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Reporting medicine-related incidents

  • Organisations we regulate

Care home use of medicines study (CHUMS), 2009

CHUMS found that “on any given day seven out of ten residents were subject to at least one form of medication error”.

NICE guidance

NICE guidance on managing medicines in care homes (SC1) states that care home providers:

"should ensure that a robust process is in place for identifying, reporting, reviewing and learning from medicines errors involving residents."

NICE guidance for adults receiving social care in the community (NG67) states:

“When social care providers have responsibilities for medicines support, they should have robust processes for identifying, reporting, reviewing and learning from medicines-related problems.”

Guidance on reporting

Report incidents internally and to relevant external organisations where appropriate. You do not normally need to notify CQC about medicines errors. You must notify us about medicines errors in the following circumstances:

  • death
  • injury
  • abuse, or allegation of abuse
  • incident reported to or investigated by the police

Where relevant, make it clear that a medicine error was a known or possible cause or effect of the incident.


Medicines error

A medicines error is any patient safety incident, where there has been an error while:

  • prescribing
  • preparing
  • dispensing
  • administering
  • monitoring
  • providing advice on medicines

It can be either:

  • an error of commission (wrong medicine or wrong dose)
  • an error of omission (omitted dose or failure to monitor)

Medicines errors are not the same as adverse drug reactions.

Near misses

NHS England defines a near miss as a ‘prevented patient safety incident’.

Adverse drug reactions (ADRs)

An ADR is a response to a medicinal product that is noxious and unintended. They can occur when a medicine is used within or outside its approved use. Report ADRs through the yellow card scheme. Report reactions from off-label use, overdose, misuse, abuse and medication error.

Duty of candour

Regulation 20 of the Regulated Activities Regulations 2014:

Unintended or unexpected incidents occur. Regulation 20 covers those incidents which could have resulted in:

  • death
  • severe harm
  • moderate harm
  • prolonged psychological harm

As soon as practicable, you must notify the person that an incident has occurred. Or you must notify the 'relevant person' who is acting on their behalf.

This regulation directs providers to be open and transparent with people. This could be the person who use services or their ‘relevant person’. When things go wrong with care and treatment, providers should:

  • inform the person who uses the service or relevant person of the incident
  • provide them with reasonable support and truthful information
  • apologise

You must notify us of certain safety incidents. The registered person should record the action taken on the relevant notification form. You must tell us about:

  • the death of a person who uses the service
  • deaths and unauthorised absences of people who are detained or liable to be detained under the Mental Health Act 1983
  • serious injuries to a person who uses the service


Be aware of local arrangements safeguarding incidents. There may be different arrangements for notifying suspected or confirmed medicine-related incidents. NICE Guidance SC1 indicates that a safeguarding issue in relation to managing medicines could include:

  • deliberate withholding of a medicine(s) without a valid reason
  • incorrect use of a medicines) for reasons other than the benefit of a resident
  • deliberate attempt to harm through use of a medicine(s)
  • accidental harm caused by incorrect administration or a medication error

Nurses should follow the Nursing and Midwifery Council professional standards of practice and behaviour.

Medicines policy

You should have a policy which includes a process for recording all medicines. This includes related safety incidents, all ‘near misses’ and incidents that do not cause any harm. The policy should cover:

  • whether to notify CQC
  • which medicines related safeguarding incidents to report under local safeguarding processes
  • how to report the incident to the person, their family or carers
  • how to handle referrals to regulators and other agencies, such as NMC

Other important points

Maintain an open "no blame" policy. Encourage staff to report medicines errors without delay.

Have a robust process for sharing learning from incidents across the organisation. There should also be mechanisms in place to put in place changes in practice in a timely manner.

Record accurate details of medicines-related safeguarding incidents. Record them as soon as possible after the incident. This information must be available for any investigation and reporting.

In all cases, the safety of the person should be the primary concern. Where necessary, contact the family or carer, the prescriber and /or emergency services. Agree a process for care staff to follow. This should be agreed between health professional(s) and commissioners. It should set out who to contact in normal office hours and out of hours.

Give people, their family or carers information about reporting medicines‑related safety incidents. This should include information about they can report their concerns about medicines. It should include:

  • your complaints process
  • any local authority (or local safeguarding) processes
  • any relevant regulators' process

Report incidents related to controlled drugs (including loss or theft) to your local NHS Controlled Drugs Accountable Officer.

Last updated:
27 January 2020