Phenobarbitone: Supply issue

Supply issue Active

The supplier, Max Health, has advised PHARMAC that due to global supply issues for phenobarbitone sodium injection the New Zealand stock levels are critically low.

As this is due to manufacturing issues, it is unknown when this product will be fully restocked. 

Please allocate any existing stock you hold for neonatal patients to treat seizure control in post-birth asphyxia, etc. Prioritisation of phenobarbitone to one patient group is not a situation we want to be in.

We are advised there are listed alternative medicines to control of status epilepticus for other patients.

Check the HML for other nervous system agents(external link)

Check the Pharmaceutical Schedule for other nervous system agents(external link)

Small amounts of phenobarbitone sourced

Max Health expects a small amount of additional stock of the inj 200 mg per ml, 1 ml amp to arrive late January 2021.

A second presentation will be funded from 1 Februrary 2021. CDC Pharmaceuticals Ltd has sourced 10 packs of phenobarbital sodium Inj 130 mg per ml, 1 ml vial from Cameron Pharmaceuticals (USA) to help supply. 

Important notes:

  • The 130 mg per ml, 1 ml vial presentation will be listed 'any brand' in Section H of the Schedule (HML) from 1 February 2021.
  • The Cameron phenobarbital sodium injection is a different strength and presentation compared to the currently listed 200 mg per ml, 1 ml amp.
  • Phenobarbital is the American name for phenobarbitone. The Cameron product will be labelled phenobarbital. 

Information for prescribers

We have asked pharmacies to allocate existing stock of phenobarbitone sodium injections for neonatal seizure control in post birth asphyxia etc. 

Neonatal paediatric specialists have expressed considerable concerns about any shortage of phenobarbitone injections. We understand that there are largely no clinical alternative medicines for neonatal patients.

Prescribers will need to:

  • Start no new patients on phenobarbitone sodium injections, except for neonate, if stock is available.
  • Use clinical judgement to transition any existing patients to funded alternatives.

Information for pharmacists

Allocate your existing stock of phenobarbitone sodium injections for neonatal seizure control in post-birth asphyxia etc. There are largely no clinical alternative medicines in this setting. 

Background to the issue 

Max Health has notified PHARMAC that there are global supply issues for phenobarbitone sodium injections (200 mg per ml, 1 ml ampoule). No alternative source of phenobarbitone sodium injections has been identified. 

There are currently no presentations of phenobarbitone injections approved by Medsafe for use in New Zealand. Phenobarbitone sodium injections are listed in the Pharmaceutical Schedule and are supplied by Max Health as an unregistered product under Section 29 of the Medicines Act.

Approximately 115 injections are used each month in palliative care in the community. In hospitals, 180 injections are used each month.

For more information

If you have questions about this stock issue, email enquiry@pharmac.govt.nz