Safe · KLOE 7
Safe delivery of treatments and medicines
Are medicines and treatments delivered safely and in a timely way, in line with people's needs and preferences?
CQC wording, mental health care draft, pages 21 to 24.
Draft, not the current assessment framework
CQC's mental health care draft, published March 2026. The current quality statements remain in use.
CQC draft scope
What this proposed KLOE covers
Scope of this key line of enquiry and topic areas include:
- Roles and responsibilities, delegation in relation to medicines
- Prescribing and medicines and treatment review
- Self-medication
- Consent/decisions/covert administration (including Mental Capacity Act and Mental Health Act)
- Controlled drugs
- Self-medication
- Storage and disposal of medicines
- Antimicrobial stewardship
- STOMP/STAMP
- Innovative medicines and safe medical technology
- Non-pharmacological anxiety/agitation strategies
- Treatment under MHA compliant with Code of Practice and appropriate authorisations.
- Physical health monitoring for the initiation and maintenance of a relevant treatment
- Monitoring high dose anti-psychotics
How would this apply to your service?
The draft applies one framework across mental health care, but useful evidence depends on your service and people.
Source: CQC, Mental health care assessment framework, draft, 19 March 2026, pages 21 to 24. Contains public sector information licensed under the Open Government Licence v3.0.
CQC draft rating characteristics
How the draft describes each rating
These are CQC's draft characteristics. CQC says rating characteristics guide judgements, they are not a mechanical checklist.
Outstanding
- People (or their representatives) are active partners in decisions, assessments and reviews about their medicines, where possible. The service implements creative, person-centred solutions to enable this.
- There is a comprehensive system to proactively promote the safe optimisation of medicines. Staff at all levels are clear about roles and responsibilities in relation to medicines, supported by a co-ordinated, multi‑professional approach across the healthcare system to ensure effective use of medicines.
- Staff contribute to innovation and research on medicine.
Good
- People (or their representatives) are appropriately involved in decisions, assessments and reviews about their medicines. This information is clearly documented in their records. Medicines information is accessible in all formats. People, or their representatives, can access support from pharmacy or a relevant healthcare professional throughout their care.
- The approach to medicines reflects current national or professional guidance, best available evidence and relevant best practice.
- People’s medicines are appropriately prescribed, supplied and administered in line with relevant legislation, current national guidance and best practice. People are supported to safely self-administer their medicines where appropriate.
- There are clear roles and responsibilities that support the safe optimisation of medicines. Staff understand their responsibilities to support the safe optimisation of medicines, including the importance of medicine reviews, physical health monitoring, audits and good record keeping.
- Where a person lacks capacity to make decisions about their medicines, formal processes (under the Mental Capacity Act 2005) and assessments are undertaken before they are administered. This includes exploring alternative ways of administration.
- People’s behaviour is not inappropriately controlled by excessive or inappropriate use of medicines.
- The service actively considers opportunities to reduce over-medicating people, in line with STOMP/STAMP/STOP principles.
- Where a person receives treatment under the Mental Health Act (MHA) 1983, treatment is given in line with the appropriate MHA authorisations, and review processes are followed in line with the code of practice. There are appropriate care plans and risk assessments in place to support people to manage anxiety and agitation including non-pharmacological approaches. There are clear records detailing when a medicine is used and why it was needed, and this informs care planning.
- Accurate, up-to-date information about people’s medicines is available, particularly when they move between healthcare settings or services.
- There are appropriate arrangements for the safe management, use and oversight of controlled drugs in line with legislation and best practice.
- Use of medicines benchmarking, learning and quality improvement initiatives mean people consistently experience positive and improving outcomes in line with legislation, standards and evidence-based guidance. Quality of life and equity are considered in outcome measures.
Requires improvement
- People are not always involved in decisions, assessments and reviews about their medicines, and this is inconsistently documented.
- Staff have a limited understanding on what to do when a person lacks capacity to make decisions concerning their medicines.
- The service does not always follow relevant national guidelines and legislation around prescribing, supplying and administering medicines, including controlled drugs.
- Staff do not always understand their responsibilities to support the safe optimisation of medicines, including the importance of medicine reviews, physical health monitoring, audits and good record keeping.
- Where medicines are prescribed for the management of anxiety and agitation, care plans and records are not always accurate or do not always reflect people’s individual needs.
Inadequate
- Staff do not involve people when making decisions, assessments and reviews about their medicines and these decisions are not recorded properly. Staff have little or no knowledge on what to do when a person lacks capacity concerning their medicines.
- People’s behaviour is inappropriately controlled by medicine.
- People are at risk because staff do not prescribe, supply and administer medicines, including controlled drugs, safely. Legislation, current national guidance and best practice is not followed.
- People’s physical health and any side effects of medicines are not monitored or recorded in line with local and national guidance.
- Where medicines are prescribed to manage anxiety and agitation, care plans and records are not accurate or do not reflect people’s individual needs. There are no assurances that these medicines are being used appropriately and safely.
- Staff are not clear about their responsibilities to support the safe optimisation of medicines. There are no medicine reviews or audits to monitor safety performance.
- Record keeping for medicines is poor, particularly when people move between healthcare settings.
Want to know how your service would fare?
Book a mock inspection run against the draft KLOEs, or call 020 8090 5346 to speak to one of our experts.