Developing Commercial Support for Medicines Management V7 22 November 2010 Contents Page Executive summary 4 Introduction 6 Section One: 1. 2. Medicines management landscape 7 Medicines pricing 7 1.1 Pharmaceutical Price Regulation Scheme (PPRS) 7 1.2 Drug Tariff 8 1.3 Payment by Results (PbR) 9 Medicines supply 11 2.1 Background 11 2.2 Supply Chain 12 2.3 Issues with supply 10 3. Clinical and cost effectiveness: the role of NICE 13 4. High cost cancer drugs 13 5. Efficient prescribing 13 6. Quality and productivity: medicines procurement and use 13 7. Improving access to innovative medicines 14 8. Support for pharmaceutical procurement 14 8.1 The NHS Commercial Medicines Unit 14 8.2 Regional arrangements 15 8.3 Local arrangements 15 Section Two: Commercial support to medicines management 17 1. Development of commercial support in the NHS 17 2. Effectiveness in medicines management 18 3. Approach to developing commercial support guidance 19 4. Design principles for commercial support to medicines management 19 5. Priorities for medicines management commercial support functions 20 5.1 Business intelligence and business modelling 20 5.2 Adoption of best practice/ innovation 21 5.3 Facilitation of collaborative working 22 5.4 Implementation support for national strategies 24 2 6. Developing extended commercial functions to support medicines management 6.1 Operational performance 26 6.2 Medicines management systems 27 6.3 Market management 28 7. Focus of commercial activity 29 8. Operational considerations 30 8.1 Establishing services and a work programme 30 8.2 Staffing models 30 8.3 Determining level of commercial support 31 1. DH policy on medicines pharmacy and industry 10 2. Key relationships and dependencies in the supply chain 12 3. The environment to support effective medicines management 16 4. Priorities for medicines management support functions 20 5. Developing extended functions to support medicines management 26 6. Pharmaceutical market segmentation and associated issues 29 Figures Tables: Summary of functions and associated services 1. Business intelligence and business modelling 21 2. Adoption of best practice/ innovation 22 3. Facilitation of collaborative working 23 4. Implementing support for national strategies 24 5. Operational performance 27 6. Systems 28 7. Market management 28 Appendices 1. CSU medicines management support functions outcomes and benefits 31 2. Services associated with functions, outputs, outcomes and benefits 3. Glossary of relevant terms used in medicines management landscape 42 35 3 Developing Commercial Support for Medicines Management Executive summary 1. The challenge The use of medicines plays a vital role in the delivery of high quality care and accounts for over 12% of NHS expenditure. The pharmaceutical market is dynamic, with new medicines coming to market and rising demand for healthcare pushing expenditure. However, across the system expenditure is rising, particularly in secondary care where prescribing costs increased by 15.2% from 2007-2008. A range of initiatives delivered from national to local levels set out to manage the use of medicines effectively and achieve best value for money in a constantly changing market. There has been considerable success but there are still many wellrecognised challenges and good practice is not always adopted systematically. In a tough financial environment, these challenges need to be tackled effectively and must not be allowed to create barriers to securing better value for money. 2. The medicines management landscape Arrangements for pricing and supply of medicines are complex and medicines shortages and product discontinuations have become increasingly prevalent for a number of reasons. There is significant national interest and leadership in the most appropriate and cost effective use of medicines with the National Institute for Health and Clinical Excellence (NICE) to be put on a firmer statutory footing. The QIPP medicines use and procurement workstream is seeking to achieve additional potential savings of £475million a year by 2013-14. The NHS Commercial Medicines Unit (CMU) provides the nationally accepted route for contracting of medicines for secondary care and has established strategic leadership in medicines procurement areas considered important to the NHS. Significant supporting structures have been developed at regional/ local level with highly effective pharmaceutical networks established. Specialist procurement pharmacists play a key role in co-ordinating local trust decisions and ensuring they are aggregated locally, thereby ensuring that the NHS CMU frameworks meet the requirements of pharmacists and clinicians within the NHS. 3. The opportunity for commercial support Commercial support arrangements have been developed to respond to local need and this has resulted in a range of models to support commissioners and providers. There is an opportunity to explore whether commercial support could add value to the established systems, processes and expertise developed by specialist procurement pharmacists and the wider medicines management community, in order to drive further improvements in cost effective prescribing and to respond effectively to the needs of emerging clinical commissioners. 4 4. Developing the guidance This guidance has been developed in consultation with senior medicines management specialists and other stakeholders. It describes the complex medicines management environment and recommends where commercial support functions should be developed to assist the work of specialist procurement pharmacists most effectively. Clear principles are set out for working in partnership and collaboration. 5. Recommendations The functions that commercial support could provide are considered as core and non-core. Core functions are those viewed as priorities by medicines management specialists involved in the development of this guidance. Non-core functions may be considered as options for development based on an assessment of local needs. Commercial support functions for medicines management Functions Core Business Intelligence and Modelling Facilitation of Collaborative Working Implementation support for national strategies Adoption of Best Practice and Innovation NonCore Operational performance Systems Market Management 6. Anticipated benefits It is important that the added benefit from commercial support to medicines management be measured in a systematic and reproducible way. Benefits will vary on a project-by-project basis but are likely to fall into one of the following areas: ■ ■ ■ ■ 7. Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better information) Commercial risk reduction (decreased budgetary and supply chain risk) Quality (improved patient outcomes and experience, lower clinical risk) Next steps A number of projects have been set up to develop best commercial practice in supporting medicines management specialists in areas considered to have potential for high impact when rolled out nationally. These projects will set out to develop systematic measures of success and learning will be shared nationally. 5 Developing Commercial Support for Medicines Management Introduction The use of medicines plays a vital role in the delivery of high quality care and account for over 12% of NHS expenditure. In 2008-09, the NHS drugs bill was approx £11.4 billion, equivalent to around 12% of the entire NHS budget and the biggest single item of spend after staff. Of this around £7.8 billion was spent in primary care and £3.6billion in secondary care. Approximately 75% of the total spend was on branded medicines and 25% on generic medicines (including appliances, testing agents etc.) This cost is increasing at a rate of about 5% per year and when associated costs such as monitoring and service costs are added the true cost of medicines is much greater. Unintended costs may arise through adverse drug reactions, which are estimated to account directly for 5% of all hospital admissions.1 Analysis of historical trends for dispensing volumes reveals that between 1998 and 2008 the number of prescription items dispensed within the community in England increased from 513.2 million items in 1998 to 842.5 million items in 2008 (an increase of over 60%). Whilst the overall picture is one of increasing direct expenditure on medicines, this is not uniformly true across the whole health system. In primary care, total costs decreased by 0.7% from 2007- 2008. Within hospitals prescribing costs increased by 15.2% from 2007 to 2008 for medicines prescribed and dispensed within hospital. For medicines prescribed in hospital but dispensed within community settings via the hospital FP10 route, the increase over the same period was 5.2%. It is likely that this upwards pressure on expenditure will continue for the foreseeable future driven by factors such as improving access to innovative medicines and increasing levels of ill health associated with a population that is living longer. The Quality Innovation Productivity and Prevention workstream (QIPP) for medicines has identified £475million of potential savings a year by 2013-14 through more efficient use of medicines in primary care, better medicines management in secondary care and supporting patients in use of medicines and reducing waste. The NHS Commercial Medicines Unit (CMU) provides the nationally accepted route for contracting of medicines for secondary care and has established strategic leadership in medicines procurement areas considered important to the NHS. Highly effective pharmaceutical networks have been established at regional and local levels with specialist procurement pharmacists playing a key role in co-ordinating local trust decisions and ensuring they are aggregated locally. Commercial support arrangements have been developed to respond to local need resulting in a range of models to support commissioners and providers. There is now the opportunity to explore whether commercial support could add value to the established systems, processes and expertise developed by specialist procurement pharmacists in order to drive further improvements in cost effective prescribing and to respond most effectively to the needs of emerging clinical commissioners. 1. Pirmohamed M, James S, Meakin S et al. Adverse drug reactions as a cause of admission to hospital: prospective analysis of 18820 patients. British Medical Journal 2004;329:15-19 6 Section One: Medicines management landscape 1. Medicines Pricing 1.1 The Pharmaceutical Price Regulation Scheme (PPRS) The National Health Service (NHS) spends over £9 billion a year on branded prescription medicines in the UK. The PPRS is the mechanism which the Department of Health (DH) (on behalf of the UK health departments) uses to control the prices of branded prescription medicines supplied to the NHS by regulating the profits that companies can make on their NHS sales. It is a voluntary agreement made between DH and the branded pharmaceutical industry – represented by the Association of the British Pharmaceutical Industry (ABPI) – under Section 261 of the National Health Service Act 2006. There have been a series of voluntary agreements with the industry since 1957 to limit branded medicine prices and profits, each lasting five years or so, although the details of these agreements have evolved over time to reflect developments in the NHS and the pharmaceutical industry. The scheme seeks to achieve a balance between reasonable prices for the NHS and a fair return for the industry to enable it to research, develop and market new and improved medicines. The 2009 PPRS agreement, effective from 1 January 2009, has the following key components: A new non-contractual voluntary scheme providing stability and predictability in pharmaceutical pricing for the next 5 years; A 3.9 per cent cut in the list price of branded medicines sold to the NHS from 1 February 2009 and a further price cut of 1.9 per cent in January 2010; Subject to discussion with affected parties, the introduction of generic substitution from January 2010; Action to support innovation so patients have faster access to new medicines that are clinically and cost-effective; New and more flexible pricing arrangements that will enable pharmaceutical companies to supply medicines to the NHS at lower initial prices, with the option of higher prices if value is proven at a later date; and A more systematic use of patient access schemes, which allow pharmaceutical companies to offer discounts or rebates that reduce the effective cost of a medicine to the NHS. Most companies have signed up to the voluntary scheme. Those companies that have not signed up to the voluntary scheme are subject to statutory controls under the Health Service Branded Medicines (Control of Prices and Supply of Information) (No.2) Regulations 2008. 7 In summary, the PPRS: Allows companies freedom of pricing for new medicines (new active substances) but requires companies to seek the agreement of DH for price increases, which are only granted if the reasons for the application meet the criteria for increases set out in the agreement Requires companies with NHS sales of more than £35 million a year to submit annual data on sales, costs, assets and profitability and to repay the excess where profits exceed the agreed threshold Provides significant support for research and development (R&D) and initiatives to encourage and reward innovation. Further information is available on the DH website at www.dh.gov.uk/pprs 1.2 Drug Tariff NHS Prescription Services (SBS) produces the Drug Tariff on a monthly basis on behalf of the Department of Health. It is supplied primarily to pharmacists and doctors surgeries.The Drug Tariff outlines: What will be paid to pharmacy contractors for NHS services provided either for reimbursement (the cost of the drugs, appliances etc which have been supplied against an NHS prescription form) or for remuneration (what will be paid as part of dispensing contract with local health trust for fees/allowances etc) The rules to follow when dispensing The value of the fees and allowances to be paid The drug and appliance prices to be paid. Category M: Around 90% of generic medicines (by value) are listed under Category M of the Drug Tariff. Prices for drugs in Category M are set by DH and are based on a calculation that incorporates the volume-weighted average prices charged by generics manufacturers in the UK based on quarterly surveys of transaction prices between manufacturers, wholesalers and pharmacies. Part IX: New arrangements, as announced in April 2009 following the Part IX Review for the NHS supply of certain appliances in primary care require changes to the NHS Pharmaceutical Service Regulations, Directions and amendments to the Drug Tariff. The Amendment Regulations - The National Health Service (Pharmaceutical Services) (Appliances) (Amendment) Regulations 2009 - came into effect on 1 April 2010. They can be found on the Office of Public Sector Information website. Where pharmacies and appliance contractors supply appliances, these amendment regulations make provision for new essential services including emergency supply at the request of the prescriber, and for certain appliances, a home delivery service, provision of wipes and disposal bags and provision of specialist advice. Appliance contractors will also be able to offer repeat dispensing and will be required to operate a system of clinical governance, similar to pharmacies. 8 The Pharmaceutical Services (Advanced Services)(Appliances) (England) Directions 2009 make the provisions for new advanced services to be offered by appliance contractors and pharmacies who choose to do so. The advanced services include customisation of stoma appliances and appliance use reviews. They can be found at the link below. A transitional period of nine months from 1 April 2010 gives pharmacies and appliance contractors sufficient time to ensure they are able to comply with the new terms of service by 31 December 2010. 1.3 Download An overview of the new arrangements under Part IX of the Drug Tariff for the provision of stoma and urology appliances, and related services, in primary care (PDF, 166K Payment by Results Under the system of Payment by Results (PbR), most services delivered by hospitals are subject to a National Tariff. PbR uses a national tariff of fixed prices that reflect national average prices for hospital procedures. There are a number of High Cost Drugs (HCDs) that are excluded from the Payment by Results (PbR) tariff. Excluding certain drugs means that additional funding can be locally agreed over and above the national mandatory tariff. Factors considered by the HCD Steering Group for inclusion on the HCD list are: • The drug and its expected associated costs of care are disproportionately high cost compared to the other expected costs of care within the HRG, which would affect fair reimbursement; and • There is, or is expected to be, more than £1.5 million spend or 600 cases in England per annum. Further information can be found on the DH website at: http://www.dh.gov.uk/en/Managingyourorganisation/NHSFinancialReforms/DH_1143 39 9 Figure 1 Medicines are the most frequently and widely used NHS treatment and account for over 12% of NHS expenditure. A coherent medicines policy aims to control costs, increase patient access and improve value for money. DH policy Components of the system DH’s policy on medicines, pharmacy and industry covers every step of the journey from the development of medicines to their use by the patient. New medicines/ technologies are developed… …decisions are made on their pricing… Pharmaceutical pricing system Life sciences products …and regulated… Government sponsorship of life sciences Co-ordinating Government’s relationship with the pharmaceutical and medical technology industries …their clinical- and costeffectiveness is assessed… Prescribers and pharmacists NICE …medicines are prescribed and dispensed to the patient. PATIENT National Prescribing Centre MHRA Pricing and supply of NHS medicines 1. Drug pricing (Pharmaceutical Price Regulation Scheme) and reimbursement for branded/generic drugs. 2. Dealing with medicine shortages/discontinuations 3. Prescription charges E.g. The pricing framework aims to balance value for the tax-payer with the need to encourage innovation and deliver a fair return to the UK pharmaceutical industry. …prescribers are supported and informed… Clinical and cost effectiveness Sponsorship of NICE and the National Prescribing Centre and drugs bill management E.g. NICE’s role is fundamentally about maximising the VFM of NHS resources spent on medicines and treatments. Prescribing (medical and non-medical) Expansion of prescribing to nonmedical roles eg nurses, pharmacists Pharmacy Community pharmacy contractual framework; hospital pharmacy; electronic prescription service; professional regulation reform; professional leadership and advice E.g. Reforming the pharmacy contract, shifting emphasis from dispensing to clinical and public health services, utilising pharmacy’s accessibility and skills through new services and incentivising quality 10 2. Medicines Supply 2.1 Background The NHS comprises primary (community) care, secondary (hospital care) and tertiary (specialised consultant care eg cancer.) Primary care GPs write a prescription for drugs. The patient takes the prescription to a pharmacy where the drug is dispensed either for a flat rate prescription fee or on the basis of exemption, at no charge to the patient. Pharmacies are responsible for purchasing drugs either directly from manufacturers or through wholesalers. They are reimbursed by the NHS for the cost of these drugs. Primary Care Trusts contract for services from GPs under the terms of the General Medical Services (GMS) contract. Cost effective prescribing is incentivised through GMS and local incentive schemes. Additional influence comes from guidance from national bodies (NICE), local formularies, PCT prescribing advice activity and other factors such as peer pressure, pharma marketing activity and patient pressure. Dispensing doctors may procure and dispense medicines. Secondary and tertiary care Hospital clinicians prescribe and drugs are dispensed by the hospital pharmacy. Hospitals are responsible for purchasing the drugs they dispense. They are not reimbursed directly but must draw on overall NHS revenue. (See previous section on Payment by Results). Patients do not pay any charge for drugs supplied during a hospital stay but charges apply on medicines associated with outpatient, A&E and day case episodes. NHS CMU working with NHS pharmacists provides a national programme delivering framework agreements for hospitals to call off supplies of both generic and branded medicines and manages arrangements to secure the benefits to be achieved during the transition from branded to off patent medicines. Homecare Hospital services may on occasion arrange for the supply and administration of medicines to the patient whilst in their own home. The use of homecare services is expanding, with more than120, 000 patients receiving their medicines via the homecare route within England. The value of medicines supplied by this route is estimated to be in excess of £500 million, and these figures are expected to increase as more clinical services move away from hospitals to the community. 11 2.2 Supply Chain Fig 2: Key relationships and dependencies in the supply chain Pharmaceutical Development & Supply Chain Research based pharmaceutical industry (ABPI) Generic pharmaceutical manufacturers (BGMA) Research & develop new medicines Produce generic copies of license expired medicines Pharmaceutical wholesalers Industry NHS Integrated Supply Chain Secondary care - Primary care/community NHS Commercial Medicines Unit Purchasing collaboratives PPRS (branded medicines) Generic reimbursement scheme Hospital Pharmacists 2.3 Community Pharmacists Issues with supply Medicine shortages & product discontinuations have become increasingly prevalent for a number of reasons that include: ● Pharmaceutical industry globalisation ● Production failures ● Regulation ● Parallel exporting ● Manufacturers’ distribution systems and quotas Best practice guidelines on shortages were published jointly by DH, the association of British Pharmaceutical Industry (ABPI) and the British Generic Manufacturers Association (BGMA) in January 2007. Guidance on Trading Medicines for Human Use: Shortages and Supply Chain Obligations was published jointly in November 2009. Further actions were agreed at a supply chain summit in March 2010 to include a proactive, targeted programme of inspection by the Medicines and Healthcare Products Regulatory Agency (MHRA), tougher standards for the issue of wholesaler licences; and development of best practice guidance on how supply difficulties are dealt with by doctors, pharmacists, manufacturers and wholesalers. DH is procuring stocks of essential medicines- those necessary to avoid hospitalisation and/or early death- to ensure that increased stocks of key medicines are held in the UK to safeguard against disruption to the medicines supply chain. 12 3. Clinical and cost effectiveness: the role of NICE The National Institute for Health and Clinical Excellence (NICE) was set up 1999 and its role currently includes: ● Development of appraisals of new and existing technologies ● Development of authoritative clinical guidelines ● Publishing of advice on new interventional procedures ●Advice on improving people’s health and preventing illness and disease ● Development and definition of the (Quality) standards of healthcare that people can expect to receive ● Overseeing the development of QOF indicators ● Fellowship programme to improve local engagement with NICE ● Hosting “NHS Evidence” service The Arms Length Body review published in July 2010 sets out the intention for provisions in the forthcoming Health Bill to put the National Institute for Health and Clinical Excellence on a firmer statutory footing and to expand its role. 4. High cost cancer drugs The Government has pledged to create a £200 million Cancer Drugs Fund, due to run until the end of the current PPRS scheme in 2014 and an interim £50 million sum has already been allocated. 5. Efficient prescribing DH supports efficient and effective prescribing. ● 80% of prescriptions are repeat prescriptions for long term conditions ● Generic (non-branded) prescribing rate is 83% - the highest in the EU ● Better Care, Better Value (BCBV) indicators are used to drive more efficient prescribing 6. Quality and Productivity: medicines use and procurement The QIPP medicines workstream has identified additional potential savings of up to £475m a year by 2013-14 through: ● More efficient medicines usage in primary care eg greater use of generic medicines, new Better Care, Better Value indicators and through focused work on specials (specially prepared medicines) and nutritional supplements ● Better medicines management in secondary care ● Supporting patients in using their medicines and reducing waste 13 7. Improving access to innovative medicines Recent actions have included: ● New and more flexible pricing arrangements and more systematic approach to use of patient access schemes in 2009 PPRS ● Innovation package in 2009 PPRS which includes a single horizon scanning process for new drugs and the development of new metrics for uptake of clinically and cost-effective medicines, both domestically and internationally ● A new timetable to speed up the NICE appraisal process ● NICE’s supplementary advice for its Appraisal Committees on end of life treatments 8. Support for Pharmaceutical Procurement 8.1 NHS Commercial Medicines Unit The NHS Commercial Medicines Unit (CMU) is part of the Procurement Investment and Commercial Division of DH. The work of the NHS CMU is focused on strategic supply management and procurement of medicines for use in secondary care. The team works in partnership with hospital pharmaceutical procurement colleagues across the NHS in England. This includes leading a selective competitive tendering work plan for the implementation of hospital framework contracts. Objectives are to ensure a stable supply of critical drugs and to maintain, develop and realise the benefits of competition. Specific procurement programmes deliver framework agreements for the NHS to call off requirements targeted at generic, branded and specialised medicines. CMU works collaboratively with both NHS Pharmacists and suppliers in the collation and analysis of secondary care medicines spend on behalf of both the department and the NHS via its information systems Members of the category team have specialist market knowledge to assist in managing the contracting process for medicines in England and to provide support for projects on behalf of the Department of Health. Support is available for procurement in the following areas: homecare medicines branded medicines generic medicines delivery of procurement savings securing the benefits of the transition from branded to off patent medicines childhood and other vaccines (UK wide) blood products medical gases information and analysis of expenditure nutrition / enteral products Pharmaceutical countermeasures 14 Specialist skills and experience is engaged via strategic groups notably 8.2 National Pharmaceutical Supply Group (NPSG) Pharmaceutical Market Support Group (PMSG) National Homecare Medicines Committee (NHMC) Regional arrangements Regional and national arrangements are part of a well-developed nationally coordinated approach the success of which is built through the regional groups and their relationships with NHS Trust chief pharmacists. Structures developed at regional level include: - SHA pharmacy procurement groups Pharmacy Clinical Networks Regional Specialist Pharmacy Services Prescribing Committees Regionally based NHS procurement pharmacists are at the centre of this activity and use their expertise to ensure that the medicines procurement approach is built through strong relationships with clinicians. The procurement pharmacist plays a key role in co-ordinating local trust decisions and ensuring they are aggregated locally, thereby ensuring that the NHS CMU frameworks meet the requirements of pharmacists and clinicians within the NHS. A more detailed description of the role of the procurement pharmacist is set out in Appendix 3. 8.3 Local arrangements Local structures have been developed to a varying extent at local level notably: - Prescribing/ drug and therapeutics committees PCT prescribing teams Hospital pharmacists Roles within regional and local arrangements are set out in more detail at Appendix 3 15 Fig 3: The environment to support effective medicines management National Direction Setting PICD and SMDU NHS Commercial Medicines Unit Pharmaceutical Market Support Group National Pharmaceutical Supply Group National Homecare Medicines Committee Quality and productivity agenda SHA Procurement Groups Collaborative Procurement Hubs Regional Support Prescribing Committees CSU Clinical Networks Regional QIPP workstreams Locally Led Delivery Providers Commissioners 16 Section Two: Commercial support to medicines management 1. Development of commercial support in the NHS Regional Commercial Support Units (CSUs) were established to offer a range of dedicated commercial support to NHS health care commissioners and providers to help them improve their commercial and business skills, gain better value from procurement and contracts and respond more effectively to the challenges of operating in today’s NHS. Commercial skills include: ● Business intelligence ● Performance improvement ● Business modelling ● Negotiating, contracting and procurement support ● Market management ● Contract compliance, management and benchmarking ● Utilisation review performance ● Commercial skills training ● Risk stratification tools ● Claims management and invoice validation There is a focus on developing commissioning support to ensure the delivery of QIPP work streams relating to right care, procurement, pharma and medtech. In particular: Right Care ● Produce categories) Procurement programme budgets (23 ● Implement high impact changes ● Maximise use of national contracts ● Support use of map of medicine to ● Produce and implement efficiency produce specifications procurement plans for key categories ● Ensure commissioners use contract ● Promote collaborative procurement levers to reduce: (achieving better prices) - variation undertaking of procedures limited clinical effectiveness ● Increase levels of automation in of procurement processes (to reduce costs) Pharma Medtech ● Implementation support for national ● Support adoption and diffusion of two strategy new technologies per region ● Business intelligence and modelling support ● Facilitation of collaborative working ● Diffusion of best practice/ innovation ● Benchmarking of medicines practice 17 Transition support for the emerging NHS landscape Models of commercial support are being developed that will be sufficiently flexible to adapt to the emerging NHS landscape and to provide effective support during transition. The initial focus was on developing commissioning support models and, in the changing NHS environment, there is a return towards this position. Developing areas for commissioning support could include: ● Producing data to GP level ●Support for contract management and maintaining business as usual ● Evaluating GP consortia requirements for commissioning support ● Providing population and health needs data through to contract and claims management, supporting all aspects of the commissioning process ● Contribution to management cost savings by collaboration/ consolidation at regional level where appropriate ● Undertaking procurements eg any willing provider ● Provider intelligence Collaborative Procurement Hubs Collaborative Procurement Hubs (CPHs) are regional purchasing organisations set up to accelerate savings through collaborative purchasing for their member trusts. There will be a need for continuing collaboration in terms of commercial support to commissioners and provider organisations to ensure a cohesive approach to local pharmacy procurement strategy where the impact across a whole community needs to be considered. 2. Effectiveness in medicines management The following principles apply in ensuring effectiveness in medicines management and encompass clinical, safety and commercial issues: ■ ■ ■ ■ ■ ■ Medicines should be evaluated on the basis of clinical and cost effectiveness, with only those demonstrated to be clinically effective at an affordable price approved for usage Approved medicines should be procured at the best possible price Approved medicines should be used only when appropriate for patient needs Systems and processes should be in place to ensure that medicines are used safely, minimising the likelihood of harming patients Wastage through over-ordering of medicines or patients not taking them should be minimised Patients take medicines as prescribed and understand and adhere to measures which reduce the likelihood of them experiencing adverse effects from medicines These factors can be thought of as a medicines value chain. When all of the links are in place then the likelihood of the optimal outcome for the patient and the best value for money is significantly increased. 18 3. Approach to developing guidance on commercial support to medicines management This guidance has been developed following: - An engagement exercise with NHS stakeholders including senior pharmacists, DH, Strategic Health Authorities and Primary Care Trusts. Interviews and workshops were held within four SHA regions to gain an understanding of challenges to effective use of medicines and explore the value that could be added from commercial support. - Input and advice from the Medicines Pharmacy Industry Division (MPI) (NHS Medical Directorate) - Liaison with the QIPP Medicines management and procurement workstream 4. Design principles for commercial support to medicines management The maximum benefit in procurement and management of medicines across the local NHS community will be derived from collaborative working and commercial support to medicines management should always seek to underpin this collaborative whole systems approach. The design of commercial support should involve: ■ ■ ■ ■ ■ ■ ■ ■ Partnership from the outset with specialist procurement pharmacists to identify opportunities for and facilitate collaboration on an appropriate scale Development of annual work plans in conjunction with the regional pharmacy community, that are regularly reviewed to reflect changes in priorities for supporting commercial effectiveness The enablement of benefit across the whole NHS community rather than at the level of an individual organisation Evaluation of the impact on the whole system; with benefits across primary and secondary care Support for invest to save initiatives such as investment in medicines to deliver over all savings on care or projects in secondary care that will deliver savings in primary care Close working with established systems and structures to identify gaps in existing commercial capability rather than duplication or seeking to become a new delivery body for existing services. However, in certain instances, it may be appropriate for the commercial support organisation to become the new ‘home’ for certain services (this will need to be determined on a local basis) Support for regional implementation of national initiatives to support greater commercial effectiveness (including QIPP medicines/ procurement work streams) Consideration as appropriate of the potential for savings generated for the health system to be re-invested into service developments or new medicines with the potential to enhance quality of care. This approach could be used as a means to achieve clinical buy-in and support for the proposed courses of action 19 5. Priorities for medicines management commercial support functions: 2010/11 Fig 4: The stakeholder engagement exercise identified four priority areas for development of core commercial support functions in 2010/2011, which are described here. Commercial support organisations will need to work with specialist procurement pharmacists to identify local needs and priorities and to identify areas where systems can be developed and improved through joint working: 5.1 Business intelligence & business modelling Diffusion of best practice / innovation Facilitation of collaborative working Implementation support for national strategy Business intelligence and business modelling Access to high quality data on pharmaceutical spend and usage patterns is essential to identifying opportunities and to understanding the full implications of any proposals designed to exploit them. Commercial support organisations may be in a good position to provide and develop improved systems for business intelligence and business modelling support to specialist procurement pharmacists for a number of reasons including: ■ ■ ■ The existence of appropriate skill sets currently deployed to support business intelligence in other areas Efficiency of service delivery – Scaling up to gain the most from limited resource Impartiality and an ability to use business intelligence as a lever for achieving better collaboration and cooperation thus delivering benefits for the region 20 Table 1: Summary of function and associated services: business intelligence and modelling Function Service Description Business Intelligence and business modelling Prescribing and spend analysis Collation and analysis of data on medicines usage and associated spend with a view to identifying opportunities for reducing costs without compromising care quality. This function could be used to identify ‘postcode prescribing’ as a starting point to addressing inequalities. Benchmarking Comparison of prescribing trends and associated spend between similar organisations. Scenario modelling Modelling capability to support more robust opportunity assessments. 5.2 Adoption of best practice / innovation There is strong evidence that pockets of best and innovative practices in the delivery of medicines management frequently exist in isolation within a region, typically where an individual organisation has taken the initiative to develop a new way of working. Systematic adoption of best practice in other organisations may not take place despite apparent benefits associated with new ways of working. Reasons for this may include: ■ ■ ■ ■ ■ Lack of awareness of initiatives underway in other organisations Lack of resource to follow suit Reluctance to adopt practices developed elsewhere on the assumption that they are not transferable or due to a desire to develop practices in different ways Lack of quantifiable evidence of benefits realised from an initiative and how they translate to other organisations Unwillingness to share materials, protocols etc which are associated with delivery of the new way of working Commercial support could include the development of systematic measures of success and transferability and leadership of collaborative working and shared learning in order to support the spread of best practice and innovation. Interestingly, a concern was raised in the stakeholder workshops that innovation might be stifled as organisations focus their energy on implementing similar practice to others. As a rule, commercial support resources and expertise are best placed where the benefits: 21 ■ ■ ■ Are assessed as: measurable, significant and likely to be transferable Do not cut across or preclude other innovation that might deliver additional benefit Raise standards across the region rather than seeking to deliver a completely homogenised service Table 2: Summary of function and associated services: best practice and innovation Function Service Description Adoption of best practice / innovation in the delivery of medicines management Identification of best / innovative practice Pro-active identification of best / innovative practice through existing regional networks. Feedback provided to support commissioning for quality in medicines management. 5.3 Benefits tracking for best / innovative practice Quantification of benefits associated with best / innovative practice Sharing materials associated with best / innovative practice Sourcing and adaption of materials to avoid duplication of effort as other organisations follow suit. Possibly enabled through contractual levers with acute providers Facilitation of collaborative working Working collaboratively across the commissioning and provider landscape will enable better value from medicines management procurement to ensure the continuing provision of high quality services. During stakeholder interviews, concern was expressed that organisations may opt for deals on medicines that would provide benefit to one organisation without considering the implications for the whole health economy. The use and development of improved business modelling expertise could support forecasting of the impact of potential decisions taken for example by secondary care on primary care. This modelling could support dialogue between sectors aimed at reaching decisions that represent best value for the whole local health economy. A core role for commercial support is to identify opportunities for collaborative working. Some opportunities may be identified through the business intelligence and modelling function; others may arise through active engagement and working with medicines management stakeholders to identify examples of duplicated activity and potential efficiency gains. The following case study describes a London initiative 22 where a joint workshop was established between commercial and medicines management leads. Table 3: Summary of function and associated services: facilitation of collaborative working Function Service Description Facilitation of collaborative working Opportunity identification Identification and verification of options for collaborative working on activities such as procurement and sharing non front line services. Project management support for collaboration Support for identifying stakeholders, developing project plans etc to enable implementation of collaborative working initiatives Case study in facilitation of collaborative working The challenge: To develop a systematic approach to improving productivity in line with QIPP priorities with a focus on reducing drug spend and prescription variability. The approach: The London Commercial Support Unit held a joint pharmacy and medicines management workshop in May 2010 with senior colleagues from the pharmacy community that included representatives from commissioning, hospital trusts and SHA procurement specialists and analysts. Commercial support contribution: A number of projects were identified in primary and secondary care and cash releasing and value improving savings opportunities were estimated. These projects were then prioritised and incorporated into the region’s QIPP plan. Commercial support included project management, procurement support to the secondary care programme and analytical support to the primary care initiatives. 23 5.4 Implementation support for national strategies A key national priority is the delivery of QIPP efficiency savings. The development of this guidance for commercial support to medicines management will be supported by a number of projects to develop commercial best practice in areas of work considered to have potential for high impact when rolled out nationally. These priority areas include therapeutic tendering within secondary care and homecare. Each of the projects is required to: i) Support QIPP objectives and achieve added value in procurement/ commissioning ii) Have systematic measures of success iii) Be delivered in close partnership with the medicines management community and with CMU iv) Develop guidance and learning that can be shared/ rolled out nationally that considers both commercial best practice and optimum scalability of approach for future commissioning models The NHS Commercial Leads meeting will consider how best to develop and support these workstreams, working in close liaison with the NHS Commercial Medicines Unit and the QIPP workstream. This work will complement the continuing development of coordinated strategies for the contracting and procurement of medicines for Generic and Branded Medicines with members of NPSG and PMSG. Relevant commercial capabilities to support the implementation of national strategies include data analysis and baselining to establish the pre-implementation position, scenario modelling to determine resource requirements associated with implementation and audit support to measure the extent of, and benefits associated with, implementation. Table 4: Summary of function and associated services: support for national strategies Function Service Description Implementation support for national strategies Baseline analysis Analysis of the pre-implementation position and steps required for implementation. Resource modelling Modelling service to determine resources required for the implementation of strategy and identify cost effective solutions for implementation. Audit support Support for measuring implementation for example through the provision of audit templates and analysis of raw audit data. 24 Implementation support for national strategies Scenario: PbR excluded drugs: The management of PbR excluded drugs can be challenging: - Both providers and commissioners have concerns about the workload created through compiling and reviewing individual patient funding requests for these drugs - Commissioners are also concerned by a lack of transparency on the costs of PbR excluded drugs. Typically they are not always aware of what it costs trusts to purchase drugs and do not see discounts reflected on invoices. There is also a lack of clarity on the level of additional charges added to the final invoice to cover unspecified ‘on’ costs - Variability in processes for approving PbR excluded drugs on a case by case basis may lead to ‘post code’ prescribing scenarios The challenge: - To develop standard protocols governing the procurement, reimbursement and individual patient approval mechanisms for PbR excluded drugs - The solution should reward providers for negotiating discounts but also allow for re-investment of savings for the benefit of the whole health economy and support the eradication of postcode prescribing within a region. Commercial support: - Could work to mediate and improve communication between providers and commissioners - Could work in partnership with medicines management specialists/ hospital providers to develop greater understanding of - o Baseline position for spend on PbR excluded drugs to include expenditure on medicines, added costs and any additional services might be included within the price by the pharmaceutical industry such as nursing support for administration. o True costs (and therefore reasonable additional charges on top of the acquisition cost) of activities associated with handling PbR excluded drugs such as re-constitution and the use of consumables such as syringes. Armed with better understanding of the costs associated with PbR excluded drugs could work to develop principles for cooperation on the re-imbursement of PbR excluded drugs. These principles would: o Encompass agreed reimbursement rates for various activities associated with handling PbR excluded drugs such as aseptic preparation and administrative processes associated with generating invoices o Require transparency from providers on how much they spend on medicines o Specify how savings made through procurement discounts are to be shared between providers and commissioners. 25 6. Developing extended commercial functions to support medicines management The previous section sets out four priority areas for developing commercial support to medicines management. Extended support could be developed in any of the following areas following an assessment of local needs and circumstances: ● Operational performance ● Systems ● Market management Further detail including mapping of the functions to outputs, outcomes and benefits is included within Appendices 1& 2. Figure 5: Developing extended functions to support medicines management Business intelligence & business modelling Diffusion of best practice / innovation Facilitation of collaborative working Implementation support for national strategy Market management (non-core) Systems (non-core) Operational performance (noncore) Market management 6.1 Operational performance A nationwide review of medicines management in acute trusts by the former Healthcare Commission recognised that effective medicines management can contribute greatly to the delivery of high quality, cost effective and safe care. Reports provided to individual organisations allowed them to better understand their own performance versus other organisations and investigate reasons for performance problems. 26 Recently there has been less opportunity for hospitals to understand how they perform on the operational aspects of delivering medicines management services. Commercial support could facilitate analysis of performance in medicines management and the impact of resulting performance improvement programmes. There may also be an opportunity to provide support to pharmacy departments to understand how they perform on measures of clinical productivity with resources at their disposal. An example of this might be the number of patients who receive a medication review on admission per pharmacist engaged in this role. Benchmarking the outputs of this type of assessment could give organisations insight into the efficiency of their service and through sharing practices with other organisations identify opportunities for performance improvement. Table 5: summary of function and associated services Function Service Description Operational performance Clinical productivity and efficiency reviews Analysis of service inputs (staff time and other over-heads) and processes versus service outputs (number of prescriptions reviewed, number of interventions made etc) to determine the productivity and efficiency of hospital pharmacy services. Medicines management capability assessments Analysis of performance in medicines management through measurement of KPIs such as error rates, intervention rates and use of patients own drugs on admission. 6.2 Medicines management systems Commercial support may identify opportunities for improving systems, for example through the identification of IT solutions, then ensure their cost effective procurement and implementation to improve efficiency and reduce administration time and costs in medicines management. This in turn could help to enable the focusing of resources on front line services. Concerns identified in workshops included resource involved in the management of: ● Patient access schemes and recuperation of costs/ rebates ● Use and associated funding for non PbR drugs ● Contract management ● Homecare schemes 27 Table 6: summary of function and associated services Function Service Description Systems E-enablement opportunity identification Support in identifying opportunities for the introduction of IT systems to increase productivity, efficiency and care quality relating to the use of medicines. E-enablement – implementation support Support for the procurement and roll out of IT systems to increase productivity, efficiency and care quality relating to the use of medicines. 6.3 Market management The introduction to this document sets out the complexity of pharmaceutical markets and the specialist structures that are in place at national regional and local levels to lead and support activity in this area. Commercial support offerings can include well developed general market analysis and management skills that could be applied to add value to these exisiting arrangements. Potential areas for involvement could include: ● Regional contract management support ● Homecare provider management Table 7: summary of function and associated services Function Service Description Market management Contract management support Support to existing bodies such as regional pharmacy procurement groups for medicines supplier performance management against contractual requirements with outputs used to support the development of sourcing plans for medicines. Homecare provider management Management of homecare providers to establish transparency in pricing and service levels and associated performance. 28 7. Focus of commercial activity The pharmaceutical market is a highly complex and specialist area and commercial support should be applied where it can be most effective and with a clear understanding of national and regional priorities. The market segmentation analysis below may indicate that the initial focus of commercial activity should be in the secondary care branded segment where: ■ ■ ■ ■ ■ There is the highest rate of increase in medicines expenditure Prescribing practices are easier to influence Influencing prescribing practices often has the knock on benefit of influencing practices in primary care There are identified challenges and opportunities such as non PbR medicines, patient access schemes and homecare There is an opportunity to deliver benefits to both hospitals and primary care, which directly funds a large proportion of prescribing through PbR exclusions. Effecting change within other market segments is likely to be more challenging. For example, within the secondary care generic segment a great deal of work has already been undertaken to ensure that best value is secured from generic medicines. Within the primary care branded segment it is generally accepted that it is more difficult to influence GP prescribing and opportunities for making savings are limited by fixed prices within the Drug Tariff. However priorities should be determined locally in partnership with the medicines management community and it will be important to provide support across the whole health economy. Figure 6: Pharmaceutical market segmentation and associated issues Secondary care Greatest rate of inflation in medicines expenditure Easier to influence prescribing practices with recognised ‘spill over’ effect on primary care Root of homecare market More opportunities for therapeutic tendering? 0% inflation (for primary care prescribing as a whole) Challenging to influence GP prescribing Opportunities limited by Drug Tariff Area of considerable focus in recent years (Category M, Better Care Better Value Indicators etc) Challenging to influence GP prescribing Generic medicines Branded medicines Source of PAS prescribing Source of PbR excluded drugs prescribing and primary care expenditure Opportunities exploited via national and divisional contracting Generally accepted that generic prescribing in secondary care is optimised Primary care 29 8. Operational considerations 8.1 Establishing services and a work programme This guidance outlines the types of commercial support functions and services that could support the effective management of medicines but priorities must be locally determined. Key steps in establishing the scope of services and a work programme will include: - Engagement with the local medicines management community from the outset for example through the Chief Pharmacists network - Assessment of existing arrangements, to identify gaps and opportunities and avoid duplication or cross cutting. It will be important to assess local regional and national activity before developing plans - Understanding of challenges and gauging the level of buy-in for functions and services designed to address them - Identification of project areas where there could be added value from commercial input and the potential for quick wins to demonstrate value and build support for continued commercial involvement - A focus on supporting the delivery of QIPP priorities for the medicines work stream - Close working with specialist procurement pharmacists and DH colleagues to ensure understanding and operation within national legislation and regulation and to gain guidance and support in interpreting this into commercial activity 8.2 Staffing models Staffing requirements should be considered on a project-by-project basis with the aim of creating a team of individuals with an optimal blend of skills and expertise. For most projects, commercial skills such as data analysis or business modelling will be needed alongside specialist pharmaceutical expertise. There is a considerable range of size, resource and approach in the way that commercial support arrangements have been established. This section considers options for developing a sufficiently flexible staffing model that can be used to resource projects appropriately and cost effectively. ■ Permanent staff It may be appropriate to consider employing a permanent member of staff with specific pharmacy expertise such a pharmacist or a pharmacy technician where there is confidence that the work programme warrants this investment and skills will be fully utilised on an on-going basis. ■ Secondments Secondments may be an attractive option for sourcing staff from local NHS organisations with specific skill sets on a temporary basis to fulfil the needs of a project. 30 ■ Collaboration with a lead organisation May be appropriate where there is a desire and capability from an individual organisation to lead on a project with potential to deliver region wide benefits to the health economy. Commercial support would provide additional skills and expertise not available within the lead organisation. ■ Interims Recruiting interims could be an attractive option where there is a need to either source an individual with a very particular skill set not available within the region or where there is a need to staff projects quickly. Ordinarily interims are a relatively expensive resource and should only be called upon when essential. 8.3 Determining level of commercial support Commercial support to medicines management can be offered at a range of levels from advisory right through to leading the delivery of a piece of work and the right approach will need to be decided based on local needs. Close partnership working with specialist procurement pharmacists and the wider medicines management community will be critical and the key to successful working will be a mutually shared understanding of roles, and responsibilities from the outset as work programmes and supporting project plans are developed. 31 Appendix 1: CSU medicines management support functions, outcomes and benefits Core Function Description Outcome Benefits Business Intelligence and Modelling Identifying and filling gaps in the collection and analysis of prescribing data and associated spend from primary and secondary care with modelling capability to support opportunity identification from data analysis. Better understanding of prescribing practices and associated spend, with identification of opportunities for securing improved value for money from prescribing budgets. Financial (cost reduction and cost containment) Support for identifying and realising opportunities which support the delivery of more efficient higher quality services through sharing services and pooling expertise – both clinical and non-clinical Greater cooperation and more uniform services reflective of best practices Financial (cost reduction and cost containment) Support for providers and commissioners on the implementation of national strategy and realisation of associated benefits in an efficient manner. Faster more comprehensive implementation of national strategies across a region Facilitation of Collaborative Working Implementati on support for national strategies Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) 32 Function Description Outcome Benefits Quality (improved patient outcomes, improved patient experience, lower clinical risk) Adoption of Best Practice and Innovation Noncore Operational performance Systems Sharing best and innovative practice across organisations to achieve replication of the benefits associated with these practices in more organisations efficiently. The management of people, systems and all other resources to deliver high quality, efficient and safe management of medicines Support for the implementation of IT systems which increase the efficiency of activities associated with medicines. Reduced lag time between invention and best / innovative practices becoming widely adopted with replication of benefits. Optimal performance of pharmacy services with resources available from a quality, efficiency and safety perspective. The development of information technology systems and infrastructure to support the management of prescribing in local health economies Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 33 Function Description Outcome Market Management The review of providers of pharmaceutical products and services and resulting actions to encourage improved provider performance Better understanding of provider performance and value for money delivered. Benefits Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 34 Appendix 2: Services associated with functions outputs, outcomes and benefits Function: Business intelligence and modelling Service Description Outputs Outcomes Benefits Prescribing and spend analysis Collation and analysis of data on medicines usage and associated spend with a view to identifying opportunities for reducing costs without compromising care quality Prescribing practices and spend analysis reports Improved understanding of prescribing practices and ability to identify potential opportunities which can then be investigated further (typically by those with clinical and pharmaceutical expertise) to determine validity Financial (cost reduction and cost containment) Benchmarking reports to support meaningful comparison of prescribing practices between organisations Improved understanding of comparative prescribing practices to support opportunities for therapeutic rationalisation Financial (cost reduction and cost containment) Scenario models of benefits associated with changes in prescribing practices. Improved understanding of the potential benefits associated with changes in prescribing practice Financial (cost reduction and cost containment) Benchmarking Scenario modelling Comparison of prescribing trends and associated spend between similar organisations Modelling capability to support more robust opportunity assessments Enablement (improved capability, better management information) Commercial risk reduction(decreased budgetary risk, reduced supply chain risk) Enablement (improved capability, better management information) Commercial risk reduction(decreased budgetary risk, reduced supply chain risk) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 35 Function: facilitation of collaborative working Service Description Outputs Outcomes Benefits Opportunity identification Identification and verification of options for collaborative working on activities such as procurement and sharing non front line services. Likely to be enabled in part by business intelligence Reports outlining opportunities and summaries of model outputs, indicating what benefits are likely to be associated with the opportunities Greater understanding of where collaborative opportunities might lie with greater buy-in for acting on them through quantification of benefits Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Project management support for collaboration Support for identifying stakeholders, developing project plans etc to enable implementation of collaborative working initiatives Project plans, project management resource (most likely in conjunction with a local clinical champion) The application of robust project management methodologies leading to projects being delivered on schedule and on budget Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 36 Function: Implementation support for national strategies Service Description Outputs Outcomes Benefits Baseline analysis Analysis of preimplementation position and steps required for implementation Gap analysis reports outlining current practices versus policy intentions Greater understanding of the pre-implementation state Enablement (released capacity, improved capability, better management information) Modelling service to determine resources required for implementation of strategy e.g. human resources and finance. Identification of cost effective solutions for implementation Models depicting the resource requirements associated with full implementation of the policy Improved understanding of how much resource is required to support policy implementation from a financial, HR and technological perspective. Support for measuring strategy implementation for example through the provision of audit templates and analysis of raw audit data. Audit reports on implementation progress Resource modelling Audit support Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Improved ability to track implementation and determine what actions may be required to address instances of partial implementation. Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 37 Function: Adoption of best practice and innovation Service Description Outputs Outcomes Benefits Identification of best / innovative practice Pro-active identification of best / innovative practice through connecting with existing regional networks and engaging with local organisations to uncover examples Database of best / innovative practice examples Greater awareness of best practice and innovation within a region, associated benefits and the potential for widespread application Financial (cost reduction and cost containment) Quantification of benefits associated with best / innovative practice Case studies incorporating benefits analysis – including estimates on the benefits of rolling the initiative out to other organisations. Independent verification of the success of initiatives and greater understanding of the benefits associated with wider roll-out Library of generic materials which can be accessed by other organisations Increased ease of implementation of new initiatives Benefits tracking for best / innovative practice Sharing materials associated with best / innovative practice Sourcing and adaption of materials to avoid duplication of effort as other organisations follow suit. Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 38 Function: operational performance Service Description Outputs Outcomes Benefits Clinical productivity and efficiency reviews Analysis of service inputs (staff time and other overheads) and processes versus service outputs (number of prescriptions reviewed, number of interventions made etc) to determine the productivity and efficiency of hospital pharmacy services. Reports outlining efficiency and productivity benchmarked against similar organisations with recommendations on areas for further investigation with potential for performance improvement. Greater understanding of departmental performance on measures of clinical productivity and capability and potential areas for improvement versus similar organisations. Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Medicines management capability assessments Analysis of performance in medicines management in hospitals through measurement of KPIs such as error rates, intervention rates and use of patients own drugs on admission Benchmarked reports outlining performance against a range of medicines management KPIs with recommendations on potential areas for further investigation and subsequent improvement Greater understanding of medicines management capability within hospital pharmacy departments and insight into potential areas for improvement Financial (cost reduction and cost containment) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 39 Function: systems Service Description Outputs Outcomes Benefits E-enablement opportunity identification Support for identifying opportunities for the introduction of IT systems to increase productivity, efficiency and care quality relating to the use of medicines. Opportunity assessments including quantification of the benefits associated with eenablement. Greater understanding of the opportunities for eenablement including likely benefits from a quality and productivity perspective Financial (cost reduction and cost containment) E-enablement – implementation support Support for the procurement and roll out of IT systems to increase productivity, efficiency and care quality relating to the use of medicines. Business cases and requirements specifications for IT systems. Project plans for the introduction of new IT systems. Better value for money in the procurement of IT systems and faster realisation of benefits associated with eenablement. Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) 40 Function: market management Service Description Outputs Outcomes Benefits Homecare provider management Management of homecare providers to establish transparency in pricing, service levels and associated performance. Performance management frameworks and service specifications for homecare providers. More consistent care delivery of a higher quality in the home setting. Financial (cost reduction and cost containment) Data sets outlining comparative prices between homecare providers, levels of service offered, governance arrangements etc Greater understanding of costs associated with homecare delivery and potential to negotiate on price for non-pharmaceutical industry schemes. Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) Quality (improved patient outcomes, improved patient experience, lower clinical risk) Contract management support Support to existing bodies such as regional pharmacy procurement groups for medicines supplier performance management against contractual requirements with outputs used to support the development of sourcing plans for medicines. Supplier performance databases and associated reports. Improved understanding of performance versus contractual requirements. Financial (cost reduction and cost containment) Enablement (released capacity, improved capability, better management information) Commercial risk reduction (decreased budgetary risk, reduced supply chain risk) 41 Appendix 3: Glossary of relevant terms used in medicines management landscape Term Abbreviation Description Association of British Pharmaceutical Industry ABPI ABPI is the trade association for more than 90 companies in the UK producing prescription medicines for human use. Its member companies research, develop, manufacture and supply more than 80 per cent of the medicines prescribed through the NHS. British Generic Manufacturers Association BGMA The BGMA represents the interests of UK-based manufacturers and suppliers of generic medicines and promotes the development and understanding of the generic medicines industry in the United Kingdom. British Healthcare Trades Association BHTA Trade Organisation, represents a wide cross range of Medical and Assistive Technologies and is consulted as a voice of industry by both Government and non-Government bodies. Clinical Networks Clinical networks are linked groups of healthcare professionals and organisations that aim to improve the treatment and prevention of ill health in particular disease area – for example cancer or cardiology. Whilst they do not tend to hold prescribing budgets directly, they are typically major influencers of prescribing through the production of treatment protocols and clinical guidelines. Collaborative Procurement Hub CPH Regional purchasing organisations set up to accelerate savings through collaborative purchasing for their member Trusts. CPHs should be aligned with the Commercial Support Unit set up. Commercial support Unit CSU Offer a range of dedicated commercial support to NHS healthcare commissioners and providers to help them improve their commercial and business skills, gain better value from procurement and contracts and respond more effectively to the challenges of operating in today’s NHS. Hospital Pharmacists All acute and mental health trusts are able to access some specialist support for the management of medicines through an in-house pharmacy department. The level of support provided varies greatly on a trust-by-trust basis but broadly aims to ensure that medicines are used within the organisation in a clinically effective, cost effective and safe manner. In practice, the support offered by most hospital pharmacy services encompasses: procurement, dispensing of medicines, advice to individual prescribers and patients and enforcement of formularies and clinical guidelines as well as the manufacture of medicinal products. Hospital pharmacy departments tend to be represented on prescribing committees and in most cases are considered to be very influential in determining how medicines are used within their organisation. 42 Term Abbreviation Description Medicines Pharmacy Industry Division MPI The Medicines Pharmacy and Industry division within the DH Medical Directorate covers the following areas: - Government sponsorship of life sciences (pharmaceutical and medical technology industries) - Pricing and supply of medicines - Clinical and cost effectiveness including sponsorship of the National Institute for Health and Clinical Excellence (NICE) - Improving access to innovative medicines - Pharmacy - Prescription charges Medicines and Healthcare products Regulatory Agency MHRA MHRA is an executive agency of DH that sets out to enhance and safeguard the health of the public by ensuring that medicines and medical devices work and are acceptably safe. Ministerial Industry Strategy Group MISG Provides a forum for government to work closely with industry on high level strategic issues Ministerial Medical Technology Strategy Group MMTSG Provides a forum for joint industry/ Government discussion of strategic issues of importance NHMC A subgroup of the National Pharmaceutical Supply Group. The committee is facilitated and managed by the NHS Commercial Medicines Unit. Representation on the committee consists of stakeholder professions with experience in the area of homecare delivery services in primary care, secondary care, specialised commissioning and industry. The main role of the committee has been to act as a national focus for developing and improving processes for homecare delivery services and advise the NHS on matters relating to these services. National Homecare Medicines Committee The key work areas are the production of standard tender documentation, supplier audits, key performance indicators, decision analysis tool and management of complaints and adverse incidents. 43 Term National Institute for Health and Clinical excellence National Pharmaceutical Supply Group Abbreviation Description NICE Independent organisation responsible for providing national guidance on promoting good health and preventing and treating ill health. NICE makes recommendations to the NHS on new and existing medicines, treatments and procedures and on treating and caring for people with specific diseases and conditions. These recommendations are a very significant factor in driving uptake of new medicines by Acute Trusts. NPSG The key purpose of the NPSG is to develop a national medicines procurement strategy in order to maintain continuity of supply of medicines for all patients and to ensure that there are effective strategic communication channels directly to NHS Trust Chief Pharmacists through their SHA networks. NPSG is the strategic focus in the relationships between the NHS Commercial Medicines Unit, the Department of Health, NHS Trust Chief Pharmacists and the SHA pharmacy procurement groups and is the ‘point of entry’ for any NPSA and MHRA input into contracting dialogue. National Prescribing Centre NPC The National Prescribing Centre is a health service organisation, formed in April 1996 by DH. It promotes and supports quality, cost-effective prescribing and medicines management across the NHS, to help improve patient care and service delivery. NHS Business Services Authority Prescription Services Division NHS BSA Calculates reimbursements and pays pharmacies, Primary Care Trusts (PCTs) budgets are then debited accordingly. Pricing is based on drug type and volume in accordance with that month’s Drug Tariff NHS Commercial Medicines Unit CMU SHA pharmacy procurement groups are supported by a dedicated NHS Commercial Medicines Unit category specialist and Quality Assurance and Technical Pharmacists. Business identified by the groups is competitively tendered on their behalf by the NHS Commercial Medicines Unit. Following adjudication of tenders by the group, reflecting the interests of its constituent trusts, their clinicians and budget holders, the NHS Commercial Medicines Units also awards and manages the resulting contracts on their behalf. Pharmaceutical Market Support Group PMSG Operating at the national level, PMSG is now accountable to the Department of Health Pharmacy NonExecutive Board on operational matters relating to the procurement and supply of medicines to the NHS. Amongst other roles, PMSG brings together a national overview of commercial and pharmaceutical expertise to assist the NHS Commercial Medicines Unit to coordinate pharmacy purchasing group activity and to advise the SHA pharmacy procurement groups on the most appropriate award decisions. This aims to achieve maximum benefit for the NHS while avoiding and managing any introduction of risk to supply. 44 Term Prescribing/ drug and therapeutics committees Specialist Procurement Pharmacist Abbreviation Description There is a wide range of committees, which aim to evaluate medicines on clinical and cost effectiveness grounds to determine which medicines should be recommended for use in the area they cover. Typically these committees focus on those medicines which are not reviewed by NICE or in some instances aim to evaluate medicines before NICE reviews are completed. Whilst these committees generally have very similar roles they vary greatly in their membership, the area they cover (some may operate on behalf of a single organisation whilst others may operate across part of or even a whole region) and their name. Terms used to describe prescribing committees include medicines management committees, drugs and therapeutics committees. Regional and national arrangements are part of a well-developed nationally coordinated approach the success of which is built through the regional groups and their relationships with NHS Trust Chief Pharmacists. Regionally based NHS procurement pharmacists are at the centre of this activity and use their specialist expertise to ensure the medicines procurement approach is built through strong relationships with clinicians. Key roles include: - PCT Prescribing Teams Promotion of robust, effective and efficient patient orientated pharmacy procurement of medicines Specialist consultancy on all aspects of the procurement storage and distribution of medicines and its application to medicines management Contribution to the development of national strategies and solutions for the long term cost-effective procurement of medicines within the secondary care sector Ensuring that procurement prioritises patient safety and leads the purchasing for safety agenda Within each PCT, there are typically a number of pharmacists who work on medicines management related activities. These activities may include working with individual GP practices to influence prescribing patterns, reviewing funding requests for PbR excluded medicines, sitting on local prescribing committees and managing aspects of the community pharmacy contract. In many cases, PCT pharmacists will liaise closely with hospital pharmacists with the aim of aligning objectives and ensuring that they are working effectively together as constituent parts of the same health system. The specific role of PCT prescribing teams and the resources at their disposal varies greatly from PCT to PCT. 45 Procurement Investment and Commercial Division PICD SHA Procurement Groups Strategic Market Development Unit PICD provides expert commercial and procurement support to both DH and the NHS and has a key system and professional leadership role encompassing oversight of the entire NHS landscape. PICD will undertake this leadership role by establishing and leading: - NHS commercial network which will be the formal arrangement for DH to work with all 10 health regions - NHS National Procurement Council which will provide the main forum for industry/NHS collaboration and exchange Each NHS trust is represented on a SHA pharmacy procurement group by a pharmacist or technician. Representing the interests of the trusts’ budget holders, clinicians and relationships with PCTs, these pharmacists meet locally and regularly on a group basis to align procurement standards and approaches, and exploit the purchasing power of their collective trusts. SMDU SMDU works alongside PICD and takes responsibility for leadership and support to commissioners in market analysis and market making. The aim is to provide a single voice for the NHS and DH to speak to the independent sector and engage the latter in the creation of new markets in healthcare. The new Cooperation and Competition Panel which investigates potential breaches of the established principles and rules of cooperation and competition for the provision of NHS-funded healthcare now sits within SMDU. 46
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