Proposal relating to tramadol hydrochloride oral solution in DHB hospitals

Medicines

Consultation Closed

PHARMAC is seeking feedback on a proposal to delist tramadol hydrochloride oral drops 100 mg per ml, and instead list a 10 mg per ml strength of tramadol hydrochloride oral solution for use in DHB hospitals. We are proposing a six month transition period for the change, commencing 1 January 2017.

Further details of the proposed changes and background information can be found on the following pages.  In summary, this proposal would result in the following changes in Part II Section H of the Pharmaceutical Schedule:

  • Listing of tramadol hydrochloride oral solution 10 mg per ml from 1 January 2017.
  • Delisting of tramadol hydrochloride oral drops 100 mg per ml on 30 June 2017.

Note this proposal would not result in any changes to the current listings of tramadol hydrochloride in Section B of the Pharmaceutical Schedule (community).

Feedback sought

PHARMAC welcomes feedback on this proposal. To provide feedback, please submit it in writing by 4pm Thursday, 20 October 2016 to:

Andrew Park
Therapeutic Group Manager
PHARMAC

Email: andrew.park@pharmac.govt.nz

Fax:     04 460 4995

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. 

Details of the proposal

  • Tramadol hydrochloride oral solution 10 mg per ml would be listed under the Opioid Analgesics subheading in Analgesics (Nervous System therapeutic group), in Part II of Section H of the Pharmaceutical Schedule from 1 January 2017 as follows:
Chemical Formulation Brand
Tramadol hydrochloride Oral soln 10 mg per ml Any brand
  • The new listing would allow DHBs to procure any brand of tramadol hydrochloride oral solution 10 mg per ml; although PHARMAC notes that no product at this strength is currently registered in New Zealand by Medsafe.   
  • DHBs could alternatively compound tramadol hydrochloride oral solution 10 mg per ml using the tramadol hydrochloride 50 mg capsules.
  • Tramadol hydrochloride 100 mg per ml oral drops would be delisted from Part II of Section H of the Pharmaceutical Schedule on 30 June 2017.
  • No changes are proposed to tramadol hydrochloride funding in the community. The 10 mg per ml is currently funded in the community when compounded using the tramadol hydrochloride 50 mg capsules listed in Section B of the Pharmaceutical Schedule. Tramadol oral drops 100 mg per ml are not funded in the community.

Background

Tramadol oral solution (or oral drops) is used for the relief of moderate to severe pain, particularly in children or those who cannot swallow tablets or capsules.

In the community, tramadol oral solution 10 mg per ml can be compounded from the listed 50 mg capsules, and has been fully funded in the community since 2014. A standardised pharmacy compounding formulation for tramadol oral liquid 10 mg per ml is available here [link no longer available], with a recommended expiry of 30 days. Tramadol oral drops 100 mg per ml are not subsidised in the community.

In DHB hospitals, tramadol oral drops 100 mg per ml are currently listed in Part II of Section H of the Pharmaceutical Schedule. Some DHB hospitals are also using the compounded 10 mg per ml formulation referred to above.  

PHARMAC’s Analgesic Subcommittee of PTAC considered tramadol oral solution at its meeting in March 2016. The Subcommittee recommended that PHARMAC delist tramadol oral drops 100 mg per ml from the Hospital Medicines List (HML) for safety reasons. The Subcommittee considered that, provided a 10 mg per ml formulation of tramadol was available in hospitals and funded in the community, there was no clinical need for the 100 mg per ml tramadol oral drops. Further details of Subcommittee’s advice are available on our website here [PDF, 57 KB].

PHARMAC would consider listing a proprietary tramadol oral solution 10 mg per ml product in the Pharmaceutical Schedule (community and hospital) if such a product gains registration in New Zealand.