How should a pharmacy report a patient safety incident?

What counts as a patient safety incident?

A patient safety incident is any event in which a patient was harmed or could have been harmed. That is the wording NHS England uses for its Learn from Patient Safety Events (LFPSE) service. The service records four kinds of event. The first is where "a patient was harmed, or could have been harmed". The second is where "there has been a poor outcome but it is not yet clear whether an incident contributed or not". The third is where "risks to patient safety in the future have been identified". The fourth is where "good care has been delivered that could be learned from to improve patient safety".

In a community pharmacy the first category is the busy one. It covers a wrong drug, strength or quantity that reaches the patient. It covers a right prescription handed to the wrong person. It covers a missed interaction or a missed allergy, a label with the wrong directions, a fridge line stored at room temperature, and a delivery left with the wrong household. It also covers the same errors caught before they left the pharmacy, because the patient could have been harmed. That is a near miss, and it is dealt with below.

Some events go elsewhere as well, or instead. The table sets out the routes.

Who requires you to report?

Three sets of rules. The NHS terms of service require the system. The GPhC's pharmacy standards require the governance around it. And the GPhC's professional standards require the honesty.

The terms of service are in Schedule 4 to the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. Paragraph 28 requires every NHS pharmacist to take part in "an acceptable system of clinical governance". That system must include a risk management programme with "an approved incident reporting system, together with arrangements for analysing and responding to critical incidents". It must also include arrangements, "including record keeping arrangements", for dealing with patient safety communications from the Secretary of State and NHS England. Community Pharmacy England's guidance is blunt: contractors "have to report patient safety incidents to the NHS", and the system to use is LFPSE.

The GPhC's standards for registered pharmacies, in the June 2018 edition, do not mention LFPSE by name. They do not need to. Standard 1.1 requires that "the risks associated with providing pharmacy services are identified and managed". Standard 1.2 requires that "the safety and quality of pharmacy services are reviewed and monitored". Standard 1.6 requires that "all necessary records for the safe provision of pharmacy services are kept and maintained". An incident log with no reporting and no review fails all three in spirit and, as the inspection section shows, in practice.

The professional layer is standard 8 of the GPhC's standards for pharmacy professionals, in force since May 2017. Pharmacy professionals "must speak up when they have concerns or when things go wrong". Applying it, they "raise a concern, even when it is not easy to do so" and "are open and honest when things go wrong". They also "say sorry, provide an explanation and put things right when things go wrong". That duty sits on each pharmacist and technician personally, whoever owns the pharmacy.

How do you report through LFPSE?

You record the event on NHS England's online service, or through a head-office system that feeds it. LFPSE launched in 2021 as the replacement for the National Reporting and Learning System, which pharmacies had reported to since 2005. Providers were asked to move across by September 2023, and "NRLS reporting was withdrawn on 30 June 2024". NHS England says organisations without a local risk management system, "typically private primary care providers, such as GP, dental and optometry practices and community pharmacies", should record directly onto LFPSE. Over 2 million patient safety events are now recorded on it each year.

The mechanics are simple. The recording site lets staff sign in or create an account, which allows drafts to be saved and earlier records reviewed. You can also "record a patient safety event without creating an account and signing in", though you then cannot save or update. Community Pharmacy England's guidance says you find the pharmacy by selecting other organisations and searching by name or ODS code. NHS England's user guide asks for the date and time, where the incident occurred and what happened. It asks for "a conscious effort not to include any identifiable information such as staff or patient names". On submission you see "the LFPSE reference number the record has been assigned". Keep it with your internal record.

Some pharmacies report through their superintendent, head office or trade body, who record the event in a local risk management system that also sends it to LFPSE. That is fine, provided the report is made and the pharmacy can show it.

Do near misses have to be recorded?

Yes. A near miss is an event in which a patient could have been harmed, which is the first LFPSE category. It is also the richest source of learning a pharmacy has, because near misses happen far more often than errors that reach patients.

The GPhC's January 2026 inspection decision making framework is specific about the quality of the log, not just its existence. Under standard 1.2, one area for improvement is near-miss records that "do not always contain a sufficient level of detail to help team members review and identify trends to support learning". Another is a pharmacy that "keeps records of errors, but it doesn't regularly review these to spot patterns or trends and prevent recurrence". A third is a team that changes how it works after a review "but these are not documented". Areas for improvement go into the published inspection report even when the standard is met.

So the near-miss record needs four things each time: the medicine involved, the type of error, the stage at which it was caught, and the likely cause. Then it needs a monthly review that looks for patterns: the same look-alike pair, the same shelf, the same time of day, the same task being interrupted. The review is what turns a log into evidence.

What does the duty of candour require?

It requires you to tell the patient, apologise and explain, and there are two versions of it with different reach. The professional duty applies to every registrant. The statutory duty applies to providers registered with the Care Quality Commission. Paragraph 28 of the pharmacy terms of service contains no separate candour clause; the professional standard does that work.

The statutory duty has a threshold. A notifiable safety incident is an unintended or unexpected incident that could result in, or appears to have resulted in, death, severe harm, moderate harm or prolonged psychological harm. Moderate harm means harm that needs a moderate increase in treatment and is significant but not permanent. Severe harm means a permanent lessening of bodily, sensory, motor, physiologic or intellectual functions. The GPhC, not the CQC, regulates registered pharmacies, so the statutory duty reaches a pharmacy business only where it also runs a CQC-registered service. Online prescribing clinics are the common case, covered in how the CQC regulates online clinics.

For most pharmacies, then, the professional duty is the operative one, and it has no harm threshold. If a supply error reached a patient, they are told. The GPhC's fitness to practise guidance treats the failure to do so as an aggravating factor. Committees "should take very seriously a finding that a pharmacy professional took deliberate steps to avoid being candid with a patient". That is the difference between an error and a case, as our analysis of what gets pharmacists struck off sets out.

What should you record internally?

Enough to reconstruct the event, show what you did, and find the pattern later. The LFPSE record carries no names and lives with NHS England. Your own record is the one the patient, the prescriber, your insurer and the inspector will ask about.

The minimum is a dated entry with the patient reference, the medicine and the prescription or order. Add the stage at which the error occurred, the stage at which it was found, and who was involved at each stage. Then record what was said to the patient and when, the clinical outcome, the LFPSE reference, and the action agreed. Keep it separate from the near-miss log or flag near misses within it, but use the same fields for both. Where the incident touched a controlled drug, record the accountable officer report too.

Two habits make the record useful. First, name the immediate cause and the contributing factors separately. "Wrong strength picked" is the immediate cause. "Two strengths stored adjacent, checker interrupted by the phone" is the contributing factor, and it is the one you can change. Second, close the loop in writing. The framework's area for improvement is changes made "but these are not documented". The fix is one line under the incident: what changed, who changed it, and the date. Our guide to writing SOPs your team will follow covers how to get the change into the procedure.

How do inspectors assess incident reporting?

Against standard 1.2, by asking the team rather than the owner. The January 2026 framework's met examples describe the evidence. One is "the pharmacy team knows what to do, and who to tell, when things go wrong". Another is a pharmacy that "records things that go wrong and uses the records to identify learning points and systemic weaknesses". A third is that "pharmacy team members give examples of learning from mistakes and the actions taken to prevent them happening again". A further met example is a pharmacy that "shares significant incidents with other healthcare professionals involved with the person's medical care".

The not met examples are the mirror image. One is "the pharmacy cannot show how it learns from things that go wrong". Another is "members of the pharmacy team do not know what to do if things go wrong or who to report this to". A third is "the pharmacy does not share incidents with other healthcare professionals involved with the person's care". None of these is about the existence of a form. All of them are about what the team can say and show.

The failure data backs this up. We cover the study of 2,197 routine inspections from 2022 to 2024 in why pharmacies fail GPhC inspections. In it, inspector comments on governance repeatedly cited ineffective management of dispensing errors and near misses. Standards 1.1, 1.2 and 1.6 were among the seven behind most failures. For the wider picture of a visit, see what GPhC inspectors look for in 2026. Expect the inspector to open the near-miss log, pick a recent entry and ask a dispenser what changed because of it.

How do you learn from incidents without blame?

Three practices deliver that culture. Review near misses monthly as a team, with the discussion aimed at the system: storage, workflow, interruptions, labelling, workload. Record the change and give it an owner. And feed the serious ones outward: the prescriber where the patient's care is affected, head office where there is one, and LFPSE every time. National analysis of LFPSE data is how NHS England spots patterns "not visible locally" and issues alerts. Your entry is part of that.

Finally, keep the two records in step. The internal entry should carry the LFPSE reference; the team review should carry the incident numbers it discussed. When an inspector, a complaint or a fitness to practise investigator asks what happened, the answer is then retrieval, not reconstruction.

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