Rationale Improving the reporting of medication-related safety incidents Research shows that organisations which regularly report more patient safety incidents usually have a stronger learning culture where patient safety is a high priority. By improving reporting in the short term, the NHS can build the foundations for driving improvement in the safety of care received by patients. At a system level, through high reporting, the whole of the NHS can learn from the experiences of individual organisations. Technical definition A patient safety incident (PSI) is any unintended or unexpected incident(s) that could have, or did, lead to harm for one or more person(s) receiving NHS funded healthcare. Medication incidents are PSIs which actually caused harm or had the potential to cause harm involving an error in the process of prescribing, dispensing, preparing, administering, monitoring or providing medicines advice. Reporting is via the National Reporting and Learning System (NRLS). Approach during 2016-17 The approach will be to encourage GP practices to report appropriate incidents to the Medicines Management Team who will enter details anonymously onto the NRLS. Practices may submit incidents themselves to NRLS but will also be encouraged to inform the Medicines Management Team so that learning can be shared. A suggested approach is to focus on errors occurring in care homes, which links with a key priority for the CCG and is supported by evidence that these are settings where medication errors regularly occur. The Care Home Use of Medicines Study (CHUMS) report published in 2009 identified an unacceptable prevalence of medication errors in care homes. Of 256 patients studied in 55 homes, 70% of patients had at least one error. The prevalence of errors was: prescribing 8.3%, monitoring 14.7% (for relevant medicines), dispensing 9.8% and administration 8.4%; these figures represent the likelihood that each act (prescribing a medicine, for example) will be an error. In terms of patients receiving errors: 39.1% received a prescribing error, 18.4% (of those who needed it) a monitoring error, 36.7% a dispensing error and 22.3% observed to receive an administration error. Annex 1 shows the process for reporting and learning from medication incidents in primary care for East Surrey CCG. All incidents involving medicines should be reported including Serious Incidents (SI) and Adverse Drug Reactions (ADRs). Definitions of an SI and ADRs are shown in Annex 2. Annex 3 shows the Primary Care Medication Incident Report form that can be used to collect the minimum data requirements to enter the incident on the NRLS.
Investigate and report to Annex 1- Process for Reporting and Learning from Medication Incidents in Primary Care Medication Incident Identified (Actual or prevented) Report all medication incidents to the CCG Medicines Management Team (All data collected will be anonymised; see Annex 3 for Reporting Form) Is this an Adverse Drug Reaction? Report to MHRA (Yellow Card Scheme) https://yellowcard.mhra.gov. uk/ See Annex 2 for definitions of Serious Incidents or Adverse Drug Reactions Is this a Serious Incident? Investigate and report to NHS England Area Team Is a Controlled Drug involved? Report to NHS England Area Team Controlled Drugs Accountable Officer england.surreysussexcds@nhs.net Learning and feedback shared with local GP Practices and Pharmacies (through CCG newsletter, local meetings) Key themes and improvement actions reported to the Clinical Governance Committee (6 monthly)
Annex 2 - Definitions Serious Incidents The National Framework for Reporting and Learning from Serious Incidents Requiring Investigation defines a Serious Incident as follows: A serious incident requiring investigation is defined as an incident that occurred in relation to NHS-funded services and care resulting in one of the following: Unexpected or avoidable death of one or more patients, staff, visitors or members of the public; Serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (this includes incidents graded under the NPSA definition of severe harm); A scenario that prevents or threatens to prevent a provider organisation s ability to continue to deliver healthcare services, for example, actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or IT failure; Allegations of abuse; Adverse media coverage or public concern about the organisation or the wider NHS; One of the core set of Never Events as updated on an annual basis and currently including (in relation to medicines): wrong route administration of chemotherapy misplaced naso-gastric or orogastric tube not detected prior to use intravenous administration of mis-selected concentrated potassium chloride Adverse Drug Reactions http://www.mhra.gov.uk/safetyinformation/howwemonitorthesafetyofproducts/medicines/theyellowcardsche me/informationforhealthcareprofessionals/adversedrugreactions/ What is an adverse drug reaction? An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorisation or from occupational exposure. Conditions of use outside the marketing authorisation include off-label use, overdose, misuse, abuse and medication errors. The reaction may be a known side effect of the drug or it may be new and previously unrecognised. Is the reaction an ADR or an adverse event? 'Adverse reactions' and 'adverse events' are not always the same. An adverse event is any undesirable event experienced by a patient whilst taking a medicine, regardless of whether or not the medicine is suspected to be related to the event. An example of an adverse event is a patient being hit by a car while on a specific medication, whereas An adverse drug reaction is any undesirable experience that has happened to the patient while taking a drug that is suspected to be caused by the drug or drugs. An example of an ADR could be a patient experiencing anaphylaxis shortly after taking the drug. The Yellow Card Scheme relies on reporting of suspected adverse drug reactions where there is a suspicion that there is a causal relationship between the medicinal product taken and the suspected reaction experienced
Annex 3 - Primary Care Medication Incident Report The purpose of this form is to comply with national guidance and enable timely information sharing and facilitate learning from medication errors in primary care. Please complete form for the Medicines Management Team to enter onto the NRLS and share learning. DO NOT INCLUDE PATIENT or STAFF IDENTIFIABLE INFORMATION Please provide contact details of the person completing this form in case further information is required (please note this is for CCG use only and will not be disclosed during reporting or learning) Name. Tel.:... Incident Details Date of medication error Incident: Time of Incident: Location of Incident: GP practice Out of Hours Centre Community Hospital Other (please describe) Community Pharmacy Care Home Residence/Home Date Incident Identified: Type of medication error / incident Documentation / communication Prescribing Dispensing Other (please describe... Administration Monitoring Advice Name of drug(s) involved: Description of medication error / incident - What Happened:
What impact or potential impact did the event have on the patient? Degree of harm to the patient (severity Potential Harm Actual Harm None Low Harm (patient(s) required extra observation or minor treatment) Moderate Harm (patient(s) required further treatment, or procedure) Severe Harm (Permanent or long term harm) Death (related to the incident) Date of Birth (if known): Sex: Male Female Not stated / unknown Ethnic category: White Mixed Asian or Asian British Please provide information about any learning that can be shared? (Optional) Black or Black British Other Not stated / unknown Return to: Ulrike Lukas Senior Pharmacy Technician ulrikelukas@nhs.net OR post to Medicine Management Team East Surrey CCG, The Council Offices, 8 Station Road East, Oxted, Surrey, RH8 0BT