Decision to delist heparin sodium injection 1,000 iu per ml, 35 ml vial

Hospital devices Medicines

Decision

PHARMAC has made a decision to delist the 1,000 iu per ml, 35 ml vial presentation of heparin sodium injection from both the community and hospital settings, but at a later date than proposed in the consultation.

Delisting will now occur as follows:

  • The Hospira brand of heparin sodium inj 1,000 iu per ml, 35 ml vial will be delisted from Section B of the Pharmaceutical Schedule (the community) from 1 February 2019; and
  • The heparin sodium inj 1,000 iu per ml, 35 ml vial presentation will be delisted from Part II of Section H of the Pharmaceutical Schedule (DHB hospitals) from 1 May 2019.

Other presentations of heparin (1,000 iu per ml, 5 ml ampoule and 5,000 iu per ml, 5 ml ampoule) will remain listed.

Any changes to the original proposal?

This decision was subject to a consultation in July 2018. The proposal was approved as consulted on except for the delay in the implementation timeframes to provide the market additional opportunity to clear stock prior to the delisting taking effect.

A longer timeframe will apply for delisting the 35 ml vial in DHB hospitals so that DHBs can choose to purchase product until stock is exhausted if it is available at favourable pricing compared to the 1,000 iu per ml, 5 ml ampoule.

Detail about this decision

For community based patients and pharmacies

Heparin sodium in the 1,000 iu per ml, 35 ml vial presentation (Hospira brand) will no longer be funded on prescription, rural PSO or BSO from 1 February 2019. Patients will need to change to an alternative presentation of heparin sodium, such as the same strength (but smaller volume) 1,000 iu per ml, 5 ml ampoule to remain on a funded product.

For DHB hospitals

Heparin sodium in the 1,000 iu per ml, 35 ml vial presentation will no longer be able to be purchased from 1 May 2019. DHB hospitals will need to change usage to an alternative presentation of heparin sodium, such as the same strength (but smaller volume) 1,000 iu per ml, 5 ml ampoule.

Who we think will be most interested

  • Hospital and community pharmacists, DHBs, suppliers and wholesalers.
  • DHB cardiothoracic surgical services
  • DHB renal services
  • Patients on home haemodialysis

Our response to what you told us

We’re really grateful for the time people took to respond to this consultation. All consultation responses received were considered in their entirety in making a decision on the proposed changes.

All responses except one were supportive of the proposal. A summary of the main themes raised in feedback, our responses to the feedback received are outlined below.

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.

Feedback theme Comment

Some large DHBs have already transitioned away from the 35 ml vials since stock issues in 2017.

Noted.

A consistent presentation for the future supply of heparin sodium injection 1,000 iu per ml is welcome. This may result in reduced administration errors and improve patient safety, particularly in the community setting for home dialysis patients.

Support for cost savings which the health system can assign to other areas of the pharmaceutical budget.

Noted.

One responder considered that the proposal should not be approved because the 35 ml vial may assist in ensuring continuity of supply given that it is manufactured in different manufacturing plant to the alternative heparin products. The 35 ml vial also has a different registered source of active pharmaceutical ingredient (API).

The same responder also considered that the 35 ml vial may be useful for patients undergoing haemodialysis, both in hospital and at home due to not having to draw up doses using multiple 5 ml ampoules.

We are confident there are sufficient arrangements in place to ensure continuity of supply of heparin sodium. This decision will increase harmonisation with other international markets where alternative supplies are likely to be available in the event of shortage. Suppliers can take measures to register other API sources if appropriate.

This feedback is inconsistent with the clinical advice we have received from the Nephrology Subcommittee and other clinicians. We understand that a patient undergoing dialysis would use two to three 5 ml ampoules per dialysis session. From an infection-control perspective, single-use ampoules may be preferable to opening and storing a vial for use on multiple occasions.

Patients who are having haemodialysis at home receive extensive training and thus we consider that drawing up their dose would not be overly significant in terms of total process requirements. If there are concerns, enoxaparin is also a potential alternative option, which is now funded for use in haemodialysis. 

During the interruption in supply, healthcare professionals, including community pharmacists, supported patients through the change process. A reversal back to the multi-dose vial will take a considerable amount of healthcare professional time to re-educate and advise patients.

PHARMAC would like to acknowledge the work of healthcare professionals during the shortage to safely manage the transition of patients to alternative presentations of heparin sodium.