Support for decision-making on new medicines

Support for decision-making on new medicines

New medicines can offer benefits to patients and to the NHS. However, whilst new medicines may result in potential savings in some parts of the care pathway, they are often more expensive than established drug therapies. Not all new medicines have advantages over existing therapy and generally, where the benefits exist, they are incremental rather than significant. As a result, the NHS has to manage the introduction of new medicines carefully, taking into account their clinical and cost-effectiveness. A number of bodies have been established in the UK to help the NHS manage this process by conducting technology appraisals. In England (and Wales), NICE assesses an increasing number of newly licensed medicines. Where NICE appraises a medicine positively, the NHS is required to adopt the medicine and make funding available for the indications for which it has been approved. In Scotland the equivalent body is SMC; in Wales, the AWMSG provides guid-ance in addition to that provided by NICE. The SMC and the AWMSG make recommendations for the use of new medicines within their populations but these do not have the statutory enforcement of NICE Technology Appraisals.

Where there is no national guidance, the decision on the introduction and funding of a new medicine has to be made locally by a trust medicines management committee (drug and therapeutics committee or area prescribing committee). Lord Darzi’s Next Stage Review.] and The NHS Constitution acknowledged that patients should have access to the most clinically and cost-effective medicines and have the right to ‘expect rational local decisions on funding of new drugs and treatments’. The robustness of the evidence base on which these committees make their decisions is therefore of great importance. Chapter 11 deals with these issues in greater depth.

In many hospitals, the MI staff support their medicines management committee by providing the evidence on which the committee will make a decision. In some cases, where no other evaluation is available, the trust MI pharmacist may critically appraise the evidence for the committee. However, wherever possible, MI pharmacists will use evaluations produced by credible other bodies, including those produced by the UKMi network, as part of the UKMi ‘new product portfolio’ of resources.

Information on newly launched medicines

The UKMi evaluations of new products are published under the title of New Medicines Profiles (http://www.ukmi.nhs.uk/Med_info/profile.asp). Medicines considered for evaluation include the first or second new medicine in a therapeutic class, and medicines with major new indications or major new formulations. The aim of the profiles is to assess the available evidence on efficacy and safety of a drug and to review its place in therapy and any risk management issues. The evaluations are written to strict criteria to ensure quality and accuracy, and comments are invited from relevant clinicians and from the pharmaceutical manufacturer before publication. In addition to supporting the needs of decision-making committees, they are also intended to support the information needs of clinicians and prescribers.

In order to prevent duplication of work and to extend the range of medi-cines for which evaluations are available, UKMi takes account of the work produced by other organisations, including the National Prescribing Centre (NPC) and the London New Drugs Group (LNDG) when deciding if a New Medicines Profile is to be written.

Planning for new medicines

Advanced notice and planning for the introduction of new medicines are essential if NHS organisations are to allocate resource appropriately. The number of high-cost treatments, the NHS Constitution and increasingly vocal interest groups make the task of allocating resources one of the most politically sensitive and complex issues facing the NHS.

Prescribing Outlook, New Medicines is a UKMi resource (produced with input from the SMC and the AWMSG) that provides advance information to NHS organisations on around 30–50 new medicines (and new licensed indi-cations) with market launches anticipated in the next 18–24 months. It is a signposting document (as opposed to an evaluation document) giving brief details of likely indications, pharmacology, available clinical trial results and estimates of potential uptake.

The content of Prescribing Outlook, New Medicines is not comprehen-sive but focuses on medicines with potential for significant clinical, financial or service delivery implications for the NHS. A number of criteria are applied to those medicines considered for inclusion to help prioritise those likely to have the largest impact, including whether:

·      the drug is expected to provide significant improvement in disease management

·      the drug is ‘first in class’

·      there are limited other drug/non-drug alternatives

·      the cost of the medicine will be high

·      the target population is large

·      there are likely to be significant service implications, e.g. there may be increased monitoring requirements

·      the medicine or disease area is considered an NHS priority

·      the medicine has significant additional indications in the advanced pipeline stage

·      the medicine is in the EU licensing process

·      there is likely to be significant media interest.

For more detailed evaluations of medicines in development, the NPC, in collaboration with UKMi, publishes evaluations of key new medicines – around six per year – under the On the Horizon title. Recently the collabo-ration has started to publish ‘blog-style’ On the Horizon commentaries evaluating the design and outcome of individual clinical trials of medicines likely to be launched in the next year or so.

The pressure on prescribing budgets is not solely associated with new medicines: a significant pressure arises from the issue of new national guidance, such as that produced by NICE, or the impact of major clinical trials on clinical practice. UKMi produces a further resource, Prescribing Outlook, National Developments, which aims to provide the NHS with advanced warning of such prescribing pressures. It includes information on relevant documents, target populations, potential financial implications for the NHS and issues that need to be considered by commissioners and providers of services.

A further UKMi planning resource is Prescribing Outlook – Cost Calculator, which is based on the other two Prescribing Outlook documents. It is an Excel spreadsheet that allows crude calculations of potential costs of prescribing changes for a local population, facilitating budgetary prediction. Prescribing Outlook is published annually in the autumn to meet the NHS planning timetable for the following year. The value of Prescribing Outlook to NHS organisations as a horizon-scanning tool has been highlighted by the Audit Commission.

Early horizon scanning

While the resources discussed above support NHS organisations’ short-term planning needs, there is also a need for a longer-term view of new medicines that are in the development pipeline. UKMi maintains a database, NewDrugsOnline (NDO) that tracks drugs from the phase IIb/III develop-ment stage to product launch. NDO is used to inform the content of Prescribing Outlook; it also drives the work plan of other organisations, such as LNDG.

NDO can be accessed by NHS staff who have a budgetary planning role relating to medicines. Although the full content is only available to those who are registered users of the database, as it contains information which has been provided by pharmaceutical companies on a confidential basis, much of the public domain information is made freely available through the NHS website portal, NHS Evidence.

NDO contains around 1000 monographs relating to medicines in devel-opment, including significant licence extensions to existing therapies. It is updated daily with information from a number of sources, including medical news feeds, journals and company and licensing authority press releases. The content is also informed through direct one-to-one meetings with all major pharmaceutical companies in the UK. The database can be used to meet a variety of needs, including allowing planners to keep up to date with devel-opments in between annual publications of Prescribing Outlook. In addition, it is used, for example, by clinical pharmacists to update directorate staff on developments in their speciality, by medicine management committees for forward-planning purposes, by specialist commissioners to identify medicines that may fall within their jurisdiction and by those involved in clinical trial work. The advanced search facility of the database allows complex reports to be run to fulfil individual requirements.

The Next Stage Review recognised the importance of horizon scanning in facilitating an increase in the rate of appropriate uptake of new medicines by the NHS. Under the auspices of the Ministerial Industry Long-term Leadership Strategy Group, the Department of Health and the Association of the British Pharmaceutical Industry proposed the development of a national horizon-scanning database, populated with information by the pharmaceutical industry, to support directly organisations, such as UKMi, that have an NHS horizon-scanning role. The database, known as UK Pharmascan, was launched in mid-2010. UKMi will be using this database to improve and advance its own early planning resources for new medicines.

Specialist information services

There are a significant number of specialised medicines-related subjects that are frequently referred to due to their nature, which MI pharmacists therefore have to address routinely. Some of these subject areas are of a clinical nature, for example drug use in pregnancy, whilst some are of a pharmaceutical nature, for example medicines that are latex-free. As they are in subject areas that are frequently encountered, a network of MI services providing a spe-cialist information advisory service in some of these areas has been established over the past 25 years (summarised in Table 8.6).

This network provides several distinct advantages. Firstly, in clinical areas, it enables the establishment of a depth of understanding and expert-ise that would not be feasible in every MI service. This includes more comprehensive coverage of the evidence base for that subject, and estab-lishment of clinical ‘expert’ contacts to augment the information provided. Secondly, for non-clinical subjects, it enables the compilation of compre-hensive databases of specialised product information, often with the col-laboration of the pharmaceutical industry. In all cases it provides either a single contact source for users or a single back-up source for MI services, and it reduces a substantial amount of work duplication. The quality of the information is also significantly enhanced. These specialised services were originally based on regional MI centres, but have expanded to encompass the specialties able to be provided from local MI centres based in specialist hospitals or in hospitals providing a high-level specialty in its clinical portfolio. The availability of some of these services is restricted to MI pharmacists only, whilst others have a more open availability and may be wholly or partly web-enabled.

National electronic Library for Medicines

NeLM (www.nelm.nhs.uk) is the largest MI portal for healthcare profes-sionals in the UK NHS. It aims to promote the safe, effective and efficient use of medicines. This free service has been in operation since 1998 and is updated daily. The site has a wide range of information products, including news, evidence-based reviews on drugs and drug therapy and material to support health promotion. It also provides a facility for sharing practice. Much of the current content is provided by UKMi.

Current awareness services offered by NeLM include a personalised daily e-mail newsletter and a wide range of rich site summary (RSS) feeds on specific topics. The Medicines A–Z facility uses codes from the NHS Dictionary of Medicines and Devices (dmþd: http://www.dmd.nhs.uk/) to present on a single page evidence about an individual medicine which is held in NeLM, integrated with links to further information in external sources, including the British National Formulary (BNF), the electronic Medicines Compendium (eMC) and the National Injectable Medicines Guide (Medusa: password-protected NHS website).

NeLM also incorporates selected content from the former Pharm-line bibliographic database to create an area of NeLM dealing with the broad area of medicines management and pharmacy practice.

The current NeLM is the result of a series of transformations as the site has been redeveloped to provide a comprehensive medicines knowledge base. It will store and link to a wide range of MI products procured or produced by the NHS. The vision is to build a system for the integration of knowledge for utilisation at local health community level. Some NeLM con-tent can already be retrieved using the NHS Evidence search interface.

Other NHS or related organisations that produce medicines information which is available through the NeLM portal include:

·      NPC

·      NICE

·      Medicines Healthcare product and Regulatory Authority

·      Department of Health

·      SMC.

In addition, information from professional bodies such as the Royal Pharmaceutical Society and the British Medical Association and independent organisations such as the eMC is also available via NeLM.

The objectives of the NeLM are:

·      to develop a ‘one-stop’ platform from which users can easily find medicines information that matters in a simple and coherent manner

·      to establish a mechanism for aggregating medicines knowledge to support electronic prescribing and similar applications

·      to produce local medicines knowledge bases for health communities to support local prescribers. These will reflect local practice while integrating with national resources of MI.

Information resources

MI services require access to a wide range of published information sources to fulfil all the activities outlined. Many activities may require access only to standard reference books or systems that provide relatively static, unchanging information. However, as the role of the MI pharmacist has developed, the information sources required have become more evidence-based and current, often with use of the primary literature as the main source of information. Whilst textbooks will remain a valuable source of information, their limita-tions (cost, currency, completeness) restrict their importance and are chang-ing the way in which information and clinical evidence are accessed and utilised. Most core, standard information sources are now available electron-ically, commonly via the internet, which makes them not only more accessible but increasingly more cost-effective to use.

MI services in the UK have established a minimum information resources standard, that is, a collection of core information resources that all MI services must either hold in house or to which they must have immediate and unrestricted access. The resources contained in this minimum standard are continually reviewed and updated for new editions, new titles and obsoles-cence. The current information resource standard contains reference and textbooks, journals and electronic databases and is common for all MI ser-vices. In addition, larger local MI centres, regional MI services and specialist MI services will have a requirement for a wider range of resources which will partly be defined by national standards and partly by service need. One basic premise of information resource use is that only the most recent editions of resources should be used. Out-of-date resources could lead to unreliable and erroneous information that could result in harm to a patient, or even a legal challenge.

There are also a large number of important resources that are freely accessible and considered useful to NHS MI services, including free paper resources (for example, BNF, Drug Tariff) and freely accessible websites via the internet or via national library arrangements. Full current lists of recom-mended and important free information resources can be found at www. ukmi.nhs.uk.

Expanding internet and intranet publishing will increasingly make many of the remaining paper-based resources more readily available, often in a form that is ‘free to end-user’, although this will inevitably include current users of MI services. The implications of this shift in the balance of information access and utilisation will have to be taken into account by service providers, includ-ing MI services.

In addition to published resources, MI services will also use in-house collections of commercial and published literature, in-house databases and collections of past outputs (past enquiries, frequently asked questions, bul-letins, reports, and so on) to augment information access.

Utilising information technology

MI services are heavily dependent on all aspects of information technology and electronic communications, both to acquire and to disseminate informa-tion. Online resources have been outlined and provide the dominant platform for evidence-based information on medicines, medicine management and pharmacy practice. Electronic and web-based internet and/or intranet appli-cations are predicted to continue to develop and expand in the foreseeable future. This presents both threats and opportunities to MI services. The main threat, as already described, is that information is becoming more directly and readily available, and in more useful formats and outputs, to the end-user, including healthcare professionals and patients. The quality, accuracy and validity of many of these ‘accessible’ sources are, however, open to question, with no guidance to users either to increase their awareness of the inherent issues or to help them make judgements about quality, appro-priateness and contextual interpretation. The opportunities, however, are for MI services to produce and present quality information that will assist patients and healthcare professionals to make valid judgements on the use of medicines that maximise safety and effectiveness. The positive aspects of these information platforms must also be fully utilised, both to communicate within the MI network and to disseminate information to patients and healthcare staff, through increasingly popular features including, at the time of writing, RSS news feeds, blogs and podcasts, personal customisation of online resources, web conferencing and webinars, online learning and assessment.

Developments in the functionality and accessibility of hardware and gadgets will also influence how MI will adapt to its users by making evidence-based information and decision support more rapidly available to the user for application at the point of care. Similarly, electronic pre-scribing will have an impact on how MI services engage with prescribing and patient care. Some of the basic decision-making processes of electronic prescribing will be embedded in the decision support and clinical knowledge systems inbuilt into electronic prescribing packages. Whilst this may remove some of the basic clinical problem-solving tasks currently undertaken by clinical and MI pharmacists, the need for patient-specific customised infor-mation and solving more complex problems will be a crucial role for the MI pharmacist. Validation of the information contained in e-prescribing sys-tems will also need to be undertaken to ensure prescribing and patient care are not compromised.

Established methods of electronic information communication, such as websites and e-mail, are now taken for granted in day-to-day practice. Over the past decade the intuitive nature of their use, their immediate access to information and users, and their ready availability in most work and home settings have radically and fundamentally changed the way in which MI services function.

·           MI services in the UK have used new technologies and electronic commu-nication to enhance service access, delivery and processes, although the poten-tial for further developments, as outlined, is enormous, largely constrained only by the need for investment. Apart from the NeLM, developments in MI include the following:

·           MiDatabank: this is a Windows software application that enables MI services to record, manage and store their enquiries. MiDatabank was developed specifically for the UKMi network, and has now been adopted as the UK national standard. It is used by over 200 MI centres processing more than 500 000 enquiries per year. It is also being used internationally. One of its crucial features is to provide an audit trail of the complete enquiry-answering process. One of the future objectives of MiDatabank is to facilitate sharing enquiry-related research and answers between MI centres nationally and internationally through web-based applications.

·      The national MI website, www.ukmi.nhs.uk, provides a one-stop resource for MI in the UK, containing a wide range of information, including training and research resources and a single source of all strategic, clinical governance and operational policies and MI guidelines. It also gives access to all the major clinical outputs of the national UKMi network. The national MI website is augmented by a UK-wide e-mail discussion group, MI-UK, which supports information-sharing.

Workforce and training

As with most areas of professional practice, the most important resource of MI services is its staff. MI services are normally managed by experienced clinical pharmacists with specialist training to develop the additional skills, competencies and knowledge required. Training in MI skills and techniques begins at the preregistration stage, with most pharmacy graduates undergoing specific MI training before registration; this also meets the core statutory requirements for pharmacists’ competencies. After registration this is aug-mented by further training, both formally and through placements in estab-lished MI centres. Developing clinical and problem-solving skills supports MI-related skill development, useful in ward and more formal MI service settings.

Pharmacists undertaking more formal work in an MI service are then normally exposed to more formal MI training on a national basis. In the UK, a structured training programme is in place, starting with a national introductory MI training course that introduces the pharmacist to the range of skills and activities relevant to an MI specialist. Entry to this course requires a basic level of predetermined competencies acquired through structured work experience. This level of training aims to enable the trainee to:

·      understand and apply the skills, knowledge and resources to provide clinically oriented MI

·      apply the basic principles of searching electronic sources of information, in particular Medline, Embase and the internet

·      know the strengths and weaknesses of the key MI databases

·      apply basic statistical tests to clinical trial data

·      identify the key components of clinical trial design and apply these to critical appraisal of the literature

·      know the necessary verbal communication skills required to deliver an effective MI service

·      identify legal and ethical problems that may be encountered when providing MI

·      understand the principles of clinical governance, and in particular risk management and quality, and apply these to the provision of MI.

This training is supported by the availability of a national MI workbook. More advanced training to develop skills,knowledge and effective use of resources is then provided to suit the needs of the individual and the service.

The whole training strategy is supported by a national competency frame-work for MI, introduced in 2001. The aim of this is to identify the compe-tencies that individuals working in MI either have, or need to develop, in order to perform their work effectively now and in the future. The framework is used to:

·      facilitate continuing professional development at an individual level

·      help managers and MI pharmacists identify ongoing training and development needs

·      provide a framework to support local recruitment and appraisal processes.

As competencies for all aspects of clinical pharmacy practice are developed, MI competencies will be aligned and integrated into more general, national competency frameworks, at both standard and advanced practice levels, to reflect the MI provider role of all clinical pharmacists.

Although pharmacists have been the principal professional component of the MI workforce in the past, other professional groups are now being developed, and actively deployed, in MI services to support and provide some of its activities. In particular, experienced pharmacy technicians are now in the service, as they are in many other areas of clinical pharmacy practice. Appropriate technicians, once identified, are trained through a rigorously controlled programme which includes core training, in-house work, super-vised work experience, development of a personal work evidence portfolio, continuous assessment, a probationary period and subsequent accreditation as an MI technician. Accredited technicians can then assume some respon-sibilities within the enquiry-answering process. Currently, there are seven common enquiry types, for which MI technicians can have a substantive responsibility, although the final responsibility for the overall process remains with the MI pharmacist. These are:

·           tablet and capsule identification

·           availability of medicines

·           formulation and stability (excluding parenteral)

·           interactions

·      adverse effects

·           complementary medicines

·           travel medicine.

Routine activity within these seven designated subject areas is covered by the accreditation process. However, MI technicians can be involved in other enquiry types and other MI activities as long as adequate training has been undertaken and risk management issues assessed.

The future development of MI technicians’ activities and responsibilities will be an important feature of future service development which will take account of skill mix, recruitment and clinical competence issues. Other pro-fessional groups, including information scientists, life science graduates, librarians and others, may also have roles to fulfil in future MI services which are yet to be defined.