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Commercial Medicines Unit (CMU) - Department of Health

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September 2012<br />

<strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong><br />

Procurement guidance<br />

For<br />

The provision <strong>of</strong> homecare delivery service <strong>of</strong> medicines to patients at<br />

home<br />

1<br />

Issue date: May 2011<br />

Review date: Sep 2012<br />

© Crown Copyright 2011


Contents Page<br />

1. Introduction 3<br />

2. National Homecare <strong>Medicines</strong> Committee (NHMC) 4<br />

3. Market overview 7<br />

4. Comparison <strong>of</strong> home delivery methods 11<br />

5. Data collection 14<br />

6. Homecare delivery service providers 17<br />

7. Stakeholders 20<br />

8. Therapy list 21<br />

9. Specification<br />

September 2012<br />

Core 26<br />

Deliver and Service 32<br />

Product Prescribing and dispensing 36<br />

Equipment and ancillaries 40<br />

Training and Education <strong>of</strong> staff and patients 43<br />

Nursing services 45<br />

10. Award Criteria 47<br />

11. <strong>CMU</strong> homecare medicines team 53<br />

Appendix 1 – Glossary <strong>of</strong> Terms 54<br />

Appendix 2 – Patient registration form 60<br />

Appendix 3 – Change management form 62<br />

Appendix 4 – Data template 79<br />

Appendix 5 – KPI’s 80<br />

Appendix 6 – Patient survey 81<br />

Appendix 7 – Complaints and adverse incidents 84<br />

Appendix 8 – Refrigeration 88<br />

2<br />

© Crown Copyright 2011


Introduction<br />

The <strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong> (<strong>CMU</strong>) in conjunction with the National Homecare <strong>Medicines</strong> Committee<br />

have produced the enclosed guidance and generic specifications to support service users, providers and<br />

most importantly patients in the procurement <strong>of</strong> a homecare delivery service <strong>of</strong> medications to patient‟s<br />

homes.<br />

The best practice guidance document gives you an insight into the market, homecare delivery service<br />

providers, stakeholders and key market information which is pertinent to the homecare delivery service <strong>of</strong><br />

medicines.<br />

Specifications have been produced with wide consultation and are intended to be as generic and reflective<br />

as possible <strong>of</strong> the NHS needs, in order that they can be used as a template for a number <strong>of</strong> therapy areas.<br />

It is intended that to the latter part <strong>of</strong> 2010 the homecare team in conjunction with NHMC will develop<br />

therapy specific guidance to support other market areas such as; Total Parenteral Nutrition (TPN) and<br />

Cystic Fibrosis (CF) as it is felt these therapy areas may require specific guidance documents.<br />

Specification and guidance documentation cover:<br />

Core<br />

Deliver and Service<br />

Product Prescribing and Dispensing<br />

Equipment and Ancillaries<br />

Training and Education <strong>of</strong> staff and patients<br />

Nursing Services<br />

Patient Registration forms<br />

Change Management guidance<br />

Data template<br />

KPI‟s<br />

Patient questionnaire<br />

Complaints and adverse incident form<br />

Refrigeration<br />

Other key documentation held on the <strong>CMU</strong> homecare website cover:<br />

Audit procedures – as best practice regional QA and pharmacy procurement specialist should<br />

review the awarded suppliers audit reports prior to the final contract decision<br />

Award criteria<br />

September 2012<br />

3<br />

© Crown Copyright 2011


National Homecare <strong>Medicines</strong> Committee (NHMC)<br />

The NHMC was formed as a sub group <strong>of</strong> National Pharmaceutical Supply Group as it was recognised that<br />

this market was expanding and needed to be managed effectively in order to ensure patient safety and<br />

clinical effectiveness.<br />

The committee consists <strong>of</strong> representatives <strong>of</strong> stakeholder pr<strong>of</strong>essions with experience in the area <strong>of</strong><br />

homecare medicines delivery and service in primary care, secondary care, specialised commissioning and<br />

industry. <strong>CMU</strong> facilitates and manages this committee.<br />

Members <strong>of</strong> the NHMC, homecare delivery service providers, Secondary care trusts, Primary Care Trust,<br />

NPSG, Specialised Commissioning, Hubs and QA have been consulted during the production <strong>of</strong> this<br />

document.<br />

The guidance will be reviewed on a six monthly basis, next review date November 2010.<br />

Committee members (as at January 2012)<br />

Allan Karr (Chair)<br />

Pharmacy Business Manager, University College London Hospitals NHS Foundation Trust<br />

Tel: 0207 3809730 email: allan.karr@uclh.nhs.uk<br />

Jim Armstrong<br />

Specialist Procurement Pharmacist, South East Coast (NHS <strong>Commercial</strong> Solutions)<br />

Tel: 01634 83 8934 email: jim.armstrong@medway.nhs.uk<br />

Karen Bell<br />

Sourcing Specialist, Homecare, NHS <strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong> (<strong>CMU</strong>)<br />

Tel: 01928 794615 email: karen.bell@cmu.nhs.uk<br />

Lorraine Booth<br />

Regional Specialist Procurement Pharmacist North West England<br />

Tel : 0161 419 4465 mob : 07769 936506 email : lorraine.booth@stockport.nhs.uk<br />

Graham Brack<br />

Pharmaceutical Adviser, NHS Cornwall and Isles <strong>of</strong> Scilly PCT<br />

Tel : 07736 553710 email: Graham.Brack@ciospct.cornwall.nhs.uk<br />

Teresa Brannigan<br />

Contracts Officer, NHS Wales Shared Service Partnership, Procurement Services<br />

(NWSSPPS)<br />

Tel: 02920 315485 email: Teresa.brannigan2@wales.nhs.uk<br />

Michael Butterfield<br />

Specialist Pharmacy Technician: Homecare <strong>Medicines</strong> Management<br />

Leeds Teachings Hospitals NHS Trust<br />

Tel: 0113 3927020 email: Michael.Butterfield@leedsth.nhs.uk<br />

September 2012<br />

4<br />

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Carol Clark<br />

Category Specialist, Homecare, NHS <strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong> (<strong>CMU</strong>)<br />

Tel: 01282 850672 email: carol.clark@cmu.nhs.uk<br />

David Cook<br />

Specialist Procurement Pharmacist, North East England<br />

Tel: 07833294025 email: david.cook@nth.nhs.uk<br />

Judi Cross<br />

Pharmaceutical Advisor, South East Coast SCG<br />

Tel: 01622 713028 email: judi.cross@secscg.nhs.uk<br />

Phil Deady<br />

Pharmacy Procurement Manager, Leeds Teaching Hospitals NHS Trust<br />

Tel: 0113 3927012 email: Phil.Deady@leedsth.nhs.uk<br />

Margaret Dolan<br />

Pharmaceutical Adviser, National Procurement, NHS National Services Scotland<br />

Tel: 0131 275 6163 Mobile: 07717 468 776 email: margaret.dolan@nhs.net<br />

Alastair Gibson<br />

Director <strong>of</strong> Pharmacy, Blackpool Teaching Hospitals NHS Foundation Trust<br />

Tel: 01253 303790 email: alastair.gibson@bfwhospitals.nhs.uk<br />

Nick Haslem<br />

Commissioning Manager, South East Coast Specialised Commissioning Group<br />

Tel: 01622 713010 email: nick.haslem@secscg.nhs.uk<br />

Stephanie Hibbs<br />

Project Manager, London Procurement Programme<br />

Tel 07768006020 email : stephanie.hibbs@imperial.nhs.uk<br />

Mark Jackson<br />

Deputy Director, Quality Control North West<br />

Tel 0151 7948110 email Mark.jackson@lrippu.nhs.uk<br />

Jane Kelly<br />

Procurement Project Pharmacist, Leeds Teaching Hospitals NHS Trust<br />

Tel: 01133927036 email: Jane.kelly@leedsth.nhs.uk<br />

Michael Mc Beth<br />

Specialist Procurement Pharmacist Newcastle Upon Tyne Hospitals NHS Foundation Trust<br />

Tel : 0191 2825952 email: michael.mcbeth@nuth.nhs.uk<br />

Sarah Pacey<br />

Assistant Chief Pharmacist, Procurement, Therapeutics and <strong>Medicines</strong> Performance,<br />

Nottingham University Hospitals NHS Trust<br />

Tel: 0115 9627674 email: sarah.pacey@nuh.nhs.uk<br />

September 2012<br />

5<br />

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Liz Payne<br />

Category Manager, Homecare, NHS <strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong> (<strong>CMU</strong>)<br />

Tel: 01926 857313 email: liz.payne@cmu.nhs.uk<br />

Dr Nick Payne<br />

Chairman, National Clinical Homecare Association (NCHA Limited)<br />

Tel : 07970 387992 email: nick.payne@clinicalhomecare.co.uk<br />

Cherryl Perry<br />

Customer Supply Chain Manager, Abbott Laboratories, representing ABPI<br />

Tel: 07950 162648 email: cherryl.perry@abbott.com<br />

Simon Perkins<br />

Category Specialist, Homecare, NHS <strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong> (<strong>CMU</strong>)<br />

Tel: 01928 794631 email: simon.perkins@cmu.nhs.uk<br />

Bernadette Porter<br />

Nurse Consultant,The National Hospital for Neurology & Neurosurgery,<br />

University College London Hospitals NHS Foundation Trust<br />

Tel: 0207 767 2083 email: bernie.porter@uclh.org<br />

David Stead<br />

<strong>Medicines</strong> Procurement Lead for South West, <strong>Unit</strong>ed Bristol Hospitals NHS Trust<br />

Tel: 07867 527491 email: david.stead@uhbristol.nhs.uk<br />

Dr.Richard Sturgess<br />

All Wales Technical and Computer Services Pharmacist<br />

Tel: 029 20 748128 email: richard.sturgess@wales.nhs.uk<br />

Liz Sutton<br />

Pharmacy Procurement Manager,Buckinghamshire <strong>Health</strong>care Trust<br />

Tel: 01296 315283 email: Liz.Sutton@buckshealthcare.nh.uk<br />

Kevan Wind<br />

<strong>Medicines</strong> Procurement Specialist Pharmacist, London and East <strong>of</strong> England<br />

Tel: 01702 385225, mobile 07534 958315 email: kevan.wind@southend.nhs.uk<br />

September 2012<br />

6<br />

© Crown Copyright 2011


Market overview<br />

A medicine homecare delivery service can be described as one that delivers ongoing medicine supplies and<br />

where necessary associated care, initiated by a hospital prescriber, direct to a patient‟s home with their<br />

consent. The purpose <strong>of</strong> the homecare delivery service is to improve patient care and choice for their<br />

clinical treatments. Patients that are typically on homecare are those with chronic diseases and stable<br />

treatment regimens that do not require acute care input.<br />

Currently, most homecare delivery service is initiated by hospital trusts, which normally administer<br />

medicines to patients within their own hospital environment. However, on some occasions the supply and<br />

administration <strong>of</strong> medicines is better provided directly to the patient in their own home. For example, there<br />

are many therapy areas which will cause patients logistic difficulties with the provision <strong>of</strong> heavy and large<br />

volumes containers which are required for their treatment e.g. dialysis solutions, total TPN, Enteral feeds.<br />

The use <strong>of</strong> such medicine homecare delivery services is expanding throughout the UK with an estimated<br />

120,000 plus patients now receive their medicines via the homecare route. The value <strong>of</strong> medicines being<br />

supplied by this route is estimated to be well in excess <strong>of</strong> £500 million. These figures are expected to<br />

increase substantially as clinical services follow the vision for building on the strengths <strong>of</strong> pharmacy, using<br />

that capacity and capability to deliver further improvements in pharmaceutical services over the coming<br />

years as part <strong>of</strong> an overall strategy to ensure safe, effective, fairer and more personalised patient care. ¹<br />

It must be noted that at the beginning <strong>of</strong> any homecare medicines service whether it is initiated by a hospital<br />

trust or pct dialogue must be undertaken with the manufacturers <strong>of</strong> the medicine at the beginning <strong>of</strong> the<br />

process to ensure product visibility and agreement for distribution.<br />

Homecare delivery service can be further sub-divided into low-tech or high tech. Other definitions are also<br />

possible.<br />

(a) High Tech Homecare<br />

This will include all:<br />

Intravenous therapy<br />

Other injectable therapy where significant support is required e.g. consumables, storage,<br />

monitoring, preparation and administration.<br />

Any oral therapy that requires significant support such as blood level monitoring or special storage<br />

requirements<br />

1. <strong>Department</strong> <strong>of</strong> <strong>Health</strong>, publications – Pharmacy in England: building on strengths – delivery the future<br />

September 2012<br />

7<br />

© Crown Copyright 2011


(b) Low-tech homecare<br />

This will include all:<br />

Oral medication and external preparations that require no other support than standard concordance<br />

monitoring from the homecare delivery service provider.<br />

Injectable therapy that is not intravenous and requires little support other than concordance monitoring.<br />

What are the benefits <strong>of</strong> homecare?<br />

There are many benefits in using homecare, key among which is that for many patients it would be<br />

necessary to make visits to hospital solely to receive periodic treatment or prescriptions. Homecare delivery<br />

services avoids this need, thereby also freeing both patient and hospital time. Homecare can also release<br />

hospital beds and return patients to their homes earlier. An example <strong>of</strong> this would be cystic fibrosis<br />

homecare services: not only does homecare decrease hospital visits but also decreases the chances <strong>of</strong><br />

cross-infection in this vulnerable patient group.<br />

Where appropriate homecare services can be commissioned with nursing support to ensure seamless<br />

delivery <strong>of</strong> care without creating any burden to community services. Where patients are receiving a range <strong>of</strong><br />

home medicines, homecare may <strong>of</strong>fer the opportunity <strong>of</strong> providing all medications through a single provider.<br />

Homecare <strong>of</strong>fers the opportunity <strong>of</strong> providing high quality, cost effective and accessible care to specific<br />

patient groups.<br />

<strong>Medicines</strong> homecare delivery services will vary according to the degree <strong>of</strong> intervention<br />

The types <strong>of</strong> medicine delivery services provided by a homecare delivery service provider can include the<br />

delivery process, pharmaceutical dispensing, and sterile preparation <strong>of</strong> injectable medicines in a ready to<br />

use form, phlebotomy services and nurse or patient administration <strong>of</strong> injectables.<br />

This potentially high level <strong>of</strong> medical and clinical care will require highly trained staff. The staff are currently<br />

either employed by the provider trust or perhaps more commonly by a commercial homecare delivery<br />

service providers. A considerable amount <strong>of</strong> attention should be given to ensure that all clinical governance<br />

arrangements are formally agreed and adhered to.<br />

It is worth clarifying that Shared Care is different from homecare. In shared care prescribing responsibility<br />

passes to the GP in agreement with the Consultant and Primary Care Trust (PCT). In the case <strong>of</strong> medicine<br />

homecare the responsibility for the clinical care remains with the hospital prescriber.<br />

How do homecare delivery services work?<br />

Typically, homecare arrangements began informally with acute trusts arranging a service for discharged<br />

patients, with reimbursement <strong>of</strong> costs by the PCT. Control was <strong>of</strong>ten minimal, but the risk to the PCT was<br />

low and the number <strong>of</strong> patients small. It is clear however that more formal arrangements are necessary. In<br />

many areas these have now been developed and robust processes with dedicated teams afford much more<br />

control and governance, but some trusts may not have yet instituted this level <strong>of</strong> control.<br />

September 2012<br />

8<br />

© Crown Copyright 2011


Effective clinical governance is fundamental to homecare delivery services due to the shared nature <strong>of</strong> the<br />

service with acute trusts retaining clinical responsibility, care usually being delivered through an<br />

independent contractor and in some case a third party being involved where services are directly funded by<br />

PCTs. In addition, each prescription causes generation <strong>of</strong> an order, delivery note and invoice which must be<br />

reconciled, and the timely issuing <strong>of</strong> prescriptions has to be managed.<br />

The use <strong>of</strong> homecare delivery services introduces an additional dimension into the care <strong>of</strong> patients. It<br />

exposes a wide range <strong>of</strong> issues including communication regarding treatment outcomes, therapeutic intent<br />

and adverse reactions. There requires to be absolute clarity regarding what information can be provided<br />

and by whom. Clear communication channels regarding concordance and adverse incidents with the<br />

responsible consultant will need to be put in place.<br />

Homecare delivery services are most effectively provided when purchased through joint working<br />

arrangements between acute trusts and PCTs. It is also recommended that pharmacy procurement<br />

specialists are involved to harness expertise <strong>of</strong> collaborative contracting and tender exercises.<br />

What is the role <strong>of</strong> PCT's in homecare?<br />

The day to day management should be retained by the organisation that has clinical responsibility <strong>of</strong> the<br />

patient, usually the acute trust. Acute trusts and PCTs should work in conjunction in agreeing and<br />

establishing service criteria and also ensuring appropriate contractual and governance arrangements for<br />

homecare delivery services. Joint working is recommended in:<br />

VAT<br />

agreed that a homecare delivery service is a suitable route for the provision <strong>of</strong> a specific clinical<br />

service.<br />

ensuring that the tendering process is appropriately conducted preferably with those with<br />

experience in homecare delivery service contracting, and a formal contract and/or Service Level<br />

Agreement is in place.<br />

ensuring that the service provided by the appointed homecare delivery service provider is<br />

monitored regularly and thoroughly.<br />

ensuring there is an appropriate, efficient and adequately resourced process to verify the<br />

administration <strong>of</strong> the prescriptions, purchase orders, delivery notes and invoices.<br />

The points below are a summary <strong>of</strong> discussions with HM Revenue & Customs (HMRC) and are an overview<br />

only. The NHMC takes no responsibility for any inaccuracies and NHS trusts are advised to secure their<br />

own advice with regard to particular arrangements.<br />

VAT liability <strong>of</strong> homecare delivered medicines and associated services.<br />

September 2012<br />

9<br />

© Crown Copyright 2011


September 2012<br />

o <strong>Medicines</strong> dispensed to individuals for their personal use, dispensed by a registered<br />

pharmacist against a prescription issued by a registered doctor or nurse for administration<br />

in their own home (or residential home) are zero-rated.<br />

o Pharmacy dispensing services provided by a registered pharmacist are exempt from VAT<br />

o Delivery services are subject to VAT at the standard rate<br />

o Where two or more <strong>of</strong> the above elements form part <strong>of</strong> a composite supply, the<br />

predominant element will determine the VAT liability <strong>of</strong> the whole.<br />

Homecare delivery service providers will seek advice from their local HMRC <strong>of</strong>fice who will advise<br />

on the VAT status <strong>of</strong> the proposed services<br />

The homecare delivery service provider is responsible for collecting the VAT where applicable. If<br />

the homecare delivery service provider fails to charge the customer VAT and later finds that its<br />

interpretation was incorrect, the HMRC will pursue the homecare delivery service provider for<br />

payment <strong>of</strong> the under declared VAT. It may be that, the homecare delivery service provider<br />

will approach its customer seeking further payment, whether or not the customer should make<br />

further payment is a commercial matter between the two parties and the HMRC would not involve<br />

itself in that issue.<br />

<strong>Medicines</strong> used while an individual is receiving care or medical or surgical treatment in a hospital or<br />

nursing home - whether as an in-patient, resident, day-patient or outpatient - cannot be zero rated.<br />

The VAT (Drugs, <strong>Medicines</strong>, and Aids for the Handicapped) Order 1997/2744 which came into effect on 1<br />

January 1998 is outlined in Business Brief 29/97 www.newsrelease-archive.netlcoi/depts/GCE/coi5955d.ok<br />

Comparison <strong>of</strong> Homecare Delivery methods<br />

The method <strong>of</strong> delivery chosen should involve a local risk assessment and give due consideration to the<br />

convenience for the patient. The final decision on the delivery route chosen should be documented in the<br />

service level agreement and also include the consent by each individual patient.<br />

The most frequent delivery method used by homecare delivery service provider is the use <strong>of</strong> dedicated vans<br />

and suitably trained drivers. The vans must be able to demonstrate validated cold chain where this is<br />

required and in all cases show that temperature control is within an acceptable range for the storage <strong>of</strong><br />

medicines. All packages should be tamper evident. It is expected that on making the delivery the driver will<br />

put away stock, remove waste packaging, rotate stock and where appropriate monitor fridge temperatures.<br />

The homecare delivery service provider must inform the patient as soon as possible if for any reason<br />

delivery cannot be made. If it is necessary to arrange delivery through third part couriers then they should<br />

adhere to the usual agreed procedures.<br />

For certain services or emergency deliveries the use <strong>of</strong> national parcel carriers or Royal Mail is used. Where<br />

such postal services are used, either via the Royal Mail or other carriers, it is advisable to check with the<br />

10<br />

© Crown Copyright 2011


homecare delivery service provider on any restrictions that apply. The Post Office has useful information on<br />

its website (www.post<strong>of</strong>fice.co.uk). Consideration should also be given to any advice from the Royal<br />

Pharmaceutical Society.<br />

All items must be securely wrapped to prevent loss or damage to the contents and also to avoid harm to<br />

recipients or postal employees. Any item should be contained in a strong inner container and enclosed in<br />

an outer packaging. This should ensure that any spillage is contained within the outer packaging. For<br />

liquids, it is recommended that any tins or bottles should be sealed with tape, wrapped in polythene, sealed<br />

again and surrounded with an absorbent material to soak up any leakage. Although medicines could be sent<br />

by ordinary post when needed, Royal Mail recommends using their 'Special Delivery' service to guarantee<br />

next day delivery and obtain the recipient's signature. It is the supplying pharmacists‟ responsibility to<br />

ensure that the patient receives their medication.<br />

In the case <strong>of</strong> the Royal Mail medicines for medical purposes may be posted provided these are supplied<br />

lawfully. This is however subject to their prior written approval, (which may be subject to conditions,<br />

including the type <strong>of</strong> medicines that may be sent, how, when, by whom and to whom), and subject to such<br />

items being sent in suitable tamper-pro<strong>of</strong> packaging and only being sent by Royal Mail's Special Delivery or<br />

Recorded Delivery services. Although the Royal Mail may request full details <strong>of</strong> any medicines being<br />

posted, registered pharmacies are not normally required to provide this information.<br />

The following restrictions for posting medicines apply.<br />

The only type <strong>of</strong> Controlled Drugs permitted are those classified as Schedule 4 e.g.<br />

Benzodiazepines. All other types <strong>of</strong> CDs are prohibited. Guidance may be sought from the Home<br />

Office 0207 035 4848 or visit www.home<strong>of</strong>fice.gov.uk<br />

Items requiring refrigeration are prohibited unless specialist containers are used which have been<br />

validated to demonstrate suitable temperature control.<br />

Any medicine that uses an aerosol where the volume exceeds 50ml is prohibited.<br />

Any aerosols that use flammable or toxic gases as propellants are also prohibited.<br />

COMPARISON OF DELIVERY METHODS<br />

SERVICE TYPE STRENGTHS WEAKNESSES<br />

Postal ( including special<br />

delivery<br />

September 2012<br />

Lowest cost option for small<br />

number <strong>of</strong> deliveries.<br />

Track & Trace capability.<br />

Insurance cover for loss <strong>of</strong><br />

product and delivery failure.<br />

Post <strong>of</strong>fice pick-up point if<br />

patient is not at home.<br />

Dedicated van and driver Deliveries consistently by<br />

the same driver.<br />

11<br />

Loss incidence higher than<br />

with dedicated van.<br />

No facility to check stock<br />

within patients‟ homes.<br />

No certainty regarding<br />

delivery time (but before<br />

9am service available)<br />

Certain categories <strong>of</strong><br />

medicines prohibited.<br />

Unable to send items<br />

requiring refrigeration.<br />

Highest cost option.<br />

Backup needed for when<br />

© Crown Copyright 2011


Data collection<br />

September 2012<br />

Ability to conduct stock<br />

checks in patients‟ homes.<br />

May <strong>of</strong>fer a secure key<br />

holding service for access<br />

when the patient is out.<br />

Lower losses than post or<br />

courier.<br />

Flexibility – facility to<br />

redirect van for urgent<br />

needs.<br />

Weekend deliveries.<br />

12<br />

the vehicle is <strong>of</strong>f the road<br />

and during holidays.<br />

Driver needs suitable<br />

training<br />

Police check <strong>of</strong> driver<br />

required<br />

<strong>CMU</strong> has not captured homecare delivery service information on either the BTT or Pharmex applications.<br />

The introductions <strong>of</strong> homecare services to <strong>CMU</strong> lead to a requirement for new business processes and<br />

applications. The strategic objectives for the collection are:-<br />

Understand value <strong>of</strong> homecare market to inform national procurement strategy.<br />

Unbundle service and delivery costs from pharmaceutical costs.<br />

Identify where savings can be made.<br />

Quantify volumes, usage and spend for contracting purposes.<br />

Benchmark prices in order to drive best practice.<br />

Identify patient numbers for homecare by trust, therapy, product and service.<br />

Manage risk in homecare market and ensure appropriate level <strong>of</strong> competition.<br />

Measure trends in growth <strong>of</strong> the homecare market.<br />

Provide a central resource <strong>of</strong> data for the NHS on homecare spend.<br />

Ensure that <strong>CMU</strong> is able to respond to <strong>Department</strong> <strong>of</strong> <strong>Health</strong> request for information on NHS<br />

Homecare spends.<br />

Enable the DH to make informed policy decisions on homecare services<br />

Avoid any duplication <strong>of</strong> effort on homecare processes within NHS organisations.<br />

Collection <strong>of</strong> data will be consistent with NHS data and coding standards.<br />

The “to be” strategic vision from the government and the NHS is to have a more “joined up”, “do<br />

Once and Share”, “Auto-identification and data capture (AIDC)” health service². <strong>CMU</strong> is a leading<br />

body <strong>of</strong> this change and is committed to supporting the standards needed to make this change<br />

happen.<br />

© Crown Copyright 2011


2. Coding for Success – Simple technology for safer patient care, <strong>Health</strong>care Quality Directorate, <strong>Department</strong> <strong>of</strong> <strong>Health</strong><br />

<strong>CMU</strong> data collection project objectives<br />

1. Collect homecare medicine usage and spend data from homecare delivery service providers.<br />

2. Collect homecare service data from homecare delivery service providers.<br />

3. Collect homecare medicine usage and spend data backdated to the beginning <strong>of</strong> 2008.<br />

4. Ensure that the data collection process does not allow duplication <strong>of</strong> transaction (spend and usage)<br />

reporting.<br />

5. Where NHS data standards do not exist, document a consistent data specification to support the<br />

exchange <strong>of</strong> medicine and service information between DH MPIG, <strong>CMU</strong>, NHS trusts and purchasing<br />

groups (for example, hubs) and suppliers.<br />

6. Provide homecare delivery service providers with the capability to provide and access homecare data<br />

direct to/from <strong>CMU</strong>.<br />

7. Provide trusts with the capability to access homecare data direct from <strong>CMU</strong>.<br />

8. Facilitate more accurate and timely (near real time) homecare reporting capability.<br />

9. Remove homecare delivery service provider reporting medicine usage and spend to individual trusts.<br />

Replace with a collective report submitted to <strong>CMU</strong>.<br />

10. Collect key performance indicators (KPI‟s) on homecare delivery service providers to use to make<br />

informed contract adjudication decisions (against award criteria weightings). Appendix 5<br />

September 2012<br />

13<br />

© Crown Copyright 2011


September 2012<br />

<strong>CMU</strong> Data collection fields<br />

14<br />

© Crown Copyright 2011


TRUST WORLD<br />

MEDICINE<br />

DATA NOT<br />

CAPTURED<br />

Trust - Pharmacist<br />

1.<br />

Secondary<br />

Care Trust<br />

medicinal spend and usage<br />

DATA CAPTURED<br />

PCA<br />

(Only FP10)<br />

3.<br />

Primary<br />

Care Trust<br />

Hospital<br />

Prescription<br />

Pharmacy Trust<br />

Procurement Systems<br />

medicinal spend and usage<br />

DATA CAPTURED<br />

2.<br />

NHS<br />

Prescription<br />

Services<br />

Secondary Trust<br />

Clinician<br />

OPD Script<br />

Purchase<br />

Order<br />

FP10<br />

Prescription<br />

(to PCA)<br />

Framework<br />

Agreements<br />

Secondary Care Trust<br />

provides<br />

medicinal product<br />

spend and usage<br />

Invoice and<br />

reports<br />

Purchase Quantity<br />

£ Purchase Price<br />

£ Service Price<br />

£ Payment<br />

NHS <strong>CMU</strong> World<br />

Email Usage<br />

NHS <strong>CMU</strong><br />

Web<br />

SUPPLIER WORLD<br />

Homecare Provider<br />

(Supplier)<br />

© Crown Copyright 2011 May 2011<br />

PPRS<br />

Usage<br />

NEW - Homecare Data Collection Project<br />

15<br />

PPRS<br />

Reports<br />

Data Analyst<br />

Delivery<br />

Note<br />

Homecare Service<br />

delivers to Patient<br />

ERM CIMS<br />

Load Transaction Files<br />

Homecare service purchases<br />

Medicinal Product<br />

£ Purchase Price<br />

Patient<br />

Pharmex<br />

Supplier email service<br />

spend and usage figures<br />

Trust may have a<br />

contract price<br />

Phate<br />

Other<br />

Reports<br />

£ Contract Price<br />

Phacter<br />

(planned)<br />

Category Specialist<br />

IBT Benefits<br />

Load Transaction Files<br />

£ Medicinal Product Baseline Price<br />

(weighted average purchase price paid by trust over the latest<br />

four months)<br />

BTT<br />

Pharmaceutical<br />

Manufacturer<br />

(Supplier)<br />

Homecare delivery services Overview - Thick vertical dotted line illustrates new Homecare delivery service provider information flow to <strong>CMU</strong>


Homecare delivery service providers<br />

The market is growing and new entrants are emerging both SME and multinationals. In the UK the major suppliers are:-<br />

These suppliers are currently providing, or have shown an interest in supplying, a home delivery service<br />

This IS NOT an approved list, these suppliers have not been vetted by <strong>CMU</strong> or the National Homecare <strong>Medicines</strong> Committee (NHMC)<br />

Homecare Service<br />

Providers Address 1 Address 2 Town County<br />

Air Products<br />

Baxter <strong>Health</strong>care Limited<br />

T/A Willow <strong>Health</strong>care<br />

Services<br />

2 Millennium<br />

Gate<br />

<strong>Unit</strong> 1 North<br />

Orbital<br />

<strong>Commercial</strong><br />

Park<br />

Westmere<br />

Drive Crewe Cheshire<br />

Napsbury<br />

Lane St Albans Herts.<br />

Bupa Home <strong>Health</strong>care<br />

<strong>Unit</strong> 4 Scimitar<br />

Park Roydon Road<br />

Eastgate<br />

Way, Manor<br />

Harlow Essex<br />

Calea UK Limited Cestrian Court Park Runcorn Cheshire<br />

Careology Ltd<br />

Central Homecare Ltd<br />

CHEMISTREE<br />

HOMECARE<br />

Evolution Homecare<br />

Services Ltd<br />

Flexible Homecare<br />

Services<br />

<strong>Unit</strong> 2-4<br />

Fenchurch<br />

Court<br />

Bobby Fryer<br />

Close Oxford<br />

Selbourne<br />

House Mill Lane Alton Hampshire<br />

<strong>Unit</strong> 7 Curo<br />

Park Park Street Frogmore St Albans<br />

Post<br />

Code Contact Position e-mail<br />

CW1<br />

6AP<br />

AL1<br />

1XB<br />

Mo<br />

Rahman<br />

Steve Lane<br />

CM19<br />

5GU Alton Austin<br />

WA7<br />

1NT<br />

OX4<br />

6ZN<br />

GU34<br />

2QJ<br />

AL2<br />

2DD<br />

16<br />

Telephone<br />

number<br />

Contracts<br />

Manager BUCKLEIP@airproducts.com 0800 389 0202<br />

Business Manager<br />

Head <strong>of</strong> Homecare<br />

(Baxter)<br />

<strong>Commercial</strong><br />

Manager<br />

Christina Senior Product<br />

Willis<br />

Manager<br />

Dominic<br />

Moreland<br />

(MD)<br />

or Natasha<br />

Arif Manging Director<br />

Gaurang Head <strong>of</strong> Homecare<br />

Majmudar Development<br />

Gitika<br />

Kalra/Sam<br />

Bhudheo/Le<br />

sley Parrott<br />

Head <strong>of</strong> Homecare<br />

Business<br />

Development<br />

Manager/Director<br />

<strong>of</strong><br />

Homecare/Senior<br />

Homecare<br />

supervisor<br />

mohammed_a_rahman@baxte<br />

r.com<br />

steve_lane@baxter.com<br />

aaustin@bupahomehealthcare.<br />

com<br />

01727 849721<br />

01635 206273<br />

01279 456789 /<br />

456946<br />

Christina.willis@caleaonline.com<br />

01928 533742<br />

dmoreland@careology.co.uk<br />

narif@careology.co.uk<br />

01865 770510<br />

- switchboard<br />

or direct 01865<br />

334925<br />

gaurang.majmudar@cen<br />

tralhomecare.co.uk 01420 540535<br />

Homecare@chemistree.co.uk<br />

Sam.b@chemistree.co.uk<br />

Gitika.k@chemistree.co.uk<br />

Lesley.p@chemistree.co.uk 01727 877954<br />

Mobile<br />

Member <strong>of</strong> the<br />

National<br />

Clinical<br />

Homecare<br />

Number Website<br />

www.airpr<br />

Comments Association<br />

07834<br />

oducts.co. Oxygen and<br />

259590<br />

07825<br />

374917<br />

uk<br />

<strong>Medicines</strong><br />

07717<br />

www.willo Low & High<br />

542261 whs.co.uk Tech.<br />

Low & High<br />

Yes<br />

www.bupa Tech<br />

07971<br />

homehealt complex and<br />

499518 hcare.com continuing care Yes<br />

0779530812<br />

4<br />

07748<br />

936914<br />

07879<br />

488000<br />

07545<br />

243796<br />

www.calea<br />

.co.uk High Tech<br />

High Tech -<br />

Clotting<br />

Factors /<br />

Yes<br />

www.careo Genetics /<br />

logy.co.uk<br />

www.centr<br />

Chemotherapy Yes<br />

alhomecar Low & High<br />

e.co.uk Tech Yes<br />

www.chem<br />

istree.co.u<br />

k<br />

Low and High<br />

tech - incl CF,<br />

all IV<br />

Technology 239 Ampthill<br />

MK42 Paul<br />

Contracts & Sales paul.probert@evolutionhomeca<br />

07713<br />

www.evolu<br />

tionhomec<br />

House<br />

Road Bedford Bedfordshire 9QG Probert Support Manager re.co.uk 01234 223673 306564 are.co.uk<br />

52 French<br />

No<br />

Westbury Laurence<br />

OX44 Julian<br />

jgooddy@eyecare-<br />

Website<br />

House<br />

Way Chalgrove Oxford<br />

7YF Gooddy Managing Director services.com 01865 400384<br />

(checked High Tech<br />

© Crown Copyright 2011 May 2011<br />

Low and High<br />

tech Yes


<strong>Health</strong>care at Home Ltd<br />

Lloyds Pharmacy - sister<br />

company <strong>of</strong> Evolution<br />

Fifth Avenue<br />

Centrum 100<br />

Technology<br />

House<br />

Mawdsleys (Mawdsley -<br />

Brooks & Co. Ltd) Number Three<br />

Burton upon<br />

Trent<br />

Staffordsh<br />

ire<br />

239 Ampthill<br />

Road Bedford Bedfordshire<br />

South<br />

Langworthy<br />

Road<br />

Medco <strong>Health</strong> Solutions<br />

(UK) Bewer House Caswell Road<br />

Nutricia Limited<br />

Pharma Service Division<br />

& Applied Dispensing (a<br />

division <strong>of</strong> <strong>Health</strong>care at<br />

Home)<br />

Newmarket<br />

Avenue<br />

Polar Speed <strong>Unit</strong> 8<br />

White Horse<br />

Business<br />

Park<br />

Chartmoor<br />

Road<br />

PO Box Salford,<br />

18<br />

Manchester<br />

Brackmills<br />

Industrial<br />

Estate Northampton<br />

Trowbridg<br />

e Wiltshire<br />

Leighton<br />

Buzzard Bedfordshire<br />

DE14<br />

2WS Mark Smith<br />

MK42<br />

9QG<br />

M50<br />

2PW<br />

NN4<br />

7BZ<br />

BA14<br />

0XQ<br />

Trevor<br />

Jones<br />

Kelly<br />

Jacques<br />

Alison<br />

Davis<br />

Dave<br />

Hobdey<br />

LU7<br />

4WG John Evans<br />

Group <strong>Commercial</strong><br />

Director Mark.Smith@hah.co.uk 0870 600 1540<br />

UK Contracts<br />

Manager<br />

Hospital contracts<br />

Manager<br />

Director- Business<br />

Development<br />

© Crown Copyright 2011 May 2011<br />

17<br />

trevor.jones@evolutionhomeca<br />

re.co.uk 01234 223600<br />

Kelly.jacques@mawdsleys.co.<br />

uk 0161 742 3360<br />

alison.davis@medcohealth.co.<br />

uk 01604 241120<br />

07772<br />

712216<br />

07788<br />

416093<br />

Contracts<br />

Manager david.hobdey@nutricia.com 01225 711586 none<br />

Director -<br />

Pharmaceutical<br />

Services john@polarspeed.com 01525 217666<br />

0785090151<br />

4<br />

07970<br />

578364<br />

03/06/08)<br />

www.hah.c<br />

o.uk<br />

www.evolu<br />

tionhomec<br />

are.co.uk<br />

www.maw<br />

dsleys.co.<br />

uk<br />

www.medc<br />

ohealth.co.<br />

uk<br />

uk.nutricia.<br />

com<br />

www.polar<br />

speed.com<br />

Low and High<br />

Tech -<br />

Integrated<br />

Homecare<br />

Services Yes<br />

High tech; HIV<br />

/ CF<br />

Low-tech<br />

therapeutic<br />

category<br />

initially<br />

Low tech-high<br />

tec Yes<br />

High Tech<br />

Feeding;<br />

Enteral Feeds,<br />

Specialised<br />

Feeds<br />

Chill Chain (act<br />

as distributors<br />

for Careology


Drug Suppliers Offering Homecare<br />

These suppliers are drug companies who <strong>of</strong>fer homecare using an in-house provider<br />

Fresenius Medical Care (UK)<br />

Gambro Lundia AB (UK &<br />

Ireland<br />

Merz Pharma UK Ltd<br />

Nunn Brook<br />

Sutton in<br />

Road Huthwaite<br />

Ermine<br />

Ashfield Nottinghamshire<br />

Lundia Business<br />

House<br />

260<br />

Park Huntington Cambridgeshire<br />

Centennial Elstree Hill<br />

Park<br />

South Elstree Hertfordshire<br />

NG17<br />

2HU<br />

PE29<br />

6XX<br />

WD6<br />

3SR<br />

Kathryn<br />

Miller<br />

David<br />

Lyons<br />

Pharmacy2<br />

Home<br />

Contracts Coordinator<br />

HND Business<br />

Development<br />

<strong>of</strong>fice<br />

Head <strong>of</strong><br />

Medical<br />

Information<br />

© Crown Copyright 2011 May 2011<br />

18<br />

ukcontracts@fmcag.com<br />

david.lyons@gambro.co<br />

m<br />

pharmacy2Home@merz<br />

.com<br />

01623<br />

445149 www.fmc-ag.com<br />

01480<br />

444000<br />

0208<br />

236<br />

3583<br />

07870<br />

624706 www.gambro.co.uk<br />

www.merzpharma.<br />

co.uk<br />

Hi Tech;<br />

Peritoneal<br />

Dialysis and<br />

Haemodialysis<br />

Hi Tech;<br />

Haemodialysis<br />

on supply for<br />

patients on<br />

Denzapine


Homecare stakeholder map<br />

HRG4<br />

(PbR)<br />

Clinicians<br />

PMSG<br />

NPSG<br />

MHRA<br />

NHS QA<br />

BCAG<br />

NICE<br />

Specialist<br />

Commissioner<br />

NHMC<br />

PCT<br />

Wider environment<br />

Business influencers<br />

Operational<br />

Secretary<br />

<strong>of</strong> State<br />

Secondary<br />

Care Trust<br />

© Crown Copyright 2011 May 2011<br />

JCWG<br />

NHS <strong>CMU</strong><br />

NHS<br />

19<br />

Homecare<br />

Provider<br />

CPHs<br />

ABPI<br />

PPD<br />

Pharmacists<br />

HM Treasury<br />

Pharmacy<br />

Manufacturers<br />

NCHA<br />

DOH MPIG<br />

OFT<br />

DOH PPRS


© Crown Copyright 2011<br />

May 2011<br />

List <strong>of</strong> products and therapies<br />

The tables below lists therapy areas and conditions which are currently treated through homecare and examples <strong>of</strong><br />

the drugs involved.<br />

The list <strong>of</strong> medicines (table 1) are catalogued as they first appear in the BNF and the list is in BNF order. They<br />

have not been duplicated where they have more than one indication e.g. Methotrexate first appears under<br />

Cytotoxic Drugs and is not repeated under Rheumatology.<br />

Table (2) is an alphabetical list <strong>of</strong> products that have been distributed to patients homes by brand name.<br />

These are not exhaustive lists. Please contact carol.clark@<strong>CMU</strong>.nhs.uk if you are aware <strong>of</strong> any other<br />

products which are being supplied via homecare.<br />

Table (1) Therapy areas and conditions which are currently treated through homecare<br />

BNF<br />

Section<br />

2.1.2<br />

2.5.1<br />

2.11<br />

3.1.1.1<br />

3.4.3<br />

3.6<br />

3.7<br />

4.2.1<br />

4.9.1<br />

Therapy area Medicine Specific medicine<br />

Cardiology<br />

Congestive heart failure<br />

Vasodilator antihypertensives<br />

Antifibrinolytics<br />

Respiratory<br />

Selective beta2 agonists<br />

Allergic asthma<br />

Oxygen<br />

Mucolytics<br />

CNS<br />

Antipsychotic drugs<br />

Parkinsons disease<br />

Milrinone<br />

Iloprost<br />

Epoprostenol<br />

Bosentan<br />

Sildenafil<br />

Sitaxentan<br />

Blood Factors<br />

V11, V11a, V111,<br />

IX<br />

Terbutaline<br />

Omalizumab<br />

Oxygen<br />

Dornase Alfa<br />

20<br />

Primacor<br />

Ventavis<br />

Flolan<br />

Tracleer<br />

Revatio<br />

Thelin<br />

Advate, Benefix, Haemate<br />

P. Helixate NexGen,<br />

Kogenate, Novoseven,<br />

ReFacto,<br />

Bricanyl<br />

Xolair<br />

Pulmozyme<br />

Clozaril<br />

Denzapine<br />

Zaponex<br />

APO-Go


BNF<br />

Section<br />

5.1.4<br />

5.1.7<br />

5.1.9<br />

5.3.1<br />

5.3.3<br />

8.2.4<br />

8.2.4<br />

5.3.5<br />

© Crown Copyright 2011<br />

Therapy area Medicine Specific medicine<br />

Infections<br />

Cystic fibrosis<br />

Antitubercolosis<br />

HIV<br />

Viral Hepatitis<br />

Hepatitis C<br />

May 2011<br />

Tobramycin<br />

Colomycin<br />

Imipenem &<br />

Cilastatin<br />

Amikacin<br />

Capreomycin<br />

Rifabutin<br />

Pyrazinamide<br />

Rifampacin &<br />

isoniazid<br />

combinations<br />

Antivirals and related<br />

medicines<br />

Entecavir<br />

Interferon<br />

Pegylated Interferon<br />

Ribavirin<br />

21<br />

Tobi<br />

Colistin<br />

Primaxin<br />

Amikin<br />

Capstat<br />

Mycobutin<br />

Rifater, Rifinah<br />

Baraclude<br />

Intron A, R<strong>of</strong>eron A,<br />

Viraferon<br />

Pegintron,<br />

ViraferonPeg<br />

Copegus, Rebetol


BNF<br />

Section<br />

6.5.1<br />

6.5.1<br />

6.6.1<br />

8.2.4<br />

8.1<br />

8.2<br />

8.3.4<br />

© Crown Copyright 2011<br />

Therapy area Medicine Specific medicine<br />

Endocrine<br />

Infertility<br />

Bone metabolism &<br />

Growth hormone<br />

Bone metabolism &<br />

Growth hormone<br />

Multiple sclerosis<br />

Malignant disease<br />

Cytotoxic drugs<br />

Immunosuppressants<br />

Hormone antagonists<br />

May 2011<br />

Chorionic<br />

Gonadotrophin<br />

Choriogonadotropin<br />

Alfa<br />

Follitropin Alfa<br />

Follitropin Beta<br />

Human Menopausal<br />

Gonadotrophins<br />

Lutropin Alfa<br />

Somatropin<br />

Teriparatide<br />

Interferon Beta 1a<br />

Interferon beta 1b<br />

Glatiramer<br />

Natalizumab<br />

Capecitabine<br />

Gemcitabine<br />

Methotrexate<br />

Erlotinib<br />

Imatinib<br />

Topotecan<br />

Trastuzumab<br />

Bortezomib<br />

Bevacizumab<br />

Mycophenolate<br />

Ciclosporin<br />

Sirolimus<br />

Tacrolimus<br />

Lanreotide<br />

Octreotide<br />

22<br />

Choragon, Pregnyl<br />

Ovitrelle<br />

Gonal-F<br />

Puregon<br />

Menogon,Menopur<br />

Luveris<br />

Saizen<br />

Zomacton<br />

Genotrope, Humatrope,<br />

Norditropin, Nutropin Aq.,<br />

Saizen, Zomacton<br />

Forsteo<br />

Avonex, Rebif<br />

Betaferon,<br />

Copaxone<br />

Tysabri<br />

Xeloda<br />

Gemzar<br />

Tarceva<br />

Glivec<br />

Hycamtin<br />

Herceptin<br />

Velcade<br />

Avastin<br />

Cellcept, Myfortic<br />

Neoral, Sandimmune<br />

Rapamune<br />

Prograf, Advagraf<br />

Somatuline LA and<br />

Autogel<br />

Sandostatin and LAR


BNF<br />

Section<br />

9.1.3<br />

9.1.3<br />

9.3<br />

9.8.1<br />

9.8.1<br />

9.8.1<br />

9.8.1<br />

© Crown Copyright 2011<br />

Therapy area Medicine Specific medicine<br />

Nutrition and Blood<br />

Anaemia<br />

Thalassaemia<br />

Parenteral nutrition<br />

Gauchers disease<br />

Fabrys disease<br />

MPS VI<br />

MPS II<br />

May 2011<br />

Darbopoetin<br />

Epoetin Alfa<br />

Epoetin Beta<br />

Desferrioxamine<br />

Desferasirox<br />

Deferipirone<br />

TPN<br />

Imiglucerase<br />

Miglustat<br />

Agalsidase beta<br />

Agalsidase alfa<br />

Galsufase<br />

Idursulfase<br />

Musculoskeletal<br />

10.1.3 Rheumatic Disease Adalimumab<br />

Etanercept<br />

Infliximab<br />

Methotrexate<br />

Rituximab<br />

23<br />

Aranesp<br />

Eprex, Retocrit<br />

NeoRecormon<br />

Desferal<br />

Exjade<br />

Ferriprox<br />

Cerezyme<br />

Zavesca<br />

Fabrazyme<br />

Replagal<br />

Nagalzyme<br />

Elaprase<br />

Humira<br />

Enbrel<br />

Remicade<br />

Metoject<br />

Mabthera<br />

13.5.3<br />

Skin<br />

Psoriasis<br />

Metabolic Disorders<br />

Efalizumab Raptiva<br />

9.8.1 Mucopolysaccharidosis Aldurazyme<br />

Laronidase<br />

Pompe‟s Disease<br />

Vaccines and antisera<br />

14.5 (IV Immunoglobulin)<br />

Alglucosidase<br />

Alfa<br />

SC<br />

IV<br />

Myozyme<br />

Subcuvia<br />

Subgam<br />

Vivaglobin<br />

Flebogamma<br />

Gammagard<br />

Octagam<br />

Sandoglobulin<br />

Vigam


Table (2) Alphabetical list <strong>of</strong> products that have been distributed to patients homes by brand name.<br />

1 APO-Go 36 Gonal-F 71 Raptiva<br />

2 Advagraf 37 Haemate P 72 Rebetol<br />

3 Advate 38 Helixate 73 Rebif<br />

4 Amikin 39 Herceptin 74 ReFacto<br />

5 Aranesp 40 Humatrope 75 Remicade<br />

6 Avastin 41 Humira 76 Replagel<br />

7 Avonex 42 Hycamtin 77 Retocrit<br />

8 Baraclude 43 Intron A 78 Revatio<br />

9 Benefix 44 Kogenate 79 Rifater<br />

10 Betaferon 45 Laronidase 80 Rifinah<br />

11 Bricanyl 46 Luveris 81 R<strong>of</strong>eron A<br />

12 Capstat 47 Mabthera 82 Saizen<br />

13 Cellcept 48 Menogon 83 Sandimmune<br />

14 Cerezyme 49 Menopur 84 Sandoglobulin<br />

15 Clozaril 50 Metoject 85 Sandostatin and LAR<br />

16 Colistin 51 Mycobutin 86 Somatuline LA and autogel<br />

17 Copaxone 52 Myfortic 87 Subcuvia<br />

18 Copegus 53 Myozyme 88 Subgam<br />

19 Choragon 54 Nagalzyme 89 Tarceva<br />

20 Denzapine 55 Neoral 90 Thelin<br />

21 Desferal 56 MeoRecormon 91 Tobi<br />

22 Dynepro 57 NexGen 92 Tracleer<br />

23 Elaprase 58 Norditropin 93 Tysabri<br />

24 Enbrel 59 Novoseven 94 Velcade<br />

25 Eprex 60 Nutropin Aq 95 Ventavis<br />

26 Exjade 61 Octagam 96 Vigam<br />

27 Fabrazyme 62 Ovitrelle 97 Viraferon<br />

28 Ferriprox 63 Pegintron 98 ViraferonPeg<br />

29 Flebogamma 64 Pregnyl 99 Vivaglobin<br />

30 Flolan 65 Primacor 100 Xeloda<br />

31 Forsteo 66 Primaxin 101 Xolair<br />

32 Gammagard 67 Prograf 102 Zomacton<br />

33 Gemzar 68 Pulmozyme 103 Zaponex<br />

34 Genotrope 69 Puregon 104 Zavesca<br />

35 Glivec 70 Rapamune<br />

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1. Introduction<br />

© Crown Copyright 2011<br />

Specification document for Homecare <strong>Medicines</strong> –<br />

Core<br />

1.1 This specification outlines the general requirements for any Homecare Medicine service<br />

purchased by the NHS in England. There are further supplementary specifications which outline<br />

the specific requirements with regard to:<br />

2. Scope<br />

• Delivery and service<br />

• Product (medicines), prescribing and dispensing<br />

• Information and training for patients and staff<br />

• Nursing services to be provided<br />

• Equipment and ancillaries.<br />

• Compounding Services.<br />

There may also be some requirements which are therapy specific which should be detailed<br />

separately.<br />

These documents have been produced in partnership with <strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong> (<strong>CMU</strong>)<br />

and the National Homecare <strong>Medicines</strong> Committee, in consultation with NHS and industry.<br />

The guidance should be utilised by all NHS Organisations.<br />

2.1 This Framework agreement is for provision <strong>of</strong> a homecare medicines service, which may include<br />

the following therapies and medicines.<br />

{insert list here}<br />

2.2 It is anticipated that the scope in terms <strong>of</strong> numbers <strong>of</strong> patients and boundaries <strong>of</strong> provision will<br />

change during the term <strong>of</strong> this framework but will be limited to the therapies listed and patients<br />

being treated by the Purchasing Authorities listed. Provision will be made for implementing these<br />

changes in a way that is acceptable to all parties, and taking into account patient choice and<br />

significant market changes.<br />

2.3 Further detail <strong>of</strong> the product and services requirements are provided throughout this specification.<br />

Appendix XX gives further detail on the current provision <strong>of</strong> these services and an indication <strong>of</strong><br />

any planned developments and strategic direction.<br />

3. Definitions<br />

Appendix One<br />

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4. Duration <strong>of</strong> Framework<br />

4.1 Subject to the provision <strong>of</strong> the Terms and Conditions, this framework shall remain in force for the<br />

period <strong>of</strong> [Period] months commencing 1 [Month] 20XX. In addition there will be an option to<br />

extend the framework for up to a further 24 months.<br />

5. Selection, Registration and Discharge <strong>of</strong> Patients<br />

5.1 Patient selection will be carried out by the Purchasing Authority. The Purchasing Authority will<br />

confirm the patient‟s motivation and suitability for the home delivery scheme.<br />

5.2 Assessment <strong>of</strong> the patient‟s home environment will be the responsibility <strong>of</strong> the Purchasing<br />

Authority.<br />

5.3 Service will not commence until the Purchasing Authority has gained patient consent and the<br />

Purchasing Authority has evidence as to the suitability for the patient to receive a home delivery<br />

service.<br />

5.4 The Purchasing Authority will complete a registration form for each patient, for dispatch to the<br />

Contractor. The NHMC recommended standard registration form is included at Appendix Two.<br />

On receipt <strong>of</strong> the registration paperwork, the Contractor will identify the service elements and<br />

activate as required.<br />

5.5 The Contractor will adopt and use the Purchasing Authority‟s patient unique identifier to identify<br />

each patient once the registration forms have been accepted.<br />

5.6 The Contractor will make initial contact with the patient to confirm registration, and explain the<br />

process in line with the requirements <strong>of</strong> the patient information section <strong>of</strong> this specification.<br />

5.7 As the home delivery <strong>of</strong> each patient is transferred to the Contractor, it will be the responsibility <strong>of</strong><br />

the Contractor and the Purchasing Authority to ensure a smooth transition from hospital to homebased<br />

supply. As the patient's delivery is transferred to the contractor, it will be the responsibility<br />

<strong>of</strong> the Contractor and the Purchasing Authority to ensure a smooth transition to the contractor.<br />

Agreement must be made and stated on the original order <strong>of</strong> when homecare provision needs to<br />

commence. It is the responsibility <strong>of</strong> the Purchasing Authority to communicate this to the patient.<br />

5.8 Following registration the Contractor must receive an <strong>of</strong>ficial order in addition to a prescription<br />

from the Purchasing Authority to commence a delivery. Failure to receive an <strong>of</strong>ficial order could<br />

result in non payment<br />

5.9 When patients care transfers between contractors, the contractors involved must follow the<br />

NHMC Change Management Policy. See appendix three.<br />

5.10 In the event <strong>of</strong> a patient no longer requiring the Homecare medicines service due to transfer to<br />

another therapy, admission into hospital or returning to collecting medicines from hospital, the<br />

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Purchasing Authority may request the Contractor to collect all new and un-used stock and<br />

dispose <strong>of</strong> them as necessary or reimburse the Purchasing Authority. Where a patient's care is<br />

transferred between contractors, all contractors must follow the NHMC procedure for change<br />

management with patient or patient's family consent. All equipment will be collected and returned<br />

to the appropriate provider.<br />

5.11 In the event <strong>of</strong> a patient‟s death the process described in 5.10 will be carried out with particular<br />

sensitivity at a time convenient to the patient‟s family or carer.<br />

6. Quality <strong>of</strong> Goods<br />

6.1 The Contractor warrants represents and undertakes that any goods held and then supplied by it<br />

will:<br />

6.1.1 Pass any tests and trials the Purchasing Authority requires to satisfy itself that the goods<br />

are not injurious to health including without limitation any tests and trials conducted by<br />

NIBSC where applicable.<br />

6.1.2 Meet the product specification. In the event <strong>of</strong> any dispute as to whether the goods have<br />

been supplied in accordance with the relevant specification, the authority shall refer the<br />

matter to the regional quality control pharmacist who shall keep a sample <strong>of</strong> the goods<br />

which the regional quality control pharmacist has previously approved as being in<br />

accordance with the specification and this sample shall be used as the standard against<br />

which all goods shall be measured in order to determine whether they have been<br />

supplied in accordance with the relevant specification; and<br />

6.1.3 The Contractor shall operate and maintain a quality control monitoring system which<br />

meets the requirements <strong>of</strong> the MHRA and NIBSC and is approved by the Purchasing<br />

Authority and make available to Purchasing Authority on demand the results <strong>of</strong> such<br />

quality control monitoring.<br />

6.1.4 The Contractor shall adhere to any relevant national quality standards and general<br />

guidance recommended by bodies such as the National Pharmaceuticals Supply Group<br />

(NPSG), the Pharmaceuticals Market Support Group (PMSG), the National Homecare<br />

<strong>Medicines</strong> Committee (NHMC), <strong>Department</strong> <strong>of</strong> <strong>Health</strong> (DH), National <strong>Health</strong> Service<br />

(NHS), Care Quality Commission (CQC) and National Patient Safety Agency (NPSA).<br />

6.1.5 The reasons for any faulty or spoiled products will be notified by the Contractor to the<br />

Purchasing Authority in writing within 24 hours <strong>of</strong> the complaint or sooner where deemed<br />

appropriate<br />

7. Management Information<br />

7.1 The Contractor must ensure that records <strong>of</strong> all hospital sales detailing volumes and prices are<br />

kept and given to a nominated Authorised Officer <strong>of</strong> the Purchasing Authority on a monthly basis<br />

in the format given in Appendix four on an agreed date in an electronic format.<br />

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7.2 The Contractor must comply with all requests by the <strong>Department</strong> <strong>of</strong> <strong>Health</strong>, <strong>CMU</strong>, the National<br />

Homecare <strong>Medicines</strong> Committee (NHCMC) and the Purchasing Authority for management data<br />

to be provided in respect <strong>of</strong> the products supplied under this framework. This information is to be<br />

provided within 10 working days for ad hoc requests.<br />

7.3 All reports <strong>of</strong> usage and expenditure will be coded so that patients‟ names are not revealed by<br />

using a patient unique identifier. All requirements <strong>of</strong> the Data Protection Act 1998 and updates<br />

must be met in full.<br />

7.4 Particular care must be taken on the security <strong>of</strong> patient information. Where identifiable patient<br />

personal information must be transmitted this must be by high level encryption, suppliers to be<br />

accredited to ISO27001. Level 2 <strong>of</strong> the Information Governance Toolkit should be adhered to.<br />

(Further information can be found on<br />

www.connectingforhealth.nhs.uk/systemsandservices/infogov or www.psnc.org.uk/IG)<br />

On occasion there will be a requirement to transmit data via electronic communication (i.e. email)<br />

and/or computer disc (CD). When electronic means are used, each party shall ensure as<br />

far as reasonably practicable, that data is properly stored, is not accessible to unauthorised<br />

persons, is not altered, lost or destroyed and is capable <strong>of</strong> being retrieved only by properly<br />

authorised persons.<br />

Each party may apply special protection to electronic messages by encryption or by other agreed<br />

means, and may apply designations to the messages for protective interchange, handling and<br />

storage procedures. Unless the parties otherwise agree, the party receiving a message so<br />

protected or designated shall use at least the same level <strong>of</strong> protection and protective procedures<br />

for any further transmission <strong>of</strong> the message and its associated data for all responses to the<br />

message and for all other communications by interchange or otherwise to any other person<br />

relating to the message.<br />

If either party becomes aware <strong>of</strong> a security breach or breach <strong>of</strong> confidence in relation to any<br />

message or in relation to its procedures or systems (including, without limitation, unauthorised<br />

access to their systems for generation, authentication, authorisation, processing, transmission,<br />

storage, protection and file management <strong>of</strong> messages) then it shall immediately inform the other<br />

party <strong>of</strong> such breach. On being informed or becoming aware <strong>of</strong> a breach the party concerned<br />

shall:<br />

Immediately investigate the cause, effect and extent <strong>of</strong> such breach;<br />

report the results <strong>of</strong> the investigation to the other party; and<br />

use all reasonable endeavours to rectify the cause <strong>of</strong> such breach.<br />

8. Performance Monitoring<br />

8.1 The Purchasing Authority is responsible for monitoring Key Performance Indicators. Key<br />

Performance Indicators have been developed for the purpose <strong>of</strong> monitoring the performance <strong>of</strong><br />

the Contractor and are detailed in Appendix five. The required information will be provided to the<br />

authorised <strong>of</strong>ficer at the Purchasing Authority at agreed intervals. In addition to this, the<br />

Homecare Provider is responsible for informing on any change in performance standards.<br />

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8.2 Contractors are required to provide a named contact responsible for the provision <strong>of</strong><br />

management and performance information. The information must:<br />

be in the spreadsheet format prescribed by the Purchasing Authority<br />

contain product and/or service level detail for each NHS site or organisation and other<br />

third parties if appropriate<br />

be provided to the Purchasing Authority within five working days <strong>of</strong> the end <strong>of</strong> the<br />

appropriate sales month.<br />

8.3 Framework monitoring meetings will be held with each <strong>of</strong> the successful Contractors by the<br />

Purchasing Authority at agreed intervals.<br />

8.4 On occasion a questionnaire will be issued by the Purchasing Authority to the patient and/or carer<br />

in order to ascertain the quality <strong>of</strong> the level <strong>of</strong> service. This will be required to be included with<br />

deliveries that are dispatched by the Contractor. The Questionnaire will be supplied in an<br />

appropriate envelope by the Purchasing Authority. The distribution <strong>of</strong> questionnaires will be<br />

provided free <strong>of</strong> charge by the Contractor and questionnaires will be returned by patients directly<br />

to the Purchasing Authority. A standard questionnaire is included in Appendix 6 but this may be<br />

subject to change by the Purchasing Authority.<br />

9. Arrangements for the Payment <strong>of</strong> Invoices<br />

9.1 The Contractor shall issue invoices detailing the unique patient identifier, items supplied, itemised<br />

unit costs and framework references.<br />

9.2 Invoices to include service charges, these charges must be separately stated on the invoice<br />

documentation and indicated by the Contractor even if only consumables and ancillaries.<br />

9.3 The patient endorsed delivery note must be sent with each invoice by the Contractor Agent to the<br />

Purchasing Authorities‟ Finance <strong>Department</strong> or Pharmacy as agreed. Only invoices that are<br />

cross-referenced to patient endorsed delivery notes must be authorised for payment by the<br />

Purchasing Authority.<br />

10. Confidentiality<br />

10.1 All contractors must comply with Section 35 on confidentiality in the NHS Conditions <strong>of</strong> Contract<br />

for the Supply <strong>of</strong> Services.<br />

10.2 Patient and family confidentiality must be respected and preserved at all times. No circulars or<br />

questionnaires should be sent to patients, relatives, carers or GPs without the prior consent and<br />

agreement <strong>of</strong> the Authority. No patient contact will be made, other than that required by the<br />

Framework Participant‟s staff in the performance <strong>of</strong> their duties, or unless specifically requested<br />

to do so by the Participating Authority clinical team or other authorised personnel<br />

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10.3 All information, including prices, made available to the service Contractor or the service<br />

Contractor‟s employees under this framework must not be divulged for any purposes to any other<br />

party including other companies within the group.<br />

11. Communications<br />

11.1 Key individuals will be designated the point <strong>of</strong> contact for the homecare service within the<br />

Purchasing Authority and their contact numbers will be made known to the Contractor. These<br />

contacts will be for:<br />

• Queries on referrals<br />

• Finance/invoice queries<br />

• Emergency/out <strong>of</strong> hours<br />

• Performance monitoring<br />

• Contractual queries<br />

• Management information<br />

• Complaints and adverse incidents.<br />

• Prescription Queries<br />

The Homecare provider must also provide a list <strong>of</strong> their designated key contacts for the specific<br />

areas listed above. Please complete Appendix XX.<br />

11.2 The Contractor must provide a named individual, deputy, and contact details for the above<br />

categories and ensure this information is kept up-to-date.<br />

11.3 A free phone Help Line will be available 8:00am to 6:00pm (plus answer phone or emergency<br />

bleep outside those hours) 365 days a year, for patients and carers to contact the service<br />

Contractor by telephone for information on their products and services. All clinical issues or errors<br />

and/or incidents must be fed back by the contractor to the purchasing authority within 24 hours or<br />

sooner if deemed appropriate.<br />

12. Managing Complaints and Adverse Incidents<br />

12.1 Any complaints regarding the delivery or service, received from patients by the Purchasing<br />

Authority will be forwarded in writing to the Contractor for a written resolution within two weeks,<br />

unless requested by the Purchasing Authority to the contrary.<br />

12.2 The Contractor must provide a complaints procedure and an incidents reporting procedure. The<br />

Purchasing Authority will share in advance their incidence policy and serious untoward incident<br />

policy with the contractor and the contractor must adhere to these policies.<br />

13. Sub-Contractors<br />

13.1 Where sub-contractors are used for the provision <strong>of</strong> products and service within this Framework<br />

agreement, all requirements within this specification will be extended to the sub-contractor and<br />

individuals involved. It is the responsibility <strong>of</strong> the Contractor to ensure that all sub-contractors<br />

meet these requirements and to inform the Purchasing Authority <strong>of</strong> any and all intended sub<br />

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14. Legal<br />

contracted parts <strong>of</strong> the service. No change can be made without the express permission <strong>of</strong> the<br />

Purchasing Authority.<br />

14.1 The requirements detailed in this specification are in addition to and compliment the NHS<br />

Conditions <strong>of</strong> Contract for the Supply <strong>of</strong> Service where the medicines and/or products are being<br />

sourced separately i.e. through national and/or regional frameworks or local arrangements. If the<br />

Contractor is required to source the medicines as well as provide the homecare service both the<br />

NHS Conditions <strong>of</strong> Contract for the Supply <strong>of</strong> Service and the NHS Conditions <strong>of</strong> Contract for the<br />

Purchase <strong>of</strong> Goods will apply. Where there is duplication on terms the supply <strong>of</strong> service will take<br />

precedent.<br />

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1. Delivery scheduling<br />

© Crown Copyright 2011<br />

Specification document for Homecare <strong>Medicines</strong> –<br />

Delivery and Service<br />

1.1 The Contractor shall ensure that the goods are delivered safely and securely to the patient‟s<br />

nominated address at any time between Monday and Friday, 8:00am and 6:00pm. Normal<br />

delivery dates should include Bank Holidays except Christmas day and New Years day. If this<br />

necessitates a revised delivery date, this should be immediately prior to the Bank Holiday. The<br />

Purchasing Authority will be advised <strong>of</strong> and agree with such arrangements. Deliveries recorded<br />

outside core hours without prior arrangement will result in that delivery charge being credited to<br />

the Purchasing Authority.<br />

1.2 The Contractor shall operate an emergency delivery service whereby delivery will be made within<br />

24 hours <strong>of</strong> the request being made by the Purchasing Authority at the agreed costs per delivery.<br />

1.3 Deliveries should be made available for Saturday, early morning (before 8:00am) evening (after<br />

6:00pm) and Sunday deliveries.<br />

1.4 The Contractor must agree a delivery time with the patient or carer which is convenient to the<br />

patient and/or carer and the delivery must be made within a two hour window (i.e. 10am – 12pm)<br />

as agreed with the patient and/or carer. The delivery time should be confirmed with the patient at<br />

least 24 hours in advance, and in accordance with any agreed Key Performance Indicators<br />

(KPI‟s)<br />

1.5 Delivery date will be no more than two working days after date <strong>of</strong> dispensing.<br />

1.6 If a patient is not available at the agreed delivery time, it is the patient‟s responsibility to contact<br />

the Contractor to re-arrange delivery.<br />

1.7 The frequency <strong>of</strong> deliveries depends on each patient group and stability <strong>of</strong> product, it is usually<br />

between every 4-12 weeks.<br />

1.8 Under sections 3 and 6 <strong>of</strong> the <strong>Health</strong> and Safety at Work Act 1974 there is a duty to protect<br />

people not in a company's employment who may be affected by handling loads they have<br />

supplied.<br />

Therefore it is good practice for manufacturers and suppliers to mark weights (and, if relevant,<br />

information about the heaviest side) on loads if this can be done easily.<br />

Please see:<br />

http://www.hse.gov.uk/msd/loadguidance.htm<br />

1.9 If it is anticipated that there will be failure to achieve the planned delivery time, the patient and/or<br />

carer must be contacted prior to the expected delivery to arrange an alternative delivery time if<br />

requested by the patient and/or carer. It is expected that providers will develop innovative<br />

communication methods such as text reminders, online tracking.<br />

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2. Refrigeration<br />

2.1 Where applicable, the Contractor must be able to maintain the cold chain, and provide details <strong>of</strong><br />

validation, up to the point <strong>of</strong> delivery required for the medicines.<br />

2.2 The Contractor may be required to provide refrigeration facilities for the product in the patient‟s<br />

home. Further detail <strong>of</strong> this requirement is outlined in Equipment and Ancillaries specification.<br />

3. Delivery location and stock control<br />

3.1 The Contractor will work with the patient, with their consent, to ensure an appropriate stock level<br />

within the patient‟s home as agreed by the patient‟s prescriber.<br />

3.2 All drivers should deliver all items to the agreed location within the patient‟s home, in some<br />

circumstances this may be in the supplied refrigerator, unless directed by the patient and/or<br />

carer.<br />

3.3 Where applicable, all stock delivered is unpacked and rotated enabling normal access to the<br />

product on a first-in-first-out basis.<br />

3.4 Stock identified as out <strong>of</strong> date will be removed from the patient‟s home with the patients consent<br />

and replaced by the Contractor upon approval from the Purchasing Authority.<br />

3.5 To ensure against over-provision, the Contractor, as required or requested by the Purchasing<br />

Authority, will at regular intervals not exceeding three months duration, undertake a stock check<br />

<strong>of</strong> items delivered to the patients home with patient consent to ensure stocks are within agreed<br />

levels and dates. The information obtained from such stock checks will be presented to the<br />

Purchasing Authority. The Purchasing Authority may wish to carry out its own check <strong>of</strong> stocks at<br />

a patient‟s home. Any shortage or surplus stock should be reported as an incident (noncompliance).<br />

4. Waste and disposal<br />

4.1 The Contractor will be responsible for the safe disposal <strong>of</strong> the patient‟s clinical waste (in<br />

accordance with legislation ruling at any time during the framework period on the collection,<br />

transportation and disposal <strong>of</strong> hazardous waste) at intervals agreed with the Purchasing Authority<br />

and will provide approved sharps disposal boxes and appropriate clinical waste bags or<br />

containers.<br />

4.2 All current UK and EU law and regulations on medicines waste must be adhered to by the<br />

Contractor.<br />

4.3 The delivery personnel must remove all delivery packaging.<br />

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4.4 Further information can be found in the <strong>Department</strong> <strong>of</strong> <strong>Health</strong>‟s document, „Safe management <strong>of</strong><br />

healthcare waste‟ Please refer to:<br />

http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/D<br />

H_126345<br />

5. Staffing and compliance<br />

5.1 The Contractor must ensure that all staff having face to face access to patients, have undergone<br />

Criminal Records Bureau (CRB) clearance. Contractors will bear the cost <strong>of</strong> carrying out these<br />

checks and will indicate how <strong>of</strong>ten these are reviewed and how frequently staff are re-checked.<br />

5.2 All delivery staff, own or courier should be trained adequately in all appropriate aspects <strong>of</strong> their<br />

part <strong>of</strong> the service and in patient‟s confidentiality requirements.<br />

5.3 The service is to be provided in a courteous, helpful and confidential manner. Drivers are to be<br />

flexible and respect patient‟s needs. Products must only be delivered and signed for to the<br />

agreed location.<br />

5.4 The Contractor will adhere to the conditions <strong>of</strong> entry into the patient‟s home which may be laid<br />

down from time to time by the Purchasing Authority or the patients themselves.<br />

5.5 On no account should any agent or servant <strong>of</strong> the Contractor enter into the patient's home unless<br />

requested by the patient for any reason. The Contractor will issue specific instructions and take<br />

all necessary steps to ensure compliance with this.<br />

5.6 The delivery personnel will carry identification, to be shown on arrival and <strong>of</strong> smart appearance<br />

and fully conversant with the delivery system. Wherever possible, patients should receive<br />

deliveries from the same driver. Patients must be informed in advance, if there is to be a<br />

permanent change <strong>of</strong> driver or if the regular driver is on holiday, or if a courier service is to be<br />

used.<br />

5.7 The delivery transport must not bear any markings other than those required by law.<br />

6. Receipt <strong>of</strong> delivery<br />

6.1 The Contractor must have a list <strong>of</strong> designated signatories (name and example signature) who are<br />

the only persons who can sign on receipt <strong>of</strong> delivery. The delivery driver must have a copy <strong>of</strong><br />

these signatories to match with who is signing on delivery.<br />

6.2 The Contractor must give patients the opportunity to provide an alternative and/or additional<br />

delivery address. This information will form part <strong>of</strong> the Contractor‟s welcome pack.<br />

6.3 All deliveries require a signature. If a patient is not contactable, the Purchasing Authority must be<br />

notified immediately unless previously agreed.<br />

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6.4 If the Purchasing Authority agrees to a postal delivery service then postal deliveries will be first<br />

class and require a signature. If a patient is not available a card will be left explaining when and<br />

from where the parcel may be collected.<br />

6.5 All Contractors should have the facility and procedures for holding keys for patients, if requested.<br />

6.6 If there is no-one at home at the agreed delivery date and time, the driver will speak to the coordinator<br />

who will in turn liaise with the Purchasing Authority. If a second delivery has to be<br />

organised, a supplementary charge may be levied to the Purchasing Authority. The<br />

supplementary charge will not be levied if the patient is absent due to a sudden hospital<br />

admission that the Purchasing Authority may be unaware <strong>of</strong>.<br />

7. Patient support<br />

7.1 The Contractor should monitor usage trends and will inform a designated person <strong>of</strong> the<br />

Purchasing Authority immediately, with regard to any patient who gives cause for concern. Areas<br />

<strong>of</strong> concern may include evidence <strong>of</strong> neglect, poor stock control, over or under use <strong>of</strong> product,<br />

deteriorating health. The Purchasing Authority should also be notified if there are any areas <strong>of</strong><br />

concern, such as poor stock control or under or over usage.<br />

7.2 At the initiation <strong>of</strong> a service for a new patient, for a first time delivery to a patient, a minimum <strong>of</strong><br />

three working days notice must be given by the contractor <strong>of</strong> the patient's first delivery.<br />

7.3 Where delivery is not made to the patient directly, the Contractor must make contact with the<br />

patient post delivery to ensure that the patient has received the medicines within 24 hours.<br />

7.4 All contact between the Contractor and the patient must be logged by the contractor with a full<br />

audit trail and made available to the Purchasing Authority on request.<br />

8. Compliance with the Appropriate Policies<br />

8.1 The Contractor shall ensure, when in the patient‟s home, that its employees and agents shall in<br />

the performance <strong>of</strong> this framework comply with all relevant health and safety policies and working<br />

practices in force within the Purchasing Authority from time to time (including without limitation<br />

smoking and alcohol consumption policies).<br />

9. Holiday Service<br />

9.1 The Contractor will be required in exceptional circumstances to provide additional supplies to<br />

cover patient holidays and travel away from home. The supplier should ensure it is clear whether<br />

this can be provided free <strong>of</strong> charge. Where this is not feasible, details <strong>of</strong> the approximate cost <strong>of</strong><br />

a holiday service should be identified. The holiday service should be able to deliver and/or<br />

arrange all medicines, including third party ancillaries and equipment. A local contact name or<br />

number in case <strong>of</strong> queries should be identified. The Contractor is also required to comply with<br />

the NHMC's UK specification on holiday services. All subcontractors must comply with these<br />

terms.<br />

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1. The dispensing process<br />

© Crown Copyright 2011<br />

Specification document for Homecare <strong>Medicines</strong> –<br />

Product Prescribing and Dispensing<br />

1.1 All prescriptions must be signed by a legally authorised prescriber and screened and validated by the<br />

appropriate clinical pharmacist at the Purchasing Authority.<br />

1.2 The product and/or medicine must be dispensed and labelled in accordance with current legislation by the<br />

Contractor. The Contractor must supply examples <strong>of</strong> current labels before the adjudication meeting.<br />

1.3 All prescriptions must be additionally clinically checked by a registered pharmacist at the Contractors<br />

premises and undergo final dispensing accuracy checks by a registered pharmacist or registered<br />

technician.<br />

1.4 The Contractor must have documented procedures for batch tracing and to facilitate batch recall. This<br />

must be implemented and maintained in line with MHRA guidance.<br />

1.5 Contractors must supply all products and medicines as agreed.<br />

1.6 The Contractor must supply all dispensed licensed product and/or medicine with a full manufacturer<br />

patient information leaflet<br />

1.7 It is the responsibility <strong>of</strong> the Contractor to put right any failure to dispense the full supply required within a<br />

timescale that ensures the patient has their required dosage at all times. The Contractor must show<br />

evidence <strong>of</strong> contingency arrangements and processes in the event <strong>of</strong> a short-fall in supplies.<br />

1.8 All dispensed product and/or medicine supplied to patients by the Contractor must have a shelf life which<br />

is appropriate to the duration <strong>of</strong> treatment.<br />

1.9 The pharmacist employed/engaged by the contractor has the legal responsibility <strong>of</strong> ensuring that the<br />

patient has adequate information with respect to the dispensed medicine. Patient information can be given<br />

by the dispensing pharmacist, purchasing authority or other healthcare worker who has appropriate<br />

pr<strong>of</strong>essional training. The pr<strong>of</strong>essional responsibilities should be known to all parties.<br />

2. Product and/or medicine manufacture<br />

2.1 For blood products and unlicensed medicinal products, records <strong>of</strong> supply, including batch number and<br />

expiry date must be kept by the Contractor for all patients, for the statutory period by the Contractor. The<br />

Purchasing Authority will share its unlicensed medicines policy which the contractor must comply with.<br />

3. Packaging and labelling requirements<br />

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3.1 All product and/or medicine supplied by the contractor against prescription shall be packaged for each<br />

patient and shall be clearly individually labelled with the name or unique patient identifier <strong>of</strong> the patient,<br />

date <strong>of</strong> dispensing and delivery date.<br />

3.2 The Contractor will comply with the General Pharmaceutical Council (GPhC) Standards for home delivery<br />

<strong>of</strong> product and/or medicine or machines and will ensure the integrity <strong>of</strong> the product is maintained<br />

throughout the delivery process.<br />

3.3 Before dispatch the Contractor should ensure that the weight <strong>of</strong> any package over 5kg is clearly specified<br />

on the external packaging <strong>of</strong> the product and/or medicine.<br />

3.4 Contractors must adhere to MHRA and NPSA guidance 'Best Practice Guidance on the Labelling and<br />

Packaging <strong>of</strong> Medicine or Product‟. This guidance is subject to review and is re-issued annually.<br />

3.5 The Contractor must ensure that all product and/or medicine are stored, transported and delivered in a<br />

clean condition in accordance with those specified by the product license holder and manufacturer. The<br />

patient reserves the right to return and/or reject goods which, upon inspection, after delivery, are found to<br />

be in a damaged condition. The reasons for any faulty or spoiled products will be notified by the<br />

Contractor to the Purchasing Authority in writing within 24 hours <strong>of</strong> the complaint or sooner where deemed<br />

appropriate<br />

3.6 The Contractor must ensure that packs are sealed as appropriate.<br />

4. Product and/or medicine recall<br />

4.1 In the event <strong>of</strong> the goods being recalled, initiated by the manufacturer <strong>of</strong> the goods, the Secretary <strong>of</strong> State<br />

for <strong>Health</strong> or MHRA (or any such similar regulatory body), the Contractor shall, without delay arrange for<br />

the collection <strong>of</strong> such goods and credit the Purchasing Authority for any goods delivered but unused by<br />

the patient including part-used product and/or medicine.<br />

4.2 The Contractor must report the outcomes to the Purchasing Authority <strong>of</strong> all product and/or medicine<br />

recalls that may affect the product and/or medicine included in this framework, whether any faulty batches<br />

have been found or not.<br />

4.3 The Contractor should recover any expenses associated from the manufacturer.<br />

4.4 Product and/or medicine within the expiry date which have spoiled as a consequence <strong>of</strong> the manufacturing<br />

process or poor packaging will be withdrawn.<br />

4.5 Any spoiled product and/or medicine will be uplifted with patient consent, from their home, by the<br />

Contractor by the next working day at no cost to the Purchasing Authority.<br />

5. Quality control, COSHH and issues<br />

5.1 The Contractor shall operate and maintain a quality control monitoring system which meets the<br />

requirements <strong>of</strong> the MHRA and is approved by the Purchasing Authority and make available to Purchasing<br />

Authority on demand the results <strong>of</strong> such quality control monitoring. Please provide evidence <strong>of</strong> a suitable<br />

system being in place e.g. ISO 9001:2008, MHRA guidance note 14.<br />

5.2 The Contractor shall operate and maintain compliance in relation to environmental standards<br />

(ISO 14001 ).<br />

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5.3 The Contractor shall reply within 24 hours in writing to all enquires and complaints by the Purchasing<br />

Authority relating to the quality, performance and availability <strong>of</strong> the goods notwithstanding that the grounds<br />

for such enquiry or complaint may be inherent in the specification.<br />

6. Product and/or medicine licensing<br />

6.1 Each party‟s rights and obligations arising in connection with this order shall be suspended unless and<br />

until the Contractor can demonstrate to the Purchasing Authority‟s satisfaction that:<br />

the Contractor has a valid MHRA wholesaler dealer license and/or is registered with the General<br />

Pharmaceutical Council (GPhC);<br />

the goods have a valid product licence awarded by the MHRA or EMEA applicable to all<br />

categories <strong>of</strong> the goods; and<br />

the goods have been supplied in accordance with current legislation and if such goods are<br />

medical devices that they are CE marked.<br />

7. Product and/or medicine purchasing by Homecare Contractor<br />

7.1 The Contractor must seek agreement with manufacturers and wholesalers to provide product and/or<br />

medicine at the Purchasing Authority framework prices.<br />

7.2 The Purchasing Authority is responsible for ensuring that the Contractor has updated framework prices<br />

throughout the duration <strong>of</strong> the framework period.<br />

7.3 The Purchasing Authority will inform the Contractor <strong>of</strong> any and all start dates <strong>of</strong> new prices if frameworks<br />

are re-negotiated with manufacturers. Product and/or medicine provided by manufacturers or wholesalers<br />

to the Contractor for the use <strong>of</strong> patients <strong>of</strong> the Purchasing Authority under this framework are not for<br />

resale by the Contractor to any third party.<br />

7.4 All new product and/or medicine that become available during the framework period are to be <strong>of</strong>fered to<br />

the Purchasing Authority at framework price, i.e. the same level <strong>of</strong> discount as all awarded product and/or<br />

medicine on the framework, after prior approval <strong>of</strong> the Purchasing Authority.<br />

8. Product and/or medicines liability<br />

8.1 The Contractor shall ensure that they comply with the requirements <strong>of</strong> all relevant legislation, Codes <strong>of</strong><br />

Practice and guidance relating to good and correct practice and particularly in relation to product liability at<br />

Common Law and under Statute - such as the provisions <strong>of</strong> the Consumer Protection Act 1987.<br />

8.2 The Contractor will be responsible for the ordering, receipt, control and payment for all product and/or<br />

medicine from nominated Contractors and will be responsible for the maintenance <strong>of</strong> adequate stock<br />

levels to satisfactorily meet the requirements <strong>of</strong> this framework.<br />

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© Crown Copyright 2011<br />

Specification document for Homecare <strong>Medicines</strong> –<br />

Equipment and Ancillaries<br />

1. Provision <strong>of</strong> equipment and maintenance<br />

1.1 The Contractor must provide and pay for all equipment required for the safe and effective storage<br />

and administration <strong>of</strong> the medication except where the Purchasing Authority has requested the<br />

use <strong>of</strong> its own equipment.<br />

1.2 Where servicing and maintenance are required by the Purchasing Authority for its own<br />

equipment, the maintenance service will be fully comprehensive. The Terms and Conditions<br />

applicable to any Maintenance Contracts arising as a result <strong>of</strong> this purchase are „NHS Conditions<br />

<strong>of</strong> Contract for the Maintenance <strong>of</strong> Equipment‟ July 2007. Suppliers should complete the<br />

enclosed maintenance schedule detailing the service they intend to <strong>of</strong>fer.<br />

1.3 All equipment provided by the Contractor should come with a complete set <strong>of</strong> data sheets with<br />

clear instructions for use.<br />

1.4 The Contractor will possess current GMP certification or CE accreditation if equipment is to be<br />

supplied in a sterile condition. The Contractor must be registered to ISO 9001:2000.<br />

1.5 The Contractor will be required to take responsibility for servicing, maintenance and emergency<br />

support for all equipment used to provide the treatment.<br />

1.6 Where replacement equipment is required, the Contractor will provide this to the patient in a time<br />

frame agreed with the Purchasing Authority based on the clinical needs <strong>of</strong> the patient.<br />

1.7 Any modifications to equipment which affects its operation will be accompanied by additional<br />

training for staff and patients as appropriate as requested by the Purchasing Authority and<br />

provided by the Contractor at no extra cost.<br />

1.8 The Purchasing Authority reserves the right to state which suppliers and supply route the<br />

Contractor will use to obtain equipment and consumables for the treatment <strong>of</strong> their patients.<br />

1.9 The Contractor will be responsible for providing a complete maintenance service for equipment<br />

used by patients at home. The Contractor will put into place a protocol to ensure that the<br />

maintenance provided satisfactorily meets the Purchasing Authority‟s and equipment<br />

manufacturer's requirements. The equipment supplier may provide the maintenance service<br />

directly or may liaise with the Contractor to ensure that maintenance and emergency provision <strong>of</strong><br />

equipment is efficiently managed.<br />

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1.10 Syringe drivers and infusion pumps will be serviced at annual intervals. A loan-equipment<br />

replacement option will be provided for equipment removed from the patients home for repair,<br />

testing or periodic servicing.<br />

1.11 Repairs will be performed or replacement equipment provided by the Contractor to the patient in<br />

a time frame agreed with the Purchasing Authority based on the clinical needs <strong>of</strong> the patient <strong>of</strong> a<br />

fault being reported to them. Such a loan shall be deemed to be a Contract for the Hire <strong>of</strong> Goods<br />

as defined by section 6 <strong>of</strong> The Supply <strong>of</strong> Goods and Services Act 1982.<br />

1.12 The Contractor should provide a manual to include step by step instruction on how to use the<br />

equipment. It should give problem-solving help lines and the name and telephone number <strong>of</strong> the<br />

co-ordinator should be provided. DVD and/or video and/or audio tape to aid training, in the<br />

patient‟s home are also useful options. Technical literature <strong>of</strong> equipment is also to be provided if<br />

necessary.<br />

1.13 Where appropriate there should be a separate instruction manual for children.<br />

1.14 The Contractor should provide a check list so that an appropriate clinician can assess the patient<br />

as competent to use the equipment and the patient can countersign. A copy <strong>of</strong> this will be kept in<br />

the patients notes.<br />

1.15 All information should be regularly updated in order to reflect any developments and/or<br />

innovations in delivery systems and equipment.<br />

2. Refrigeration<br />

2.1 The Contractor will supply a suitable medicines refrigerator, which has been PAT tested and<br />

should be installed by the Contractor into the patient‟s home prior to the first scheduled delivery<br />

<strong>of</strong> medicines. If there is no fridge provided because the volume <strong>of</strong> refrigerated product is deemed<br />

too small by the Purchasing Authority to warrant its own fridge, then the patient must need to<br />

have suitable space in their own domestic fridge and be trained on how to store the product and<br />

monitor temperatures according to the manufacturer‟s instructions by the Contractor. Appendix<br />

eight example refrigerator specification.<br />

2.2 A permanent record <strong>of</strong> the refrigerator temperature must be made available to the Purchasing<br />

Authority and will be noted each time a delivery is made together with any details or action taken<br />

or instructions given to maintain the temperature within acceptable limits <strong>of</strong> any fridge that has<br />

been provided. If the temperature <strong>of</strong> the refrigerator falls outside the range <strong>of</strong> +2 degrees C to +8<br />

degrees C, the Contractor will be responsible for advising the Purchasing Authority and seeking<br />

authorisation on the continued use <strong>of</strong> the medical product and the refrigerator.<br />

2.3 Where the Contractor has supplied a refrigerator and where the integrity <strong>of</strong> the product is<br />

compromised due to the failure <strong>of</strong> the Contractor to service and maintain the refrigerator (if<br />

supplied), the Contractor will be responsible for stock replenishment at no additional charge to<br />

the Purchasing Authority within a timescale that ensures the patient has the required product to<br />

continue treatment.<br />

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3. Third Party Ancillary Items<br />

3.1 Ancillary items will be determined by the clinical needs <strong>of</strong> the patient and will reflect the local<br />

clinical practice <strong>of</strong> the Purchasing Authority.<br />

3.2 Ancillary requirement forms will be completed by the Purchasing Authority at the beginning <strong>of</strong> a<br />

patients home delivery inclusion. These will be sent to the Contractor who will be responsible for<br />

checking ancillary product requirements with the patient in the first pre-delivery call. It is the<br />

Contractor‟s responsibility to check stock levels and replenish the patient‟s additional<br />

requirements for ancillary products on a regular basis.<br />

3.3 The Contractor will be responsible for the ordering, receipt, control and payment for all ancillary<br />

products from agreed suppliers, and as agreed with the Purchasing Authority, and will be<br />

responsible for the maintenance <strong>of</strong> adequate stock levels to satisfactorily meet the requirements<br />

<strong>of</strong> this framework. The Contractor will ensure that adequate shelf-life remains on products<br />

delivered to patient‟s homes.<br />

© Crown Copyright 2011<br />

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1. Training<br />

© Crown Copyright 2011<br />

Specification document for Homecare <strong>Medicines</strong> –<br />

Training and Education for Staff and Patients<br />

1.1 Contractors should supply information on the level <strong>of</strong> knowledge and expertise on the medicines<br />

and equipment used in the clinical specialities <strong>of</strong> their staff involved in homecare services<br />

provision, including the methods and frequency <strong>of</strong> training and accreditation used. The<br />

Purchasing Authority should check the contractors training manuals and accreditation status to<br />

ascertain they are equivalent <strong>of</strong> the Purchasing Authority. Any gaps indentified need to be<br />

addressed.<br />

1.2 Where the Purchasing Authority changes it's provider <strong>of</strong> medicine or device, the Purchasing<br />

Authority may require the Contractor to provide the retraining <strong>of</strong> patient's in the use <strong>of</strong> the new<br />

medicines or device. If the change <strong>of</strong> medicine or device is enforced upon the Purchasing<br />

Authority by the manufacturer, <strong>of</strong> the medicine or device, then the Contractor should seek the retraining<br />

costs from the manufacturer.<br />

1.3 Contractors must agree with the Purchasing Authority a training and education plan detailing the<br />

implementation <strong>of</strong> the new framework. This will include timescales, number <strong>of</strong> company resource<br />

available and a detailed training programme. This should be completed in line with the framework<br />

start date.<br />

1.4 Training <strong>of</strong> patients and/or carers will be agreed by the Purchasing Authority and Contractor and<br />

will be designed according to individual need. In certain circumstances training may be initiated<br />

by the Purchasing Authority and continuing education and training devolved to the Contractor.<br />

1.5 Prior to hospital discharge, there should be a facility if requested, whereby the Contractor has<br />

nursing personnel trained to appropriate agreed standards. Such personnel should be available<br />

to do patient and/or carer education at ward level or at the patients home throughout the<br />

framework period and should be prepared to undertake further training until patient and/or carer<br />

are competent. If this level <strong>of</strong> competence is not attained then self administration should not be<br />

considered. There should be signed agreement <strong>of</strong> training delivered by both parties.<br />

1.6 If a nursing service is required by the Purchasing Authority, training <strong>of</strong> the Contractors clinical<br />

nurse specialist will be undertaken by the Purchasing Authority. This training should include level<br />

three clinical knowledge to ensure competence in Trust protocols. All clinical nurse specialists<br />

employed by the Contractor must be deemed competent by the specialist nurse within the<br />

Purchasing Authority before commencing delivery <strong>of</strong> hands on patient care.<br />

1.7 The Contractor must provide therapy specific on-going training and education support. This will<br />

include:<br />

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© Crown Copyright 2011<br />

Delivery <strong>of</strong> training packages to the Contractor's and Purchasing Authority's new staff;<br />

Refresher courses for existing staff;<br />

Provide access to advice and/or support on to patients;<br />

Regular training focusing on Audit and new Developments in the therapy;<br />

Educational materials which support the current use <strong>of</strong> their products and services.<br />

These would include product data (which is regularly updated), computer generated<br />

slides, videos, and interactive learning tools. This should be available free on loan;<br />

Instruction manuals translated into various languages, in pictorial format, and large print<br />

where appropriate;<br />

Separate instruction manual and training programme for children where appropriate;<br />

Check list so that the patient and/or carer can self-evaluate whether he or she has been<br />

appropriately trained. A copy <strong>of</strong> this will be placed in patients notes;<br />

Supply <strong>of</strong> results <strong>of</strong> regular regional and/or national audits for benchmarking purposes.<br />

2. Patient and carer education and information<br />

2.1 Contractors should provide and demonstrate how they are able to provide communication tools<br />

such as leaflets, brochures, and other media to patients, carers, and staff, samples to be<br />

provided.<br />

2.2 Contractors should include how they will ensure patient confidentiality and data protection is<br />

respected in all aspects <strong>of</strong> the homecare services provided when training is received by their<br />

staff.<br />

2.3 Should a patient and/or carer not be fluent in English, information should be provided in their own<br />

language. Contractors should indicate which languages they are able to provide this service for at<br />

no extra cost.<br />

2.4 The Contractor will provide each patient with a „welcome pack‟ that has been agreed with the<br />

Purchasing Authority, detailing useful and helpful information, as a minimum this should include<br />

details on:<br />

Welcome – role <strong>of</strong> the driver and provider<br />

Therapy information – description <strong>of</strong> service and items they will receive<br />

Training and support – help cards<br />

Ordering and delivery information – stock management, customer care teams, what to do<br />

if…. driver details<br />

Contacts – out <strong>of</strong> hours<br />

Holiday and Travel service<br />

Glossary <strong>of</strong> terms.<br />

Prescription Queries<br />

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1. Nursing Services<br />

© Crown Copyright 2011<br />

Specification document for Homecare <strong>Medicines</strong> –<br />

Nursing Services<br />

1.1 The standard <strong>of</strong> nursing care provided will be comparable in every way to the care that a patient would<br />

expect to receive in a hospital setting.<br />

1.1 This guidance gives an outline <strong>of</strong> the minimum nursing services required to treat a home patient, however<br />

the specific care will be dependant on the therapy and speciality.<br />

1.2 The purchasing authority will identify and authorise the requirement <strong>of</strong> nursing services as part <strong>of</strong> the<br />

approval process.<br />

1.3 The Contractor must employ suitably qualified nursing staff for adults and children as appropriate, this<br />

level <strong>of</strong> care will be agreed with the Purchasing Authority.<br />

1.4 The Contractor must ensure that the nursing staff they employ have been legally checked specifically:<br />

The Nurse has a current NMC (Nursing and Midwifery Council) registration. The Nurse has sufficient<br />

experience and skills, and/or has received sufficient training, as applicable, to enable him/her to carry out<br />

his/her duties in the delivery <strong>of</strong> the Services.<br />

As a registered nurse, the Nurse is subject to the Nursing and Midwifery Council Code.<br />

The Nurse is subject to a satisfactory Criminal Record Bureau (enhanced disclosure) checks and with<br />

effect from 1 July 2010 the Nurse will be registered with the Independent Safeguarding Authority.<br />

The Nurse is subject to satisfactory pre-employment medical checks and holds a valid Fitness to Practice<br />

certificate issued by an independent occupational health provider.<br />

The Nurse should have a personal portfolio with a summary <strong>of</strong> their verified qualifications and Personal<br />

Identification Number issued by the NMC as well as, CRB and pre-employment medical screening,<br />

generic training and competency assessments/validations available for inspection.<br />

1.5 The contractor must facilitate CPD for all employed nursing staff and must demonstrate for all staff:<br />

job specifications<br />

orientation and induction<br />

evidence <strong>of</strong> CPD<br />

individual‟s responsibility towards <strong>Health</strong> and Safety.<br />

1.6 The Contractor must ensure the nursing staff have been assessed as competent in:<br />

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phlebotomy<br />

knowledge <strong>of</strong> phlebotomy in relation to specific medication – blood tests throughout the course <strong>of</strong><br />

treatment<br />

cannulation<br />

intravenous therapy in line with RCN and NMC guidelines<br />

anaphylaxis management/ basic life-support<br />

relevant equipment management<br />

aseptic technique<br />

adult and paediatric management which is evidence based in line with NICE guidance<br />

side effect management<br />

disease awareness<br />

specific therapies as prescribed.<br />

1.7 Contractors must ensure nursing staff have knowledge <strong>of</strong> clinical governance and be committed to clinical<br />

supervision, customer care and complaints handling.<br />

1.8 Contractors must ensure that nursing staff are given copies <strong>of</strong> hospital and PCT policies and comply to work<br />

within them including:<br />

<strong>Medicines</strong> Policy<br />

Anaphylaxis Management Guidelines<br />

Infection Control Manual<br />

Policy for consent to examination or treatment<br />

<strong>Health</strong> and safety<br />

Records Management Policy<br />

Zero tolerance and policy for the withdrawal <strong>of</strong> care<br />

Lone Worker Policy (incorporating working alone care and chaperoning)<br />

Resuscitation Policy and Guidelines<br />

Confidentiality<br />

Data protection<br />

Acceptance <strong>of</strong> gifts<br />

Adverse incident reporting policy<br />

1.9 Contractors must ensure that the risk management policy is calculated in collaboration with the Hospital/<br />

PCT Clinical Governance <strong>Department</strong>s and be deemed to be <strong>of</strong> an acceptable risk score.<br />

10.1 Example <strong>of</strong> a Rick Management Tool<br />

10.2<br />

10.3 RISK MANAGEMENT TOOL<br />

10.4 IMPACT<br />

10.5 LIKELIHOOD<br />

© Crown Copyright 2011<br />

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10.6 2- MINOR<br />

10.7<br />

10.8 2- UNLIKELY 10.9 4- Acceptable Risk<br />

10.10<br />

10.11 Potential Risks- Patient safety<br />

Anaphylaxis All nursing staff involved in the administration <strong>of</strong> will be trained in the treatment <strong>of</strong><br />

anaphylaxis and will act in accordance with the agreed anaphylaxis policy. Anaphylaxis kits<br />

will be replaced yearly.<br />

MRSA Patient will receive either a daily cannula or the peripheral cannula will not stay insitu for<br />

greater than 72 hours, which falls within infection controls guidelines.<br />

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Intravenous<br />

Cannulation<br />

10.12<br />

© Crown Copyright 2011<br />

The nurse will remain with the patient for the duration <strong>of</strong> the infusion. The nurse competent<br />

in cannulation and IV administration will observe the cannula forsigns <strong>of</strong> tissuing regularly.<br />

If the nurse suspects tissuing they will remove the cannula immediately. The nurse will not<br />

attempt more than 3 unsuccessful cannulations.<br />

Training- All nurses must complete a cannulation-training course and be have level <strong>of</strong><br />

competence assessed.<br />

Infection Control Disposable sterile dressing packs will be used in the home setting to reduce the chance <strong>of</strong><br />

infection.<br />

10.13<br />

It is considered best practice to use volumetric pump to regulate the infusion flow rate. This<br />

will wiped with 70% alcohol between each patient contact as infection control procedures.<br />

Blood spillages- In the unlikely event that a blood spillage occurs, the nurse must act in<br />

accordance with the infection control policy.<br />

Disposal <strong>of</strong> sharps The nurse will carry a sharps container with them and remove this from the patient‟s home<br />

following each infusion in accordance with infection control policy.<br />

Cardiac arrest In the unlikely event <strong>of</strong> cardiac arrest the nurse will carry a mobile phone to call 999. The<br />

nurse will then start CPR, using a mouthpiece in accordance with the resuscitation policy.<br />

All nurses must attend a yearly mandatory CPR training update.<br />

10.14 Potential risks- staff safety<br />

Violent patient The nurse must act in accordance with the Zero tolerance and policy for the withdrawal <strong>of</strong><br />

care.<br />

Buddy system It is considered best practice to ensure that another member <strong>of</strong> staff knows where the nurse<br />

Transportation <strong>of</strong><br />

drug<br />

is at all times.<br />

The nurse will collect the drug in person store in a secure facility.<br />

Contractors must outline transparent procedures for handling <strong>of</strong> concerns or complaints with full<br />

details on how to contact their Medical Director<br />

Contractors must maintain pr<strong>of</strong>essional indemnity (medical malpractice) insurance and encourage nursing staff to<br />

ensure they are pr<strong>of</strong>essionally indemnified personally by membership <strong>of</strong> an appropriate union such as The Royal<br />

College <strong>of</strong> Nursing.<br />

Contractors must ensure that nursing staff deliver clinical procedures and services<br />

in accordance with written protocols agreed with the hospital/ PCT.<br />

Contractors will ensure that the Hospital / PCT designate an appropriate suitably medically qualified Practitioner to<br />

be available for the Nurse to contact at all times whilst the Nurse is involved in delivery <strong>of</strong> the service. The named<br />

hospital / PCT Designated Practitioner will obtain in advance any approvals required for delivery <strong>of</strong> any <strong>of</strong> the<br />

services. They will also ensure that the Nurse is provided with adequate facilities and information for the<br />

performance <strong>of</strong> the services in accordance within agreed protocols and parameters.<br />

Contractors must ensure that Nursing staff are responsible to the Hospitals/ PCT Designated<br />

Practitioner, in respect <strong>of</strong> clinical matters.<br />

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The Hospital / PCT must ensure that all patients are informed that their personal information may be shared with<br />

other healthcare pr<strong>of</strong>essionals and may be used to support clinical audit for the purpose <strong>of</strong> assuring and monitoring<br />

the quality <strong>of</strong> their treatment.<br />

Contractors must use its best endeavours to ensure that any services are performed at the times and venues<br />

agreed between the parties and shall give as much notice as reasonably practicable if for any reason they are<br />

unable to deliver any services at times and venues agreed between the parties.<br />

Contractors must ensure that in accordance with NMC code <strong>of</strong> conduct the Nurse will keep confidential all patient<br />

identifiable data to which the Nurse may have access during the provision <strong>of</strong> the Services. The Nurse will deal with<br />

all confidential information in accordance with any reasonable policy <strong>of</strong> the Recipient in accordance with clause 11<br />

hereunder and in accordance with the provisions <strong>of</strong> the Data Protection Act 1998.<br />

Contractors must ensure that the Nurse will not remove any patient identifiable information from the Recipient‟s<br />

premises at any time other than as set out in the service documentation. The Nurse may report anonymised<br />

aggregated data to other parties only if the Nurse has obtained written consent from the patient to the<br />

anonymisation <strong>of</strong> their data and the reporting <strong>of</strong> anonymised aggregated data in accordance with a consent form.<br />

The contractor will ensure that they use only anonymised data so that no individual patient or Trust can be<br />

identified by name or other characteristics in publications or in educational and/or promotional materials and that all<br />

data will be processed in accordance with the Data Protection Act 1998.<br />

Contactors will ensure that the Nurse will obtain informed consent from the patients prior to participation in the<br />

service and that the Nurse will ensure that patients are clearly informed that they have the right to refuse such<br />

consent and participation.<br />

2. On Call service<br />

2.1 The Contractor will provide an out <strong>of</strong> hour‟s service. Such a service will support the purchasing authority‟s<br />

patients where circumstances dictate there are issues that need resolution. Such a service will also make<br />

use <strong>of</strong> a variety <strong>of</strong> forms <strong>of</strong> communication technology that will be specified in the out line <strong>of</strong> the service.<br />

2.2 The hours <strong>of</strong> contact should be from:<br />

Nursing support 7:00am to 10:00pm, 7 days a week (including bank holidays).<br />

© Crown Copyright 2011<br />

It is important to realise that the service hours <strong>of</strong> a nurse may extend beyond this in attending to<br />

a patients needs.<br />

Administration support 8:00am to 6:00pm, 5 days a week excluding bank holidays.<br />

3. Nursing support services<br />

3.1 Patient support:<br />

Nurses will have the duty to advise over the telephone or provide attendance at patients homes.<br />

3.2 Nurses have a responsibility to report to the Purchasing Authority immediately <strong>of</strong> any errors or adverse<br />

events. The Contractor must ensure clear guidelines and procedures are developed and communicated<br />

to all nurses to follow if any adverse reactions occur.<br />

May 2011<br />

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© Crown Copyright 2011<br />

May 2011<br />

48


Award criteria and weightings - details for adjudication purposes<br />

Framework Agreement for a Home Delivery Service -<br />

XXXXXXX<br />

OJEU Reference<br />

Offer Reference<br />

Ref Indicators Weight Reference Supplier A Supplier B Supplier C Supplier D Supplier E Supplier F Supplier G<br />

Supplier infrastructure <strong>of</strong> home delivery<br />

company<br />

SUP1 Description <strong>of</strong> service - premises,<br />

structure, company pr<strong>of</strong>ile, contact<br />

names, confidentiality, previous<br />

homecare experience, implementation<br />

programme, communication leaflets<br />

SUP2 Experience <strong>of</strong> HIV homecare delivery<br />

SUP3 Training and education <strong>of</strong> staff -<br />

methods and frequency <strong>of</strong> training and<br />

accreditation used, records <strong>of</strong> training<br />

[5a_12.1]<br />

[5b_4.1]<br />

[5b_4.2]<br />

[5d_2.3]<br />

[5d_2.4]<br />

[5d_2.5]<br />

[5e_1.1]<br />

[5e_2.1]<br />

[5b_4.3]<br />

[5b_4.4]<br />

[5b_4.5]<br />

[5b_4.6]<br />

[5b_7.1]<br />

[5b_7.2]<br />

[5d_1.1]<br />

[5d_1.2]<br />

© Crown Copyright 2011 May 2011<br />

49


SUP4 Method <strong>of</strong> recruiting / registering<br />

patients - patient consent form,<br />

registering patients, patient<br />

confidentiality<br />

SUP5 Adherence to legal and advisory<br />

practices e.g. COSHHProduct licensing<br />

and product liability.EU law<strong>Health</strong> &<br />

Safety<br />

SUP 6 Member <strong>of</strong> the National clinical<br />

homecare association (NCHA)<br />

Supplier infrastructure Total<br />

Quality Assurance<br />

QA1 Performance standards i.e. Quality std,<br />

service performance, complaints,<br />

contingency planning, disposal, patient<br />

survey<br />

[5d_1.3]<br />

[5a_5.2]<br />

[5a_5.3]<br />

[5a_5.4]<br />

[5a_5.5]<br />

[5a_5.6]<br />

[5a_8.3]<br />

[5a_10.1]<br />

[5d_2.2]<br />

[5a_13.1]<br />

[5c_5.1]<br />

[5b_3.6]<br />

[5b_8.1]<br />

[5c_7.1]<br />

[5a_6.1]<br />

[5b_1.6]<br />

[5b_3.5]<br />

[5b_6.6]<br />

[5b_7.3]<br />

© Crown Copyright 2011 May 2011<br />

50


QA2 Prescription process, validation, length,<br />

records, errors<br />

QA3 Audit i.e. pro<strong>of</strong> del, service reporting,<br />

complaints, contingency planning<br />

Quality Assurance Total<br />

Storage and Distribution<br />

DIST1 Delivery <strong>of</strong> medicines - post, vehicle,<br />

courier, emergency, failures to deliver,<br />

lost medicines, traceability, product<br />

[5c_1.7]<br />

[5c_2.2]<br />

[5c_2.3]<br />

[5c_3.8]<br />

[5c_3.7]<br />

[5c_4.1]<br />

[5c_4.2]<br />

[5c_4.3]<br />

[5a_9.3]<br />

[5c_1.1]<br />

[5c_1.2]<br />

[5c_1.3]<br />

[5c_2.2]<br />

[5b_5.1]<br />

[5b_6.4]<br />

[5b_1.3]<br />

[5b_6.5]<br />

[5b_3.4]<br />

[5a_5.7]<br />

[5a_5.9]<br />

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51


ecall, cold chain, waste disposal<br />

[5b_1.1]<br />

[5b_1.2]<br />

[5b_1.4]<br />

[5b_1.5]<br />

[5b_1.8]<br />

[5b_2.1]<br />

[5b_2.2]<br />

[5b_3.2]<br />

[5b_3.5]<br />

[5b_4.7]<br />

[5b_4.8]<br />

[5b_4.9]<br />

[5b_5.2]<br />

[5b_5.4]<br />

[5b_5.5]<br />

[5b_5.6]<br />

[5b_5.8]<br />

[5c_1.4]<br />

[5c_1.6]<br />

[5c_1.8]<br />

[5c_1.9]<br />

[5c_1.10]<br />

[5c_1.11]<br />

[5c_3.1]<br />

[5c_3.2]<br />

[5c_3.3]<br />

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DIST2 Drug purchasing by Homecare supplier<br />

- agreement from manufacturer,<br />

access/updating contract pricing<br />

Storage and Distribution Total<br />

Customer Services<br />

CUST<br />

Provision <strong>of</strong> Data<br />

1<br />

CUST<br />

2<br />

CUST<br />

3<br />

Customer services, communication,<br />

free phone help lines, response time<br />

Invoicing and payment - invoice<br />

queries, payment method, discounts, e- 5<br />

[5c_3.5]<br />

[5c_3.6]<br />

[5c_6.1]<br />

[5c_6.2]<br />

[5c_6.3]<br />

[5a_8.1]<br />

[5a_8.2]<br />

[5a_8.3]<br />

[5a_8.4]<br />

[5b_6.3]<br />

[5a_11.1]<br />

[5a_11.2]<br />

[5b_6.3]<br />

[5b_6.4]<br />

[5b_6.5]<br />

[5b_7.2]<br />

[5b_1.10]<br />

[5b_5.4]<br />

[5d_2.1]<br />

[5a_9.1]<br />

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53


commerce arrangements, emergency<br />

delivery<br />

Customer Services Total 18<br />

Price Total Score<br />

Homecare Service Total 100<br />

[5a_9.2]<br />

[5a_9.3]<br />

[5b_1.2]<br />

[5c_6.4]<br />

[5c_7.2]<br />

Offer<br />

schedules<br />

0 0 0 0 0 0 0<br />

© Crown Copyright 2011 May 2011<br />

54


<strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong> homecare medicine team.<br />

<strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong><br />

Castle View House<br />

East Lane<br />

Runcorn<br />

WA7 2AA<br />

Liz Payne<br />

Category Manager<br />

Tel. 01926 857313<br />

Liz.Payne@cmu.nhs.uk<br />

Carol Clark<br />

Category Specialist<br />

Tel. 01282 850672<br />

Carol.Clark@cmu.nhs.uk<br />

Simon Perkins<br />

Category Specialist<br />

Tel. 01928 794601<br />

Simon.Perkins@cmu.nhs.uk<br />

Karen Bell<br />

Sourcing Specialist<br />

Tel. 01928 794615<br />

Karen.Bell@cmu.nhs.uk<br />

© Crown Copyright 2011<br />

May 2011<br />

55


Glossary <strong>of</strong> Terms<br />

Name Acronym Description<br />

Accredited checking<br />

Technician<br />

Appendix 1<br />

ACT Accredited checking technician jobs are<br />

similar to pharmacy technician jobs. While<br />

the latter receives the prescription, takes out<br />

the drugs from shelves and packs them, the<br />

former checks the dispensed prescription for<br />

its accuracy. Checking, labelling and packing<br />

have all become formal procedures and the<br />

accredited checking technician will be trained<br />

in all these in a pharmacy context.<br />

Benefits Tracking Tool BTT Benefits Tracking Tool. Integrated date<br />

warehouse and reporting tool providing<br />

stakeholders with a single point <strong>of</strong> access for<br />

their management information. Manages the<br />

performance <strong>of</strong> <strong>CMU</strong> framework agreements<br />

maximise compliance by NHS trusts to<br />

improve future estimates <strong>of</strong> framework<br />

agreement and product volumes and values.<br />

British Pharmacopoeia BP The British Pharmacopoeia (BP) is the<br />

authoritative collection <strong>of</strong> standards for UK<br />

medicines<br />

British Standard BS British Standards are produced by BSI British<br />

Standards, a division <strong>of</strong> BSI Group that is<br />

incorporated under a Royal Charter and is<br />

formally designated as the National Standards<br />

Body (NSB) for the UK.<br />

BS 7320 British standard specification for sharps<br />

containers<br />

Benefits Tracking Tool BTT BTT is an integrated data warehouse and<br />

reporting tool providing our stakeholders with<br />

a single point <strong>of</strong> access for their management<br />

Collaborative procurement<br />

hubs<br />

information.<br />

CPH‟s Collaborative procurement organisations<br />

within the NHS, generally referred to as<br />

collaborative procurement hubs (CPHs),<br />

commercial procurement collaborative (CPCs)<br />

or supply management confederations<br />

(SMCs), consist <strong>of</strong> NHS trusts and primary<br />

care trusts. These are normally within the<br />

same strategic health authority or regional<br />

boundary, collaborating to make the most<br />

effective procurement and supply chain<br />

decisions, in conjunction with <strong>CMU</strong> and other<br />

organisations including Office <strong>of</strong> Government<br />

Commerce (OGC) and Regional<br />

Developments Agencies, in order to provide<br />

best value for stakeholders within their<br />

respective health economies.<br />

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Contractor Someone whose business is to supply a<br />

particular service or commodity. Can be<br />

referred to as a supplier or an <strong>of</strong>feror<br />

CE Accreditation Declaration <strong>of</strong> conformity<br />

CE Mark CE marking when applied to any product or<br />

equipment indicates that the manufacturer or<br />

its authorised representative has declared that<br />

the product or equipment complies with all<br />

applicable European Directives. The principal<br />

function <strong>of</strong> the EU directives is to ensure free<br />

trade <strong>of</strong> goods within the European<br />

Community<br />

Compliance Compliance (or Adherence) is a medical term<br />

that is used to indicate a patient's correct<br />

following <strong>of</strong> medical advice. Most commonly it<br />

is a patient taking medication (drug<br />

compliance)<br />

Criminal Records Bureau CRB<br />

Delivery packaging Is any additional packaging that is not<br />

required by the patient following a treatment.<br />

<strong>Department</strong> <strong>of</strong> <strong>Health</strong> DH<br />

European <strong>Medicines</strong> Agency EMEA European agency for the evaluation <strong>of</strong><br />

medicinal products<br />

European Pharmacopoeia EP The European Pharmacopoeia (Ph. Eur.) <strong>of</strong><br />

the Council <strong>of</strong> Europe is a pharmacopoeia,<br />

listing a wide range <strong>of</strong> active substances and<br />

excipients used to prepare pharmaceutical<br />

products in Europe<br />

General Practitioner GP<br />

Good Manufacturing Practice GMP Good Manufacturing Practice (GMP) is<br />

defined as “That part <strong>of</strong> Quality Assurance<br />

which ensures that products are consistently<br />

produced and controlled to the quality<br />

standards appropriate to their intended use.”<br />

The principles and guidelines for GMP are<br />

stated in the Directive 2003/94/EC for<br />

medicinal products.<br />

Quality risk management ICH Q9 ICHQ9 is a document on quality risk<br />

management. The principles can be applied<br />

in connection with pharmaceutical<br />

development and preparation <strong>of</strong> the quality<br />

part <strong>of</strong> marketing authorisation dossiers<br />

Pharmaceutical Quality System ICH Q10 ICHQ10 is a document on pharmaceutical<br />

quality system and provides an example <strong>of</strong> a<br />

pharmaceutical quality system for the entire<br />

57<br />

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product lifecycle.<br />

Internal standards organisation ISO ISO 9001: 2008 - Quality management<br />

system<br />

Key performance indicators KPI‟S Key Performance Indicators are quantifiable<br />

measurements, agreed to beforehand, that<br />

reflect the critical success factors <strong>of</strong> an<br />

organisation<br />

Manufacturers Licence ML Medicinal products manufactured in the UK<br />

must be produced on a site that holds an<br />

appropriate Manufacturer's Licence (ML).<br />

<strong>Medicines</strong> and <strong>Health</strong>care<br />

Products Regulatory Agency<br />

<strong>Medicines</strong> Pharmacy and<br />

Industry Group<br />

MHRA An executive agency <strong>of</strong> the <strong>Department</strong> <strong>of</strong><br />

<strong>Health</strong>. Enhance and safeguard the health <strong>of</strong><br />

the public by ensuring that medicines and<br />

medical devices work and are acceptably<br />

safe. No product is risk-free. Underpinning all<br />

the work lie robust and fact-based judgements<br />

to ensure that the benefits to patients and the<br />

public justify the risks<br />

MPIG MPIG are responsible for the PPRS and<br />

report to DH Board who report to the<br />

Secretary <strong>of</strong> State.<br />

Multi disciplinary team Collaborative efforts <strong>of</strong> pr<strong>of</strong>essionals from<br />

different disciplines toward a common goal.<br />

Can be made up <strong>of</strong> Consultant's, Clinician's,<br />

Nurses, Pharmacists and <strong>Health</strong>care<br />

National Clinical Homecare<br />

Association<br />

National <strong>Health</strong> Service NHS<br />

National <strong>Health</strong> Service Quality NHS QA staff<br />

Assurance Staff<br />

<strong>Commercial</strong> <strong>Medicines</strong> <strong>Unit</strong><br />

(<strong>CMU</strong>)<br />

Workers.<br />

NCHA Represents and promotes the interests <strong>of</strong><br />

industries whose business is substantially to<br />

provide medical supplies and/or clinical<br />

services directly to patients in the community<br />

within an appropriate quality framework.<br />

Provide a forum for lobbying on issues that<br />

affect homecare. Set and debate policy<br />

decisions with the National Homecare<br />

Medicine Supply Committee and other<br />

relevant government bodies.<br />

<strong>CMU</strong> is an executive agency <strong>of</strong> the<br />

<strong>Department</strong> <strong>of</strong> <strong>Health</strong>. <strong>CMU</strong> work to ensure<br />

that the NHS in England makes the most<br />

effective use <strong>of</strong> its resources by getting the<br />

best possible value for money when<br />

purchasing goods and services. We enhance<br />

and safeguard the health <strong>of</strong> the public by<br />

ensuring that medicines and medical devices<br />

work and are acceptably safe. No product is<br />

risk-free. Underpinning all our work lie robust<br />

58<br />

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National Homecare <strong>Medicines</strong><br />

Committee<br />

National Institute for Biological<br />

Standards and Control<br />

National Pharmaceutical<br />

Supply Group<br />

and fact-based judgements to ensure that the<br />

benefits to patients and the public justify the<br />

risks<br />

NHMC Facilitated and managed by <strong>Commercial</strong><br />

<strong>Medicines</strong> <strong>Unit</strong>. NHMC formed to develop<br />

appropriate systems, policies and procedures<br />

in order to assist service users, service<br />

providers and patients.<br />

NIBSC The National Biological Standards Board<br />

(NBSB) is a non-departmental public body<br />

(NDPB) <strong>of</strong> the UK government. NIBSC<br />

provides independent testing <strong>of</strong> biological<br />

medicines for the UK market<br />

NPSG Provide advice to Chief Executive, <strong>CMU</strong>,<br />

concerning the cost effective purchasing and<br />

distribution <strong>of</strong> pharmaceutical products to the<br />

NHS in England. Acts as a focal point for the<br />

NHS for pharmaceutical issues <strong>of</strong> a national<br />

nature and provide pharmaceutical advice<br />

accordingly. Acts as a link between<br />

pharmacists and <strong>CMU</strong> at national level.<br />

Advise the <strong>Department</strong> <strong>of</strong> <strong>Health</strong> and<br />

pharmaceutical industry on significant<br />

commercial matters.<br />

Portable Appliance Testing PAT There is a legal obligation for many<br />

businesses and organisations to take<br />

precautions to ensure any electrical<br />

equipment is safe, maintained and fit for<br />

purpose. It has become common practice for<br />

PAT testing to be carried out as part <strong>of</strong> a<br />

regular system <strong>of</strong> maintenance and<br />

inspection.<br />

Purchasing Authority Secondary Care Trusts, Primary Care Trusts,<br />

Foundation Trusts, Collaborative Procurement<br />

Hubs and Confederations<br />

Pharmaceutical Price<br />

PPRS A British mechanism for determining the<br />

Regulation Scheme<br />

Pharmaceutical market Support<br />

Group<br />

prices the NHS pays for brand name drugs.<br />

PMSG Committee <strong>of</strong> pharmacists from England,<br />

Wales, Northern Ireland and Scotland. A<br />

representative from each purchasing group or<br />

division makes up the English representation.<br />

Provide strategic advice to the pharmaceutical<br />

industry and contracting groups. The PMSG<br />

use market intelligence including Phate<br />

analyses and licence and patent information<br />

Pharmex Pharmex collects and stores medicinal<br />

59<br />

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Regional Quality Control Regional QC<br />

Royal Pharmaceutical Society<br />

Great Britain<br />

product transaction usage and spend level<br />

details from trusts.<br />

RPSGB The Royal Pharmaceutical Society <strong>of</strong> Great<br />

Britain (RPSGB) is the statutory regulatory<br />

and pr<strong>of</strong>essional body for pharmacists and<br />

Pharmacy Technicians in England, Scotland<br />

and Wales.<br />

Serious Untoward incidents SUI‟s An SUI is in general terms something out <strong>of</strong><br />

the ordinary or unexpected, with the potential<br />

to cause serious harm and/or likely to attract<br />

public and media interest that occurs on NHS<br />

premises or in the provision <strong>of</strong> an NHS or a<br />

commissioned service<br />

Service Level Agreemen SLA A service level agreement (frequently<br />

abbreviated as SLA) is a part <strong>of</strong> a service<br />

contract where the level <strong>of</strong> service is formally<br />

defined. In practice, the term SLA is<br />

sometimes used to refer to the contracted<br />

delivery time (<strong>of</strong> the service) or performance.<br />

Sub-contractor A subcontractor is an individual or in many<br />

cases a business that signs a contract to<br />

perform part or all <strong>of</strong> the obligations <strong>of</strong><br />

another's contract. A subcontractor is hired<br />

by a general contactor (or prime contractor) to<br />

perform a specific takes as part <strong>of</strong> the overall<br />

project.<br />

<strong>Unit</strong>ed States Pharmacopoeia USP The <strong>Unit</strong>ed States Pharmacopoeia (USP) is<br />

an <strong>of</strong>ficial public standards–setting authority<br />

for all prescription and over–the–counter<br />

medicines and other health care products<br />

manufactured or sold in the <strong>Unit</strong>ed States.<br />

60<br />

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Patient Registration Form<br />

Appendix 2<br />

61<br />

May 2011 © Crown Copyright 2011


62<br />

May 2011 © Crown Copyright 2011


Appendix 3<br />

How to organise changeover <strong>of</strong> suppliers for existing homecare services<br />

1. Purpose<br />

To describe how to change to a new supplier for an existing homecare service.<br />

Appendix 1 summarises the tasks needed to be undertaken by department.<br />

Appendix 2 is intended to be used as an aide-memoire for the tasks.<br />

Appendix 3 is an example <strong>of</strong> a suggested agenda for each meeting (part 1 and 2).<br />

2. Scope<br />

All staff involved in the homecare service for an area where there is a change in supplier<br />

3. Responsibility<br />

Pharmacy Procurement manager<br />

4. Equipment /resources<br />

Contract specification, access to meeting rooms<br />

5. Procedure<br />

As part <strong>of</strong> contract award, a member <strong>of</strong> the procurement team should be nominated as project manager to facilitate the<br />

change process. The project manager can then act as a central point <strong>of</strong> contact for all involved and can have responsibility<br />

for ensuring the actions below are carried out efficiently.<br />

5.1. Initial Planning<br />

5.1.1 After award <strong>of</strong> contract, a meeting to discuss the change management process should be arranged. Typically, this<br />

will be a two hour meeting. The first hour (part one) will include the trust‟s multidisciplinary team and the new<br />

suppliers. For the second hour (part two), the group will be joined by the incumbent supplier. Ideally this meeting<br />

should be arranged within one month <strong>of</strong> contract award to ensure a timely and efficient transition <strong>of</strong> services.<br />

5.1.2 Suggested attendees at the meeting:<br />

Lead pharmacist for the therapy area(s). NB: If homecare service is for adults and paediatrics, both lead<br />

pharmacists should be included.<br />

Clinical Nurse Specialist/clinicians for the therapy area(s). NB: If homecare service is for adults and<br />

paediatrics, both Clinical Nurse specialists should be included.<br />

Pharmacy Procurement team.<br />

Appropriate representation from the new supplier. Typically:<br />

o Business Development Manager<br />

o Customer Services Manager<br />

o Pharmacy/Dispensary Manager<br />

o Logistics Manager<br />

o Finance Manager<br />

Appropriate representation from the incumbent supplier. Typically:<br />

o Business Development Manager<br />

o Customer Services Manager<br />

5.1.3 Send e-mail to new supplier 3 weeks before meeting to establish what information is required from<br />

Trust/incumbent supplier to ensure smooth transition.<br />

5.1.4 Send e-mail to incumbent suppliers 2 weeks before with a request to provide information from the new supplier,<br />

typically the following:<br />

i. All patients names on homecare service (including current, on hold, planned and unscheduled patients)<br />

ii. Copies <strong>of</strong> current prescriptions<br />

iii. Summary <strong>of</strong> prescription status (number <strong>of</strong> deliveries made against it, number <strong>of</strong> deliveries left, date <strong>of</strong><br />

renewal)<br />

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May 2011 © Crown Copyright 2011


iv. Patient demographics by drug/treatment type (name, address, unit number, date <strong>of</strong> birth, next <strong>of</strong> kin)<br />

v. Hardware - details <strong>of</strong> any pumps, refrigerators etc in the patients possession that are currently owned by<br />

the incumbent suppliers.<br />

vi. List <strong>of</strong> current ancillary items in the patient‟s home.<br />

vii. Future delivery schedules<br />

viii. Special delivery instructions by patient e.g. alternative delivery addresses, instructions on how to access<br />

property, any patients who currently use the „key holding‟ facility, if <strong>of</strong>fered<br />

ix. Any consent data<br />

x. Inventory <strong>of</strong> current stock holding<br />

5.1.5 Trust to prepare and make available at the meeting all required data received<br />

The above information must not be stored on electronic devices, CDs, memory sticks or similar without suitable encryption.<br />

It is suggested that the advice <strong>of</strong> the trust‟s data protection and governance manager is sought.<br />

5.2. Meeting - Part One: Suggested Agenda Items<br />

5.2.1 Introductions and welcome - allow the group to meet and all names and job titles minuted for future reference.<br />

5.2.2 Overview <strong>of</strong> specification - go through key points <strong>of</strong> the specification to ensure clarity in the expected service level<br />

from the trust and new supplier.<br />

5.2.3 Patient data required - review list <strong>of</strong> data required by the new supplier/Trust (as requested 3 weeks before<br />

meeting). Ensure systems and deadlines are in place to help with the smooth transition <strong>of</strong> this information.<br />

5.2.4 Prescription format/requirements - discussion between the clinical team/new suppliers regarding the style and<br />

format <strong>of</strong> the prescription and registration documents. It may be helpful to provide the new supplier with a copy <strong>of</strong><br />

the old prescriptions in advance <strong>of</strong> the meeting. Thought should be given to any lead times with printing and a<br />

contingency plan in place should the bespoke prescriptions not be ready in time (e.g. will new suppliers accept<br />

prescriptions on stationery from incumbent supplier in the interim?).<br />

5.2.5 Prescription process -<br />

How long will the prescription be valid for?<br />

What will be the expected turnaround time for new and existing prescriptions?<br />

How should treatment/prescriptions be cancelled?<br />

Will suppliers send a reminder to the Trust informing <strong>of</strong> expiry <strong>of</strong> prescription (prescription<br />

management service) or will this be handled by the clinical team?<br />

Will a buffer stock be required?<br />

5.2.6 Delivery Schedule - clarification and agreement regarding how <strong>of</strong>ten treatments will be delivered<br />

and any unusual delivery schedules for specific patients. Discussion will also be held with new<br />

supplier regarding how patients who currently use a key holding facility will be recruited to the<br />

service.<br />

5.2.7 Ancillary list - Clarify and agree list <strong>of</strong> ancillaries with new supplier and clinical team. Discuss how<br />

ancillaries will be replaced (set monthly amount delivered or „topped up‟ as necessary).<br />

5.2.8 Removal <strong>of</strong> waste - Agreement from new supplier <strong>of</strong> how they intend to handle removal <strong>of</strong> waste<br />

(i.e. packaging etc) and clinical waste (i.e. full sharps bins, expired stock etc).<br />

5.2.9 Purchase <strong>of</strong> hardware - discussion surrounding whether new supplier intends to purchase any<br />

relevant hardware from incumbent supplier or provide patients with new equipment (if requested in<br />

specification).<br />

5.2.10 Invoicing requirements - agreement on best process for invoicing trust for homecare services. The<br />

Trust need to consider the following:<br />

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o Will an order be raised before the prescription is sent or retrospectively?<br />

o Who will receive the invoice?<br />

o Will any new drug codes/cost centres need to be set up on the pharmacy computer<br />

system?<br />

o Will the Trust require a consolidated monthly invoice or an individual invoice?<br />

What data will the Trust require on the invoice (e.g. cost per case drugs will require<br />

some way <strong>of</strong> identifying the patient name. unit number)<br />

5.2.11 Start dates:<br />

o Of contract - Group to suggest a start date <strong>of</strong> contract which will be agreed in part two <strong>of</strong><br />

meeting.<br />

o New patients - typically, new patients would start on or immediately after the contract start<br />

date with the new supplier. It may be sensible to delay potential new starters until after the<br />

new contract start date, unless this would disrupt the patient‟s treatment.<br />

o Existing patients - will all existing patients receive their deliveries from one set date or will<br />

there be a phased approach (in cases <strong>of</strong> large patient numbers)? The main issue<br />

surrounding the transfer <strong>of</strong> existing patients is how to handle the mid prescription patients<br />

i.e. they have received half their deliveries against a six month prescription. This can be<br />

handled one <strong>of</strong> three ways:<br />

Process Pros Cons<br />

1) Rewrite all prescriptions with a<br />

new six month validity<br />

2) Rewrite the remainder <strong>of</strong> the prescription<br />

i.e. if two months <strong>of</strong> treatment have been<br />

made against a six month prescription, new<br />

prescription is written for four months<br />

3) Stagger the changeover <strong>of</strong> contract.<br />

Patients come on to the new service upon<br />

expiry <strong>of</strong> old prescription<br />

Assured accuracy and<br />

currency <strong>of</strong> new prescriptions<br />

Transcription can take place<br />

directly from copies provided<br />

by incumbent supplier<br />

Would ensure that prescription expiry is<br />

staggered<br />

Assured accuracy and currency <strong>of</strong> new<br />

prescriptions<br />

Would reduce bottleneck <strong>of</strong> workload<br />

for all staff<br />

Assured accuracy and currency <strong>of</strong> new<br />

prescriptions<br />

Large workload for clinical team<br />

Prescriptions will all expire at same<br />

time in six months<br />

May prove to be a complicated task<br />

Would require detailed information and cooperation<br />

from incumbent supplier<br />

Greater possibility <strong>of</strong> error in delivery times<br />

Would prolong the length <strong>of</strong> time taken to<br />

transfer patients (up to six months)<br />

Would reduce any savings made on contract.<br />

5.2.12 Contacting patients - key staff from the Trust and new supplier should be given the responsibility <strong>of</strong> contacting<br />

patients. The patients should be contacted in a three stage approach:<br />

i. Letter from the Trust informing patients <strong>of</strong> change, when change will be effective from, reasons for<br />

change and reassurance that their care will not be affected.<br />

ii. Goodbye letter from incumbent supplier informing patient that their deliveries will be made by another<br />

supplier effective from the agreed date. The letter should be agreed by the Trust before being sent to<br />

patient.<br />

iii. A welcome letter and welcome pack from new supplier, reassuring patient <strong>of</strong> seamless care, and<br />

informing them <strong>of</strong> their new contact number and the date from which the change will be effective. This<br />

letter should be agreed by the Trust before being sent to patients.<br />

5.2.13 Review and summary <strong>of</strong> actions. Each agreed action should have a date <strong>of</strong> completion and a person responsible.<br />

5.3. Meeting - Part Two: Suggested Agenda Items<br />

5.3.1 Introductions and welcome - Introduce the incumbent suppliers to the rest <strong>of</strong> the group from part one.<br />

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5.3.2 Required patient data - review <strong>of</strong> data provided by incumbent supplier to ensure all required fields <strong>of</strong> data have<br />

been provided. The clinical team will carefully review accuracy <strong>of</strong> data after the meeting and feedback to<br />

incumbent supplier any errors.<br />

5.3.3 Ancillary items - agreement requested from incumbent supplier that ancillary items currently with the patient will<br />

not be removed upon contract termination.<br />

5.3.4 Hardware - person identified from new supplier and incumbent supplier charged with negotiating over the sale <strong>of</strong><br />

hardware. Agreement should be reached within one week <strong>of</strong> date <strong>of</strong> meeting and fed back to project manager.<br />

5.3.5 Proposed start date <strong>of</strong> contract - discussion by all on the feasibility <strong>of</strong> start date.<br />

5.3.6 Existing patients - agreement made between all regarding the most efficient process <strong>of</strong> managing the transfer <strong>of</strong><br />

existing patients.<br />

5.3.7 Contacting patients - incumbent supplier to be informed that patients will require a letter to say goodbye and<br />

wishing them well for the future. The letter shall be sent after initial contact by the Trust has been made. Project<br />

manager to agree letter and advise incumbent supplier when to issue.<br />

5.3.8 Review and summary <strong>of</strong> actions. Each agreed action should have a date <strong>of</strong> completion and a person responsible.<br />

5.4. Tasks for clinical team following meeting<br />

5.4.1 Arrange letter to inform patients <strong>of</strong> change and provide telephone number <strong>of</strong> a Trust contact who they can call if<br />

they have any questions.<br />

5.4.2 Rewrite any prescriptions or registration forms required by the new supplier in advance <strong>of</strong> first delivery.<br />

5.4.3 Check the list <strong>of</strong> patient demographics and prescription copies provided by incumbent supplier for accuracy<br />

5.4.4 Review and follow-up any named actions resulting from the meeting<br />

5.4.5 Notify project manager once a task has been completed.<br />

5.5 Tasks for new supplier following meeting<br />

5.5.1 Print new prescriptions and registrations forms in agreement with requirements <strong>of</strong> clinical team.<br />

5.5.2 Arrange deliveries for existing Trust patients to ensure seamless care. Deliveries should match closely the next<br />

expected delivery date by the incumbent supplier. Patients should not be left without treatment beyond their due<br />

date.<br />

5.5.3 Upon notification by Trust, the new supplier will send out welcome packs and letter to patients stating the<br />

following:<br />

i. Brief overview <strong>of</strong> company<br />

ii. Reassurance that they will receive seamless care and quality service<br />

iii. A named contact at the company along with a direct telephone line, preferably free-phone or<br />

geographical number.<br />

iv. A back up contact in case <strong>of</strong> absence or holiday<br />

v. A 24 hour emergency number if appropriate<br />

vi. Date <strong>of</strong> next delivery<br />

5.5.4 Negotiate with incumbent supplier regarding purchase <strong>of</strong> hardware. Negotiations should be completed within one<br />

week <strong>of</strong> meeting. If agreement cannot be reached, new supplier will have a contingency plan to replace hardware.<br />

5.5.5 Arrange a key holding service for patients if required as part <strong>of</strong> contract.<br />

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5.6. Tasks for incumbent supplier following meeting<br />

5.6.1 Arrange goodbye letter to patients<br />

5.6.2 Enter into negotiations with new supplier regarding purchase <strong>of</strong> hardware. If agreement cannot be reached,<br />

incumbent supplier will arrange for removal <strong>of</strong> hardware from patients home. This will be conducted discreetly and<br />

at the patient‟s convenience and soon after installation <strong>of</strong> new equipment by new supplier.<br />

5.6.3 Incumbent supplier will be fully compliant in the transfer <strong>of</strong> patient data and ensure that such data is transferred<br />

securely.<br />

5.6.4 Patients who have provided a key to the incumbent supplier for access to house during deliveries will have their<br />

key returned to them securely with last delivery or before end <strong>of</strong> contract date.<br />

5.7. Miscellaneous tasks following meeting<br />

5.7.1 A robust invoicing system set up. Trust may need to add new drug codes and/or cost centres to stock<br />

management system.<br />

5.7.2 Arrange follow up meeting at least one week prior to contract start date to review actions if necessary. Meeting<br />

should include all named contacts including incumbent supplier.<br />

5.8 Tasks following start <strong>of</strong> contract<br />

5.8.1 Clinical teams to feed back to project manager any initial problems<br />

5.8.2 New supplier‟s named contact will also act as trouble-shooter for initial problems<br />

5.8.3 Meeting to be arranged after two months to assess changeover process.<br />

5.8.4 In liaison with Trust, new supplier will conduct a patient survey to assess the effectiveness <strong>of</strong> the changeover.<br />

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Task list for changing contract to new supplier for homecare medicines<br />

1. Pharmacy Procurement Team Tasks<br />

After award <strong>of</strong> contract:<br />

1.1 Identify key staff to attend a change management meeting and assign a „project leader‟ to manage the changeover <strong>of</strong><br />

suppliers.<br />

1.2 Arrange change management meeting between clinical teams, new supplier and incumbent supplier.<br />

1.3 Book room for meeting.<br />

1.4 Notify attendees <strong>of</strong> time and venue<br />

1.5 Request details from new supplier regarding what information they need for the meeting<br />

1.6 Arrange agenda for meetings<br />

1.7 Send meeting agendas to clinical team and new supplier<br />

1.8 Send relevant section <strong>of</strong> meeting agenda to the incumbent supplier<br />

1.9 Send list <strong>of</strong> requirements identified in 1.5 to incumbent supplier along with a request to provide patients demographics<br />

at the meeting<br />

1.10 Print <strong>of</strong>f contract specification for meeting<br />

1.11 Liaise with procurement business manager (if not attending meeting) to assess invoicing requirements<br />

Points at meeting (part one):<br />

a) Intro and welcome<br />

b) Overview <strong>of</strong> specification<br />

c) Patient data required<br />

d) Prescription format/requirements<br />

e) Prescription process<br />

f) Delivery schedule<br />

g) List <strong>of</strong> ancillaries<br />

h) Removal <strong>of</strong> waste<br />

i) Purchase <strong>of</strong> hardware<br />

j) Invoicing requirements<br />

k) Agreement on start dates<br />

l) Process for contacting patients regarding change <strong>of</strong> contract<br />

m) Review and summary <strong>of</strong> actions including assigning a designated named contact for new supplier and clinical team<br />

Points at meeting (part two)<br />

a) Intro and welcome<br />

b) Patient data required<br />

c) Ancillary items<br />

d) Hardware<br />

e) Proposed start date <strong>of</strong> contract<br />

f) Transfer <strong>of</strong> existing patients<br />

g) Contacting patients<br />

h) Review and summary <strong>of</strong> actions including assignment <strong>of</strong> a named contact at incumbent supplier<br />

Post meeting<br />

1.12 Check with information governance manager that the method <strong>of</strong> transfer <strong>of</strong> data is compliant with guidance relating to<br />

the transfer and security <strong>of</strong> patient identifiable data<br />

1.13 Inform PASA <strong>of</strong> change <strong>of</strong> contract (if required)<br />

1.14 Produce Gantt chart for time line <strong>of</strong> actions and distribute to all involved<br />

1.15 Organise follow up meeting to occur 1 week before agreed start date<br />

1.16 Write letter to inform patients <strong>of</strong> supplier change. Agree with clinical team prior to distribution<br />

1.17 Send patient letter to new supplier to distribute on behalf <strong>of</strong> the Trust<br />

1.18 Inform incumbent supplier that they can now send their „Goodbye‟ letter<br />

1.19 Inform new supplier that they can distribute welcome packs.<br />

1.20 Discuss effect on Trust stock holding with store managers<br />

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Post-start tasks<br />

1.21 Arrange patient questionnaire to assess changeover<br />

1.22 Arrange post change meeting with new suppliers/clinical teams<br />

2. Incumbent Supplier tasks<br />

After award <strong>of</strong> contract<br />

2.1 Arrange suitable representation <strong>of</strong> staff to attend change management meeting at the Trust<br />

2.2 Prepare file <strong>of</strong> patient demographic data<br />

Points at meeting:<br />

a) Provide requested data to clinical team<br />

b) Provide new supplier with current list <strong>of</strong> patient‟s ancillary requirements<br />

c) Provide new supplier with current hardware held in patients home<br />

d) Arrange process <strong>of</strong> negotiation with new supplier for sale/transfer <strong>of</strong> hardware and ancillaries<br />

e) Provide Trust procurement team with details <strong>of</strong> any stock held by company that may be part <strong>of</strong> a designated allocation under<br />

the Purchasing and Supplies Agency national framework<br />

f) Provide project manager with a designated named contact<br />

Post Meeting:<br />

2.3 Send letter to patients informing them <strong>of</strong> their last delivery and provide reassurance that their next delivery will be from<br />

the new supplier<br />

2.4 Arrange collection <strong>of</strong> any hardware in patients home that is not included as part <strong>of</strong> the sale/transfer <strong>of</strong> hardware items<br />

3. Clinical team tasks<br />

After award <strong>of</strong> contract:<br />

3.1 Provide list <strong>of</strong> all current, on hold, and planned patients to procurement team<br />

Points at meeting:<br />

a) Provide a named contact for clinical team<br />

b) Agree how to transfer data for existing patients<br />

c) Agree start date <strong>of</strong> new contract<br />

d) Agree style and format <strong>of</strong> prescription<br />

e) Agree on prescription process<br />

Post meeting<br />

3.2 Check all data provided by incumbent supplier for accuracy and forward checked data to the project manager<br />

3.3 Write new prescriptions and registration forms if necessary and forward to new supplier<br />

3.4 Agree patient letter with procurement team<br />

3.5 Act as information contact for patients regarding the switch<br />

Post-start tasks:<br />

3.6 Monitor and record any initial problems with deliveries. Notify project manager and new suppliers named contact <strong>of</strong> any<br />

incidents/occurrences<br />

3.7 Attend meeting to assess efficiency <strong>of</strong> change management process<br />

4. New Supplier tasks<br />

After award <strong>of</strong> contract<br />

4.1 Arrange suitable representation <strong>of</strong> attendees for meeting<br />

4.2 Send list <strong>of</strong> preliminary requirements to procurement team<br />

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Points at meeting:<br />

a) Present change management plan<br />

b) Provide clinical team and project manager with examples <strong>of</strong> prescription/registration form stationery<br />

c) Arrange negotiations with incumbent supplier for possible purchase <strong>of</strong> hardware<br />

d) Provide project manager with a named contact<br />

e) Agree start date <strong>of</strong> contract<br />

Post meeting:<br />

4.4 Assist clinical teams in the writing <strong>of</strong> new prescriptions<br />

4.5 Arrange initial delivery schedules<br />

4.6 Arrange installation <strong>of</strong> hardware in patient‟s homes if not included in the sale/transfer <strong>of</strong> hardware from the incumbent<br />

supplier<br />

4.7 Distribute „welcome packs‟ to patients before first scheduled delivery<br />

4.8 Telephone patients to arrange mutually convenient time for first delivery<br />

Post-start tasks<br />

4.9 Make first delivery - provide feedback and evidence to project manager and clinical team that these have occurred<br />

4.10 Attend post change review meeting<br />

4.11 Distribute a Trust led questionnaire to assess the patient‟s opinion <strong>of</strong> the switch<br />

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1 - Pharmacy Procurement Team Tasks after award <strong>of</strong><br />

contract<br />

1.1 Identify key staff to attend meeting. Assign a project manager<br />

1.2 Arrange implementation meeting between clinical teams and new<br />

homecare supplier<br />

1.3 Book room for meeting<br />

1.4 Notify attendees <strong>of</strong> time and venue<br />

1.5 Send e-mail to new supplier requesting details <strong>of</strong> pre-requirements<br />

for meeting<br />

1.6 Arrange agenda for both meetings<br />

1.7 Send agenda to clinical team and new supplier<br />

1.8 Print <strong>of</strong>f contract specification for meeting<br />

1.9 Liaise with procurement business manager (if not attending<br />

meeting) to discuss invoicing requirements<br />

Points at meeting: Part 1<br />

a) Intro and welcome<br />

b) Overview <strong>of</strong> specification<br />

c) Patient data required<br />

d) Prescription format/requirements<br />

e) Prescription process<br />

Individual<br />

Responsibility<br />

Deadline/ Date Completed<br />

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Points at meeting: Part 2<br />

1 - Pharmacy Procurement Team Tasks after award <strong>of</strong><br />

contract<br />

f) Delivery schedule<br />

g) List <strong>of</strong> ancillaries<br />

h) Removal <strong>of</strong> waste<br />

i) Purchase <strong>of</strong> hardware<br />

j) Invoicing requirements<br />

k) Agreement on start dates<br />

l) contacting patients<br />

m) Review and summary <strong>of</strong> actions - assignment <strong>of</strong><br />

named contact for new supplier and clinical team.<br />

a) Intro and welcome<br />

b) Patient data required<br />

c) Ancillary items<br />

d) Hardware<br />

e) Proposed start date <strong>of</strong> contract<br />

f) Transfer <strong>of</strong> existing patients<br />

g) Contacting patients<br />

h) Review and summary <strong>of</strong> actions including<br />

assignment <strong>of</strong> a named contact at incumbent<br />

supplier<br />

Individual<br />

Responsibility<br />

Deadline/ Date Completed<br />

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Post meeting:<br />

1 - Pharmacy Procurement Team Tasks after award <strong>of</strong><br />

contract<br />

1.12 Check with Information Governance and Data Protection Manager<br />

that the method <strong>of</strong> transfer <strong>of</strong> patient data is secure<br />

1.13 Inform PASA <strong>of</strong> change <strong>of</strong> contract (if required)<br />

1.14 Produce Gantt chart <strong>of</strong> change process and distribute to clinical<br />

teams, existing supplier and new supplier<br />

1.15 Arrange follow up meeting to check progress<br />

1.16 Draft letter to patients for clinical teams approval<br />

1.17 Send letter to new supplier to distribute on behalf <strong>of</strong> LTH<br />

1.18 Inform incumbent supplier they can now distribute a letter <strong>of</strong><br />

goodbye to patients<br />

1.19 Inform new supplier that welcome packs can be sent out to<br />

patients immediately after the letter from the Trust<br />

1.20 Discuss with pharmacy supplies on proposed effect (if any) on<br />

stock holding<br />

START DATE<br />

1.22 Plan for questionnaire to assess efficiency <strong>of</strong> change management<br />

plan<br />

1.23 Arrange post change meeting with new suppliers/clinical teams<br />

Individual<br />

Responsibility<br />

Deadline/ Date Completed<br />

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2 - Existing Provider Tasks after award <strong>of</strong> contract<br />

2.1 Arrange suitable representation <strong>of</strong> staff to attend change<br />

management meeting at the Trust<br />

2.2 Prepare file <strong>of</strong> current patient data and any other data<br />

requested by procurement team<br />

Points at meeting<br />

post meeting:<br />

a) Provide requested data to clinical team<br />

b) Provide new supplier with current list <strong>of</strong> patient's ancillary<br />

requirements<br />

c) Provide new supplier with current hardware held in patients<br />

home<br />

d) Arrange process for negotiating sale/transfer <strong>of</strong> hardware<br />

items<br />

e) Provide procurement team with details <strong>of</strong> any stock held<br />

that may be part <strong>of</strong> a designated allocation under the<br />

Purchasing and Supplies Agency national framework<br />

f) Provide project manager with a designated named contact<br />

2.3 Letter to patient informing them <strong>of</strong> their last delivery and<br />

provide reassurance that their next delivery will be from the<br />

new supplier.<br />

2.4 Arrange collection <strong>of</strong> any hardware in patients home that is not<br />

part <strong>of</strong> the transfer/sale <strong>of</strong> hardware items<br />

Individual<br />

Responsibility<br />

Deadline Completed<br />

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3 - Clinical Team Tasks after award <strong>of</strong> contract<br />

3.1 Provide list <strong>of</strong> all current, on hold and planned patients to<br />

procurement team<br />

Points at meeting<br />

a) Provide a named contact for clinical team<br />

b) Agree how to transfer data for existing patients<br />

c) Agree start date <strong>of</strong> new contract<br />

d) Agree style/format <strong>of</strong> prescription<br />

e) Agree prescription process<br />

3.2 Check all data provided by incumbent supplier for accuracy.<br />

Forward checked data to the project manager<br />

3.3 Write new prescriptions and registration forms, if required,<br />

and forward to new supplier<br />

3.4 Agree patient letter <strong>of</strong> notification with project manager<br />

3.5 Act as an information contact for patients during the<br />

changeover<br />

3.6 Monitor and record any initial problems with deliveries. Notify<br />

project manager and new supplier named contact <strong>of</strong> any<br />

incidents/occurrences<br />

3.7 Attend meeting to assess efficiency <strong>of</strong> change management<br />

process<br />

Individual<br />

Responsibility<br />

Deadline Completed<br />

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4 - New Supplier Tasks after award <strong>of</strong> contract<br />

4.1 Arrange suitable representation to attend change management<br />

meeting<br />

4.2 Send a list <strong>of</strong> preliminary requirements to procurement team prior<br />

to change meeting<br />

Points at meeting<br />

Post meeting<br />

a) Present company change management plan<br />

b) Provide clinical team/procurement team with examples <strong>of</strong><br />

prescription/registration form stationery<br />

c) Negotiate with previous suppliers on transfer/purchase <strong>of</strong><br />

ancillary items/hardware<br />

d) Provide project manager with a named contact<br />

e) Agree start date <strong>of</strong> contract<br />

4.3 Assist clinical teams in rewriting any 'part used' prescriptions for<br />

existing patients (if required)<br />

4.4 Arrange initial delivery schedules<br />

4.5 Arrange installation <strong>of</strong> hardware in patient's homes if not included<br />

in the sale/transfer <strong>of</strong> hardware from the incumbent supplier<br />

4.6 Distribute 'welcome packs' to patients before first scheduled<br />

delivery<br />

4.7 Telephone patients to arrange mutually convenient time for first<br />

delivery<br />

START DATE<br />

4.8 Make first deliveries - provide feedback and evidence to the<br />

clinical teams that these have occurred<br />

4.9 Attend post change review meeting<br />

Individual<br />

Responsibility<br />

Deadline Completed<br />

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4 - New Supplier Tasks after award <strong>of</strong> contract<br />

4.10 Distribute post change questionnaire (provided by Procurement<br />

team)<br />

Agenda for part 1 <strong>of</strong> Change management meeting:<br />

Individual<br />

Responsibility<br />

NO TIME AGENDA ITEM PURPOSE OWNER<br />

1. Introductions and welcome<br />

2. Overview <strong>of</strong> specification<br />

3. Required patient data<br />

4. Prescription format/requirements<br />

5. Prescription process<br />

6. Delivery schedule<br />

7. Ancillary requirements<br />

8. Removal <strong>of</strong> waste<br />

9. Purchase <strong>of</strong> hardware<br />

10. Invoicing requirements<br />

11. Agreement on start dates<br />

12. Notifying patients <strong>of</strong> change<br />

13. Review <strong>of</strong> actions<br />

Agenda for part 2 <strong>of</strong> meeting (including incumbent supplier):<br />

NO TIME AGENDA ITEM PURPOSE OWNER<br />

1. Introductions and welcome<br />

2. Patient data required<br />

3. Ancillary items<br />

4. Hardware<br />

5. Proposed start date <strong>of</strong> contract<br />

6. Transfer <strong>of</strong> existing patients<br />

7. Notifying patients <strong>of</strong> change<br />

8. Review and summary <strong>of</strong> actions<br />

Deadline Completed<br />

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<strong>CMU</strong> Data collection fields<br />

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Appendix 4


General KPI Summary Trusts are required to amend these specimen KPI's to reflect each therapy area<br />

Complaints Pro<strong>of</strong> <strong>of</strong> Delivery<br />

Type Status ComplaintRef Number <strong>of</strong> Deliveries returned<br />

Cost <strong>of</strong> unused<br />

products<br />

Patient (Van/Postal/Other) Issued Unique ref to form Deliveries Number <strong>of</strong> deliveries returned £<br />

Trust Investigation underway Deliveries on time & in full Why<br />

Manufacturer Resolved Deliveries outside agreed window<br />

Part deliveries<br />

Emergency deliveries<br />

Deliveries outside normal Mon-Fri<br />

Deliveries where stock has been damaged from homecare provider to patient<br />

No <strong>of</strong> Adhoc/Other deliveries (not covered above)<br />

Why<br />

Dispensing At Trust level At Delivery location<br />

Number <strong>of</strong> Patients Stock check <strong>of</strong> items<br />

Prescriptions dispensed Number <strong>of</strong> Patients registered home<br />

Items on prescription Unable to be supplied in total/not dispensed Van<br />

Items dispensed Reason why not dispensed Postal<br />

Dispensing errors Out <strong>of</strong> stock On Service<br />

Dispensed with less than 6 months expiry date Manufacturer unable to supply On Hold<br />

Off Service<br />

Why<br />

Clinical Details <strong>of</strong> untoward clinical incidents/Adverse Drug Reactions (ADRs)<br />

1<br />

2<br />

3<br />

4<br />

5<br />

Invoicing<br />

Number <strong>of</strong> £ Total value <strong>of</strong> Number <strong>of</strong> £ Total value <strong>of</strong><br />

Invoices dispatched Invoices dispatched Invoices paid by trust within 30 days Invoices paid by trust within 30 days<br />

Total invoice lines Total invoice lines Invoices not paid by trust within 30 days Invoices not paid by trust within 30 days<br />

Invoice queries from trusts Invoice queries from trusts<br />

Monthly performance rating<br />

Please self-assess your performance this month:<br />

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Appendix 5


Date:<br />

Name<br />

Address<br />

Dear<br />

1<br />

Appendix 6<br />

2 The XXXXXXXXX Hospital/PCT would like to know what you think <strong>of</strong> the Home delivery service<br />

provided by XXXXXX. Please could you complete the enclosed questionnaire and return it to us in<br />

the pre-paid envelope provided. It is only with your opinions can we continue to maintain and<br />

improve the service you receive.<br />

Kind Regards,<br />

2.1 [A signed copy <strong>of</strong> this letter is held on file at XXXXXXXXXXXHospital/PCT]<br />

NAME<br />

TITLE<br />

HOSPITAL/PCT<br />

80<br />

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Name:<br />

[This survey has been sent to you with the permission <strong>of</strong> the XXXXXXXXX teams responsible for your treatment]<br />

Patient Survey<br />

Name <strong>of</strong> Treatment:<br />

Name <strong>of</strong> Homecare provider:<br />

Section ONE: How do you currently rate (company name)performance in the following areas:<br />

Please circle ONE score, where 1= POOR and 5= EXCELLENT)<br />

Communication<br />

Poor<br />

Excellent<br />

1 2 3 4 5<br />

Comments:<br />

Delivery times<br />

Poor<br />

Excellent<br />

1 2 3 4 5<br />

Comments:<br />

Customer Services Support<br />

Poor<br />

Excellent<br />

1 2 3 4 5<br />

Comments:<br />

Driver assistance/attitude:<br />

Poor<br />

Excellent<br />

1 2 3 4 5<br />

Comments:<br />

Clinical Waste Collection (Sharps bins etc)<br />

Poor<br />

Excellent<br />

1 2 3 4 5<br />

Comments:<br />

Overall Service<br />

Poor<br />

Excellent<br />

1 2 3 4 5<br />

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Comments:<br />

Continued overleaf….<br />

Section TWO: How important are each <strong>of</strong> the following to you<br />

This section is designed to find out which areas <strong>of</strong> the service mean the most to you, to give us some<br />

idea <strong>of</strong> what you, the patient, consider a priority<br />

(Score 1= Not important 5= Very important)<br />

Communication<br />

Not important Very<br />

important<br />

1 2 3 4 5<br />

Comments:<br />

Delivery times<br />

Not important Very<br />

important<br />

1 2 3 4 5<br />

Comments:<br />

Customer Services Support<br />

Not important Very<br />

important<br />

1 2 3 4 5<br />

Comments:<br />

Driver assistance/attitude:<br />

Not important Very<br />

important<br />

1 2 3 4 5<br />

Comments:<br />

Clinical Waste Collection (sharps bins etc)<br />

Not important Very<br />

important<br />

1 2 3 4 5<br />

Comments:<br />

Overall Service<br />

Not important Very<br />

important<br />

1 2 3 4 5<br />

Comments:<br />

Thank You for your time<br />

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Appendix 7<br />

Procedure to define the framework for reporting <strong>of</strong> incidents occurring in the<br />

Homecare <strong>Medicines</strong> Supply Chain.<br />

1. Purpose<br />

To describe the pathway <strong>of</strong> contact in the occurrence <strong>of</strong> an „incident‟ in the Homecare Medicine<br />

supply chain.<br />

2. Scope<br />

This procedure covers all events which can be classed as „an incident‟ or a „Serious Untoward<br />

incident‟, as defined by Trust policies on Incidents and Serious Untoward Incidents. This<br />

procedure details the pathway for recording, responding and actioning incidents and is not<br />

intended to direct any remedial clinical activity which may be necessary as a result <strong>of</strong> the<br />

incident<br />

3. Responsibility<br />

It is the responsibility <strong>of</strong> all staff members involved in the Homecare <strong>Medicines</strong> supply chain<br />

(Trust and Homecare provider staff) to be aware <strong>of</strong> the procedure and aware <strong>of</strong> the chain <strong>of</strong><br />

communication in the event <strong>of</strong> „an incident‟.<br />

All staffed named as key contacts in the Homecare Incident Contact Matrix will, as part <strong>of</strong> this<br />

procedure, read and acknowledge understanding <strong>of</strong> the procedures for Incident reporting and<br />

Serious Untoward Incidents.<br />

4. Procedure<br />

All Homecare providers will have their own procedure for dealing with incidents which will be<br />

made available to the Trust.<br />

4.1. Upon discovery <strong>of</strong> an incident, the member <strong>of</strong> staff discovering the incident will complete the<br />

homecare incident report form (see appendix 1).<br />

4.2. Attach this form to an e-mail and send to all the named contacts shown on the incident<br />

contact matrix* (within the Trust and the Homecare Provider).<br />

4.3. For incidents that have a direct effect on the patient‟s care, the person discovering the<br />

incident will contact and discuss with the Trust‟s key contact (as shown on contact matrix) the<br />

nature <strong>of</strong> the incident. That key contact will then assume responsibility for any remedial action<br />

that the patient may require. Where an incident has potential to or has caused harm to a<br />

patient, a senior Pharmacy Manager must be contacted immediately. Incidents classified as<br />

having potential for harm include, but are not limited to, dispensing errors where patients<br />

have taken a dose, missed doses, dispensing <strong>of</strong> expired stock etc.<br />

4.4. The member <strong>of</strong> staff assuming the responsibility for the incident will advise the other named<br />

contacts for that therapy area (as detailed in the contact matrix) the details <strong>of</strong> the incident,<br />

what action has already been taken and any subsequent actions required. All future<br />

communication regarding the incident should be copied to all contacts for information.<br />

4.5. The homecare provider shall assist the Trust lead in providing remedial care. Emergency<br />

deliveries will be made available if necessary without prejudice.<br />

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4.6. The Trust lead will complete a Trust incident reporting form (IR1) in accordance with Trust<br />

policy within 48 hours <strong>of</strong> the incident. The unique IR1 number will then be communicated to<br />

the rest <strong>of</strong> the key contacts (including Homecare provider contacts) by email.<br />

4.7. The key contact at the Homecare provider must initiate the company‟s incident reporting<br />

procedure and supply the Trust with the name <strong>of</strong> an operational lead at the company to assist<br />

the clinical team with any remedial action.<br />

4.8. The homecare provider must provide a detailed, chronological report <strong>of</strong> the incident to the<br />

Trust, from the moment <strong>of</strong> occurrence to the point <strong>of</strong> closure. Report must include details <strong>of</strong><br />

any communication between the Trust, Homecare provider and the patient. The report should<br />

where possible include a root cause analysis. The report should be communicated via email<br />

to the key contacts within two weeks <strong>of</strong> discovery <strong>of</strong> incident. The report must have a unique<br />

number and be cross referenced to the Trust‟s IR1 number.<br />

4.9. An incident shall be classed as „Closed‟ when it is agreed by the clinical lead and the<br />

Homecare provider key contact that all actions have been undertaken to remedy the incident,<br />

a root cause analysis has been conducted and actions have been undertaken to avoid/reduce<br />

the risk <strong>of</strong> a repeat <strong>of</strong> the incident. If closure has not been achieved within the 2 week time<br />

frame defined in point 4.8, then a second and subsequent report shall be required. Closure <strong>of</strong><br />

an incident should be achieved within this 2 week time scale unless circumstances make this<br />

impossible. The second report should include details as to why closure within 2 weeks was<br />

not achieved. The first report will include an action plan together with deadlines for the actions<br />

to enable closure to occur.<br />

4.10. The IR1 shall be forwarded to the Trust‟s senior Pharmacy Manager for final sign <strong>of</strong>f and risk<br />

evaluation score.<br />

4.11. The Homecare provider will keep a record <strong>of</strong> all incidents per quarter and present these<br />

figures to the by way <strong>of</strong> a quarterly report showing number <strong>of</strong> incidents per month and status<br />

<strong>of</strong> incident i.e. „Ongoing‟ or „Closed‟. This data will be used as a performance management<br />

tool in future service reviews for purpose <strong>of</strong> learning.<br />

4.12. The Homecare provider will communicate any key staff changes which may affect the<br />

reporting framework. This should ideally be done before any <strong>of</strong> the key contact staff at the<br />

homecare provider leave or, if not possible, as soon as possible after.<br />

4.13. The key contact matrix shall be maintained by the Trust.<br />

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Section A: Please Complete All Fields* Before Submitting This Report<br />

(Fields marked * are mandatory)<br />

Hospital Name*: IR1 Number*:<br />

(to be completed by Trust only)<br />

Issue Raised by*:<br />

Position and <strong>Department</strong>*:<br />

Date Issue Raised*: Date Issue Reported to<br />

Homecare Provider*:<br />

2.2 Patient<br />

Information:<br />

Patient Initials*: Date <strong>of</strong> Birth*:<br />

Hospital Number:<br />

(optional)<br />

Details <strong>of</strong> Issue*<br />

Does the patient require a written response *?<br />

Name <strong>of</strong> First Contact for Completed Report (including email<br />

address)<br />

Therapy Area/Contract Name*:<br />

Yes No (please select )<br />

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Section B: To be completed by Homecare Provider Personnel Only:<br />

Investigation and Immediate Corrective Actions Taken:<br />

Details <strong>of</strong> Preventative Actions and Conclusion:<br />

3 Completed by<br />

Homecare Provider unique<br />

Reference:<br />

Date Completed<br />

(including written<br />

response to patient<br />

where appropriate):<br />

Date Issued to Trust:<br />

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Refrigeration<br />

87<br />

May 2011 © Crown Copyright 2011<br />

Appendix 8<br />

Temperature range 2-8°c<br />

Temperature distribution – maintain the required range across its entire load area<br />

Capacity – at least one third greater than required to allow for circulation <strong>of</strong> cooled air<br />

Lockable for child safety<br />

Suitable indicator/visual alarm to alert if temperature exceeds parameters (for length <strong>of</strong> time) or<br />

door left open<br />

Fridge with fan preferred<br />

Easy to read temperature measurement shown on outside <strong>of</strong> fridge, calibrated to proven standard

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