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

Medicines Decision

30 October 2023 Update

Following this decision, we received feedback on removing Schedule Rule 1.2.1. Rule 1.2.1 required that a prescription be presented to the Contractor within 3 Months of the date on which the Prescription was written.

While we did consult on aligning the Schedule Rules with existing legislation, we acknowledge that this specific change would have an impact beyond the main subject of the consultation, which was controlled drug prescriptions.

We have considered your concerns and decided to keep the requirement for prescriptions to be presented within 3 Months of the date on which they were written. Rule 1.2 will now read as follows:  

1.2  Community Pharmaceuticals periods of supply for Subsidy: Community Pharmaceuticals will be Subsidised 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; and

1.2.1   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.

What we’re doing

We're pleased to announce that we are amending the General Rules of the Pharmaceutical Schedule from 1 November 2023 to align funding with recent legislative changes to the prescribing and dispensing of opioid controlled drugs.

This decision means that:

  • the period of subsidised supply for opioids prescribed under Opioid Substitution Treatment services will increase from one month to three months
  • the maximum period for subsidy on all opioid controlled drug prescriptions will be one month across all prescriber groups
  • ten days supply will continue to be the default dispensing period for Class B opioids
  • discretion to supply Class B opioids in a single monthly lot will continue, through Rule 4.4.2.a of the Pharmaceutical Schedule

Any changes to the original proposal?

This decision was subject to a consultation letter dated 26 September 2023.

We are grateful for the time people took to provide us with their feedback which has helped determine our final decision. Most of the feedback was supportive and there are no changes to the original proposal.

A summary of the main themes in the feedback and our response 

Who we think will be most 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

Detail about this decision

The following changes to the General Rules (Part A) of the Pharmaceutical Schedule will occur from 1 November 2023 (amended sections only shown, additions in bold, deletions in strikethrough):

Part 1 – Prescribing and initiating Subsidies for Community Pharmaceuticals

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.

Part 4 – Community Pharmaceutical Dispensing Quantities 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.

Note that not all medicines have the same legal limit on period of supply under the relevant Acts and Regulations. For example, the legal period of supply for oral contraceptives is six months.

The Misuse of Drugs Amendments Regulations (No2) 2023 reduce to one month the maximum period of supply for the Class C opioids (such as tramadol, codeine, dihydrocodeine and buprenorphine with naloxone). The amended Schedule Rules will give effect to the amended one-month supply limit.

For more information about these changes, see FAQs on the Misuse of Drugs Amendments Regulations – Manatū Hauora website

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. Most responses were supportive of the proposal.

We have summarised the main themes raised in the feedback and our response below.

Theme

Comment

Feedback supported alignment of the Schedule rules with legislation in relation to prescriptions for Opioid Substitution Treatment and the retention of the current default dispensing period of 10 days.

We appreciate the responses in support of this proposal.

There was some concern that aligning subsidy rules for dentists with legislation

may delay dental interventions and increase risk of illicit diversion or inappropriate prescribing of controlled drugs.

 

The Safe Access to Opioids working group(external link) publicly engaged on the alignment of limits for all controlled drug prescribers before a decision was made by Cabinet and enacted through amendments to the Misuse of Drugs Regulations.

We support Manatū Hauora’s view that professional standards and guidance set by colleges and other professional bodies and comprehensive monitoring are appropriate controls on practice.

Concern that there would be a financial and access impact on patients due to the reduced prescribing limit on Class C opioids.

This was a legislative decision made following public engagement. The Schedule rules do not override legal limits.

 

Some feedback expressed concern about inconsistency in practice between legislation taking effect and the proposed funding changes. There was also feedback that the implementation timeframe was too short to make changes to pharmacy software.

 

We appreciate that gaps between legislative and funding changes cause practice issues for prescribers/pharmacists, with inconvenience and additional costs for patients. We consulted on this proposal as soon as possible following notification of the legislative changes.

We also acknowledge the impact of rapid implementation timeframes on software vendors.

We consider it important to give effect to the legislative amendments as soon as possible and will implement this decision from 1 November 2023, as consulted on.

If you have any questions about this decision, you can email us at enquiry@pharmac.govt.nz; or call our toll-free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.