Safe · KLOE 7
Safe delivery of medicines and treatments
Are medicines and treatments delivered safely and in a timely way, in line with people's needs and preferences?
CQC wording, secondary and specialist hospital care draft v0.6, pages 17 to 21.
Draft, not the current assessment framework
CQC's secondary and specialist hospital care draft v0.6, 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:
- Prescribing
- IV medicines / fluids / medical gasses
- Roles, responsibilities and delegation in relation to medicines
- Storage and disposal of medicines
- Controlled drugs
- Self-medication
- Consent / decisions / covert administration (including Mental Capacity Act and Mental Health Act)
- Antimicrobial stewardship
- STOMP / STAMP
- Innovative medicines and safe medical technology
How would this apply to your service?
The draft applies one framework across secondary and specialist hospital care, but useful evidence depends on your service and people.
Source: CQC, Hospitals (secondary and specialist care) assessment framework, draft v0.6, 19 March 2026, pages 17 to 21. 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
- The service has implemented creative, person-centred solutions to enable people (or their representatives) to participate in decision-making about their medicines and treatments.
- Staff lead on quality improvement initiatives, innovative use of medicines and research.
- Enhanced pharmacy roles, including pharmacist prescribers, have been embedded in clinical areas and multi-disciplinary teams to meet people’s medicines needs.
- Staff competently and consistently use tools to assess medicines-related risks to patients and prioritise clinical services accordingly.
Good
- Where possible, people (or their representatives) are active partners in decisions, assessments and reviews about their medicines and treatments. Information to support decision-making meets a person’s needs and is clearly documented in their records.
- The approach to medicines reflects current national guidance, best available evidence and relevant best practice.
- People’s medicines are prescribed, supplied and administered in a timely way and in line with relevant legislation, current national guidance and best practice. People are supported to self-administer their medicines, where appropriate.
- The service has a comprehensive system and clear roles and responsibilities to promote the safe optimisation of medicines.
- Staff at all levels are clear about their roles and responsibilities in relation to medicines and treatments. They are supported by a co-ordinated, multi-professional approach across the healthcare system to ensure effective use of medicines.
- Where a person lacks capacity to make decisions about their medicines and treatments, formal processes (under the Mental Capacity Act 2005) and assessments are undertaken before administration. This includes exploring alternative ways to administer medicines.
- Where a person is given treatment without their consent (under the Mental Health Act 1983), review processes are followed in line with the code of practice.
- People’s behaviour is not controlled by excessive or inappropriate use of medicines.
- Accurate, up-to-date information about people’s medicines and treatments is available, particularly when they move between healthcare settings.
- There are appropriate arrangements for the safe management, use and oversight of medicines, including controlled drugs, in line with legislation and best practice.
- Medicines are stored safely, in accordance with manufacturer’s instructions and national guidance.
- The service meets targets for medicines reconciliation. Medicine reviews are undertaken regularly and documented in care records. Medicines audits are completed and clearly documented, with action plans in place, where required. Staff understand the importance of this.
- The service contributes to medicines research. It uses benchmarking, learning and quality improvement initiatives to ensure that 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 treatments, and these are inconsistently documented.
- People’s medicines are not always prescribed, supplied and administered in line with relevant legislation, current national guidance and best practice. People are given limited support to self-administer their medicines, where appropriate.
- Staff do not always understand their responsibilities to support the safe optimisation of medicines, including the importance of medicines reconciliation, ongoing medicines reviews, audits and good record-keeping.
- Information about medicines is not always accessible in different formats. People, or their representatives, can’t always access support with their medicines from a pharmacy or from a relevant healthcare professional.
- There are inconsistent arrangements for the safe management, use and oversight of medicines, including controlled drugs. Systems are not always in line with legislation and best practice.
- Medicines are not always stored safely, or in accordance with manufacturer’s instructions and national guidance.
- The service does not contribute to medicines research. It does not consistently use benchmarking, learning and quality improvement initiatives to improve outcomes. Quality of life and equity are not always considered in outcome measures.
Inadequate
- Staff do not involve people when making decisions, assessments and reviews about their medicines and treatments, and these decisions are not recorded properly.
- People are at risk because staff do not prescribe, supply and administer medicines safely, including controlled drugs. Legislation, current national guidance and best practice is not followed.
- Staff are not clear about their responsibilities to support the safe optimisation of medicines.
- Staff do not know what to do when a person lacks capacity to make decisions concerning their medicines, or to give consent to medicines being prescribed.
- People’s behaviour is inappropriately controlled by excessive or inappropriate use of medicines.
- Record-keeping in relation to people’s medicines and treatments is poor and medicines reconciliation is not completed at the point of admission. Information is poor, particularly when people move between healthcare settings.
- Information about medicines is not accessible. People or their representatives receive limited support with their medicines.
- Medicines are not stored safely, or in accordance with manufacturer’s instructions and national guidance.
- The service does not meet targets for medicines reconciliation. Medicines reviews are not standard practice and medicines audits are not completed.
- The service does not use benchmarking, learning and quality improvement initiatives to improve outcomes from the use of medicines. Quality of life and equity are not considered in outcome measures.
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.