Medication Incidents SOP

Document Control
Title
Medication Incidents - Standard Operating Procedure
(Managing and Supporting Staff Following a Medication
Incident)
Author Author’s job title
Non-Medical Prescribing Lead
Directorate Department
Planned Care and Surgery Medicines Management
Date
Version Status Comment / Changes / Approval
Issued
1.0 June Final Approved by Drugs and Therapeutics Committee 16th May
2013 2013
1.2 June Revision Updated to include references to medicines governance
2016 group, process for investigation and escalation for
medicines incidents (appendix E) and MHRA patient safety
alert information (2014).
1.3 July Revision Changes to wording following comments from Workforce
2016 Development. Governance Pharmacist, Senior Nurse
Community, Lead Pharmacist (Eastern Area), Clinical
Lead Pharmacist (Northern Area), Interim Head of Quality
and Safety.
2.0 July Final Approved by Drugs and Therapeutics Committee 21st July
2016 2016
2.1 January Revision Removed reference to NPSA incident decision tree and
2019 replaced with NHS improvement just culture guide. Added
section to 5.2.2 stating line managers may request staff
complete critical incident reflective exercise at their
discretion if incident is of low/moderate severity. Updated
references.
2.2 March Revision Following feedback from Chief Nurse, Patient Safety Lead,
2019 HR, Governance Lead, Datix lead and Investigations Lead
added Just Culture guidance as an appendix, updated with
references to new incident management policy, clarified
wording.
3.0 May Final Approved at Drugs and therapeutics Committee 16th May
2019 2019, following change to Appendix A to ensure colour
coding of matrix reflected that within the new incident
reporting policy.
Main Contact
Unit 1 Tel:
Exeter International Office Park Email:
Clyst Honiton
Exeter, EX5 2HL
Lead Director
Chief Nurse

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Medication Incidents SOP

Document Class Target Audience

Standard Operating Procedure All staff
Distribution List Distribution Method
Senior Management Trust’s internal website
Superseded Documents
None
Issue Date Review Date Review Cycle
May 2019 May 2022 Three years
Consulted with the following Contact responsible for implementation
stakeholders and monitoring compliance:
 Drugs and Therapeutics Committee Non-medical Prescribing Lead
 Chief Nurse and Deputy Chief Nurse
 Chief Pharmacist and Lead Pharmacist Education/ training will be provided by:
 Medical Director Non-medical Prescribing Lead
 Divisional Nurses (Planned and
Unplanned care)
 Clinical Matron Community
 Clinical Lead for MIU
 Investigations Lead
 Patient Safety Lead
 Human Resources department
 Clinical training manager
 Midwife and maternity clinical risk
manager
Approval and Review Process
 Drugs and Therapeutics Committee
Local Archive Reference
X: PHARMACY\Policies&Procedures\SOP – Medication Incidents
Local Path
Policies&Procedures\SOP – Medication Incidents
Filename
Medication Incidents SOP V2.0 FINAL
Policy categories for Trust’s internal Tags for Trust’s internal website (Bob)
website (Bob) Medication Incidents, medication errors
Pharmacy/Medicines management

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Medication Incidents SOP

CONTENTS
Document Control ............................................................................................................... 1
1. Background .................................................................................................................. 4
2. Purpose ........................................................................................................................ 4
3. Scope and Location ..................................................................................................... 4
4. Definitions .................................................................................................................... 4
4.1 Prescribing Incidents ........................................................................................... 4
4.2 Dispensing Incidents ........................................................................................... 5
4.3 Preparation and Administration Incidents ............................................................ 5
4.4 Monitoring Incidents ............................................................................................ 5
5. Procedure ..................................................................................................................... 6
Actions to be taken following the discovery of a medication incident ........................... 6
5.1 Immediate Actions ............................................................................................... 6
5.2 Medium Term Actions (within a 72 hours – 1 week of the incident) – see
Appendix C .................................................................................................................... 7
5.3 Long Term Actions (within 3 months of the incident) ........................................... 8
6. References ................................................................................................................... 8
7 Associated Documentation ......................................................................................... 9
Appendix A – Grading Matrix – Definitions for Consequence of Incident (Actual and
Future Potential) ............................................................................................................... 10
Appendix B – Critical Incident Reflective Exercise ........................................................ 13
Appendix C – Flowchart of actions needed following an incident ................................ 17
Appendix D – Trust Process for the Investigation and Escalation of Medicines
Incidents ............................................................................................................................ 18
Appendix E – Just Culture Guide..................................................................................... 20

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Medication Incidents SOP

1. Background
Northern Devon Healthcare NHS Trust recognises the importance of
supporting staff when they have been involved in a medication incident. It is
essential that a sensitive response is demonstrated through a comprehensive
assessment, taking full account of the context and circumstances surrounding
the incident, prior to any action being taken in a clear and consistent way.

2. Purpose
The Standard Operating Procedure (SOP) has been written to:

 Promote a learning and just culture within the Trust in response to

adverse healthcare events, in line with the NICE Medicines Optimisation
Guideline (2015) and Just Culture Guide (2018)

 Facilitate organisational learning through the findings of thorough and

careful investigation at local level.

 Provide a framework for practitioners to improve practice, safety and

patient experience.

 Ensure appropriate actions are taken by managers and applied

consistently across the trust.

3. Scope and Location

This Standard Operating Procedure (SOP) applies to all staff involved in any
medication process, including prescribing, dispensing, preparation,
administration and monitoring, within Northern Devon Healthcare NHS Trust
provided services.

4. Definitions
The following list gives examples of scenarios where medication incidents can occur
(National Patient Safety Agency, 2007). It should not be considered a definitive list
and professional judgement must be used. Near misses in any of the sections below
should also be considered.

4.1 Prescribing Incidents

 Patient prescribed the wrong medication/dose/route/rate.

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 Medication prescribed to the wrong patient.

 Transcription incidents.
 Prescribing without taking into account the patients clinical condition.
 Prescribing without taking into account patients clinical parameters e.g.
weight.
 Prescription not signed.

4.2 Dispensing Incidents

 Patient dispensed the wrong medication/dose/route
 Medication dispensed to the wrong patient
 Patient dispensed an out of date medicine
 Medication is labelled incorrectly

4.3 Preparation and Administration Incidents

 Patient administered the wrong medication/dose/route.
 Patient administered an out of date medicine.
 Medication administered to the wrong patient.
 Medication omitted without a clinical rationale.
 Medication incorrectly prepared.
 Incorrect infusion rate.
 Medication administered late or early (where it would have a
significantly detrimental effect on patient care).

4.4 Monitoring Incidents

 Patient allergic to medication but the medication was prescribed and/or
dispensed and/or administered.
 Numerical incidents for controlled drugs record recording.
 Failure to provide the patient with correct information regarding their
medication e.g. when to take, what it is for, side effects.
 Failure to monitor therapeutic levels.
 Lack of timely review regarding effectiveness and duration of medication

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Medication Incidents SOP

5. Procedure
Actions to be taken following the discovery of a medication incident

5.1 Immediate Actions

5.1.1 Assess the patient’s condition, record a full set of physiological

observations and take necessary action to maintain patient safety.

5.1.2 Ensure appropriate medical assessment and treatment is provided as

necessary.

5.1.3 The incident must be reported immediately to the line manager/person

in charge, and the doctor in charge of care for the patient (e.g. GP or
consultant). Within community nursing the incident must be discussed
within the patient safety handover.

5.1.4 If unsure, seek advice from the Pharmacy department regarding the
possible outcomes of medication incident and ongoing monitoring that
may be required.

5.1.5 Record details of the incident in the medical/nursing notes.

5.1.6 Report the incident, following the Trust’s Incident reporting, analysing,
investigating and learning policy and procedures. The report must
include the following information:

 The patient’s name, hospital number and area where the incident
occurred

 Time the incident occurred and was detected

 A factual account of what happened

 The medicines involved and doses

 The route of administration

 Actions taken to ensure patient safety

 The team/individual/s involved in the incident

 The correct procedure/process that should have been followed

 Any mitigation and key factors present at the time which impacted on
the incident.

5.1.7 Inform the patient and their carer or relatives of the incident as soon as
possible, provide a Duty of Candour leaflet and document in the
patient’s notes, following the Trust’s Duty of Candour Policy.

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5.2 Medium Term Actions (within a 72 hours – 1 week of the incident) –

see Appendix C

5.2.1 The grading matrix contained within the Trust Incident reporting,
analysing, investigating and learning policy and procedures (Appendix
A) should be used by the line manager to grade the incident
5.2.2 If the incident is of low/moderate severity (green or yellow risk),
clinicians involved should reflect on the incident at a face to face
meeting with the investigating manager and any comments/learning
from this discussion should be included within the incident report review.
At the manager’s discretion the clinician may be asked to complete the
critical incident reflective exercise (see Appendix B).
5.2.3 If the incident is of high or extreme severity (orange or red risk), or if this
is this is the 2nd medication incident within a 2 month period, clinicians
involved must complete the critical incident reflective exercise (see
Appendix B). This should be completed within a week of the incident, at
most and should include a plan to share the outcome and learning with
the wider team.
5.2.4 A copy of the agreed actions as identified within the critical incident
reflective exercise must be kept on the member of staff’s personal
record and reviewed in line with the supervision and appraisal
approach, confirming positive change.
5.2.5 The Just Culture Guide (2018) (Appendix E) should be used to
determine the type of action that is required and this should be detailed
within the reflective exercise.
Line managers must also consult with HR, clinical/education supervisor
and/or Professional Lead, if there are concerns about the performance
of a member of staff.
5.2.6 Guidance on the management of incidents and the criteria for escalation
are included within the Trust’s Incident reporting, analysing, investigating
and learning policy and procedures and The Process for Investigation
and Escalation of Medication Incidents (Appendix D).
5.2.7 There may be occasions where staff wish to stand themselves down
from prescribing, dispensing or administration following a medication
incident, even if this is not identified as an action from the Just Culture
Guide (2018) (Appendix E). This should be respected and addressed
within the critical incident reflective exercise. If this impacts significantly
upon the role they hold this would need to be discussed with their line
manager so arrangements could be made to support this decision with
minimal impact on service continuity.
Alternatively the line manager, with advice from the professional leads
may consider restriction of practice for an individual whilst an
investigation takes place. This would be appropriate to reduce risk,
whilst competence is confirmed and skills are attained which have not
been demonstrated by incidents relating to the incident.
5.2.8 The line manager is responsible for supporting the member of staff
during this process, in line with the Trust’s Supporting staff with an
incident, complaint or claim policy. The member of staff must be kept

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informed of the progress of any investigation, and should also be

informed of the support and counselling service available from the
Occupational Health Department.

5.3 Long Term Actions (within 3 months of the incident)

5.3.1 If the critical incident reflective exercise highlights an issue with

competency relating to medication prescribing, dispensing, drug
calculation or administration, the individual must undertake a period of
education, training and re-assessment planned in collaboration with
their line manager, with support from the workforce development
department. Specific timescales must be set and regularly reviewed.

During this time the individual’s practice may be restricted and this
should be clearly described to them with assistance from the HR team
and followed up in writing. This will enable all concerned to understand
how these restrictions are being supported and in what timeframe
improvement is anticipated.
5.3.2 If, after the period of education, training and re-assessment, the
member of staff is still not deemed to be competent, they should be
managed in accordance with the Trust’s Capability Procedure.
5.3.3 All medication incidents will be reviewed within the Medicines
Governance Group, on a quarterly basis. This group comprises
representatives from Medical, Nursing and Pharmacy senior staff; any
actions or learning agreed within the group will be disseminated
throughout the trust (e.g. via the Trust governance co-ordinators,
Getting Medicines Right Bulletins, newsletters or incorporated into
Policy / Procedure reviews). Any concerns that are identified will be
shared with the Trust Executive Board.
Themes from Serious Incidents Requiring Investigation and Significant
Event Audits will be reported through the normal processes to the
Medicines Governance Group.
5.3.4 The Trust level process for investigation and escalation of medicines
incidents can be found in Appendix D.

6. References
 General Medical Council (2009) EQUIP Study. An in-depth investigation into
causes of prescribing errors by foundation trainees in relation to their
medical education [online]Availablefromhttp://www.gmc-
uk.org/FINAL_Report_prevalence_and_causes_of_prescribing_errors.pdf_28
935150.pdf (Accessed 17/01/2019)

 General Medical Council (2009) Good Medical Practice. London: GMC.

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Medication Incidents SOP

 Gibbs, G. (1998) Learning by Doing: A Guide to Teaching and Learning.

London: FEU.

 Meadows, S., Baker, K. and Butler, J. (2005) The Incident Decision Tree:
Guidelines for Action Following Patient Safety Incidents [online] Available
from http://www.ncbi.nlm.nih.gov/books/NBK20586/ (Accessed on
17/01/2019).

 Medicines Health and Regulatory Authority (2014) Improving Medication Error

Incident Reporting and Learning. Alert reference number
NHS/PSA/D/2014/005.

 National Patient Safety Agency (2004) Incident Decision For

Secondary/Tertiary Care, Ambulance and Mental Health Studies. London:
NPSA

 National Patient Safety Agency (2007) Safety in Doses: Medication safety

incidences in the NHS. London: NPSA

 National Patient Safety Agency (2008) A Risk Matrix for Risk Managers.
London: NPSA

 National Patient Safety Agency (2010) Medical Error: What to do if things go

wrong, a guide for junior doctors. London: NPSA

 NHS Improvement (2018) Just Culture Guide. London: NHS Improvement

 NICE (2015) Medicines Optimisation. London: NICE

 Nursing and Midwifery Council (2007) Standards for Medicines Management.

London: NMC

 Nursing and Midwifery Council (2015) The code: professional standards of

practice and behaviour for nurses and midwives. London: NMC

 Royal Pharmaceutical Society (2015) Medicines, Ethics and Practice (Volume

39). London: RPS.

7 Associated Documentation
 Duty of Candour Policy

 Capability Procedure

 Incident reporting, analysing, investigating and learning policy and

procedures

 Medicines policy

 Supporting staff with an incident, complaint or claim policy

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Appendix A – Grading Matrix – Definitions for

Consequence of Incident (Actual and Future Potential)

Consequence Score (severity levels) and examples of descriptors

1 2 3 4 5
Domains None Minor Moderate Major Catastrophic
Impact on the Minimal Minor injury or Moderate injury Major injury leading to Incident leading to death
safety of injury illness, requiring requiring professional long-term Multiple permanent injuries
patients, staff requiring minor intervention intervention Requiring incapacity/disability or irreversible health effects
or public no/minimal time off work for over 7 Requiring time off work
(physical/ intervention Requiring time off An event which impacts on
days for
psychological or treatment. work for less than a large number of patients
harm) 7 days Increase in length of hospital >14 days
No time stay by 4-15 days
off work Increase in length of Increase in length of
hospital stay by 1-3 Externally reportable hospital stay by >15
days incident An event which days Mismanagement
impacts on a small number of patient care with
of patients long-term effects
Quality/ Peripheral Overall treatment Treatment or service Non-compliance with Totally unacceptable level
complaints/ element of or service national standards or quality of
audit treatment suboptimal has significantly with significant risk to treatment/service
or service reduced effectiveness patients if unresolved
suboptimal Formal complaint Gross failure of patient
(stage 1) Formal complaint (stage Multiple complaints/ safety if findings not acted
Informal 2) complaint independent review on
complain Local resolution
t/ inquiry Single failure to Local resolution (with Low performance Inquest/ombudsman inquiry
meet internal potential to go to rating Critical report Gross failure to meet national
standards Minor independent review)
implications for Repeated failure to meet standards
patient safety if
internal standards
unresolved
Reduced performance Major patient safety
rating if unresolved implications if findings are
not acted on

Patient Unsatisfactory Unsatisfactory Mismanagement of patient Mismanagement of patient Totally Unsatisfactory

experience patient patient patient outcome or
care – short term effects care – short term effects experience
Patient experience not experience –
Experience directly readily
related to resolvable
patient care

Human Short-term low Low staffing level Late delivery of key Uncertain delivery of Non-delivery of key
resources/ staffing level that reduces the objective/ service due to lack key objective/service objective/service due to
organisa- that service quality of staff Unsafe staffing level due to lack of staff lack of staff
tional temporarily or competence (>1 day)
development/ reduces Unsafe staffing Ongoing unsafe staffing
staffing/ service quality Low staff morale level or levels or competence
competence (< 1 day) competence (>5 Loss of several key staff
Poor staff attendance for days) Loss of key
mandatory/key training staff No staff attending mandatory
training /key training on an
Very low staff ongoing basis
morale No staff
attending
mandatory/ key
training

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 Medication Incidents SOP

Statutory duty/ No or Breach of statutory Single breach in statutory Enforcement Multiple breaches in stat.duty
minimal legislation duty Challenging external action Multiple Prosecution
inspections
impact or breaches in
breach of Reduced performance recommendations/ Complete systems
guidance/ rating if unresolved change required
statutory duty
statutory improvement notice
Zero performance
duty Improvement notices
rating Severely critical
Low performance report
rating

Critical report

Adverse Rumours Local media coverage Local media coverage – National media coverage National media coverage with
publicity/ short-term reduction long-term reduction in public with <3 days service well >3 days service well below
reputation in public confidence
Potential for confidence below reasonable reasonable public
public Elements of public public expectation expectation. MP
concern expectation not concerned (questions in
being met the House) Total loss of
public confidence
Business Insignificant <5 per cent 5–10 per cent over Non-compliance Incident leading >25 per
objectives/ cost over project project budget with national 10–25 cent over project budget
projects increase/ budget per cent over project Schedule slippage
schedule Schedule slippage
budget Schedule
slippage Schedule slippage Key objectives not met
slippage

Finance Small loss Loss of 0.1–0.25 Loss of 0.25–0.5 per cent of Key objectives
Uncertain not met
delivery of Non-delivery of key
including Risk of claim per cent of budget budget key objective/Loss of objective/ Loss of >1 per
claims remote Claim less than 0.5–1.0 per cent of cent of budget
Claim(s) between £10,000 budget
£10,000 and
Failure to meet
Claim(s)
£100,000 between specification/ slippage

Service/ Loss/interrupti Loss/interruption of Loss/interruption of >1 day £100,000 and of£1

Loss/interruption Loss of contract
Permanent / payment
loss of by
service or
business o n of >1 hour >8 hours Moderate impact on million results.
facility Claim(s) >£1 million
interruption environment >1 week
Minimal or no
Environmental impact on the Minor impact on Purchasers failing to Catastrophic impact on
environment
Major
pay
impact on environment
impact environment environment
Informati No personal Limited Celebrity /VIP Sensitive personal Highly sensitive personal
on data lost demographic involved. Basic data, high level of data, multiple
Governan data Less than demographic data stress / financial occurrences of loss, 100
10 people Limited clinical loss, 51 – 100 + people
ce
information 10-50 people
people
Likelihood Score

1 2 3 4 5
Descriptor Rare Unlikely Possible Likely Almost certain
Frequency This will Do not expect it Might happen Will probably Will undoubtedly
probably never to happen/ or recur happen/recur happen/recur,
How often happen/recur recur but it occasionally but it is not a possibly
might it/does persisting frequently
(< once per year) is possible it
it happen may do so to issue
Examples Not expected Expected Expected to Expected to Expected to occur at
of to occur for occur at least occur at least occur at least least daily
frequency years or annually monthly weekly
<once/year

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Grading Matrix

Rare 1 Unlikely 2 Possible 3 Likely 4 Almost certain 5

5 Catastrophic 5 10 15 20 25
4 Major 4 8 12 16 20
3 Moderate 3 6 9 12 15
2 Minor 2 4 6 8 10
1 None 1 2 3 4 5

Action guidance summary

For Red incident / near misses – Inform the Chief Nurse, Risk Lead, Head of Quality and
Safety, and Patient Experience Matron, On-call Senior Manager. Carry out full root cause
analysis investigation; formulate action plan and remedial actions. Full investigation / report
required

For amber incidents / near misses – Inform Head of Quality and Safety, Risk Manager
within 48 hours via automated trigger at grading stage. Carry out a moderate screening tool
to ascertain whether a full investigation is required, within 45 days, formulate action plan and
remedial actions.

For green incidents – Incident form to be completed and graded within 48 hours. Person
in charge of area to discuss with staff involved. Document any remedial actions on the
electronic copy of the incident form.

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Appendix B – Critical Incident Reflective Exercise

This document is designed to enable practitioners to have a formal process of learning from
incidents that they have been involved in. You must complete this form in conjunction with
your line manager. You will keep the original form and your manager will keep a copy.
The exercise is modelled around Gibbs reflective cycle (1998), shown below:

Action Plan
If the situation Description
arose again what What happened?
would you do?

Analysis
What sense can Feelings
you make of the What were you
situation? What thinking and
else could you feeling?
have done?

Evaluation
What was good
and bad about
the experience?

The critical incident reflective exercise is in three parts:

Part A You write a factual statement about the incident. This will be kept by your
manager and included within the incident report.
Part B This is an informal learning exercise, for you to reflect on the incident and to
discuss any issues with your manager.
Part C This is an action plan that arises from the incident and will be kept as part of
your appraisal documentation, to be reviewed as appropriate.
There are several hints and suggestions in each part of the document to assist you in
completing it. These do not have to be followed exactly as set out.

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Part A – Formal Statement of the Incident

Write a detailed account of what happened before, during and after the incident.
 What exactly occurred?
 What did you see?
 What did you do?
 What were the consequences of your actions to yourself, the patient, visitors, your colleagues?
 What did other people do? (e.g. colleagues, patient, visitors)

Write your statement here, and continue on another sheet if necessary

Name of person Signature: Date:

completing form:

Name of person Signature: Date:

reviewing form:

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Part B – Reflection on the Incident

Write a reflective account of the events leading up to, during and after the incident.
 What was I trying to achieve? Why did I act as I did?
 What internal/external factors influenced my decision-making or actions?
 What sources of knowledge did or should have influenced my decision-making or actions?
 What were my feelings at the time?
 What are my feelings now? Are there differences? Why?
 What were the effects of what I did or did not do?
 What “good” emerged from the situation for myself and for others?
 What would I have done differently/better?
 What troubles me now (if anything)?

Write your reflection here, and continue on another sheet if necessary

Date the reflection was completed:

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Part C – Action plan arising out of the incident

List your learning points from the incident, with an action plan of what you need to focus on
or do differently as a result.
 What needs to happen to alter the situation?
 What are you going to do about the situation?
 What happens if you decide not to alter anything?
 What information do you need to face a similar situation again?
 What are the best ways of getting further information about the situation should it arise again?
 Indentify anything that may hinder your action plan and how you can tackle these
 Have you taken effective action to support yourself and others as a result of this experience?

Write your learning points here

Learning Need Actions to address need (including Progress review

timescales)

Name of person Signature: Date:

completing form:

Name of person Signature: Date:

reviewing form:

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Appendix C – Flowchart of actions needed following an incident

Assess the medication error or
near miss using the Risk Matrix
(Appendix A)

Low or Moderate Risk High or Extreme Risk

(Green) (Orange/Red)

Is this the 2nd Complete the Critical

Medication error in a Incident Reflective
2 month period? Exercise (Appendix B)
within 1 week of the
incident and share
learning with the wider
team where appropriate

Is there an issue with competency

relating to medication prescribing,
No Yes dispensing or administration?

Informal discussion with

investigating manager Yes No

Consider the use of Critical
Incident Reflective Exercise
(Appendix B) if appropriate or
useful
Line manager to agree a plan, in collaboration with the
individual (and workforce development and/or medicines
management or pharmacy team if appropriate), to
include education, training and re-assessment. Agree a
timescale for review.

Use the Just Culture Guide (2018) (Appendix E) to determine the

Learning should be included within further actions required, in consultation with HR partner where
the incident report and shared necessary. Follow the Northern Devon healthcare trust Incident
with the wider team Management and Investigation Policy

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 Medication Incidents SOP V1.5 DRAFT
14 March 2019

Appendix D – Trust Process for the Investigation and

Escalation of Medicines Incidents
Medication Incident
reported on Datix

Medication incidents reported to the Trust Medicines Safety Officer / Chief Pharmacist and relevant
Pharmacists via DATIX for screening and onward prioritisation, investigation and / or escalation

Controlled drugs medication incidents reported to the Trust Chief Pharmacist who will inform the
Trust’s Accountable Officer for Controlled Drugs in line with the Trust Medicine Policy

Completion of 72 hour Initial Investigation report by Responsible Manager (as identified on

Datix), involving others as appropriate

Medicines incident screening by Trust Medicines Safety Officer:

Pharmacist allocated from pharmacy / medicines management team to support investigation and with
identification of learning outcomes; outcomes recorded on Datix
(professional issues addressed via Medication Errors - Standard Operating Procedure:
Managing and Supporting Staff Following a Medication Error)

Other key staff notified of medication incident via Datix alert:

Clinical Services Manager and Governance Pharmacist (Northern area)
Community Services Lead Pharmacist and Governance Pharmacist (Eastern area)
Community Nurse Leads (Northern / Eastern)
Trust Lead for non-medical prescribing (Trustwide)
Lead Clinician (identified via Datix team) – Prescriber / clinical errors

Decision made to escalate incident to Concise Investigation, Serious Incident Investigation

(Corporate Governance / Senior Pharmacy advice), based on the following:
 Level of harm
 Poor patient outcome
 High volume of incidents in one area / practitioner
 Recurring theme or concern
 Impact on service / staff

Concise Investigations reviewed by Medicines Governance Group quarterly to ensure that

appropriate actions have been taken; Feedback submitted to Corporate Governance following review

Causal Analysis of Concise Investigations considered by Medicines Governance Group

quarterly to review causal themes and trends and to identify further actions or recommend further
actions for the improvement of medicines safety

Quarterly medication incident report reviewed by Trust Medicines Governance Group to identify
themes and trends and to identify further actions or recommend further actions for the improvement of
medicines safety

Narrative produced by Trust Governance Pharmacist for Patient Safety Report submitted to the
Quality Assurance Committee (QAC); for onward reporting to the Trust Board (via QAC minutes)

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14 March 2019
Medicines incidents involving third party / external providers shared (e.g. Out of
Hours Service, Ambulance Trust, Primary Care Contractors – GPs / Community
Pharmacists etc)

Local investigation processes for high risk medication incidents

Local investigation – Chief Pharmacist / Governance Pharmacist / Clinical Pharmacy

Manager review, for onward investigation and / or escalation:
 Anticoagulants
 Antiepileptics
 Anti-infectives (antibacterial drugs, antifungal drugs, antivirals including antiretrovirals)
 Anti-Parkinsons medication
 Desmopressin for cranial diabetes insipidus
 Insulin and oral hypoglycaemics
 Regular opioid analgesia
 Medicines prescribed via intra-venous (IV) route
 Resuscitation medicines
Email discussion to facilitate expert opinion to inform decision about escalation to
Serious Incident Investigation

Reports for the following groups sent to Clinical leads each quarter (for high risk medicines):
Datix reports reviewed by the following groups for investigation and follow up:
 Anticoagulants (including INRs >6) : Anticoagulation group
 Antibiotics : Antibiotic working group
 Chemotherapy / oncology : Chemotherapy Governance Group
 Medical gasses : Medical Gases Committee
 Controlled drugs : Accountable Officer for Controlled drugs / Local Intelligence Network
 IV drugs : IV infusions group

Medicines Governance Group to receive quarterly updates from groups on actions taken to
improve medicines safety, which will cover:

In addition to the above groups, the Medicines Governance Group will review incident
themes and trends for:
 High risk medicines (as per Trust omitted / delayed medicines SOP) not covered in the
above
 Non-intentional omitted doses (as defined in Trust omitted / delayed medicines SOP)
 INRs >6 (origin within service i.e. not primary care nor other Trust / service)
 Other anticoagulants
 Allergy / other adverse drug reaction
 Anti-Parkinson Disease medication
 Anti-epileptic medication
 Methotrexate and DMARDs
 Insulin and oral hypoglycaemics

Pharmacist allocated by Chief Pharmacist / Governance Pharmacist / Clinical Pharmacy

Manager to support incident / further investigation (unless professional issue) as per
process outlined above.
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Medication Incidents SOP V1.5 DRAFT
14 March 2019

Appendix E – Just Culture Guide

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