Commercial Medicines Unit

Procurement guide

Dose banding of cytotoxic pharmaceuticals

Homecare

Introduction3

Section A – Market overview4

Market
Environmental Appraisal
Products
Suppliers
Benchmarking
Websites
Publications

Section B – EU legislation8

Introduction
Procedure
CPV codes

Section C – Procurement Process9

Introduction
OJEC advertisement
Offer documentation
Specification
Key performance indicators
Award criteria
Product evaluations
Pre offer discussions
Issuing offer documents
Return of offer documents
Assessment of offers
Contract award
OJEU award notice
Contract review /

Appendices

1Supplier Profiles 16
2Specification 18
3Specification questionnaire 19
4Award and evaluation criteria 20
5Offer schedule 21

Section D– Feedback 14

Introduction

The Commercial Medicines Unit (CMU) has produced this procurement guide to help NHS trusts purchase dose banded cytotoxic pharmaceuticals as effectively as possible.

The guide falls into two primary sections. Firstly, a market overview, giving details of market conditions, products, suppliers and useful links to websites and publications.

Secondly, it provides guidance through the main areas of a procurement process with template documents covering suggested award and evaluation criteria, a sample specification and an offer schedule.

The guide is an evolving document and will be updated in the light of new experience and knowledge gained from contacts between CMU, trusts and the marketplace.

To ensure that the whole NHS can benefit from the experience of individual trusts, CMU invites you to provide feedback after the completion of your procurement process. This feedback will be used to provide anonymous benchmarking data to other trusts and to support development of the procurement guide.

If you have any questions or comments, please contact Jan Bevan, Category Manager by email to or by telephone on 01928 794623.

Section A - Market overview

Market

At present the majority of chemotherapy doses are prepared in house by the technical services units within trusts. However, as workload grows some of these units are reaching capacity. This process is being speeded by the demands of the NPSA Safety Alerts1 as they impact on pharmacy technical services. A possible solution to the increasing requirement for chemotherapy doses is to outsource some of the doses to a commercial compounding service.

These compounding services operate by supplying a range of products in ready to use form; typically those agents with a reasonably long shelf life which are used on a predictable basis. The trust augments this by preparing the other products in-house using the capacity that has been freed up. Procurement of these products may be coordinated through a contract for a compounding service covering an agreed product range.

Dose banding is a system whereby, through agreement between prescribers and pharmacists, doses of intravenous cytotoxic drugs calculated on an individual basis that are within defined ranges, or bands, are rounded up or down to predetermined standard dose. A range of pre-filled syringes, infusions or minibags, manufactured by pharmacy staff or purchased from commercial sources, can be used to administer the predetermined standard dose.

Andrew Gillian, Network Pharmacist (NELCN) on behalf of Cancer Network Pharmacists Forum has produced a toolkit: How to implement dose banding of chemotherapy 2008 which sits on the British Oncology Pharmacy Association website, This toolkit provides guidance to facilitate the introduction of dose banding by hospitals; the evidence base for dose banding is explored and examples of good practice and sample dose banding schedules are provided.

Environmental Appraisal

Wastage may increase as there tends to be an increase in the range of product lines used. This needs to be managed very carefully otherwise the exercise may become expensive.

1 NPSA safety alerts – purchasing for safety, injectable medicines and using vinca alkaloid minibags. Pages 6 and 7 provide links NB: NPSA is under review following formation of a new HM Government. Current information may be found at

Products

Any drug which is dosed in mg/m2, has documented long term stability and is a high usage

line is a candidate for dose banding. A sample of products that have been tendered for are given below:

BleomycinGemcitabine

CarboplatinIrinotecan

CisplatinMethotrexate

CyclophosphamideMitoxantrone

CytarabineOxaliplatin

DocetaxelPaclitaxel

DoxorubicinRituximab

EpirubicinTrastuzumab

Fludarabine Vinblastine

FluorouracilVincristine

GanciclovirVinorelbine.

Suppliers

Suppliers who have expressed an interest in this service are as follows:

  • Baxter Healthcare Limited
  • B.Braun Medical Limited
  • Beacon Pharmaceuticals Limited
  • Eli Lilly & Company Limited
  • Fresenius Kabi Oncology PLC
  • Hospira UK Limited
  • ITH Pharma Limited
  • MaCarthys Laboratories Limited t/a Martindale Pharma
  • Medac UK
  • Mylan
  • Qualasept Limited t/a Bath ASU
  • Sandoz Limited
  • Sun Pharmaceuticals UK Limited

This list of companies is not an approved or vetted list but identifies for the buyer those suppliers likely to respond to EU adverts or whom they may wish to approach for product information.

Supplier profiles are provided in Appendix 1, giving address, website details and telephone numbers.

Benchmarking

CMU has price comparison data from procurements we have undertaken on this product area and we are currently in the process of receiving bespoke trust data to build a national picture.

Should you require details please contact Jan Bevan, Category Manager by email to or by telephone on 01928 794623.

Websites

For further research and reading below is a list of useful sites with hyperlinks:

  • Commercial Medicines Unit:
  • Commercial Medicines Unit website for purchasing for safety injectable medicines
  • The Office of Government Commerce:

The Office of Government Commerce (OGC) is an independent office of HM Treasury, established to help Government deliver best value from its spending. The OGC works with central Government departments and other public sector organisations. OGC provides policy standards and guidance on best practice in procurement.

  • National Patient Safety Agency (NPSA):

The NPSA is an Arm’s Length Body of the Department of Health and covers the UK health service. Its aims are to reduce risks to patients receiving NHS care and improve safety. Support the resolution of concerns about the performance of individual clinical practitioners to help ensure their practice is safe and valued and protects the rights, safety, dignity and well-being of research participants that are part of clinical trials and other research within the NHS.

  • Medicines and Healthcare products Regulatory Agency:

The MHRA is the Government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health.

  • British Oncology Pharmacy Association:

The British Oncology Pharmacy Association (BOPA) is devoted to promoting excellence in the pharmaceutical care of British cancer patients.

  • Official Journal of the European Community:

OJEC is now recognised as OJEU - the Official Journal of the European Union. This is the publication in which all tenders from the public sector which are valued above a certain financial threshold according to EU legislation must be published.

  • SIMAP –for information on public sector electronic procurements and to place on-line adverts go to:
  • BiP - to place an advertisement on-line go to

Publications

  • The supply of unlicensed relevant medicinal products for individual patients
  • Using vinca alkaloid minibags – Rapid response report 11/08/2008 V1

Using vinca alkaloid minibags - Rapid Response Report -

  • Using vinca alkaloid minibags – Rapid response report - supporting information

Using vinca alkaloid minibags - Rapid Response Report supporting information

Section B - EU legislation

Introduction

Any procurement utilising public sector funding for goods or services above a financial threshold value must be carried out in accordance with EU procurement legislation. Procurements below the EU threshold will be subject to the trust’s Standing Orders and Standing Financial Instructions. For the practical application of the EU procurement legislation see Section C.

For up to date information on threshold values visit:

Page 9 Ojeu advertisement also refers.

Procedure

CMU has undertaken procurements on behalf of The London Cancer Network and the East of England Region using the restricted procedure as opposed to the open or negotiated procedures. This procedure is administratively less complicated and allows the rejection of non-compliant suppliers prior to the invitation of offers.

Timescales when using the restricted procedure are 37 day for suppliers to express an interest and a maximum of 40 days for return of the tender. Timescales for the return of the tender may be reduced if a prior indicative notice has been place.

For details of procedures and timescales please refer to The Public Contracts Regulations 2006 and the Public Contracts (Amendment) Regulations 2009:

CPV codes

EU directives are supported by a common coding system (CPV codes) to describe supplies and services. Their use is mandatory in completion of all OJEU notices. Examples of codes previously used are:

  • 85149000 Pharmacy services
  • 33690000 Various medicinal products

Current CPV codes can be found at:

Section C – Procurement process

Introduction

This section provides advice on a selection of the processes to be followed when undertaking procurementfor this product group. It also provides a number of template documents for use by the trust where appropriate.

Ojeu advertisement

Official Journal of the European Community

(OJEC is now recognised as OJEU - the Official Journal of the European Union)

Having established that the contract value exceeds the relevant EU threshold, a contract notice must be placed in the Official Journal of the European Union to invite expressions of interest from suppliers.

EU threshold values can be found on the OGC website, link attached for ease:

Page 8 Introduction also refers.

To place an on-line advertisements in the OJEU visit SIMAP website for the Contract notice form visit: and select on the left hand side section headed standard forms for public procurement

Offer documents

It is recommended that offer documentation be produced in accordance with the trust’s procedures however within this guide, as appendices, are templates for a specification, award and evaluation criteria, and an offer schedule.

Specification

A specification is given at Appendix 2. This document details the most common requirements but should be checked with the clinical staff responsible for decision making to ensure all expectations are covered. For the outcome of a tender exercise to be successful, the information contained within the specification detailing the trust’s requirements needs to be the most complete picture available.

From the lessons learnt following CMU’s procurements particular attention should be given to:

  • commitment from users to the process and outcome. This is fundamental to the success of the contract. It is essential that production unit managers are fully informed and committed to the process both during and after the award process
  • product stability requirements and what data sets are required. Within the Specification Tab 9 there is an example of stability data and Tab 10 is a standard protocol for deriving the chemical stability of aseptic preparations. Within the Supplier questionnaire, Appendix 3, there is a stability pro-forma for suppliers’ completion at Tab 5
  • labelling of the products. Example labels for guidance only are covered within the Specification, Tab 8. Amend as you feel appropriate
  • making internal stakeholders aware of the workload of changing practice - evaluating the current infrastructure within the unit to accommodate dose banding
  • time needed to setup, change and validate e-prescribing systems. This is not a requirement for dose banding but an added value
  • clinical consensus on details such as the dose bands themselves, most trusts seem to have agreed on bandwidths of 5% with some saying they tried and failed to agree 10%. Andrew Gillian’s toolkit referred to on page 4 will help with this. This is helpful to have agreed but not essential as long as you include all the dose forms in the sample
  • rationalisation of the range of packs. This is not a requirement for dose banding but an added value.

Key performance indicators

Key Performance Indicators (KPI’s) are used to monitor the service provided by contractors. They should be quantifiable measurements, agreed to beforehand, usually covered within the specification, that reflect the critical success factors of the framework. They will differ depending on the trusts requirements. Whatever Key Performance Indicators are identified, they must reflect the frameworks goals, they must be key to its success, and they must be quantifiable (measurable).

Examples of the KPI’s that have been developed for this product area are covered within the Specification, Tab 11. Please amend as you feel appropriate.

Award criteria

Criteria for the award of a public contract is subject to regulation 18(27) of The Public Contracts Regulations 2006. Examples of award criteria that have been developed for this product area are covered within Appendix 4.

Product evaluations

The trusts and the suppliers selected to submit offers should be aware of each other’s requirements and expectations. The trusts should have a good understanding of the products each company is able to offer and where appropriate undertake product evaluations as early as possible. The trusts should be aware of the advantages and disadvantages of the products offered by each company in order to make a fully informed award decision at the offer adjudication stage paying particular attention to the labelling and stability data.

Pre offer discussions

It is best practice to hold pre-offer meetings after the Ojeu advert closing date and before the issue of offer documents to ensure a mutual understanding of contract requirements. It is also useful to make sure all trusts party to the arrangements are represented here. Ideally the technical leads from the trusts should be present. The trusts may have a recommended meeting protocol.

It is an opportunity for the trusts to convey a clear idea of theirrequirements and key objectives and it may be helpful to invite the short-listed suppliers to make presentations (stipulate a time limit) on the products and services they offer. These discussions may identify specific requirements/amendments that the trusts may wish to incorporate in the invitation to offer documents.

Issuing offer documents

Formal invitations to offer must be issued and returned in accordance with the EU procurement legislation and the trust’s Standing Orders and Standing Financial Instructions. For the full recommended protocol for the issue of offers visit the OGC website for best practice guidanceat:

Return of offer documents

Formal invitations to offer should be received by the trust in accordance with the EU procurement legislation and the trust’s Standing Orders and Standing Financial Instructions.

Assessment of offers

It is recommended that tender analysis be evaluated in accordance with the trusts’ Standing Orders and Standing Financial Instructions and the award criteria.

Award and evaluation criteria as detailed in Appendix 4 are for the most economically advantageous tender in terms of:

  • Price
  • Product specification
  • Supplier performance
  • Ordering and invoicing

The criteria is weighted as follows:

Criteria / Sub-criteria/Measurement
Price – 25% / Product Cost
Product Specification – 52% / Shelf Life
Product labelling, including conformance to NPSA and MHRA guidance, individual containers, use of colour and layout and use of bar codes
Product packaging – including inner and outer packaging and stock management/control labelling
Supplier Performance – 17% / Delivery capability, flexibility and contingency arrangements.
Delivery lead times
Recall and complaint procedures
Ordering and Invoicing – 6% / Ability to trade electronically
Invoicing

The evaluation methodology is a staged approach:

Stage 1 – The supplier is required to confirm adherence to or describe how they would comply with pre-defined mandatory conditions. Evaluation is either acceptable or unacceptable and if the supplier does not pass these requirements, they do not move onto the second stage.

Stage 2 – All offers that passed stage 1 are then evaluated and scored against pre-determined model answers and scoring mechanisms. The scores for price, shelf life and delivery lead time are awarded on a line by line basis with the best offer receiving the top mark and all other offers scored on a pro-rata basis from the best. The average of these scores is taken to provide an overall score for that drug line.

Scores for each drug line are then added together and the award is made to the complaint bid that achieved the highest score.

Due to the number of medicines and forms and for ease of identification a colour coding was used to present scores to the adjudication panel.

For example:

Evaluation Measure / Award Score / Effective Weighting
Lowest offer / 5 / 25
Up to 20% higher / 4 / 20
21% to 40% higher / 3 / 15
41% to 60% higher / 2 / 10
61% to 80% higher / 1 / 5
Over 81% higher / 0 / 0

A data analyst will be able to assist with the creation of a spreadsheet which can be formatted to automatically generate the colour codes.

Please be aware that within the Specification Tab 1, Instructions and Tab 1 of the Specification questionnaire there are sections within these locations that give the Offeror an opportunity to submit any additional comments/feedback. Any details submitted will need to be evaluated and presented to the adjudication panel.

Contract award

For all public sector and utilities procurements covered by the full regime of the EU Directives, a minimum ten (10) calendar days mandatory standstill period is required between communicating the award decision to all offerors (successful and unsuccessful) and contract conclusion.

The following link is to OGC’s rules on the Standstill Period. It contains guidance on the standstill rules, including current changes to the contents of the standstill notice, the duration of the standstill period and the situations in which the standstill period can be waived.

OJEU award notice

For all contracts placed in accordance within EU legislation a contract award notice must be published in OJEU within 48 days of the contract award date.

To place an award notice in the OJEU visit SIMAP website for the Contract notice form visit: and select on the left hand side section headed standard forms for public procurement

Contract review

It is recommended that regular review meetings with internal stakeholders and suppliers be held to ensure that agreed specifications and key performance indicators are being adhered to and to evaluate suppliers based on performance against the contract specification.