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Post Exposure Prophylaxis (PEP/oPEP)

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Presentation on theme: "Post Exposure Prophylaxis (PEP/oPEP)"— Presentation transcript:

1 Post Exposure Prophylaxis (PEP/oPEP)
Dr Don Ajith Karawita MBBS (PERA), PgD Ven (COL), MD Venereology (COL) (Senior Registrar in Venereology) National STD/AIDS Control Programme

2 CDC Guidelines 2001. CDC headquarters in Atlanta

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11 Standard Precautions Hand washing Gloves
Personal protective equipment (PPE) Patient care equipments Cleaning of instruments Environmental control Management of spills Linen management 7. Occupational health and blood borne pathogens Handling of sharps Prevention of mucous membrane exposures Management of needle stick accident or mucous membrane exposure Collection and transport of specimens 8. Patient isolation

12 Additional Precautions
Transmission based precautions Airborne precautions (droplet nuclei < 5µm) Droplet precautions (droplet nuclei > 5µm) Contact precautions / isolation Strict isolation Aseptic precautions Cleaning of entry site of the body Hands of the staff must be disinfected and gloved.

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16 Choice of method High risk (Critical)
RISK GROUP EXAMPLES CHOICE OF PROCESSING High risk (Critical) Direct contact with a break in skin or mucous membrane or entering a sterile body area. Surgical instruments, Needles, Syringes, cystoscopes, Laparoscopes, Surgical dressings. Must be sterile Heat sterilization (autoclaving), chemical sterilants Intermediate risk (Semi-critical) Direct contact with mucous membranes or non-intact skin Endoreacheal tubes, Gastroscopes & other endoscopes. High level disinfection acceptable, liquid chemicals. Low risk (Non-critical) Items in contact with intact skin. Stethoscopes, BP apparatus, bed pans, urinals Low level disinfection or through cleaning with detergent acceptable

17 Disinfectant / Antiseptic
Alcohol Surgical spirit (60% isopropyl alcohol) 70% ethyl alcohol Alcohol hand rub (Isopropyl alcohol with glycerol) Aldehydes Cidex (2% glutaraldehyde solution) Chlorhexidines Hibisol (0.5% chlorhexidine in 70% alcohol Hibitane (4% chlorhexidine gluconate Hibiscrub (4% chlorhexidine gluconate with a detergent)

18 Disinfectant / Antiseptic
Iodophors Betadine, Wokadine (10% solution, available iodine 1%) Betadine scrub, Wokadine scrub (7.5% Povidone iodine scrub, avilable iodine 0.75% Peracetic acid Perasafe (Peracetic acid) Phenolic disinfectants Lysol (2%, 5% solutions) Chlorine releasing agents TCL, Bleaching powder (Calcium hypochiorite 35% w/w of available chlorine) Sodium hypochlorite liquid form 5% stock solution 1% (10,000ppm) 0.1%(1000ppm) 0.01% (125ppm) Milton

19 Hospital waste Hazardous waste General or Non-hazardous waste
Sharps Infectious waste (incinaration/ Burial) Pathologicl waste (incinaration/ Burial) Chemical waste (Returned to supplier/ MSD) Pharmaceutical waste (Returned to supplier/ MSD) Radioactive waste (Keep for radioactive decay→Dispose as non hazardous waste) Dispose to common garbage site/bin Collected by local authorities

20 Can produce chronic infection Transmissible in healthcare settings
Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV) Bloodborne viruses Can produce chronic infection Transmissible in healthcare settings Data from multiple sources (e.g., surveillance, observational studies, serosurveys) used to assess risk of occupational transmission Hepatitis B virus (HBV), hepatitis C virus (HCV), and the human immunodeficiency virus (HIV) are all bloodborne viruses that can produce chronic infection and are transmissible in healthcare settings. Data from multiple sources, including surveillance, observational studies, and serosurveys are used to assess the risk of occupational transmission.

21 Risk of Bloodborne Virus Transmission after Occupational Percutaneous Exposure
Source Risk HBV HBeAg + HBeAg - % % HCV 1.8% HIV 0.3% The risk of HBV transmission after a percutaneous exposure to HBV-infected blood, without postexposure treatment, varies, depending on the e-antigen status of the source. If the source is e-antigen positive, the risk of transmission will be up to 30%, whereas if the source is e-antigen negative, the risk is from 1-6%. The average risk of HCV transmission after a percutaneous exposure to HCV-infected blood is 1.8%, with a range of 0-7%. The average risk of HIV infection after a percutaneous exposure to HIV-infected blood is 0.3%, or 1 in 300 exposures (with a 95% confidence interval of 0.2%-0.5%). The average risk is based on aggregate data, and may not apply to specific exposure events.

22 Evaluation - Occupational exposure to infectious materials
Patient 1.Exposure 2. Exposure Substance Health care worker (HCW) Percutaneous Severe, Less severe Mucous membrane/Non intact skin Small volume, Large volume. Blood, Bloody fluid, OPIM 3. Determine Infectious Status of Source 4. Determine Susceptibility of Exposed Person

23 Elements of Postexposure Management
Wound management & Exposure reporting → Step 1 Risk Assessment → Step 2 (1) blood borne infection status of source person (2) Infectious material (3) type and severity of exposure (4) Susceptibility of HCW Appropriate treatment → Step 3 Follow-up, and counseling → Step 4 The key elements of postexposure management are listed here. Over the next few slides, wound management, exposure reporting, assessment of the infection risk by type and severity of exposure, determination of the bloodborne status of the source person, and appropriate treatment, follow-up, and counseling are explored in more detail.

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25 Step 1 Provide immediate care to the exposure site
Post exposure Wound Management: Wash wounds and skin with soap and water Flush mucous membranes with water No evidence of benefit for: application of antiseptics or disinfectants squeezing (“milking”) puncture sites Avoid use of bleach and other agents caustic to skin Inform authorities → Infection control unit. The first element in post exposure management is wound care. Wounds should be cleaned with soap and water. Mucous membranes should be flushed with water. Eyes should be flushed with eye irrigant or clean water. There is no evidence that application of antiseptics or disinfectants, or squeezing (or milking) puncture sites provides any benefit. The use of bleach and other agents that are caustic to the skin should be avoided.

26 Management of sharps accidents
WHO / SEAR 1999

27 WHO / SEAR 1999

28 Elements of Postexposure Management
Wound management & Exposure reporting → Step 1 Risk Assessment → Step 2 (1) blood borne infection status of source person (2) Infectious material (3) type and severity of exposure (4) Susceptibility of HCW Appropriate treatment → Step 3 Follow-up, and counseling → Step 4 The key elements of postexposure management are listed here. Over the next few slides, wound management, exposure reporting, assessment of the infection risk by type and severity of exposure, determination of the bloodborne status of the source person, and appropriate treatment, follow-up, and counseling are explored in more detail.

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30 Postexposure Management: Risk Assessment (Seek expert advice)
1 Type of exposure (EC) percutaneous mucous membrane non-intact skin bites resulting in blood exposure Determine susceptibility of exposed person (HCW) Hepatitis B vaccine status HBV immune status if vaccine response status in unknown Anti-HCV and ALT HIV antibody 3 Infectious status of the source person (SC) presence of HBsAg presence of HCV antibody presence of HIV antibody if source unknown, assess epidemiologic and clinical evidence (Do not test discarded needles) Body substance blood bloody fluid Other potentially infectious materials (OPIM) (semen, vaginal secretions and CSF, synovial, pleural, peritoneal, pericardial and amniotic fluids) or tissue 4 2 To assess the risk of infection, first consider the type of exposure. Those that pose a risk of infection are percutaneous injuries, mucous membrane exposures, exposures to non-intact skin, and bites resulting in blood exposure. In general, percutaneous injuries pose a greater risk than mucous membrane and non-intact skin exposures. The next thing to consider is the body substance involved in the exposure. Although blood and bloody fluid exposures are the most risky, there are other potentially infectious fluids or tissues, such as semen, vaginal secretions, cerebrospinal, synovial, pleural, peritoneal, pericardial, and amniotic fluid. Finally, the infection status of the source of the exposure must be evaluated. If the source is known but infection status unknown, HBV, HCV, and HIV testing should be performed. However, if the source is unknown, information on the type of exposure, and body substance, along with any other pertinent information must be considered before deciding postexposure management.

31 Elements of Postexposure Management
Wound management & Exposure reporting → Step 1 Risk Assessment → Step 2 (1) blood borne infection status of source person (2) Infectious material (3) type and severity of exposure (4) Susceptibility of HCW Appropriate treatment → Step 3 Follow-up, and counseling → Step 4 The key elements of postexposure management are listed here. Over the next few slides, wound management, exposure reporting, assessment of the infection risk by type and severity of exposure, determination of the bloodborne status of the source person, and appropriate treatment, follow-up, and counseling are explored in more detail.

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33 Step 3 Give PEP for exposures posing risk of infection transmission
HBV Give oPEP as soon as possible within 24 hours. PEP can be given to pregnant women HCV PEP not recommended HIV Initiate PEP within hours of exposure (2-72 Hours) Offer pregnancy testing to all women of child bearing age not known to be pregnant. Seek expert consultation if viral resistance suspected. Administer PEP for 4 weeks if tolerated.

34 oPEP Hepatitis B Infection

35 Concentration of HBV in Body Fluids
High Moderate Low/Not Detectable Blood Semen Urine Serum Vaginal Fluid Feces Wound exudates Saliva Sweat Tears Breast Milk As mentioned earlier, one factor to consider in assessing the risk of infection is the body substance to which healthcare personnel are exposed. This shows the concentration of HBV in various body fluids. On the left, in red, are the fluids with the highest concentration of virus. Moving from the left to the right side, the concentration decreases. Blood, for instance, has a higher virus concentration than urine or sweat.

36 Vaccination and antibody response status of exposed worker*
Treatment when source is found to be: HBsAg positive HBsAg negative Source unknown or not available for testing Unvaccinated HBIG x1 and initiate Hepatitis B vaccine series. Initiate hepatitis B vaccine series Previously vaccinated Known responder No treatment No treat. Known non-responder HBIGx1 and initiate re-vaccination or HBIGx2 If known high risk source, treat as if source were HBsAg positive Antibody response unknown Test exposed person for anti-HBs 1. If adequate, no treatment. 2. If inadequate, HBIGx1 and vaccine booster. Test exposed person for anti-HBs: 1. If adequate, no Treatment 2. If inadequate, vaccine booster and recheck titer in 1-2 months.

37 Persons who have previously been infected with HBV are immune to reinfection and do not require PEP.
Hepatitis B immunoglobulin: dose 0.06ml/kg im A responder is a person with adequate levels of serum antibody to HBsAg (i.e. anti-HBs > 10mIU/ml): a non-responder is a person with inadequate response to vaccination (i.e. serum anti-HBs antibody< 10mIU/ml) The option of giving one dose of HBIG and reinitiating the vaccine series is preferred for non-responders who have not completed a second 3-dose vaccine series. For those who previously completed a second vaccine series but failed to respond, 2doses of HBIG are preferred. Give one dose at time of exposure, and the second dose one month later.

38 Prevention of HBV Infection
Efficacy of HBV PEP* Regimen Prevention of HBV Infection Multiple doses of HBIG alone when 1st dose initiated within 1 week 70-75% Hepatitis B vaccine series alone Combination of HBIG and vaccine series 85-95% * Estimated for adults, based on perinatal data Studies of the long-term efficacy of the hepatitis B vaccine have shown that anti-HBs titers decline to <10 mlU/mL in 30-50% of adults within 8-10 years after vaccination. Nevertheless, exposure to HBV results in an anamnestic anti-HBs response that prevents clinically significant HBV infection. Despite the decrease of antibodies, this immune memory remains intact for at least 20 years after hepatitis B immunization, and chronic HBV infection has only rarely been documented among vaccine responders. Therefore, booster doses of hepatitis B vaccine are currently not recommended.

39 Hepatitis B Vaccine: Long-Term Efficacy
Anti-HBs titers decline to <10 mIU/mL in 30-50% of adults within 8-10 years after vaccination Exposure to HBV results in anamnestic anti-HBs response that prevents clinically significant HBV infection Immune memory remains intact for at least 20 years after immunization Chronic HBV infection rarely documented among vaccine responders Booster doses currently not recommended

40 oPEP Hepatitis C Infection

41 oPEP Hepatitis C Infection Not recommended

42 oPEP HIV Infection

43 Overview of the HIV clinical disease
AIDS Clinical stage 4 AIDS Defining illnesses HIV Seroconversion illness Clinical stage 3 Clinical stage 2 75% 33% Clinical stage 1 1-4wks 3wks 8 to 12 years

44 Natural History of HIV Infection

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46 Percutaneous injuries Infection status of the source
Exposure type Infection status of the source HIV-positive, class 1 Aymptomatic HIV infection or known low viral load (e.g. <1500) HIV-positive, class 2 Symptomatic HIV infection, AIDS, Acute seroconversion, or known high viral load Source of unknown HIV status (e.g deceased source person with no samples available for HIV testing) Unknown source (e.g. a needle from a sharps disposal container) HIV negative Less severe (e.g. solid needle, superficial injury) Recommend basic 2-drug PEP Recommend expanded 3-drug PEP. Generally, no PEP No PEP More severe (e.g. large-bore hollow needle, deep puncture, visible blood on device or needle used in patient’s artery or vein)

47 Mucous membrane exposures and non-intact skin exposures.
Exposure type Infection status of the source HIV-positive, class 1 Asymptomatic HIV infection or known low viral load (e.g. <1500) HIV-positive, class 2 Symptomatic HIV infection, AIDS, acute seroconversion, or known high viral load Source of unknown HIV status (e.g. deceased source person with no samples available for HIV testing) Unknown source (e.g. splash from inappropriately disposed blood) HIV-Negative Small volume (e.g. few drops) Consider basic 2-drug PEP Recommend basic 2-drug PEP Generally, No PEP No PEP Large volume (e.g. major blood splash) Recommend expanded 3-drug PEP

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49 If drug resistance is a concern, obtain expert consultation
If drug resistance is a concern, obtain expert consultation. Initiation of PEP should not be delayed pending expert consultation and, because expert consultation alone cannot substitute for face-to-face counseling, resource should be available to provide immediate evaluation and follow-up care for all exposures. The designation “consider PEP” indicates that PEP is optional and should be based on as individualized decision between the exposed person and the treating clinician. However, consider basic 2-drug PEP for a source with HIV risk factors, or occurs in a setting where exposure to HIV-infected persons is likely. If PEP is offered and taken, and the source is later determined to be HIV negative, PEP should be discontinued. For skin exposures, follow-up is indicated only if there is evidence of compromised skin integrity (e.g. dermatitis, abrasion, or open wound)

50 Considerations When Using PEP Risk of Adverse Effects
Ultimately, the decision to use postexposure prophylaxis must balance the risk of transmission against the risk of adverse effects associated with the use of prophylaxis. Risk of Transmission Risk of Adverse Effects PEP

51 Postexposure Management: HIV PEP Basic Regimen
Zidovudine (ZDV) Lamivudine (3TC) 200 mg tid (300 mg PO bid) 150 mg bid Alternate Basic Regimens Didanosine (ddI) Stavudine (d4T) Stavudine (d4T) Lamivudine (3TC) 200 mg bid (125 mg bid if <60 kg) 40 mg bid (30 mg bid if <60 kg) Most HIV exposures will warrant a two-drug regimen with two nucleoside analogues, as shown on this slide. The standard “basic” regimen consists of 200 milligrams of ZDV taken three times a day (tid) or 300 milligrams taken orally two times a day, in conjunction with 150 milligrams of 3TC taken two times a day (bid). In addition, two alternate basic regimens also may be considered.

52 Postexposure Management: HIV Expanded Regimen
Basic regimen plus one of the following Indinavir (IDV) 800 mg q8h Nelfinavir (NFV) 750 mg tid or 1250 mg bid Efavirenz (EFV) 600 mg daily Abacavir (ABC) 300 mg bid The addition of a third drug to the two-drug regimen should be considered for exposures that pose an increased risk for transmission. Agents to consider as a third drug include indinavir (800 milligrams taken every 8 hours), nelfinavir, efavirenz, and abacavir. The choice of drug should take into account the advantages and disadvantages of each drug, including the complexity of the regimen, serious toxicity, and the possibility of drug interaction with other drugs which the exposed person may already be taking.

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54 Elements of Postexposure Management
Wound management & Exposure reporting → Step 1 Risk Assessment → Step 2 (1) blood borne infection status of source person (2) Infectious material (3) type and severity of exposure (4) Susceptibility of HCW Appropriate treatment → Step 3 Follow-up, and counseling → Step 4 The key elements of postexposure management are listed here. Over the next few slides, wound management, exposure reporting, assessment of the infection risk by type and severity of exposure, determination of the bloodborne status of the source person, and appropriate treatment, follow-up, and counseling are explored in more detail.

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56 Step 4 Perform follow up testing and provide counseling
HBV Infection HCV infection HIV Infection Advice exposed persons to seek medical evaluation for any acute illness occurring during follow-up Perform HIV antibody testing for illness compatible with an acute retroviral syndrome. Test for anti-HBs 1-2 months after last dose of vaccine if only vaccine given. (anti-HBs response to vaccine cannot be ascertained if HBIG received in the previous 3-4 months) Perform testing for anti-HCV and ALT 4-6 months after exposure Evaluate exposed persons taking PEP within 72 hours after exposure and monitor for drug toxicity for at least 2 weeks. Follow-up not indicated if exposed person immune to HBV or received HBIG PEP Perform HCV RNA testing at 4-6 weeks if earlier diagnosis of HCV infection desired Perform HIV-antibody testing for at least 6 months postexposure (e.g. at baseline, 6 weeks, 3 months, and 6 months) Prevent secondary transmission on during the follow-up period. Refrain from donating blood, plasma, organs, tissue, or semen. No need for: modification of sexual practices or patient care, refraining from conception Confirm repeatedly reactive anti-HCV EIA with supplemental test Prevent secondary transmission on during the follow-up period. Follow-up anti-HBs testing of the exposed person depends on the postexposure prophylaxis administered. If only vaccine was given, anti-HBs testing should be done 1-2 months after receipt of the last vaccine dose. If, however, the exposed person is immune to HBV, or received HBIG in the previous 3-4 months, no follow-up testing is recommended. Nor is follow-up testing necessary if the source is not HBV infected. Healthcare personnel exposed to hepatitis B-infected blood should be counseled about refraining from donating blood, plasma, organs, tissue, or semen during the follow-up period. There is no need to modify sexual practices or refrain from becoming pregnant, or breastfeeding, or for special precautions to prevent secondary transmission. The healthcare personnel should continue to follow recommended infection control practices, including standard precautions and appropriate use of hand washing, protective barriers, and care in the use and disposal of needles and other sharp instruments. Additionally, there is no need to modify patient care responsibilities for the exposed person. If the healthcare personnel are found to have acute HBV infection, they should be evaluated according to published recommendations for infected healthcare personnel.

57 Preventing Transmission of Blood borne Viruses in Healthcare Settings

58 Frequency of Percutaneous Injury in Healthcare Personnel
Based on CDC estimates, 384,325 (95% CI 311, ,922) percutaneous injuries are sustained by healthcare personnel in US hospitals annually* The number of injuries sustained outside of hospital settings is unknown Frequency of percutaneous injury varies by occupational group and healthcare setting The third factor influencing the occupational risk of bloodborne infection is the nature and frequency of blood exposure. Based on CDC estimates, approximately 384,325 percutaneous injuries (i.e., approximately 1,000 a day) are sustained by healthcare personnel in US hospitals annually. The number of injuries sustained outside of hospital settings is unknown. The frequency of exposure to blood due to a percutaneous injury varies by occupational group and healthcare setting. * Panlilio, AL, et. al. Estimate of the Annual Number of Percutaneous Injuries in U.S. Healthcare Workers. 4th Decennial Conference, March 5-9, 2000

59 Preventing Transmission of Bloodborne Viruses in Healthcare Settings
Promote hepatitis B vaccination Treat all patients as potentially infectious Use barriers to prevent blood/body fluid contact Prevent percutaneous injuries Preventing transmission of bloodborne viruses in healthcare settings requires a multifaceted approach, including promoting hepatitis B vaccination of all healthcare personnel who may have contact with blood, considering all patients as potentially infectious, using appropriate barriers to prevent blood and body fluid contact, and preventing percutaneous injuries, by eliminating unnecessary needle use, implementing safety devices (devices with safety features), using safe work practices when handling needles and other sharp devices, and safely disposing sharps and blood-contaminated materials.


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