Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004

Victorian Legislation and Parliamentary Documents i Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 TABLE OF PROVISIONS Regulation Page PART 1—PRELIMINARY 1 1. Objective 1 2. Authorising provisions 2 3. Principal Regulations 2 PART 2—NURSE PRACTITIONER PROVISIONS AND CERTAIN REFERENCE AMENDMENTS 3 4. New Part 1A inserted 3 PART 1A—PRESCRIBED POISONS FOR CATEGORIES OF NURSE PRACTITIONER 3 4A. Prescribed poisons related to certain categories of nurse practitioner 3 5. Possession and administration of drugs of dependence, Schedule 4, Schedule 8 and Schedule 9 poisons 4 6. New regulation 7A inserted 4 7A. Patient identity and therapeutic need to be determined— nurse practitioners 4 7. Patient identity and therapeutic need to be determined for drugs of dependence—pharmacists 5 8. Notification of fraudulently obtaining of drugs and poisons 5 9. Pharmacist administration, sale or supply authorised from within Victoria 6 10. Pharmacist administration, sale or supply authorised from outside Victoria 6 11. Permit required in particular circumstances for specialised supply 7 12. Disclosure of drug use within previous 8 weeks required 7 13. Persons authorised to write prescriptions 7 14. Style and required particulars for prescriptions 8 15. Emergency directions to pharmacists regarding supply 8 -- 1 of 20 -- Victorian Legislation and Parliamentary Documents Regulation Page ii 16. Containers of drugs to be labelled with certain details 9 17. Retention of original prescriptions or orders once supply completed 9 18. Details to be contained in records 9 19. Administration of drugs and poisons to be authorised 10 20. Self administration of drugs and poisons restricted 11 21. Exceptions 11 22. New regulation 58A inserted 12 58A. Therapeutic need to be determined—nurse practitioners 12 23. Therapeutic need to be determined—pharmacists 13 24. Personal supply and use requirements 13 25. Poisons to be sold by wholesale and retail in original unopened packs 13 26. Amendments to Schedule 2 13 27. New Schedule 3 inserted 14 PART 3—UPDATE OF VARIOUS REFERENCES 17 28. Update of various references 17 ═══════════════ ENDNOTES 18 -- 2 of 20 -- Victorian Legislation and Parliamentary Documents 1 STATUTORY RULES 2004 S.R. No. 150/2004 Drugs, Poisons and Controlled Substances Act 1981 Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 The Governor in Council makes the following Regulations: Dated: 30 November 2004 Responsible Minister: BRONWYN PIKE Minister for Health DIANE CASEY Clerk of the Executive Council PART 1—PRELIMINARY 1. Objective The objective of these Regulations is to amend the Drugs, Poisons and Controlled Substances Regulations 1995 to— (a) make further provision for the obtaining and the possession, use, sale and supply of certain Schedule 2, 3, 4 and 8 poisons by nurse practitioners under the Drugs, Poisons and Controlled Substances Act 1981; and (b) update various references in those regulations. -- 3 of 20 -- Victorian Legislation and Parliamentary Documents Part 1—Preliminary Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 2 2. Authorising provisions These Regulations are made under sections 129, 132 and 132B of the Drugs, Poisons and Controlled Substances Act 1981. 3. Principal Regulations In these Regulations, the Drugs, Poisons and Controlled Substances Regulations 19951 are called the Principal Regulations. __________________ r. 2 -- 4 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 3 PART 2—NURSE PRACTITIONER PROVISIONS AND CERTAIN REFERENCE AMENDMENTS 4. New Part 1A inserted After Part 1 of the Principal Regulations insert— "PART 1A—PRESCRIBED POISONS FOR CATEGORIES OF NURSE PRACTITIONER 4A. Prescribed poisons related to certain categories of nurse practitioner (1) The prescribed Schedule 2, 3, 4 and 8 poisons that a nurse practitioner whose registration is endorsed with the category of nurse practitioner–wound management is authorised to obtain and have in his or her possession and to use, sell or supply are the poisons set out in Part 1 of Schedule 3. (2) The prescribed Schedule 3 and 4 poisons that a nurse practitioner whose registration is endorsed with the category of nurse practitioner–intensive care unit liaison is authorised to obtain and have in his or her possession and to use, sell or supply are the poisons set out in Part 2 of Schedule 3. (3) The prescribed Schedule 3 and 4 poisons that a nurse practitioner whose registration is endorsed with the category of nurse practitioner–young people's health is authorised to obtain and have in his or her possession and to use, sell or supply are the poisons set out in Part 3 of Schedule 3.". r. 4 -- 5 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 4 5. Possession and administration of drugs of dependence, Schedule 4, Schedule 8 and Schedule 9 poisons (1) After item 4 in Part 1 of the table in regulation 5 of the Principal Regulations insert— "4A. A person for whom a Schedule 4 poison or a Schedule 8 poison has been supplied by a nurse practitioner in accordance with the Act and these Regulations, or that person's agent That Schedule 4 or Schedule 8 poison to the extent and for the purpose for which it is supplied.". (2) In the table in regulation 5 of the Principal Regulations— (a) in item 5 for "veterinary surgeon" substitute "veterinary practitioner"; (b) in item 9 for "chiropodist" substitute "podiatrist". (3) In regulation 5 of the Principal Regulations, for "Chief General Manager" (wherever occurring) substitute "Secretary". 6. New regulation 7A inserted After regulation 7 of the Principal Regulations insert— "7A. Patient identity and therapeutic need to be determined—nurse practitioners (1) A nurse practitioner must not administer, prescribe, sell or supply a Schedule 8 poison unless— (a) that poison is for the treatment of a person under his or her care; and (b) he or she has taken all reasonable steps to ascertain the identity of that person; and r. 5 -- 6 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 5 (c) he or she has taken all reasonable steps to ensure a therapeutic need exists for that poison. Penalty: 100 penalty units. (2) A nurse practitioner must not administer, prescribe, sell or supply a Schedule 4 poison unless— (a) that poison is for the treatment of a person under his or her care; and (b) he or she has taken all reasonable steps to ensure a therapeutic need exists for that poison. Penalty: 100 penalty units.". 7. Patient identity and therapeutic need to be determined for drugs of dependence—pharmacists In regulation 9 of the Principal Regulations— (a) after "medical practitioner," insert "nurse practitioner,"; (b) for "veterinary surgeon" substitute "veterinary practitioner". 8. Notification of fraudulently obtaining of drugs and poisons At the end of regulation 11 of the Principal Regulations insert— "(2) A nurse practitioner who suspects or has reason to believe that a person has obtained from him or her by means of a false pretence— (a) a Schedule 4 poison or Schedule 8 poison; or r. 7 -- 7 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 6 (b) an order or prescription for a Schedule 4 poison or Schedule 8 poison— must immediately inform the Secretary and a member of the Victoria Police of that suspicion or belief. Penalty: 50 penalty units.". 9. Pharmacist administration, sale or supply authorised from within Victoria In regulation 12 of the Principal Regulations— (a) in sub-regulation (1)— (i) after "medical practitioner," insert "nurse practitioner,"; (ii) for "veterinary surgeon" substitute "veterinary practitioner"; (b) in sub-regulation (2) after "medical practitioner" (where twice occurring) insert "or nurse practitioner". 10. Pharmacist administration, sale or supply authorised from outside Victoria In regulation 14 of the Principal Regulations— (a) after "medical practitioner," insert "nurse practitioner,"; (b) for "veterinary surgeon" substitute "veterinary practitioner"; (c) for "veterinary surgery" substitute "nursing, veterinary science". r. 9 -- 8 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 7 11. Permit required in particular circumstances for specialised supply In regulation 18 of the Principal Regulations— (a) after "medical practitioner" (wherever occurring) insert "or nurse practitioner"; (b) for "Chief General Manager" (wherever occurring) substitute "Secretary"; (c) for sub-regulation (2)(d) substitute— "(d) in the case of a medical practitioner, he or she is a paediatrician or a psychiatrist who is treating a person for attention deficit disorder; or". 12. Disclosure of drug use within previous 8 weeks required In regulation 21 of the Principal Regulations— (a) after "medical practitioner," insert "nurse practitioner,"; (b) for "veterinary surgeon" substitute "veterinary practitioner". 13. Persons authorised to write prescriptions (1) In regulation 22(1) of the Principal Regulations— (a) after "medical practitioner," insert "nurse practitioner,"; (b) after "Schedule 9 poison" insert "(as the case requires)". (2) In regulation 22(2) of the Principal Regulations after "Schedule 9 poison" insert "(as the case requires)". r. 11 -- 9 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 8 (3) After regulation 22(2) of the Principal Regulations insert— "(2A) A nurse practitioner must not write a prescription for a Schedule 4 poison or Schedule 8 poison other than for the treatment of a person named on the prescription. Penalty: 100 penalty units.". 14. Style and required particulars for prescriptions In regulation 23 of the Principal Regulations— (a) for "Chief General Manager" (wherever occurring) substitute "Secretary"; (b) after "medical practitioner," insert "nurse practitioner,"; (c) for "veterinary surgeon" (where twice occurring) substitute "veterinary practitioner". 15. Emergency directions to pharmacists regarding supply (1) After regulation 24(1) of the Principal Regulations insert— "(1A) Despite anything in these Regulations to the contrary, a nurse practitioner may issue oral instructions to a pharmacist to supply a Schedule 4 poison or Schedule 8 poison if, in the opinion of the nurse practitioner, an emergency exists.". (2) In regulation 24(2) of the Principal Regulations after "medical practitioner," insert "nurse practitioner,". (3) In regulation 24 of the Principal Regulations for "veterinary surgeon" (wherever occurring) substitute "veterinary practitioner". r. 14 -- 10 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 9 16. Containers of drugs to be labelled with certain details In regulation 26(2) of the Principal Regulations— (a) after "medical practitioner," (where twice occurring) insert "nurse practitioner,"; (b) for "veterinary surgeon" (where twice occurring) substitute "veterinary practitioner". 17. Retention of original prescriptions or orders once supply completed In regulation 30(1) of the Principal Regulations— (a) for "veterinary surgeon" substitute "veterinary practitioner"; and (b) after "dentist" insert "or a Schedule 8 poison on the prescription or order of a nurse practitioner"; and (c) in paragraph (a) after "Schedule 9 poison" insert "(as the case requires)". 18. Details to be contained in records In regulation 39 of the Principal Regulations— (a) after "medical practitioner," insert "nurse practitioner,"; (b) for "veterinary surgeon" substitute "veterinary practitioner"; (c) after sub-regulation (1)(f) insert— "(fa) in the case of a Schedule 8 poison which has been destroyed by a nurse practitioner in accordance with regulation 50(1)(da), the details set out in regulation 50(1)(da)(ii); and". r. 16 -- 11 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 10 19. Administration of drugs and poisons to be authorised (1) After regulation 46(1) of the Principal Regulations insert— "(1A) A nurse practitioner who orders the administration of a Schedule 4 poison or Schedule 8 poison to a person must provide that instruction in writing in a legible and durable form and must date and confirm that order with his or her handwritten signature. Penalty: 100 penalty units.". (2) After regulation 46(2) of the Principal Regulations insert— "(2A) A person must not administer a Schedule 4 poison or Schedule 8 poison to another person on the instruction of a nurse practitioner if— (a) in the case of a Schedule 4 poison, it is more than 12 months after the date on which the instruction was given; or (b) in the case of Schedule 8 poison, it is more than 6 months after the date on which the instruction was given. Penalty: 100 penalty units.". (3) In regulation 46(3) of the Principal Regulations for "Chief General Manager" substitute "Secretary". (4) In regulation 46(4) of the Principal Regulations— (a) in paragraphs (a) and (b) after "medical practitioner," insert "nurse practitioner,"; r. 19 -- 12 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 11 (b) in paragraph (c) after "medical practitioner" (where twice occurring) insert ", nurse practitioner"; (c) in paragraph (e) for "Chief General Manager" substitute "Secretary". (5) In regulation 46(5) of the Principal Regulations after "medical practitioner" insert ", nurse practitioner". 20. Self administration of drugs and poisons restricted In regulation 47 of the Principal Regulations after "medical practitioner," insert "nurse practitioner,". 21. Exceptions (1) After regulation 50(1)(d) of the Principal Regulations insert— "(da) subject to sub-regulation (2), a Schedule 8 poison if— (i) it is destroyed by a nurse practitioner in the presence of another person who is a medical practitioner, nurse practitioner, pharmacist, veterinary practitioner or dentist; and (ii) the details of the destruction, including the name, strength and quality of the poison or controlled substance destroyed, the method and place of destruction and the names of the person carrying out the destruction and the witness are recorded in the records to be kept under regulation 39 and made available for the inspection of an authorised officer when requested; or". r. 20 -- 13 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 12 (2) For regulation 50(1)(e)(i) of the Principal Regulations substitute— "(i) it is destroyed by a medical practitioner, veterinary practitioner or dentist in the presence of another person who is a medical practitioner, nurse practitioner, veterinary practitioner or dentist; and". (3) For regulation 50(2) of the Principal Regulations substitute— "(2) The Secretary may direct a person referred to in sub-regulation (1)(da) or (e) to comply with any requirements relating to the destruction of a Schedule 8 poison or Schedule 9 poison (as the case requires) specified in writing by the Secretary.". 22. New regulation 58A inserted After regulation 58 of the Principal Regulations insert— "58A. Therapeutic need to be determined— nurse practitioners A nurse practitioner must not administer, prescribe, sell or supply a Schedule 3 poison unless— (a) that poison is for the treatment of a person under his or her care; and (b) he or she has taken all reasonable steps to ensure a therapeutic need exists for that poison. Penalty: 50 penalty units.". r. 22 -- 14 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 13 23. Therapeutic need to be determined—pharmacists In regulation 61 of the Principal Regulations— (a) after "medical practitioner," insert "nurse practitioner,"; (b) for "veterinary surgeon" substitute "veterinary practitioner". 24. Personal supply and use requirements In regulation 63 of the Principal Regulations— (a) after "medical practitioner," insert "nurse practitioner,"; (b) for "veterinary surgeon" substitute "veterinary practitioner". 25. Poisons to be sold by wholesale and retail in original unopened packs In regulation 66(2) of the Principal Regulations for "veterinary surgeon" substitute "nurse practitioner, veterinary practitioner". 26. Amendments to Schedule 2 In Schedule 2 to the Principal Regulations— (a) in Form DP1 omit "Dr."; (b) for the heading to Form DP2 substitute— "TREATMENT WITH SCHEDULE 8 POISONS OR SCHEDULE 9 POISONS BY A MEDICAL PRACTITIONER OR SCHEDULE 8 POISONS BY A NURSE PRACTITIONER"; (c) in Part A of Form DP2— (i) after "medical practitioner" (wherever occurring) insert "/nurse practitioner"; (ii) for "Schedule 9 poison(s)" substitute "Schedule 9 poison(s)*"; r. 23 -- 15 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 14 (iii) for "Schedule 9 poison" (where first occurring) substitute "Schedule 9 poison*"; (iv) at the end of Part A of the Form insert— "*References to Schedule 9 poisons must be deleted where this Form is completed by a nurse practitioner"; (d) in Form DP3— (i) for the heading to that Form substitute— "PERMIT TO ADMINISTER, PRESCRIBE OR SUPPLY A SCHEDULE 8 POISON OR SCHEDULE 9 POISON BY A MEDICAL PRACTITIONER OR A SCHEDULE 8 POISON BY A NURSE PRACTITIONER"; (ii) after "medical practitioner" (where twice occurring) insert "/nurse practitioner"; (iii) for "CHIEF GENERAL MANAGER" substitute "Secretary". 27. New Schedule 3 inserted After Schedule 2 to the Principal Regulations insert— "SCHEDULE 3 Regulation 4A PART 1 NURSE PRACTITIONER–WOUND MANAGEMENT The prescribed poisons that a nurse practitioner–wound management is authorised to obtain and have in his or her possession and to use, sell or supply are the substances listed below— r. 27 -- 16 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 15 Schedule 2 poisons— Codeine Lignocaine Paracetamol Schedule 3 poisons— Clotrimazole Codeine Iron compounds Miconazole Schedule 4 poisons— Amoxycillin Betamethasone Bupivacaine Cephalexin Ciprofloxacin Clavulanic acid Clindamycin Codeine Dicloxacillin Doxycycline Flucloxacillin Lignocaine Methylprednisolone Metronidazole Mupirocin Silver sulfadiazine Terbinafine Tramadol Triamcinolone Schedule 8 poisons— Morphine Oxycodone r. 27 -- 17 of 20 -- Victorian Legislation and Parliamentary Documents Part 2—Nurse Practitioner Provisions and Certain Reference Amendments Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 16 PART 2 NURSE PRACTITIONER–INTENSIVE CARE UNIT LIAISON The prescribed poisons that a nurse practitioner–intensive care unit liaison is authorised to obtain and have in his or her possession and to use, sell or supply are the substances listed below— Schedule 3 poison— Adrenaline Schedule 4 poisons— Adrenaline Digoxin Dobutamine Dopamine Frusemide PART 3 NURSE PRACTITIONER–YOUNG PEOPLE'S HEALTH The prescribed poisons that a nurse practitioner–young people's health is authorised to obtain and have in his or her possession and to use, sell or supply are the substances listed below— Schedule 3 poisons— Levonorgestrel Salbutamol Schedule 4 poisons— Azithromycin Ethinyloestradiol Hepatitis B vaccine Levonorgestrel Medroxyprogesterone". __________________ r. 27 -- 18 of 20 -- Victorian Legislation and Parliamentary Documents Part 3—Update of Various References Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 17 PART 3—UPDATE OF VARIOUS REFERENCES 28. Update of various references (1) In regulation 4 of the Principal Regulations— (a) in the definition of "approved", for "Chief General Manager" substitute "Secretary"; (b) in the definition of "child resistant closure", in paragraph (b), for "Chief General Manager" substitute "Secretary"; (c) the definition of "chiropodist" is revoked; (d) after the definition of "pharmacy department" insert— ' "podiatrist" means a person registered as a podiatrist under the Podiatrists Registration Act 1997;'. (2) In the Principal Regulations— (a) in regulations 6, 10, 11, 20, 22 and 59, for "veterinary surgeon" (wherever occurring) substitute "veterinary practitioner"; (b) in regulations 11, 20, 28, 36, 42, 43, 51, 68 and 72, for "Chief General Manager" (wherever occurring) substitute "Secretary". ═══════════════ r. 28 -- 19 of 20 -- Victorian Legislation and Parliamentary Documents Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 S.R. No. 150/2004 18 ENDNOTES 1 Reg. 3: S.R. No. 63/1995. Reprint No. 3 as at 1 November 2002. Reprinted to S.R. No. 86/2002 and subsequently amended by S.R. Nos 67/2003, 43/2004 and 44/2004. Endnotes -- 20 of 20 --