Pharmacy Procedure Manual 2023 PDF

6. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 6.1. Controlled Drug Prescribing 6.1.1. Changes under the Misuse of Drugs Amendment Regulations 2022 The Misuse of Drugs Amendment Regulations 2022, which came into force on 22 December 2022, enables signature-exempt prescriptio...

6. Legal Requirements of Prescribing Under the Misuse of Drugs Act 1975 6.1. Controlled Drug Prescribing 6.1.1. Changes under the Misuse of Drugs Amendment Regulations 2022 The Misuse of Drugs Amendment Regulations 2022, which came into force on 22 December 2022, enables signature-exempt prescriptions for controlled drugs when prescribed through NZePS. Prescribers will no longer need to provide a hard copy, signed version of any prescription for a controlled drug as long as they generate the script using an approved system which is integrated with the NZePS. The changes establish an exemption which allows certain prescribers (medical practitioners, nurse practitioners, designated prescriber pharmacists, and designated prescriber nurses) to issue three-month NZePS prescriptions for Class B controlled drugs. Prescribers must (under reg 31A(6A)) direct on that script the appropriate number of intervals for dispensing, which can be on three or more occasions (no more than one months’ worth at a time). This change only affects the period of supply that a Class B, NZePS prescription can cover. The maximum dispensing amount has not changed and remains at a quantity that must not exceed supply for a period of one month. Prescribers must continue to take a cautious approach to prescribing controlled drug medicines. While NZePS can be used to issue controlled drug prescriptions (which eliminates the need to hand-write triplicate CD prescriptions) all other requirements for controlled drug prescriptions remain unchanged. For example, no forward dating of prescriptions is allowed. 6.1.2. Definitions A controlled drug Prescriber means a Medical Practitioner, a Dentist, a Nurse Practitioner, a Midwife, a Designated Prescriber Nurse, a Designated Prescriber Pharmacist, or a Veterinarian, who is registered in New Zealand in that profession and who holds a current annual practising certificate under the HPCA Act 2003. A controlled drug Prescription Form written by overseas Prescribers who are not registered to practice in New Zealand are not legal. When a Provider is unsure of the registration or signature of the Prescriber a check should be made of the Prescriber’s annual practising certificate, or a check of their registration with their Regulatory Body. Pharmacy Procedures Manual version 10.0 –July 2023 28 6.1.3. Summary of prescribing rules Legislation: Refer to: www.legislation.govt.nz. Professional Group Misuse of Drugs Act (1975) and Regulations (1977) Repeats Restrictions on Dispensing Medical Practitioners and Nurse Practitioners (an Authorised Prescriber) For the medical treatment of a patient under their care:19 Class B: Maximum period of supply is one month,20 or three months if on an electronic prescription.21 Class C: Maximum period of supply is three months.22 May authorise multiple repeats, eg, daily or at such other regular intervals, as the prescriber considers necessary.23 The total quantity per repeat must not exceed one month. Class B: For the dental treatment of a patient under their care: Class B and C: For a maximum period of seven days.27 Every controlled drug Prescription Form must state ‘for dental treatment only’.28 Note: Not authorised to telephone prescriptions for controlled drugs.29 May NOT authorise any repeats.30 Dentists (an Authorised Prescriber) 19 20 21 22 23 24 25 26 27 28 29 30 31 32 Not more than seven days after the date of prescription.24 Maximum quantity for any Dispensing is onemonth supply.25 Repeats must be Dispensed no more than seven days after the previous supply is exhausted. Class C: First Dispensed within six months of prescribing,26 or first presented to the pharmacy within three months from date it was prescribed. Class B: Not more than seven days after the date of prescription.31 Only subsidised for five days treatment.32 Class C: Only subsidised for seven days treatment. Misuse of Drugs Regulations 1977, reg 21(2),(5B) Misuse of Drugs Regulations 1977, reg 31(1)(d) Misuse of Drugs Regulations 1977, reg 31A(6A) Misuse of Drugs Regulations 1977, reg 31A(4) Misuse of Drugs Regulations 1977, reg 31A(7) Misuse of Drugs Regulations 1977, reg 31(1)(b) Misuse of Drugs Regulations 1977, reg 31A(2) Misuse of Drugs Regulations 1977, reg 31(1)(c) Misuse of Drugs Regulations 1977, reg 21(3) Misuse of Drugs Regulations 1977, reg 29(4)(g) Misuse of Drugs Regulations 1977, reg 34(6) Misuse of Drugs Regulations 1977, reg 31A(7) Misuse of Drugs Regulations 1977, reg 31(1)(a) Pharmaceutical Schedule Section A: General Rules, rule 1.2.1(a) Pharmacy Procedures Manual version 10.0 –July 2023 29 Professional Group Misuse of Drugs Act (1975) and Regulations (1977) Repeats Restrictions on Dispensing Midwives (an Authorised Prescriber) For the treatment of a patient under their care.33 Midwives may only prescribe tramadol, pethidine, morphine or fentanyl.34 Maximum period of supply is one month.35, or three months if on an electronic prescription.36 Every controlled drug Prescription Form must state ‘for midwifery use only’.37 Note: Midwives may not prescribe any other controlled drugs, such as codeine and benzodiazepines. May only authorise one repeat at a specified interval.38 First Dispensed no more than four days after the date of the prescription.39 Repeats must be Dispensed no more than four days after the previous supply is exhausted. Pharmacist Prescribers (a Designated Prescriber) For the treatment of a patient under their care.40 Limited to drugs listed in the Misuse of Drugs Regulations 1977, Schedule 1B.41 Maximum period of supply is three days for class B or Class C,42 or three months if on an electronic prescription for Class B.43 First Dispensed not more than seven days after the date of prescription. Designated Nurse Prescribers (a Designated Prescriber) For the treatment of a patient under their care.44 Limited to drugs listed in the Misuse of Drugs Regulations 1977, Schedule 1A.45 For a maximum of seven days.46 First Dispensed not more than seven days after the date of prescription. Note: The Nursing Council of NZ further limits medicines which may be prescribed by Designated Nurse Prescribers to medicines relevant to their 33 34 35 36 37 38 39 40 41 42 43 44 45 46 Misuse of Drugs Regulations 1977, reg 21(5A) Misuse of Drugs Regulations 1977, reg 12A(c) Misuse of Drugs Regulations 1977, reg 31A(6) Misuse of Drugs Regulations 1977, reg 31A(6A) Misuse of Drugs Regulations 1977, reg 29(4)(h) Misuse of Drugs Regulations 1977, reg 31A(5) Misuse of Drugs Regulations 1977, reg 31A(5)(a) Misuse of Drugs Regulations 1977, reg 21(5)(a) Misuse of Drugs Regulations 1977, reg 12A(1)(b) Misuse of Drugs Regulations 1977, reg 21(5)(b) Misuse of Drugs Regulations 1977, reg 31A(6A) Misuse of Drugs Regulations 1977, reg 21(4)(a) Misuse of Drugs Regulations 1977, reg 12A(1)(a) Misuse of Drugs Regulations 1977, reg 21(4)(c) Pharmacy Procedures Manual version 10.0 –July 2023 30 Professional Group Misuse of Drugs Act (1975) and Regulations (1977) Repeats Restrictions on Dispensing practice.47 The Nursing Council provides separate lists for those practising in the scopes of Primary and specialty health teams, diabetes health, and community health and ECP. For more information see: Registered Nurse Prescribing Veterinarians For the treatment of an animal under their care:48 Class B: Maximum period of supply is one month.49 Class C: Maximum period of supply is 90 days Every Prescription Form must state ‘For animal treatment only’.50 May NOT authorise any repeats.51 Veterinarians are not required to prescribe controlled drugs on a triplicate Prescription Form. No veterinary prescriptions are funded. Note: Optometrists have no prescribing rights for controlled drugs. 47 48 49 50 51 Nursing Council of NZ: Registered Nurse Prescribing Misuse of Drugs Regulations 1977, reg 21(5C) Misuse of Drugs Regulations 1977, reg 31(1)(d) Misuse of Drugs Regulations 1977, reg 29(4)(i) Misuse of Drugs Regulations 1977, reg 31A(7) Pharmacy Procedures Manual version 10.0 –July 2023 31 6.2. Legal Requirements of a Controlled Drug Prescription Form The following list refers to Class A and Class B controlled drugs plus specified Class C controlled drugs when they are intended for human use. Specified Class C controlled drugs include amobarbital, amobarbital sodium, buprenorphine, butobarbitone, glutethimide, ketamine, secobarbital, or secobarbital sodium either in combination or not. These products do not fall under this category if they are combined with another substance not in Schedule 3, Part 4 (1) of the Misuse of Drugs Act 1975. For example, a Prescription Form for buprenorphine on its own must meet all the requirements specified on the list, whereas a Prescription Form for buprenorphine plus naloxone does not need to meet the requirements on the list. There are two physical types of controlled drug Prescription Forms, a barcoded NZePS controlled drug Prescription Form and a triplicate form. Both versions may be received from the same Prescriber, and other than the physical form of the Prescription Form, and the fact that the NZePS are signature exempt and don’t require a paper copy of the Prescription Form, all other requirements are the same. Legal and Contractual Requirements for Class A, B and specified Class C Controlled Drug Prescriptions. A controlled drug Prescription Form can be either: An H572 or H572M triplicate Prescription Form provided by the Director General of Health and completed in the handwriting of the controlled drug Prescriber with the Prescriber signature in their own handwriting; or An NZePS controlled drug Prescription Form electronically generated by a system approved by the Director General of Health containing a barcode which is scanned (or the barcode number is manually entered if the scan fails). See notes specific to NZePS. The information supplied on either form of the controlled drug Prescription Form must be legible and indelible (it cannot be written in pencil) and must include all of the following: date on which it was signed or generated in the case of NZePS prescriptions Prescriber details, which must be set out or stamped with the Prescriber’s full name Prescriber’s physical work address, or postal address for those who do not have a place of work Prescriber’s telephone number patient details of which the controlled drug is intended to be administered, which includes: o Surname and each given name of the patient o Physical address of the patient o Patient's date of birth and set out in words the age in years and months of that person if the patient is under the age of 12 years name of the controlled drug in full or abbreviated only by the use of British Pharmacopoeia (BP), British Pharmaceutical Codex (BPC) or other recognised titles Pharmacy Procedures Manual version 10.0 –July 2023 32 strength of the controlled drug total amount of the controlled drug to be Dispensed the number of occasions on which the controlled drug may be Dispensed (where appropriate) dose and frequency of the dose for internal controlled drugs method and frequency of use for external controlled drugs where the controlled drug Prescription Form has an unusual dose, or what may be regarded as a dangerous dose, the dose should be underlined and initialled by the Prescriber. Any alterations must be signed by the Prescriber for methadone prescribed by a Prescriber who is authorised by the Ministry of Health or its delegate or works in a place for the time being specified by the Minister of Health under the Misuse of Drug Act 1975, the Prescription Form must be legibly and indelibly written, or in a form approved from time to time by the Director General of Health (including electronically generated forms from an approved system). The following are the legal requirements that all must be added by the Pharmacy to all three copies of the triplicate form or the NZePS controlled drug Prescription Form: name and address of the proprietor of the business at which the controlled drug Prescription Form is Dispensed each item Annotated with the: o date of Dispensing on each occasion o its unique identifying number on each occasion o the quantity of the controlled drug Dispensed on each occasion o strength of the controlled drug Dispensed on each occasion o identity of the individual Dispensing each item o initials of the checking Pharmacist on each occasion for completeness and accuracy. Telephoned Prescription Forms for controlled drugs are permitted from medical practitioners, nurse practitioners; midwives, designated prescriber pharmacists, and designated prescriber nurses (when prescribing within their scope) personally known to the Pharmacist. However, no repeat of a telephone or faxed controlled drug Prescription Form is permitted until the original controlled drug Prescription Form is received by the Pharmacy. Dentists and veterinarians are not authorised to prescribe controlled drugs verbally or by telephone.52 The original of an electronically transmitted NZePS controlled drug Prescription Form is not required but the barcode/SCID must be used to dispense the prescription. 52 Misuse of Drugs Regulations 1977, reg 34(6) Pharmacy Procedures Manual version 10.0 –July 2023 33