POLICY AND PROCEDURES FOR THE PRESCRIBING AND ADMINISTRATION OF INJECTABLE MEDICINES TO BE USED IN CONJUNCTION WITH W.A.H.

Transcription

1 POLICY AND PROCEDURES FOR THE PRESCRIBING AND ADMINISTRATION OF INJECTABLE MEDICINES TO BE USED IN CONJUNCTION WITH W.A.H.T Medicines Policy Department /Service: Pharmacy Originator: Philip Goode Steve Graystone Accountable Director: Alan Catterall Director of Pharmacy Lindsey Webb Chief Nursing Officer Mark Wake Chief Medical Officer Approved by: Medicines Safety Committee Date of approval: 7 th October 2014 Revision Due: 7 th October 2016 Target Organisation(s) Worcestershire Acute Hospitals NHS Trust Target Departments Trust wide Target staff categories Nurses/Midwives/ODPs/Medical Staff/Radiographers and any other staff authorised by the Trust to administer injectable medicines. Policy Overview: This Policy and Procedure describes how injectable medicines are to be prescribed and administered safely within the Trust. Key amendments to this Document: Date Amendment By: Aug 2010 Change of Lead Nurse and reformatted into Trust Policy Alison Smith Template in line with Trust Policy for Key Documents. Reformat approved by Nick Hubbard, Chairman of Medicines Safety Committee 8/9/10 Aug 2010 Clarification of advice on needle-free intravascular connectors and addition of MHRA Medical Device Alerts Sallyanne Simpson to References Nov 2010 Update of content and references Sallyanne Simpson Dec 2010 Addition of warning to Procedure 2 re drawing up of Alison Smith insulin Mar 2012 Extended unchanged for a period of 3 months to allow Alison Smith completion of the review process. June 2012 Policy updated in relation to checking of IV Drugs by agency nurses and the addition of procedures for IM and Andrea Edwin WAHT-CG-516 Page 1 of 32 Version 3

2 October 2012 October 2012 September 2014 September 2014 September 2014 subcutaneous injection Amendments to section 4 to ensure clarity in respect to staff roles and competencies required. Amendments to section 5.2 to ensure that all the process for second checking is clearly described for all injectable medicines. Change of Directors to reflect organisational changes Amendment of section 4 to include Agency Nurse administration of intravenous medication. Addition of agreement between ward manager and agency nurse to administer intravenous medication (appendix B) Martina Morris Martina Morris Phil Goode Phil Goode Phil Goode WAHT-CG-516 Page 2 of 32 Version 3

3 Contents page SECTION PAGE 1. Introduction 4 2. Scope of this document 6 3. Definitions 7 4. Responsibility and Duties 4.1 Introduction 4.2 Responsibilities of prescribers 4.3 Responsibilities of staff authorised to administer injectable Medicines 5. Policy Detail 5.1 General principles 5.2 Checking of administration 5.3 Medicine Calculations 5.4 Displacement Values 5.5 Supply and Storage 5.6 Documentation 5.7 Treatment of anaphylaxis during/following administration of an injectable medicine 5.8 Adverse reaction during administration of an injectable medicine 5.9 Extravasation 6. Implementation of key document 6.1 Plan for implementation 6.2 Dissemination 6.3 Training and awareness 7. Monitoring and compliance Policy Review References Background 10.1 Consultation 10.2 Approval Process 10.3 Equality requirements 10.4 Financial risk assessment Appendices Appendix A PROCEDURES FOR ADMINISTERING INJECTABLE MEDICINES Procedure 1- Preparing to administer injectable medicines Procedure 2 - Reconstituting and drawing up injectable medicines Procedure 3 - Medicine administration by direct intravenous (bolus) injection via peripheral or central venous cannula. Procedure 4 - Preparation of intravenous medicine infusions Procedure 5 - Maintaining and monitoring an intravenous infusion Procedure 6 Intramuscular injection WAHT-CG-516 Page 3 of 32 Version

4 Procedure 7 Subcutaneous injection Appendix B Contract between Ward Manager and agency nursing staff for administration of intravenous medication. 1. Introduction The use of injectable medication has many healthcare benefits for patients. However, 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. Weak operating systems increase the potential risk of harm and safe systems of work are needed to minimise these risks. The main risks are: Incomplete and/or ambiguous prescriptions which do not include important information, for example, details of the solution to be used to dilute the injectable medicine (diluent), the final volume of medication to be administered, the final concentration or intended rate of administration. Injectable medicines may be prescribed on other documentation such as anaesthetic records or casualty cards, which increases the chance of duplication of doses. 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 healthcare professionals at the point of use. This information may not always be included in the manufacturer's pack or in commonly available reference sources. 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, and administration of the medicine, leading to administration of the wrong dose and/or at the wrong concentration or rate. e.g. extended interval gentamicin doses are calculated on ideal body weight rather than actual body weight and adjusted according to blood levels see WAHT-PHA-004 GUIDELINES ON EXTENDED INTERVAL GENTAMICIN REGIME Unsafe handling or poor aseptic (non-touch) technique leading to contamination of the injection and harm to, or infection of, the patient. Incompatibility between 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 of the wrong dose or via the wrong route. Health and safety risks to the operator or environment. Equipment failure/ inappropriate selection of recommended equipment Risk of medication error due to incorrect use of an infusion device. All practitioners administering injectable medication through an infusion device must have evidence of training and competency assessment for the device being used. Variable levels of knowledge, training and competence amongst healthcare practitioners. All practitioners administering injectable medication should have recorded evidence they have received the Trust approved training and have the necessary competencies to administer injectable medicines safely. WAHT-CG-516 Page 4 of 32 Version 3

5 These risks were highlighted by the NPSA Patient Safety Alert Promoting safer use of injectable medicines (March 2007) which required the Trust to: 1. Undertake a risk assessment of injectable medicine procedures 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. Death or severe harm as a result of a wrongly prepared high-risk injectable medication is now classified as a Never Event by the Department of Health. A further safety alert on the particular risks of Loading Doses (including injectable medicines) was issued by the NPSA in A loading dose is an initial large dose of a medicine used to ensure a quick therapeutic response. It is usually given for a short period before therapy continues with a lower maintenance dose. The use of loading doses of medicines can be complex and error prone. Incorrect use of loading doses or subsequent maintenance regimens may lead to severe harm or death. To reduce the risk of harm, the Trust was required to ensure that: 1. All medicines used by the organisation that are likely to cause harm if loading doses and subsequent maintenance doses are not prescribed and administered correctly are risk assessed and used to produce a list of critical medicines (which may contain speciality subsections). This must include warfarin, amiodarone, digoxin, phenytoin and any other medicines identified locally. Following a risk assessment, for WAHT these were identified as IV heparin, IV omeprazole IV, and IV morphine in paediatrics. 2. There is effective communication regarding loading dose and subsequent maintenance dose regimens when prescribing, dispensing or administering critical medicines. This should include handover of patients between healthcare organisations. Tools such as loading dose work sheets, loading dose prescription charts, handover and clinical protocols, and patient-held information should be considered. In WAHT, there is a dedicated prescription chart for IV heparin, and clinical guidelines and/or drug monographs and neonatal formulary for the other medicines on the critical list. 3. Clinical checks are performed by medical, nursing, AHP and pharmacy staff (when available) so that loading and maintenance doses are correct. Appropriate WAHT-CG-516 Page 5 of 32 Version 3

6 information should be available to support these checks. In WAHT, hard copy BNF and BNFc are available on wards, and MEDUSA Injectable Medicines Administration Guide is available at 2. Scope of this document This policy covers the administration of all injectable medicines to all patients requiring medication via an injectable route (except Neonates, for whom there is a separate policy). The policy is intended for use by: Medical / Dental Officers Registered Nurses / Midwives / ODPs Radiographers Physiotherapists Any other suitably trained person authorised by the Trust to administer injectable medicines This policy must be used in conjunction with: WAHT Medicines Policy (WAHT- CG-580) WAHT Blood Transfusion Policy (WAHT HAE-001) WAHT Cannulation Policy (WAHT-NUR-043) WAHT Safe use of Medical Devices (WAHT-CG-021) WAHT Latex Policy (WAHT-CG-004) WAHT Treatment of Acute Anaphylaxis Policy (WAHT-ANA-012) WAHT Guideline for the use and monitoring of intravenous unfractionated (UFH) Heparin in Adults WAHT-HAE-010 NMC (2008) The Code: Standards for Conduct, Performance & Ethics for Nurses and Midwives Health and Care Professions Council (2012): Standards of Proficiency for Operating Department Practitioners Acute Pain and Palliative Care Guidelines Any other Policies, Guidelines or Procedures which include injectable medicines, including MedPolSOPs: Medicines Policy SOPs for higher risk injectable medicines In addition to this policy, the following Medicines Policy Standard Operating Procedures describe specific safety measures to be taken with certain injectable medicines identified locally and/or nationally as being associated with higher risks to patients; MedPolSOP04 Policy for the control of higher strength morphine and diamorphine injections MedPolSOP09 Supply, Administration, Storage and Transfer/TTOs of Insulin MedPolSOP14 Policy for reducing the risk of overdose with midazolam in adults MedPolSOP23 Supply, storage, prescribing and handling of strong potassium infusions and concentrated potassium solutions WAHT-CG-516 Page 6 of 32 Version 3

7 3. Definitions Injectable medicines covered in this document are those given by one of the following main methods: - a) Intramuscular injection b) Direct subcutaneous injection c) Subcutaneous infusion d) Intradermal Injection e) Intravenously by: Direct injection (bolus) into a vein Direct injection into infusion line tubing (bolus) Intravenous infusion either continuous or intermittent Other injectable routes NOT covered in this Policy and procedures are f) Intrathecal (see Policy & Guideline for Adult Intrathecal Cytoxic Chemotherapy WAHT- HAE-004 and Medicines Policy ) g) Epidural (see Acute Pain Guideline WHAT-ANA-007, WAHT-OBS-063 and Medicines Policy ) h) If medication is to be given via any other route, such as intra-arterial, intraosseous, intraventricular, intravitreal, intrapleural and intra-ocular, reference should be made to specific Policies and Guidelines used in specific clinical areas. The principles and basic preparation procedures covered in this policy will generally apply. Competencies required The Trust Medicines Policy (section ) states that: An appropriately trained and authorised member of trust staff who has been assessed as competent to do so safely may administer medicines that have been prescribed by an authorised prescriber to an individual patient. The medicines may only be administered to that named patient. This principle applies to trust staff at all levels This applies to medicines given by the injectable route, provided that A training and competency assessment procedure for each staff group to administer injectable medication is approved by the Trust, and that Standard Operating Procedures are in place (see Medicines Policy section 5.3 Administration of Medicines for more details) The NPSA has published work competences for the prescribing, preparing, administering, and monitoring of injectable medicines (available at Education, training and competency assessment programmes used by each professional group must either include the NPSA work competences (which can be adapted for local use) or evidence must be provided that any existing programmes (e.g. Trust IV Therapy Course) cover the same material, and these must be approved by the Trust Medicines Safety Committee. WAHT-CG-516 Page 7 of 32 Version 3

8 An appropriately trained and competent doctor/nurse/midwife/ahp is able to administer all prescribed injectable medication including FIRST DOSE intravenous medication and should be able to successfully handle any anaphylactic reactions. The Trust may approve different levels of training and levels of authorisation for different staff groups depending on the needs of the Trust, for example to authorise Radiographers to administer contrast media, or designated and appropriately trained staff to administer an intravenous saline flush. 4. Responsibility and Duties A member of Trust staff is permitted to administer injectable medicines as authorised provided that: She / he has completed the required training programme and been assessed as competent and can provide up to date evidence of their competency. She/he is satisfied with her/his competence and mindful of her/his personal accountability. The Appointed Nurse-in-Charge or registered health-care professional appointed to be in charge of a clinical area is satisfied with the trained and authorised person s competence, including the selection of infusion devices where appropriate. Any Nurse/Midwife/ODP who administers injectable medicines must ensure that their competence is assessed and reviewed yearly and evidenced via the Trust PDR Process as outlined in the Guidelines for Completion of the Annual PDR Checklist in Relation to Medicines. The guidelines can be accessed in the documents folder on the Trust intranet. Consultants must ensure that they and all medically trained members of their team are competent to prescribe, prepare, administer and monitor injectable therapy, familiar with their responsibilities concerning the addition of medicines to intravenous infusion fluids, and aware of the hazards associated with IV therapy, particularly when using an infusion pump or syringe pump / drivers. Each clinical area should also undertake a risk assessment based on the frequency of IV medications administered, the use and regularity of Agency Staff within the area incorporating this into the risk assessments undertaken in the area for the preparation and administration of injectable medicines. Third Party Agency nurses / ODPs / midwives and NHSP nurses / midwives who are not employed by the Trust must receive local induction to the clinical area in line with the Trust agreed process, which includes medicines safety. The Third Party Agency nurses / ODPs / midwives and NHSP nurses / midwives who are not employed by the Trust are permitted to administer injectable medicines with the exception of chemotherapy, epidurals and paediatrics. Where medications are administered by direct (bolus) injection into a vein, direct injection into an infusion line or by intravenous infusion - either continuous or intermittent this will be subject to an agreement between the agency nurse and the ward manager. (Appendix 2) For second checking requirements please refer to section 5.2 of this policy. WAHT-CG-516 Page 8 of 32 Version 3

9 Nurses/Midwives /ODPs in training may participate in the administration of certain medicines under the direct supervision of registered nurse/midwife /ODP. However, they may not administer medicines via the intravenous route (other than replacing infusion bags without additives under the direct supervision of a registered nurse/ midwife /ODP who has been assessed as competent in the administration of intravenous therapy.) Third party Agency Nurses will be required to produce evidence of training in the administration of IV drugs and undertake an observed assessment of competency in the clinical area in which they are administering IV medication. Evidence of training should be retained by the Ward Sister/Charge Nurse. Evidence of the competency assessment will be retained on the ward and a copy sent to the Learning and Development for recording on Trust records. The Ward Sister/ Charge Nurse should also ensure that the nurse has access to and has read and understands the Trust Medicines Policy and Injectable Medicines Policy. Competency must be reviewed every six months All medical students attending placement within clinical areas, must be supervised by a doctor or nurse who is competent in the administration of injectable medication while completing competencies as indicated within their clinical skills passport and identified within Tomorrow s Doctors (2009). Medical devices should not be used by the medical students unless they have received medical device training and are directly observed by a competent practitioner. Medical officers or any trained practitioners who have attended a cannulation course can establish peripheral vascular access for the administration of medicine by the IV route. 4.1 Responsibilities of prescribers Medicines should be given by injection only when the practicality and appropriateness of other routes of administration have been excluded. The prescriber is responsible for reviewing the use of the IV route regularly and switching to oral administration as soon as clinically appropriate It is the responsibility of all prescribers to ensure that the medicines prescribed are appropriate for the injectable route and for the vehicle of administration, taking account of stability and incompatibility information. If in doubt, prescribers should seek information from Pharmacy Consultants must ensure that junior Medical Officers are aware of the hazards associated with this aspect of patient care, particularly when particularly when prescribing medications for use in syringe pumps/drivers Prescribers must write prescriptions for injectable medicines clearly and in accordance with the Trust Medicines Policy. Prescriptions for injections must clearly specify the medicine name, dose, frequency and route of administration. Where relevant, the prescription, or a readily available local protocol, must specify the following: name and volume of diluent and/or infusion fluid, concentration of final infusion, rate of administration, duration and rate control pump or device to be used. WAHT-CG-516 Page 9 of 32 Version 3

10 When two or more prescription charts are in use, it is essential that they be crossreferenced so that practitioners are aware of all prescribed medicines Prescribers are responsible for establishing with the Assigned Healthcare Professional-in-Charge that the patient has appropriate intravenous access for any intravenous medicines prescribed so that they can be administered. Cannulation may be delegated to an appropriately trained person who has attended and attained competency on a Trust recognised cannulation course. Any suitably trained person, authorised by the trust, can administer up to 5mls 0.9% Sodium Chloride to establish initial patency of a peripheral intravenous cannula The prescriber has responsibility for telling the assigned Healthcare Professional-in-Charge of a clinical area about any new prescriptions that have been written and that he/she has not administered themselves (Medicines Policy ). Effective communication is especially important with loading doses and subsequent maintenance dose regimens. 4.2 Responsibilities of staff authorised to prepare and administer injectable medicines Injections should be prepared only by healthcare staff that understand the risks involved, have been trained to use safe procedures, and have demonstrated their competence for the task. Preparation should only take place if: there is a prescription, a Patient Group Direction or other written instruction; and essential technical information is available about the product(s) and processes needed for safe preparation and administration Staff must not prepare substances for injection in advance of their immediate use or administer medication drawn into a syringe or container by another practitioner when not in their presence 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 or sooner depending on the product (refer to preparation information). In exceptional circumstances where 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 All syringes, including flushes and infusions, must be labelled immediately after preparation by the person who prepared them. 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 unlabelled medicine must be handled at one time Only medical devices with luer connectors must be used for preparation and administration of injections Risk assessments will have identified those products representing the highest risk to patients at the time of preparation. Where supplied by pharmacy, products supplied in a ready-to-use form should be used. WAHT-CG-516 Page 10 of 32 Version 3

11 The authorised person will also be responsible for: Checking the expiry dates of the medicines to be administered, including, diluents and infusion fluid where used Checking the container and fluid show no obvious faults or contamination, this check MUST take place immediately before use. The container should be examined for: - Cracks Faults in the plastic Defects in the closure, or other damage. The injectable medicine should be examined for unexpected: - Particles Cloudiness Change in colour Invert the container and use a good light. Evidence of defects should lead to rejection of the container and the procedure for Defective Medical Products must be followed (Section 5.8 of the Medicines Policy ) Checking that the intravenous medicine is administered to the right patient For intravenous medicines, inspecting the site of injection, reporting any abnormality and documenting the Phlebitis score (if different from the initial assessment on that same day). The cannula should be removed and/or re-sited every 72 hours unless earlier change is indicated by the phlebitis score or clinical need Giving sets should be changed Every 72 hours for clear fluids Every 12 hours colloid and blood products Every 24 hours for IV medicine infusions/feeding (TPN) This includes changing the infusion contents The administration giving set should be labelled with the date and time of when it was set up NB: If at any time an administration set is disconnected it must be discarded and a new set attached. When administering bolus injections the cannula/vascular device must be flushed before and after (and between medicines if more than one is administered) with 2-5 mls of 0.9% Sodium Chloride or other agent prescribed for the purpose (see Trust Guideline WAHT-NUR-043 The Procedure for the Insertion, Management and Removal of Peripheral Vascular Devices ) WAHT-CG-516 Page 11 of 32 Version 3

12 Maintaining infusions at the prescribed rate, either manually or electronically. The authorised person must have evidence of competency based training and assessment with regard to the method and equipment used. In the event of a malfunction of an infusion device with possible patient consequences the responsible medical officer must be informed. The patient should be checked for any adverse effects, a clinical incident form must be completed and the equipment removed from circulation and decontaminated, before being sent for repair. It is recommended that all intravenous infusions containing Potassium Chloride are delivered via an infusion device. All potassium infusions with a concentration of more than 40mmol per litre MUST be given via a pump or syringe driver, using a non return valve if more than one infusion is in progress Observing and reporting on the condition of the patient Obtaining a check on the administration, maintaining records, ensuring documentation, and communicating effectively regarding loading dose and subsequent maintenance dose regimens e.g. rates of infusion. 5. Policy and Procedures for the Administration of Injectable Medicines 5.1 General Principles Medicines should be given by injection only when the use of no other route is possible and acceptable to the patient (NPSA, March 2006) Staff administering injectable medication must familiarise themselves with the method of administration of the medicine which they are to give, by reference to the B.N.F., Pharmacy, manufacturer's literature, UKMI Guidelines on IV administration or MEDUSA at Package inserts should be returned to the correct ampoule box after use. Please note that not all medicines may be given by intravenous bolus injection. Some medicines must only be given by infusion. Some medicines must be further diluted before administration. Some medicines must not be diluted before administration See Appendix 1 for Procedures for each method Most medicines licensed for injectable use are intended for single use only and should not be used more than once. Exceptions include vials of insulin, which contain antibacterial preservatives; even so each vial should be reserved for a single patient (see Medicines Policy SOP MedPolSOP9). Two or more medicines should not be mixed together unless the compatibility has been confirmed, by pharmacy or other approved guidelines. Where more than one medicine is given intravenously, the line/cannula/vascular device should be flushed between medicines. This is usually with sodium chloride 0.9%, however where the first medicine is incompatible with saline e.g. Amiodarone the cannula should be flushed with a compatible fluid e.g. 5% Glucose. WAHT-CG-516 Page 12 of 32 Version 3

13 Prepared medication and reconstituted products will have a different expiry date to that given by the manufacturer, this will be no longer than 24 hours but may be less dependent on medicine stability. For further guidance the B.N.F. and the manufacturer's literature should be consulted. Exceptions to this will be for medicines where additional advice is provided by pharmacy e.g. medicine monographs for specific areas (e.g. ITU) or prescribing guidelines. 5.2 Checking of administration by a second person who is also authorised to administer the medicine, or who is a pharmacist, is required for injectable medicines in the following circumstances (Trust Medicines Policy): Checking of administration by a second person applies in the following circumstances: where a patient s condition makes it necessary when administering controlled drugs and two authorised persons are available on duty when a dose calculation is required (e.g. volume of liquid, fraction of reconstituted vial to administer, or a weight-related dose is to be administered) when administering medicines by intravenous bolus or infusion, via epidural catheter, and by infusion pump where continuous variable rate intravenous insulin infusion (sliding scale insulin) is prescribed administration of cytotoxics by any route when the medicine is to be administered to a child under 12 years of age when a clinical area s standard operating procedures defines that local circumstances make the involvement of two persons desirable e.g. units dependant on temporary agency or other locum staff a person training to administer a medicine(s) must always be checked by a person trained and authorised to administer the medicine(s) In addition to the above checking of administration requirements, registered nurses, midwives and ODPs (agency and Trust employees) must ensure that checking of administration by a second person who is also authorised to administer the medicine, or who is a pharmacist, takes place when administering medicines via the following route: intra-muscular injection direct subcutaneous injection subcutaneous infusion intradermal injection The exceptions to the second checking of administration requirement for registered nurses, midwives and ODPs are: Prophylactic dose of a low molecular weight heparin from a single dose prefilled syringe (enoxaparin or dalteparin) Vaccinations administered by occupational health nurses Injectable medicines outlined in section administered by midwives in an emergency situation or during a home birth when a second person is not present WAHT-CG-516 Page 13 of 32 Version 3

14 Any planned variations from this must be approved by Medicines Safety Committee. The Director of Nursing has authorised Third Party Agency Nurses/ODPs /Midwives and NHSP nurses/midwives/odps who are not employed by the Trust to undertake second checking of administration of all injectable medicines except chemotherapy, epidurals and paediatric medicines, provided that they have been inducted to the clinical area in line with the Trust agreed process and confirm to the Appointed or Assigned Healthcare Professional-in-Charge that they are trained and competent to do so and have read and understood the Trust s Medicines Policy and Injectable Medicines Policy. The registered practitioner administering the injectable medicine is responsible for informing the Third Party Agency Nurses/ODPs /Midwives and NHSP nurses/midwives/odps who are not employed by the Trust about MEDUSA and making it available to them in order for the second check to take place. When the administration of a medicine is checked by another person, this check must incorporate the whole administration process e.g. valid prescription, product accuracy, correct patient, check of infusion rate programmed into the appropriate device. If there are insufficient staff to administer and check according to this Policy, the Assigned Healthcare Professional-in-Charge must be informed at once who must escalate to the Matron or Nurse / Midwife bleep holder if the situation cannot be resolved, and complete a Datix incident report (with subcategory Medicines/Drugs ). 5.3 Medicine Calculations The calculation of injectable medicine dosages is a potential source of error. All staff authorised to administer injectable medicines must be satisfied that they have the ability to calculate the medicine dose safely and accurately, using standard formulas where necessary. When checking calculations all calculations must be conducted independently and the results of the calculations must correspond. If they do not, calculations 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 (or the oncall pharmacist) to check this is correct. Except for established exception of gentamicin (refer to Trust Guideline WAHT PHA-004) and acetylcysteine. 5.4 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 MEDUSA at Supply and Storage The NPSA requires the Trust to undertake risk assessments of injectable medicines procedures and products to identify high risks, and develop action plans to minimize them. WAHT-CG-516 Page 14 of 32 Version 3

15 There must also be a Purchasing for Safety Policy (see MedPolSOP19) to promote the procurement of injectable medicines with inherent safety features. For example, the purchase of ready-to-administer presentations, where available and necessary to reduce risks. Injectable cytotoxics and parenteral nutrition must be supplied to clinical areas only as ready-to-administer products (also see Medicines Policy ) Most medicines licensed for injectable use are intended for single use only and should not be used more than once. Exceptions include vials of insulin, which contain antibacterial preservatives; even so each vial must be reserved for a single patient and labeled with the patient s name. Epidural solutions should be stored separately from those intended for intravenous use. 5.6 Documentation All infusion therapy must be given in accordance with the instructions written by the prescriber on the Prescription Sheet for Infusions When medicines need to be added prior to administration these must also be prescribed and recorded on the Prescription Sheet for Infusion When a medicine has been added to the infusion a label must be attached to the container or syringe with the following information, ensuring that no information details/graduation markings are obscured: a) Patient s name and DOB b) Name and dose of the medicine c) Date and time of the addition d) Signature of those making and checking the additions e) Expiry date & time of infusion after reconstitution For continuous administration (e.g. via intravenous infusions or syringe driver) there shall be a record on the Prescription Sheet for Infusions of those involved in setting up the medication On cessation of an infusion containing a Controlled Drug before it has been fully used i.e. on the death of a patient or discontinuation of the infusion, the remainder should be destroyed and a record to this effect must be made in the Controlled Drug Register (see section of the Medicines Policy ). 5.7 Treatment of anaphylaxis during/following injectable therapy Signs and Symptoms of Anaphylactic Shock Angio-oedema/laryngeal oedema Rash urticaria/erythema Hypotension WAHT-CG-516 Page 15 of 32 Version 3

16 Bronchoconstriction Rhinitis/conjunctivitis Abdominal pain, vomiting and diarrhoea Collapse For the treatment of anaphylaxis see Trust Anaphylaxis Policy WAHT-ANA Adverse reaction during administration of injectable medicines or infusion If a patient exhibits any adverse reaction receiving an injectable medicine it must be stopped and the medical/dental officer notified. It should only be continued on his/her decision The medical/dental officer is responsible for taking 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 and follow Medicines Policy procedure MedPolSOP If a defect in an infusion is suspected take specimens for blood culture from another vein and follow the procedure for Defective Medical Products (section 5.8 of the Medicines Policy ) Watch any other patients having medication of the same batch. The order of use of the containers concerned should be noted. When the medication has been completed the containers should be retained for a period of 24 hours to ensure that they can be examined should any reaction follow All suspect containers and accessories should be labelled and returned to pharmacy at the earliest opportunity The senior nurse and senior pharmacist on duty (or the on-call pharmacist) should be informed immediately and the procedure MedPolSOP15 followed 5.9 Extravasation Extravasation is the inadvertent administration of vesicant drugs or solutions into the surrounding tissues instead of the intended vascular pathway (RCN 2010) Vesicant solutions have the potential to cause blistering and tissue damage which may lead to necrosis and damage to underlying nerves, tendons and blood vessels. Risk factors Patient factors neonates, patients unable to vocalise, unable to sense pain Medicine factors cytotoxic, vasoconstrictor, irritant (ph, osmolarity), vasoactive Administration factors site, method of venepuncture (see Cannulation Policy) Sign and Symptoms Pain at the intravenous site may be modest or severe, usually burning or stinging. There may be erythema, swelling and tenderness, and lack of blood return from the cannula. Not all of these symptoms may be present. Local blistering is indicative of at least a partial-thickness skin injury. There may also be mottling and darkening of the skin, persistent pain, and firm induration. WAHT-CG-516 Page 16 of 32 Version 3

17 Early firm induration, with or without tenderness, has been shown to be a reliable sign of eventual ulceration. When the full thickness of the skin is damaged, the surface may appear very white and cold with no capillary filling, and later may develop a dry, black eschar. Ulceration is not usually evident until one or two weeks after the injury when the eschar sloughs to reveal the underlying ulcer cavity. Ulcers have a typical necrotic, yellowish fibrotic base with a surrounding rim of persistent erythema. Escalation details and Treatment Stop the administration IMMEDIATELY leaving the cannula in place (for cytotoxics see relevant Cancer Network Policy) Aspirate the residual medicine through the cannula Elevate the limb Inform medical staff immediately Where appropriate, medical staff should refer to the Trust extravasation policy Guideline for the management of extravasation of a cytotoxic agent or a monoclonal antibody used in the treatment of malignant disease (WAHT-HAE-014) During the day (Mon-Fri) Medicines Information (ext ) can also contact medicine manufacturers to check if there is any further information on specific medicines. In the case of a severe extravasation where surgical intervention may be needed (e.g. skin breakdown and/or tissue necrosis), the patient s consultant or registrar should be contacted, who may consider a referral to the plastics team at University Hospital Birmingham. Documentation Document in the patient s notes: Medicine involved and approximate amount, appearance of site, date/time of incident, administration technique, needle size, type and insertion site, patient s symptoms, name of person administering and doctor notified, follow up procedure Report as a patient safety incident on Datix. 6. Implementation of the Policy 6.1 Plan for implementation This Policy is implemented via publication on the Trust intranet, the Trust IV Therapy Course for Nurses/Midwives/Radiographers and is included in medical staff induction. 6.2 Dissemination This Policy is available on the Trust intranet. 6.3 Training and awareness WAHT-CG-516 Page 17 of 32 Version 3

18 Training requirements are included in the Trust s Training Needs Analysis Appendix A of the Trust s Mandatory Training Policy. 7. Monitoring and compliance An audit of compliance will be undertaken and reported in the Annual Medicines Management Report. The report will also include the following: the results of risk assessments of injectable medicine practices the ranges of products used in clinical areas incident reports and associated harm compliance with NPSA recommendations action required to improve poorly performing aspects of the system The report will be approved by the Medicines Safety Committee and Patient Safety Committee and form part of the Trust s assurance framework. 8. Policy Review This Policy is reviewed by the Medicines Safety Committee every 2 years, as part of the Medicines Policy Review Process 9. References Injectable Medicines Administration Guide 2 nd edition, Pharmacy department, University College London Hospitals, Blackwell Publishing MHRA Medical Device Alert MDA/2005/030 All brands of needle-free intravascular connectors MHRA Medical Device Alert MDA/2007/051 All brands of needle-free intravascular connectors MHRA Medical Device Alert MDA/2007/089 Intravenous (IV) infusion lines: all brands MHRA Medical Device Alert MDA/2008/016 Needle-free intravascular connectors: all brands National Patient Safety Agency Patient Safety Alert Promoting safer use of injectable medicines March 2007 NPSA/2010/RRR013 Safer administration of insulin European Oncology Nursing Society 2007 Extravasation Guidelines Ingram P, Lavery I (2007) Peripheral intravenous cannulation: safe insertion and removal technique. Nursing Standard. 22,1, NS355 Lavery I, Ingram P (2006) Prevention of infection in peripheral intravenous devices. Nursing Standard. 20, 49, Hoctor B (2009) Nurse cannulation: introducing an advanced clinical skill. Nursing Management. 16, 6, Epic2:National Evidence-based Guidelines for preventing healthcare-associated infections in NHS Hospitals in England. WAHT-CG-516 Page 18 of 32 Version 3

19 Dougherty, L and Lister, S (2008) The Royal Marsden Hospital Manual of Clinical Nursing Procedures 7th Edition Oxford: Blackwell Science Limited RCN (2010) Royal College of Nursing Standards for Infusion Therapy NHS Pharmaceutical Quality Assurance Committee Multiple Use of Injections 3 rd edition November 2004 NMC (2008) Code of Professional Conduct, Standards for Conduct, Performance & Ethics London NMC NMC (2010) Standards for Medicines Management WAHT Medicines Policy on the Prescribing, Requisition, Storage, Administration and Control of Medicinal Products. WAHT Blood Transfusion Policy WAHT Treatment of Acute Anaphylactic Reactions in Adults Policy DOH Saving Lives High Impact Interventions nos. 1,2,3 (August 2007) NPSA Never Events NPSA Loading Doses 10. Background 10.1 Equality requirements This Policy and Procedures for administration of injectable medicines have been assessed by the Medicines Safety Committee as having NO IMPACT on equality and diversity on the grounds of race, religion/belief, or disability and NO IMPACT on Race Relations Financial Risk Assessment This Policy and Procedures for administration of injectable medicines have been assessed by the Director of Nursing and Medicines Safety Committee as requiring no financial support that is additional to that already in place Consultation Process This Policy and Procedures are reviewed and updated by the NPSA Injectable Medicines sub-group of the Medicines Safety Committee, which includes the Lead Nurse for IV Therapy and representatives of all professional groups administering injectable medicines are invited to participate Approval Process This Policy and Procedure is approved by the Medicines Safety Committee. WAHT-CG-516 Page 19 of 32 Version 3

20 Appendices Appendix A Procedures for preparation, mixing and administration of intravenous, intramuscular and subcutaneous medication. Procedure 1 preparing to administer injectable medicines Injections should be administered only by healthcare staff or patients/carers who understand the risks involved, have been trained to use safe procedures, and who have demonstrated their competence for the task. Before administration, the following should be available: a current prescription, a Patient Group Direction or other written instructions, essential technical information and a prepared and labelled injectable medicine. The patient's identity and details should be confirmed according to local 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 in 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. Consideration should be given to the use of safer products and systems of administration, for example, double-checking, use of smart infusion pumps or similar rate control technologies. The selection, preparation and administration of IV medications should be checked by a second registered member of staff All required materials should be assembled in a clean location designated for the task. The area should be clean, uncluttered and free from interruption and distraction. Infusions should be monitored according to local policy to ensure safe administration of prescribed treatment a) Identify the patient who is to receive the medicine by their wristband. (The wristband must have the patient s name, patient number and date of birth). Then check the cannula site for inflammation and pain. Compare it with the visual phlebitis score as a guide to whether you should continue with the procedure or ensure device is resited. Document the Phlebitis score if not previously documented that day or the score differs from that documented. b) Select the medicine (including diluent and/or infusion fluid where required) and all the equipment required to give the medicine, including flushes. Check that the packaging of all equipment is intact prior to use. c) Check the medicine against the prescription chart and check the expiry date, container and fluid, compatibility between the medicine and the reconstitution fluid and/or infusion fluid. Decontaminate hands thoroughly and put on non-sterile gloves. WAHT-CG-516 Page 20 of 32 Version 3

21 Procedure 2 - reconstituting and drawing up injectable medicines. Many injectable medicines are already in liquid form but some are presented as powder in vials and must be reconstituted before use. The following procedure should be used for those medicines requiring reconstitution. a) Open the ampoule/vial of diluent and draw up the appropriate amount using a blue 23 gauge needle or blunt ended filter needle attached to the syringe. WARNING All regular and single insulin (bolus) doses are measured and administered using an insulin syringe or commercial insulin pen device. Intravenous syringes must never be used for insulin administration. b) Flick the cap off the medicine vial. Clean the exposed rubber bung with Chlorhexidine 2% and Isopropyl Alcohol 70% (PDI Sanicloth) and allow to dry. c) Inject the correct diluent volume as stated by the manufacturers/bnf into the vial to dissolve the medicine (see 5.4 Displacement Values) d) To avoid aerosol formation, keep the needle above the fluid and withdraw air from the vial equal to the amount of diluent inserted (e.g. 3 ml). e) Unless otherwise directed, gently agitate the diluent and the medicine in the vial until the solution is clear. Keep the needle and syringe attached. f) Gently reinsert the air from the syringe into the vial. g) Draw up the medicine solution from the vial into the syringe; angle the vial until the last few drops of the solution can be drawn up into the syringe. h) Disconnect the syringe containing the medicine solution, leaving the needle in the vial; place a new Blue needle on the end of the syringe. i) Put the prepared syringe, vial, diluent (if used) container and alcohol swab in a suitable rigid receptacle. j) Immediately label the prepared medication (unless given immediately) Do not leave unlabelled syringes unattended or in the presence of other unlabelled medication as this may lead to error/. k) Administer the medicine and dispose of all equipment according to local policy e.g. at the point of use. l) Document (see section 5.6 of this policy) WAHT-CG-516 Page 21 of 32 Version 3

22 Procedure 3 - medicine administration by direct intravenous (bolus) injection via peripheral or central venous cannula. This method is used to give a small volume of medicine into the cannula or injection site of the administration set, using a syringe/needle. This may take a few seconds (as in an emergency in order to get the maximum concentration of the medicine to vital organs), or 3 to 5 minutes, as for most antibiotics (unless specific time stated). Alternatively, administration into the injection site of a fast running infusion may be advised, if the infusion fluid is compatible with the medicine. If it is not compatible, a stop-start procedure can be used: The infusion fluid is switched off and 2 to 5ml sodium chloride solution 0.9% used as a flush before administering the medicine. If a number of medicines are being administered, flush as above between each, to prevent interactions. Flush again at the end of the administration. The infusion fluid can then be restarted. The insertion site should be checked throughout the procedure for swelling or redness. Patients must be consulted regularly about any pain or discomfort they may be experiencing. Whichever port or site is used for medicine administration, it must be cleaned with 2% chlorhexidine/70% isopropyl alcohol swab (e.g. PDI Sani-Cloth CHG 2%) prior to procedure. This procedure may be carried out via the following ports or sites: a) The injection site of any intravenous administration set. b) Needle free connector. NB If Bionector needle free connector is being used, manufacturer s instructions must be followed and any defective device discarded and replaced. Prior to use, the device should be checked to ensure that the top/septum of the connector is in its closed/home position. For application of IV lines/catheter fitted with these connectors, follow the manufacturer s instructions for use In the event of cardiac arrest the top port of the cannula should be used for the Aurum prefilled syringes, not the Bionector c) A three-way tap or extension line into a C.V.P. line. d) A Y extension line is preferable to a 3-way stopcock to reduce bacterial contamination. e) The capped port of the peripheral cannula The injection port of the cannula should be recapped after use. If obturator caps have been removed to administer medicines, replace with a sterile obturator cap. If it is necessary to administer intravenous medicines by means of a syringe pump then either the syringe pump should be connected to an intravenous access separate from a normal drip. If venous access is difficult, use a 2 or 3 tailed device with nonreturn valves. Packaging of equipment should be checked carefully to ensure the chosen device does have non-return valves. WAHT-CG-516 Page 22 of 32 Version 3

23 Procedure 4 - preparation of intravenous medicine infusions for use a) Use aseptic-non touch technique b) Addition of medicines to intravenous fluids: Medicines should only be added to an infusion when the intravenous route is prescribed. If adding medicines to an infusion bag a blue needle or smaller should be used to prevent leakage/prevent channel for infection When using syringe pump/drivers, the size of the syringe used must be specified. All pumps are calibrated to a specific manufacturer of syringes therefore the correct syringe must be used for the pump being used e.g. only BD Plastipack syringes must be used in any pump calibrated for BD Plastipack. Extension sets connected to syringe pump/drivers, where possible (in line with NPSA (2010) recommendations) should have clamps and anti-siphon valves to guard against accidental siphoning of medications. If using Bionector, see Procedure 3 section (b) When drawing diluent for syringe pumps, a needle larger than a blue is sometimes used. In this circumstance extra care should be taken to inspect the syringe for particulate matter or a filter needle used. When continuous infusion is prescribed, the medicine must be THOROUGHLY mixed with the fluid and administered at the prescribed rate. Prepare the solution immediately before administration and use within time stated on the package insert. Administration of potassium chloride is potentially hazardous. Standard solutions with Potassium Chloride included are available and should be used whenever possible to avoid the need to add concentrated solutions of Potassium Chloride to infusions. SEE MEDICINES POLICY PROCEDURE MedPolSOP23 before administering any potassium infusion >40 mmol/litre. There are safety restrictions on the availability of potassium ampoules and strong potassium infusions (>40mmol/litre) It is recommended that all intravenous infusions containing Potassium Chloride are delivered via an infusion device. All potassium infusions with a concentration of more than 40mmol per litre MUST be given via a pump or syringe driver. For intravenous use antibiotics should be given by bolus or intermittent infusion unless continuous infusion specifically indicated. Medicine must not be added to a partly used infusion. Multiple additions of medicines to a fluid should be avoided. Medicines should not be added to, or run through the same giving set as: - Any blood product including plasma, platelets and albumin Lipid Preparations Mannitol WAHT-CG-516 Page 23 of 32 Version 3

24 Sodium Bicarbonate Parental Nutrition Where specific information is not available (e.g. British National Formulary, UCL Guide) a Pharmacist should be consulted or contact Medicines Information ext Repeat the examination procedure after adding and mixing of any medicine and again during administration, rejecting if any precipitation, particles, cloudiness or unexpected colour change is present, and immediately inform the prescriber. The container with added medicine must be labelled Procedure 5 - maintaining and monitoring an intravenous infusion a) Frequent checks should be made of the infusion rate and volume remaining and the prescription, and these should be recorded on the appropriate chart. b) For small volume medicine infusions e.g. 100ml and depending on the giving set used, the volume remaining in the line may represent a significant proportion of the medicine dose. Where this is the case and the line will not be flushed by an already prescribed compatible infusion, a 50ml to 100ml sodium chloride 0.9% mini bag may be prescribed and administered to ensure the patient receives the whole dose. Caution should be exercised where patient is fluid restricted. c) When a patient has an infusion running and an additional, continuous infusion is required, it is preferable for the medicine infusion to have its own venous access for administration, even if the medicine and fluid are compatible. If this is impossible to achieve and both infusions have to use the same venous access, then both should have a one-way valve in place. Wherever possible both infusions should also be controlled via a mechanical device such as a syringe pump or infusion pump. WAHT-CG-516 Page 24 of 32 Version 3

25 Procedure 6 Intramuscular Injections Intramuscular (I.M) injections deposit medication deep into muscle tissue. This route of administration provides rapid systemic action and absorption of relatively large doses (up to 5ml in appropriate sites). Common sites used for IM injection are the mid deltoid, dorsogluteal, rectus femoris and vastus lateralis injection sites. Preparation Patient Equipment/Environment Registered Practitioner Explain the procedure and gain patient s consent and cooperation. Check the patient understands the reason for injection. Select the site of injection and assist patient into a comfortable position. Prescription chart. Prescribed medication and diluent if needed. Clean plastic tray with sharps bin. Sterile syringe (2-5 ml) Two Sterile needle usually (21G) & (23G). 2% alcohol wipes. Knowledge of the local drug policy, medication informations (indications, therapeutic dose, common side effects) are vital. Make sure the medication is labelled for IM route. Wash and dry hand thoroughly and wear protective clothing appropriately. Procedure Check drugs against the prescription chart and patient s wrist band. Open the syringe and needle from the packaging and attach a filter needle or a 23G needle firmly to the syringe using aseptic non touch technique and place it in the tray. If using a glass ampoule, clean the ampoule s neck with 2% alcohol wipes, let it dry and snap off the top, directing the force away from your body. Withdraw the medication from the ampoule and tap the syringe to clear air from it and discard the filter needle or the 23G in the sharps bin and replace with an appropriate needle for administration to the syringe using aseptic non touch technique. WAHT-CG-516 Page 25 of 32 Version 3

26 If the medication is in powder form, draw up the diluent, clean the rubber stopper of the vial/ampule with 2% alcohol wipe and allow it to dry. Inject the appropriate amount of diluent into the vial/ampoule. Mix thoroughly by gently agitating or rolling the container until all the powder has dissolved. Making sure that the needle remains below the surface of the liquid, draw the medication into the syringe. Hold the syringe upright and expel the air, ensure droplets of liquid are seen at the top of the needle and discard the needle in the sharps bin and replace with an appropriate needle for administration of injection. Take the tray containing the made up syringe, ampoule/vial, alcohol swabs and the sharps bin to the patient. Check the medicine and prescription again and the patient s ID band. Ensure privacy and select site and assist patient to a suitable position. Clean the skin with alcohol swab and allow it to dry. With the thumb and index finger of your non-dominant hand gently stretch the skin of the injection site taut. Holding the syringe like a dart in your dominant hand, inform the patient, then insert the needle swiftly and firmly at an angle of 90 to the skin. Leave cm of needle showing. Support the syringe with the non-dominant hand, pull back slightly on the plunger with your dominant hand to check for blood, and if no blood slowly inject the medication into the muscle. A slow and steady injection rate allows the muscle to distend gradually and accept the medication under minimal pressure. After the injection, wait for several seconds to facilitate absorption of the drug then gently but quickly remove the needle at the same angle that you inserted and release the skin from your hand. Apply pressure with gauze on the site until any bleeding stops. Dispose of the needle and syringe as one unit in the sharps bin. Do not resheath the needle. Post Procedure Patient Equipment/Environment Registered Practitioner Assist the patient into a comfortable position and help to dress up as needed. Intramuscular medicines given will usually take effect within 20 minutes. Check for desired effects and for side effects. Clean and discard equipment appropriately. Wash and dry hands thoroughly. Sign the prescription chart to indicate the medication has been administered. Points to remember IM injections should not be administered at inflamed, oedematous, sensitive or irritated sites, or at sites that contain moles and birthmarks. WAHT-CG-516 Page 26 of 32 Version 3

27 IM injections may be contraindicated in patients with impaired coagulation mechanisms, peripheral vascular disease or oedema. If a patient needs regular IM injection keep a rotation record that lists all available injection sites. Procedure 7 -Subcutaneous injection Subcutaneous injections (S/C) are delivered into the adipose tissue beneath the skin for a slower and more sustained drug administration than IM injections. Drugs and solutions are injected through short needles. Common sites are upper arms, anterior thigh, abdomen, upper hips, buttocks and upper back. Preparation Patient Equipment/Environment Registered Practitioner Explain the procedure and gain consent and cooperation. Assist patient to choose the injection site. Prescription chart. Prescribed drugs (often are prefilled syringes with needle). Clean plastic tray with sharps bin. Syringe (0.5-2 ml) if needed. Orange (25g) needle if needed. 2% cinell wipes to wipe vials and ampules. Knowledge of local drug policy and drug information (indications, therapeutic dose, common side effects) are vital. Wash and dry hands thoroughly and to wear protective clothing as appropriate. WAHT-CG-516 Page 27 of 32 Version 3