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POLICY FOR THE SAFE MANAGEMENT OF INJECTABLE MEDICINES (ADULTS AND CHILDREN) Version 3 Name of responsible (ratifying) committee Formulary and Medicines Committee Date ratified Chair of Formulary and Medicines Committee Document Manager (job title) Director of Pharmacy Date issued 12th June 2014 Review date 11th June 2016 Electronic location Corporate Policies Related Procedural Documents Medicines Management Policy Key Words (to aid with searching) Medicines; Prescribing; Administration; Dispensing; Injection; injectable Drugs; Intravenous; Intramuscular; Subcutaneous; Prescriptions; Pharmacy; Label; Preparation; Patients; Children; Young People; Adults. Version Tracking Version Date Ratified 1 ?? 2 26.09.2011 Brief Summary of Changes New author, incorporation of NPSA recommendations in to Policy Author HM Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 1 of 32 3 : Policy reviewed by Author- Student nursing and student midwife duties and responsibilities and Training sections were updated based on changes in legislation. A reference to the UCL guide as a source of information to determine which infusion pumps should be used for various drugs was included Removal of section on Midwife administration of epidural top ups. HM Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 2 of 32 CONTENTS 1. 2. 3. 4. 5. 6. 7. 8. 9. QUICK REFERENCE GUIDE....................................................................................................... 4 INTRODUCTION.......................................................................................................................... 5 PURPOSE ................................................................................................................................... 5 SCOPE ........................................................................................................................................ 6 DEFINITIONS .............................................................................................................................. 6 DUTIES AND RESPONSIBILITIES .............................................................................................. 9 PROCESS ................................................................................................................................. 14 TRAINING REQUIREMENTS .................................................................................................... 15 REFERENCES AND ASSOCIATED DOCUMENTATION .......................................................... 17 MONITORING COMPLIANCE WITH, AND THE EFFECTIVENESS OF, PROCEDURAL DOCUMENTS ............................................................................................................................ 17 Appendices: 1. Trust Standard Operating Procedure for Prescribing, Preparing and Administration of Injectable Medicines in Clinical Areas…………………………………………………………… 16 2. Prevention of Over Infusion of Intravenous Fluids and Medicines in Neonates……………….26 Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 3 of 32 QUICK REFERENCE GUIDE For quick reference the guide below is a summary of actions required. This does not negate the need for the document author and others involved in the process to be aware of and follow the detail of this policy. This policy applies to all healthcare workers who prescribe, handle, supply or administer intravenous medicines in the course of their duties. This includes, but is not exclusive to, doctors, dentists, pharmacists, nurses, midwives, operating department practitioners, radiographers, podiatrists, dental nurses, nursery nurses, dialysis assistants, pharmacy technicians/assistant technical officers, healthcare support workers, and delivery drivers including taxi drivers delivering medicines. The policy covers professional accountability of groups of workers, and the following processes regarding intravenous medicines: Risk assessment Prescribing Preparation Administration Resources required for the safe prescribing, preparation and administration of injectable medicines Procurement Training Exemptions to medicines legislation in the event of a pandemic Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 4 of 32 1. INTRODUCTION The use of injectable medication has many health care benefits for patients of all ages. The complexities associated with prescribing, preparing and administering injectable medicines means that there are greater potential risks for patients than for other routes of administration. The risks associated with injectable medicines include: Incomplete and/or ambiguous prescriptions which do not include important information. Presentations of injectable medicines that may require complex calculation, dilution and handling procedures before the medicine can be administered. Lack of information about injectable medicines available to health care professionals at the point of use. Selection of the wrong medicine or diluent. Use of a medicine, diluent or infusion after its expiry time and date. Calculation errors made during prescription, preparation, administration of the medicine, leading to administration of the wrong dose and/or at the wrong concentration or rate. Unsafe handling or poor aseptic technique leading to contamination of the injection and harm to, or infection of the patient. Incompatibility between the diluent, infusion, other medicines and administration devices. Failure to follow patient identification procedures leading to administration to the wrong patient. Failure to follow administration checking procedures leading to administration via the wrong route. Health and safety risks to the operator or environment. Variable levels of knowledge, training and competence amongst health care practitioners. Incorrect programming of infusion pumps. The National Patient Safety Alert 20 “Promoting safer use of injectable medicines,” made six key recommendations for action to identify and minimise risks associated with the administration of injectable medicines. 1) Undertake a risk assessment of injectable medicines procedure and products in all clinical areas to identify high risks, and develop an action plan to minimise them 2) Ensure there are up to date protocols and procedures for prescribing, preparing and administering injectable medicines in all clinical areas. 3) Ensure essential technical information on injectable medicines is available and accessible to healthcare staff in clinical areas at the point of use. 4) Implement a ‘purchasing for safety’ policy to promote procurement of injectable medicines with inherent safety features. 5) Provide training for, and supervision of, all healthcare staff involved in prescribing, administering and monitoring injectable medicines. 6) As part of the annual medicines management audit programme, healthcare organisations should include an audit of medication practice with injectable medicines. This policy documents actions to be undertaken within Portsmouth Hospitals NHS Trust 2. PURPOSE Ensure compliance with National Patient Safety Agency (NPSA) Patient Safety Alert 20 Promoting Safer Use of Injectable Medicines. To minimise risks associated with the management and administration of injectable medicines. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 5 of 32 3. SCOPE This policy covers the risk assessment, prescribing, preparation, administration of all injectable medicines to all patients requiring medication via an injectable route. Injectable routes not covered within this policy are: Intrathecal (see PHT Trust Policy for Intrathecal Chemotherapy in Adults – Oncology and Haematology Departments) Epidural (see PHT Trust Policy for Continuous Epidural Infusions) Other routes such as intra-arterial, intraventricular, intravitreal, intrapleural and intraocular The Royal Marsden Manual should be used as the default reference, and other specialist competences and techniques are also used in specific clinical areas. The principles and basic preparation procedures covered in this policy will generally apply. It also outlines the required: resources for safe prescribing, preparation and administration of injectable medicines, procurement training. All staff within Portsmouth Hospitals with responsibility for the procurement, supply, prescription, preparation, administration and monitoring of injectable medicines are required to read and apply the recommendations set out below and to ensure that the policy document is continually available for reference. ‘In the event of an infection outbreak, flu pandemic or major incident, the Trust recognises that it may not be possible to adhere to all aspects of this document. In such circumstances, staff should take advice from their manager and all possible action must be taken to maintain ongoing patient and staff safety’ 4. DEFINITIONS Administer To give to a patient a medicinal product, dressing or medical device, either by introduction into the body, either orally or by injection, etc., or by external application (e.g. application of an ointment or dressing). ADR Adverse Drug Reaction ATO Pharmacy assistant technical officer BNF The British National Formulary (latest edition). CD Controlled drug CIVAS Centralised Intravenous Additives Services Clinician A health care professional who is engaged in the direct examination, diagnosis, treatment and care of patients. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 6 of 32 Clinical Support Worker A clinical support worker is not registered with a professional body. They may be registered within the Trust. For the purposes of this policy these include: Healthcare Support Workers (HCSW) Pharmacy Assistant Technical Officers (ATOs) Nursery Nurses Dental Nurses Clinical/ Medical Technicians Radiographic Department Assistant Assistant Practitioners Dispense To prepare and/or supply a clinically appropriate medicinal product to a patient for self administration or for administration by another, usually a healthcare professional. Dispensing must be in response to a legally valid prescription. The act of dispensing should be accompanied with the provision of advice to the patient on safe and effective use of these products. FMG Formulary and Medicines Group GMC General Medical Council HCSW Healthcare Support Workers HPC Health Professions Council Healthcare Professional A registered practitioner in an occupation which requires specialist education and training in practical skills in health care. The professions concerned are self-regulating and practitioners are expected to satisfy their profession’s accepted standards of practice and conduct. For the purposes of this policy, these practitioners are accepted to include: • Registered nurses or midwives • Doctors (medical practitioners) • Dentists • Dietitians • Pharmacists • Radiographers • Registered Pharmacy Technicians • Registered Operating Department Practitioners • Podiatrists Injectable medicine An injectable medicine may be given by one of the following methods: Intramuscular injection Direct subcutaneous injection Subcutaneous infusion Intradermal injection Intravenously by o Direct injection (bolus) into a vein o Direct injection into infusion line tubing (bolus) o Intravenous infusion – either continuous or intermittent Other injectable routes covered by the NPSA Patient Safety Alert 20, but not covered within this policy are: Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 7 of 32 Intrathecal (see Trust Policy for Intrathecal Chemotherapy in Adults – Oncology and Haematology Departments) Epidural (see Trust Policy for Continuous Epidural Infusions) Other routes such as intra-arterial, intraventricular, intravitreal, intrapleural and intraocular - The Royal Marsden Manual should be used as the default reference, and other specialist competences and techniques are also used in specific clinical areas. The principles and basic preparation procedures covered in this policy will generally apply. Medication error Any preventable event that may cause or lead to inappropriate medication use and/or patient harm while the medication is in the control of the healthcare professional, patient or carer. Medicinal product Any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways: (a) use by being administered to one or more human beings for a medicinal purpose (b) use as an ingredient in the preparation of a substance or article which is to be administered to one or more human beings for a medicinal purpose Multi-disciplinary Health Record Also known as Patient’s Notes, Medical Notes, Casenotes NMC Nursing and Midwifery Council (UK). NHS National Health Service (UK) NHSP NHS Professionals. This is the public sector locum agency for NHS professional staffs. Each individual practitioner’s professional credentials are vetted by NHSP before admission to the scheme. It is the only such agency that NHS organizations are allowed to use. NPSA National Patient Safety Agency (a Special Health Authority of the DoH) This role has now transferred to the NHS Commissioning Board Special Health Authority PGD Patient Group Direction PHT Portsmouth Hospitals NHS Trust Prescribe To order in writing (or electronically) the supply of a medicinal product (within the meaning of the Medicines Act, 1968, this means a POM) for a named patient (see “Prescription”). Prescriber A healthcare professional that is legally authorised to prescribe a medicinal product, including medical and non-medical prescribers. Prescription An order for the dispensing of a medicinal product. The order is presented to a professional who is legally authorised to dispense. The order must be either: a) in writing in a legally prescribed format and signed by the person authorised by law to prescribe Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 8 of 32 b) made, using a Trust-agreed electronic prescribing system, by the person authorised in law to prescribe medicinal substances, and who has been provided with a secure, individual computer access password. Prescription Record Chart Authorised Drug chart for recording inpatient prescriptions and administration. There are also “Long Stay” and Mental Health Unit versions. QAH The Queen Alexandra Hospital, Cosham, Portsmouth rINN Recognised International Name – European Law requires the use of the rINN for medicinal substances except for adrenaline and noradrenaline which remain the British approved names. SCIP South Central Injectables Practice Group SOPs Standard Operating Procedures Treatment The management and care (including medicines and procedures) of a patient to prevent or cure disease or to ameliorate suffering and disability. TTO To Take Out Medication (Medication the patient is discharged on) UCL Guide Injectable Medicines Administration Guide – book on injectable drug administration 5. DUTIES AND RESPONSIBILITIES The Director Medicines Management and Pharmacy is responsible for the preparation, implementation and audit of this policy. All staff must comply with their responsibilities when undertaking their duties involving injectable medicines both at ward/department level and within pharmacy. 5.1. Nurses 5.1.1. Registered Nurses Each registered nurse is accountable for her/his own conduct and practice in accordance with the NMC Code of conduct, performance and ethics for nurses and midwives and in exercising professional accountability will: Always act in a manner as to promote and safeguard the interests and well being of patients and clients Ensure that no action or omission on their part, or within their sphere of responsibility, is detrimental to the interests, condition or safety of patients and clients. Maintain, update and improve their professional knowledge and competence Acknowledge any limitations in their knowledge and competence and decline any duties or responsibilities unless able to perform them in a safe manner. Report to a senior person or authority any circumstance in which a safe and acceptable care for patients and clients cannot be provided. Avoid any improper delegation to others, which compromises the interests, wellbeing or safety of patients and clients. 5.1.2. Ward/Department Managers Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 9 of 32 Ward/Department managers are responsible for ensuring that their staff meet required competencies for the administration of medicines. It is every manager’s responsibility to ensure that all their staff are informed as to which members of the team are competent to accept delegation of duties. First level nurses will have established basic competencies in pre-registration education and competency will be maintained. If evidence cannot be produced, then further training should be undertaken. Ward department managers in conjunction with their ward pharmacist are also responsible for ensuring a risk assessment for injectable medicines is carried out annually for their area (See Standard Operating Procedure – Risk assessment Process for Injectable Medicines and Associated Practice in Clinical Areas 5.1.3. NHS Professionals (NHSP) Nurses Nurses working for NHS Professionals (NHSP) should adhere to the required standards for the administration of medicines. They should acknowledge any limitations in their knowledge and competencies, and decline any duties or tasks, unless able to perform them in a safe and skilled manner. The nurse in charge of a ward/department where NHSP nurses are deployed, should ensure that NHSP staff receive adequate orientation in relation to local practices regarding the administration of medicines. Medication Administration by Agency Nurses Buying Solutions is the current national framework agreed to supply agency staffing where liability is covered. 1. IV medications are to be given only by staff who have completed the PHT IV competencies to the required level. 2. Chemotherapy is only given by staff who have completed the appropriate chemotherapy administration competencies to the required level, as per PHT Policy for Prescribing, Handling and Administration of Cytotoxic Drugs 3. Multipost holders who are PHT competent may administer according to their competency training. 3. Agency Nurses supplied under the Buying Solutions agency framework: may administer medications except medications given by the IV route. 5. Nurses from agencies outside of the Buying Solutions agency framework are not to give any medications on PHT wards / departments. In any situations where this is thought not to be workable, a full risk assessment must be carried out and approved by the Director of Nursing. 5.1.4. Student Nurses (other than Student Midwives) During each practice placement the mentor should assess the student’s proficiency in the administration of medicines in accordance with the expectations stated in their Assessment of Practice portfolio. Students must never administer or supply medication without direct continuous supervision. Student nurses may observe the administration of medicines and assist in the administration of medicines by the following routes under the direct and constant supervision of a qualified nurse, midwife or medical practitioner. NB. This does not apply to student nurses on Critical Care who cannot prepare or administer any medications. oral/ buccal/sublingual Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 10 of 32 topical medicines (including eye /ear drops) inhaled / nebulised medicines subcutaneous (not via infusions) intramuscular rectal /vaginal Students may not participate in the administration of medicines by the following routes: peripheral lines central line epidural intravenous line (see below for IV fluids) medication given by any other route that requires a clinician to undertake further education and training (e.g. intrathecal). Final year students or at an equivalent stage (e.g. stage 3 of the Open University 4 year part time course) can, under the direct and continuous supervision by a competent registered practitioner assist in the preparation of (but not administration of) intravenous medicines. Administration of IV/SC fluid infusions by student nurses. Student nurses may not participate in the initiation or alteration of administration by the above routes which involves infusion, mechanical pumps or a patient controlled device. As an exception, students may administer prescribed pre-prepared standard IV bags of 0.9% sodium chloride or 5% glucose via an existing intravenous or subcutaneous line. This activity must be carried out only under the direct and continuous supervision of a qualified nurse, midwife or medical practitioner. This is the only situation where the student can participate in the administration of intravenous or subcutaneous fluid. 5.2. Midwives Midwives should adhere to the Nursing and Midwifery Council Code of Conduct Midwife Exemptions Midwives working within the Maternity Unit may give, without prior prescription, medicines listed on the Midwives Exemptions in the course of their professional practice or by an approved Patient Group Direction. See PHT Midwives’s Exemption Policy. 5.2.1. Student Midwives Administration Under Direct and Constant Supervision In PHT student midwives can be permitted to administer medication on the midwives exemption list, (except controlled drugs, epidurals and intravenous medication) only under the direct and continuous supervision of a registered midwife. Direct supervision means that the student must be witnessed both visually and audibly, when administering the medicine, by a registered midwife. Where this is done both the student and registrant must sign the patient’s medication chart or document in the notes. The registrant is responsible for delegating to a student, and where it is considered the student is not yet ready to undertake administration in whatever form, this should be delayed until such time that the student is ready. Equally a student may decline to undertake a task if they do not feel confident enough to do so. The relationship between the registrant and the student is a partnership and the registrant should support the student in gaining competence in order to prepare for registration. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 11 of 32 Under the DIRECT and CONSTANT SUPERVISION of a registered midwife student midwives can be permitted to: administer medicines on the Midwife Exemption List, except any intravenous drugs, epidurals or controlled drugs. administer medication prescribed on a valid prescription except any intravenous drugs or epidurals. check intravenous fluids against a valid prescription check prescribed additives, working with registered healthcare professionals against a valid prescription Discontinue IV infusions/ decannulate Student midwives MAY NOT: Carry out any medication administration tasks listed above unless they are under the direct and continuous supervision of a registered midwife. Give medicines via the epidural route Administer boluses or infusions of any intravenous drugs Administer any controlled drugs on the midwives exemption list 5.3 Occupational Health Nurses Under Occupational Health Schemes, Occupational Health Nurses can supply and administer certain medicines to patients/clients. 5.4. Registered Operating Department Practitioners (RODPs) RODPs will be registered with the Health Professions Council. RODPs should follow the agreed PHT policies and procedures when dealing with medicines For detailed guidance on CD’s and RODP’s refer to the PHT Controlled Drugs Policy and Theatre CD SOP 5.5. Radiographers Radiographers are allowed to administer medicines such as contrast media to patients, in accordance with a doctor’s or dentist’s prescription, or in accordance with an authorised PGD on which they are named. 5.6. Clinical Support Staff A HCSW, Nursery Nurse, Dental Nurse, Radiographic department assistant, Medical or Clinical Technician or Assistant Practitioner who has undertaken suitable training for specific tasks and has had their competency assessed and recorded, may assist in the administration of medicines in specific areas, with proper delegation being the responsibility of the registered nurse, midwife, radiographer or RODP. Whilst their competency is being assessed, candidates should be under the supervision of the registered nurse, midwife, radiographer or RODP. 5.7. Doctors Each doctor is responsible for prescribing and administering medications correctly in accordance with this policy. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 12 of 32 When a doctor is not confident of his/her own competence to prescribe or administer a particular medicinal product, he/she should not continue until he/she has sufficient working knowledge of it Doctors are responsible for: Adhering to the Portsmouth District Prescribing Formulary Ensuring the safe and clinically appropriate use of medicines Using up-to-date information and guidance on all pharmaceutical aspects of drug therapy Discussing the aims and side effects of drug treatment with the patient or their representative, if possible. Conforming to legal requirements Ensure the medicines given are appropriate and patient-centred by taking account of their: age, choices, lifestyle, cultural and religious beliefs, allergies and intolerances, existing medical conditions and prescriptions, adverse drug reactions and recommended prescribing regimens. Documenting patients’ allergy status in patient notes and on patients drug charts including the type of reaction and source of information. Documenting the treatment plan, including how the response to drug therapy is to be monitored, clearly in the patient’s clinical notes. Checking the patient’s medical record before a new prescription is written Ensure the prescription is up to date and is reviewed and changed as the patient’s needs or conditions change. 5.8. Dentists Each dentist is responsible for prescribing and administering medications correctly in accordance with this policy. Oral and maxillofacial consultants and registrars are on the GMC register, and therefore they practice as any other doctor would (rather than as a dentist) Junior dental staff who are only dentally qualified, whilst working in the hospital setting can prescribe from the Dental Practitioners’ Formulary in the current BNF (www.bnf.org) When a dentist is not confident of his/her own competence to prescribe a particular medicinal product, he/she must not prescribe it until he/she has sufficient working knowledge of it. 5.9. Pharmacists Each registered pharmacist is accountable for his/her own conduct and practice in accordance with the Royal Pharmaceutical Society of Great Britain’s Code of Ethics. Pharmacists are responsible for: Ensuring the safe, clinically appropriate and cost effective use of pharmaceutical products through involvement at all stages of medicines usage and management (including prescribing) Providing up-to-date information and guidance to other healthcare professionals on all pharmaceutical aspects of drug therapy, pharmaceutical care and medicines management. Conforming to legal requirements Advising on the individualization of patient therapy Advising on patient monitoring of drug effects and side effects Education and counseling patients, carers and hospital staff on the safe and correct use of medicinal products Acting within the current PHT Pharmacists’ Enabling Protocol Advising on drug-drug and drug-fluid interactions and compatibilities in parenterals Advising on the pharmaceutical requirements and proper undertaking of clinical trials Ensuring annual risk assessment of injectable medicines is carried out for their area. The South Central Injectable Practice (SCIP) lead will be responsible for implementing SCIP action points where appropriate. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 13 of 32 5.10. Committees 5.10.1. Trust Board The Trust Board will receive an annual report/action plan from the Director for Medicines Management and Pharmacy on all matters of medicines management including the use of injectables. 5.10.2. Patient Safety Steering Group Will receive an annual report from the Director for Medicines Management and Pharmacy on all matters of medicines safety including injectables and the appropriate risk control measures to eliminate or reduce identified risks. 5.10.3. Formulary and Medicines Group The Formulary and Medicines Group has responsibility for receiving the results of the annual medicines management audit, sharing it with the divisional/clinical service centre governance leads and requesting further actions where gaps have been identified. 5.10.4. Divisional/Clinical Service Centre Governance Leads Responsible for leading on the actions requested by the Formulary and Medicines Group where gaps have been identified following the annual medicines management audit. 5.1.1. Medication Safety Committee Responsible for: Reviewing medication errors Monitoring the national patient safety agenda (e.g. NPSA Alerts) identifying themes to implement changes in practice to reduce risk of medication errors Reviewing the results of the annual medicines management audit, sharing it with the divisional/clinical service centre governance leads and requesting further actions where gaps have been identified Reviewing and assessing compliance with Outcome 9 of CQC standards. 6. PROCESS 6.1 Risk Assessment The PHT Pharmacy Standard Operating Procedure - Risk Assessment Process for Injectable Medicines and Associated Practice in Clinical Areas (PHPSWI 09:002) should be carried out annually for each department by the directorate pharmacist and the manager or senior nurse of the clinical area. The results of the risk assessment should be given to the Medication Safety Pharmacy Technician. 6.2 Standard Operating Procedure for Prescribing, Preparing and Administering Injectable Medicines in Clinical Areas Injectable medicines must be prescribed, prepared and administered according to the Standard Operating Procedure for Prescribing, Preparing and Administering Injectable Medicines in Clinical Areas (see Appendix 1) to minimize associated risks. 6.3 Technical information on administration of medicines The following technical information is available in clinical areas: o UCL Guide to Administration of Injectable Medicines, o BNF (and BNFc in paediatric departments) o Summary of Product characteristics supplied with the product or available on the internet on http://www.medicines.org.uk/emc/ and Trust intranet. o Neonatal Formulary through the pharmacy home page via the medicines information link. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 14 of 32 o Further information is available through medicines information (ext. 7700 6632 bleep 1468). o Standard operating procedures for high risk drugs o Basiliximab Preparation and Administration Guideline o Ciclosporin Preparation and Administration Guideline o Ganciclovir Preparation and Administration Guideline o Mycophenolate Preparation and Administration Guideline o Tacrolimus Preparation and Administration Guidline Further guidance, e.g. concerning the mixing of drugs in subcutaneous syringe drivers is being made available to the Rowans Hospice, F1, F6/F5/F7 and is available through the Pharmacy Medicines Information Department (ext 7700 6632 bleep 1468). 6.4 Purchasing for Safety Policy Wherever possible and in line with the NHS Purchasing and Supply Agency (PASA) and South Central Guidance the pharmacy service will follow the PHT Trust Medicines Purchasing for Safety Policy to promote the purchase of injectable medicines with inherent safety features. See: National Patient Safety Agency “Design for patient safety – a guide to the design of dispensed medicines” (1st Ed 2007). 7. TRAINING REQUIREMENTS Medication safety should be covered comprehensively in induction programmes for all new NHS clinical staff (including medical, registered nurses, pharmacy, theatre and any other staff who handle medicines), and regularly updated through further training and continuing professional development programmes. In accordance with the essential training matrix, all clinical staff are required to undertake an annual update of medicines management. 7.1 Prescribing of Injectable Therapy Medical and dental practitioners cover this requirement during their undergraduate training. Non-medical prescribers should complete the Non-Medical Prescribing course and its associated competencies. 7.2 Preparation and Administration of Injectable Therapy. Nurses, Midwives and other healthcare professionals must have demonstrated their competence to a minimum of level 2 of the Administration of Medication (excluding intravenous, intrathecal and epidural routes) competency and are required to complete the PHT process for Achieving Competency in IV Drug Administration prior to undertaking the administration of intravenous therapy. The administration of intravenous medicines and infusions and their maintenance should be undertaken only by healthcare professionals who have undergone the Trust IV study day which includes the PHT Administration of IV Medication Training Pack. They must also have completed the PHT IV drug calculation e-learning pack on ESR/ learning zone or moodle. In addition, they must have completed the Intravenous Drug Administration – Adults/Child/Neonate competency. Note: new staff who are employed by PHT from other healthcare organizations are not required to attend the IV study day if they can provide evidence of post registration IV competency training before employment by PHT and their proficiency can be demonstrated by assessment in practice. Departments may have their own additional competency and training packages that are required to be completed before injectable medications can be administered. For example on the Department of Critical Care the following additional training must be completed: o Attend a drug lecture provided by the unit Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 15 of 32 o Complete a drug calculations paper (provided by the unit) o Complete the Critical Care Units IV competency package. Staff administering injectables to children and young people must also have completed the PHT on-line paediatric medication calculations assessment. The above information is summarized in the table below: Staff group Competency/ Course required Administration of S/C or IM injections All nurses and midwives PHT Level 2 Administration of Medication (excluding intravenous, intrathecal, epidural routes) competency Administration of IV medications All nurses and midwives NHSP Nurses and Midwives 1. PHT Level 2 Administration of Medication (excluding intravenous, intrathecal, epidural routes) competency 2. PHT IV Drug Calculation Online Assessment (on ESR/ learningzone or moodle) 3. PHT Intravenous Drug Administration Competency Adults/ Child/ Neonate Assessment 4. PHT IV study day (including PHT Administration of IV Medication Training Pack) NB. attendance on the IV study day is not required if staff can provide evidence of post registration IV competency training before employment with PHT and their proficiency can be demonstrated by assessment in practice Multipost holders who are PHT competent may administer according to their competency training. Agency nurses supplied by Buying Solutions Framework Not to give IVs in PHT Agency nurses supplied not covered by Buying Solutions Paediatric nurses Not to give any medication by any route All nurses on DCCQ Department Critical Care Competency Training Critical Care drug lecture Complete drug calculations test IV competency package Nursing staff required to give Chemotherapy Completed PHT chemotherapy administration competency PHT paediatric medications calculations assessment Final year students or at an equivalent stage (e.g. Stage 3 of the Open University 4 year part time course) can, under the direct and continuous supervision by a competent registered practitioner assist in the preparation of (but not administration of) intravenous medicines. Medical and dental practitioners cover this requirement during their undergraduate training. 7.2 Administration of Cytotoxic Chemotherapy Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 16 of 32 The administration of chemotherapy by the intrathecal route can be undertaken only by medical practitioners who have undergone the PHT training, and are certified as competent. See PHT Policy for the Prescribing, Handling and Administration of Cytotoxic Drugs. 7.3 Administration of Epidural Therapy of Epidural Top-ups All healthcare professionals who administer epidural analgesia in post-operative situations or epidural top-ups are required to complete the appropriate PHT competency training. Only anaesthetists are permitted to initiate epidural therapy. 7.4 Continuing Professional Development All healthcare staff involved with medicines should undertake continuing professional development, which is aligned to clinical governance requirements and professional guidance, to ensure that their knowledge is up to date. 8. REFERENCES AND ASSOCIATED DOCUMENTATION Promoting Safer use of Injectable Medicines, Patient Safety Alert 20: NPSA, March 2007. www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=59812&p=2 PHT Medicines Management Policy PHT Controlled Drugs Policy PHT Trust Policy for the Provision and Management of Parenteral Nutrition in Adults in Hospital PHT Trust Hand Hygiene Policy PHT Trust Policy for Intrathecal chemotherapy in Adults – Oncology and Haematology Departments PHT Policy for the Management of Infusions with Pumps PHT Central Venous Catheters: Care and Management Policy PHT Clinical Policy for Peripheral Venous Cannula Insertion and Management (Adults) PHT Trust Policy for the Safe Handling and Disposal of Sharps PHT Waste Handling Policy PHT Patient Identification Policy PHT Medicines Purchasing for Safety Policy Mixing of medicines prior to administration in clinical practice – responding to legislative changes. Supporting guidance for healthcare providers, practitioners and commissioners. National Prescribing Centre, May 2010. 9 EQUALITY IMPACT STATEMENT Portsmouth Hospitals NHS Trust is committed to ensuring that, as far as is reasonably practicable, the way we provide services to the public and the way we treat our staff reflects their individual needs and does not discriminate against individuals or groups on any grounds. This policy has been assessed accordingly 10 MONITORING COMPLIANCE PROCEDURAL DOCUMENTS WITH, AND THE EFFECTIVENESS OF, The following points will be carried out/audited by the pharmacy department and compliance will be reported to the Formulary and Medicines Committee who will take action as required. Aspect to be monitored Evidence Review of the PHT Policy for the Safe Copy of PHT Policy for the Safe Management of Injectable Medicines Management of Injectable Medicines including approval dates Copy of distribution list for the Policy for the Safe Management of Frequency Review and approval every 2 years or earlier if necessary by current Injectables Policy author or inheriting pharmacist. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 17 of 32 Injectable Medicines to be kept by policy author. Availability of the PHT Policy for the Check Trust intranet Safe Management of Injectable Medicines on the trust intranet Availability of UCL guide and PHT See medicines management audit Drug Therapy guidelines in clinical areas Review PHT Purchasing for Safety Copy of PHT Purchasing for Safety policy to ensure it incorporates policy including approval dates procurement of injectable medicines Documented ‘purchasing for safety’ with inherent safety features decisions and product changes to Monitor adherence to the policy be kept by the Specialist Pharmacist IT and Procurement and Regional Stores Operations Manager. Aspect to be monitored Ensure all staff who prescribe, prepare, administer and monitor injectable medicines have received training and have the necessary work competencies to undertake their duties safely Evidence Prescribers: Medical prescribers and dentists: Evidence of completion of undergraduate medical training/registration. Non-medical prescribers – evidence of completion of independent prescribing course and associated competencies. Healthcare professionals preparing and administering IV drugs: Copy of IV study day training curriculum, Copy of training/assessment materials, Dates of training sessions, Records of staff who have received training. Evidence of completion of post- Annual spot check by IV policy author. Annual medicines management audit Review policy every 2 years or earlier if necessary by policy author Review annually by PHT Formulary and Medicines Group Frequency Clinical areas to compile training record at staff induction/ on completion of relevant training. Pharmacy (Injectables policy author to delegate as appropriate) to review staff register in relation to area training record annually. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 18 of 32 registration IV training. Evidence of completion of relevant All clinical areas to have a documented risk assessment of injectable products and procedures. All clinical areas to introduce risk reduction methods as result of risk assessment Review of patient safety incident data involving injectable medicines competencies Pharmacy Manufacturing Technical Staff preparing CIVAS and Parenteral Nutrition Evidence of completion of appropriate stages of the Aseptic Preparation Training programme and 3 Broth test validations. Documented Risk assessment as per policy, Number of high risk injectable products and procedures Number of high risk injectable products and procedures following the introduction of risk reduction methods Number of incident reports involving injectable medicines per division. Clinical outcome Type of report Type of incident Top 10 incidents/themes High risk injectable medicines added to trust risk register Record of actions taken to decrease incidents/risk associated with injectable medicines Pharmacy Manufacturing Unit manager to audit training files for each member of Pharmacy Manufacturing Unit staff Annually by Directorate Pharmacist and ward manager. Departments that do not have directorate pharmacists will have the risk assessment delegated to a pharmacist as deemed appropriate. Annually by Pharmacist Risk Management Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 19 of 32 Appendix 1: Standard Operating Procedure for Prescribing, Preparing and Administering Injectable Medicines in Clinical Areas Introduction The use of injectable medication has many healthcare benefits for patients. The complexities associated with the prescription, preparation and administration of injectable medicines means that there are greater potential risks for patients than for other routes of administration. Weak operating systems increase the potential risk of harm, and safe systems of work are needed to minimise these risks. The prescription of intravenous drugs, infusions, transfusion and their preparation, administration and maintenance should only be undertaken by healthcare professionals who have undergone specific training in this skill and have demonstrated their competence to do so. They should work within the Portsmouth Hospitals NHS Trust Medicines Management Policy. The healthcare professional should also: be aware of their legal and professional responsibilities; be accountable for their actions or omissions; know the mechanism for reporting adverse reactions of prescribing or administering errors and how to manage them; Departmental managers are responsible for ensuring that the system of training, recording and documentation is properly maintained. Supply and storage of Injectable Medicines A risk assessment of all injectable medicines (see PHT Pharmacy Standard Operating Procedure – Risk Assessment Process for Injectable Medicines and Associated Practice in Clinical Areas PHPSWI 09:002) must be undertaken in all clinical areas annually by the directorate pharmacist and ward manager or senior nurse to determine the safest presentation and location for storage and preparation. The resulting assessment documentation will be kept by the Medication Safety Pharmacy Technician. Injectable cytotoxics and parenteral nutrition must be supplied to clinical areas only as ready-to administer products. Ready-to-administer or ready-to-use products should be stocked in all clinical areas in preference to those needing preparation before use, or those which are classified as high-risk. Concentrates should only be supplied where safer alternatives are not available. Multiple use of an unpreserved injectable medicine should be eliminated. Most injectable medicines are licensed for ‘once-only’ use. Unless the manufacturer’s label specifically indicates that the injection contains a preservative, the container should only be used to prepare a single dose for a single patient on one occasion. Any departments that have reasons not to comply with this guidance must seek approval from the Formulary and Medicines Committee/Medications Safety Committee and a record of the medication and situation in which it is to be used more than once should be made on the risk register. Epidural solutions should be stored separately from those intended for intravenous use. See PHT Controlled drugs policy for storage of high strength opiates and controlled drugs See the Trust Policy for Intrathecal chemotherapy in Adults – Oncology and Haematology Departments for information on storage of intrathecals. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 20 of 32 Step 1: Prescribing of Injectable Medicines Medicines should be given by injection only when the practicality and appropriateness of other routes of administration have been excluded. The use of this route should be regularly reviewed in favour of switching to oral administration as soon as clinically appropriate. It is the responsibility of all prescribers to: o ensure that the medicines prescribed are appropriate for the injectable route and for the vehicle of administration, taking account of stability and incompatibility information. o provide a legal, legible, signed prescription as stated below to enable the drug to be administered safely and correctly (note: if medicines are to be mixed i.e. in a syringe/bag or administered through a single line, the instruction to mix must be in writing by the prescriber see section 2.9 Mixing of Medicines). o ensure that the patient has appropriate intravenous access for intravenous medicines prescribed so that they can be administered. o be aware of agreed departmental protocols and the role of designated health care professionals in administration of Injectable drugs o ensure that no drug is added directly to any blood product. o if in doubt, prescribers should seek information from the pharmacy department. 1.1 All prescriptions for injectable medicines (including injectables on TTO’s) should be written in capital letters and must specify the following: Patient’s name, date of birth, NHS number and weight; Prescriber’s signature and bleep number; The approved medicine name; The dose and frequency of administration; The date and route of administration; The allergy status of the patient. 1.2 Where relevant, the prescription must specify the following: Brand name and formulation of the medicine; Concentration or total quantity of medicine in the final infusion container or syringe; Name and volume of diluent and/or infusion fluid; Rate and duration of administration; Stability information to determine the expiry date of the final product; Type of rate-control pump or device(s) to be used; The age and weight of any patient under 16 years of age, where relevant; Date on which treatment should be reviewed; Arrangements for fluid balance or clinical monitoring should be made on an individual patient basis and according to local protocol and clinical need. If medicines are to be mixed, the instruction to mix must be in writing by the prescriber if the combination is not covered in the PHT Trust mixing guideline (see section 2.9 Mixing of Medicines) 1.3 When two or more prescription charts are in use, it is essential that they are cross referenced so that practitioners are aware of all prescribed medicines (e.g. extra drug charts, insulin, heparin, fluid epidural charts). NOTE: inpatient injectable medicines should be prescribed on the inpatient drug chart not the IV fluid chart. 1.4 Some injectable medicines may be administered under a PGD (see Medicines Policy) or Midwife Exemption (see Medicines Policy) Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 21 of 32 Step 2: Preparation of Injectable Medicines The preparation and administration of intravenous medicines, infusions, transfusions and their maintenance should be undertaken only by healthcare professionals who have undergone the training detailed in section 7 (Training requirements) and meet requirements stated in Section 5 (Duties and Responsibilites) of the Policy for the Safe Management of Injectable Medicines (Adults and Children) Preparation should only take place if: there is a prescription; a patient group directive or other written instruction; and essential information is available about the product(s) and processes needed for safe preparation and administration. (see section 6.3 for reference resources). Aseptic (non-touch) technique should be used during preparation and administration. Injectable medicines prepared in clinical areas should always be administered immediately after preparation. They should not be stored for a period of time before use. Administration of infusions prepared in clinical areas should be completed within 24 hours of preparation. In exceptional circumstances where an infusion from a single container is intended to continue for more than 24 hours, a risk assessment should be undertaken to determine the safest course of action. Every effort should be made to use a ready-to-administer product. Parenteral nutrition – Each bag of parenteral nutrition may be administered for up to 48 hours. See the PHT Trust Policy for the Provision and Management of Parenteral Nutrition in Adults in Hospital for further information on parenteral nutrition administration. All syringes, including flushes and infusions, must be immediately identifiable at all stages after preparation by the person who prepared them (see 2.7). ‘Flag labelling’ should be used to ensure that volume graduations on small syringes are not obscured. The only exception to this is in situations where preparation and bolus (push) administration is one uninterrupted process and the unlabelled product does not leave the hands of the person who prepared it. Only one unidentifiable medicine must be handled at one time. Medical devices with luer connectors must be used only for preparation and administration of injections. Risk assessment will have identified those products representing the highest risk to patients at the time of preparation. Consideration must be given to the use of safer products and systems, for example, doublechecking. Neonatal infusions: see Appendix 2 for additional information on infusions of IV fluids and medicines for neonates Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 22 of 32 2.1 2.1.1 2.1.2 2.1.3 2.1.4 2.1.5 2.1.6 2.1.7 2.1.8 2.1.9 2.1.10 2.1.11 2.1.12 2.1.13 2.1.14 2.1.15 2.2 2.2.1 2.2.2 2.2.3 General Read all prescription details carefully and confirm that they relate to the patient to be treated. Ensure that the area in which the medicine is to be prepared is as clean, uncluttered and free from interruption and distraction as possible. Ideally, preparation should take place in an area dedicated to this process. Assemble all materials and equipment: sharps bin for waste disposal, medicine ampoules/vials, diluent, syringes, needles, alcohol and chlorhexidine wipes, disposable protective gloves, clean re-usable plastic tray. Check the following: Expiry dates; Damage to containers, vials or packaging; That medicines were stored as recommended, e.g. in the refrigerator. Beware of the risk of confusion between similar looking medicine packs, names and strengths. Read all labels carefully. Check that: The formulation, dose, diluent, infusion fluid and rate of administration correspond to the prescription and the product information; The drug is compatible with the diluent and infusion fluids The patient has no known allergy to the medicine You understand the method of preparation. A second healthcare professional is required to check all agents for intravenous administration. This check must incorporate the whole preparation and administration process i.e. valid prescription, product accuracy, correct patient, check of infusion rate programmed into the appropriate device. Calculate the volume of medicine solution needed to give the prescribed dose. Write the calculation down and obtain an independent check by another qualified healthcare professional. If the calculations do not correspond they must be repeated independently. If there is still a discrepancy between the two calculations, assistance should be sought from a third authorised person, doctor or pharmacist. If there is any doubt, or if the dose seems to require the administration of the contents of more than 4 ampoules of a stock medicine, contact pharmacy to check this is correct. Displacement values: where the dose of a medicine is less than a complete vial and the vial requires reconstitution, e.g. for paediatrics, it is necessary to take into account the displacement value of the medicine (see PHT Trust guideline: Reconstitution of Dry Powder Antibiotics for Paediatrics; the UCL Injectable Medicines Administration Guide and package inserts for information on displacement values NOTE: there can be variation in displacement values between brands therefore always ensure you refer to the correct information.) Prepare the label for the prepared medicine (see section 2.7 of this policy) Cleanse your hands according to the PHT Hand Hygiene Policy. Put on a pair of disposable protective gloves. Use a detergent spray or wipe or soap and water to disinfect the surface of the plastic tray. Assemble the syringe(s) and needle(s). Peel open wrappers carefully and arrange all ampoules/vials, syringes and needles neatly in the tray. Use a ‘non-touch’ technique, i.e. avoid touching areas where bacterial contamination may be introduced, e.g. syringe-tips, needles, vial tops. Never put down a syringe attached to an unsheathed needle. Prepare the injection by following the manufacturer’s product information/UCL guide or local guidelines, and the relevant guidance in standards 2.2 to 2.7. Withdrawing solution from an ampoule (glass or plastic) into a syringe Tap the ampoule gently to dislodge any medicine in the neck. If the ampoule contains a suspension rather than solution, it should be gently swirled to mix the contents immediately before they are drawn into the syringe. Clean the ampoule with an alcohol and chlorhexidine wipe before opening. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 23 of 32 2.2.4 2.2.5 2.2.6 2.2.7 2.2.8 2.2.9 Snap open the neck of glass ampoules, using an ampoule snapper if required. Attach a filter needle to a syringe and draw the required volume of solution into the syringe. Tilt the ampoule if necessary. Invert the syringe and tap lightly to aggregate the air bubbles at the needle end. Expel the air carefully. Ensure the syringe is identifiable (see standard 2.7) Keep the ampoule and any unused medicine until administration to the patient is complete to enable further checking procedures to be undertaken. The neck of some plastic ampoules is designed to connect directly to a syringe without the use of a needle, after the top of the ampoule has been twisted off. 2.3 2.3.1 Withdrawing a solution or suspension from a vial into a syringe Remove the tamper-evident seal from the vial and wipe the rubber septum with an alcohol and chlorhexidine wipe. Allow to dry for at least 30 seconds. 2.3.2 With the filter needle sheathed, draw into the syringe a volume of air equivalent to the required volume of solution to be drawn up. 2.3.3 Remove the filter needle cover and insert the needle into the vial through the rubber septum. 2.3.4 Invert the vial. Keep the needle in the solution and slowly depress the plunger to push air into the vial. 2.3.5 Release the plunger so that solution flows back into the syringe. 2.3.6 If a large volume of solution is to be withdrawn, use a push-pull technique. Repeatedly inject small volumes of air and draw up an equal volume of solution until the required total is reached. This ‘equilibrium method’ helps to minimise the build-up of pressure in the vial. 2.3.7 Alternatively, the rubber septum may be pierced with a second needle to let air into the vial as solution is withdrawn. The tip of the vent must always be kept above the solution to prevent leakage. 2.3.8 With the vial still attached, invert the syringe. With the needle and vial uppermost, tap the syringe lightly to aggregate the air bubbles at the needle end. Push the air back into the vial. 2.3.9 Fill the syringe with the required volume of solution then draw in a small volume of air. Withdraw the needle from the vial. 2.3.10 Expel excess air from the syringe. Remove the needle and exchange it for a new needle or a sterile blind hub. 2.3.11 The vial(s) and any unused medicine should be kept until administration to the patient is complete. 2.2.12 If the vial contains a suspension rather than solution, it should be gently swirled to mix the contents, immediately before they are drawn into the syringe. 2.4 2.4.1 2.4.2 2.4.3 2.4.4 2.4.5 2.4.6 2.4.7 2.5 2.5.1 Reconstituting powder in a vial and drawing the resulting solution or suspension into a syringe Remove the tamper-evident seal from the vial and wipe the rubber septum with an alcohol and chlorhexidine wipe. Allow to dry for at least 30 seconds. Use the procedure in 2.2 above to withdraw the required volume of diluent (e.g. water for injection or sodium chloride 0.9%) from ampoule(s) into the syringe. Inject the diluent into the vial. Keeping the tip of the needle above the level of the solution in the vial, release the plunger. The syringe will fill with the air which has been displaced by the solution (if the contents of the vial were packed under a vacuum, solution will be drawn into the vial and no air will be displaced). If a large volume of diluent is to be added, use a push-pull technique (see above). With the syringe and needle still in place, gently swirl the vial(s) to dissolve all the powder, unless otherwise indicated by the product information. This may take several minutes. Follow the relevant steps in 2.3 above to withdraw the require volume of solution from the vial into the syringe. Alternatively, the rubber septum may be pierced with a second needle to let air into the vial as solution is withdrawn. The tip of the vent needle must always be kept above the solution to prevent leakage. If a purpose-designed reconstitution device is used, the manufacturer’s instructions should be read carefully and followed closely. Adding a medicine to an infusion Prepare the medicine in a syringe using one of the methods described in 2.2 to 2.4 above. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 24 of 32 2.5.2 2.5.3 Check the outer wrapper of the infusion container is undamaged. Remove the wrapper and check the infusion container itself in good light. It should be intact and free of cracks, punctures/leaks. 2.5.4 Check the infusion solution, which should be free of haziness, particles and discolouration. 2.5.5 Where necessary, remove the tamper-evident seal on the additive port according to the manufacturer’s instructions or wipe the rubber septum on the infusion container with an alcohol and chlorhexidine wipe and allow to dry for at least 30 seconds. (Note: there is no need to clean the additive port if the bag has just been taken out of its sterile packaging. 2.5.6 If the volume of medicine solution to be added is more than 10% of the initial contents of the infusion container (more than 50ml to a 500ml or 100ml to a 1litre infusion), an equivalent volume must first be removed with a syringe and needle. 2.5.7 Inject the medicine into the infusion container through the centre of the injection port, taking care to keep the tip of the needle away from the side of the infusion container. Withdraw the needle and invert the container at least five times to ensure thorough mixing before starting the infusion. 2.5.8 Do not add anything to any infusion container other than a burette when it is hanging on the infusion stand since this makes adequate mixing impossible. 2.5.9 Before adding a medicine to a hanging burette, administration must be stopped. After the addition has been made and before administration is re-started, the contents of the burette must be carefully swirled to ensure complete mixing of the contents. 2.5.10 Check the appearance of the final infusion for absence of particles, cloudiness or discolouration. 2.5.11 Label the infusion (see standard 2.7) 2.6 2.6.1 2.6.2 2.6.3 2.6.4 2.6.5 2.6.6 2.6.7 2.6.8 2.7 2.7.1 2.7.2 Diluting a medicine in a syringe for use in a pump or syringe-driver Prepare the medicine in a syringe using one of the methods described above. Draw the diluent into the syringe to be used for administration by the pump or syringe-driver. Draw in some air (slightly more than the volume of medicine needed) and remove the needle. Stand the diluent syringe upright. Insert the needle of the syringe containing the medicine into the top of the diluent (administration) syringe and add the medicine to it. Alternatively, a disposable sterile connector may be used to connect two syringes together directly. Check the following: The total volume of injection solution in the syringe is as specified in the prescription and that the infusion can be delivered at the prescribed rate by the administration device chosen; The rate of administration is set correctly on the administration device and according to the manufacturer’s instructions and the BBraun drug library if applicable. Fit a blind hub to the administration syringe and invert several times to mix the contents. Remove the blind hub. Tap the syringe lightly to aggregate the air bubbles at the needle end. Expel the air and refit the blind hub. Carefully check the syringe for cracks and leaks and then label it (see standard 2.7) especially noting the requirements specific to syringe drivers. Check that the rate of administration is set correctly on the device before fitting the syringe, priming the administration set and starting the infusion device. Labelling injection and infusion containers All injections should be immediately identifiable at all stages after preparation, except for syringes intended for immediate push (bolus) administration by the person who prepared them. Under no circumstances should an operator be in possession of more than one unidentifiable syringe at any one time, nor must an unlabelled syringe be fitted to a syringe driver or similar device. Labels used on injectable medicines prepared in clinical areas should contain the following information: Name of the medicine; Dose/quantity of drug in the syringe/bag ; Route of administration; Diluent and final volume; Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 25 of 32 Patient’s name; Expiry date and time; Batch number of the medicine; Name of the practitioners preparing and checking the medicine. 2.7.3 2.7.4 Inotropes and vasopressors should be labelled with a purple infusion label as above. Pre-printed purple labels are available for noradrenaline, dobutamine and adrenaline, these pre-printed labels should be used in preference to plain purple labels for these particular drugs. Place the final syringe or infusion and the empty ampoule(s)/vial(s) in a clean plastic tray with the prescription for taking to the patient for administration. 2.8 2.8.1 Multiple use of injectable medicine Multiple use of an unpreserved injectable medicine should be eliminated. Most injectable medicines are licensed for ‘once-only’ use. Unless the manufacturer’s label specifically indicates that the injection contains a preservative, the container should only be used to prepare a single dose for a single patient on one occasion. Any departments that have reasons not to comply with this guidance must seek approval from the PHT Formulary and Medicines Committee/Medications Safety committee and a record of the medication and situation in which it is to be used more than once should be made on the departmental risk register. 2.9 2.9.1 Mixing of medicines In some settings it will be in the patient’s best interests for medicines to be mixed, for instance administration through a SC syringe driver or single line. Mixing of medicines should: Only be undertaken in the best interests of the patient e.g. to avoid multiple injections or only one access point is available. Be avoided where possible Only be done by a person competent and willing to do so Take place in a pharmacy, where possible. The Department of Health has recommended that: Doctors, dentists, nurse and pharmacist independent prescribers who can mix medicines themselves, can direct others to mix. Supplementary prescribers can mix medicines themselves and direct others to mix, only where that preparation forms part of the clinical management plan for an individual patient. Prescribers should seek advice from a pharmacist in deciding whether there are alternatives to administering mixed medicines for individual patients, or if not possible refer to the PHT Trust Mixing Guideline for a list of drugs authorized to be mixed in the Trust. If the guideline does not provide information on a particular combination of drugs then Prescribers should seek advice from a pharmacist in determining which substances can be mixed and in what concentrations. If the required combination of drugs is found to be compatible in an alternative reference source the instruction/direction to mix must be in writing by the prescriber on the drug chart or in the patients notes. The prescriber must take responsibility for satisfying him/herself that the clinical governance arrangements are in place to ensure that the “mixer” is competent to undertake the task safely and effectively. The person mixing the medicines must be competent to administer the injectable medication. No-one should be obliged to mix and administer medicines if they do not feel competent of content to do so. 2.9.2 2.9.3 2.9.4 2.9.5 2.9.6 2.9.7 Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 26 of 32 Step 3: Administration of an injectable medicines The preparation and administration of injectable medicines, infusions, transfusions and their maintenance should be undertaken only by healthcare professionals who have undergone the training detailed in section 7 (Training requirements) and meet requirements stated in Section 5 (Duties and Respnsibilites) of the Policy for the Safe Management of Injectable Medicines (Adults and Children) Before administration, the following should be available: a current prescription, a patient group direction, essential technical information and a prepared and labelled injectable medicine. The patient’s identity and details should be confirmed according to The Patient Identification Policy. The person administering the medicine should personally make a record of administration as soon as possible after the event. This is extremely important in circumstances such as theatres, where the person administering the medicines may also be the prescriber and there may be no written prescription. Risk assessment will have identified those products representing the highest risk to patients at the time of administration. The UCL Hospitals Injectable Medicines Administration Guide should be used to determine if a drug should be administered using an infusion pump and which type of pump should be used. If the UCL guide states that a drug should be given by infusion but does not specify which type of infusion device should be used, the administering practitioners discretion should be used when deciding whether to use an electronic pump or not, but they must ensure that the drug is given at an appropriate rate regardless of the method used. Drugs that should be administered intravenously via a syringe driver should be given via an intravenous B Braun smart pump syringe driver. (See Trust Policy for the Management of Infusions with Pumps) Infusions of noradrenaline, dobutamine or adrenaline should be administered via B Braun volumetric smart pumps using the drug library. All other drugs requiring a volumetric infusion pump should be administered using a Grasby volumetric infusion pump. (See Trust Policy for the Management of Infusions with Pumps) Fluids should always be given via a graseby volumetric pump Drugs that are administered via subcutaneous infusion should be administered via a McKinley T34 syringe driver. The patient should be observed throughout intravenous treatment for any change in condition/ adverse reactions. Infusions should be monitored according to the UCL Injectable Medicines Administration Guide and any relevant Drug Therapy Guidelines and clinical policies to ensure safe administration of prescribed treatment. Neonatal infusions: see Appendix 2 for additional information on infusions of IV fluids and medicines for neonates Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 27 of 32 3.1 3.1.1 3.1.2 3.1.3 3.1.4 3.1.5 3.1.6 3.1.7 3.2 3.2.1 3.2.2 3.2.3 3.2.4 3.2.5 3.2.6 3.2.7 3.2.8 3.2.9 3.3 3.3.1 3.3.2 3.3.3 Before administering any injection Check all the following: Patient’s name, hospital/NHS number or date of birth or address with the patient and their wrist band; Prescriber’s signature; The approved medicine name; The dose and frequency of administration (remember to consider patient weight where appropriate e.g. paracetamol IV, enoxaparin etc); The date and route of administration (including whether the drug should be given via a central line or peripherally); The allergy status of the patient. Also check, where relevant: Brand name and formulation of the medicine; Concentration or total quantity of medicine in the final infusion container or syringe; Name and volume of diluent and/or infusion fluid; Rate and duration of administration; Type of rate-control pump or device(s) to be used; The age and weight of any patient under 16 years of age, where relevant; Date on which treatment should be reviewed. Check that the medicine is due for administration at that time and has not already been given. Assemble everything you need including any flushing solution(s) needed, and ensure that any drugs necessary for dealing with reactions are available. Explain and discuss the procedure with the patient. Check any infusion already in progress. It should be free of haziness, particles and discolouration. Check that an appropriate access device is in place and is patent. Health care professionals should only inject into an established intravenous access point. Flush it immediately before and after administration of a medicine, and between doses of different medicines administered consecutively. Also check the administration site for signs of leakage, infection or inflammation. Administration of injections – general Check infusions. They should be free of haziness, particles and discolouration. Use aseptic (non-touch) technique at all times. Attach administration sets to infusion containers carefully, on a flat surface and using the technique appropriate to the type of container. Prime the access device immediately before starting and infusion. Before adding a medicine to a hanging burette, administration must be stopped. After the addition has been made and before re-commencement, the contents of the burette must be carefully swirled to ensure complete mixing. Ensure the giving sets are changed in accordance with the trust guidelines. All drugs that can be given peripherally can be given by a central line. A second healthcare professional is required to check all agents for intravenous administration. This check must incorporate the whole administration process i.e. valid prescription, product accuracy, correct patient, check of infusion rate programmed into the appropriate device For information on mixing medicines see section 2.9 Mixing of medicines. After administration After completion of an intermittent infusion, flush the access device according to (standard 4). Ask the patient to report promptly any soreness at the injection site or discomfort of any sort. Make a detailed record of administration. Discard the empty ampoule(s)/vial(s) from which the injection was prepared and any unused medicine according to the PHT Trust Waste Handling Policy. Ampoules or vials should never be used to prepare more than one injection unless specifically labelled by the manufacturer for ‘multi-dose’ use. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 28 of 32 3.3.4 3.3.5 4 Re-check the administration site for signs of leakage, infection or inflammation and continue to monitor the patient, contents of the infusion container and the rate of infusion. Check that arrangements for monitoring fluid balance or clinical parameters have been made. Ensure that relevant documentation is made available for subsequent regular monitoring to take place. Flushing IV access devices should be flushed daily (as per the PHT Clinical Policy for Peripheral Venous Cannula Insertion and Management and the PHT Central Venous Catheters: Care and Management Policy) to maintain the patency and immediately before and after administration of a medicine, and between doses of different medicines administered consecutively. Flushes to maintain the patency of the line should be prescribed on the prescription chart stating the flush to be used, volume and times of administration. Flushes administered pre and post drug administration are an integral part of the intravenous drug administration process. Therefore an appropriate flush should be administered as standard pre and post drug administration, these will not be prescribed. Any suitably trained person authorised by the Trust to cannulate patients as part of their role, can administer 1 – 2ml of sodium chloride 0.9% to establish initial patency of a peripheral intravenous cannula. Document this administration in the Cannula Insertion and Management Form. See the PHT Clinical Policy for peripheral venous cannula insertion and management. 5 Cannula Management Refer to thePHT Clinical Policy for Peripheral Venous Cannula Insertion and Management (Adults) and the PHT Central Venous Catheters: Care and Management Policy 6 7 Reactions to intravenous drugs Anaphylaxis Refer to: PHT Cardiopulmonary Resuscitation Policy (Including Anaphylaxis and Defibrillation). Adverse reactions a patient exhibits any adverse reaction receiving an injectable medicine it must be stopped and the prescriber/medical/dental officer notified. It should only be continued on his/her decision. The prescriber/medical/dental officer should take a full clinical history. List signs, temperature, all medicines and the times and batch number of any infusions given. Update the adverse medicine reaction box on the front of the patient’s medicine chart with the causative drug and the type of reaction that occurred. If a defect in an infusion is suspected take specimens for blood culture from another vein and inform pharmacy. Watch any other patients having mediation of the same batch. The order of use of the containers concerned should be noted. When the administration of the medication has been completed the containers should be retained for a period of 24 hours to ensure that then can be examined should any reaction follow. All suspect containers and accessories should be labelled and kept in case they are needed for investigation. The senior nurse and senior pharmacist on duty (or the on-call pharmacist) should be informed immediately. See PHT Policy for the management of adverse incidents and near misses If any incident relates to an infusion then the pump should be isolated so that the ifnroamtion settings can be down loaded by medical electronics. If Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 29 of 32 8 Extravasation 9 In-line Intravenous filters Extravasation is the accidental infiltration in intravenous fluids/medicines into the subcutaneous tissue see the Central Venous Catheters: Care and Management Policy and fill in an incident form. The current guidelines on the use of 0.2 micron in-line intravenous filters are: There is no need for the routine use of these filters. Individual clinical areas are free to develop their own policy if required, for example clinical needs to reduce particulate contamination or to increase cannula life. It is recommended that these should be discussed with microbiology and directorate pharmacist. Specific drugs require the use of these filters, so these must be stocked in clinical areas where these drugs are used, (obtain through supplies) Current examples: Phenytoin infusion Infliximab infusion Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 30 of 32 Appendix 2: Prevention of Over Infusion of Intravenous Fluids and Medicines in Neonates. Prior to commencing any infusion Do not use any syringe pump/volumetric pump unless you are competent to do so and have signed the Group Competency Statement for Registered NICU staff within the last 2 years. Two nurses must double check the IV prescription chart against the current NICU local formulary (route of administration & working weight of baby needs to be on prescription chart). If the prescription differs from the formulary, the reason why needs to be documented in the baby’s notes. Clearly identify the baby for who the fluids are intended by double checking name bands against prescription chart. When using a syringe pump to administer IV fluids, a bag of fluids must not be left connected to the syringe (excluding blood, see NICU blood transfusion guideline). Ensure all administration equipment is correctly loaded onto the infusion pump before connecting to the infant and the clamps are in the off closed position. The infusion rate and the total volume to be infused will be double checked by another Registered Nurse and against the prescription. (This will also apply if any changes are made to the rate once the infusion is commenced) . During Each Infusion Check and document the infusion rate, total volume infused and pressure indicator hourly on the fluid chart. If the rate is changed, double check the rate and total volume against the prescription. Continuously monitor the baby and record observations hourly and more frequently if required. Set pressure alarm on volumetric pumps at 30 mmHg above the venous pressure reading. Set pressure alarm at 1 bar (≡ 75 mmHg) on B Braun pumps. If a burette is used, place only 4 hours volume of fluid plus 10 mls in the chamber. To prevent over infusion and prevent chamber from emptying, set the volume to be infused at a volume equivalent to 4 hours infusion. If the baby deteriorates, consider the possibility of fluid overload along side other potential causes. Check blood sugar level within an hour of starting any glucose infusion and then 4-6 hourly (frequency may vary depending on clinical needs, this should be confirmed with medical team and documented). Any blood sugar level results outside normal limits should be reported to the medical team. Close all clamps prior to the removal of an administration set from the infusion device. Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 31 of 32 At handover Double check the infusion rate and total volume to be infused with the registered nurse (or nursery nurse with competencies in medicines management) taking over care. For babies receiving a glucose infusion, check that the most recent blood sugar level is within acceptable limits in accordance with the clinical management plan. Ensure all discontinued infusions are clamped off and have been disconnected from the baby. Ensure octopus clamps are slid to their full extent to ensure effectiveness of clamp Using the Neonatal Vascular IV Care Bundle double check and document observation of all cannula sites. References Neonatal Intensive Care Nursing Care Plan August 2011, National Patient Safety Agency August 2010 Reference 1264 August 2010, PHT Policy for the Management of Infusions with Pumps, Issue 1. 19.07.2005 V2 PHT Policy for the Safe Management of Injectable Medicines (adults and Children) Version1 16.09.10 Appendix 2 is managed by: Kim Edwards and Susi Hill Practice Educators and Nicola Hill Women’s and Children’s Divisional Pharmacist Policy for the Safe Management of Injectable Medicines. Version 3. 12/06/2014 (Review date June 2016) Page 32 of 32
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