- Terms used in this guideline
- 1.1 Systems for identifying, reporting and learning from medicines‑related patient safety incidents
- 1.2 Medicines-related communication systems when patients move from one care setting to another
- 1.3 Medicines reconciliation
- 1.4 Medication review
- 1.5 Self-management plans
- 1.6 Patient decision aids used in consultations involving medicines
- 1.7 Clinical decision support
- 1.8 Medicines-related models of organisational and cross-sector working
People have the right to be involved in discussions and make informed decisions about their care, as described in NICE's information on making decisions about your care.
Making decisions using NICE guidelines explains how we use words to show the strength (or certainty) of our recommendations, and has information about prescribing medicines (including off-label use), professional guidelines, standards and laws (including on consent and mental capacity), and safeguarding.
The following guidance is based on the best available evidence. The full guideline gives details of the methods and the evidence used to develop the guidance.
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.
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:
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.
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
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
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
any monitoring that is needed.
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.
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.
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).