Update on baclofen oral liquid proposal

Medicines Decision

What is happening

We’re pleased to share that the concentration of baclofen oral liquid will be the same across both community and hospitals. The New Zealand standardised batch sheet for extemporaneously compounded baclofen oral liquid will change from 10 mg per ml to 1 mg per ml concentration from 1 November 2021. The Pharmaceutical Schedule listings for baclofen will not be changing. 

We hope this will reduce the risk of medication errors causing harm to patients. These medication errors most commonly happen when patients move between hospital and the community. 

We’re really grateful to everyone who has made this happen. 

Any changes to the original proposal?

We originally consulted on a proposal to delist baclofen oral liquid (1 mg per ml) from Section H in July 2020. After reviewing the consultation feedback, we decided not to delist baclofen oral liquid from Section H as was proposed. We have since worked with advisors across the sector to develop a new proposal that ensures the same concentration of baclofen oral liquid across community and hospital settings. 

Consultation is a very important step in our process. It’s how we check that what we are proposing can be implemented by the healthcare sector and supports the best health outcomes for New Zealanders. We’re really grateful for the time people took to respond to the consultation last year and everyone who has worked towards a solution. 

Who we think will be most 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 

Detail about this decision

No changes will occur in the Pharmaceutical Schedule. Baclofen oral liq 1 mg per ml will continue to be listed as ‘any brand’ in Section H (the Hospital Medicines List). 

The standardised batch sheet for extemporaneously compounded baclofen oral liquid suspension will be changed to a 1 mg per ml concentration from 1 November 2021. For doses that require a high volume of the 1 mg per ml concentration, the tablets can be crushed and dispersed in water prior to administration as an alternative. You can find the full alert, with instructions for pharmacies to manage this change, on the Health Quality & Safety Commission New Zealand’s website(external link)

The Health Quality & Safety Commission Compounding Working Group standardised batch sheets are hosted on the Pharmaceutical Society of New Zealand’s website. You can find all the New Zealand standardised batch sheets on their website(external link)

Our response to what you told us

We’re really grateful for the time people took to respond to the original consultation last year. A summary of the main themes raised in feedback and our responses to the feedback received are set out in the table below. 

Theme

Pharmac Comment

General support for one concentration in both community and hospital settings to improve safety

We acknowledge that consistency between community and hospital baclofen oral liquid will reduce medication errors and potential harm. The change in batch sheet will help provide this consistency.

Support for a 1 mg per ml formulation in the community setting

We are grateful to those who told us it would be preferable to have a 1 mg per ml formulation in the community, instead of the original proposal.

The community formulation (10 mg per ml) is hard to titrate to small doses

We acknowledge a 1 mg per ml formulation is easier to titrate to small doses and hope this change supports parents and caregivers.

Request to fund a proprietary baclofen oral liquid product

We would still consider listing a proprietary baclofen oral liquid product in the Pharmaceutical Schedule (community and hospital) if such a product gains Medsafe approval in New Zealand.

Some community pharmacies are already compounding a 1 mg per ml concentration

All community pharmacies should use the new standardised batch sheet to ensure consistency for patients. This will also ensure there is stability data available for the compounded product.

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.