Decision to amend the Pharmaceutical Schedule Rules on prescribing and dispensing of methylphenidate and dexamfetamine
What we’re doing
We're pleased to announce that we are amending the General Rules of the Pharmaceutical Schedule from 1 June 2023 to allow three months of the stimulant/ADHD treatments, methylphenidate and dexamfetamine, to be funded when prescribed electronically.
This is to make funded supply consistent with recent legislative changes to the prescribing and dispensing of these medicines, which are Class B controlled drugs.
This decision means that:
- The number of times people need to visit a prescriber for funded repeat prescriptions for these medicines will be reduced from every month to every three months if they are prescribed via the New Zealand ePrescription Service (NZePS). The amount that can be prescribed on a paper prescription will stay as one month.
- People taking methylphenidate and dexamfetamine will pay a prescription co-payment every three months instead of every month when these medicines are prescribed via the NZePS.
Any changes to the original proposal?
This decision was subject to a consultation letter dated 28 November 2022(external link).
The original proposal in the consultation was to amend the Pharmaceutical Schedule General Rules for all Class B controlled drugs to make funding of them consistent with the Medicines Amendment Regulations 2022(external link) and the Misuse of Drugs Amendment Regulations 2022(external link).
In response to the consultation Pharmac received feedback about the inclusion of opioids in this process. Manatū Hauora then asked Pharmac to delay making a decision on the proposed changes to the Schedule Rules to allow them to revisit the regulatory arrangements for opioids.
Manatū Hauora recently indicated that there was no longer a reason to delay Pharmac’s decision in relation to funding of three-month prescriptions for methylphenidate and dexamfetamine.
This decision only gives effect to the funding arrangements for methylphenidate and dexamfetamine as consulted on in the original proposal and considering all of the feedback we received, we have decided not to make any changes to the original proposal for these medicines.
As stated above, a decision for Class B controlled drugs that are opioids remains on hold, pending further work on regulatory arrangements by Manatū Hauora so they have been excluded from any changes and in this notification of funding arrangements.
We’re really grateful for the time people took to respond to this consultation. Many people who responded were supportive of the proposal in relation to prescribing and dispensing of methylphenidate and dexamfetamine.
A summary of the main themes raised in feedback and our responses to the feedback received are summarised below.
Who we think will be most interested
- People with ADHD and other conditions treated with methylphenidate and dexamfetamine and their whānau
- Organisations with an interest in ADHD
- Clinicians and prescribers in the community and secondary care
- Pharmaceutical suppliers and wholesalers
- Te Whatu Ora
Detail about this decision
From 1 June 2023 methylphenidate and dexamfetamine will be funded for up to three months on a prescription, when prescribed electronically.
The following changes to the General Rules (Part A) of the Pharmaceutical Schedule will occur (amended sections only shown, additions in bold, deletions in 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: Other than methylphenidate hydrochloride and dexamfetamine sulfate, Oonly 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
4.4 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 methylphenidate hydrochloride and dexamfetamine sulfate, may be dispensed in one Lot in the following circumstances:
b A Class B 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.
While the Regulations allow electronic prescriptions for methylphenidate and dexamfetamine to be issued for three months at a time instead of one month, the frequency of dispensing for these medicines remains monthly.
Prescribers are able to issue shorter prescriptions, or specify more frequent dispensing.
Our response to what you told us
A summary of the main themes raised in feedback and our responses to the feedback received are shown below. We have included feedback where there was a clear reference to stimulant medicines either directly or indirectly.
Support for the proposal, with improved equity of access to stimulants resulting from less frequent prescription renewals
We are grateful for the number of people and organisations that took the time to submit feedback in support of the proposal.
We appreciate those who shared their personal experiences and of those their whānau members with ADHD with us about the barriers to accessing medicines.
Concern at increased supply 30 days to 90, unless the prescriber specifies a restricted dispensing frequency
Under this proposal and within the legislation, prescribers have flexibility to prescribe for shorter periods than 90 days to meet the needs of patients. 30 days’ supply remains most that can be dispensed at a time on a 3-month electronic prescription
Support for improved safety and monitoring from ePrescribing
We welcome these benefits from expansion of the NZ ePrescription Service.
Concerns about the consultation process for the legislative changes
We have shared feedback with Manatū Hauora who have advised us that they are revisiting the regulatory settings for opioids.
Concerns about the original implementation timeframes
Pharmac consulted on the Schedule Rules proposal as soon as possible after the Regulations were publicly notified by Gazette on 24 November 2022.
The original implementation timeframes in the proposal reflected the timing required to support the sector with this change, while balancing the needs of the community.
We are pleased that this change comes into effect in one month’s time on 1 June 2023.
Requests for a review of subclassifications within Class B controlled drugs and that opioids should be considered separately to stimulants
We agree this is appropriate and this decision acknowledges and reflects the different considerations for opioids and stimulants.
Impact on pharmacy of increased controlled drug storage requirements and stock management
We acknowledge these concerns, however we note in regard to this decision, the maximum amount of methylphenidate and dexamphetamine issued to a person at each dispensing does not change.
Suggestions about Special Authority applicant types and criteria
We are aware there are other areas to explore to improve access to ADHD treatments and we intend to work with our sector partners on this as we consider these suggestions.
If you have any questions about this decision, you can email us at email@example.com; or call our toll free number (9 am to 5 pm, Monday to Friday) on 0800 660 050.