Decision on bulk fluids listings for DHB Hospitals

Some responders discussed that although the proposal may be an overall cost saving, there are substantial changes in pricing, including significant increases in price on some of the products, particularly potassium containing intravenous fluids and mannitol.

Interim pricing agreements between Baxter and DHBs currently exist.

Concerns about significant price increases for pre-mixed paediatric fluids which will lead to a disproportionate increase in cost to Child Health. There is a risk that DHBs will compound their own solutions by making additions to less expensive bags rather than implement the safest practice of using pre-mixed bags.

Changes in practices may follow the price changes.

If there was any future change in product mix used by DHBs this could significantly impact on costs.

Limited competition currently exists in the New Zealand market for bulk fluids. Where this exists PHARMAC procurement activity has resulted in very low pricing. We are taking a long-term view to this market and consider that rationalising and standardising the product range and setting transparent national pricing will ensure the best possible pricing through enhanced future competition.

Noted.

Noted. We agree and also note compounding these formulations using additives is costly. On balance, PHARMAC staff consider the preferable outcome is to award the RFT bids at the higher prices noting this will secure contracted supply and may encourage future competitor entry. We consider there is value in using these products and would encourage them to be used in favour of making additions to other bags.

Noted, although we consider the majority of clinicians who determine usage are unlikely to be aware of product pricing. Any changes would therefore likely need to be protocol driven and would likely take considerable time to occur. We will monitor any changes in usage going forward.

PHARMAC used the indicative usage data specified in the RFT for our analysis. We have not forecasted changes in overall volumes or in the product mix unless a proposed discontinuation is likely to result in usage changing to another product line.

Some DHB responders mentioned logistics considerations related to this proposal, including different implementation dates requiring multiple purchasing catalogue updates, the need to use multiple suppliers, concerns about back up stockholding and historical supply record and provisions for emergency/pandemic supply.

PHARMAC has an agreement in place with all suppliers who are being awarded sole-supply as a result of the RFT. This contains standard terms around delivery to DHBs, minimum stock holdings and terms that apply if a supplier fails to supply the products. These agreements mitigate much of the risk of out-of-stock events.

PHARMAC rely on DHBs and contracted suppliers to have appropriate logistical arrangements in place. While we recognise DHBs would need to implement the changes proposed, we consider the duration of this agreement provides DHBs with certainty for an extended period and national agreements for continuity of supply that PHARMAC will manage on behalf of all DHBs.

PHARMAC has existing agreements in place with the proposed suppliers being Baxter, Fresenius Kabi, B Braun, Interpharma and Pfizer, so they will not be new suppliers for any DHBs.

Various DHB representatives, including sustainability officers, noted issues around the sustainability of bulk fluid procurement and recycling practices.

Some respondents did not support the funding of non-PVC bags that cannot be recycled in the PVC recycling programme operated by Baxter in some DHBs.

There was a particular concern that non-PVC bags would be inappropriately disposed of in the collection bins used for the PVC recycling programme.

PHARMAC is guided by the Government procurement principles published by the Ministry of Business, Innovation & Employment (MBIE) which directs those responsible for procurement to make balanced decisions considering the social, environmental and economic effects of the deal.

Although the expected initial usage quantities of non-PVC bags would not justify the set-up of a dedicated recycling programme, this may be possible over time and we have been informed that this is being established in Australia.

We have been informed that relevant DHB staff have received considerable education on the requirements of the PVC recycling operation. This may need an update if a non-PVC bag was introduced. We will work with the new suppliers and DHBs to support this.

Respondents noted implementation issues surrounding the proposed potassium chloride standardisation by discontinuing 30 mmol/l pre-made fluids.

The two DHBs who currently use potassium chloride 30 mmol/l instead of 20 mmol/l and 40 mmol/l, noted issues related to the implementation of a change to standardise potassium chloride fluids to 20 mmol/l and 40 mmol/l as proposed.

A potential safety risk was noted if prescribers continue to prescribe 30 mmol/l bags for some time after the changeover and potassium additions are made to 20 mmol/l bags instead of amending the prescription.

We also received feedback supporting the long-term advantages of standardising with other international markets.

There is considerable variability in utilisation between DHBs. Our advice from the Bulk Fluids Clinical Advisory Group (BFCAG) is that there is no clinically significant difference between 30 mmol/l and 20 mmol/l when daily potassium requirements are considered.

BFCAG recommended standardising the concentration of potassium chloride, noting that 20 mmol/l and 40 mmol/l containing solutions are clinically appropriate and consistent with international practice.

PHARMAC staff will engage with those DHBs who are affected by this change and will assist with the implementation as required.

Some responders noted issues related to the suitability of this new intravenous fluid bag presentation proposed. The proposed bags are physically quite different to the incumbent products.

Labelling is important to prevent errors.

The PVC and DeHP-free and rigidity of the additive ports material is useful for compounding, although master compounding worksheets will require updating.

The glucose 5% (Freeflex) bags supplied by Fresenius Kabi bags have been approved by Medsafe and are in widespread use in other countries. BFCAG and PHARMAC staff have reviewed product samples and are satisfied that, although it is made of a harder plastic compared to soft/flexible PVC bags, the product is suitable for use.

BFCAG discussed the labelling of intravenous fluids and noted its importance and potential manufacturing constraints. We will work with intravenous fluids suppliers to monitor this issue and suggest possible improvements to labelling, in line with Medsafe regulations.

Noted. We will ensure the new supplier communicates sufficient information about its products to compounders to enable these changes to occur smoothly.

The evidence associated with harm for hydroxyethyl starch containing fluids was performed in the context of critically unwell populations only and may not be generalisable to all, especially if use is limited to certain patients.

There is not enough evidence to derive any conclusions about either clinical effectiveness or harm of succinylated gelatin 4% (Gelofusine). We received requests to retain Gelofusine for endoscopic mucosal resections (polyp removal).

At its first meeting, after a comprehensive review of the evidence and considering consultion responses on the draft product list, the BFCAG recommended that hydroxyethyl starch containing fluids (Voluven and Voluvyte) be delisted from the Pharmaceutical Schedule as their continued funding could not be justified. PHARMAC at that point excluded these products from the RFT.

At its second meeting, BFCAG considered that there was insufficient evidence to support the use of succinylated gelatin over alternative fluids including saline or balanced crystalloid solutions that are known to be suitable for the correction of hypovolemia, but recommended PHARMAC consult with DHBs on the topic of delisting.

After considering all the feedback and our clinical advice, PHARMAC determined that retaining succinylated gelatin is the pragmatic approach at this time, particularly considering the gastroenterological use which was not explored by BFCAG.

We received some divided feedback on our proposal to delist various aqueous chlorhexidine containing irrigation fluids.

PHARMAC extended considerable effort to understand these products. We sought information on clinical uses from BFCAG, the Anti-infective and Dermatology Subcommittees, certain ophthalmologists and ENT specialists and during two public consultations. We were unable to identify any robust clinical rationale to justify their retention in addition to the proposed chlorhexidine + cetrimide alternative.

Given pricing, we consider awarding a RFT bid to many of these products is a poor use of funding given unidentifiable health benefits.

We received some requests to retain availability of the 100 ml or 500 ml bottles of water and sodium chloride for irrigation as the size of the bottle means less wastage or convenience for certain applications. Storage space is a concern for some departments.

Requests to retain availability of both 2L and 3L bags of irrigations used for urological surgery.

We have awarded 30 ml ampoules along with 250 ml and 1000 ml bottles. The BFCAG considered selecting the most cost-effective option within a range of “100-250 ml” was appropriate.

PHARMAC staff sought advice from specialist urologists who advised that they would prefer 3L bags given the quantities of fluids used for each case.

DHBs provided feedback on our proposal to delist various bulk fluid products including the use of Ringers solution to flush harvested veins prior to grafting them in cardiac surgery, a use for Inj glucose 2.5%; sodium chloride 0.45%, 500 ml in the paediatric oncology and haematology setting as part of the chemotherapy hydration regimens and a preference in some NICU units for Inj glucose 10%; 20 mmol/l in 500ml.

We also received a request for Inj glucose 5%; potassium chloride 20 mmol/l in 1000 ml.

We received general feedback that the outcomes in the critical care literature are recognised and removal of most of the items proposed for delisting would not pose any concerns.

Noted – following consideration of consultation feedback we have decided to retain these listings on the HML.

The BFCAG noted that this fluid was not widely used (<2000 bags p.a.) and alternatives were available. This fluid was subsequently excluded from the RFT.

Noted.

One supplier considered there was insufficient information on clinical preferences in the RFT document which compromised the integrity of the process.

We do not agree. PHARMAC made no assertions that every product tendered would be listed and/or awarded a contract.

PHARMAC kept an open mind until all information (including visibility of the full range of bids and prices) was available for a comprehensive assessment by PHARMAC and the BFCAG using our Factors for Consideration.

If the BFCAG had, at its first meeting, reached a firm view that certain fluids were not required (as it did for starch-containing fluids and others) they would have been excluded from the RFT product list.