Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes

Introduction

Getting the most from medicines for both patients and the NHS is becoming increasingly important as more people are taking more medicines. Medicines prevent, treat or manage many illnesses or conditions and are the most common intervention in healthcare. However, it has been estimated that between 30% and 50% of medicines prescribed for long‑term conditions are not taken as intended (World Health Organization's world health report 2003). This issue is worsened by the growing number of people with long‑term conditions. In 2012, the Department of Health's long term conditions compendium of information: third edition suggested that about 15 million people in England now have a long‑term condition and the number of long‑term conditions a person may have also increases with age: 14% of people aged under 40 years and 58% of people aged 60 years and over report having at least one long‑term condition. The report defines a long‑term condition as 'a condition that cannot, at present, be cured but is controlled by medication and/or other treatment/therapies'. When one or more non‑curable long‑term conditions are diagnosed, this is termed 'multimorbidity'. The number of people with multimorbidity in 2008 was 1.9 million, but this is expected to rise to 2.9 million by 2018. Twenty‑five per cent of people aged over 60 years report having 2 or more long‑term conditions.

Data from the Health and Social Care Information Centre (HSCIC) shows that between 2003 and 2013 the average number of prescription items per year for any one person in England increased from 13 (in 2003) to 19 (in 2013). When a person is taking multiple medicines this is called polypharmacy, a term that has been used in health care for many years. With an increasing ageing population, polypharmacy has become more important to consider when making clinical decisions for individual people.

In 2013, The King's Fund polypharmacy and medicines optimisation – making it safe and sound paper outlined the view that polypharmacy was something to avoid, but proposed an alternative approach to the concept of polypharmacy: that it may have positive (appropriate) or negative (problematic) potential. Reducing the number of medicines a person is taking may not be the only factor to consider when reviewing polypharmacy.

As the population ages and life expectancy increases, more people are living with several long‑term conditions that are being managed with an increasing number of medicines. Maintaining a careful balance gets more difficult for people and health professionals, particularly when also trying to reduce health inequalities of the population.

Optimising a person's medicines is important to ensure a person is taking their medicines as intended and can support the management of long‑term conditions, multimorbidities and polypharmacy. Medicines optimisation is defined as 'a person‑centred approach to safe and effective medicines use, to ensure people obtain the best possible outcomes from their medicines. Medicines optimisation applies to people who may or may not take their medicines effectively. Shared decision‑making is an essential part of evidence‑based medicine, seeking to use the best available evidence to guide decisions about the care of the individual patient, taking into account their needs, preferences and values' (Evidence based medicine: a movement in crisis Greenhalgh et al. 2014; Evidence based medicine: what it is and what it isn't Sackett et al. 1996).

An important part of shared decision‑making is about health professionals understanding the person's desired level of involvement in decision‑making about their medicines. When having these discussions it is often difficult for the person and the health professional to decide whether the medicines being taken are appropriate and the decision may be different for each individual person.

Involving people in decisions about their care and treatment is not a new concept. Over several years the UK government has supported an approach to change how the NHS engages with patients. The Department of Health's equality and excellence: liberating the NHS outlined the government's vision of putting the public and patients first through shared decision‑making. This White paper stressed that this would only happen by 'involving patients fully in their own care, with decisions made in partnership with clinicians, rather than by clinicians alone' and would be implemented by making shared decision‑making the 'norm'. Subsequent to the government's White paper, The King's Fund's making shared decision-making a reality: no decision about me, without me aimed to outline the skills and resources needed by health professionals to use shared decision‑making, and suggested tools that may help patients in decision‑making when implementing this principle throughout the NHS.

The NICE guidelines on patient experience in adult NHS services and service user experience in adult mental health provide recommendations aiming to improve the experience of care for people using adult NHS and adult mental health services to create sustainable changes that aim to move the NHS towards a truly person‑centred service. In relation to medicines, the NICE guideline on medicines adherence recommends that all patients have the opportunity to be involved in decisions about their medicines at the level they wish, through shared decision‑making. Furthermore, General Medical Council's good practice in prescribing and managing medicines and devices also emphasises the need to take account of the patient's needs, wishes and preferences.

The safety of medicines is another important consideration when optimising medicines and can be a continual challenge. The Department of Health's exploring the costs of unsafe care in the NHS report found that 5% to 8% of unplanned hospital admissions are due to medication issues. This report focused on preventable adverse events which can be attributed to a specific error or errors. Incidents involving medicines have a number of causes, for example: lack of knowledge, failure to follow systems and protocols, interruptions (for example, during prescribing, administration or dispensing), staff competency, poor instruction, and poor communication. Organisations should have a standard approach to determine when a medicines‑related incident or error should be referred to local safeguarding services. Effective systems and processes can minimise the risk of preventable medicines‑related problems such as side effects, adverse effects or interactions with other medicines or comorbidities. The risk of people suffering harm from their medicines increases with polypharmacy.

The Francis Report (2013) emphasised the need to put patients first at all times, and that they must be protected from avoidable harm. In addition, the Berwick report (2013) recommended 4 guiding principles for improving patient safety, including:

Adverse events of medicines represent a considerable burden on the NHS and have a significant impact on patients (Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients Pirmohamed et al. 2004). When people transfer between different care providers, such as at the time of hospital admission or discharge, there is a greater risk of poor communication and unintended changes to medicines (Royal Pharmaceutical Society getting the medicines right). When people move from one care setting to another, between 30% and 70% of patients have an error or unintentional change to their medicines.

Patient safety in relation to medicines is not a new issue and several national initiatives exist to help improve patient safety. In 1964, the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission on Human Medicines launched the national yellow card scheme for reporting side effects to medicines. The scheme is still in existence today and over 600,000 UK yellow cards have been received.

The National Reporting and Learning System (NRLS) was introduced in 2010 by the National Patient Safety Agency (NPSA) as a single, national reporting system for patient safety incidents in England and Wales. The NRLS staff reviewed all alerts to help NHS organisations understand patient safety incidents and why and how they happened, learning from these experiences and taking action to prevent future harm to people. In June 2012, the key functions and expertise for patient safety developed by the NPSA transferred to NHS England.

In 2014, NHS England and the MHRA issued a joint alert Patient safety alert improving medication error reporting and learning. The alerts aim to improve the quality of data reported by providers and introduce national networks to maximise learning and provide guidance on minimising harm relating to medication error reporting. NHS England also launched at this time a new National Patient Safety Alerting System (NPSAS) to strengthen the rapid dissemination of urgent patient safety alerts to healthcare providers via the Central Alerting System (CAS). The new system is a three‑stage system to provide 'useful educational and implementation resources to support providers to put appropriate measures in place to prevent harm and encourage and share best practice in patient safety'.

To further support the patient safety agenda, the NHS Safety Thermometer was introduced by the Department of Health as a measurement tool to support an additional programme of work aimed at supporting patient safety and improvement. The tool is accessible to organisations across all healthcare settings, such as hospitals, care homes and community nursing, and allows them to measure, monitor and analyse patient harms and harm‑free care at a local level to assess improvement over time.

Medicines use can be complex and how people can take their medicines safely and effectively has been a challenge for the health service for many years. The Department of Health's liberating the NHS emphasised the need to improve the outcomes of healthcare for all, to deliver care that is safer, more effective and provides a better experience for patients. Furthermore, the focus of health and social care to become a more integrated service, with person‑centred care, has been made a priority after the Health and Social Care Act was passed in 2012. The Act aims to modernise the NHS, putting clinicians at the centre of commissioning and empowering patients. The NHS Constitution outlined the values and principles of the NHS in England and gave people the right to be involved in discussions and decisions about their health and care, and to be given information to enable them to do this. Patients with capacity have the right to make an informed decision and can refuse to take their medicines.

Before medicines optimisation, the term 'medicines management' was used which has been defined as 'a system of processes and behaviours that determines how medicines are used by the NHS and patients' (National Prescribing Centre 2002). Medicines management has primarily been led by pharmacy teams. Medicines management is an important enabler of medicines optimisation. The definition of 'optimise' is to 'make the best or most effective use of (a situation or resource)'. Medicines optimisation focuses on actions taken by all health and social care practitioners and requires greater patient engagement and professional collaboration across health and social care settings.

The Royal Pharmaceutical Society's medicines optimisation: helping patients make the most of medicines guide was produced to support the medicines optimisation agenda. This guide suggests 4 guiding principles for medicines optimisation, aiming to lead to improved patient outcomes:

To further support the implementation of the guiding principles, the prototype NHS England medicines optimisation dashboard was launched. The dashboard aims to 'encourage Clinical Commissioning Groups (CCGs) and trusts to think more about how well their patients are supported to use medicines and less about focusing on cost and volume of drugs'. NHS England's medicines optimisation supporting information outlines the purpose of the dashboard.

Better use of data and technology can give people more control over their health and support the medicines optimisation agenda. The National Information Board (NIB) has been established by the Department of Health to bring together 'national health and core organisations from the NHS, public health, clinical science, social care and local government, together with appointed lay representatives'. The National Information Board personalised health and care 2020: a framework for action was published to support people using health and social care services and frontline health and social care practitioners to take better advantage the digital opportunity. Using the potential of information technology and data will help bridge the gaps between care services and enable people who use these services have access to their health care information, all of which can help optimise the use of medicines.

Striving towards a person‑centred service through joint working across health and social care and cross‑sector working (for example with commercial organisations) achieves the best possible outcomes for the person. This incorporates a patient's values and preferences and minimises harm, supporting effective medicines optimisation. This guideline reviews the evidence available to support health and social care practitioners, and health and social care organisations, in considering the systems and processes required to ensure safe and effective medicines optimisation.

In this guideline, the term 'medicines' covers all healthcare treatments, such as oral medicines, topical medicines, inhaled products, injections, wound care products, appliances and vaccines.