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Safe · KLOE 7

Safe medicines and treatments

Are medicines and treatments safe and delivered in a timely way, in line with people's needs and preferences?

In brief

Safe medicines and treatments is key line of enquiry 7 under the Safe key question in the Care Quality Commission (CQC) draft adult social care assessment framework (v9, 19 March 2026), currently published for consultation. It covers roles and responsibilities and delegation, self-medication, safe administration and record keeping, consent/decisions/covert administration (including mental capacity act 2005 and mental health act 1983), controlled drugs, storage and disposal, innovative medicines and medtech safety, antimicrobial stewardship. CQC describes performance against it at four rating levels: Outstanding, Good, Requires improvement and Inadequate. Each statement and rating characteristic quoted here is reproduced verbatim from CQC's draft; plain-English summaries are HLTH's own.

Key question
Safe
Line of enquiry
KLOE 7 of 7 under Safe
Rating levels
Outstanding, Good, Requires improvement, Inadequate
Source
Adult social care assessment framework, v9 (19 March 2026)
Status
Draft, published by CQC for consultation
Reference
pp. 18–21 of the CQC draft

Scope and topic areas

What this line of enquiry covers

Scope of this key line of enquiry and topic areas include:

  • Roles and responsibilities and delegation
  • Self-medication
  • Safe administration and record keeping
  • Consent/decisions/covert administration (including Mental Capacity Act 2005 and Mental Health Act 1983)
  • Controlled drugs
  • Storage and disposal
  • Innovative medicines and MedTech safety
  • Antimicrobial stewardship

Rating characteristics

How CQC describes each rating

The four characteristic sets for this KLOE, best to worst. Every point is CQC's wording, reproduced exactly.

Outstanding

In plain terms: Care is exceptional and consistently better than the Good standard.

  • There is a proactive approach to the optimal use of medicines, with a high degree of person-centred detail to achieve the best outcomes for people.
  • Staff work creatively with people to involve them in managing and administering their medicines, including medicines that are not prescribed. They look for new ways to promote independence and work closely with partners in doing so.
  • People are treated as partners in assessing their medication needs. People’s understanding of what their medicines are for, how they take them and possible side effects is maximised.
  • There is a collaborative and person-centred approach that involves the person and those close to them, where required, so that people can have their PRN medicines (medicines taken when required) when they need or want them.
  • The service proactively keeps up-to-date and quickly embeds national guidance and recommendations.
  • Medicines management is proactive, evidence based and continuously updated through learning and innovation. Staff are empowered and encouraged to engage with the latest research and guidance, and good practice is shared with partners across health and care.
  • The service uses creative and innovative ways to avoid using covert administration of medicine.
  • The service has clear PRN protocols for sedative medicines with clear guidance linked to positive behaviour support plans or equivalent. These demonstrate an innovative and creative approach to developing personalised strategies to reduce the need for sedative medicines.
  • The service works proactively with external health professionals to ensure medicines protocols contain personalised information and are up-to-date.

Good

In plain terms: The service meets the expected standard.

  • There is a clear approach to the safe use of medicines, and roles and responsibilities are understood.
  • People and their representatives are involved in assessments, reviews and decisions, including the level of support needed and self-medication. This is clearly documented in care records.
  • People are supported to access treatment for minor ailments or self-care, for example with over-the-counter medicines (OTC) or homely remedies.
  • The administration of PRN medicines (medicines taken when required) is guided by clear protocols, and there are timely reviews.
  • Where the service is responsible, medicines are ordered, administered, recorded, stored and disposed of safely in line with legislation and guidance.
  • People are supported with their medicines in line with the Mental Capacity Act 2005, and this is clearly documented in their care plan. Where a person lacks capacity to make decisions about taking medicines, the correct processes are followed before medicines are administered.
  • People receiving their medicines covertly are supported in line with the Mental Capacity Act 2005. Staff fully understand any risk associated with mixing medicines with different foods.
  • People’s behaviour is not controlled by excessive or inappropriate use of medicines.
  • The service actively considers opportunities to reduce the over-medication of people, in line with STOMP/STAMP principles where applicable.
  • Controlled drugs are stored, recorded, administered and disposed of in line with legislation and guidance.
  • Cultural and dietary considerations about medicines are recorded and acted on.

Requires improvement

In plain terms: The service is not yet Good and has areas that must improve.

  • Responsibilities and roles in relation to medicines are unclear.
  • People are not consistently involved in assessments, reviews or decisions about their medicines, or the support they need, when they should be.
  • There is limited support and consideration for people to access treatment for minor ailments or self-care, such as over-the-counter medicines (OTC) or homely remedies.
  • Where the service is responsible for medicines, people do not consistently receive their medicines as prescribed, including time-sensitive medicines.
  • Protocols to support the administration of PRN medicines (medicines taken when required) are unclear, inconsistently followed or not reviewed in a timely way.
  • Medicines are not consistently ordered, administered, recorded, stored and disposed of safely in line with legislation and guidance.
  • People are not always supported in line with the Mental Capacity Act 2005, or this is not clearly documented in care plans as appropriate.
  • Correct procedures are not always followed where people lack capacity to make decisions about taking medicines and when medicines may need to be administered without their knowledge or consent.
  • The service does not consistently ensure that medicines that can control people’s behaviour are managed appropriately.
  • Opportunities to reduce the over-medication of people are not routinely identified. Where applicable, STOMP/STAMP principles may not be followed.
  • Controlled drugs are not consistently stored, recorded, administered and disposed of in line with legislation and guidance.
  • Cultural and dietary considerations about medicines are not routinely recorded or acted on.

Inadequate

In plain terms: Performance is well below the expected standard; enforcement may follow.

  • Responsibilities and roles in relation to medicines are unclear or not understood.
  • People are not involved when they should be in assessments, reviews or decisions about their medicines or the support they need.
  • People are discouraged from accessing treatment for minor ailments or self-care, such as over-the-counter medicines (OTC) or homely remedies.
  • Where the service is responsible for medicines, people are at risk because staff do not administer medicines safely or people do not receive them as prescribed.
  • The service does not follow relevant national guidelines in relation to non-prescribed medicines that it manages for people.
  • The service prevents any opportunities to promote people’s independence in managing medicines. Staff may actively or passively discourage people from looking after their own medicines, when they are capable of doing so.
  • People are not supported with their medicines in line with the Mental Capacity Act 2005.
  • The service does not follow correct procedures when people lack capacity to make decisions about taking medicines and when they may need to be administered without their knowledge or consent.
  • Medicines that can control people’s behaviour are not managed appropriately.
  • The service and staff do not act on opportunities to reduce the over-medication of people. Where applicable, they are not aware of STOMP/STAMP principles, or they do not follow them.
  • The service does not have effective oversight of controlled drugs. Controlled drugs are not stored, recorded, administered or disposed of in line with legislation and guidance.
  • Cultural and dietary considerations about medicines are not considered.

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