1 Recommendations | Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes | Guidance

Terms used in this guideline

Adverse drug reaction This is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. See also Medicines and Healthcare Products Regulatory Agency for further information.

Complementary medicine Treatments that fall outside of mainstream healthcare. These medicines and treatments range from acupuncture and homeopathy to aromatherapy.

'Fair blame' culture In health and social care, this enables open and honest reporting of mistakes that are treated as an opportunity to learn to improve care.

Over‑the‑counter medicines Medicines that can be bought without a prescription.

Person's baseline risk Patient decision aids illustrate the absolute benefits and risks of interventions, assuming a particular baseline risk. It is important to take into account the person's likely starting or baseline risk when using a patient decision aid. Even though the relative risk is the same regardless of the person's baseline risk, people with a lower baseline risk than that illustrated in a patient decision aid will have a lower absolute chance of benefiting and a lower residual risk. People with a greater baseline risk than that illustrated will have a greater absolute chance of benefiting but also a greater residual risk.

PINCER (pharmacist‑led information technology intervention for medication errors) Method for reducing a range of medication errors in general practices with computerised clinical records.

Polypharmacy Use of multiple medicines by a person.

Preference‑sensitive decision Decisions about treatment made based on the person's preferences and personal values of each treatment option presented. Decisions should be made only after patients have enough information to make an informed choice, in partnership with the prescriber.

Robust and transparent Robust and transparent processes, including sharing of information and appropriate collaboration with relevant stakeholders, aims to improve the consistency of decision‑making about medicines and ensure that patient safety is not compromised. This should reduce inappropriate variation in patient care when decisions are made due to inconsistent, inadequate or unsafe processes and policies. However, even with robust and transparent processes in place, legitimate variation will remain. Organisations will make decisions within their local governance arrangements that are based on local priorities and the needs of their local population.

1.1 Systems for identifying, reporting and learning from medicines‑related patient safety incidents

Improving learning from medicines‑related patient safety incidents is important to guide practice and minimise patient harm. Medicines‑related patient safety incidents are unintended or unexpected incidents that are specifically related to medicines use, which could have or did lead to patient harm. These include potentially avoidable medicines‑related hospital admissions and re‑admissions, medication errors, near misses and potentially avoidable adverse events.

1.1.1 Organisations should support a person‑centred, 'fair blame' culture that encourages reporting and learning from medicines‑related patient safety incidents.

1.1.2 Health and social care practitioners should explain to patients, and their family members or carers where appropriate, how to identify and report medicines‑related patient safety incidents.

1.1.3 Organisations should ensure that robust and transparent processes are in place to identify, report, prioritise, investigate and learn from medicines‑related patient safety incidents, in line with national patient safety reporting systems – for example, the National Reporting and Learning System.

1.1.4 Organisations should consider using multiple methods to identify medicines‑related patient safety incidents – for example, health record review, patient surveys and direct observation of medicines administration. They should agree the approach locally and review arrangements regularly to reflect local and national learning.

1.1.5 Organisations should ensure that national medicines safety guidance, such as patient safety alerts, are actioned within a specified or locally agreed timeframe.

1.1.6 Organisations should consider assessing the training and education needs of health and social care practitioners to help patients and practitioners to identify and report medicines‑related patient safety incidents.

1.1.7 Health and social care practitioners should report all identified medicines‑related patient safety incidents consistently and in a timely manner, in line with local and national patient safety reporting systems, to ensure that patient safety is not compromised.

1.1.8 Organisations and health professionals should consider applying the principles of the PINCER intervention to reduce the number of medicines‑related patient safety incidents, taking account of existing systems and resource implications. These principles include:

using information technology support
using educational outreach with regular reinforcement of educational messages
actively involving a multidisciplinary team, including GPs, nurses and support staff
having dedicated pharmacist support
agreeing an action plan with clear objectives
providing regular feedback on progress
providing clear, concise, evidence‑based information.

1.1.9 Consider using a screening tool – for example, the STOPP/START tool in older people – to identify potential medicines‑related patient safety incidents in some groups (STOPP, Screening Tool of Older Persons' potentially inappropriate Prescriptions; START, Screening Tool to Alert to Right Treatment). These groups may include:

adults, children and young people taking multiple medicines (polypharmacy)
adults, children and young people with chronic or long‑term conditions
older people.

1.1.10 Organisations should consider exploring what barriers exist that may reduce reporting and learning from medicines‑related patient safety incidents. Any barriers identified should be addressed – for example, using a documented action plan.

1.1.11 Health and social care organisations and practitioners should:

ensure that action is taken to reduce further risk when medicines‑related patient safety incidents are identified
apply and share learning in the organisation and across the local health economy, including feedback on trends or significant incidents to support continuing professional development. This may be through a medicines safety officer, controlled drugs accountable officer or other medicines safety lead.

1.2 Medicines-related communication systems when patients move from one care setting to another

Relevant information about medicines should be shared with patients, and their family members or carers, where appropriate, and between health and social care practitioners when a person moves from one care setting to another, to support high‑quality care. This includes transfers within an organisation – for example, when a person moves from intensive care to a hospital ward – or from one organisation to another – for example, when a person is admitted to hospital, or discharged from hospital to their home or other location.

Recommendations in this section update and replace recommendation 1.4.2 in NICE's guideline on medicines adherence.

1.2.1 Organisations should ensure that robust and transparent processes are in place, so that when a person is transferred from one care setting to another:

the current care provider shares complete and accurate information about the person's medicines with the new care provider and
the new care provider receives and documents this information, and acts on it.

Organisational and individual roles and responsibilities should be clearly defined. Regularly review and monitor the effectiveness of these processes. See also section 1.3 on medicines reconciliation.

Take into account the 5 rules set out in the Health and Social Care Information Centre's guide to confidentiality in health and social care when sharing information.

1.2.2 For all care settings, health and social care practitioners should proactively share complete and accurate information about medicines:

ideally within 24 hours of the person being transferred, to ensure that patient safety is not compromised and
in the most effective and secure way, such as by secure electronic communication, recognising that more than one approach may be needed.

1.2.3 Health and social care practitioners should share relevant information about the person and their medicines when a person transfers from one care setting to another. This should include, but is not limited to, all of the following:

contact details of the person and their GP
details of other relevant contacts identified by the person and their family members or carers where appropriate – for example, their nominated community pharmacy
known drug allergies and reactions to medicines or their ingredients, and the type of reaction experienced (see NICE's guideline on drug allergy)
details of the medicines the person is currently taking (including prescribed, over-the-counter and complementary medicines) – name, strength, form, dose, timing, frequency and duration, how the medicines are taken and what they are being taken for
changes to medicines, including medicines started or stopped, or dosage changes, and reason for the change
date and time of the last dose, such as for weekly or monthly medicines, including injections
what information has been given to the person, and their family members or carers where appropriate
any other information needed – for example, when the medicines should be reviewed, ongoing monitoring needs and any support the person needs to carry on taking the medicines. Additional information may be needed for specific groups of people, such as children.

1.2.4 Health and social care practitioners should discuss relevant information about medicines with the person, and their family members or carers where appropriate, at the time of transfer. They should give the person, and their family members or carers where appropriate, a complete and accurate list of their medicines in a format that is suitable for them. This should include all current medicines and any changes to medicines made during their stay.

1.2.5 Consider sending a person's medicines discharge information to their nominated community pharmacy, when possible and in agreement with the person.

1.2.6 Organisations should consider arranging additional support for some groups of people when they have been discharged from hospital, such as pharmacist counselling, telephone follow‑up, and GP or nurse follow‑up home visits. These groups may include:

adults, children and young people taking multiple medicines (polypharmacy)
adults, children and young people with chronic or long‑term conditions
older people.

1.3 Medicines reconciliation

Medicines reconciliation, as defined by the Institute for Healthcare Improvement, is the process of identifying an accurate list of a person's current medicines and comparing them with the current list in use, recognising any discrepancies, and documenting any changes, thereby resulting in a complete list of medicines, accurately communicated. The term 'medicines' also includes over‑the‑counter or complementary medicines, and any discrepancies should be resolved. The medicines reconciliation process will vary depending on the care setting that the person has just moved into – for example, from primary care into hospital, or from hospital to a care home.

1.3.1 In an acute setting, accurately list all of the person's medicines (including prescribed, over‑the‑counter and complementary medicines) and carry out medicines reconciliation within 24 hours or sooner if clinically necessary, when the person moves from one care setting to another – for example, if they are admitted to hospital.

1.3.2 Recognise that medicines reconciliation may need to be carried out on more than one occasion during a hospital stay – for example, when the person is admitted, transferred between wards or discharged.

1.3.3 In primary care, carry out medicines reconciliation for all people who have been discharged from hospital or another care setting. This should happen as soon as is practically possible, before a prescription or new supply of medicines is issued and within 1 week of the GP practice receiving the information.

1.3.4 In all care settings organisations should ensure that a designated health professional has overall organisational responsibility for the medicines reconciliation process. The process should be determined locally and include:

organisational responsibilities
responsibilities of health and social care practitioners involved in the process (including who they are accountable to)
individual training and competency needs.

1.3.5 Organisations should ensure that medicines reconciliation is carried out by a trained and competent health professional – ideally a pharmacist, pharmacy technician, nurse or doctor – with the necessary knowledge, skills and expertise including:

effective communication skills
technical knowledge of processes for managing medicines
therapeutic knowledge of medicines use.

1.3.6 Involve patients and their family members or carers, where appropriate, in the medicines reconciliation process.

1.3.7 When carrying out medicines reconciliation, record relevant information on an electronic or paper‑based form. See section 1.2 on medicines‑related communication systems.

1.4 Medication review

Medication review can have several different interpretations and there are also different types which vary in their quality and effectiveness. Medication reviews are carried out in people of all ages. In this guideline medication review is defined as 'a structured, critical examination of a person's medicines with the objective of reaching an agreement with the person about treatment, optimising the impact of medicines, minimising the number of medication‑related problems and reducing waste'. See also recommendation 1.6.3.

1.4.1 Consider carrying out a structured medication review for some groups of people when a clear purpose for the review has been identified. These groups may include:

adults, children and young people taking multiple medicines (polypharmacy)
adults, children and young people with chronic or long‑term conditions
older people.

1.4.2 Organisations should determine locally the most appropriate health professional to carry out a structured medication review, based on their knowledge and skills, including all of the following:

technical knowledge of processes for managing medicines
therapeutic knowledge on medicines use
effective communication skills.

The medication review may be led, for example, by a pharmacist or by an appropriate health professional who is part of a multidisciplinary team.

1.4.3 During a structured medication review, take into account:

the person's, and their family members or carers where appropriate, views and understanding about their medicines
the person's, and their family members' or carers' where appropriate, concerns, questions or problems with the medicines
all prescribed, over-the-counter and complementary medicines that the person is taking or using, and what these are for
how safe the medicines are, how well they work for the person, how appropriate they are, and whether their use is in line with national guidance
whether the person has had or has any risk factors for developing adverse drug reactions (report adverse drug reactions in line with the yellow card scheme)
any monitoring that is needed.

1.5 Self-management plans

Self‑management plans can be patient‑led or professional‑led and they aim to support people to be empowered and involved in managing their condition. Different types of self‑management plan exist and they vary in their content depending on the needs of the individual person. Self‑management plans can be used in different settings. In this guideline self‑management plans are structured, documented plans that are developed to support a person's self management of their condition using medicines. People using self‑management plans can be supported to use them by their family members or carers who can also be involved when appropriate during discussions – for example, a child and their parents using a self‑management plan.

1.5.1 When discussing medicines with people who have chronic or long‑term conditions, consider using an individualised, documented self‑management plan to support people who want to be involved in managing their medicines. Discuss at least all of the following:

the person's knowledge and skills needed to use the plan, using a risk assessment if needed
the benefits and risks of using the plan
the person's values and preferences
how to use the plan
any support, signposting or monitoring the person needs.

Record the discussion in the person's medical notes or care plan as appropriate.

1.5.2 When developing an individualised, documented self‑management plan, provide it in an accessible format for the person and consider including:

the plan's start and review dates
the conditions being managed
a description of medicines being taken under the plan (including the timing)
a list of the medicines that may be self‑administered under the plan and their permitted frequency of use, including any strength or dose restrictions and how long a medicine may be taken for
known drug allergies and reactions to medicines or their ingredients, and the type of reaction experienced (see the NICE guideline on drug allergy)
arrangements for the person to report suspected or known adverse reactions to medicines
circumstances in which the person should refer to, or seek advice from, a health professional
the individual responsibilities of the health professional and the person
any other instructions the person needs to safely and effectively self‑manage their medicines.

1.5.3 Review the self‑management plan to ensure the person does not have problems using it.

1.6 Patient decision aids used in consultations involving medicines

Many people wish to be active participants in their own healthcare, and to be involved in making decisions about their medicines. Patient decision aids can support health professionals to adopt a shared decision‑making approach in a consultation, to ensure that patients, and their family members or carers where appropriate, are able to make well‑informed choices that are consistent with the person's values and preferences. More information is available in NICE's guidelines on decision-making and mental capacity and shared decision making.

1.6.1 Offer all people the opportunity to be involved in making decisions about their medicines. Find out what level of involvement in decision‑making the person would like and avoid making assumptions about this.

1.6.2 Find out about a person's values and preferences by discussing what is important to them about managing their conditions and their medicines. Recognise that the person's values and preferences may be different from those of the health professional and avoid making assumptions about these.

1.6.3 Apply the principles of evidence‑based medicine when discussing the available treatment options with a person in a consultation about medicines. Use the best available evidence when making decisions with or for individuals, together with clinical expertise and the person's values and preferences.

1.6.4 In a consultation about medicines, offer the person, and their family members or carers where appropriate, the opportunity to use a patient decision aid (when one is available) to help them make a preference-sensitive decision that involves trade‑offs between benefits and harms. Ensure the patient decision aid is appropriate in the context of the consultation as a whole.

1.6.5 Do not use a patient decision aid to replace discussions with a person in a consultation about medicines.

1.6.6 Recognise that it may be appropriate to have more than one consultation to ensure that a person can make an informed decision about their medicines. Give the person the opportunity to review their decision, because this may change over time – for example, a person's baseline risk may change.

1.6.7 Ensure that patient decision aids used in consultations about medicines have followed a robust and transparent development process, in line with NICE's Standards framework for shared-decision-making support tools, including patient decision aids or the International Patient Decision Aid Standards criteria.

1.6.8 Before using a patient decision aid with a person in a consultation about medicines, read and understand its content, paying particular attention to its limitations and the need to adjust discussions according to the person's baseline risk.

1.6.9 Ensure that the necessary knowledge, skills and expertise have been obtained before using a patient decision aid. This includes:

relevant clinical knowledge
effective communication and consultation skills, especially when finding out patients' values and preferences
effective numeracy skills, especially when explaining the benefits and harms in natural frequencies, and relative and absolute risk
explaining the trade‑offs between particular benefits and harms.

1.6.10 Organisations should consider training and education needs for health professionals in developing the skills and expertise to use patient decision aids effectively in consultations about medicines with patients, and their family members or carers where appropriate.

1.6.11 Organisations should consider identifying and prioritising which patient decision aids are needed for their patient population through, for example, a local medicines decision‑making group. They should agree a consistent, targeted approach in line with local pathways and review the use of these patient decision aids regularly.

1.6.12 Organisations and health professionals should ensure that patient decision aids prioritised for use locally are disseminated to all relevant health professionals and stakeholder groups, such as clinical networks.

1.7 Clinical decision support

Clinical decision support software is a component of an integrated clinical IT system providing support to clinical services, such as in a GP practice or secondary care setting. These integrated clinical IT systems are used to support health professionals to manage a person's condition. In this guideline the clinical decision support software relates to computerised clinical decision support, which may be active or interactive, at the point of prescribing medicines.

1.7.1 Organisations should consider computerised clinical decision support systems (taking account of existing systems and resource implications) to support clinical decision‑making and prescribing, but ensure that these do not replace clinical judgement.

1.7.2 Organisations should ensure that robust and transparent processes are in place for developing, using, reviewing and updating computerised clinical decision support systems.

1.7.3 Organisations should ensure that health professionals using computerised clinical decision support systems at the point of prescribing have the necessary knowledge and skills to use the system, including an understanding of its limitations.

1.7.4 When using a computerised clinical decision support system to support clinical decision‑making and prescribing, ensure that it:

identifies important safety issues
includes a system for health professionals to acknowledge mandatory alerts. This should not be customisable for alerts relating to medicines-related 'never events'
reflects the best available evidence and is up‑to‑date
contains useful clinical information that is relevant to the health professional to reduce 'alert fatigue' (when a prescriber's responsiveness to a particular type of alert declines as they are repeatedly exposed to that alert over time).

1.8 Medicines-related models of organisational and cross-sector working

The introduction of skill mixing of various health and social care practitioners to meet the needs of different groups of people has led to different types of models of care emerging across health and social care settings. Cross‑organisational working further provides seamless care during the patient care pathway when using health and social care services. The type of model of care used will be determined locally based on the resources and health and social care needs of the population in relation to medicines.

1.8.1 Organisations should consider a multidisciplinary team approach to improve outcomes for people who have long‑term conditions and take multiple medicines (polypharmacy).

1.8.2 Organisations should involve a pharmacist with relevant clinical knowledge and skills when making strategic decisions about medicines use or when developing care pathways that involve medicines use.