Reporting medicine related incidents

Page last updated: 3 November 2022
Organisations we regulate


Care home use of medicines study (CHUMS), 2009

The care homes use of medicine study 2009 (CHUMS) found:

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

Medication without harm

In March 2017, the World Health Organisation launched its global patient safety challenge. 'Medication without harm' aims to reduce severe avoidable medication related harm. The aim is to reduce this harm by 50% globally in the next 5 years.

National reporting and learning

NHS England’s national reporting and learning system is known as NRLS. It states that 'low’ reporting from an organisation should not be taken as a ‘safe’ organisation. This may represent under-reporting. A ‘high’ reporting rate should not be taken as an ‘unsafe’ organisation. In fact, this may represent a culture of greater openness.

Considerations for providers

Providers should:

  • maintain an open 'fair blame' policy
  • encourage staff to report medicines errors without delay
  • have a robust process for sharing learning from incidents across the organisation
  • have mechanisms in place to make changes in practice to improve safety
  • 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 prescriber or emergency services, the family or carer. 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 how they can report their concerns about medicines. It should include:

  • your complaints process
  • any local authority (or local safeguarding) processes
  • any relevant regulatory processes.

Medicines error

Errors can occur at different stages of the medication use process.

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

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

Medicines errors are not the same as adverse drug reactions.

Medicine errors occur when weak medication systems or human factors affect processes.

Human factors to consider:

  • fatigue
  • environmental conditions
  • staffing levels.

Medicine errors can result in severe harm, disability and death.

Adverse drug reactions

An adverse drug reaction (ADR) is an unwanted or harmful reaction which occurs after administration of a drug or drugs.

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. Off-label use is when medicines are prescribed outside the terms of the licence in the best interest of the patient based on available evidence.

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.”

Near misses

NHS England defines a near miss as a ‘prevented patient safety incident’. A ‘near miss is an event not causing harm but has the potential to cause injury or ill health. Reviewing near misses can provide useful learning and areas for improvement.

Duty of candour

All providers have an overarching duty of candour to be open and transparent with people using their services. The duty of candour applies at all times and in all cases. So you must let the person know what has happened.

If you have a safety incident, you should also check Regulation 20 to see if it is a ‘notifiable safety incident’. If it is, the regulation also tells you how you must support the relevant people. They could be people who use services or people acting on their behalf. You must:

  1. Act in an open and transparent way with relevant persons about the care and treatment provided.
  2. Tell them in person as soon as possible after finding out about the incident. Support them around the incident, including when you tell them what happened.
  3. Provide an accurate account of what happened. This must include all the facts, to the best of your knowledge, at the time.
  4. Tell them in person what further enquiries you will need to make.
  5. Offer an apology in person.
  6. Follow this by giving the same information in writing. Give an update on the enquiries.
  7. Keep a written record of all communication with the relevant person.


You must tell CQC about 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
  • other safety incidents.

There is no requirement to notify CQC about medicines errors, but you must tell us if a medicines error has caused:

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

Where relevant, you should make it clear that a medicine error was a known or possible cause or effect of these incidents or events being notified.


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

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

NICE guidance (NG67) states:

When social care providers are responsible for medicines support, they must have robust processes for medicines-related safeguarding incidents, in line with Regulation 13 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

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 related incidents. This also includes all ‘near misses’ and incidents that do not cause any harm. The policy should cover:

  • whether to notify CQC
  • which medicines related safety 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.

Controlled drugs

Report incidents related to controlled drugs (including loss or theft) to your local NHS Controlled Drugs Accountable Officer (CDAO) at NHS England. You should also report incidents to the police (if necessary).

You must tell CQC if the incident meets the criteria of a statutory notification.