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The NHS has to provide health services within a finite budget and this represents a considerable challenge. The drugs budget is an area that deserves special attention because it is a significant sum (£170 million in NHS Lothian) and the choice of drug has considerable cost implications. Prescribing of medicines has to be clinically appropriate for the patient and financially efficient for the NHS. This section discusses the issues involved and the importance of medicines management to ensure that all patients who require drug therapy receive the most clinically and cost-effective medicines.

Medicines Management

Medicines Management is defined by the National Prescribing Centre (NPC) as:

“…a system of processes and behaviours that determines how medicines are used by patients and by the NHS. Effective medicines management will place the patient as the primary focus, thus delivering better targeted care and better informed individuals.” (1)

The aim of Medicines Management is to ensure that all patients who require drug therapy receive the most clinically and cost-effective medicines; or, put another way, a successful medicines management process provides the right drug at the right dose to the right person for the right diagnosis.

It is an often challenging, sometimes uncomfortable, but a necessary fact that the NHS has to provide health services within finite resources. This has recently been emphasised by the Scottish Government in the Better Health, Better Care Action Plan 2008/2009 Heat Targets (2) which states that NHS Boards need to:
  • operate within their agreed revenue resource limit;
  • operate within their capital resource limit;
  • meet their cash requirement; and
  • meet their cash efficiency target.

Medicines management processes aim to optimise the use of medicines by achieving financial efficiency in prescribing (getting value for money and reducing waste) and providing high quality, safe and appropriate prescribing (maximising therapeutic benefit, minimising medication errors, and avoiding drug interactions and adverse events).

This is a challenge to medicines management at a local Health Board level and has also been recognised as a world wide issue by the World Health Assembly.

“The Sixtieth World Health Assembly, aware that irrational use of medicines continues to be an urgent and widespread problem in the public and private health sector in developed and developing countries with serious consequences in terms of poor patient outcomes, adverse drug reactions, increasing antimicrobial resistance and wasted resources,…urges Member States: to expand to national level sustainable interventions successfully implemented at local level… (3)

Economic sustainability

Medicines management processes must ensure prescribing efficiency in order to be economically sustainable. Possible threats to economic sustainability are considered below.

The elderly population
The number of elderly people is increasing each year as people live longer and chronic diseases are treated with new drugs that prolong life. This has an impact on the drug budget. On average an elderly patient (75+ years) receives drug treatments that cost 10 times that of an average 30-year-old. The challenge is to ensure that longer life means good quality longer life. It is essential that the benefit to harm ratio of any drug treatment is discussed fully between patient and doctor. Only then will patients be able to make an informed choice of whether they wish to receive drug treatment.

New drugs produced by the pharmaceutical industry
The pharmaceutical industry receives permission to market (licence) approximately 80 new drugs each year. Some of these will be genuine therapeutic advances and some will be alternatives to drugs already in use in clinical practice. It is therefore vital that these drugs are reviewed so that their clinical and costeffectiveness are established in relation to current therapies. We are fortunate in Scotland that this essential work is undertaken by the Scottish Medicines Consortium (SMC). The SMC reviews all new medicines and makes a recommendation to all Health Boards on whether they should be accepted for use, or not recommended for use in NHS Scotland.

The pharmaceutical industry has a part to play in understanding that the NHS (its main customer in the UK) has to operate within the limitations of a finite budget. There are recent signs that it recognises the challenge faced by the NHS:

“The industry faces a critical challenge in understanding and successfully managing the limits of society’s willingness and ability to pay for breakthrough innovation – particularly high-priced biologicals.” (4)

Though, at the same time, the industry has to report to its shareholders.

Old drugs used for new indications
Therapeutic advances have been achieved with new medicines but can also be found with ‘old’ medicines used in new indications (applications). For example, Thalidomide is well known as a drug sold and prescribed during the late 1950s and early 1960s for pregnant women with morning sickness and as an aid to help them sleep. Before its release inadequate tests were performed to assess the drug’s safety, with catastrophic results for the children of women who had taken thalidomide during their pregnancies. From 1956 to 1962, approximately 10,000 children were born with severe malformities, including phocomelia because their mothers had taken Thalidomide during pregnancy. However, further research work has shown that it is effective in multiple myeloma, and it is now approved for use in this malignancy.

New diseases and the re-emergence of old disease requiring drug treatment
New diseases appear from time to time that are serious threats to public health. The World Health Organization has warned that new diseases could spread in the wake of the deadly SARS virus. Severe acute respiratory syndrome (SARS) is a respiratory disease in humans, is caused by the SARS coronavirus and has a 9% fatality rate.

New ‘diseases’ also appear that may seem to be an excuse to provide a drug treatment. One example is ‘shyness’ or ‘social anxiety disorder’. This condition can now be treated by a drug called Seroxat®, an antidepressant that has obtained a licence for ‘social anxiety disorder’. This is one of several so called ‘lifestyle’ drugs launched in the last few years.

There is no doubt that for some people social anxiety disorder is a disabling condition which can leave patients too frightened of encountering others to leave their own homes. However, for many it is a feature of their personality and does not require treatment. It is easy to understand that when there is a ‘diagnosis’ attached then there is pressure from patients, and increased public awareness from the media, to find a treatment. When Viagra was launched for the treatment of impotence, the UK Government recognised the potential for demand for prescriptions and brought in regulations to restrict NHS treatment to patients with a physical cause or those ‘suffering serious distress’. This raises the question of whether further regulation should be introduced to restrict the provision of non-therapeutic treatments in the NHS.

New vaccines and immunisation programmes
New vaccines have been licensed for use against certain types of the human papillomavirus (HPV). HPV types 16 and 18 cause about 70% of HPV-related cervical cancer cases. Human papillomavirus (HPV) infection causes virtually all cases of cervical cancer, the seventh most common cause of death from cancer among women worldwide. These new vaccines represent a significant medical advance and plans are underway to develop a nationwide immunisation programme.

The abolition of prescription charges
Proposals to abolish prescription charges were announced by the Scottish Government in December 2007. In April 2008 prescription charges will be reduced to £5.00, a cut of over 25%, with further phased reduction towards a total abolition of the charges in 2011. Those people who suffer from chronic or long-term conditions will also benefit from an over 50% reduction in the cost of prescription pre-payment certificates. These proposals are welcome, as the existing prescription charges arrangements were out of date and contained anomalies in the medical exemption arrangements. However, the income previously generated and provided to the Health Boards will disappear. To address this, provision for the cost of the proposals has been made in the Spending Review allowing £20m, £32m and £45m for the three financial years from 2008-09. Does prioritisation of health funds in this way reduce funding available elsewhere in the NHS?

Drug pricing
The UK Health Departments and the Association of the British Pharmaceutical Industry (ABPI) have a common interest in ensuring that safe and effective medicines are available on reasonable terms to the NHS and in a strong, efficient and profitable pharmaceutical industry in the United Kingdom. Drug pricing is one of the key levers that determine the profitability of a drug company. Premium pricing of a new drug helps cover the high cost of innovation and helps run a profitable enterprise. This is good for the overall UK economy. However, drug pricing also determines the cost of the drug to the NHS and subsequently the affordability of the NHS drugs budget. There is an inevitable tension about drug pricing between industry and the NHS. To cope with this, the UK Government has used a scheme for many years, called the Pharmaceutical Price Regulation Scheme (PPRS), to ensure the NHS has access to good quality branded medicines at reasonable prices, and at the same time promotes a healthy, competitive pharmaceutical industry.

Despite the PPRS, issues remain. The UK Office of Fair Trading (OFT) in 2007 recommended that the PPRS should be reformed to deliver better value for money from NHS expenditure on drugs and to focus business investment on drugs that have the greatest benefits for patients. This followed an OFT study which identified a number of drugs where prices are significantly out of line with patient benefits. These include treatments for cholesterol, blood pressure and stomach acid. At present, many alternative products are available in these and other major areas of expenditure, yet some drugs are much more expensive, but not significantly more effective, than others. Specifically, some drugs currently prescribed in large volumes are up to 10 times more expensive than substitute treatments that deliver very similar benefits to patients.

Drug pricing set by the PPRS applies to all new branded drugs. After the patent on a brand drug expires (usually between 5-10 years), it is possible for manufacturers to produce the same drug at a much reduced price. These drugs are called generic drugs. Generic prescribing is a key strategy encouraged by medicines management that ensures high prescribing efficiency. All of the above examples illustrate increases in drug costs where the efficiency of prescribing has to be considered very carefully. Unless there are robust medicines management arrangements in place there is a risk of increased spend without any increase in patient benefit.

Medicines Management in Lothian

Within NHS Lothian we already have a number of mechanisms in place which can help in the local management of medicines. These include:

  • Local support – on a multidisciplinary basis – for a rational approach to medicines management, especially amongst prescribers;
  • Clear and effective prescribing policies produced by respected committees e.g. the Area Drugs and Therapeutics Committee and local Drug and Therapeutics committees;
  • An agreed Drug Formulary for hospital and general practice that is kept up-to-date – the Lothian Joint Formulary (5);
  • An effective communication process supported by the Lothian Prescribing Bulletin;
  • A system for implementing advice on prescribing and drug information; and
  • Professional resources to ensure that medicines management is sustainable.

key points

  • Prescribing efficiency is essential if the NHS wishes to provide clinically effective and cost-effective medicines to patients who need them on a sustainable basis.
  • Demographic changes, development of new health technologies and the emergence of new diseases will continue to place financial pressure on drug budgets and increase the need for sustainable and effective medicines management.
  • It is essential that the benefit to harm ratio of any drug treatment is discussed fully between patient and doctor to allow patients to make an informed choice of whether they wish to receive drug treatment. The challenge is to ensure that longer life means good quality longer life.
  • It is important to recognise that there are several factors outwith the control of Health Boards, such as the PPRS, which determine the cost of drugs and thus ultimately the affordability of medicines.
  • This would be aided by a better understanding of what constitutes value for money within the healthcare system as this would benefit the NHS, the pharmaceutical industry and ultimately patients.