Decision to delist tramadol hydrochloride oral drops 100 mg per ml

Medicines

Decision

PHARMAC has decided to progress the proposal to delist tramadol hydrochloride oral drops 100 mg per ml from Part II of Section H of the Pharmaceutical Schedule, and instead list a 10 mg per ml strength of tramadol hydrochloride oral solution for use in DHB hospitals.

This was the subject of a consultation letter dated 4 October 2016. In summary, the effect of the decision is that:

  • tramadol hydrochloride oral solution 10 mg per ml will be listed for use in DHB hospitals from 1 January 2017.
  • tramadol hydrochloride oral drops 100 mg per ml will be delisted from 30 June 2017.

Note this decision will not result in any changes to the current listings of tramadol hydrochloride tablets and capsules in Section B of the Pharmaceutical Schedule (community).

Details of the decision

  • Tramadol hydrochloride oral solution 10 mg per ml will 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 will allow DHBs to procure any brand of tramadol hydrochloride oral solution 10 mg per ml.
    • PHARMAC notes that there is no proprietary product currently registered with Medsafe, however, we understand there may be unregistered products, including a third party compounded product available in New Zealand.
    • 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 will be delisted from Part II of Section H of the Pharmaceutical Schedule on 1 July 2017.
  • No changes are proposed to the current listings of tramadol hydrochloride tablets and capsules in Section B of the Pharmaceutical Schedule (the community listing). An oral liquid formulation (10 mg per ml) is funded in the community when compounded using tramadol hydrochloride 50 mg capsules. 

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 21 October 2016 were considered in their entirety in making a decision on the proposed changes. Most responses were supportive of the proposal, and the following issues were raised in relation to specific aspects of the proposal:

Theme Comment

Multiple responders were generally supportive of the proposal and particularly noted:

  • it would prevent ambiguity in prescribing;
  • there is already a preference for 10 mg per ml formulation, particularly in paediatrics.
  • in some DHB hospitals it would not change practice, as they have not stocked 100 mg per ml oral drops for years;
  • it would improve safety for patients. In particular, the 10 mg per ml strength would provide a greater safety margin for the health workforce and would likely reduce risk of adverse outcomes for patients;
  • it would reduce wastage; and
  • it would increase access to tramadol for patients unable to swallow, particularly those who require doses less than 50 mg.

Noted.

Concern around potential initial confusion this could create, particularly around prescribing the wrong strength.

PHARMAC has allowed for a 6-month transition period and will provide information about the change to prescribers.

Concerns around the cost.

PHARMAC considers that whilst an increased cost is possible, it is likely to be small and would be dependent on how the product is compounded or the price obtained for a proprietary product.

Concern that proposal would have little to no effect on the volume of GP prescribing. Data provided from one responder noted a significant number of dispensed prescriptions for the non-funded 100 mg per ml product in the community in the Auckland region. The risk of mix-up would remain while two strengths remain available for use, regardless of funding.

As there is no registered 10 mg per ml brand, it is not listed on the NZULM and is not available in the drop down selection list for electronic prescribing in the community or hospitals setting. Instead, 100 mg per ml product is available via electronic systems (e.g. MedTech, Concerto) for prescribers to use. This has potential for error when prescribing and if done in conjunction with prescribing in volume rather than mg, could lead to 10-fold overdose.

Noted. PHARMAC is only able to control the listings in the Pharmaceutical Schedule and the decision to delist tramadol 100 mg per ml strength means that only one strength (10 mg per ml) will be listed on the Schedule in both community and hospital settings.

PHARMAC will provide information to prescribers about the benefits of prescribing the 10 mg per ml, the safety concerns identified with the use of 100 mg per ml and the change in the Schedule listing.

We also plan to discuss, with relevant stakeholders, the potential to add a 10 mg per ml tramadol oral solution (compounded) to electronic prescribing software in the absence of a registered product.

Recommend PHARMAC fund a commercial product rather than rely on compounded product in both hospital and community settings. There were concerns around the practicalities of extemporaneous compounding which could be prohibitive and delay treatment for patients. There were further concerns around risks of compounding by a pharmacist (particularly in a busy environment in the community), a process which may be vulnerable to error.

This proposal will allow DHBs to procure any brand of tramadol hydrochloride oral solution 10 mg per ml for use within DHB hospitals, including a compounded product from a third party compounding service. However, because there are currently no Medsafe registered products, at this time prescribing would need to be in accordance with s29 of the Medicines Act.

Concerns around the risks of compounding in a community setting are noted. 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 Medsafe registration in New Zealand.

On balance, based on the clinical advice and consultation responses received, PHARMAC considers the safety benefits from delisting the 100 mg per ml product outweigh the potential risks with both products remaining available in DHB hospitals or utilising a compounded product.

In the absence of a registered proprietary 10 mg per ml tramadol oral solution product, responders recommend PHARMAC fund an unregistered product in the community under section 29. This could be restricted under Special Authority for children (i.e. less than 12 years of age).

Medsafe ensures medicines meet acceptable standards of safety, quality, and efficacy.  At this time PHARMAC is not prepared to fund a third party compounded unregistered product in the community.

PHARMAC considers a restriction to limit funding to a specific population on the basis of age would not be appropriate unless there was a clear clinical rationale to differentiate them from others i.e. adult patients unable to swallow.

More information

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 66 00 50.