Commercial Medicines Unit (CMU) - Department of Health
Commercial Medicines Unit (CMU) - Department of Health
Commercial Medicines Unit (CMU) - Department of Health
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
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 />
© Crown Copyright 2011
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 />
© Crown Copyright 2011
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 />
© Crown Copyright 2011<br />
May 2011<br />
24
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 />
May 2011<br />
25
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 />
© Crown Copyright 2011<br />
May 2011<br />
26
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 />
© Crown Copyright 2011<br />
May 2011<br />
27
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 />
© Crown Copyright 2011<br />
May 2011<br />
28
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 />
© Crown Copyright 2011<br />
May 2011<br />
29
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 />
© Crown Copyright 2011<br />
May 2011<br />
30
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 />
© Crown Copyright 2011<br />
May 2011<br />
31
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 />
May 2011<br />
32
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 />
© Crown Copyright 2011<br />
May 2011<br />
33
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 />
© Crown Copyright 2011<br />
May 2011<br />
34
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 />
© Crown Copyright 2011<br />
May 2011<br />
35
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 />
May 2011<br />
36
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 />
© Crown Copyright 2011<br />
May 2011<br />
37
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 />
© Crown Copyright 2011<br />
May 2011<br />
38
© 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 />
May 2011<br />
39
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 />
© Crown Copyright 2011<br />
May 2011<br />
40
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 />
May 2011<br />
41
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 />
May 2011<br />
42
© 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 />
May 2011<br />
43
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 />
May 2011<br />
44
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 />
May 2011<br />
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 />
45
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 />
May 2011<br />
46
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 />
47
© 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 />
© Crown Copyright 2011 May 2011<br />
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 />
© Crown Copyright 2011 May 2011<br />
52
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 />
© Crown Copyright 2011 May 2011<br />
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 />
56<br />
May 2011 © Crown Copyright 2011
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 />
May 2011 © Crown Copyright 2011
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 />
May 2011 © Crown Copyright 2011
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 />
May 2011 © Crown Copyright 2011
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 />
May 2011 © Crown Copyright 2011
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 />
63<br />
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 />
64<br />
May 2011 © Crown Copyright 2011
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 />
65<br />
May 2011 © Crown Copyright 2011
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 />
66<br />
May 2011 © Crown Copyright 2011
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 />
67<br />
May 2011 © Crown Copyright 2011
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 />
68<br />
May 2011 © Crown Copyright 2011
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 />
69<br />
May 2011 © Crown Copyright 2011
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 />
70<br />
May 2011 © Crown Copyright 2011
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 />
71<br />
May 2011 © Crown Copyright 2011
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 />
72<br />
May 2011 © Crown Copyright 2011
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 />
73<br />
May 2011 © Crown Copyright 2011
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 />
74<br />
May 2011 © Crown Copyright 2011
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 />
75<br />
May 2011 © Crown Copyright 2011
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 />
76<br />
May 2011 © Crown Copyright 2011
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 />
77<br />
May 2011 © Crown Copyright 2011
<strong>CMU</strong> Data collection fields<br />
78<br />
May 2011 © Crown Copyright 2011<br />
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 />
79<br />
May 2011 © Crown Copyright 2011<br />
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 />
May 2011 © Crown Copyright 2011
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 />
81<br />
May 2011 © Crown Copyright 2011
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 />
82<br />
May 2011 © Crown Copyright 2011
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 />
83<br />
May 2011 © Crown Copyright 2011
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 />
84<br />
May 2011 © Crown Copyright 2011
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 />
85<br />
May 2011 © Crown Copyright 2011
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 />
86<br />
May 2011 © Crown Copyright 2011
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