NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST. Parenteral Concentrated Potassium and Sodium Policy
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1 NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST Parenteral Concentrated Potassium and Sodium Policy Reference CL/MM/025 Approving Body Senior Management Team Date Approved 17 Implementation Date 17 Version 8 Summary of Changes from Previous Version Cardiac perfusionists are now on the list of staff permitted to order the specific preparation of concentrated potassium that is required in their areas. The Pharmacy CD and Pharmacy theatre technicians are also permitted to order this preparation. Supersedes CL/MM/025 version 7 (March 2016) Consultation Undertaken Medicines Management Committee Date of Completion of Equality Impact Assessment Date of Completion of We Are Here for You Assessment Date of Environmental Impact Assessment (if applicable) Legal and/or Accreditation Implications Target Audience 1 st March st March st March 2017 N/A Review Date June 2020 All staff who prescribe, administer, supply and order parenteral concentrated potassium and sodium Lead Executive Medical Director Author/Lead Manager Medicines Safety Officer Further Guidance/Information James Hooley Acting chair, Medicines Management 1
2 Committee Ext: Sonia Gilmore Medicines Management Committee secretary Ext
3 CONTENTS Paragraph Title Page 1. Introduction 4 2. Executive Summary 4 3. Policy Statement 5 4. Definitions (including Glossary as needed) 5 5. Roles and Responsibilities 6 6. Policy and/or Procedural Requirements 7 7. Training, Implementation and Resources Impact Assessments Monitoring Matrix Relevant Legislation, National Guidance 15 and Associated NUH Documents Appendix 1 Equality Impact Assessment 16 Appendix 2 Environmental Impact Assessment 19 Appendix 3 Here For You Assessment 21 Appendix 4 Certification Of Employee Awareness 23 3
4 1.0 Introduction 1.1 Errors made during the prescribing and administration of concentrated potassium and sodium solutions can cause serious patient harm and may even be fatal. This document outlines the reasons why the storage of these concentrated electrolyte solutions is restricted to certain areas, and what special arrangements are required for prescribing and administration and supply. 2.0 Executive Summary 2.1 In 2002 the National Patient Safety Agency issued a patient safety alert; Potassium Solution risks to patients from errors occurring during intravenous administration (1).The alert aimed to reduce the risk of accidental overdose of intravenous potassium arising from use of potassium chloride concentrate solutions and other strong potassium solutions. It also aimed to ensure that seriously ill patients who urgently require intravenous potassium as part of their treatment continue to receive it promptly. In 2012 the Department of Health issued a list of Never Events. Never Events are serious incidents that are wholly preventable, as guidance or safety recommendations that provide strong systemic protective barriers, are available at a national level and should have been implemented by all healthcare providers. (2) Administration errors with Concentrated Potassium are one of the Never Events. A revised Never Event list was launched by NHS England 1 st April 2015 and the definition changed to Mis-selection of a strong potassium containing solution. Mis-selection is defined as when a patient intravenously receives a strong potassium solution rather than an intended different medication.(2) Concentrated sodium chloride is subject to increased controls at NUH due to the risk of maladministration identified in a previous Serious Incident (3). This policy incorporates the requirements of the legacy NPSA alert, the NHS England Never Events List and the recommendations from 4
5 the serious incident investigation. It is intended to provide NUH staff with a framework for the safe prescribing, supply and administration of concentrated potassium and concentrated sodium solutions. 3.0 Policy Statement 3.1 The Trust supports the safe use of concentrated potassium and concentrated sodium solutions. All staff who prescribe, administer, supply and order concentrated potassium and concentrated sodium solutions must follow the guidance in this document. Only clinical areas approved by MMC may store these concentrated electrolytes. A list of areas authorised to hold concentrated potassium and sodium solutions is available on the intranet with this policy. 4.0 Definitions Concentrated potassium: potassium chloride For a full list of concentrated potassium preparations see MMC website. Concentrated potassium chloride products at NUH include: 15% (1.5g potassium in 10mL)= 20mmol in 10mL Pre-filled syringes potassium 20mmol in 20mL and 50mmol in 50mL Sterile concentrate of cardioplegia mmol in 20mL potassium acid phosphate (potassium dihydrogen phosphate) 13.6%=10mmol in 10mL Exclusions A readymade bag of potassium acid phosphate 9mmol in 250mL sodium chloride 0.9% is available from Pharmacy 5
6 Concentrated sodium chloride Intravenous sodium chloride 30% (50mmol in 10mL) injection. Exclusions ORAL sodium chloride 30% made by Pharmacy which is used widely in paediatrics. See MMC website for list of concentrated potassium and concentrated sodium chloride products available: NUH Authorised stockholding areas for concentrated potassium and sodium solutions 5.0 Roles and Responsibilities 5.1 Committees MMC is responsible for maintaining this policy and an up to date list of areas that are permitted to stock concentrated potassium and sodium solutions. MMC are responsible for approving amendments to ward stock-holding areas The NUH Medicines Safety Group is responsible for overseeing the Trustwide risk assessment on potassium and informing MMC of any revision to the potassium policy to mitigate risks identified. 5.2 Individual Officers Ward and clinical managers are responsible for ensuring that storage of concentrated potassium and sodium solutions are in line with this procedure It is the responsibility of all NUH staff to follow the guidance in this procedure It is the responsibility of Pharmacy to apply Controlled Drug regulations to the ordering, supply and storage of concentrated potassium and sodium. 6
7 6.0 Policy and/or Procedural Requirements 6.1 Authorisation to hold a stock of concentrated potassium or concentrated sodium Potassium chloride concentrated solutions and concentrated sodium solutions will be restricted within the Trust to those areas listed in the document NUH Authorised stockholding areas for concentrated potassium and sodium solutions. Practitioners must refer to the most current version of this document on the MMC website before ordering or supplying these concentrated electrolyte solutions. Concentrated potassium and sodium solutions will not be supplied to a non-stockholding area under any circumstances 6.2 Storage Potassium chloride concentrate solutions should be stored in a separate locked cupboard away from common diluting solutions such as sodium chloride (normal saline) solution.(1) At NUH, concentrated potassium and sodium solutions will be stored in : locked controlled drugs cupboards or designated locked cupboards approved by pharmacy 6.2 Ordering of concentrated potassium and sodium solutions and documentation For concentrated potassium, documentation should follow the pattern for controlled drugs and should record the requisition, supply, receipt and administration of potassium chloride concentrate solution (1). At NUH, the documentation procedure for requisition, supply and receipt of concentrated potassium and sodium solutions must follow the procedure outlined in CLMM012 (Controlled drugs). Supplies of concentrated potassium and sodium solutions must be 7
8 requested through the Main Pharmacy at City and the Pharmacy CD room at QMC using the CD requisition order book. The registered nurse must record the receipt and administration of the concentrated potassium or sodium on a designated page in the ward CD register. Separate designated registers and/or requisition books may be used in high usage areas. In addition, cardiac perfusionists are permitted to order the specific preparation of concentrated potassium that is needed for use in their practice. The Pharmacy CD technicians or Pharmacy theatre technicians may also order this specific preparation. 6.3 Borrowing of concentrated potassium and sodium solutions Potassium chloride concentrate solutions should not be transferred between clinical areas. All supplies should be made directly from the pharmacy department. (1) At NUH, all supplies for potassium chloride concentrate solutions and concentrated sodium solutions must be requested through the Pharmacy department. The transfer of stock between clinical areas is not permitted under any circumstances, even between 2 authorised stockholding areas. Cardiac perfusionists are permitted to transfer to the relevant theatre area under their direct supervision. The concentrated potassium products will remain in the dedicated transfer bags for this purpose until their use, or their return to the CD cupboard. This will mitigate any risk of neat potassium being inadvertently mixed with theatre stock. A local procedure for perfusionists to fill these bags and record administration is held by the Chief Perfusionist. Out of hours, supplies must be obtained through the oncall pharmacist (bleep via switchboard). Once an infusion of a concentrated potassium or sodium solution is running, this must be allowed to finish before transferring the patient to an area which does not stock that concentrated electrolyte. Alternatively the patient should be switched to a standard infusion bag. Refer to NUH guideline for Management of Hypokalaemia. for 8
9 details of standard potassium infusion bags. 6.4 Prescribing of potassium (including standard bags) Refer to NUH guideline for Management of Hypokalaemia. All prescriptions for potassium must specify the dose of potassium in millimoles (mmol). Potassium must NOT be prescribed in grams or percent (%). Potassium additions to infusion bags should be avoided. Whereever possible, potassium must be prescribed in concentrations which are available as commercially prepared ready-to-use diluted products (1). Prescribing of dilute solutions containing potassium or sodium Non-standard fluid infusions requiring addition of concentrated potassium or sodium must only be prescribed for patients being cared for in stockholding areas. Patients that require fluids which can only be made using concentrated potassium or sodium must be transferred to an approved stockholding area where possible. NUH pharmacy does not provide an iv additive service. In extreme circumstances, when a patient s potassium or sodium requirement cannot be met by a standard bag, and the patient cannot be transferred to a stockholding area, the Consultant responsible for the patient should contact the Head of Pharmacy or Assistant Head of Pharmacy (production and manufacturing) (ext QMC campus ext City campus) to discuss whether the pharmacy are able to manufacture an infusion. 6.5 Checking use of concentrated potassium and concentrated sodium solutions in clinical areas A second practitioner should always check for correct product, dosage dilution, mixing and labelling during the preparation of and again prior to intravenous administration of solutions prepared from potassium chloride concentrate and other strong potassium solutions (1). 9
10 Operating Theatres except cardiac theatres A potassium infusion may only be prepared against a written prescription, by two registered practitioners who must have completed the IV competency package. (Refer to Administration of concentrated potassium chloride in theatres excluding cardiac theatres ) Cardiac Theatres A potassium solution may be prepared by a Clinical Perfusionist and must be checked by an anaesthetist. Refer to Local agreement and Clinical Perfusion Medicines Management Protocols for Patients Undergoing Cardiac Surgery, Feb All other stockholding areas All intravenous infusions & dialysis solutions prepared from concentrated potassium, and all intravenous infusions prepared from concentrated sodium must be checked by two registered practitioners. The second practitioner should check both during the preparation and again prior to administration for: correct product calculation dilution mixing labelling All concentrated ready prepared potassium infusions must be checked by two registered practitioners. 6.6 Administration of concentrated potassium and sodium Administration must follow the NUH Medicines Policy on Administration of Medicines CLMM008 Refer to NUH guideline for Management of Hypokalaemia Or Local guidelines in Stockholding Areas.Some areas may also have 10
11 a local agreement in place which may be used in addition to this policy. 7.0 Training and Implementation 7.1 Training The risks associated with the storage, prescribing, preparation and administration of concentrated potassium and sodium solutions must be highlighted in the induction training of nurses, doctors, pharmacists and other health professionals (1). Line managers must identify any other staff involved in the medication process who must receive training in the risks associated with concentrated potassium sodium. 7.2 Implementation Implementation will be carried out through pharmacist review of prescription charts, Pharmacy control of stock lists, and education of relevant staff at induction. 7.3 Resources None additional required 8.0 Trust Impact Assessments 8.1 Equality Impact Assessment An equality impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.2 Environmental Impact Assessment An environmental impact assessment has been undertaken on this draft and has not indicated that any additional considerations are 11
12 necessary. 8.3 Here For You Assessment A Here For You assessment has been undertaken on this document and has not indicated that any additional considerations are necessary. 12
13 9.0 Policy / Procedure Monitoring Matrix Minimum requirement to be monitored Responsible individual/ group/ committee Process for monitoring e.g. audit Frequency of monitoring Responsible individual/ group/ committee for review of results Responsible individual/ group/ committee for development of action plan Responsible individual/ group/ committee for monitoring of action plan Undertake CD audit Rolling Pharmacy CD audit Audit of storage of concentrated potassium Review of concentrated potassium incidents and update of Trustwide Ward nursing staff Pharmacy staff Ward nursing staff Medicines Safety Pharmacist Audit Annually MMC Divisional Governance group Audit Audit Incident review Rolling programme, all areas covered in 18month Annually as a question in the Trustwide medicines audit MMC MMC Divisional Governance group Divisional Governance group Annually MSG MSG MSG Divisional Governance group Divisional Governance group Divisional Governance group 13
14 potassium risk assessment Review local potassium risk assessments for stockholding areas Governance leads for specialties with stockholding of concentrated potassium Incident review Annually Divisional Governance group Divisional Governance group Divisional Governance group 14
15 10.0 Relevant Legislation, National Guidance and Associated NUH Documents Legislation: N/A 2. National Guidance: NPSA alert 2002, further revised November 2003 (Potassium solutions: risks to patients from errors occurring during intravenous administration) NHS England Revised Never Events Policy and Framework, March 2015 WHO High 5s initiative 3. Associated NUH Documents: NUH Guideline for the treatment of Hypokalaemia in adults. NUH Guideline for the treatment of Hypophosphataemia in adults. Administration of concentrated potassium chloride in the Operating Theatres (excluding cardiac theatres) (2013). Local agreement and Clinical Perfusion Medicines Management Protocols for Patients Undergoing Cardiac Surgery, March 2016 NUH authorised stockholding areas for concentrated potassium and sodium solutions. Nottinghamshire Joint Formulary 11 References 1. NPSA alert Potassium Solution risks to patients from errors occurring during intravenous administration 2. NHS England Revised Never Events Policy and Framework, March Monitoring plasma sodium levels in babies NPSA Signal, March
16 Insert templates of relevant impact assessments (page break after each) APPENDIX 1 Equality Impact Assessment (EQIA) Form (Please complete all sections) Q1. Date of Assessment: 2 nd February 2016 Q2. For the policy and its implementation answer the questions a c below against each characteristic (if relevant consider breaking the policy or implementation down into areas) Protected Characteristic a) Using data and supporting information, what issues, needs or barriers could the protected characteristic groups experience? i.e. are there any known health inequality or access issues to consider? The area of policy or its implementation being assessed: b) What is already in place in the policy or its implementation to address any inequalities or barriers to access including under representation at clinics, screening Race and None N/A N/A Ethnicity Gender None N/A N/A Age None N/A N/A Religion None N/A N/A Disability None N/A N/A c) Please state any barriers that still need to be addressed and any proposed actions to eliminate inequality Sexuality None N/A N/A 16
17 Pregnancy and None N/A N/A Maternity Gender None N/A N/A Reassignment Marriage and None N/A N/A Civil Partnership Socio-Economic None N/A N/A Factors (i.e. living in a poorer neighbour hood / social deprivation) Area of service/strategy/function Q3. What consultation with protected characteristic groups inc. patient groups have you carried out? None Q4. What data or information did you use in support of this EQIA? None Q.5 As far as you are aware are there any Human Rights issues be taken into account such as arising from surveys, questionnaires, comments, concerns, complaints or compliments? None Q.6 What future actions needed to be undertaken to meet the needs and overcome barriers of the groups identified or to create confidence that the policy and its implementation is not discriminating against any groups What By Whom By When Resources required 17
18 None N/A N/A N/A Q7. Review date March
19 Environmental Impact Assessment Appendix 2 The purpose of an environmental impact assessment is to identify the environmental impact of policies, assess the significance of the consequences and, if required, reduce and mitigate the effect by either, a) amend the policy b) implement mitigating actions. Area of impact Environmental Risk/Impacts to consider Action Taken (where necessary) Waste and materials Soil/Land Water Air Is the policy encouraging using more materials/supplies? Is the policy likely to increase the waste produced? Does the policy fail to utilise opportunities for introduction/replacement of materials that can be recycled? Is the policy likely to promote the use of substances dangerous to the land if released (e.g. lubricants, liquid chemicals) Does the policy fail to consider the need to provide adequate containment for these substances? (e.g. bunded containers, etc.) Is the policy likely to result in an increase of water usage? (estimate quantities) Is the policy likely to result in water being polluted? (e.g. dangerous chemicals being introduced in the water) Does the policy fail to include a mitigating procedure? (e.g. modify procedure to prevent water from being polluted; polluted water containment for adequate disposal) Is the policy likely to result in the introduction of procedures and equipment with resulting emissions to air? (e.g. use of a furnaces; combustion of fuels, emission or particles to the No no No No No No No no No 19
20 Energy Nuisances atmosphere, etc.) Does the policy fail to include a procedure to mitigate the effects? Does the policy fail to require compliance with the limits of emission imposed by the relevant regulations? Does the policy result in an increase in energy consumption levels in the Trust? (estimate quantities) Would the policy result in the creation of nuisances such as noise or odour (for staff, patients, visitors, neighbours and other relevant stakeholders)? n/a n/a No no 20
21 We Are Here For You Policy and Trust-wide Procedure Compliance Toolkit- appendix 3 The We Are Here For You service standards have been developed together with more than 1,000 staff and patients. They can help us to be more consistent in what we do and say to help people to feel cared for, safe and confident in their treatment. The standards apply to how we behave not only with patients and visitors, but with all of our colleagues too. They apply to all of us, every day, in everything that we do. Therefore, their inclusion in Policies and Trust-wide Procedures is essential to embed them in our organization. Please rate each value from 1 3 (1 being not at all, 2 being affected and 3 being very affected) Value Score (1-3) 1. Polite and Respectful 1 Whatever our role we are polite, welcoming and positive in the face of adversity, and are always respectful of people s individuality, privacy and dignity. 2. Communicate and Listen 1 We take the time to listen, asking open questions, to hear what people say; and keep people informed of what s happening; providing smooth handovers. 3. Helpful and Kind 1 All of us keep our eyes open for (and don t avoid ) people who need help; we take ownership of delivering the help and can be relied on. 4. Vigilant (patients are safe) 3 Every one of us is vigilant across all aspects of safety, practices hand hygiene & demonstrates attention to detail for a clean and tidy environment everywhere. 5. On Stage (patients feel safe) 1 21
22 We imagine anywhere that patients could see or hear us as a stage. Whenever we are on stage we look and behave professionally, acting as an ambassador for the Trust, so patients, families and carers feel safe, and are never unduly worried. 6. Speak Up (patients stay safe) 1 We are confident to speak up if colleagues don t meet these standards, we are appreciative when they do, and are open to positive challenge by colleagues 7. Informative 1 We involve people as partners in their own care, helping them to be clear about their condition, choices, care plan and how they might feel. We answer their questions without jargon. We do the same when delivering services to colleagues. 8. Timely 1 We appreciate that other people s time is valuable, and offer a responsive service, to keep waiting to a minimum, with convenient appointments, helping patients get better quicker and spend only appropriate time in hospital. 9. Compassionate 1 We understand the important role that patients and family s feelings play in helping them feel better. We are considerate of patients pain, and compassionate, gentle and reassuring with patients and colleagues. 10. Accountable 1 Take responsibility for our own actions and results 11. Best Use of Time and Resources 1 Simplify processes and eliminate waste, while improving quality 12. Improve 1 Our best gets better. Working in teams to innovate and to solve patient frustrations TOTAL 13 22
23 APPENDIX 4 CERTIFICATION OF EMPLOYEE AWARENESS Document Title Parenteral Concentrated Potassium and Sodium Policy Version (number) 8 Version (date) 17 I hereby certify that I have: Identified (by reference to the document control sheet of the above policy/ procedure) the staff groups within my area of responsibility to whom this policy / procedure applies. Made arrangements to ensure that such members of staff have the opportunity to be aware of the existence of this document and have the means to access, read and understand it. Signature Print name Date Division/ Directorate The manager completing this certification should retain it for audit and/or other purposes for a period of six years (even if subsequent versions of the document are implemented). The suggested level of certification is; Clinical Divisions Divisional General Manager or nominated deputies Corporate Directorates - Deputy Director or equivalent. The manager may, at their discretion, also require that subordinate levels of their directorate / department utilize this form in a similar way, but this would always be an additional (not replacement) action. 23
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