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POST-EXPOSURE PROPHYLAXIS (PEP) PROCEDURES TO BE FOLLOWED IN CASE OF ACCIDENTAL EXPOSURE TO BLOOD AND OTHER BODY FLUIDS Médecins Sans Frontières Medical Departments December 2004 Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 1 TABLE OF CONTENTS Preface................................................................................................................................................................................................3 Abbreviations ....................................................................................................................................................................................4 1. Introduction ..................................................................................................................................................................................5 2. Risks of transmission .................................................................................................................................................................6 2.1 Occupational exposure to blood and other body fluids ................................................................................................6 2.2 Sexual Exposure .......................................................................................................................................................................7 3. Preventing exposure to and transmission of HIV and other viruses..........................................................................8 4. Procedures to be followed to prevent hiv transmission after an accidental exposure to blood .....................10 4.1. Immediate First aid after an accident ........................................................................................................................... 11 4.2. Risk assesment of HIV transmission ..............................................................................................................................12 4.3. Deciding on therapy ..............................................................................................................................................................15 4.4. Post-exposure prophylactic (PEP) regimen for HIV ...................................................................................................17 5. Post-exposure measures against hepatitis B and C....................................................................................................... 20 6. Psychological support and information ...............................................................................................................................21 7. Follow up of an exposed person ........................................................................................................................................... 23 8. Accidental exposure to HIV through sexual contact................................................................................................... 25 9. Information and notification of the accident ................................................................................................................ 28 10. Practical details ...................................................................................................................................................................... 30 11. References ................................................................................................................................................................................31 Appendix 1: HIV, HBV and HCV prevalence by country ................................................................................................... 33 Appendix 2: Standard medicalAL precautions in health-care settings ....................................................................... 37 Appendix 3: Risk assessment guide for the source patient ............................................................................................ 38 Appendix 4: Accidental Exposure to Blood Notification Form ...................................................................................... 40 Appendix 5: Notification of an AE - HQ form .................................................................................................................... 42 Appendix 6: PEP Treatment Informed Consent/Refusal form ...................................................................................... 43 Appendix 7: Information sheet on prophylaxis and follow-up after an AE ............................................................... 44 Appendix 8: Emergency contraceptive regimen .................................................................................................................. 45 Appendix 9: Medical certificate for Swiss insurances .................................................................................................... 46 Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 2 PREFACE MSF provides post-exposure prophylaxis (PEP) to its staff in case of occupational or accidental sexual exposure. This guideline describes the risks of infection, the preventive measures and the procedures to follow in case of such exposure. This document is intended for medical doctors and is meant to assist in deciding when and how post-exposure prophylaxis should be given. This guideline has been prepared by the MSF international working group on AIDS, in consultation with specialists*. This third version has been updated in line with MSF field experience and the latest scientific advances on the issue; the main modifications are related to the indications of bi or tritherapy with anti-retrovirals for postexposure prophylaxis to blood or other body fluids. The international working group on AIDS Médecins Sans Frontières December 2004 * We acknowledge the useful comments on specific issues from: Pr Sven A. Danner (Academic Medical Centre, Amsterdam), Pr Elisabeth Bouvet, Dr M Gerard (Hospital Saint Pierre, Brussels, Belgium), the doctors of the Bichat Hospital, the doctors involved in the Groupe d'Etude sur le Risque d'Exposition au Sang GERES, Paris, Dr Anne Leentvaar (GG&GD, Amsterdam), Dr Jim V. Steenbergen (Landelijk Coordinatie Centrum Infectieziektenbestrijding, Netherlands) and Dr P ustero (Spain). Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 3 ABBREVIATIONS PEP AE AEB CDC HIV HBV HCV HQ HR AZT 3TC FDC NFV PLWHA STIs Post-exposure prophylaxis Accidental exposure Accidental exposure to blood Centre for Disease Control Human immuno-deficiency virus Hepatitis B virus Hepatitis C virus Headquarters Human resources Zidovudine Lamivudine Fixed Dose Combination Nelfinavir People living with HIV/AIDS Sexually transmitted infections Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 4 1. INTRODUCTION Most countries in which MSF is working face a high prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV) and hepatitis C (HCV) viruses (see appendix nº1). Transmission of these agents occur through: - sexual contact; - unsafe blood transfusion; - injury with a needle or any other sharp instrument contaminated with infected blood or other body fluids; - direct contact between infected blood or body fluids and cutaneous cuts or abrasions. Field workers are therefore at risk of infection through occupational exposure and accidental sexual exposure. MSF should assure that prophylactic treatment is available for MSF field workers (expatriate or nationals) who have experienced an accident involving exposure to blood or other body fluids as well as in case of involuntary high risk sexual intercourse (eg sexual abuse). The combination of 2 or 3 anti-retroviral drugs (according to the magnitude of exposure), administred during 28 days, is now the standard prophylactic treatment worldwide. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 5 2. RISKS OF TRANSMISSION 2.1 Occupational exposure to blood and other body fluids An accidental exposure (AE) is defined as : - any contact with blood or other body fluid as a result of a percutaneous injury with a needle or any other sharp instrument; - any exposure to blood or body fluid via mucous membranes (eye, mouth) or non-intact skin (wound, dermatitis, abrasion). Body fluids include : cerebrospinal fluid, semen, vaginal secretions, amniotic liquid or other body fluids contaminated with visible blood. The average risk for HIV transmission after a single percutaneous exposure to HIVpositive blood is low and this risk is considerably lower than that arising from hepatitis B and C viruses. Table 1: Risk for transmission after occupational exposure to infected blood1,2 Agents HIV HIV HBV HCV Exposure mode Percutaneous Mucocutaneous contact* Percutaneous exposure Percutaneous exposure Risk of infection 0.3% 0.03-0.09% 10-30% 0-10% *refers to the exposure of mucous membranes or cutaneous cuts or abrasions The most common procedures presenting a risk of percutaneous exposure with contaminated blood include the following: taking blood samples from arteries or veins and samples of other body fluids (see above), inserting and handling drips, particularly in emergency situations; activities related to surgery, particularly during major surgical interventions of long duration or where haemorrhage may occur; the handling of blood or infectious body fluids by laboratory staff; activities related to the cleaning, handling and destroying of contaminated medical material and medical waste. Performing these activities in a rush carries an additional risk. Personnel at risk does not only include medical staff but also non-medical staff of health facilities. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 6 2.2 Sexual Exposure Sexual exposure includes unprotected sexual intercourse including the case of broken or slipped condom. Sexual exposure through a forced intercourse requires special attention, as the risk for HIV transmission is higher. Risk of transmission3 - Proven: vaginal and anal penetration. - Possible: oral penetration with ejaculation. (In case of sexual violence: victim has bitten the rapist or been bitten by him and blood is present in the mouth, refer to exposure to blood chapter). - No risk: kissing; digital penetration or penetration by a foreign object in the vagina, anus or mouth; ejaculation onto intact skin. Table 2: Risk of HIV transmission after sexual exposure Type of exposure (from a source known HIV positive) Receptive oral sex Insertive vaginal sex Receptive vaginal sex Insertive anal sex Receptive anal sex 4-6 Risk of HIV transmission per exposure 0- 0.04% 0.03-0.09% 0.1-0.3% 0.03% 0.5-3% The risk of transmission is increased: - If blood is present - If any of the partners has a STI - In case of vaginal, anal or oral lesions (very frequent in case of forced intercourse) - If ejaculation took place - In case of multiple penetrations or mass rape Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 7 3. PREVENTING EXPOSURE TO AND TRANSMISSION OF HIV AND OTHER VIRUSES STAFF INFORMATION All MSF staff (expatriate and national) should be informed about how to protect themselves against HIV and other pathogens transmitted by blood or sexual contact. Medical coordinators have the responsibility to inform all new staff about: the universal precautions to be followed in health services (see Appendix nº2); the use of condoms in private life; other preventive measures to be taken against these viruses (including vaccination); the procedures to be followed in case of an accidental exposure or sexual abuse. Staff must be reminded of these precautions on a regular basis. All MSF staff share an individual and collective responsibility in this regard. According to the policy in each MSF section, MSF expats will have to follow the recommendations concerning HIV testing before departure. In MSFCH testing before departure is strongly advised but not compulsory. BIOSESAFETY COMPONENT IN EACH MSF PROJECT Every health care setting where MSF is working should apply effective standard universal precaution practices. Standard biosafety recommendations, especially for laboratory workers include: prevention of puncture wounds, cuts and abrasions and protection of existing wounds, skin lesions, the conjunctiva and mucosal surfaces protective measures to prevent contamination of the person and his clothing; basic hygiene practices control of surface contamination by containment and disinfection’s procedures effective use of sterilisation safe disposal of contaminated waste safe handling, transfer and shipment of specimens safe collection of blood samples (never pipette by mouth, never recap needles) (see biosafety guidelines for diagnostic and research laboratories working with HIVWHO 1991) Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 8 PROTECTION AGAINST HEPATITIS B AND C All MSF medical staff (national and expatriate) should be correctly vaccinated against the hepatitis B virus 1,7 : one dose at month 0, 1, 2 and 12, and boosters every 5 years.i An anti-HbS antibody control should preferably be carried out after the fourth dose (min. 1 month later), or if the recommended schedule was not properly applied, to check whether the level of antibody protection is sufficiently high. If the level of anti-HbS is lower than 10 IU/L, an additional dose is recommended (before the next scheduled booster).8 There is no danger in vaccinating someone who is already infected with HBV. There is no vaccine or prophylaxis available against hepatitis C. . Another scheme is widely used and recommended by MSF for staff not considered at risk (see MSF guidelines on expatriate health): 3 doses at month 0, 1 and 6. The need for boosters is still debated at scientific level and national recommendations for booster vaccination vary in each Western country. MSF prefers to stay on the safe side and recommend regular systematic boosters. i Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 9 4. PROCEDURES TO BE FOLLOWED TO PREVENT HIV TRANSMISSION AFTER AN ACCIDENTAL EXPOSURE TO BLOOD An AE is a medical emergency. The procedure must be conducted in such a way that the prophylactic treatment, if needed, is started as soon as possible - ideally within 1 or 2 hours - preferably within 4 hours - within 48 hours, in any case - in some cases, and at the latest, within 72 hours. Accidental exposure 4.1. Immediate first aid 4.2. Risk assessment by a medical doctor 4.3. Decision regarding therapy by medical doctor together with exposed person Offer of psychological support (Chapter 6) 4.4. Start of prophylactic treatment Notification (appendix 4 to 6) 7. Monitoring and follow-up Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 10 4.1. IMMEDIATE FIRST AID AFTER AN ACCIDENT PERCUTANEOUS EXPOSURE In case of injury by material contaminated with blood, contact between non-intact skin and blood or body fluid let the wound bleed (without scrubbing or squeezing), immediately wash both wound and surrounding skin with water and soap (without scrubbing), and then rinse; disinfect the wound and surrounding skin with: povidone iodine 2.5% (Betadine) during 5 minutes, or a solution of chlorine 12° chlorometric (diluted to 1/1Oth) during 10 minutes or alcohol 70% during 3 minutes. Avoid irritating solutions like caustic agents such as bleach. EXPOSURE AFFECTING THE EYES OR MUCOUS MEMBRANES Rinse the exposed area immediately with an isotonic saline solution during 10 minutes. Antiseptic eye drops can also be used for eye exposure. If none of these solutions are available, use clean water. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 11 4.2. RISK ASSESSMENT OF HIV TRANSMISSION A medical doctor must assess the risk of HIV transmission following an AE. This evaluation must be made rapidly, so as to start any treatment, if required, as soon as possible after the accident. Table 3: Factors which determine the risk of infection1 Type of exposure - percutaneous injury - mucous membrane exposure - non-intact skin exposure - bites resulting in blood exposure to either person involved Type and amount of fluid/tissue - Blood - Fluids containing blood - Potentially infectious fluid or tissue (semen; vaginal secretions; and cerebrospinal, synovial, pleural, peritoneal, pericardial and amniotic fluids) - Direct contact with concentrated virus Status of the source patient - Presence of HIV antibody - Viral load of the source patient (acute seroconversion, advanced disease, etc) 4.2.1 - Assessment of the magnitude of the exposure In case of percutaneous injuries High risk exposure In case two of the following circumstances are present : - high calibre needle (>18 G); - a deep injury; - visible blood in device; - needle in patient artery or vein Low risk exposure - In case only one of the circumstances mentioned above is present Injury with low calibre needle ( 18 G) No visible blood contamination Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 12 - Injury with solid (suture) needle Superficial wound In case the hand is injured, the wearing of gloves during any of these accidents constitutes a protective factor. - In case of mucous membranes, eye and non-intact skin (dermatitis, abrasion, wound) exposures High risk: major blood or body fluid splashes Low risk: small volume (drops) of blood or body fluids Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 13 4.2.2 The HIV status of the source patient Knowing the HIV status of the source patient will determine whether PEP is going to be taken or not. Therefore whenever possible, it should always be verified, taking into account that there are some conditions to be met before testing the source patient: access to VCT, confidentiality, parallel testing, etc. HIV testing, if performed, should not delay the start of PEP. Give first dose as soon as possible; prophylaxis can still be cancelled afterwards if needed. When his/her HIV status is not known, the source patient has to be examined clinically and a full history has to be taken (see risk assessment guide in Appendix 3). It is important to assess whether s/he is likely to be HIV infected and particularly if she/he is likely to have a high viral load (symptomatic primo-infection or advanced stages of AIDS). Table 4: Risk assessment of the source patient9 High Risk Patient HIV positive: - symptomatic HIV infection - acute seroconversion - high viral load (if known) - patient under HAART with indications of treatment failure (*) Unknown status or unknown source: - Prevalence in general population > 1% - Symptoms of primary infection - Source person has risk factors for HIV infection Low risk patient HIV positive: - asymptomatic HIV infection - low viral load - patient under HAART without treatment failure Unknown status or unknown source: - Prevalence in general population 1% - clinical examination does not establish HIV-related illnesses or AIDS symptoms - The patient’s history does not indicate risk factors for HIV infection, nor signs of HIV primo-infection Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 14 (*) See definition of treatment failure in WHO revised version of “scaling up antiretroviral therapy in resource-limited settings: treatment guidelines for a public health approach10. Try to find out previous treatments and risk of infection by a resistant strain, especially if bad adherence does not seem the reason for the treatment failure. Need for the advice of a specialist, for the adaptation of the protocol, to assess the risk as the standard prophylaxis will not be efficient (consult MSF headquarters in each section). In case, the patient is found to be HIV+, cotrimoxazole prophylaxis and curative treatment if feasible, should be provided. HIV negative The source patient may be in the window period. Check if any symptoms compatible with a primary infection syndrome in the last three months. 90 % of the infections are symptomatic: fever (96 %), adenopathy (74 %), pharyngitis (70 %), rash (70 %), myalgias (54 %), etc. 4.3. DECIDING ON THERAPY The combination of the two factors will allow the medical doctor in charge of PEP to advise whether or not to start prophylactic treatment and the indications for bi or tritherapy. Table 5: Recommendations for PEP after percutaneous injury (adapted from the Public health Service guidelines CDC- NEJM 348;9 2003)9,11 Magnitude Source Exposure patient High Low HIV-Positive High risk Low risk 3 drugs-PEP recommended 3 drugs-PEP recommended 3 drugs-PEP recommended 2 drugs-PEP recommended Unkown Status High risk Low Risk 2 drugs-PEP recommended 2 drugs-PEP recommended 2 drugs-PEP possible No PEP recommended Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 HIV negative No PEP necessary No PEP necessary 15 In case of mucous membranes and non-intact skin exposures follow the same recommendations but prescribing tritheraphy only when the patient is HIV positive and there is large volume of blood (major blood splash) 12. If the source patient is unknown (e.g. injury while cleaning contaminated material), the main parameter to take into account in deciding on therapy is the magnitude of the exposure. However, if prophylaxis is administered and the source person is subsequently determined to be HIV negative, the prophylaxis should be discontinued. 16. The medical doctor advises on PEP and the exposed person will be the one to decide whether s/he will take PEP or not (see also Appendix 6). It is essential to ensure clinical, biological and psychological follow-up of the exposed person whether PEP is taken or not. This is discussed in Chapters 6 and 7. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 16 4.4. POST-EXPOSURE PROPHYLACTIC (PEP) REGIMEN FOR HIV In order to work effectively, the treatment must preferably be started within the first 4 hours after an AE, and certainly within 48-72 hours. Treatment after an interval greater than 48-72 hours may be considered in case of massive exposure – a situation that requires the opinion of an AIDS specialist (see chapter 6). As antiretroviral combinations are proven to be more effective than mono-therapy in suppressing HIV replication in established HIV infection, the use of a double therapy (two antiretrovirals) or a triple therapy (three antiretrovirals) has become the standard PEP treatment in Western countries.12-14 MSF recommends as prophylactic treatment a combination therapy with 2 or 3 antiretrovirals (according to the indications) to be taken daily over a period of one month when there are evidences of high-risk exposure and confidence that the treatment is going to be completed. A triple therapy is known to be more potent than a bi-therapy in suppressing HIV viral replication (in already infected individuals)2, but presents more frequent side effects (in otherwise healthy persons) with higher rates of abandon.15 Triple therapy is recommended in high risk situations such as: massive exposure and HIV positive source. It can also be considered in massive exposure and status of the source patient unknown in a high prevalence country. In all other situations, when a prophylaxis is necessary, consider dual PEP. PROTOCOLS Dual PEP: first option AZT (Zidovudine) 300mg bid + 3TC (Lamivudine) 150mg bid (FDC) (Combivir®, Duovir®,…) Triple PEP: add Nelfinavir 1250mg bid The combination therapy available in the field depends from the possibilities of rapid supply from the capital of the complete treatment, therefore the Medical Coordinator should decide between: Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 17 - a complete treatment for one month a 7-day kit allowing PEP to be started as soon as possible after the exposure. In this case, the remaining 3-week treatment is available at capital level or can be sent from the headquarters by a rapid mail service. The remaining 3 weeks can be completed in the field if the conditions required for the follow up of the exposed person are available: a medical doctor, who can supervise treatment and follow up; the necessary laboratory testing (see Chapter 7): tests for HIV (including confirmation test, confidentiality and counselling), HBV and HCV serology, transaminases to detect any hepatitis, control of renal function, full blood count (specially if AZT is given. This requires that every mission identifies whether such facilities are available locally or regionally. When it is decided to complete PEP on the field, the coordinator and headquarters must be quickly informed so that they can immediately send the remaining treatment. CONTRAINDICATIONS Nevirapine is STRICLY FORBIDDEN for toxicity reasons In pregnancy16 : Efavirenz should be avoided because of its teratogenic effects. Repatriation (of expatriate staff) or referral to a specialised centre should be considered if: the above conditions cannot be met in the field; the exposed person requests it;. If the medical doctor recommends it e.g. because adverse effects to treatment In this case, repatriation or referral should better take place within a week of initiating treatment for clinical reasons. However, it can take place later on, e.g. if the exposed person is too anxious. It is the responsibility of the medical coordinator to assess whether the necessary conditions are met before allowing continuation of PEP treatment in the field. The medical department should be informed and agree with the proposed strategy. In case of repatriation, a medical certificate should be provided (see repatriation procedures). TREATMENT OF SIDE-EFFECTS Possible side effects occur mainly at the beginning of the treatment and include nausea, diarrhoea, muscular pain and headache. The person taking the treatment should be informed that these may occur and should be dissuaded from stopping the treatment as most side effects are mild and transient, though possibly uncomfortable. Drugs for Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 18 adverse effects should be administered if necessary to secure adherence. Anaemia and/or leucopoenia and/or thrombocytopenia may occur during the month of treatment. In the long term, the side-effects of this treatment are not yet fully known. Data on carcinogenic effects, fertility, spermatogenesis and teratogenesis16 are still lacking. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 19 5. POST-EXPOSURE MEASURES AGAINST HEPATITIS B AND C HEPATITIS B All MSF staff, whether expatriate or national, should be correctly vaccinated against hepatitis B (see Chapter 3). After an AEB: if the anti-HBS antibody level is known and sufficient (anti-HbS level > 10 IU/L), no particular measure needs to be taken; if the antibody level is not known and/or insufficient (below 10 IU/L), a booster vaccination should be administered (and the antibody level checked later on);. if the exposed person was vaccinated (or last booster administered) more than 5 years before, a booster vaccination should be administered; if the exposed person was never vaccinated, the hepatitis B vaccine series should be initiated.1 HEPATITIS C There is presently no prophylaxis available against hepatitis C.17,18 Neither immune globulin nor antiviral therapy is recommended after exposure. Recommendations for post-exposure management are intended to achieve early identification of established infection and, if present, referral for evaluation of treatment options. Perform baseline and follow-up testing for anti-HCV and alanine aminotransferase (ALT) 4-6 months after exposure Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 20 6. PSYCHOLOGICAL SUPPORT AND INFORMATION Many people will feel anxious after exposure. Every exposed person needs to be informed about the risks and the measures that can be taken (see below). This will help to relieve part of the anxiety, but some may require further psychological support. In some cases, psychological support can be offered locally. When this is not the case, repatriation is advised in order to offer specialised psychological services. This can be decided at any moment after exposure. Development of post-traumatic stress disorder have been described, therefore long term follow-up must be indicated. INFORMATION During a confidential encounter with the exposed person, the doctor should bring up the following points : The average risk of HIV transmission after an AEB is estimated at 0.3% if the source patient is HIV positive after a percutaneous exposure and o.09% after mucous-membrane exposure1,2. The prescription of prophylactic treatment after an AEB depends both on the gravity of the exposure and the supposed HIV status of the source patient. PEP is not 100% effective. The possible side effects of double/triple therapy are minor and do not require specialised medical surveillance. They should not lead to stopping PEP. The insurance companies covering expatriates require an HIV test within 8 days of exposure. Staff who might opt for repatriation or referral for medical reasons should best do so within the week following the initiation of treatment. However, repatriation is always possible later on when requested by the person or advised for the provision of psychological support. After any AE, the exposed person should not have unprotected sexual intercourse until it is confirmed, 3 months after the exposure, that s/he is not HIV infected. It is also advised to avoid pregnancy. If the exposed person has been advised PEP, but refuses to start it, s/he should sign a refusal form (see Appendix 6). The medical coordinator should keep this paper. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 21 Once prophylactic treatment has begun, the exposed person must sign a specific form (see Appendix 6). An information sheet covering the PEP and the biological follow-up after any AE (see Appendix 7) is given to the person under treatment. However, this sheet cannot replace verbal explanations. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 22 7. FOLLOW UP OF AN EXPOSED PERSON Whether PEP prophylaxis has been started or not, medical follow up to monitor possible infections (see Table 6) and psychological support are indicated. If this follow up cannot be done properly in the field, repatriation (of expatriate staff) or referral to a specialised centre is strongly recommended (see Chapter 4.4). BIOLOGICAL FOLLOW UP Table 6: Biological tests indicated after AEB Timing Baseline (within 8 days after AE) Week 2 Week 6 Month 3 Month 6 In persons taking PEP HIV, HCV, HBV Hémoglobin Transaminases Hémoglobin Transaminases Transaminases HIV, HCV, HBV, FBC Transaminases HIV, HCV, HBV, FBC Transaminases In persons not taking PEP HIV, HCV, HBV HIV, HCV, HBV Transaminases HIV, HCV, HBV Transaminases HIV, HCV, HBV Transaminases HIV, HBV and HCV testing of exposed expatriate staff is required within 8 days of an AEB for insurance purposes (baseline sero-status). Pre- and post-test counselling should be offered. Expatriate staff refusing an HIV test cannot be covered in case of sero-conversion due to AEB . Extended HIV follow up (for 12 months) is recommended for personnel who became infected with HCV following exposure to a source coinfected with HIV and HCV. 1 Consider specialised follow up. Most national insurance companies do not cover for HIV, HBV or HCV exposure. Testing of exposed national staff for these infections is thus not required for insurance purposes. It is, however, advised to offer an HIV test (external to MSF) in case of an AEB, as a positive HIV status may indicate the need to discontinue PEPi (see below). The decision on whether to test for HIV or not should anyway be taken by the exposed person, after adequate counselling. A single HIV test cannot be used for diagnosis purposes, and the UNAIDS/WHO guidelines for HIV testing need to be followed19. This means that a single result is insufficient to confirm or exclude HIV infection and cannot be used for follow up after exposure. i The administration of PEP in a positive person is not indicated Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 23 If HIV, HBV and HCV tests are negative, subsequent tests will be necessary in the third and sixth month after an AEB. For expatriate staff, it is essential that the tests be carried out within the specific time frame if the incident is to be considered as an occupational accident. ii In any of these stages, exposed persons testing HIV positive should be offered psychological support. Repatriation or referral to a specialized centre for an appropriate follow-up should be proposed, and PEP discontinued. Whether PEP is taken or not, transaminases should be checked at week 4 to detect hepatitis (this can be done at the end of the PEP intake), as well as at 3 months and 6 months after exposure. For persons taking PEP, a complete blood count (including numeration) and transaminase levels should preferably be checked to detect any side effects. If the person is receiving Nelfinavir blood glucose levels should be included. In case serology cannot be performed locally, blood can be collected on filter paper and sent to a laboratory. In case coagulated blood is used, refrigeration (4°-8°C) is preferred. CLINICAL FOLLOW UP In addition, in the weeks following an AEB, the exposed person must be monitored for the eventual appearance of signs indicating an HIV seroconversion: acute fever, generalised lymphadenopathy, cutaneous eruption, pharyngitis, non-specific flu symptoms, ulcers of the mouth or genital area. These symptoms appear in 50%-70% of individuals with an HIV primo-infection and almost always within 3 to 6 weeks after exposure. When a primo-infection is suspected, repatriation or referral should be arranged rapidly so that the person may be taken in charge by a competent health service. ii MSF insurance covers the risk of sero-conversion, whether PEP has been taken or not. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 24 8. ACCIDENTAL EXPOSURE TO HIV THROUGH SEXUAL CONTACT20-22 The risk of HIV transmission after a single vaginal intercourse is approximately of the same magnitude as the risk after percutaneous exposure (0.1%). Ejaculation during intercourse and anal sex (specially receptive intercourse) has a higher risk of transmission (<3%). See table nº 2. SEXUAL VIOLENCE : DUAL PEP Rape – as compared to regular sexual intercourse – presents a higher risk of HIV and STIs transmission because the act is violent and entails traumatic lesions of genital mucous membranes. Menstruation, bleeding during intercourse, genital ulcers, STIs and more than one assailants leads to a higher risk of HIV transmission. Psychological support must always be offered to the victim, considering repatriation if necessary. Post-exposure prophylactic regimens are indicated in case of rape for both anal or vaginal sexual intercourse (with or without ejaculation) and receptive oral sex with ejaculation. 1. The same measures and procedures described for the provision of PEP after an AE should be applied. Repatriation or referral to a specialised centre is highly recommended. PEP should be given as soon as possible and within 72 hours from the time of exposure. If the survivor is too distraught to decide about PEP, offer a first dose of medication and re-open the discussion about treatment within the next 24 hours21. Motivation and adequate counselling is specially important to complete treatment as the rate of lost to follow-up is higher in this group of patients, therefore scheduling a visit in about 24h is recommended. When there are no risk factors (see above), the prevalence in the country is low and the source is likely to be HIV negative, prophylaxis only is recommended in receptive anal sex with ejaculation. Choice of triple therapy can be considered in case of exposures to high risk HIV sources and significant exposures where the risk of transmission is increased (see above), always taking into account that good adherence to treatment can be assured and followed. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 25 2. Post-coital contraception must be provided not later than 120 hours after the rape (see Appendix 8). 3. Other STIs may be transmitted as a result of rape and prophylaxis treatment may also be indicated (immediately or a few days after PEP and post-coital contraception to avoid additive gastro-intestinal side effects)3,23 to prevent from gonorrhea, clamydia and incubating syphilis: Cefixime single dose 400mg p.o or ciprofloxacine 500mg single dose p.o PLUS Azithromycin 1g single dose PLUS Benzathine benzylpenicilin IM 2.4 MIU single dose.iii Countries with high prevalence of Trichomoniasis should include: Metronidazol 2gr po single dose Examination for STIs can be done (including cervico-vaginal swab if necessary) the first day deferring the prophylactic treatment, and repeated within 1-2 weeks of assault, if treatment wasn’t provided20. 4. Exams for HBV and syphilis should be done for an immediate evaluation, with serologic tests on successive weeks and complete vaccination of HBV with HBIG if they were not previously vaccinated20. 5. Tetanus prophylaxis and /or vaccination if there are wounds and vaccination status is unknown. IF A CONDOM TEARS OR SLIPS The risk of HIV transmission must be assessed in line with the risk that the source person is infected and the risk factors for the exposed person (lesions of genital mucous membranes, STIs etc). When the source is of low risk, in low prevalence countries (<1%) PEP is only recommended for receptive anal sex.20 This regimen is effective against sifilis. Azithromycin in a 2g single dose can also be used when available (for gonorrhea and chlamydia) but causes frequent gastro-intestinal side-effects. If azithromycin is not available, use doxycycline 200mg 7 days. In case of pregnancy, use cefixime 400mg PO and erythromycin 500mg QID for 7 days. Clinical MSF Guidelines 2004. iii Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 26 The same risk evaluation and procedures should be applied as in an AEB and PEP can be proposed. Other prophylactic regimens can also be proposed (post-coital contraception and presumptive STI treatment). It is, of course, out of the question to consider PEP as a “morning-after pill” for unprotected sexual contact. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 27 9. INFORMATION AND NOTIFICATION OF THE ACCIDENT CONFIDENTIALITY must be respected in the notification of an AE, even during emergencies and stressful situations. This applies to everyone in the field, in the country capital and at headquarters. COMMUNICATION AND RESPONSIBILITY After first aid, the AE must be reported by the exposed person to the medical person responsible for PEP in order to take a decision as quickly as possible. Whether PEP is prescribed or not, the accident should also be reported to the country medical coordinator. The person responsible for PEP will analyse the risk of HIV transmission, provide psychological support to the exposed person and will advise whether or not PEP treatment should be taken. If treatment is advised, the ultimate decision is taken by the exposed person. In case of doubt about whether or not treatment is indicated, it is advised to already start PEP - while requesting specialised advice from an AIDS specialist. Treatment can be discontinued afterwards if the specialist does not recommend it. When repatriation or transfer is opted for, it is the responsibility of the medical coordinator to organize this. An additional medical certificate for repatriation should be provided (see repatriation procedures). Follow-up by a specialised medical team will be done in collaboration with the headquarters. Specific procedures from each section will be followed. REPORTING THE ACCIDENT In every case of accidental exposure to blood, different administrative forms have to be completed as soon as possible (within max. 1 week) and sent to the FIELD HQ ADMINISTRATOR (Cristiano Canuti) that will be in charge of dispaching them. A nominative form describing the AE and its management is found in Appendix 4. This form is confidential and has to be filled in by the medical doctor in charge of PEP. It is the equivalent of a medical file. It can be used for insurance purposes and for establishing the initial medical certificate for an occupational accident. It can also be given to the medical doctor to whom that person would be referred. It has to be handed over to the field HR administrator in the HQ when an expatriate is concerned, or to the country administrator when a national staff member is involved. The exposed person keeps a copy. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 28 A detailed notification of the AE (see Appendix 5) must be filled in by the medical doctor in charge of PEP and sent with the others form. This will be given to the person in charge of PEP at the medical department in headquarters, whether it concerns an expatriate or a national staff member. It should not name the exposed person. Details are required in order to update the information given in this guideline. All the invoices of expenses related to the accident follow up (drugs and lab expenses) should be sent to the field HR administrator in the HQ. A standard medical certificate is requested by the Swiss Insurance (appendix 9), the medical doctor in charge of the person should fill it. In case PEP treatment was advised: An informed consent/refusal form confirming that a named individual has consented or refused to take PEP can be found in Appendix 6. It should be completed and signed by the exposed person, and countersigned by the medical doctor. This form will be passed on in a sealed envelope marked "confidential" to the field HR administrator at headquarters when it concerns an expatriate, or to the country administrator when it concerns a national staff member. It will be kept confidentially in the personal file of the exposed person. It is important to report to the headquarters (HR administration) the follow up of the accident up to its end (medical and administrative). Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 29 10. PRACTICAL DETAILS DRUG STOCKS PEP has to be available in the field, wether as a 7-DAY kit containing AZT with 3TC (FDC) and Nelfinavir (see Chapter 4.4) or availlable as part of the stock in HIV/AIDS projects. Combivir (AZT+3TC) has a shelf life of two years and Nelfinavir for three years. They must be kept at an ambient temperature (between 2° and 30°C) in a dry place and must not be exposed to light. The medical coordinators are responsible for supervising the stock management of both drugs in each country. It is important to monitor the expiry dates of the drugs and the conditions under which they are kept. The medical coordinator at capital level decides whether a 7-day PEP or a stock for more days should be located in the field. The availability of a PEP kit in the field depends on the conditions of access between the field project and the capital (where there is generally a medical person and PEP kits), the nature of the work carried out by the staff (curative intervention, project management etc.), and whether or not there is someone responsible for medical aspects in the project. TRAINING Every MSF staff should be informed about the procedures to be followed in case of an AE. At every location, one medical person, preferably a medical doctor, will be assigned responsibility for PEP. COSTS / REPATRIATION / INSURANCE The cost of a 28 days course is estimated at around 40 U$ for Duovir and 60 U$ for Nelfinavir and will be reimbursed by the insurance company if the accident is correctly reported. The 7-day kits are placed in the field and paid for by MSF. Repatriation or referral to a specialised centre is paid for by MSF or covered by insurance. This includes the costs of treatment, tests etc, if all the invoices are sent to the HQ. The exposed person could be regarded as being on sick leave. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 30 11. REFERENCES 1 Update U.s. Public Health Service Guidelines for the Managment of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis. MMWR. June 29, 2001/Vol.50 2 Henderson DK. Postexposure chemoprophylaxis for occupational exposures to the human immunodeficiency virus. JAMA: 281 (10), 931-936, 1999. 3 MSF guidelines for Medical care for rape survivors; June 2004. 4 Bamberger J. and al. Am. J. med. 1999 106323-326 Ippolito G. Editorial: Prophylaxis after occupational exposure to HIV. BMJ: 315: 557-8, 1997. 5 Mastro TD, De Vicenzi I. Probabilities of sexual HIV-1 transmission. AIDS 1996; (suppl A): 575-82 6 CDC. Public health service Management of possible sexual, injecting-drug-use, or other nonoccupational exposure to HIV, included considerations to antiretroviral therapy MMWR: Sept 1998/Vol 47. 7 CDC. Immunization of health-care workers. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC). MMWR, 46, RR-18, 22-3, 1997. 8 European Consensus Group on Hepatitis B Immunity. Are booster immunisations needed for lifelong hepatitis B immunity? The Lancet 12, 355 (9203), 561-5, 2000. 9 Gerbending JL, M.D, M.P.H, Occupational Exposure to HIV in Health Care Settings. N Engl J Med 2003;348:826-33. 10 WHO 3x5 Scaling up antiretroviral therapy in resource-limited settings: treatment guidelines for a public health approach; 2003 revision. 11 Barlett & Gallant. Medical management of HIV Infection, 2004. Johns Hopkins Medicine, Baltimore. www.hopkins-aids.edu 12 Recomendations for Post-Exposure Prophylaxis against HIV infection in Health Care Workers in Europe, March 2002. www.inmit.it 13 Ippolito G. Editorial: Prophylaxis after occupational exposure to HIV. BMJ: 315: 5578, 1997. 14 Department of Health. HIV post-exposure prophylaxis. Guidance from the UK Chief medical officers. Febr. 2004. 15 I.V. Bassets, K.A. Freeberg & R.P. Walensky. Two drugs or three? Balancing efficacy, toxicity and resistance in post-exposure prophylaxis for occupational exposure to HIV. HIV/AIDS. CID 2004:39. 16 Parkin JM, Murphy M, Anderson J, et al. Tolerability and side effects of postexposure prophylaxis for HIV infection. The Lancet, 355, 9205, 722, 2000. 17 CDC. Recommendations for prevention and control of hepatitis C virus (HCV) infection and HCV-related chronic disease. MMWR, 47, RR-19, 1998. 18 Practice guideline review of diagnosis and treatment of HCV. American Association for liver disease 2004. www.aasld.org/eweb/docs/hepatitisc.pdf Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 31 19 WHO 3x5 Rapid HIV tests : guidelines for use in HIV testing and counselling services in resource-constrained settings ; 2004. 20 Managment of non-occupational post exposure prophylaxis to HIV (NONOPEP): SexuaL, Injecting drug user or other exposures. European NONOPEP Project. April 2002. 21 Guía de actuación para la profilaxis postexposición no ocupacional del VIH. Recmendaciones GESIDA/CEESCAT/PNS. Feb.2003 www.gesidaseimc.com 22 Katz M, Geberding JL. The care of persons with recent sexual exposure to HIV. Ann Intern Med: 128, 306-12, 1998. 23 MMWR. Sexually transmitted diseases treatment guidelines 2002. May 10, 2002/Vol. 51. 24 CDC. Dept of health & human services. Exposure to blood. What health care personnel need to know; July 2003. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 32 APPENDIX 1: HIV, HBV AND HCV PREVALENCE BY COUNTRY HDI Rank Country HIV prevalence (% ages 15-49) 2003 1 HCV prevalence (Rates %) 1999 1 2 3 4 5 6 7 8 9 10 Norway Sweden Australia Canada Netherlands Belgium Iceland United States Japan Ireland 0.1 [0.0 - 0.2] 0.1 [0.0 - 0.2] 0.1 [0.1 - 0.2] 0.3 [0.2 - 0.5] 0.2 [0.1 - 0.4] 0.2 [0.1 - 0.3] 0.2 [0.1 - 0.3] 0.6 [0.3 - 1.1] <0.1 [<0.2] 0.1 [0.0 - 0.3] 0.1 0.003 0.3 0.1 0.1 0.9 0.1 1.8 2.3 0.1 11 12 13 14 15 Switzerland United Kingdom Finland Austria Luxembourg 0.4 [0.2 - 0.6] 0.1 [0.1 - 0.2] <0.1 [<0.2] 0.3 [0.1 - 0.4] 0.2 [0.1 - 0.4] 0.2 0.02 0.02 0.2 0.5 16 17 18 19 20 France Denmark New Zealand Germany Spain 0.4 [0.2 - 0.7] 0.2 [0.1 - 0.3] <0.1 [<0.2] 0.1 [0.1 - 0.2] 0.7 [0.3 - 1.1] 1.1 0.2 0.3 0.1 0.7 0.5 [0.2 - 0.8] 0.1 [0.1 - 0.2] 0.5 0.4 0.5 21 22 23 24 25 Italy Israel Hong Kong, China (SAR) Greece Singapore 0.1 [<0.2] 0.2 [0.1 - 0.3] 0.2 [0.1 - 0.5] 1.5 0.5 0.5 0.4 1.7 26 27 28 29 30 Portugal Slovenia Korea, Rep. of Barbados Cyprus 0.4 [0.2 - 0.7] <0.1 [<0.2] <0.1 [<0.2] 1.5 [0.4 - 5.4] .. 31 32 33 34 35 Malta Czech Republic Brunei Darussalam Argentina Seychelles 0.2 [0.1 - 0.3] 0.1 [<0.2] <0.1 [<0.2] 0.7 [0.3 - 1.1] .. 36 37 38 39 40 41 42 43 44 45 Estonia Poland Hungary Saint Kitts and Nevis Bahrain Lithuania Slovakia Chile Kuwait Costa Rica 1.1 [0.4 - 2.1] 0.1 [0.0 - 0.2] 0.1 [0.0 - 0.2] 0.1 0.2 0.6 0.8 1.4 0.9 .. 0.2 [0.1 - 0.3] 0.1 [<0.2] <0.1 [<0.2] 0.3 [0.2 - 0.5] .. 0.6 [0.3 - 1.0] 0.4 0.9 3.3 0.3 Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 33 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 Uruguay Qatar Croatia United Arab Emirates Latvia 0.3 [0.2 - 0.5] .. <0.1 [<0.2] Bahamas Cuba Mexico Trinidad and Tobago Antigua and Barbuda 3.0 [1.8 - 4.9] 0.1 [<0.2] 0.3 [0.1 - 0.4] Bulgaria Russian Federation Libyan Arab Jamahiriya Malaysia Macedonia, TFYR <0.1 [<0.2] 1.1 [0.6 - 1.9] Panama Belarus Tonga Mauritius Albania Bosnia and Herzegovina Suriname Venezuela Romania Ukraine .. 0.6 [0.3 - 1.0] 3.2 [1.2 - 8.3] 0.3 [0.1 - 0.6] 3.0 0.9 [0.5 - 1.5] 0.5 [0.2 - 0.8] .. .. .. 0.1 1.4 1.7 [0.5 - 5.8] 0.7 [0.4 - 1.2] <0.1 [<0.2] 1.4 [0.7 - 2.3] 5.5 0.9 4.5 1.2 2.6 1.0 0.9 76 77 78 79 80 Thailand Saudi Arabia Kazakhstan Jamaica Lebanon 1.5 [0.8 - 2.8] .. 0.2 [0.1 - 0.3] 1.2 [0.6 - 2.2] 0.1 [0.0 - 0.2] 81 82 83 84 85 Fiji Armenia Philippines Maldives Peru 0.1 [0.0 - 0.2] 0.1 [0.1 - 0.2] <0.1 [<0.2] .. 0.5 [0.3 - 0.9] 88 89 90 2.1 <0.1 [<0.2] .. 0.7 [0.3 - 1.1] 0.7 [0.4 - 1.2] 0.1 [0.0 - 0.2] .. Turkmenistan Saint Vincent and the Grenadines Turkey Paraguay Jordan 1.1 2.0 7.9 0.4 [0.2 - 0.7] <0.1 [<0.2] Saint Lucia Brazil Colombia Oman Samoa (Western) 87 0.8 0.7 4.9 .. 71 72 73 74 75 86 0.5 2.8 1.4 0.8 5.6 1.8 0.3 3.6 1.6 <0.1 [<0.2] .. <0.1 [<0.2] 0.5 [0.2 - 0.8] .. 1.5 0.3 2.1 0.7 1.1 3.0 91 92 93 94 95 Azerbaijan Tunisia Grenada China Dominica <0.1 [<0.2] <0.1 [<0.2] .. 0.1 [0.1 - 0.2] .. 96 Sri Lanka <0.1 [<0.2] Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 34 97 98 99 100 Georgia Dominican Republic Belize Ecuador 0.2 [0.1 - 0.4] 1.7 [0.9 - 3.0] 2.4 [0.8 - 6.9] 0.3 [0.1 - 0.5] 101 Iran, Islamic Rep. of Occupied Palestinian Territories El Salvador Guyana Cape Verde 0.1 [0.0 - 0.2] 102 103 104 105 2.4 0.1 0.7 .. 0.7 [0.3 - 1.1] 2.5 [0.8 - 7.7] .. 0.2 1.5 107 108 109 110 Syrian Arab Republic Uzbekistan Algeria Equatorial Guinea Kyrgyzstan 0.1 [0.0 - 0.2] 0.1 [<0.2] .. 0.1 [<0.2] 111 112 113 114 115 Indonesia Viet Nam Moldova, Rep. of Bolivia Honduras 0.1 [0.0 - 0.2] 0.4 [0.2 - 0.8] 0.2 [0.1 - 0.3] 0.1 [0.0 - 0.2] 1.8 [1.0 - 3.2] 11.2 0.1 116 117 118 119 120 Tajikistan Mongolia Nicaragua South Africa Egypt <0.1 [<0.2] <0.1 [<0.2] 0.2 [0.1 - 0.3] 21.5 [18.5 - 24.9] <0.1 [<0.2] 10.7 0.6 1.7 18.1 1.1 [0.6 - 1.8] 8.1 [4.1 - 15.3] 0.7 6.5 106 121 122 123 124 125 126 127 128 129 130 131 132 133 134 135 Guatemala Gabon São Tomé and Principe Solomon Islands Morocco Namibia India Botswana Vanuatu Cambodia Ghana Myanmar Papua New Guinea Bhutan Lao People's Dem. Rep. <0.1 [<0.2] 0.2 2.1 6.1 .. .. 0.1 [0.0 - 0.2] 0.9 1.1 21.3 [18.2 - 24.7] [0.4 - 1.3] 37.3 [35.5 - 39.1] .. 2.6 [1.5 - 4.4] 1.8 0.0 0.9 4.0 3.1 [1.9 - 5.0] 1.2 [0.6 - 2.2] 0.6 [0.3 - 1.0] .. 2.8 0.6 0.1 [<0.2] 136 137 138 139 140 Comoros Swaziland Bangladesh Sudan Nepal .. 38.8 [37.2 - 40.4] [<0.2] 2.3 [0.7 - 7.2] 0.3 [0.2 - 0.5] 141 142 143 144 145 Cameroon Pakistan Togo Congo Lesotho 6.9 [4.8 - 9.8] 0.1 [0.0 - 0.2] 4.1 [2.7 - 6.4] 4.9 [2.1 - 11.0] 28.9 [26.3 - 31.7] 12.5 2.4 3.3 146 147 148 149 Uganda Zimbabwe Kenya Yemen 4.1 [2.8 - 6.6] 24.6 [21.7 - 27.8] 6.7 [4.7 - 9.6] 0.1 [0.0 - 0.2] 1.2 7.7 0.9 2.6 1.5 2.4 3.2 0.6 Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 35 150 Madagascar 1.7 [0.8 - 2.7] 3.3 151 152 153 154 155 Nigeria Mauritania Haiti Djibouti Gambia 5.4 [3.6 - 8.0] 0.6 [0.3 - 1.1] 5.6 [2.5 - 11.9] 2.4 [0.7 - 7.5] 1.2 [0.3 - 4.2] 1.4 1.1 2.0 156 157 158 159 160 Eritrea Senegal Timor-Leste Rwanda Guinea 2.7 [0.9 - 7.3] 0.8 [0.4 - 1.7] .. 5.1 [3.4 - 7.6] 3.2 [1.2 - 8.2] 161 162 163 164 165 Benin Tanzania, U. Rep. of Côte d'Ivoire Zambia Malawi 166 167 168 169 170 Angola Chad Congo, Dem. Rep. of the Central African Republic Ethiopia 171 172 173 174 175 Mozambique Guinea-Bissau Burundi Mali Burkina Faso 176 177 Niger Sierra Leone 2.9 17.0 10.7 1.9 [1.1 - 3.3] 8.8 [6.4 - 11.9] 7.0 [4.9 - 10.0] 16.5 [13.5 - 20.0] 14.2 [11.3 - 17.7] 1.5 0.7 3.9 [1.6 - 9.4] 4.8 [3.1 - 7.2] 1.0 4.8 6.4 4.2 [1.7 - 9.9] 13.5 [8.3 - 21.2] 0.0 4.5 4.4 [2.8 - 6.7] 0.8 12.2 [9.4 - 15.7] .. 6.0 [4.1 - 8.8] 1.9 [0.6 - 5.9] 4.2 [2.7 - 6.5] 2.1 11.1 1.2 [0.7 - 2.3] .. 2.5 2.0 Source : UNAIDS (Joint United Nations Programme on HIV/AIDS). 2004. Correspondence on HIV prevalence rate. May. Geneva. ; aggregates calculated for the Human Development Report Office by the UNAIDS. PREVALENCE OF HEPATITIS B IN VARIOUS AREAS % of population positive for Area HBsAg anti-HBs Northern, Western, and Central Europe, North America, 0.2-0.5 4-6 Australia Eastern Europe, the Mediterranean, Russia and the Russian Federation, Southwest Asia, Central and 2-7 20-55 South America Parts of China, Southeast Asia, tropical Africa 8-20 70-95 infection neonatal childhood rare infrequent frequent frequent very frequent very frequent From: Zuckerman AJ. Hepatitis Viruses. In: Baron S, eds. Medical Microbiology, 4th ed. Galveston, TX, The University of Texas Medical Branch at Galveston, 1996:849-863,52 with permission. Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 36 APPENDIX 2: STANDARD MEDICAL PRECAUTIONS IN HEALTH-CARE SETTINGS Universal precautions are intended to prevent the exposure of health-care workers and patients to blood-borne pathogens. These must be respected in regard to the blood and body fluids of all patients, regardless of their infection status.iv Universal precautions include: safe handling and safe disposal of sharps: never recap needles; use special containers for sharp disposals; safe decontamination of instruments; hand-washing after all medical procedures; use of protective barriers as needed to prevent direct contact with blood and body fluid such as gloves, masks, goggles, aprons, and boots. Whenever a health worker receives a cut or abrasion, the wound should be covered. safe disposal of contaminated waste. For further details, see: 1. 2. Bouvet E et al. Politique de prévention des AES. In: Accident d'exposition au VIH. Bases scientifiques et recommandations pour la prise en charge. Bash éditions médicales, 1999. CDC. Perspective in disease prevention and health promotion update: Universal precautions for prevention of transmission of HIV, HBV and other blood-borne pathogens in health-care settings. MMWR 37;377-88. 1988. CDC. Perspective in disease prevention and health promotion update: Universal precautions for prevention of transmission of HIV, HBV and other blood-borne pathogens in healthcare settings. MMWR 37;377-88. 1988. iv Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 37 APPENDIX 3: RISK ASSESSMENT GUIDE FOR THE SOURCE PATIENT The following points need to be covered when questioning and examining the patient. These will need to be adapted in line with local epidemiological, clinical and cultural conditions. There is no such thing as a "score" in this regard; it is up to the doctor to interpret the results of the clinical assessment. It is important that questioning be conducted in a way that reveals relevant events that may have occurred several years ago. 1. Family history • Have any family members recently been ill or died. What was the cause? 2. Recent personal history of primo-infection symptoms Primo-infection symptoms generally appear 3 to 6 weeks after contamination: • general lymphadenopathy, predominently in the cervical and axillary areas; • fever of unknown origin; • muscular cramps, joint pain; • skin rash, urticaria; • oral and genital ulcers. 3. Individual’s personal "risk history" of HIV • Has the patient ever had a blood transfusion? If so, under which conditions? • Has the patient been exposed to injections or surgical procedures (including any traditional scarification) with non-sterile material? • Is the patient an intravenous drug user and does s/he possess injection material? • Does the patient belong to a population group considered at risk? For example: - sex worker - truck driver; - migrant worker; - soldier. • Is the patient involved in high-risk sexual activites? - practising unsafe sex - already treated or undergoing treatment for a sexually transmitted disease; - the sexual partners of a person in any of the above categories. 4. Suspicion or actual presence of symptoms and/or HIV infection within the previous six months or more • tuberculosis; • continuous or intermittent fever; • chronic diarrhoea; • weight loss; • chronic cough lasting longer than a month; Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 38 • skin infections (severe and/or recurrent) • oral thrush; • night sweats. 5. Clinical examination findings • Cardinal signs: - Kaposi sarcoma; Pneumocystis carinii pneumonia; cerebral toxoplasma; oesophageal candidiasis; cytomegalovirus retinitis. • Characteristic signs: - oral thrush; - hairy leukaplasia of the tongue; - cryptococcal meningitis; - pulmonary or extra-pulmonary tuberculosis; - herpes zooster, particularly multi-dermatomal; - severe prurigo; - high-grade B-cell extranodal lymphoma. • Associated signs: - weight loss (recent, unexplained) of more than 10% of initial body weight; - fever (continuous or intermittent) for longer than a month; - diarrhoea (continuous or intermittent) for longer than a month; - ulcers (genital or perianal) for more than a month; - cough lasting longer than a month; - neurological complaints or findings; - generalised lymphadenopathy (extra-inguinal lymphatic areas); - reactions to drugs (not previously observed); - skin infections (severe and/or recurrent): e.g. warts, dermatophytes, folliculitis. - lymphopenia (known). Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 39 APPENDIX 4: ACCIDENTAL EXPOSURE TO BLOOD NOTIFICATION FORM Confidential form to be filled in by the medical doctor in charge of the PEP and to be sent to the administration department. Medical file to be used for referral and insurance purposes. Exposed person Surname and first name: ........................................................................................ Date of birth: ....................................................................................... Exposure Date of the accident :............................................ Local time: .......................... Place (country) :.............................................................................................................. Contact with: blood any other body fluid (specify):........................ Type of contact (injury with a needle or any other sharp instrument, contact with healthy or broken skin, or mucous membranes, etc.) ........................................................................................................................................... ........................................... ...................................................................................................................................................................…………… Description of the circumstances of the accident: ...................................................................................................................................................................................... ............................................................................................................................. ......................................…………… Description of the wound: ...................................................................................................................................................................................... .................................................................................................................................................................................. If the accident involved a needle, specify: hollow needle plain needle size of needle : ............................ Contact with: blood any other body fluid (specify):.......................................... During the accident • were gloves worn? yes no • were protective goggles worn? yes no Health status of the source patient Is the patient known? yes no If patient is known, results of the medical evaluation (including HIV status if testing has been performed): .................................................................................................................................................................................... Measures taken after the accident First aid (specify)................................................................................................ Prophylactic treatment : Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 40 advised prescribed yes yes no no Time elapsed between the exposure accident and the beginning of treatment: < 4 hours between 4 and 24 hours > 24 hours< 48h longer (specify) : ................. Type of treatment: .................... ...... mg ........ times a day Any other comments ............................................................................................................................. .................. .............................................................................................................................. ................. ............................................................................................................................................... The victim of an accidental exposure to blood is unable to work for a minimum period of 8 days starting from the day of the accident and until the next medical consultation: yes no Date ......................., Place ............................................................................................. Signature of doctor ...................................................................... Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 41 APPENDIX 5: NOTIFICATION OF AN AE - HQ FORM To be filled in by the medical doctor in charge of PEP and to be sent to the Medical Department at MSF headquarters. Type of wound Date of the accident:............................................ Local time: .......................... Place (country):.............................................................................................................. Contact with: blood any other body fluid (specify):........................ Type of contact (injury with a needle or any other sharp instrument, contact with healthy or broken skin, or mucous membranes, etc.) ...................................................................................................................................................................................... ........................................................................................................ .................... ................................................….. Description of the circumstances of the exposure: ............................................................................................................................. ......................................................... ............................................................................................................................. ......................................................... ................................................................................................................................................................................... ... ............................................................................................................................. ................................................. Exposed person HIV testing performed 15 days prior to departure on mission: yes no Vaccination against Hepatitis B (doses and dates): Level of anti-HbS antibodies known prior to the accident yes (result):.................... no Health status of the source patient Is the patient known? yes no If patient is known, results of the evaluation of the source patient (including HIV testing if performed): ............................................................................................................................. ....................................................... What measures were taken immediately after the accident? ............................................................................................................................. ......................................................... ................................................................................................................................. ................................................. .................................................................................................................................................................................... Prophylactic treatment Proposed yes no Prescribed yes no Hours between the exposure accident and the beginning of treatment: < 4 hours between 4 and 24 hours > 24 hours< 48h longer (specify) : ......................... Type of treatment: .................... ...... mg ........ times a day Any other comment ................................................................................................................................................... Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 42 APPENDIX 6: PEP TREATMENT INFORMED CONSENT/REFUSAL FORM When PEP has been advised this form should be filled in and signed by the exposed person, and signed by the medical doctor in charge of PEP in the field. It must be sent to the person in charge of PEP at administration level (in the HQ human resources dept. for expatriates or the country administrator for national staff) in a sealed envelope marked confidential. A copy should be given to the exposed person. Surname and first name: .............................................................................. Date of birth: ........................................................................... Sex: ................................ Date of the accident: ..................................................... I, the undersigned, ................................................................................., hereby declare: – – – That I have been informed of MSF recommendations in regard to prophylactic treatment after accidental exposure to HIV. That I understand the risk of transmission after accidental exposure. That I have been informed of the effectiveness and the possible side- -effects of this treatment; I was offered prophylactic treatment, and: I have decided not to take it. I agree to follow this prophylactic treatment for a total period of one month and I agree to accept medical supervision. Date:......................................... Signature of the exposed person: .......................................................................... Signature of the medical doctor in charge: ........................................................................ Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 43 APPENDIX 7: INFORMATION SHEET ON PROPHYLAXIS AND FOLLOWUP AFTER AN AE This is to be given to the exposed person, for information only. The doctor assessed that there is a risk of transmission of HIV infection as a result of this accident and that you can start anti-viral prophylaxis, if you agree. 1. You must understand that this preventive medication: Must be started, if possible, within 4 hours of the AE (within 48 hours at the latest); Although some failures to post-exposure prophylaxis have been described, a case control study showed that the administration of AZT reduces the risk of sero-conversion post-exposure by 79%; May cause minor side-effects (as with any medication), especially digestive problems, headache, fatigue, malaise, myalgia or arthralgia; Must be taken regularly in two doses per day for four weeks; Must be backed up by regular medical check-ups (see below); Requires the use of condoms during the period of treatment until the results of the sixth’s month’s serology are known; Requires the use of efficient contraceptive measures during the period of treatment until the results of the sixth month’s serology are known; Requires your consent. 2. The following is proposed as biological follow up: HIV and Hepatitis C serology before the eighth day and at the third month and sixth month, after appropriate counselling. An HIV confirmation test will be carried out if the result of the test is either positive or indeterminate. This is a health insurance requirement for expatriates, but is only optional for national staff. Before the eighth day, at 4 weeks, 3 months and 6 months, control of transaminases to detect hepatitis. Before the eighth day and at the end of PEP intake, a complete blood count (optional). Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 44 APPENDIX 8: EMERGENCY CONTRACEPTIVE REGIMEN When high-dose pills containing 0.5 mg ethinylestradiol and 0.25 mg of levonorgestrel are available: two pills should be taken as the first dose as soon as convenient, but not later than 120 hours after the rape. These should be followed by two more pills 12 hours later. When only low-dose pills containing 0.3 mg ethinylestradiol and 0.15 mg of levonorgestrel are available: four pills should be taken as the first dose as soon as convenient, but not later than 120 hours after the rape. These should be followed by four more pills 12 hours later. Side-effects Nausea occurs in about 50% of those using combined emergency contraceptive pills (ECPs). Administration of an anti-emetic can be proposed prophylactically. Taking the pills with food may reduce nausea. If vomiting occurs within two hours of taking ECPs, repeat the dose after the administration of an anti-emetic. Contraindications There are no known medical contraindications to the use of ECPs. The dose of hormones used in ECPs is relatively small and the pills are only used for a short time. Contraindications associated with the continuous use of hormonal contraceptives do not apply. ECPs should not be given if there is a confirmed pregnancy. ECPs may be given when pregnancy status is unclear and pregnancy testing is not available as there is no evidence of harm to the woman or to an existing pregnancy. Source: Reproductive health in refugee situations interagency handbook Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 45 APPENDIX 9: MEDICAL CERTIFICATE FOR SWISS INSURANCES This form has to be send to the field HR administrator of you desk with an official letterhead of MSF and has to be filled in by the medical DOCTOR in charge of the person. The name of the treating doctor has to be clearly stated, as well as the date of the consultation and the date and duration of the working incapacity (time for travelling to a place where the tests can be done, where a medical treatment is possible and if psychological problems of the exposed person require a certain time of rest). The insurances prefer that a medical doctor from the country you work in does this certificate, but it can be done in exceptional cases by the treating MSF doctor, if the country does not have medical practitioners capable of taking in charge a person under PEP. Usually the working incapacity does not exceed a few days if the exposed person stays in the country and up to 4 weeks if repatriation is necessary. ---------------------------------------------------------------------------------------------------------------- MEDICAL CERTIFICATE Mrs/Mr: ………………………………………………………………….. Born: ……………………………. Currently in mission in: ………………………………………………… I hereby certify that the above mentioned person is under treatment for accidental exposure to blood since the …………………. and is unable to work until the ………………… Name of treating doctor: ………………………………………. Country:………………………….. Signature Date Accidental Exposure to Blood and other body fluids/Médecins Sans Frontières/December 2004 Stamp 46