MMGUI60 Managing Supporting Staff following a Med Error

Page 1


Version: V5

Ratified by: MGSG

Date ratified:

29.6.2023

Job Title of author: Assistant Clinical Director Pharmacy and Medicines

Reviewed by Sub Group or Expert Group Medicines Governance & Safety Group

Related Procedural Documents

Review Date:

MMPOL30 Medicines Policy

MMSOP34 Management of Pharmaceutical Waste in Community Hospitals and Community Clinics

MMSOP41 Controlled Drugs Suite of SOPs

MMPOL31 Controlled Drugs Policy

MMSOP63 Safe use of Gabapentin and Pregabalin in Community Inpatient Wards

HRPOL26 Psychological Wellbeing of Staff Policy

QSPOL01 All Incident Reporting (including Serious Incident Reporting) & Management Policy

29.6.2026

It is the responsibility of users to ensure that you are using the most up to date document template – ie obtained via the intranet.

In developing/reviewing these guidelines Provide Community has had regard to the principles of the NHS Constitution.

Version Control Sheet

Version Date Author Status Comment

V1 August 2014 Head of Medicines Management Approved New

V2 November 2016 Head of Medicines Management Review

V3 March2019 Headof Medicines Management Review

V4 August2019 Community Health Specialist Pharmacist Update

V5 May2023 Clinical Lead Pharmacist Review

1. Introduction

Provide recognises the importance of supporting staff when they have been involved in a medication error or a near miss. Such an event can present stress and concern for health practitioners and especially where there is a direct impact on a patient.

The National Patient Safety Agency (NPSA), now part of NICE, published a report in 2009 ‘Tackling medication incidents and increasing patient safety’ in which they reported that the number of medication incidents being reported had increased significantly, indicating that the NHS had improved its reporting culture and was willing to come forward when mistakes have been made, and that the majority of those reported had resulted in no or low harm to patients.

However, the NPSA chief executive stated that ‘millions of medicines are prescribed in the community and in hospitals across England and Wales each day – the majority of these are delivered correctly and do exactly what they are meant to do. However when an incident does occur, it is vital that we learn from this to ensure patients are not harmed’.

The report went on to state that ‘we have learnt from industries such as aviation, that scrupulous reporting and analysis of safety related incidents, particularly ‘near misses’ provides an opportunity to reduce the risk of future incidents. Through the NPSA, the whole of the NHS can learn from the experiences of individual organisations’.

Therefore, Provide has a responsibility to the patients we care for to reduce wherever possible the risk of harm related to medication processes, and Provide needs to encourage reporting of incidents and to ensure all reported incidents are dealt with in a timely, consistent, objective and fair manner.

2. Purpose

This Guidance aims to standardise the management of medication errors or near misses across Provide, and to ensure that staff who are involved in a medication incident are treated objectively, fairly and consistently across all services within the organisation.

This guidance aims to encourage timely reporting of all medication errors or near misses, in order to improve patient safety by identifying and learning the lessons arising from these incidents.

This guidance outlines the responsibilities of staff when involved in a medication error or near miss, the responsibilities of managers when dealing with medication errors or near misses, and sets out the appropriate actions and support necessary for all staff when an error or near miss occurs.

3. Definitions

Patient Safety Incident

The National Reporting and Learning Systems (NRLS) defines a ‘patient safety incident’ (PSI) as, ‘any unintended or unexpected incident, which could have or did lead to harm for one or more patients receiving NHS care.’ (NHS Improvement, 2017)

Medication Error

Medication errors are anyPSIs where there has been an error in the process of prescribing, preparing, dispensing, administering, monitoring or providing advice on medicines. These PSIs can be divided into two categories; errors of commission or errors of omission. The former include, for example, wrong medicine or wrong dose. The latter include, for example, omitted dose or a failure to monitor, such as international normalised ratio for anticoagulant therapy.

Near Miss

This is defined as an event or situation that could have resulted in harm, loss or damage but because of timely intervention, did not actually occur.

4. Scope

This Guidance applies to any health care practitioner who is involved in any stage of the medication process, which will normally include:

• Nursing staff

• Medical staff

• Pharmacy staff

• Allied Health Professionals

• Clinical support staff – where relevant

• Agency or Locum staff

• Administrative staff with responsibility for handling prescribing paperwork and/or clinical/patient notes

5. Responsibilities

Assistant Directors (ADs)

All Assistant Directors must be familiar with this guidance to ensure they understand how the guidance should be applied in practice.

Service Managers

All Managers operationally responsible for service delivery must understand how this guidance should be implemented, and to ensure the staff they have responsibility for are aware of this guidance and how to comply with its content.

Medicines Management Team

In the event of a medication error or near miss, the Medicines Management Team may be approached at any stage for immediate advice and support.

The Medication Safety Officer (MSO) will review each reported medicine incident in a systematic way, and advise on any further action required. Feedback will be provided to the relevant senior managers, as well as to the person reporting the incident, and via the Medicines Governance & Safety Group (MGSG). The Medicines Management Team will offer re-training support as required, for any staff member involved in a medication error or near miss, arising from the error or near miss.

Clinical Managers

It is the responsibility of all clinical managers, e.g. Ward managers, clinical team leads, community matrons, to ensure they understand and apply this guidance in their own clinical area.

Employees

All employees who are involved in the medication process must familiarise themselves with this guidance, so they understand their individual responsibilities and those of Provide.

6. Process to Follow

Provide acknowledges that medication errors or near misses will sometimes happen. What is important is that the organisation and those staff involved in the incident have a clear understanding after the event of the following:

• If there has been any harm done to a patient as a consequence of the incident

• The causal factors that contributed to the incident

• Any potential actions that could have been taken to prevent it happening

• Any training needs arising from the incident

• Whether any staff involved in the current incident have been involved in more than one medication incident over a defined period of time (see Appendix 1)

• If there is an immediate need to address any disciplinary issues arising from the incident

• If there are any Provide processes that need to be reviewed

• If there is any Organisational learning

Provide expects that after each reported medication error or near miss, a thorough investigation should be carried out at local level. The purpose of this investigation is to ensure the points set out above can be answered. This process should be carried out sensitively and any necessary support offered to the staff involved, in line with recommendations made by the NPSA.

However it must be noted that, where incidents are found to involve gross carelessness, repeated errors, criminal, deliberate or malicious actions, action will proceed in line with the Provide Capability or Disciplinary procedures.

Actions to be taken by a member of staff involved in a medication error or near miss

The following action should be taken:

• As soon as the error or near miss is identified, assess the patient’s condition if appropriate, to establish if the patient has suffered any harm

• Discuss and agree who will inform the patient/carer that a medication error has occurred

• Report the incident to the Doctor responsible for the patient’s care

• Document the nature of the incident in the patient’s notes

• Report the incident immediately to the person in charge, and record the error on Datix

• If the error involved a Schedule 2 or 3 Controlled Drug (Sch 2/3CD) then the Accountable Officer (AO), Nisha Desai, needs to be informed within 24 hours and a Datix raised WITHIN 48 hours

Contact Details: Nisha Desai, 07580 911601 Nisha.desai@nhs.net

• If required, seek further advice from a member of the Medicines Management Team

• If the incident involves a dispensing error, inform the relevant pharmacy immediately. The Medicines Management team should also be informed at the same time, so they can also consider the implications of the error

• Consider any further actions necessary following the incident (see Appendix 2)

Actions to be taken by

the senior clinician in charge/

Senior Manager

It is the responsibility of the senior clinician or manager to whom the incident has been reported, to undertake the following actions:

• Follow the ‘Algorithm for the Management of Medication Errors/Near Misses (Appendix 1)

• In the first instance they must:

• Confirm the status of the patient, if relevant, and check if any harm has occurred

• Ensure that all appropriate support has been offered to the member of staff involved in the incident

• Confirm that the Doctor in charge of the patient’s care has been informed

• Confirm that the incident has been reported on Datix

• In following the algorithm, they should ensure that:

• Once the severity of risk has been confirmed, the manager should follow the steps of the algorithm set out in Appendix 1

• An investigation of the incident should be carried out using a Root Cause Analysis (RCA) Template (see Appendix 3), to review the causal factors involved

• At the appropriate time, allow the member(s) of staff involved in the incident to reflect on the circumstances, and identify their own learning

• Identify if there are any training or performance issues with the member(s) of staff, and depending upon the level of risk, take any necessary actions. According to the level of risk identified, this could involve re-assessment of competency or immediate suspension of the member of staff from prescribing, dispensing, preparing or administering medication

Informing the Patient/Carer if a medication administration error has occurred

• It is important for Provide to be open and honest when things go wrong, and therefore it is of great importance that a patient or their carers are informed if a medication error has occurred

• The patient/carer should be informed at an appropriate time by either the nurse or doctor in charge of the patient’s care, and an apology offered This apology should be noted in the patient’s record as per the Duty of Candour processes

• If the error is of a serious nature, following a formal investigation and at the appropriate time, the patient/carer should be offered the opportunity to discuss the outcome of the investigation and to discuss the findings. This provides an opportunity to reassure the patient/carer that Provide is keen to always learn lessons from medication errors, and to prevent similar occurrences in the future

After a medication error/near miss had occurred

After a medication error or near miss has occurred, and all necessary immediate steps have been taken, it is important there should be an opportunity for the staff member(s) to discuss the incidents with their manager, as soon as possible after the incident.

The purpose of this discussion is to:

• Discuss the incident to enable the member of staff to reflect on the circumstances and identify what can be done to prevent future occurrence

• Allow the member of staff to discuss how they feel and discuss any concerns they may have

• Identify if there are any training or performance issues with the member of staff

• Determine if the medication incident is a repeat incident; check if the member of staff has made a previous similar medication error and within what timeframe

• Dependent upon the severity of the error/near miss, to ensure all appropriate support has been offered to the member of staff

• Determine whether the medication incident is a procedural/ system error and policies need to be reviewed accordingly

• If the error occurred due to a Provide process then the organisation can learn from this error to prevent similar errors in the future

A medication error/incident may be a source of concern and stress for employees and it is the line manager’s responsibility to ensure that employees’ mental health issues are understood and where appropriate, supported. Line managers can refer employees to Occupational Health (OH) if an employee exhibits or has potential stress related ill health.

The contact details for OH: Telephone: 0345 643 3468 Email: ang-sa.Occupationalhealth@nhs.net

The Human Resources (HR) department is responsible for leading on all matters relating to the employees of Provide and can help employees resolve any queries and issues they have during their employment. HR focuses on ways to help all employees to perform to the best of their abilities. Refer to Psychological wellbeing of staff policy and procedure (HRPOL26) for information about addressing concerns regarding work related stress or psychological well-being.

Appendix 4 sets out guidance on how to minimise errors from occurring. This highlights some of the problems which may occur in a community setting and identifies solutions on how to reduce the errors.

7. Staff who make Repeat Medication Errors/Near Misses

It is important that all members of staff and their managers comply fully with this guidance, to ensure the organisation is able to manage medication errors and near misses appropriately and particularly to ensure members of staff who make repeat errors/near misses are identified as soon as possible.

By following the Algorithm in Appendix 1, line managers should seek to establish if this is a repeat error or near miss that has occurred within the preceding 3 months.

8. Role of the Medicines Management Team

Medication incidents that are reported via Datix will be reviewed by the Medication Safety Officer. Any incidences relating to Controlled Drugs will be reviewed by the Accounty Officer, Nisha Desai, Assistant Clinical Director Pharmacy and Medicines. The purpose of this review is essentially twofold:

• To establish if appropriate medicines management policies and procedures are in place to support staff in their practice

• To support the process of learning lessons and sharing these lessons with key staff following any medication incident, via the Medicines Governance & Safety Group

• To ensure Provide processes are reviewed by the relevant department

• To determine where Controlled Drug (CD) incidents have been reported need reporting to the Police

(Please refer to QPOL01: All Incident Reporting (including Serious Incident Reporting) & Management Policy for further details on reporting requirements).

9. Training and Competencies

The implementation of this guidance requires that managers are able to carry out a Root Cause Analysis (RCA) into the medication incident where appropriate. The template in Appendix 3 must be used to help identify any learnings and to understand the root cause of the incident, to enable steps to be taken to avoid similar incidents in the future.

The Learning and Development unit should be used to register for any Medicines Management related training needs identified.

Appendix 1: Algorithm for the Management of Medication Errors/Near Misses

Assess Patient

Seek Specialist Advice 999

Follow Appendix 2 if appropriate

Low / Medium Severity (yellow risk) (No harm to patient/minor harm)

• Inform Senior Manager

• Report incident on Datix

• Carry our RCA (Root Cause Analysis)

• Duty of Candour

• Support staff involved

• Ask staff involved to reflect on incident and include comments on the Datix Form

• Follow up patient condition

• Arrange discussion between member of staff and Line Manager / Senior Nurse dependant on the outcome of the RCA

• Supportive discussion to include reflection by member/s of staff

• Establish if this is a repeat error/near miss by member/s of staff – is re-training required?

Actions:

• Refer for Medicines Management Training & Support

• If first occurrence, offer additional support and supervised administration to re-assess competencies

• If repeat occurrence within the last 3 months, suspension from medicines administration until competencies re-assessed

• If repeat occurrence, confirm the first error’s actions are completed

Significant Severity (Orange risk) (Moderate Harm)

High Severity (Red risk) (Severe harm/death)

• Inform Senior Manager

• Report Incident on Datix

• Carry out RCA (Root Cause Analysis)

• Duty of Candour

• Support staff involved

• Member/s of staff involved to complete reflective account, include comments on the Datix Form

• Follow up patient condition

1. If this is a first medication error/near miss:

• Arrange medication training

• Arrange supportive discussion with member/s of staff and line manager and to explain process for review that is to be followed

• Supervised practice only for 10 occasions, or as appropriate to service 2. If this is a repeat medication error/near miss within the preceding 3 month period:

• Suspend member/s of staff from medication process while RCA in progress

• Arrange medication training

• Arrange supportive discussion with member/s of staff and line manager and to explain the process for review that is to be followed

Actions:

• Suspension from medicines administration if a serious incident has occurred from either Critical A and/or Critical B medicines

• Consideration of initiating the Capability / Disciplinary Procedure if formal investigation is required

• Training is completed before lifting suspension period

• A period of supervision is arranged after suspension has been lifted (3 months)

• Check equipment is not faulty

• Check individual competencies

• If any further doubt in competency, raise with Senior Management

Appendix 2: Managing a Medication Error/Near Miss – Things to Consider

Are there immediate/potential risks to the patient from the incident?

Does the patient require immediate medical intervention? If so, seek help immediately ringing 999

If a drug error has occurred, consider the potential for serious harm and if a reversible should be administered? Ask for an urgent medical review.

Have immediate necessary observations been completed e.g. Pulse, BP, Blood Glucose, consider any on-going patient observations if appropriate

Has the doctor responsible for the patient’s care been informed with medical review requested? Urgency dependent upon seriousness of incident.

Has someone agreed the appropriate time to inform the patient/carers of the nature of the incident?

Has the senior nurse / senior manager been informed and has appropriate support been offered to the healthcare personnel involved in the incident?

Have you identified who will report the incident on Datix – this must be as soon as practicably possible but within 48 hours. For Sch2 and 3 CD the AO needs to be contacted within 24 hours and a Datix MUST be raised within 48 hours. For missing Sch2 and 3 CD a crime reference number is needed for the Datix (from the Police).

Accountable Officer: Nisha Desai 07580911601

Has the incident been documented in the patient record?

Has the incident been risk assessed and lessons for learning been identified?

Appendix 2: Clinical Incidents Related to Medicines

Introduction

Relevant to all Provide staff in procurement, prescribing, administration, dispensing and handling medicines within Provide.

Purpose

To define the Provide procedure for clinical incidents related to medicines, and to provide a resource to direct clinicians to other relevant policies, procedures and guidelines.

Refer to:

• MMPOL30 Medicines Management Policy

• MMGUI60 Managing and Supporting Staff following a Medication Error

• Professional body standards for prescribers and non-medical prescribers (NMPs)

Religion,

Equality, Human Rights and Promoting Dignity and Respect

Clinicians must ensure they consider religious observances, equality, human rights and the promotion of dignity and respect in relation to prescribing, administering and handling medicines. The principles of informed consent and the Mental Capacity Act should be followed.

Process to Follow

Clinicians involved in identifying clinical incidents related to medicines should be mindful of their professional obligations related to patient safety. In any clinical incident related to medicines, patient safety is paramount and reasonable steps should always be taken to minimise any immediate risk to patients.

Reasonable steps include:

• Isolating stocks of medicines that are defective or may display evidence of tampering

• Seeking medical advice as soon as possible

• Involving senior staff as soon as possible

• Considering the appropriate cause of action in relation to the member of staff involved, depending upon the severity of the incident and whether this is an isolated incident or if the member of staff has been involved in other medicines incidents in the last 3 months

• Suspending a member of staff from administration duties if necessary after assessment

• Contacting a patient promptly in relation to an identified dispensing or administration error

• Contacting the Medicines Management team where appropriate, to aid in the incident

• Raising a Datix

• Informing the Accountable Officer for Controlled Drugs Schedule 2 and 3

• Raising as a Patient Safety Incident (PSI) if appropriate

Where foul play is suspected, the member of staff should be suspended and the police contacted. Internal security is essential to instigate an investigation as soon as possible. Senior staff should be contacted immediately to aid in the decision making process.

All medication incidents and near misses must be reported via Datix within 48 hours of the incident occurring. Any incidents thought to be of a serious nature must be reported immediately.

Adverse Drug Reactions

Suspected adverse reactions to drugs are notifiable by doctors, nurses, patients and pharmacists through the Yellow Cards Scheme. Advice and Yellow Cards are available from the MHRA Website and are included in the British National Formulary (BNF). For the reporting of suspected adverse drug reactions, refer to the Yellow Card Scheme. See current British National Formulary (BNF) or via www.mhra.gov.uk

Controlled Drugs

The Accountable Officer must be provided with information regarding any complaints, incidents or concerns in relation to controlled drug within 24 hours of the incident being identified. Controlled drugs issues relating to independent contractors (e.g. General Practitioners and Community Pharmacy) will be forwarded to the respective CCG and NHS England. Refer to MMPOL31 Controlled Drugs Policy, MMSOP41 Controlled Drugs Suite of SOPs and MMSOP63 Safe use of Gabapentin and Pregabalin in Community Inpatient Wards.

Contact Details for Poisons and Drug Overdoses

UK National Poisons Information Service (NPIS) – Telephone 0344 892 0111, https://www.toxbase.org/

Monitoring and Compliance

Compliance will be monitored continuously via the Datix incident reporting system and will be reviewed bi-monthly at the Medicines Governance & Safety Group (MGSG) meetings.

Appendix 3: Root Cause Analysis (RCA) Template

Medication incident brief RCA

Date of incident

Datix number(s)

Manager requesting investigation

Author of report

Date report completed

Status of report

Distributed to

Draft / final

Terms of reference

To review root causes and contributing factors to medication incidents within Provide

Incident description and its consequences

What happened?

What was the effect on the patient?

What was done following the incident to ensure the safety of the patient?

Medicine involved (include name of drug, dose and delivery method)

Please include name of delivery method/device used

Involvement and support of the patient, carers or relatives

Was the patient aware? Were others involved or informed? What was the reaction?

Involvement and support for staff involved

How has the member of staff involved been supported?

Chronology of events leading to the incident

Include all relevant events, date and time

Notable practice within the case

What went well before or after the incidents?

Care and service delivery problems

What didn’t go so well in the incident or how it was handled afterwards?

Contributory factors

Were there any circumstances that didn’t cause the incident, but may have contributed to why it happened or how it was responded to?

Root causes

Why did this happen? Use the ‘5 whys’ to help get to the root cause (ask why? 5 times)

Why?

Why?

Why?

Why?

Why?

Lessons learned

What needs to be done in future

Will doing this prevent future incidents Would doing this have prevented this incident?

Recommendations

What needs to change to improve the processes and procedures so that the lessons are learnt and embedded intro practice?

Action plan

How will you put the recommendations into practice? Be realistic and specific

If there are actions for others or the ‘Trust’ only describe what’s within your control (i.e. Raise with the medicines management group a change required in the SOP”

Strategy for monitoring action plan

Who and when will this action plan be monitored?

Arrangements for shared learning

Actions will be discussed at team meeting (enter date)

RCA to be sent to:

• Medication Safety Officer

• Accountable Officer (AO) for Controlled Drugs Sch2 and 3

• Quality & Safety Manager

• Assistant Director of Service

Appendix 4: Stages of Medication

STAGES OF MEDICATION PROCESSES

PROBLEMS SOLUTIONS

• Overlooking drug allergies

• Major Drug Interactions

• Suboptimal medication choices based on clinical indication, Comorbid conditions, existing medication

• Drug substitution due to similar name e.g. Cerebyx and Celebrex

• Missed decimal point on lined paper, carbon copies or faxed copies

• Ambiguous or hastily written abbreviations for frequency, units or route of administration

• System and Human Errors internal to the pharmacy, which can be impacted by:

Look alike sound alike drugs, similar packaging can result in drug substitution

• Incorrect dosage administered

• Not all tablets given to patient

• Patient not wanting to take

• Patient self-administering

• Electrolyte disturbances

• Decreased Renal function

• Prolonged over or under anticoagulation

PRESCRIBING

TRANSCRIBING

DISPENSING

ADMINISTERING

• Access to drug information

• Computerised Alerts and Decision Support

• Write both brand and generic; where needed write indication

• Do not use trailing zeros (1 mg NOT 1.0 mg) but do use leading zeros (0.1 NOT .1)

• Avoid abbreviations – micrograms NOT mcg or ug units NOT U or IU (this can look like a 0)

• Use of caution stickers if similar medication is kept together

• Keep possibility of dispensing errors in mind

• Clearly explain to patient what the intended medication is for in simple terms

• Periodically review what and when patients are taking

• Clearly check documentation of what is to be administered (highlight AM dose and PM dose in different markers

• Check blister pack slot is empty or use a Pil-Bob to administer

• Tabards to be worn on in-patient ward when carrying out medication round

• Nursing staff not to be disturbed during medication round

MONITORING

• Checklist reminders for high-risk drugs especially in the elderly and those medicines which are weight or creatine level dependent

Appendix

Please refer to: https://improvement.nhs.uk/resources/just-culture-guide/

Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.