Patient safety incident reporting

Patient safety incident reporting

Since 2005, pharmacies have been required to record patient safety incidents in an incident log and report these to the National Reporting and Learning Service (NRLS).

How to report patient safety incidents

As part of the Clinical Governance provisions in the Terms of Service, community pharmacies have to report patient safety incidents through the NRLS; one way to make these reports is via the NRLS website, but some pharmacies may report via their head office/superintendent pharmacist or via another organisation, such as the National Pharmacy Association. To facilitate the collection and recording of the information needed to report an incident to the NRLS a form has been produced which community pharmacies may choose to use.

PSNC Briefing 034/14: Reporting patient safety incidents to the NRLS (December 2014) provides pharmacy teams with a brief explanation of how to report a patient safety incident to the NRLS.

Recording pharmacy errors:

Community Pharmacy Medication Safety Incident (Pharmacy Error) Report Form (this Microsoft Word document can be completed electronically or can be used to create a form personalised for use within an individual pharmacy)

Community Pharmacy Medication Safety Incident (Pharmacy Error) Report Form (this PDF document can be completed by hand)

Recording errors/incidents external to the pharmacy (e.g. prescribing errors):

Community Pharmacy Medication Safety Incident (External Incident) Report Form (this Microsoft Word document can be completed electronically or can be used to create a form personalised for use within an individual pharmacy)

Community Pharmacy Medication Safety Incident (External Incident) Report Form (this PDF document can be completed by hand)

Report an Incident (NRLS Online Form) 

Changes to the PSI reporting arrangements agreed in 2014/15

In order to help meet NHS England’s objectives to improve patient safety, in 2014/15 it was agreed that:

  • there must be an increase in the number of patient safety incidents reported by community pharmacies to the NRLS; and
  • from the implementation date (see below), reports submitted to the NRLS will have to identify the pharmacy making the report.

The requirements for patient safety incident reporting by community pharmacy contractors are set out in the Approved Particulars. To implement the above changes it was agreed that the existing Approved Particulars would be amended from the implementation date to require the identification of pharmacies making reports to the NRLS.

The Approved Particulars would also be amended to clarify which patient safety incidents should be reported to the NRLS. At present the Approved Particulars require that all patient safety incidents must be reported to NRLS. This will be amended to clarify that patient safety incidents that did or could have led to patient harm must be reported. Incidents where there was no implied or actual patient harm, for example picking errors that are identified and corrected during the pharmacy’s checking procedures, will not be required to be reported to the NRLS.

Throughout the discussions on these changes PSNC ensured that any changes would be manageable for pharmacies, for example persuading NHS England that minimum targets for reports would not be feasible for the majority of contractors and may well overestimate the number of errors actually happening. We were also very clear that the reporting requirements and systems must be simple and speedy for pharmacy teams to use and that there must be no need to report trivial errors that have no impact on patient safety. These points have all been reflected in the amended Approved Particulars which will be published in due course.

A key concern for many pharmacists in reporting errors has always been the laws surrounding dispensing errors and the fact that the errors were a criminal offence. Work was carried out (by the Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board) to change medicines legislation, with a key aim being to decriminalise dispensing errors.

NHS England has decided not to implement the requirement to report incidents on a non-anonymised basis until the amendment of the legislation. NHS England said this was because it was keen to avoid a situation where the contractual requirements are not fully supported by legislative requirements (when the change to non-anonymised reporting was discussed in negotiations, it had been envisaged that the new requirement would happen at approximately the same time as the move to de-criminalise dispensing errors).

On 16th April 2018, the Pharmacy (Preparation and Dispensing Errors – Registered Pharmacies) Order 2018 came into force which provides legal defences for inadvertent preparation and dispensing errors under section 63 and section 64 of the Medicines Act 1968, made by registered pharmacy professionals working at or from registered pharmacies.

NHS England should make the changes to the Approved Particulars, which set out the requirements on incident reporting, to require non-anonymised reporting in due course.

Actions for contractors

From the implementation date, pharmacies will need to identify the pharmacy when reporting a patient safety incident to the NRLS. Where reports are submitted via the NRLS eForm there is an option to include the pharmacy’s ODS code (F code) prior to submitting the report. Contractors may also wish to review their current approach to reporting incidents to ensure that they are meeting the contractual requirements.

FAQ: Why have these changes been agreed?
In the reformed NHS and following the Francis report, there is a need for all healthcare professionals to refocus on patient safety and to demonstrate that they are putting it at the heart of all their work. Improving patient safety is consequently a key objective for NHS England and the changes in community pharmacy patient safety incident reporting are part of NHS England’s efforts to meet that objective and are intended to increase the learning from reported incidents. Where relevant this learning may be used to educate others and bring about changes in practice that will ultimately help to prevent further similar incidents, thus reducing the risk of harm to patients. NHS England are also eager to establish and maintain appropriate levels of reporting for both prescribing and dispensing incidents and to increase the overall level of the reporting of such patient safety incidents from community pharmacies.

FAQ: Why can we no longer report anonymously?
The lack of anonymity will allow easier shared learning and it will help NHS England to identify any pharmacies reporting significantly below expected levels so they can explore the reasons for this.

FAQ: How do we know that reporting of incidents has been ‘low’ in the past?
The majority of patient safety incidents identified in community pharmacy are medication related, e.g. prescribing or dispensing errors. Between 1 January to 31 December 2012 only 7,919 patient safety incidents of any kind were reported by community pharmacies – an average of less than one per pharmacy.

FAQ: How much more work will this be for pharmacies?
Contractors will note that this is not a new requirement – recording and reporting patient safety incidents has been a requirement under the CPCF since 2005. The intention of the changes is to increase patient safety incident reporting from community pharmacies to the level already required by the NHS (Pharmaceutical Services) Regulations 2013 and the associated Approved Particulars for incident reporting. 

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