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Needle Stick Injury Title of Guideline (must include the Guideline for the management of needlestick word “Guideline” (not protocol, injury in children policy, procedure etc) Contact Name and Job Title (author) Dr Louise Wells, Consultant Paediatrician Directorate & Specialty Directorate: Family Health; Specialty: Emergency Date of submission August 2016 Date on which guideline must be reviewed July 2020 Explicit definition of patient group to which it applies (e.g. inclusion and This guideline applies to all children and young people exclusion criteria, diagnosis) under the age of 19 years. Abstract This guideline describes the management of needlestick injury in children Key Words Children; Paediatrics; Needle stick; injury Statement of the evidence base of the guideline – has the guideline been peer reviewed by colleagues? 1a meta-analysis of randomised controlled trials 2a at least one well-designed controlled study without randomisation 2b at least one other type of well-designed quasi-experimental study 3 well –designed non-experimental descriptive studies (i.e. comparative / correlation and case studies) 4 expert committee reports or opinions and / or clinical experiences of respected Yes authorities 5 recommended best practice based on the clinical experience of the guideline developer Consultation Process Childrens Services Guideline Process Target audience Staff of Nottingham Children’s Hospital This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date. Louise Wells Page 1 of 10 Issued: August 2016 Document Control Document Amendment Record Version V1 V2 V3 Issue Date November 2011 November 2013 June 2016 Lead Author Dr Louise Wells Dr Louise Wells Dr Louise Wells Description Review contact details Review PEP isis guidelinePEP guidelines General Notes: Change made in this update: Post exposure prophylaxis (PEP) guidance has changed. This update includes the new recommendations for this. Contact details updates Most recent National Guidance reviewed and their recommendations included (frequency of blood tests and follow up included) Statement of Compliance with Child Health Guidelines SOP This guideline has had only minor changes made and therefore this version has not been circulated to all for review. A previous version had been approved by circulation to senior team members. Martin Hewitt Clinical Guideline Lead 5th October 2016 Louise Wells Page 2 of 10 Issued: August 2016 Needle Stick Injury In Children HIV HBV HCV vaccination Dr Louise Wells June 2016 Overview Injury from discarded needles is not uncommon in children (10‐15 cases presenting to NUH paediatric ED each year). The management of such injuries has to be realistic and based on the best available evidence. The main risk comes firstly from hepatitis B and then hepatitis C (HBV and HCV) transmission whereas the main public concern will frequently be with regard to transmission of Human Immunodeficiency Virus (HIV). No data exists on the efficacy of antiretroviral Post Exposure Prophylaxis (PEP) apart from in the health care setting. Some Paediatricians have prescribed PEP on an individual basis when the risk of HIV is considered high. Following exposure to blood-borne viruses, it should be remembered that the risk of transmission is highest for Hepatitis B, then Hepatitis C and then HIV. As this document has been prepared for the CHIVA website its focus is on HIV. However, it is important to consider risk of pregnancy and sexually transmitted infections following high-risk sexual exposure, and any safeguarding concerns General Measures. Record details of the exposure incident Assess significance of exposure Assess infectivity of source (most will be unidentifiable) ✔ Encourage bleeding at the site of injury ✔ Wash thoroughly with disinfectant and water ✔ Cover the wound with a dressing Blood Samples. Blood should be obtained from the child exposed after obtaining informed consent from those with parental responsibility. The discussion should be documented in the notes, but written consent is not required. This should be 2mls of clotted (red top) and sent to microbiology for serum save, HIV, hepatitis B and C serology. FBC, U and Es and LFTs should also be sent if PEP is being considered. Storage should then be arranged with the laboratory. Clearly label the samples as high risk with yellow stickers and biohazard bags and do not sent by chute. The child should be tested for HIV PCR and antibodies 2 months post exposure and hepatitis serology 2 and 6 months post exposure. Counselling will clearly be then be required if the tests are positive as reference will then need to be made to the original stored sample. The implications of a positive result from the pre‐exposure sample for both parents (are we bleeding parents as routine?) and children should be discussed. Literature is available and parents should have access to this (contact CSSU or HIV liaison nurse in ED). If the baseline result is positive follow up testing will need to be arranged for parents. This should be arranged with the consultant responsible and the GU clinic at NCH. The issue of testing other members of the family will need to be addressed. Assess Risk of Exposure. Take a careful history and examination to assess the risk of exposure to HIV. Establish whether exposure occurred within the last 72 hours. Dr Louise Wells June 2016 No Risk Intact skin visibly contaminated with blood or bodily fluids Action Reassure parents and child Discharge Low Risk Action Superficial injury that does not draw blood Associated with needle/instrument not visibly contaminated with blood or bodily fluid Counsel family about risks of HIV, HBV and HCV transmission Recommend standard HBV immunisation: Day 0, 1 month, 6 months (or booster if already immunised) PEP not recommended (explain risks of HIV PEP drug side effects (see table 2) which outweigh the extremely low risk of HIV transmission). Moderate Risk Skin penetrating injury that draws blood by needle/instrument contaminated with blood or body fluid Wound causing bleeding and produced by sharp instrument visibly contaminated with blood Action Counsel family about risks of HIV, HBV and HCV transmission Recommend standard HBV immunisation: Day 0, 1 month, 2 months (or booster if already immunised) Discuss risks of HIV PEP (see table 2) Consider HIV PEP but on balance the risk of drug side effects from PEP probably outweigh the benefit. High Risk Significant exposure to blood or body fluids from source known to be HIV, HCV or HBV infected Action Counsel family about risks of HIV, HBV and HCV transmission Recommend standard HBV immunisation: Day 0, 1 month, 2 months (or booster if already immunised) Consider HBV Ig if source is a highly infectious HBV carrier and child is susceptible (see below, under Management) Discuss risks of HIV PEP (see table 2) Recommend starting Standard HIV PEP (later modifications may be required dependent on source's current viral load, treatment history and viral resistance). Specific Measures. HIV The risk of HIV transmission following needlestick injury from a known positive source is 0.3%. This figure is based on a number of studies within the health care environment. The risk is altered by the amount of blood inoculated, depth of wound and viral load of the source In rare situations the source may be known, and if the individual gives consent HIV, HBV and HCV serology may be tested. If the source is already known to be HIV positive, obtain details of present and past antiretroviral medications, and known resistant mutations In the community the risk will be substantially lower. The seroprevalance of HIV in Nottingham is low (0.03%) and HIV is a fragile virus with its infectivity reducing rapidly with time outside the body Dr Louise Wells June 2016 Two small studies following up children after sustaining needlestick injuries from discarded syringes found no HIV infection PEP is only recommended for needlestick injuries where the source is a known HIV carrier. In needlestick injuries in the community PEP will rarely be recommended and only be given in exceptional circumstances after discussion with the consultant on call Post Exposure Prophylaxis (PEP). The current recommendations are (www.chiva.org.uk): 1. Children aged 10 years and over and over 35kg (who are able to swallow tablets) : raltegravir and Truvada® 2. Children aged 10 years and over with renal insufficiency: raltegravir and a fixed dose combination of lamivudine/zidovudine 3. Children aged 6-10 years: Raltegravir and lamivudine and zidovudine 4. Children aged <6 years: Kaletra® and lamivudine and zidovudine The doses for children are shown below, should be started ideally within an hour of exposure (but up to 72 hours following exposure can be considered) and should be given for 28 days: HIV PEP Drugs, Doses, Side effects and Interactions Drug Formulation Dose Side Effects Raltegravir (RAL) (for child >6y) Tablet: 400mg Chewable tablet: 25mg Tablet: From 25kg: 400mg BD Chewable tablet: 11-14kg – 75 mg BD 14-20kg – 100mg BD 20-28kg – 150mg BD 28-40kg – 200mg BD >40kg – 300mg BD Rash, nausea, hepatitis NB: tablet and chewable tablet are not bioequivalent Zidovudine (AZT, ZDV) (for child <10y) Capsule: 100mg, 250mg Liquid: 10mg/ml Capsule or liquid: 180mg/m2/dose BD to a max dose of 250mg BD (max. 300mg BD when used in combination products) Granulocytopenia and/or anaemia, nausea, headache, myopathy, hepatitis, neuropathy. Lamivudine (3TC) (for child <10y) Tablet: 100mg, 150mg Liquid: 10mg/ml Tablet or liquid: 4mg/kg/dose BD to a maximum dose of 150mg BD Peripheral neuropathy, nausea, diarrhoea, headache. Truvada® (TDF+FTC) (for child >10y) Combined tablet: TDF 300mg/FTC 200mg Combined tablet: >35kg – 1 tablet OD Headache, diarrhoea, nausea, vomiting, renal tubular dysfunction, bone demineralisation NB: do not use in children with renal impairment Dr Louise Wells June 2016 Lamivudine/zidovudine Combined tablet: (for child >10y with 3TC 150mg/ZDV renal insufficiency) 300mg Combined tablet: >30kg – 1 tablet BD As for ZDV and 3TC Kaletra® (LPV/RTV) (for child <6y) Liquid: 300mg/m2/dose BD Dose in mls = (300 × SA)/80 Paed tablet: 15-25kg – 2 tabs BD 25-35kg – 3 tabs BD >35kg – 4 tabs BD Adult tablet: >35kg – 2 tabs BD Diarrhoea, abdominal pain, nausea, vomiting, headache. Liquid: LPV 80mg/ RTV 20mg/mL Paed tablet: LPV 100mg/RTV 25mg (yellow) Adult tablet: LPV 200mg/RTV 50mg (orange) NB: 2 adult tablets = 4 paediatric tablets = 5ml of liquid. In the case of a known source, it may be possible to check the sensitivities of their virus to this combination and suggest a more suitable treatment. If you are planning on commencing PEP and the child is already on other medications please utilise the following website or liaise with your trust pharmacist to ensure there are no known potential drug interactions. http://www.hiv-druginteractions.org Hepatitis B. The risk of transmission of Hepatitis B following needlestick injury is 30% when the contact is known to be Hep B eantigen positive and 20% when the contact is known to be Hep B sAg positive but e antigen negative. The risk of HBV transmission depends on: 1. Significant exposure Percutaneous exposure (needlestick, bites or other injuries resulting in bleeding or visible skin puncture) or muco-cutaneous exposure to blood (contamination of non intact skin, conjunctiva or mucous membranes) 2. HBV status of the source In most community needlestick injuries the source will be unknown and unidentifiable. If the source is available blood should be obtained for urgent Hep B sAg testing and blood should also be stored 3. HBV status of the exposed child Most children will be of unknown HBV status. An initial exposure blood should be obtained from the exposed child and stored. An accelerated course of HBV vaccination at 0, 1 and 2 months should be arranged if significant exposure from an unknown source occurs in a non‐vaccinated child. The first dose should be given prior to discharge. The following 2 doses should be arranged with their GP. Blood should be taken in 3 months and 6 months to ensure an adequate response has been mounted. In a significant exposure from a known positive source (especially if e antigen positive), Hepatitis B immunoglobulin should be considered, although some studies in vertical transmission have found the additional benefit over accelerated vaccination minimal. Dr Louise Wells June 2016 Hepatitis C. Hepatitis C is a blood borne transmissible viral disease. Studies show that the risk of transmission post needlestick is as low as 0.2 to 0.4%. PEP with interferon has been shown to be ineffective, however there is evidence that interferon alpha 2B can prevent chronic infection if used during the initial acute illness (98% clearance in one study). Again the treatment is sensible reassurance, a stored sample and repeat serology in 3 months and 6 months for Hepatitis C antibodies. Follow Up. Prior to discharge, families embarking on HIV PEP should have the following: An outpatient appointment, preferably within the next 72 hours to see a named clinician with experience in prescribing antiretroviral drugs Contact telephone numbers in case of concerns about any aspect of the HIV PEP 5 days of Antiretroviral therapy (with anti‐emetic and anti‐diarrhoeal for prn use) A letter for their GP, with patients/parents’ consent Outpatient Visits. Within 72 hours: Review in clinic, assess adherence and toxicity Decide whether PEP should continue for the full four‐week course. Document and give baseline HIV, HBV, HCV Ab results. Arrange psychological support as necessary. Day 14: Review in clinic, assess adherence and toxicity Check FBC, U&E, LFTs. Day 28: Review in clinic, assess adherence and toxicity Check FBC, U&E, LFTs (if abnormalities on previous blood tests). 1-3 months AFTER PEP completion (8 weeks from high risk exposure) Follow‐up HIV testing should be undertaken with a fourth generation combined HIV antibody/ antigen assay. Antibody screening for Hepatitis B and C is recommended. (Optimally 4-8 weeks after completing the 3 doses of HBV vaccine) References Marcus R. Surveillance of health care workers exposed to blood from patients infected with the human immunodeficiency virus. N Engl J Med 1988;319:1118‐23. Centres for Disease Control and Prevention. Case‐control study of HIV seroconversion in health‐ care workers after percutaneous exposure to HIV‐infected blood – France, United Kingdom, and United States, January 1988‐August 1994. MMWR Morb Mortal Wkly Rep 1995;44:929‐33. Montella F, Di Sora F, Recchia O. Can HIV‐1 infection be transmitted by a “discarded” syringe? J Acquir Immune Defic Syndr 1992;5:1274‐5. Aragon Pena AJ, et al Hepatitis B prevention and risk of HIV infection in children injured by Dr Louise Wells June 2016 discarded needles and/or syringes Aten Primaria 1996;17:138‐40. Department Of Health, HIV post‐exposure prophylaxis: Guidance from the UK Chief Medical Officer's Expert Advisory Group on AIDS February 2004 http://www.dh.gov.uk/assetRoot/04/08/36/40/04083640.pdf Yang YJ, et al Role of hepatitis B immunoglobulin in infants born to hepatitis B e antigen‐ negative carrier mothers in Taiwan. Pediatr Infect Dis J. 2003 Jul;22:584‐8. Chung H, et al. Risk of HCV transmission after needlestick injury, and the efficacy of short‐ duration interferon administration to prevent HCV transmission to medical personnel. J Gastroenterol. 2003;38:877‐9. Elmar Jaeckel, M.D et al Treatment of Acute Hepatitis C with Interferon Alfa‐2b N Engl J Med 2001; 345:1452‐1457. http://content.nejm.org/cgi/content/full/345/20/1452 Other Guidelines. Children’s HIV association http://www.chiva.org.uk Royal Children's' Hospital Melbourne http://www.rch.org.au/clinicalguide/cpg.cfm?doc_id=5231 Canadian Paediatric Society http://www.cps.ca/english/statements/ID/id99‐02.htm Appendix 1 ‐ Multidisciplinary units. The following are major units which can provide advice on the management of children and families with HIV infection. Many other units especially in London, are providing services for children and their families. Dr Sam Walters/ Dr Gareth Tudor‐Williams / Dr Hermione Lyall Dept Of Paediatrics QEQM Wing St Mary's Hospital Praed Street London W2 1NY Dr Diana Gibb / Dr Vas Novelli / Dr Nigel Klien Ms Clapsom (Nurse Counsellor) / Sue Trickett (Social Worker) Great Ormond Street Hospital For Children NHS Trust London WC1N 3JH Dr Mike Sharland / Wendy Faulkner (nurse) Dept Child Health St Georges NHS Trust Cranmet Terrace London SW17 ORE Dr Louise Wells Tel 0207 7256 666 Tel 020 7405 9200 x5946 Tel 0208 672 1255 June 2016 Dr Jaqueline Mok Consultant Paediatrician Edinburgh Sick Children's NHS Trust Community Child Health Services 10 Chalmer Crescent Edinburgh EH9 1TS Tel 0131 536 0971 National AIDS Helpline For more information about help available in your area, you can phone the National AIDS helpline at any time. The number is 088 567123 and calls are free and entirely confidential. They should be able to provide a variety of information including details of any support / self help groups in your area. Changes in this revision Changes to HIV PEP doses as per chiva guidance Dr Louise Wells June 2016