Proposal to amend Pharmaceutical Schedule Rules to align funding with the Misuse of Drugs Amendment Regulations (No 2) 2023

Medicines Consultation Closed

What we’re proposing

We are seeking feedback on a proposal to amend the Pharmaceutical Schedule General Rules (the Schedule Rules) to make funding consistent with recent legislative changes to the prescribing and dispensing of controlled drugs.

Consultation closes at 5 pm on 10 October 2023 and feedback can be emailed to consult@pharmac.govt.nz

What would the effect be?

This proposal means that from 1 November 2023:

Funded supply of controlled drugs would be consistent with the maximum periods of supply allowed in the Misuse of Drugs Amendments Regulations (No2) 2023(external link).

Specifically, changes to the Schedule rules would permit:

  • funded prescriptions for opioids prescribed under Opioid Substitution Treatment Services to be written for up to three months; and
  • dentists’ controlled drug prescriptions to be funded for a period up to the legal maximum period of supply. The Schedule rules currently limit funding of controlled drugs prescribed by a dentist to five days’ supply.

The default dispensing amount for Class B opioid controlled drugs would remain at ten days supply. Class B opioids are listed in the schedules of the Misuse of Drugs Act 1975(external link). They include fentanyl methadone, morphine, oxycodone and pethidine.

There is some discretion to supply these medicines in a single monthly lot under rule 4.4.2.a of the Pharmaceutical Schedule. We are not proposing to change this.

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)
  • Pharmacists
  • Pharmaceutical suppliers and wholesalers

About this proposal

The Misuse of Drugs Amendments Regulations (No2) 2023 will come into effect from 5 October 2023 and will amend the Misuse of Drugs Regulations 1977.

Our proposal aims to align funding rules to the updated legislation, by:

  • allowing funded prescriptions for opioids prescribed under Opioid Substitution Treatment Services to be written for up to three months; and
  • removing the 5-day limit on subsidy for dentists’ controlled drug prescriptions. The maximum period for subsidy on prescription would be the same across all prescriber groups, as specified in the Regulations.

The Misuse of Drugs Amendments Regulations (No2) 2023 were developed by the Manatū Hauora Safe Access to Opioids(external link) working group which publicly engaged on possible approaches to regulation for opioids.

FAQs on the Misuse of Drugs Amendments Regulations can be downloaded from the controlled drugs(external link) section of the Manatū Hauora website.

Note that The Misuse of Drugs Amendments Regulations (No2) 2023 establish one month as the maximum period of supply for the Class C opioids tramadol and codeine. 

Not part of this proposal

Changes to ten-day default dispensing for Class B opioids are not being considered as part of this proposal, therefore:  

  • ten days supply would continue to be the default dispensing period for Class B opioids
  • discretion to supply these medicines in a single lot would remain under rule 4.4.2.a of the Pharmaceutical Schedule

Why we’re proposing this

The legislative changes that will come into force on 5 October 2023 will permit opioids prescribed under Opioid Substitution Treatment Services to be written for up to three months and establish the same upper limits on prescribing of controlled drugs across all prescriber groups. However, these changes are not currently fully enabled by the current Schedule subsidy rules.

We also want to provide clarity on proposed changes in our November 2022 consultation that we do not currently intend to implement.

Details about our proposal

We are proposing the following changes to the General Rules (Section A) of the Pharmaceutical Schedule from 1 November 2023.

Note: Not all medicines have the same legal limit on period of supply under the Medicines Act 1981, Medicines Regulations 1984, the Misuse of Drugs Act 1975, and Misuse of Drugs Regulations 1977.

For example, the legal period of supply for oral contraceptives is six months.

Only relevant parts of the rules are shown, with changes in bold and strikethrough:

1.2        Community Pharmaceuticals Pperiods of supply for Subsidy: For Community Pharmaceuticals:

1.2.1    periods of supply are as follows (note that legislative and regulatory requirements regarding periods of supply must also be met):  Only a quantity sufficient to provide treatment up to the legal period of supply limit will be Subsidised as specified in the Medicines Act 1981 and Medicines Regulations 1984 and the Misuse of Drugs Act 1975 and Misuse of Drugs Regulations 1977.

1.2.2     Where there is no legal period of supply limit, only a quantity sufficient to provide treatment for a period up to 3 Months will be Subsidised.

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: Other than methylphenidate hydrochloride and dexamfetamine sulfate, 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.

b  Oral Contraceptives: The Prescriber must specify on the Prescription the period of treatment for which the oral contraceptive is to be supplied. To be eligible for Subsidy, this period must not exceed 6 Months. Where the Oral Contraceptive is prescribed for non-contraceptive indications, then the Subsidised period of supply is up to 3 Months per Prescription.

c  Nicotine Replacement Therapy on Quitcard: Only a quantity sufficient to provide treatment for a period of up to 3 Months with nicotine patches, lozenges or gum will be eligible for Subsidy.

 

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 opioid 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 methylphenidate hydrochloride and dexamfetamine sulfate, may be dispensed in one Lot, where legally permitted, 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 dispensings are due.

b  A Class B opioid Controlled Drug with default dispensing of 10 day Lots may be dispensed in Monthly Lots if the patient meets the requirements of the criteria in 4.4.2.a.

There are no changes proposed to Practitioners’ Supply Order and Bulk Supply Order requirements for controlled drugs as these are unaffected by the legislative changes.

There are no changes proposed to the rules for the use of controlled drugs in Te Whatu Ora - Health New Zealand hospitals.

We propose to implement any changes to the Schedule Rules from 1 November 2023.

The current Schedule Rules(external link) will apply to the funded prescribing and dispensing of controlled drugs between 5 October 2023 and the implementation date of any changes to the Schedule Rules.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5 pm on 10 October 2023. 

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, the Medicines Amendment Regulations 2022 legislation and the Misuse of Drugs Amendments Regulations (No2) 2023(external link); 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.