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Changes to the listing of clarithromycin grans for oral liquid

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MIL OSI – Source: Pharmac – Press Release/Statement

Headline: Changes to the listing of clarithromycin grans for oral liquid

PHARMAC is pleased to announce the approval of an agreement with BGP Products for the supply of the antibiotic clarithromycin 250 mg per 5 ml, 50 ml, grans for oral liquid (Klacid) in the community and to DHB hospitals.

This was the subject of a consultation letter dated 12 February 2016.

In summary, the effect of the decision is that:

  • Clarithromycin 250 mg per 5 ml, 50 ml, grans for oral liquid (Klacid) will be listed on the Pharmaceutical Schedule fully funded, subject to restrictions, from 1 April 2016.
  • Clarithromycin 125 mg per 5 ml, 70 ml grans for oral liquid (Klacid) will be delisted from the Pharmaceutical Schedule from 1 October 2016.

This change of strength will result in a change in the volume of liquid dispensed per dose. Prescribers should continue to calculate the correct dosage based on the recommended dose in mg/kg. Further information on recommended dosages of clarithromycin can be found at www.nzfchildren.org.nz/nzf_3152 (external link) .

Details of the decision

  • Clarithromycin 250 mg per 5 ml, 50 ml grans for oral liquid will be listed in Section B and in Part II of Section H of the Pharmaceutical Schedule from 1 April 2016 at the following price and subsidy (ex-manufacturer, excluding GST):

Chemical

Presentation

Brand

Pack size

Price and subsidy

Clarithromycin

Grans for oral liquid250 mg per 5 ml

Klacid

50 ml

$23.12

  • Clarithromycin 250 mg per 5 ml, 50 ml grans for oral liquid will be listed in Section B of the Pharmaceutical Schedule subject to the following dispensing rule and Special Authority for Waiver of Rule:

Maximum of 500 mg per prescription; can be waived by Special Authority SA1131:

SA1131 Special Authority for Waiver of Rule

Initial Application – (Mycobacterial infections) only from a respiratory specialist, infectious disease specialist or paediatrician. Approvals valid for 2 years for applications meeting the following criteria:

Either:

  1. Atypical mycobacterial infection; or
  2. Mycobacterium tuberculosis infection where there is drug-resistance or intolerance to standard pharmaceutical agents.

Renewal – (Mycobacterial infections) only from a respiratory specialist, infectious disease specialist or paediatrician. Approvals valid for 2 years where the treatment remains appropriate and the patient is benefiting from treatment.

  • Clarithromycin 250 mg per 5 ml, 50 ml is an antibiotic oral liquid and therefore the wastage rule will apply.
  • Clarithromycin 250 mg per 5 ml, 50 ml grans for oral liquid will be listed in Part II of Section H of the Pharmaceutical Schedule subject to the following restriction:

Restricted

  1. Atypical mycobacterial infection; or
  2. Mycobacterium tuberculosis infection where there is drug resistance or intolerance to standard pharmaceutical agents.
  • Clarithromycin 125 mg per 5 ml, 70 ml grans for oral liquid (Klacid), will be delisted from Section B, and clarithromycin 25 mg per ml, 70 ml grans for oral liquid (Klacid) will be delisted from Part II of Section H of the Pharmaceutical Schedule from 1 October 2016.

Feedback received

We appreciate all of the feedback that we received and acknowledge the time people took to respond. All consultation responses received by 26 February 2016 were considered in their entirety in making a decision on the proposed changes. Responses were supportive of the proposal.

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.

Last updated: 11 March 2016



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