Decision to list non-surgical antimicrobial hand hygiene products

Hospital devices

Decision

We are pleased to announce the approval of listing agreements with 3M New Zealand Limited (“3M”) and Schülke New Zealand Limited (“Schülke”) for the supply of non-surgical antimicrobial hand hygiene (“Hand Hygiene”) products.

In summary this will result in:

  • 3M and Schülke’s Hand Hygiene products being listed in the Pharmaceutical Schedule from 1 July 2018 under national agreements that all DHBs may purchase under (“Agreements”).
  • Estimated national cost increase of $23,000 per annum from the 3M Agreement.
  • Estimated national savings of $150,000 per annum from the Schülke Agreement.
  • 3M and Schülke providing training and education on the appropriate use of the products, at times as agreed with individual DHBs.

Any changes to the original proposal?

This decision was subject to a consultation letter dated 7 May 2018.

During consultation it was identified that one of the accessories included in the 3M Agreement is not used with any of the Hand Hygiene products included in the Agreement. The accessory has been removed from 3M’s Agreement.

Who we think will be most interested

  • Suppliers and Wholesalers
  • DHB Staff
    • Clinicians
    • Procurement and supply chain personnel
    • Infection control personnel

Detail about this decision

In October 2017 PHARMAC issued a Request for Proposals (“RFP”) for Hand Hygiene products. The RFP requested proposals for non-exclusive national agreements for listing in the Pharmaceutical Schedule.

After completing the RFP evaluation processes and consulting on the provisional Agreements reached with 3M and Schülke, PHARMAC has decided to list 3M and Schülke’s ranges of Hand Hygiene products in Part III of Section H of the Pharmaceutical Schedule from 1 July 2018.

The list of products will be available on PHARMAC's website from 1 July 2018, in both a PDF document and an Excel spreadsheet.

DHBs can continue to choose which Hand Hygiene products they purchase. DHBs that purchase 3M and Schülke’s Hand Hygiene products must do so under the terms and conditions, and at the prices, included in the Agreements, from 1 July 2018.

A mandatory requirement of the RFP was that the Hand Hygiene products hold, or are significantly through the process of obtaining, Medsafe consent to be distributed as a medicine in New Zealand. 3M and Schülke were the only suppliers who met this requirement and these are the only Agreements to result from this RFP. DHBs can purchase other suppliers’ brands of Hand Hygiene products, but may wish to consider the regulatory status of consents.

Our response to what you told us

We appreciate the time people took to consider this consultation.

All consultation responses received were considered in their entirety in making a decision to approve 3M and Schülke’s provisional Agreement.

A summary of the main themes raised in feedback and our responses to the feedback received are set out below:

Theme

Comment

Feedback that no technical or resource impacts are expected as a result of the proposal.

Noted.

Support the proposal for listing Schülke products.

Noted.

Clarification on the need for Hand Hygiene products to be approved as medicines. 

Medsafe is the New Zealand regulatory body responsible for the approval of medicines. Medsafe has advised PHARMAC that all antimicrobial skin products used as part of the provision of health services are considered medicines as defined in regulation 58A of the Medicine Regulations 1984. Suppliers of Hand Hygiene products are responsible for ensuring that products hold the necessary consents before they are promoted and distributed in New Zealand. As part of the procurement process a mandatory requirement was that products were approved as medicines, or significantly through the approval process.

Require Hand Hygiene products to have at least 70% ethanol concentration or 60% isopropyl alcohol concentration.

The proposed products meet the legislative requirements in New Zealand. DHBs still make decisions about which Hand Hygiene products are most suitable for their clinical setting but PHARMAC encourages DHBs to consider whether the products hold the necessary regulatory consents.

Lack of clinical advice received from Infection Prevention Control Nurses and Health Quality and Safety Commission.

Currently during the national contracting phase DHBs retain the choice about which products they purchase. Because DHB choice is not impacted in depth clinical advice was not sought.

Clarification on whether other requirements, such as approval by the Therapeutic Goods Administration of Australia was considered.

Other requirements were not considered due to there being specific legislative requirements in New Zealand.

Lack of container styles and sizes could limit compliance.

PHARMAC considered product and container sizes based on the products and accessories that were proposed by suppliers. If there are specific product or container sizes that the proposed suppliers currently provide but are not proposed for listing then this could be discussed further with the suppliers.

PHARMAC should reconsider including products with chlorhexidine in a proposal for non-surgical Hand Hygiene products to decrease the potential risk of antimicrobial resistance.

Chlorhexidine based Hand Hygiene products are used widely throughout DHBs, not just in surgical settings. Individual DHBs can continue to have their own internal protocols regarding the use of chlorhexidine based Hand Hygiene products.

Clarification on the volume of DHB staff that have indicated a preference to PHARMAC for Hand Hygiene products that are not proposed for listing.

Currently DHBs are still able to purchase from suppliers that are not listed in the Pharmaceutical Schedule but PHARMAC has recommended that they consider the regulatory approval status of products. 

Clarification on how the costs and savings are calculated, and whether it takes into account the cost of change

Estimated savings are based on suppliers’ historic sales data and proposed pricing as detailed in the RFP response with the assumption that purchasing volumes remain constant. Savings analysis does not assume any DHB is switching to an alternative supplier therefore the cost of change is assumed to be zero. PHARMAC is aware that there are costs of change associated with switching from one supplier to another, if a DHB was considering switching to one of the listed suppliers they would take this into consideration as part of their decision process, as well as any additional savings this change may give rise to. 

Clarification on whether DHB annual purchasing volumes have been provided to suppliers.

PHARMAC does not provide any DHB sales volumes to suppliers as part of national contracting RFPs.

Clarification on whether proposals included rebates.

While we prefer simple pricing models, PHARMAC is generally willing to consider alternative pricing models that include tiered pricing and rebates. Whether these are included in an agreement would depend on the proposal demonstrating benefit to DHBs. The specific details of these agreements are commercially sensitive.

 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.