Proposal to delist baclofen oral liquid from Section H

What we’re proposing

This proposal would not result in any changes to the current listings of baclofen tablet and injections in Section B of the Pharmaceutical Schedule (community).

Compounding of an oral baclofen liquid would continue in accordance with the New Zealand Standardised Oral Formulation Batch Sheet.(external link)

Further details on this proposal, including how to provide feedback, can be found below.

Consultation closes at 5pm Wednesday 11 August 2020 and feedback can be emailed to consult@pharmac.govt.nz.

What would the effect be?

From 1 February 2021, baclofen oral liquid 1 mg per ml would be delisted from Section H of the Pharmaceutical Schedule, concluding any use of proprietary baclofen oral liquids by DHB hospitals. This would mean that all DHBs would need to compound baclofen oral liquid, using baclofen 10 mg tablets, for patients who find alternative formulations of baclofen (e.g. tablets or injections) unsuitable. 

Access to baclofen oral liquid in the community would be unchanged, as compounding from baclofen tablets could continue in accordance with New Zealand Standardised Oral Formulation Batch Sheet recommendation, as a baclofen 10mg per ml suspension.

Who we think will be interested

• Community and hospital pharmacists
• Pharmaceutical compounding services
• Paediatric patients and their whānau
• Paediatricians, General Practitioners, Neurologists, rehabilitation and palliative care physicians and other clinicians, health professionals and health services involved in the care and management of people who have severe spasticity

About baclofen

Baclofen is used for the treatment of spasticity, a muscle disorder that results in tight or stiff muscles, typically as a result of prolonged muscle contractions. Spasticity can affect muscles in any part of the body but is most common in the legs and is associated with damage to the brain, spinal cord, or motor nerves in conditions such as; multiple sclerosis, traumatic brain or spinal cord injury, stroke, cerebral palsy, and illnesses impacting the brain or spinal cord.  

In the community, baclofen tablets are listed without restriction, while the injections are subsidised “only for use in a programmable pump in patients where oral antispastic agents have been ineffective or have caused intolerable side effects and the prescription is endorsed accordingly.”

In the hospital, baclofen oral liquid 1 mg per ml is also funded, without restrictions. It is listed as “any brand”, meaning that a hospital pharmacist can purchase any product meeting the description. We are aware that there are a number of DHB hospitals who both compound and purchase baclofen 1 mg/ml oral liquid products. 

In some cases, patients are unable to swallow the tablets that are funded. This includes babies and small children, as well as adults who are unable to swallow tablets. These patients are currently able to receive funded baclofen oral suspension through compounding of the tablet in the community (strength 10 mg per ml), and either the compounded solution, or a pre-made solution (strength 1 mg per ml), in hospital. 

Why we’re proposing this

We are proposing to delist baclofen oral liquid 1 mg per ml from the Pharmaceutical Schedule in order to standardize compounding in accordance with the New Zealand Standardised Oral Formulation (NZSOF) batch sheet for baclofen suspension. At present, the only available standardised formula for compounding of a baclofen oral liquid recommends compounding in a strength of 10 mg per ml, resulting in inconsistency between the strengths of hospital and community supply of baclofen oral liquid. This presents a high risk of error of both over and under dosing when patients move between primary (community) and secondary (hospital) care, potentially moving between a 1 mg per ml product (in secondary care) to a 10 mg per ml product (in primary care).

Dosing errors associated with the dispensing and supply of different strengths of baclofen liquids can result in serious consequences such as inadvertent unintended overdose (patients receiving 10 times their normal dose), or mismanagement of underlying spastic symptoms. In order to reduce the risk of serious harm to patients, consistency in the dispensed strength of baclofen is needed across both community and hospital.

A large proportion of patients who use baclofen oral liquid in both community and hospital are children, due to the requirement for smaller doses than those provided by the 10 mg tablet and difficulty in swallowing a tablet formulation.  There are currently no presentations of baclofen oral liquid approved by Medsafe; therefore, there are no proprietary liquid products that are available for supply in both the community and hospital setting to enable consistency of strengths when patients move between primary and secondary services.

PHARMAC has received feedback from the Compounding Working Group, a Medication Safety Expert Advisory Group of the Health Quality and Safety Commission New Zealand, who highlighted the risk of error associated with baclofen oral liquid when patients move between primary and secondary care. In order to ensure national consistency, the working group requested that baclofen oral liquid 1 mg per ml be delisted, to enable standardisation to the NZSOF formulation.   

PHARMAC would consider listing a proprietary baclofen oral solution (either 10 mg per ml, or 1 mg per ml) in the Pharmaceutical Schedule (community and hospital) if such a product gains approval by Medsafe in New Zealand.

Details about our proposal

From 1 February 2021, baclofen oral liquid 1 mg per ml would be delisted from the Muscle Relaxants and Related Agents subgroup of the Musculoskeletal Therapeutic group in Part II of Section H of the Pharmaceutical Schedule.

No changes are proposed to the funding of other funded formulations of baclofen:

• Tablet 10 mg
• Injection 0.05 mg per ml, 1 ml ampoule
• Injection 2 mg per ml, 5 ml ampule

Baclofen oral liquid 1 mg per ml is not currently funded in the community.

Compounding of baclofen oral liquid in the community would continue as per current practise, using baclofen tablets according to the New Zealand Standardised Oral Formulation Batch Sheet formula.

To provide feedback

Send us an email: consult@pharmac.govt.nz by 5pm Wednesday 11 August 2020.

All feedback received before the closing date will be considered by PHARMAC’s Board (or its delegate) prior to making a decision on this proposal.

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.