Proposal to amend Pharmaceutical Schedule Rules on prescribing and dispensing of Class B controlled drugs
Update: 21 December 2022
Pharmac would like to thank everybody for their feedback to this proposal. We appreciate the time taken to share your support for, or concerns about, changes to the prescribing and dispensing of Class B controlled drugs.
In light of this feedback, Manatū Hauora, the Ministry of Health, has indicated that it would like to revisit the regulatory arrangements for opioids. They have asked Pharmac to delay making a decision on the proposed changes to the Schedule Rules to support this work.
We have agreed to this delay, meaning that the proposed changes will not happen in February as initially planned.
We will keep you updated as this work progresses.
We have extended consultation to 21 December 2022.
We are seeking feedback on a proposal to amend the Pharmaceutical Schedule General Rules (the Schedule Rules) to bring funding in line with legislative changes to the prescribing and dispensing of controlled drugs.
Submitters should note that this consultation does not seek feedback on the changes in the Medicines Amendment Regulations 2022(external link) and the Misuse of Drugs Amendment Regulations 2022(external link). We note decisions on these regulatory changes have been confirmed, and this proposal relates to supporting that change within the Pharmaceutical Schedule.
Consultation closes at 5 pm on 21 December 2022 and feedback can be emailed to firstname.lastname@example.org
What would the effect be?
This proposal means that people in the community could:
- Be prescribed funded Class B controlled drugs for three months, instead of one month, when an electronic prescription is used. The amount that could be prescribed on a paper prescription would stay as one month.
- Collect Class B controlled drugs from the pharmacy in monthly lots, when an electronic prescription is used (or as a single monthly lot on a paper prescription), unless the prescriber directs dispensing in smaller quantities.
Under the current Schedule Rules, people generally have Class B controlled drugs dispensed at ten-day intervals, with the exception of methylphenidate and dexamfetamine, which may be dispensed in a single monthly lot.
While the change from ten day dispensing to monthly dispensing would increase the amount of a Class B controlled drug able to be given to a person per visit, the total amount being dispensed would not change.
Who we think will be interested
- People who are prescribed controlled drugs, their caregivers, whānau and communities
- Prescribers authorised to prescribe controlled drugs (doctors, nurse practitioners, midwives, dentists, registered nurse prescribers, pharmacist prescribers)
- Pharmaceutical suppliers and wholesalers
About this proposal
On 22 December 2022 the Medicines Amendment Regulations 2022(external link) and the Misuse of Drugs Amendment Regulations 2022(external link) will come into force.
This amends the law to enable controlled drugs to be prescribed electronically and, for some controlled drugs, the amount of drug that can be on a single prescription will be increased when using the New Zealand Electronic Prescription Service(external link) (NZePS).
Before 22 December 2022, the Misuse of Drugs Act 1975 and Misuse of Drugs Regulations 1977(external link) mean that prescriptions for Class B controlled drugs can legally only be written for a supply of up to one month. The Schedule Rules allow supply for up to one month on a prescription, with dispensing in ten day lots (with the exception of methylphenidate and dexamfetamine, which may be dispensed in a single monthly lot).
This proposal is intended to align funding rules more completely with the updated legislation, by allowing funded prescriptions for Class B controlled drugs to be written for up to three months. In addition, we would be removing the requirement for dispensing in ten day lots, as this is inconsistent with the Regulations.
Why we’re proposing this
The legislative changes that will come into force on 22 December 2022 permit Class B controlled drugs to be prescribed for up to three months on a single prescription (depending on the scope of practice of the prescriber) with dispensing in monthly lots, unless smaller amounts are directed by the prescriber. However, the current Schedule Rules for Class B controlled drugs do not allow these medicines to be funded when prescribed or dispensed in this way.
Reducing the frequency prescribers need to issue prescriptions for Class B controlled drugs, when issued through the NZePS, will reduce the number of times people need to visit a prescriber for repeat prescriptions of medications for some chronic conditions, like ADHD. Removing the ten-day dispensing rule from the Schedule would reduce the number of times people need to collect other Class B controlled drugs from a pharmacy, and removes the inconsistency between the Schedule Rules and the Misuse of Drugs Regulations.
These changes would affect the following medicines listed in Section B of the Pharmaceutical Schedule:
- Dexamfetamine sulphate
- Methadone hydrochloride
- Methylphenidate hydrochloride
- Morphine hydrochloride
- Morphine sulphate
- Oxycodone hydrochloride
- Pethidine hydrochloride
Details about our proposal
We are proposing the following changes to the General Rules (Section A) of the Pharmaceutical Schedule from 1 February 2023. Only relevant parts of the rules are shown, with changes in bold and strikethrough:
Part 1 – Prescribing and initiating Subsidies for Community Pharmaceuticals
1.2 Periods of supply for Subsidy: For Community Pharmaceuticals, periods of supply are as follows (note that legislative and regulatory requirements regarding periods of supply must also be met):
1.2.1 Only a quantity sufficient to provide treatment for a period of up to 3 Months will be Subsidised, and only if the Prescription under which the Community Pharmaceutical has been dispensed was presented to the Contractor within 3 Months of the date on which the Prescription was written, subject to the following exceptions:
a Class B Controlled Drugs: Only a quantity sufficient to provide treatment for a period of up to 1 Month in total (or up to 5 days when prescribed by a Dentist) will be Subsidised.
Part 4 – Community Pharmaceutical Dispensing Quantities for Subsidy
4.1 Long Term Conditions (LTC) registered patients: With the exception of prescriptions for Class B controlled drugs, LTC patients can be dispensed to as often as the dispensing Pharmacist deems appropriate to meet that LTC patient's compliance and adherence needs.
4.4 Community Pharmaceuticals identified in the Schedule without the ❋ or ▲ symbols
4.4.1 Default dispensing is Monthly Lots, or 10 day Lots for Class B Controlled Drugs, other than methylphenidate hydrochloride and dexamfetamine sulfate, in which case default dispensing is Monthly Lots.
4.4.2 A Community Pharmaceutical, other than a Class B Controlled Drug, may be dispensed in one Lot in the following circumstances:
a. a patient or their representative signs the Prescription to qualify for single Lot dispensing. In signing the Prescription, the patient or their nominated representative must certify which of the following criteria the patient meets:
i they have limited physical mobility
ii they live and work more than 30 minutes from the nearest pharmacy by their normal form of transport
iii they are relocating to another area, or
iv they are travelling and will be away when the repeat Prescriptions are due.
b A Class B Controlled Drug may be dispensed in Monthly Lots if the patient meets the requirements of the criteria in 4.4.2.a.
4.4.3 Community Pharmaceuticals, other than Class B Controlled Drugs, identified in the Schedule without the ❋ symbol (where default dispensing is Monthly Lots) and prescribed in a quantity sufficient to provide treatment for more than 1 Month may be dispensed in variable dispensing periods under the following conditions:
a for stock management where the proprietary pack(s) result in dispensing greater than 30 days’ supply
b to synchronise a patient’s medication where multiple medicines result in uneven supply periods, or
c when the total quantity and dispensing period does not exceed the total quantity and period prescribed on the Prescription.
Part 5 – Community Pharmaceutical Modified Dispensing Quantities
5.2 Residential care: Community Pharmaceuticals, other than Class B Controlled Drugs, may be dispensed in modified dispensing quantities to a person whose placement in a Residential Disability Care Institution is funded by the Ministry of Health or Health NZ, or to a person residing in an Age Related Residential Care Facility, on the request of the person, their agent or caregiver provided that the following conditions are met:
5.2.1 The quantity or period of supply to be dispensed at any one time must not be less than:
a 7 days' supply for a Class B Controlled Drug, or
The legislation requires the prescriber to specify dispensing frequency of Class B controlled drugs. Therefore pharmacist adjustment of dispensing frequency would not apply to Class B controlled drugs under this proposal. Specifically, this applies to Parts 4 and 5 of the Schedule Rules in relation to:
- Long Term Conditions registered patients
- synchronisation of medicines
- single lot dispensing due to patient circumstances
- people in residential care
There are no changes proposed to PSO and BSO requirements for Class B controlled drugs as these are unaffected by the legislative changes.
There are no changes proposed to the rules for the use of Class B controlled drugs in Te Whatu Ora - Health New Zealand hospitals.
Although the legislative changes come into force on 22 December 2022, we propose to implement any changes to the Schedule Rules from 1 February 2023. This is to allow:
- sufficient time for technical and system changes to occur
- pharmacies to consider their controlled drug stockholding and storage requirements
- suppliers to ensure there is sufficient stock in the supply chain to meet any initial increase in demand for funded Class B controlled drugs
The current Schedule Rules will apply to the funded prescribing and dispensing of Class B controlled drugs between 22 December 2022 and the implementation date of any changes to the Schedule Rules.
To provide feedback
Send us an email: email@example.com by 5 pm on 21 December 2022.
All feedback received before the closing date will be considered by Pharmac prior to making a decision on this proposal.
This consultation process is limited to feedback relating to Pharmac’s proposal to amend Pharmaceutical Schedule funding rules. Submitters should note that the consultation does not cover the changes to the Misuse of Drugs Amendment Regulations 2022 and Medicines Amendment Regulations 2022 legislation; these fall outside Pharmac’s scope of responsibility.
Feedback we receive is subject to the Official Information Act 1982 (OIA) and we will consider any request to have information withheld in accordance with our obligations under the OIA. Anyone providing feedback, whether on their own account or on behalf of an organisation, and whether in a personal or professional capacity, should be aware that the content of their feedback and their identity may need to be disclosed in response to an OIA request.
We are not able to treat any part of your feedback as confidential unless you specifically request that we do, and then only to the extent permissible under the OIA and other relevant laws and requirements. If you would like us to withhold any commercially sensitive, confidential proprietary, or personal information included in your submission, please clearly state this in your submission and identify the relevant sections of your submission that you would like it withheld. Pharmac will give due consideration to any such request.