Strategic medicines management in practice

Strategic medicines management in practice

In describing various approaches to implementing strategic medicines management in practice, it is appropriate to discuss the issue in the context of the medicines management pyramid shown in Figure 11.1. As can be seen from the diagram, there are three key elements to strategic medicines management:

·        managed entry of new medicines

·        prescribing policies and guidelines

·        monitoring and feedback on medicines use.

Managed entry of new medicines

At a national level the entry of new medicines is controlled in the licensing process by the Medicines and Healthcare products Regulatory Agency (MHRA); only medicines with an appropriate product licence may be mar-keted in the UK. However, the MHRA licence is primarily concerned with whether a new medicinal product works and is no less safe than existing medicines. The MHRA licensing process makes no judgement on the cost-effectiveness of a new medicine. The establishment of the National Institute for Health and Clinical Excellence (NICE) in England in 1999 was an attempt to introduce a system to assess the cost-effectiveness of new and established medicines. NICE is discussed further in the section on prescribing policies and guidelines, below.

The cornerstone of any system to manage the introduction of new medi-cines at health economy or trust level is the medicines formulary.

Formularies

In the 2007 review of acute trusts medicines management systems, 88% of trusts reported they had a formulary – a published list of preferred med-icines to be used within the organisation. A view many hospitals take is that prescribing information is contained in the British National Formulary, and the purpose of a local formulary is to inform the prescrib-ing doctor what medicines are available for prescription within the organ-isation or health economy. Historically, formularies have been applied to junior doctors, whereas consultants have been allowed to prescribe out-side this restricted list. However, with increased management control, rising drug expenditure and the advent of clinical governance, some hos-pital formularies have been applied rigorously to all grades of staff, including consultants. Clearly, when implementing such a policy it is necessary to make arrangements for the exceptional clinical situation, since a limited range of medicines may not be sufficient to cover every clinical situation.

Deciding the content of the formulary is usually the responsibility of the hospital drug and therapeutics or medicines management committee. It is important that such decisions are evidence-based and transparent if the for-mulary is to improve prescribing and be owned by prescribers. When consid-ering the evidence for new medicines, a number of questions need to be addressed:

·      What is the safety profile of the medicine?

·      Is it better or worse than existing medicines?

Clearly, an application would fail if the new medicine had significantly more side-effects than the current standard treatment unless there were exception-ally large benefits. Therefore, newer ‘black triangle’ medicines may require a more cautious approach.

In addition:

·      What is the efficacy of the new medicine?

·      Are there any advantages over what is already available? Often benefits are marginal and need to be balanced against cost.

Finally:

·      What are the financial implications of the new medicine to the organisation or health economy?

Hospitals must consider the cost to primary care if treatment is to be con-tinued. In particular ‘loss-leading’ should be avoided, where a pharmaceutical company sets the price in hospital artificially low in order to get a drug used, whereas the drug is very expensive in primary care.

One way of ensuring both primary and secondary care issues are consid-ered when making formulary decisions is to have a joint hospital–primary care formulary covering a whole health economy.

In order to inform formulary decisions, the published evidence about the new medicine should be reviewed by someone with critical appraisal skills. This is often a medicines information pharmacist or, in larger hospitals, a dedicated formulary pharmacist.

Formularies are an effective way of controlling the introduction of new medicines in hospital, because the hospital pharmacy controls the medicines supply chain. However, in primary care, formularies can only be advisory, since the suppliers (the community pharmacy) are independent contractors. PCTs use a variety of methods to encourage compliance with formularies. These can include PCT medicines management teams amending practice computer systems, and prescribing targets in the GP quality outcomes frame-work scheme.

The Healthcare Commission recommended that formularies be linked to evidence-based guidelines.

Medicines management committees

Drug and therapeutic (D&T) committees have been established in most hospitals in the UK for many years. Their role in facilitating the develop-ment of formularies was endorsed in the Department of Health circular, HC (88)54, issued in the late 1980s.In a survey of hospitals in 1994, 97% indicated they had a D&T committee. More recently, in the Healthcare Commission’s review of acute hospitals medicines management, all trusts reported they had such a committee. D&T committees or, as a number are now called, medicines management committees are a multidisciplinary group reporting to the chief executive, medical director or management board and their remit is to look at prescribing issues in the trust. Table 11.1 shows the range of activities reported by D&T committees.

Table 11.1 Activities at drug and therapeutic (D&T) committees

Activity : % D&Ts undertaking

Evaluating medicines : over 90%

Developing medicines policy : circa 90%

Reviewing treatment guidelines : 85–90%

Considering financial effectiveness of medicines : 80–85%

Overseeing errors and incidents : 75–80%

Medicines risk management analysis : circa : 75%

Medication alerts : circa 70%

Medicines spend versus budget : 65–70%

Training for medicines for staff groups : 50–55%

Implementation and training on new medicines : 50–55% 

D&T committees have played an important role in controlling the introduction of new medicines and managing medicines policies in hospitals for over 30 years. However, with the establishment of PCTs in 2002, and more recently their changing role as commissioners of services, it has become clear that there needs to be a joined-up approach to effective medicines management across health economies. This can be effectively achieved through area prescribing committees, either undertaking the role of individual organisations committees or as an umbrella committee into which the various organisations committees feed, and which takes the final decision on health economy formulary. The latter is more likely, since within a health economy there may be a mixture of acute, mental health and social care trusts. Furthermore, the establishment of clinical networks, particularly cancer networks, which have their own therapeutics commit-tees, adds to the potential plethora of decision-making committees around medicines, and requires overall coordination, particularly in relation to formulary decisions.

Funding new medicines

A further complication in managing the introduction of new medicines into a hospital, and ultimately a health economy, is the development of PCTs as commissioners of health services and the NHS tariff system (Chapter 1 dis-cusses the payment by results system). The tariff has various prices within it for particular treatments depending on whether there are complications and varying lengths of stay. Table 11.2 is an example of the 2008–2009 tariff payments for respiratory-related treatments. Usually the tariff payment includes the cost of medicines used; the hospital is expected to fund the medicines treatment from the tariff payments it receives.

Medicines budgets in most hospitals have been devolved to clinical direct-orates so applications for the introduction of new medicines from consultants usually require financial sign-off by the directorate management team supporting the application. The process is further complicated by medi-cines excluded from tariff. Medicines excluded from tariff are expensive medicines whose cost is not covered by the tariff income. In these cases PCTs pay for these excluded medicines separately. The mechanism varies between different health economies, but often involves recharging the cost to the patient’s PCT. Therefore, an application for funding to the PCT, usually through the hospital contracting and commissioning system, has to be made for formulary applications involving these medicines. For hospi-tals that are tertiary referral centres, such as cancer centres, the patient’s PCT may not be the local host PCT, adding a further complication to the process. Figure 11.2 illustrates the medicines management process in the author’s health economy showing how complex the process can be if all stakeholders are to be involved.

Prescribing policies and guidelines

National guidance

At a national level the most authoritative guidance is that issued by NICE. Prior to 1999, hospitals had discretion as to which new medicines were prescribed there. If funding a new medicine was problematic, decisions were taken in conjunction with the district health authority. This resulted in vari-ations in availability of new medicines across the whole NHS – so-called postcode prescribing. NICE was established in 1999 with the explicit remit of eliminating postcode prescribing.

The terms of reference for NICE were:

·      to reduce inequalities in treatment

·      to produce evidence-based guidance on treatments

·      to identify new developments which will most improve patient care

·      to help protect patients from outdated and inefficient treatments. With respect to medicines, there are two key types of NICE guidance: clinical guidelines and technology appraisals.

Clinical guidelines are recommendations by NICE on the appropriate treat-ment and care of people with specific disease conditions. The guidelines are based on the best available evidence but it is recognised that these are guide-lines and cannot replace the health professional’s knowledge and skill being applied to specific patients.

Technology appraisals are recommendations on the use of new and exist-ing medicines and treatments within the NHS; for medicines they usually focus on one or a small group of medicines. The recommendations are based on NICE’s review of clinical and economic evidence. Unlike clinical guidelines there is a statutory obligation (in England) for medicines supported by a technology appraisal to be funded via the NHS.

Whilst NICE guidelines and technology appraisals are based on critical review of clinical and economic evidence, they also take into account the views of stakeholders, including patient groups and the pharmaceutical industry.

NICE outputs are aimed at the NHS in England and Wales, though they are accessed much more widely. In Scotland, the Scottish Medicines Consortium provides guidance on medicines that may be used. Its remit is to provide advice to NHS boards and their D&T committees about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products. The All Wales Strategy Group undertakes a similar role.

There are other types of national guidelines produced by Royal Colleges and organisations such as the Scottish Intercollegiate Guidelines Network. The NHS Health Information Resources (formerly the National Library for Health) provides a single portal for accessing these guidelines through its website (www.library.nhs.uk). Searching by disease on the guidance section of the website, various guidelines can be accessed through hyperlinks to the appropriate guideline producer.

At a more local level, guidelines can take a variety of forms such as complete care pathways designed around a particular disease state and include instructions on the use of medicines. The advantage is that the pre-scribing message is an integral part of the care pathway the doctor will be using rather than a separate guideline.

A good example of this is the West Mercia guidelines that have been developed by a consortium of hospitals in the West Midlands and North West of England. The guidelines are then individualised by each hospital (for example, to complement local formularies). These guidelines take the practitioner through the whole treatment of a particular event, including diagnostic tests and medicines to be used. Other guidelines focus mainly on the use of medicines.

The most widely used example of local guidelines focusing on the medi-cines is antibiotic guidelines. The emergence of resistance to antibiotics first gained national attention in the UK with the publication of the House of Lords inquiry. This was followed by the Standing Medical Advisory Committee report and the Department of Health document Getting Ahead of the Curve. The latter resulted in the Department of Health allocating £12 million to establish antibiotic pharmacists within hospitals in England, as discussed in Chapter 9. The need for such posts has been further strengthened by the association of certain antibiotics with Clostridium difficile-associated diarrhoea (CDAD). Antibiotic guidelines are a tool that is central to this area of work, which can take a variety of forms, but need to be readily accessible, and in a form that can be easily understood. Leeds teaching hospi-tals have developed a web-based set of antimicrobial guidelines that can be searched by body system.

Monitoring and feedback on medicines use

Clearly, if senior management is to be aware of prescribing issues, there needs to be a robust system for collating and reporting information on medicines usage. All hospital pharmacies have computerised stock control systems for medicines. These systems have been designed around purchasing and stock control, and not producing prescribing reports. However, the main suppliers of these systems have built in reporting modules in newer versions, although the ease of reporting varies from system to system. Prescribing reports can be used for a variety of purposes. The most common is providing feedback to clinical directorates on medicines use and expenditure for budget manage-ment purposes. Most hospitals are managed on a directorate structure, whereby wards or clinical specialties are grouped together as a clinical directorate, with their own budget and management team. The directorate usually has a clinician as clinical director who is supported by a manager, financial accountant and human resources manager. In large hospitals, these clinical directorates may be grouped into clinical divisions (that is, medicine, surgery, and so on) that are directly accountable to and represented on trust management boards. A survey published in 1997 indicated that 77% of drug budgets were devolved to clinical directorates. The Audit Commission in its review of acute hospitals medicines management systems showed that 21% of trusts managed the drug budget at directorate level, 27% at specialty level and 45% at ward/consultant level, with only 6% managing the budget at trust level. In the same review 96% of budget-holders received medicines budget reports. In many hospitals these reports are supported by directorate pharmacists, a concept which was established over a decade ago. These pharmacists are employed by the pharmacy to provide prescribing advice at clinical directorate level.

In the author’s own trust directorate pharmacists present prescribing reports to their clinical directorates, usually at directorate governance meet-ings. These reports address not only financial issues but also clinical issues and prescribing initiatives either specific for the directorate or across the trust. More recently we have introduced a system where common prescribing errors picked up by clinical pharmacists on the wards are fed back to clinical teams as a learning exercise. This non-blame approach has resulted in a reduction in prescribing errors.

Since much of the work at directorate level involves reviewing medicines usage data and producing graphical representation of prescribing trends, pharmacy technicians are now being employed to support directorate pharmacists.

Medicines management reports are also produced for trust level commit-tees. In view of the increased interest in antibiotic use, particularly as a relationship has been established that antibiotics predispose patients to develop CDAD, antibiotic-prescribing reports are presented regularly to the trust’s infection prevention group.

Although monitoring of medicines use has a long history in hospitals, there is no national comparison of hospital prescribing similar to the system which exists in primary care using practice detailed prescribing information data, previously called PACT data. This is detailed information on an individual primary care practice prescribing patterns, and allows PCTs to compare practice prescribing patterns to PCT and national patterns.

A project was initiated over a decade ago by the National Prescribing Centre (NPC) to undertake comparison of hospital prescribing patterns. This aimed to collect detailed prescribing information routinely from a cohort of hospitals. The results of this pilot project showed some interesting trends, but it proved impossible to roll out across the whole of the NHS because there are a variety of commercial pharmacy systems being used with no common identifier for medicines. Computerised prescribing linked with electronic patient records will alleviate this problem and provide better information on hospital prescribing patterns, since usage data can be linked to individual patients and diagnosis. More importantly, where computerised prescribing has been implemented, it has delivered significant improvements in the quality of patient care. However, the national information technology project to develop electronic prescribing for hospitals that was aimed to be in place by 2004 has now largely been abandoned, and individual trusts are developing their own solutions. This suggests that the problems identified in the NPC project over a decade ago will still remain.

More recently the concept of comparing medicines use across hospitals has been resurrected. However, the methodology is much different from that adopted by the NPC. In this new initiative the author and colleagues have used existing data sets, such as IMS and PharmEx data, which are already collected routinely from hospital pharmacy computer systems. However, even when data are available, comparing hospitals of different size, activity and case mix is problematic. We are developing tools to compensate for these variables, such as defined daily dose/finished consultant episode and propor-tionality. We have shown that it is possible to support change in hospital medicines use using such comparative data.

For example, Figure 11.3 shows use of different formulations of lansoprazole expressed in terms of proportionality to compensate for activity variable in a group of hospitals in one English strategic health authority.

Figure 11.4 shows the use in the same cohort of hospitals after an action plan to reduce the use of tablet formulation of lansoprazole was put in place.