Classification of patient safety incidents and definitions
The WHO Patient Safety Incident Reporting and Learning Systems: Technical report and guidance (see resources) classifies patient safety incidents into three types. A patient safety incident that does not reach the patient is classified as a ‘Near miss’. Where the incident reaches the patient, it can be classified as either a ‘No harm incident’ or a ‘Harmful incident’. Harmful incidents can be further subdivided into an ‘Adverse event’ or an ‘Adverse reaction’.
Near miss: an incident that did not reach the patient.
No harm incident: an incident that reached the patient but no harm resulted.
Harmful incident: an incident that results in harm to the patient.
Adverse event: an incident that results in preventable harm to a patient.
Adverse reaction: unexpected and non-preventable harm resulting from a justified action where the correct process was followed for the context in which the event occurred. NICE CKS Adverse drug reactions includes further information. See below for information on Yellow Card reporting.
Why should an incident be reported?
Incidents occur on a regular basis with respect to the prescribing, dispensing and administration of medications. One aspect of improving patient safety is to report incidents, for the purpose of sharing learning. It is important to recognise that reporting and investigating an incident is not about apportioning blame but is an opportunity to review practice and share learning with the aim of preventing recurrence of a similar incident in the future. There is also a professional obligation to provide safe, effective and quality care and Standard 2.2.5 of The Code1 highlights that pharmacists must “Contribute appropriately to ‘near-miss’ and error reporting systems”.
Anonymous reporting of Incidents by Community Pharmacy Services
Community Pharmacists in the region are encouraged to report incidents, including near misses, via the Online Anonymous Incident Reporting System to the Pharmacy and Medicines Management Team so that learning and good practice advice can be shared without any concerns for the reporting pharmacist.
There are no hidden identifiers in the online form and it is not possible for staff to identify where reports have come from. Please do not include any information that will identify patients or staff. The completed form can be printed and saved and used to form, or include in, your own incident log.
Reporting of Controlled Drug (CD) incidents.
If the incident involves a Controlled Drug, the Accountable Officer (AO) and Pharmacy Inspectorate Medicines Regulatory Group (MRG), Department of Health NI must be notified as soon as possible without compromising the steps needed to ensure patient safety.
ControlledDrugsAccountableOfficer@health-ni.gov.uk
mrg_inspectors@health-ni.gov.uk
Reporting an incident non-anonymously
If you want to report a ‘named’ incident, please contact your local SPPG office – see ‘Contact us’.
Note: A Serious Adverse Incident (SAI) is an incident or event that must be reported to the Strategic Planning and Performance Group (SPPG) by the organisation where the SAI has occurred. Where an incident has caused harm, it is encouraged that this is discussed with a Pharmacy Adviser at your local SPPG office.
Yellow Card (Adverse reaction) reporting
You should report suspected adverse effects to healthcare products – medicines (including vaccines, blood products and immunoglobulins), AND medical devices*, fake and counterfeit medicines, herbal and complementary products and e-cigarette products to the MHRA’s Yellow Card scheme at Yellow Card | Making medicines and medical devices safer (mhra.gov.uk)
*Healthcare professionals should report suspected adverse effects to medical devices to the Northern Ireland Adverse Incident Centre (NIAIC) at Northern Ireland Adverse Incident Centre (NIAIC) | Department of Health (health-ni.gov.uk)
1. The Pharmaceutical Society of NI —The Code – Professional standards of conduct, ethics and performance for pharmacists in Northern Ireland