Commercial Medicines Unit

Transcription

1 Commercial Medicines Unit Procurement guidance For The provision of homecare delivery service of medicines to patients at home Issue date: May 2011 Review date: Sep September 2012 Crown Copyright 2011

2 Contents Page 1. Introduction 3 2. National Homecare Medicines Committee (NHMC) 4 3. Market overview 7 4. Comparison of home delivery methods Data collection Homecare delivery service providers Stakeholders Therapy list Specification Core 26 Deliver and Service 32 Product Prescribing and dispensing 36 Equipment and ancillaries 40 Training and Education of staff and patients 43 Nursing services Award Criteria CMU homecare medicines team 53 Appendix 1 Glossary of Terms 54 Appendix 2 Patient registration form 60 Appendix 3 Change management form 62 Appendix 4 Data template 79 Appendix 5 KPI s 80 Appendix 6 Patient survey 81 Appendix 7 Complaints and adverse incidents 84 Appendix 8 Refrigeration 88 2 September 2012 Crown Copyright 2011

3 Introduction The Commercial Medicines Unit (CMU) in conjunction with the National Homecare Medicines Committee have produced the enclosed guidance and generic specifications to support service users, providers and most importantly patients in the procurement of a homecare delivery service of medications to patient s homes. The best practice guidance document gives you an insight into the market, homecare delivery service providers, stakeholders and key market information which is pertinent to the homecare delivery service of medicines. Specifications have been produced with wide consultation and are intended to be as generic and reflective as possible of the NHS needs, in order that they can be used as a template for a number of therapy areas. It is intended that to the latter part of 2010 the homecare team in conjunction with NHMC will develop therapy specific guidance to support other market areas such as; Total Parenteral Nutrition (TPN) and Cystic Fibrosis (CF) as it is felt these therapy areas may require specific guidance documents. Specification and guidance documentation cover: Core Deliver and Service Product Prescribing and Dispensing Equipment and Ancillaries Training and Education of staff and patients Nursing Services Patient Registration forms Change Management guidance Data template KPI s Patient questionnaire Complaints and adverse incident form Refrigeration Other key documentation held on the CMU homecare website cover: Audit procedures as best practice regional QA and pharmacy procurement specialist should review the awarded suppliers audit reports prior to the final contract decision Award criteria 3 September 2012 Crown Copyright 2011

4 National Homecare Medicines Committee (NHMC) The NHMC was formed as a sub group of National Pharmaceutical Supply Group as it was recognised that this market was expanding and needed to be managed effectively in order to ensure patient safety and clinical effectiveness. The committee consists of representatives of stakeholder professions with experience in the area of homecare medicines delivery and service in primary care, secondary care, specialised commissioning and industry. CMU facilitates and manages this committee. Members of the NHMC, homecare delivery service providers, Secondary care trusts, Primary Care Trust, NPSG, Specialised Commissioning, Hubs and QA have been consulted during the production of this document. The guidance will be reviewed on a six monthly basis, next review date November Committee members (as at January 2012) Allan Karr (Chair) Pharmacy Business Manager, University College London Hospitals NHS Foundation Trust Tel: allan.karr@uclh.nhs.uk Jim Armstrong Specialist Procurement Pharmacist, South East Coast (NHS Commercial Solutions) Tel: jim.armstrong@medway.nhs.uk Karen Bell Sourcing Specialist, Homecare, NHS Commercial Medicines Unit (CMU) Tel: karen.bell@cmu.nhs.uk Lorraine Booth Regional Specialist Procurement Pharmacist North West England Tel : mob : lorraine.booth@stockport.nhs.uk Graham Brack Pharmaceutical Adviser, NHS Cornwall and Isles of Scilly PCT Tel : Graham.Brack@ciospct.cornwall.nhs.uk Teresa Brannigan Contracts Officer, NHS Wales Shared Service Partnership, Procurement Services (NWSSPPS) Tel: Teresa.brannigan2@wales.nhs.uk Michael Butterfield Specialist Pharmacy Technician: Homecare Medicines Management Leeds Teachings Hospitals NHS Trust Tel: Michael.Butterfield@leedsth.nhs.uk 4 September 2012 Crown Copyright 2011

5 Carol Clark Category Specialist, Homecare, NHS Commercial Medicines Unit (CMU) Tel: David Cook Specialist Procurement Pharmacist, North East England Tel: Judi Cross Pharmaceutical Advisor, South East Coast SCG Tel: Phil Deady Pharmacy Procurement Manager, Leeds Teaching Hospitals NHS Trust Tel: Margaret Dolan Pharmaceutical Adviser, National Procurement, NHS National Services Scotland Tel: Mobile: Alastair Gibson Director of Pharmacy, Blackpool Teaching Hospitals NHS Foundation Trust Tel: Nick Haslem Commissioning Manager, South East Coast Specialised Commissioning Group Tel: Stephanie Hibbs Project Manager, London Procurement Programme Tel stephanie.hibbs@imperial.nhs.uk Mark Jackson Deputy Director, Quality Control North West Tel Mark.jackson@lrippu.nhs.uk Jane Kelly Procurement Project Pharmacist, Leeds Teaching Hospitals NHS Trust Tel: Jane.kelly@leedsth.nhs.uk Michael Mc Beth Specialist Procurement Pharmacist Newcastle Upon Tyne Hospitals NHS Foundation Trust Tel : michael.mcbeth@nuth.nhs.uk Sarah Pacey Assistant Chief Pharmacist, Procurement, Therapeutics and Medicines Performance, Nottingham University Hospitals NHS Trust Tel: sarah.pacey@nuh.nhs.uk 5 September 2012 Crown Copyright 2011

6 Liz Payne Category Manager, Homecare, NHS Commercial Medicines Unit (CMU) Tel: Dr Nick Payne Chairman, National Clinical Homecare Association (NCHA Limited) Tel : nick.payne@clinicalhomecare.co.uk Cherryl Perry Customer Supply Chain Manager, Abbott Laboratories, representing ABPI Tel: cherryl.perry@abbott.com Simon Perkins Category Specialist, Homecare, NHS Commercial Medicines Unit (CMU) Tel: simon.perkins@cmu.nhs.uk Bernadette Porter Nurse Consultant,The National Hospital for Neurology & Neurosurgery, University College London Hospitals NHS Foundation Trust Tel: bernie.porter@uclh.org David Stead Medicines Procurement Lead for South West, United Bristol Hospitals NHS Trust Tel: david.stead@uhbristol.nhs.uk Dr.Richard Sturgess All Wales Technical and Computer Services Pharmacist Tel: richard.sturgess@wales.nhs.uk Liz Sutton Pharmacy Procurement Manager,Buckinghamshire Healthcare Trust Tel: Liz.Sutton@buckshealthcare.nh.uk Kevan Wind Medicines Procurement Specialist Pharmacist, London and East of England Tel: , mobile kevan.wind@southend.nhs.uk 6 September 2012 Crown Copyright 2011

7 Market overview A medicine homecare delivery service can be described as one that delivers ongoing medicine supplies and where necessary associated care, initiated by a hospital prescriber, direct to a patient s home with their consent. The purpose of the homecare delivery service is to improve patient care and choice for their clinical treatments. Patients that are typically on homecare are those with chronic diseases and stable treatment regimens that do not require acute care input. Currently, most homecare delivery service is initiated by hospital trusts, which normally administer medicines to patients within their own hospital environment. However, on some occasions the supply and administration of medicines is better provided directly to the patient in their own home. For example, there are many therapy areas which will cause patients logistic difficulties with the provision of heavy and large volumes containers which are required for their treatment e.g. dialysis solutions, total TPN, Enteral feeds. The use of such medicine homecare delivery services is expanding throughout the UK with an estimated 120,000 plus patients now receive their medicines via the homecare route. The value of medicines being supplied by this route is estimated to be well in excess of 500 million. These figures are expected to increase substantially as clinical services follow the vision for building on the strengths of pharmacy, using that capacity and capability to deliver further improvements in pharmaceutical services over the coming years as part of an overall strategy to ensure safe, effective, fairer and more personalised patient care. ¹ It must be noted that at the beginning of any homecare medicines service whether it is initiated by a hospital trust or pct dialogue must be undertaken with the manufacturers of the medicine at the beginning of the process to ensure product visibility and agreement for distribution. Homecare delivery service can be further sub-divided into low-tech or high tech. Other definitions are also possible. (a) High Tech Homecare This will include all: Intravenous therapy Other injectable therapy where significant support is required e.g. consumables, storage, monitoring, preparation and administration. Any oral therapy that requires significant support such as blood level monitoring or special storage requirements 1. Department of Health, publications Pharmacy in England: building on strengths delivery the future 7 September 2012 Crown Copyright 2011

8 (b) Low-tech homecare This will include all: Oral medication and external preparations that require no other support than standard concordance monitoring from the homecare delivery service provider. Injectable therapy that is not intravenous and requires little support other than concordance monitoring. What are the benefits of homecare? There are many benefits in using homecare, key among which is that for many patients it would be necessary to make visits to hospital solely to receive periodic treatment or prescriptions. Homecare delivery services avoids this need, thereby also freeing both patient and hospital time. Homecare can also release hospital beds and return patients to their homes earlier. An example of this would be cystic fibrosis homecare services: not only does homecare decrease hospital visits but also decreases the chances of cross-infection in this vulnerable patient group. Where appropriate homecare services can be commissioned with nursing support to ensure seamless delivery of care without creating any burden to community services. Where patients are receiving a range of home medicines, homecare may offer the opportunity of providing all medications through a single provider. Homecare offers the opportunity of providing high quality, cost effective and accessible care to specific patient groups. Medicines homecare delivery services will vary according to the degree of intervention The types of medicine delivery services provided by a homecare delivery service provider can include the delivery process, pharmaceutical dispensing, and sterile preparation of injectable medicines in a ready to use form, phlebotomy services and nurse or patient administration of injectables. This potentially high level of medical and clinical care will require highly trained staff. The staff are currently either employed by the provider trust or perhaps more commonly by a commercial homecare delivery service providers. A considerable amount of attention should be given to ensure that all clinical governance arrangements are formally agreed and adhered to. It is worth clarifying that Shared Care is different from homecare. In shared care prescribing responsibility passes to the GP in agreement with the Consultant and Primary Care Trust (PCT). In the case of medicine homecare the responsibility for the clinical care remains with the hospital prescriber. How do homecare delivery services work? Typically, homecare arrangements began informally with acute trusts arranging a service for discharged patients, with reimbursement of costs by the PCT. Control was often minimal, but the risk to the PCT was low and the number of patients small. It is clear however that more formal arrangements are necessary. In many areas these have now been developed and robust processes with dedicated teams afford much more control and governance, but some trusts may not have yet instituted this level of control. 8 September 2012 Crown Copyright 2011

9 Effective clinical governance is fundamental to homecare delivery services due to the shared nature of the service with acute trusts retaining clinical responsibility, care usually being delivered through an independent contractor and in some case a third party being involved where services are directly funded by PCTs. In addition, each prescription causes generation of an order, delivery note and invoice which must be reconciled, and the timely issuing of prescriptions has to be managed. The use of homecare delivery services introduces an additional dimension into the care of patients. It exposes a wide range of issues including communication regarding treatment outcomes, therapeutic intent and adverse reactions. There requires to be absolute clarity regarding what information can be provided and by whom. Clear communication channels regarding concordance and adverse incidents with the responsible consultant will need to be put in place. Homecare delivery services are most effectively provided when purchased through joint working arrangements between acute trusts and PCTs. It is also recommended that pharmacy procurement specialists are involved to harness expertise of collaborative contracting and tender exercises. What is the role of PCT's in homecare? The day to day management should be retained by the organisation that has clinical responsibility of the patient, usually the acute trust. Acute trusts and PCTs should work in conjunction in agreeing and establishing service criteria and also ensuring appropriate contractual and governance arrangements for homecare delivery services. Joint working is recommended in: agreed that a homecare delivery service is a suitable route for the provision of a specific clinical service. ensuring that the tendering process is appropriately conducted preferably with those with experience in homecare delivery service contracting, and a formal contract and/or Service Level Agreement is in place. ensuring that the service provided by the appointed homecare delivery service provider is monitored regularly and thoroughly. ensuring there is an appropriate, efficient and adequately resourced process to verify the administration of the prescriptions, purchase orders, delivery notes and invoices. VAT The points below are a summary of discussions with HM Revenue & Customs (HMRC) and are an overview only. The NHMC takes no responsibility for any inaccuracies and NHS trusts are advised to secure their own advice with regard to particular arrangements. VAT liability of homecare delivered medicines and associated services. 9 September 2012 Crown Copyright 2011

10 o Medicines dispensed to individuals for their personal use, dispensed by a registered pharmacist against a prescription issued by a registered doctor or nurse for administration in their own home (or residential home) are zero-rated. o Pharmacy dispensing services provided by a registered pharmacist are exempt from VAT o Delivery services are subject to VAT at the standard rate o Where two or more of the above elements form part of a composite supply, the predominant element will determine the VAT liability of the whole. Homecare delivery service providers will seek advice from their local HMRC office who will advise on the VAT status of the proposed services The homecare delivery service provider is responsible for collecting the VAT where applicable. If the homecare delivery service provider fails to charge the customer VAT and later finds that its interpretation was incorrect, the HMRC will pursue the homecare delivery service provider for payment of the under declared VAT. It may be that, the homecare delivery service provider will approach its customer seeking further payment, whether or not the customer should make further payment is a commercial matter between the two parties and the HMRC would not involve itself in that issue. Medicines used while an individual is receiving care or medical or surgical treatment in a hospital or nursing home - whether as an in-patient, resident, day-patient or outpatient - cannot be zero rated. The VAT (Drugs, Medicines, and Aids for the Handicapped) Order 1997/2744 which came into effect on 1 January 1998 is outlined in Business Brief 29/97 Comparison of Homecare Delivery methods The method of delivery chosen should involve a local risk assessment and give due consideration to the convenience for the patient. The final decision on the delivery route chosen should be documented in the service level agreement and also include the consent by each individual patient. The most frequent delivery method used by homecare delivery service provider is the use of dedicated vans and suitably trained drivers. The vans must be able to demonstrate validated cold chain where this is required and in all cases show that temperature control is within an acceptable range for the storage of medicines. All packages should be tamper evident. It is expected that on making the delivery the driver will put away stock, remove waste packaging, rotate stock and where appropriate monitor fridge temperatures. The homecare delivery service provider must inform the patient as soon as possible if for any reason delivery cannot be made. If it is necessary to arrange delivery through third part couriers then they should adhere to the usual agreed procedures. For certain services or emergency deliveries the use of national parcel carriers or Royal Mail is used. Where such postal services are used, either via the Royal Mail or other carriers, it is advisable to check with the 10 September 2012 Crown Copyright 2011

11 homecare delivery service provider on any restrictions that apply. The Post Office has useful information on its website ( Consideration should also be given to any advice from the Royal Pharmaceutical Society. All items must be securely wrapped to prevent loss or damage to the contents and also to avoid harm to recipients or postal employees. Any item should be contained in a strong inner container and enclosed in an outer packaging. This should ensure that any spillage is contained within the outer packaging. For liquids, it is recommended that any tins or bottles should be sealed with tape, wrapped in polythene, sealed again and surrounded with an absorbent material to soak up any leakage. Although medicines could be sent by ordinary post when needed, Royal Mail recommends using their 'Special Delivery' service to guarantee next day delivery and obtain the recipient's signature. It is the supplying pharmacists responsibility to ensure that the patient receives their medication. In the case of the Royal Mail medicines for medical purposes may be posted provided these are supplied lawfully. This is however subject to their prior written approval, (which may be subject to conditions, including the type of medicines that may be sent, how, when, by whom and to whom), and subject to such items being sent in suitable tamper-proof packaging and only being sent by Royal Mail's Special Delivery or Recorded Delivery services. Although the Royal Mail may request full details of any medicines being posted, registered pharmacies are not normally required to provide this information. The following restrictions for posting medicines apply. The only type of Controlled Drugs permitted are those classified as Schedule 4 e.g. Benzodiazepines. All other types of CDs are prohibited. Guidance may be sought from the Home Office or visit Items requiring refrigeration are prohibited unless specialist containers are used which have been validated to demonstrate suitable temperature control. Any medicine that uses an aerosol where the volume exceeds 50ml is prohibited. Any aerosols that use flammable or toxic gases as propellants are also prohibited. COMPARISON OF DELIVERY METHODS SERVICE TYPE STRENGTHS WEAKNESSES Postal ( including special delivery Lowest cost option for small number of deliveries. Loss incidence higher than with dedicated van. Track & Trace capability. No facility to check stock Insurance cover for loss of within patients homes. product and delivery failure. No certainty regarding Post office pick-up point if patient is not at home. delivery time (but before 9am service available) Certain categories of medicines prohibited. Unable to send items requiring refrigeration. Dedicated van and driver Deliveries consistently by the same driver. Highest cost option. Backup needed for when September Crown Copyright 2011

12 Ability to conduct stock checks in patients homes. May offer a secure key holding service for access when the patient is out. Lower losses than post or courier. Flexibility facility to redirect van for urgent needs. Weekend deliveries. the vehicle is off the road and during holidays. Driver needs suitable training Police check of driver required Data collection CMU has not captured homecare delivery service information on either the BTT or Pharmex applications. The introductions of homecare services to CMU lead to a requirement for new business processes and applications. The strategic objectives for the collection are:- Understand value of homecare market to inform national procurement strategy. Unbundle service and delivery costs from pharmaceutical costs. Identify where savings can be made. Quantify volumes, usage and spend for contracting purposes. Benchmark prices in order to drive best practice. Identify patient numbers for homecare by trust, therapy, product and service. Manage risk in homecare market and ensure appropriate level of competition. Measure trends in growth of the homecare market. Provide a central resource of data for the NHS on homecare spend. Ensure that CMU is able to respond to Department of Health request for information on NHS Homecare spends. Enable the DH to make informed policy decisions on homecare services Avoid any duplication of effort on homecare processes within NHS organisations. Collection of data will be consistent with NHS data and coding standards. The to be strategic vision from the government and the NHS is to have a more joined up, do Once and Share, Auto-identification and data capture (AIDC) health service². CMU is a leading body of this change and is committed to supporting the standards needed to make this change happen. 12 September 2012 Crown Copyright 2011

13 2. Coding for Success Simple technology for safer patient care, Healthcare Quality Directorate, Department of Health CMU data collection project objectives 1. Collect homecare medicine usage and spend data from homecare delivery service providers. 2. Collect homecare service data from homecare delivery service providers. 3. Collect homecare medicine usage and spend data backdated to the beginning of Ensure that the data collection process does not allow duplication of transaction (spend and usage) reporting. 5. Where NHS data standards do not exist, document a consistent data specification to support the exchange of medicine and service information between DH MPIG, CMU, NHS trusts and purchasing groups (for example, hubs) and suppliers. 6. Provide homecare delivery service providers with the capability to provide and access homecare data direct to/from CMU. 7. Provide trusts with the capability to access homecare data direct from CMU. 8. Facilitate more accurate and timely (near real time) homecare reporting capability. 9. Remove homecare delivery service provider reporting medicine usage and spend to individual trusts. Replace with a collective report submitted to CMU. 10. Collect key performance indicators (KPI s) on homecare delivery service providers to use to make informed contract adjudication decisions (against award criteria weightings). Appendix 5 13 September 2012 Crown Copyright 2011

14 CMU Data collection fields 14 September 2012 Crown Copyright 2011

15 TRUST WORLD PPRS Reports Other Reports PPRS NHS CMU World Phacter (planned) Trust - Pharmacist Pharmacy Trust Procurement Systems medicinal spend and usage DATA CAPTURED Usage ERM CIMS Phate Contract Price Category Specialist Secondary Care Trust provides medicinal product NHS CMU Web Usage Load Transaction Files Pharmex IBT Benefits BTT 1. Secondary Care Trust spend and usage Data Analyst Load Transaction Files Medicinal Product Baseline Price (weighted average purchase price paid by trust over the latest four months) medicinal spend and usage DATA CAPTURED NEW - Homecare Data Collection Project Supplier service spend and usage figures MEDICINE DATA NOT CAPTURED PCA (Only FP10) 2. NHS Prescription Services Invoice and reports Purchase Quantity Purchase Price Service Price SUPPLIER WORLD Homecare service purchases Medicinal Product Purchase Price Payment Homecare Provider Pharmaceutical (Supplier) Manufacturer (Supplier) Delivery Note 3. Primary Care Trust Secondary Trust Clinician Purchase Order Homecare Service delivers to Patient Hospital Prescription OPD Script FP10 Prescription (to PCA) Patient Framework Agreements Trust may have a contract price Homecare delivery services Overview - Thick vertical dotted line illustrates new Homecare delivery service provider information flow to CMU Crown Copyright 2011 May

16 Homecare delivery service providers The market is growing and new entrants are emerging both SME and multinationals. In the UK the major suppliers are:- These suppliers are currently providing, or have shown an interest in supplying, a home delivery service This IS NOT an approved list, these suppliers have not been vetted by CMU or the National Homecare Medicines Committee (NHMC) Homecare Service Providers Address 1 Address 2 Town County Alcura UK Ltd (formerly known as Central Selbourne Homecare) House Mill Lane Alton Hampshire Baxter Healthcare Limited T/A Willow Healthcare Services B Braun Medical Ltd Bupa Home Healthcare Calea UK Limited Chemistree Homecare Evolution Homecare Services Ltd (Part of Celesio AG.) Unit 1 North Orbital Commercial Park Brookdale Road Napsbury Lane St Albans Herts. Thorncliffe Park Estate Chapeltown Sheffield Unit 4 Scimitar Park Roydon Road Harlow Essex Eastgate Way, Manor Cestrian Court Park Runcorn Cheshire Unit 7 Curo Park Park Street Frogmore St Albans Technology House 239 Ampthill Road Bedford Bedfordshire Post Code Contact Position Head of GU34 Sarah Commercial 2QJ Purvis Support AL1 1XB S35 2PW CM19 5GU WA7 1NT AL2 2DD MK42 9QG Mo Rahman Steve Lane Zbigniew Zapalowski Sukhbir Rall Colin Hughes Alton Austin Christina Potts Gitika Kalra/Sam Bhudheo Paul Prober Business Manager Head of Homecare (Baxter) Sales and Marketing Manager Sales and Market Development Manager Service and Product Manager Commercial Manager Senior Product Manager Business Development Homecare Manager/ Director of Homecare Contracts & Sales Support Manager Telephone number Sarah.purvis@alliancehealthcare.co.uk e@baxter.com zbigniew.zapalowski@b braun.com; sukhbir.rall@bbraun.co m; colin.hughes@bbraun.c om aaustin@bupahomeheal thcare.com / Mobile Number Website Comments Low and High Tech Services provided christina.potts@caleaonline.co.uk Sam.b@chemistree.co.u k Gitika.k@chemistree.co. uk paul.probert@evolutionh omecare.co.uk s.co.uk co.uk mehealthcar e.com Low and High Tech Services provided Low and High Tech Services provided Low & High Tech complex and continuing care Member of the National Clinical Homecare Association Yes Yes Yes Yes o.uk High Tech Yes ree.co.uk nhomecare.c o.uk Low and High tech - incl CF, all IV Low and High Tech Services provided No Yes Crown Copyright 2011 May

17 Healthcare at Home Ltd 2nd Floor, The Kings Fund Cavensish Square Medco Health Solutions (UK) Bewer House Caswell Road Polar Speed Unit 8 Chartmoor Road London Brackmills Industrial Estate Leighton Buzzard Northampton Bedfordshire W1G 0AN NN4 7BZ LU7 4WG Ruth Poole Stephen McAndrew Graeme Duncan Alison Davis Richard Holmes / Rosie Jeans Group Commercial Director Commercial Director - NHS Commercial Director - NHS Pharma Sales and Marketing Director Managing Director (designate)/ Chief Pharmacist Ruth.Poole@hah.co.uk; stephen.mcandrew@ha alison.davis@medcohea lth.co.uk (Richard richard.holmes@polarsp (Main Line) Holmes) eed.com;rosie.jeans@p olarspeed.com; (Pharmacy) (Rosie Jeans) uk health.co.uk eed.com Low and High Tech - Integrated Homecare Services Low and High Tech Services provided Chill Chain (act as distributors for Careology Yes Yes Yes Homecare stakeholder map Crown Copyright 2011 May

18 Wider environment NICE Secretary of State PPD MHRA Business influencers HM Treasury HRG4 (PbR) PMSG BCAG JCWG Operational Pharmacists DOH MPIG Specialist Commissioner NHS CMU Homecare Provider Pharmacy Manufacturers DOH PPRS Clinicians NPSG NHS QA PCT Secondary Care Trust CPHs NCHA OFT NHMC NHS ABPI Crown Copyright 2011 May

19 List of products and therapies The tables below lists therapy areas and conditions which are currently treated through homecare and examples of the drugs involved. The list of medicines (table 1) are catalogued as they first appear in the BNF and the list is in BNF order. They have not been duplicated where they have more than one indication e.g. Methotrexate first appears under Cytotoxic Drugs and is not repeated under Rheumatology. Table (2) is an alphabetical list of products that have been distributed to patients homes by brand name. These are not exhaustive lists. Please contact if you are aware of any other products which are being supplied via homecare. Table (1) Therapy areas and conditions which are currently treated through homecare BNF Section Therapy area Medicine Specific medicine Cardiology Congestive heart failure Milrinone Primacor Vasodilator antihypertensives Antifibrinolytics Respiratory Selective beta2 agonists Iloprost Epoprostenol Bosentan Sildenafil Sitaxentan Blood Factors V11, V11a, V111, IX Terbutaline Ventavis Flolan Tracleer Revatio Thelin Advate, Benefix, Haemate P. Helixate NexGen, Kogenate, Novoseven, ReFacto, Bricanyl Allergic asthma Omalizumab Xolair 3.6 Oxygen Oxygen Mucolytics CNS Antipsychotic drugs Dornase Alfa Pulmozyme Clozaril Denzapine Zaponex Parkinsons disease APO-Go Crown Copyright 2011 May

20 BNF Section Therapy area Medicine Specific medicine Infections Cystic fibrosis Tobramycin Colomycin Imipenem & Cilastatin Amikacin Tobi Colistin Primaxin Amikin Antitubercolosis Capreomycin Rifabutin Pyrazinamide Rifampacin & isoniazid combinations Capstat Mycobutin Rifater, Rifinah HIV Antivirals and related medicines Baraclude Viral Hepatitis Entecavir Hepatitis C Interferon Intron A, Roferon A, Viraferon Pegylated Interferon Pegintron, ViraferonPeg Ribavirin Copegus, Rebetol Crown Copyright 2011 May

21 BNF Section Therapy area Medicine Specific medicine Endocrine Infertility Chorionic Gonadotrophin Choriogonadotropin Alfa Follitropin Alfa Follitropin Beta Human Menopausal Gonadotrophins Lutropin Alfa Choragon, Pregnyl Ovitrelle Gonal-F Puregon Menogon,Menopur Luveris Bone metabolism & Growth hormone Somatropin Saizen Zomacton Genotrope, Humatrope, Norditropin, Nutropin Aq., Saizen, Zomacton Forsteo Bone metabolism & Growth hormone Multiple sclerosis Malignant disease Cytotoxic drugs Teriparatide Interferon Beta 1a Interferon beta 1b Glatiramer Natalizumab Capecitabine Gemcitabine Methotrexate Erlotinib Imatinib Topotecan Trastuzumab Bortezomib Bevacizumab Avonex, Rebif Betaferon, Copaxone Tysabri Xeloda Gemzar Tarceva Glivec Hycamtin Herceptin Velcade Avastin 8.2 Immunosuppressants Mycophenolate Ciclosporin Sirolimus Tacrolimus Cellcept, Myfortic Neoral, Sandimmune Rapamune Prograf, Advagraf Hormone antagonists Lanreotide Octreotide Somatuline LA and Autogel Sandostatin and LAR Crown Copyright 2011 May

22 BNF Section Therapy area Medicine Specific medicine Nutrition and Blood Anaemia Darbopoetin Epoetin Alfa Epoetin Beta Aranesp Eprex, Retocrit NeoRecormon Thalassaemia Desferrioxamine Desferasirox Deferipirone Desferal Exjade Ferriprox 9.3 Parenteral nutrition TPN Gauchers disease Imiglucerase Miglustat Cerezyme Zavesca Fabrys disease Agalsidase beta Agalsidase alfa Fabrazyme Replagal MPS VI Galsufase Nagalzyme MPS II Idursulfase Elaprase Musculoskeletal Rheumatic Disease Adalimumab Etanercept Infliximab Methotrexate Rituximab Humira Enbrel Remicade Metoject Mabthera Skin Psoriasis Efalizumab Raptiva Metabolic Disorders Mucopolysaccharidosis Aldurazyme Laronidase Pompe s Disease Alglucosidase Alfa Myozyme Vaccines and antisera 14.5 (IV Immunoglobulin) SC IV Subcuvia Subgam Vivaglobin Flebogamma Gammagard Octagam Sandoglobulin Vigam Crown Copyright 2011 May

23 Table (2) Alphabetical list of products that have been distributed to patients homes by brand name. 1 APO-Go 36 Gonal-F 71 Raptiva 2 Advagraf 37 Haemate P 72 Rebetol 3 Advate 38 Helixate 73 Rebif 4 Amikin 39 Herceptin 74 ReFacto 5 Aranesp 40 Humatrope 75 Remicade 6 Avastin 41 Humira 76 Replagel 7 Avonex 42 Hycamtin 77 Retocrit 8 Baraclude 43 Intron A 78 Revatio 9 Benefix 44 Kogenate 79 Rifater 10 Betaferon 45 Laronidase 80 Rifinah 11 Bricanyl 46 Luveris 81 Roferon A 12 Capstat 47 Mabthera 82 Saizen 13 Cellcept 48 Menogon 83 Sandimmune 14 Cerezyme 49 Menopur 84 Sandoglobulin 15 Clozaril 50 Metoject 85 Sandostatin and LAR 16 Colistin 51 Mycobutin 86 Somatuline LA and autogel 17 Copaxone 52 Myfortic 87 Subcuvia 18 Copegus 53 Myozyme 88 Subgam 19 Choragon 54 Nagalzyme 89 Tarceva 20 Denzapine 55 Neoral 90 Thelin 21 Desferal 56 MeoRecormon 91 Tobi 22 Dynepro 57 NexGen 92 Tracleer 23 Elaprase 58 Norditropin 93 Tysabri 24 Enbrel 59 Novoseven 94 Velcade 25 Eprex 60 Nutropin Aq 95 Ventavis 26 Exjade 61 Octagam 96 Vigam 27 Fabrazyme 62 Ovitrelle 97 Viraferon 28 Ferriprox 63 Pegintron 98 ViraferonPeg 29 Flebogamma 64 Pregnyl 99 Vivaglobin 30 Flolan 65 Primacor 100 Xeloda 31 Forsteo 66 Primaxin 101 Xolair 32 Gammagard 67 Prograf 102 Zomacton 33 Gemzar 68 Pulmozyme 103 Zaponex 34 Genotrope 69 Puregon 104 Zavesca 35 Glivec 70 Rapamune Crown Copyright 2011 May

24 1. Introduction Specification document for Homecare Medicines Core 1.1 This specification outlines the general requirements for any Homecare Medicine service purchased by the NHS in England. There are further supplementary specifications which outline the specific requirements with regard to: Delivery and service Product (medicines), prescribing and dispensing Information and training for patients and staff Nursing services to be provided Equipment and ancillaries. Compounding Services. There may also be some requirements which are therapy specific which should be detailed separately. These documents have been produced in partnership with Commercial Medicines Unit (CMU) and the National Homecare Medicines Committee, in consultation with NHS and industry. The guidance should be utilised by all NHS Organisations. 2. Scope 2.1 This Framework agreement is for provision of a homecare medicines service, which may include the following therapies and medicines. {insert list here} 2.2 It is anticipated that the scope in terms of numbers of patients and boundaries of provision will change during the term of this framework but will be limited to the therapies listed and patients being treated by the Purchasing Authorities listed. Provision will be made for implementing these changes in a way that is acceptable to all parties, and taking into account patient choice and significant market changes. 2.3 Further detail of the product and services requirements are provided throughout this specification. Appendix XX gives further detail on the current provision of these services and an indication of any planned developments and strategic direction. 3. Definitions Appendix One Crown Copyright 2011 May

25 4. Duration of Framework 4.1 Subject to the provision of the Terms and Conditions, this framework shall remain in force for the period of [Period] months commencing 1 [Month] 20XX. In addition there will be an option to extend the framework for up to a further 24 months. 5. Selection, Registration and Discharge of Patients 5.1 Patient selection will be carried out by the Purchasing Authority. The Purchasing Authority will confirm the patient s motivation and suitability for the home delivery scheme. 5.2 Assessment of the patient s home environment will be the responsibility of the Purchasing Authority. 5.3 Service will not commence until the Purchasing Authority has gained patient consent and the Purchasing Authority has evidence as to the suitability for the patient to receive a home delivery service. 5.4 The Purchasing Authority will complete a registration form for each patient, for dispatch to the Contractor. The NHMC recommended standard registration form is included at Appendix Two. On receipt of the registration paperwork, the Contractor will identify the service elements and activate as required. 5.5 The Contractor will adopt and use the Purchasing Authority s patient unique identifier to identify each patient once the registration forms have been accepted. 5.6 The Contractor will make initial contact with the patient to confirm registration, and explain the process in line with the requirements of the patient information section of this specification. 5.7 As the home delivery of each patient is transferred to the Contractor, it will be the responsibility of the Contractor and the Purchasing Authority to ensure a smooth transition from hospital to homebased supply. As the patient's delivery is transferred to the contractor, it will be the responsibility of the Contractor and the Purchasing Authority to ensure a smooth transition to the contractor. Agreement must be made and stated on the original order of when homecare provision needs to commence. It is the responsibility of the Purchasing Authority to communicate this to the patient. 5.8 Following registration the Contractor must receive an official order in addition to a prescription from the Purchasing Authority to commence a delivery. Failure to receive an official order could result in non payment 5.9 When patients care transfers between contractors, the contractors involved must follow the NHMC Change Management Policy. See appendix three In the event of a patient no longer requiring the Homecare medicines service due to transfer to another therapy, admission into hospital or returning to collecting medicines from hospital, the Crown Copyright 2011 May

26 Purchasing Authority may request the Contractor to collect all new and un-used stock and dispose of them as necessary or reimburse the Purchasing Authority. Where a patient's care is transferred between contractors, all contractors must follow the NHMC procedure for change management with patient or patient's family consent. All equipment will be collected and returned to the appropriate provider In the event of a patient s death the process described in 5.10 will be carried out with particular sensitivity at a time convenient to the patient s family or carer. 6. Quality of Goods 6.1 The Contractor warrants represents and undertakes that any goods held and then supplied by it will: Pass any tests and trials the Purchasing Authority requires to satisfy itself that the goods are not injurious to health including without limitation any tests and trials conducted by NIBSC where applicable Meet the product specification. In the event of any dispute as to whether the goods have been supplied in accordance with the relevant specification, the authority shall refer the matter to the regional quality control pharmacist who shall keep a sample of the goods which the regional quality control pharmacist has previously approved as being in accordance with the specification and this sample shall be used as the standard against which all goods shall be measured in order to determine whether they have been supplied in accordance with the relevant specification; and The Contractor shall operate and maintain a quality control monitoring system which meets the requirements of the MHRA and NIBSC and is approved by the Purchasing Authority and make available to Purchasing Authority on demand the results of such quality control monitoring The Contractor shall adhere to any relevant national quality standards and general guidance recommended by bodies such as the National Pharmaceuticals Supply Group (NPSG), the Pharmaceuticals Market Support Group (PMSG), the National Homecare Medicines Committee (NHMC), Department of Health (DH), National Health Service (NHS), Care Quality Commission (CQC) and National Patient Safety Agency (NPSA) The reasons for any faulty or spoiled products will be notified by the Contractor to the Purchasing Authority in writing within 24 hours of the complaint or sooner where deemed appropriate 7. Management Information 7.1 The Contractor must ensure that records of all hospital sales detailing volumes and prices are kept and given to a nominated Authorised Officer of the Purchasing Authority on a monthly basis in the format given in Appendix four on an agreed date in an electronic format. Crown Copyright 2011 May

27 7.2 The Contractor must comply with all requests by the Department of Health, CMU, the National Homecare Medicines Committee (NHCMC) and the Purchasing Authority for management data to be provided in respect of the products supplied under this framework. This information is to be provided within 10 working days for ad hoc requests. 7.3 All reports of usage and expenditure will be coded so that patients names are not revealed by using a patient unique identifier. All requirements of the Data Protection Act 1998 and updates must be met in full. 7.4 Particular care must be taken on the security of patient information. Where identifiable patient personal information must be transmitted this must be by high level encryption, suppliers to be accredited to ISO Level 2 of the Information Governance Toolkit should be adhered to. (Further information can be found on or On occasion there will be a requirement to transmit data via electronic communication (i.e. e- mail) and/or computer disc (CD). When electronic means are used, each party shall ensure as far as reasonably practicable, that data is properly stored, is not accessible to unauthorised persons, is not altered, lost or destroyed and is capable of being retrieved only by properly authorised persons. Each party may apply special protection to electronic messages by encryption or by other agreed means, and may apply designations to the messages for protective interchange, handling and storage procedures. Unless the parties otherwise agree, the party receiving a message so protected or designated shall use at least the same level of protection and protective procedures for any further transmission of the message and its associated data for all responses to the message and for all other communications by interchange or otherwise to any other person relating to the message. If either party becomes aware of a security breach or breach of confidence in relation to any message or in relation to its procedures or systems (including, without limitation, unauthorised access to their systems for generation, authentication, authorisation, processing, transmission, storage, protection and file management of messages) then it shall immediately inform the other party of such breach. On being informed or becoming aware of a breach the party concerned shall: Immediately investigate the cause, effect and extent of such breach; report the results of the investigation to the other party; and use all reasonable endeavours to rectify the cause of such breach. 8. Performance Monitoring 8.1 The Purchasing Authority is responsible for monitoring Key Performance Indicators. Key Performance Indicators have been developed for the purpose of monitoring the performance of the Contractor and are detailed in Appendix five. The required information will be provided to the authorised officer at the Purchasing Authority at agreed intervals. In addition to this, the Homecare Provider is responsible for informing on any change in performance standards. Crown Copyright 2011 May

28 8.2 Contractors are required to provide a named contact responsible for the provision of management and performance information. The information must: be in the spreadsheet format prescribed by the Purchasing Authority contain product and/or service level detail for each NHS site or organisation and other third parties if appropriate be provided to the Purchasing Authority within five working days of the end of the appropriate sales month. 8.3 Framework monitoring meetings will be held with each of the successful Contractors by the Purchasing Authority at agreed intervals. 8.4 On occasion a questionnaire will be issued by the Purchasing Authority to the patient and/or carer in order to ascertain the quality of the level of service. This will be required to be included with deliveries that are dispatched by the Contractor. The Questionnaire will be supplied in an appropriate envelope by the Purchasing Authority. The distribution of questionnaires will be provided free of charge by the Contractor and questionnaires will be returned by patients directly to the Purchasing Authority. A standard questionnaire is included in Appendix 6 but this may be subject to change by the Purchasing Authority. 9. Arrangements for the Payment of Invoices 9.1 The Contractor shall issue invoices detailing the unique patient identifier, items supplied, itemised unit costs and framework references. 9.2 Invoices to include service charges, these charges must be separately stated on the invoice documentation and indicated by the Contractor even if only consumables and ancillaries. 9.3 The patient endorsed delivery note must be sent with each invoice by the Contractor Agent to the Purchasing Authorities Finance Department or Pharmacy as agreed. Only invoices that are cross-referenced to patient endorsed delivery notes must be authorised for payment by the Purchasing Authority. 10. Confidentiality 10.1 All contractors must comply with Section 35 on confidentiality in the NHS Conditions of Contract for the Supply of Services Patient and family confidentiality must be respected and preserved at all times. No circulars or questionnaires should be sent to patients, relatives, carers or GPs without the prior consent and agreement of the Authority. No patient contact will be made, other than that required by the Framework Participant s staff in the performance of their duties, or unless specifically requested to do so by the Participating Authority clinical team or other authorised personnel Crown Copyright 2011 May

29 10.3 All information, including prices, made available to the service Contractor or the service Contractor s employees under this framework must not be divulged for any purposes to any other party including other companies within the group. 11. Communications 11.1 Key individuals will be designated the point of contact for the homecare service within the Purchasing Authority and their contact numbers will be made known to the Contractor. These contacts will be for: Queries on referrals Finance/invoice queries Emergency/out of hours Performance monitoring Contractual queries Management information Complaints and adverse incidents. Prescription Queries The Homecare provider must also provide a list of their designated key contacts for the specific areas listed above. Please complete Appendix XX The Contractor must provide a named individual, deputy, and contact details for the above categories and ensure this information is kept up-to-date A free phone Help Line will be available 8:00am to 6:00pm (plus answer phone or emergency bleep outside those hours) 365 days a year, for patients and carers to contact the service Contractor by telephone for information on their products and services. All clinical issues or errors and/or incidents must be fed back by the contractor to the purchasing authority within 24 hours or sooner if deemed appropriate. 12. Managing Complaints and Adverse Incidents 12.1 Any complaints regarding the delivery or service, received from patients by the Purchasing Authority will be forwarded in writing to the Contractor for a written resolution within two weeks, unless requested by the Purchasing Authority to the contrary The Contractor must provide a complaints procedure and an incidents reporting procedure. The Purchasing Authority will share in advance their incidence policy and serious untoward incident policy with the contractor and the contractor must adhere to these policies. 13. Sub-Contractors 13.1 Where sub-contractors are used for the provision of products and service within this Framework agreement, all requirements within this specification will be extended to the sub-contractor and individuals involved. It is the responsibility of the Contractor to ensure that all sub-contractors meet these requirements and to inform the Purchasing Authority of any and all intended sub Crown Copyright 2011 May