulation 53(1) is repealed and the following subregulation is
inserted instead -(1) If a medical practitioner, dentist or veterinary surgeon in a case of emergency directs, orally or by telephone or other electronic means, the dispensing of a poison included in Schedule 8, he or she shall, within 24 hours, issue to the person by whom the poison was dispensed a prescription complying with regulation 51 that clearly indicates that it is in confirmation of the
direction given by him or her under this subregulation.
(2) Regulation 53(2) is amended by deleting "him" and inserting
instead -or accessible via an approved electronic prescribing
system to, him or her
14. Regulation 53A amended
(1) Regulation 53A(1) is amended as follows:
(a) in paragraphs (a) and (b) by inserting after "he" -
44 or she ";
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(b) in paragraph (b) by deleting "written by him." and
inserting instead -
"
issued by him or her; or
(c) the prescription is issued electronically via an approved electronic prescribing system.
(2) Regulation 53A(2) is amended by inserting after "he" -
44 or she ".
15. Regulations 54 and 55 amended
Regulations 54(2) and 55 are amended by inserting after
"his" -" or her ".
16. Appendix K inserted
After Appendix J the following Appendix is inserted -
Appendix K
[r. 32B]
Criteria for electronic prescribing systems
The electronic prescribing system must be designed so that -
(a) the system records each person who was given an
access code, when it was given and (where relevant)
when it was cancelled and each person who has a
current access code, in a way that cannot be
amended or erased; and
(b) for each entry made in the system -
(i) a unique, sequential number is given to that entry; and (ii) the time and date is recorded; and (iii) the system identifier of the person whose access code was used to make the entry is recorded;
and
(c) the system requires that persons with access to it
change their access code in accordance with
standard industry practice; and
(d) appropriate backup arrangements are in place; and
(e) the system records the details of the administrator oreach person who is an administrator of the system, and retains those details for 7 years after the person ceases to be an administrator; and
7 November 2008 GOVERNMENT GAZETTE, WA 4819 (f) the system can generate appropriate reports from its
records, for example —
(i) of persons with, or who were given, an access code;
(ii) of access to the system, or entries made in the system, during a certain period;
(iii) of entries made in the system during a certain period, sorted according to drug type, strength or dose or according to patient;
(iv) of corrections to entries made during a certain period;
and (g) the records of the system can be printed.
By Command of the Governor,
M. C. WAUCHOPE, Clerk of the Executive Council.
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