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Adverse Event Reporting Policy

This document outlines an adverse event reporting policy and standard operating procedures for addressing occupational health hazards for hospital employees. It provides guidance on pre-exposure prophylaxis for hepatitis B vaccination, post-exposure management including wound cleaning and risk assessment, and post-exposure prophylaxis protocols for hepatitis B, hepatitis C, and HIV depending on the nature and risk of exposure. It details assessment of exposure risk and source, recommended drug regimens and durations, follow-up procedures, and situations requiring expert consultation. The goal is to protect staff from accidental exposure to infectious diseases and properly manage any exposures according to established guidelines.

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0% found this document useful (0 votes)
77 views5 pages

Adverse Event Reporting Policy

This document outlines an adverse event reporting policy and standard operating procedures for addressing occupational health hazards for hospital employees. It provides guidance on pre-exposure prophylaxis for hepatitis B vaccination, post-exposure management including wound cleaning and risk assessment, and post-exposure prophylaxis protocols for hepatitis B, hepatitis C, and HIV depending on the nature and risk of exposure. It details assessment of exposure risk and source, recommended drug regimens and durations, follow-up procedures, and situations requiring expert consultation. The goal is to protect staff from accidental exposure to infectious diseases and properly manage any exposures according to established guidelines.

Uploaded by

cs nagar
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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DISCTRICT HOSPITAL AHMEDNAGAR

Issue date: 01-OCT-2021


DHP/PRE/Doc no;03
Issue No.: 01
Rev. date: 23/10/2021
Adverse Event Reporting Policy
Rev No.:2
Page no-1-5 Effective Date: : 01-oct 2021

SOP for Addressing Occupational health hazards of


Employee
Purpose: HIV, hepatitis B and Hepatitis C infections are known to get transmitted
from the
infected patients to the health care provider. The hospital should offer protection to
its staff
from occupational hazards by providing care for accidental exposures. Hospitals
should also
conduct training of HCPs to avoid accidental percutaneous ( needle stick) or mucosal
exposure to blood and body fluids.
Scope: All staff including doctors, nurses, housekeeping and cleaning staff of the
hospital.
SOP on Pre-exposure prophylaxis for Hepatitis B
 Check status of hepatitis B vaccination of all staff. If there is no evidence of
Hepatitis
B vaccination in the past, the vaccination should be started.
 The vaccination schedule: Three intramuscular injections, 0, 1, 6 months
SOP on post-exposure prophylaxis
Offer post-exposure prophylaxis when the staff member is exposed to blood or body
fluid or
needle-stick injury.
Initiate following steps after a needle-stick injury or exposure of skin and mucous
membranes to blood and body fluids.
Wound or mucous membrane management
 Clean skin wounds with soap and water.
 Flush mucous membranes ( eye, mouth) with water.
 No application of antiseptics or disinfectants or squeezing puncture site. Avoid the
use of chlorine solution, alcohol or other agents.
Immediate reporting to designated individual (Casualty or Duty medical officer)
 Date and time of exposure.
 Type of Procedure done
 Type of exposure : Percutaneous or mucus membrane (how, with what device).
 Exposure details: route, body fluid involved, volume or duration of contact.
 Information about source person. Post-exposure management: Assessment of
infection risk
 If source person testing is possible: test for presence of HBsAg /HCV antibody/HIV
antibody
 If source person testing is not possible: consider risk factors in the source that
predict higher incidence of HBV, HCV, HIV infection.
 Check whether blood sample of the source is available for testing
 Follow guidelines for post-exposure prophylaxis for individual situations.
 Provide free evaluation, testing and medication to exposed staff

Post-exposure prophylaxis for Hepatitis B


Percutaneous or mucosal exposure to HBsAg-positive blood or body fluids:
PEP depends on whether the exposed person had previous hepatitis B vaccination or
not. If the person is vaccinated the regime depends upon whether he is a known
responder ( has anti hepatitis B surface antigen > 10 IU/ml)
Completely vaccinated person: If available, test exposed person for antibody to
HBsAg. If adequate, no treatment required. If nonresponder ( Anti HBs < 10 IU/ml,
administer HBIG and one Hepatitis B vaccine booster dose.
Percutaneous or mucosal exposure to HBsAg-negative blood or body fluids:
 Unvaccinated person: Administer Hepatitis B vaccine regimen.
 Vaccinated person: No treatment required.
Percutaneous or mucosal exposure to HBsAg status-unknown blood/ body
fluids:
If known high-risk source, treat as if source were positive.
Hepatitis B Vaccination After Accidental exposure
HBV vaccination Status of exposed person
Action after AEB
Never vaccinated
Give complete Hepatitis B vaccine series
Vaccinated , anti-HbS not known
Give Hepatitis B vaccine booster
Vaccinated > 5 years ago
Give Hepatitis B vaccine booster
If available, testing for the antibody level (anti-HbS)
Hepatitis B vaccine should be given as soon as possible after the exposure. Do not
wait for anti-HbS results, if test is done.
Adequate levels of serum antibody to HbSAg ( anti-HbS is > 10 IU/L
Comparative risk after needle stick injury for HBV is 9-30% and for HCV is 1 -1.8%.
Prevention of HBV with Vaccine series alone gives 70-75% protection. Combination
of HbIG and vaccination gives 85-95% protection.
Dose of HbIG 0.06 ml/Kg body weight. HBIG provides passive antibodies and
temporary protection upto 3-6 months only.
Post exposure prophylaxis for HIV
Risk of transmission depends upon nature of exposure and status of source patient.
See the flow diagram showing categorization of exposure code and source code. PEP
drugs should be available at the designated clinic (in emergency room/labour
room /ICU).
Assessing the nature of Exposure
Category
Definition and Example
Mild Exposure
Mucus membrane/non-intact skin with small volume with a plane or
low caliber needle. Contact with eyes or mucus membranes.
Subcutaneous injections with small bore needles
Moderate Exposure
Mucus membrane/non-intact skin with large volume or
percutaneous superficial exposure with solid needle ( cut or needle
stick injury penetrating gloves)
Severe Exposure
Percutaneous with large volume( wide bore needle > 18 G visibly
contaminated with blood, a deep wound, transmission of a
significant volume of blood, needle used for IV or intra arterially

11.4.2 Assessing HIV status of the source of exposure


 HIV status known/unknown
 Unknown status : Patient available for testing : Counselling and testing of source
 Patient refuses testing, blood sample available : Testing on sample
 If the patient is known HIV positive : Evaluation of risk. Whether on ART,
symptomatic or asymptomatic, most recent CD4 count, viral load & resistance status
Low Risk
HIV positive and clinically asymptomatic.
High Risk
HIV positive and clinically symptomatic, OI/AIDS89
11.4.3 Assessment of Exposed Person
 Assess the nature of exposure : Mild, moderate, severe ( See table below)
 Perform baseline Laboratory investigations : Complete blood count and ALT/AST
before starting PEP. HIV, Hepatitis B surface antigen, Anti- Hepatitis C within 6 days
of exposure
PEP Regimes for HIV for Healthy adults and adolescents (NACO)
Drugs & Dosagefor PEP
Recommendations for PEP
Duration
Tenofovir 300 mg + Lamuvidine
300 mg one tab FDC once daily
1 tab within 2 hours of exposure
either at day time or night time
Next day 1 tab once daily,
for 4 weeks
Lopinavir 200 mg + Ritonavir 50
mg two tablets FDC twice daily
two tablets within 2 hours of
exposure either at day time or
night time
Next day 2 tablets twice
daily, for 4 weeks
If Lopinavir/R is not available or cannot be used, Tenofovir 300 mg + Lamuvidine 300 mg +
Efavirenz
600 mg one tab FDC once daily may be given for 4 weeksIf the source is on ART , start the
first dose of PEP as above immediately and then seek
expert opinion from physician at ART + centre/ centre of excellence by telephone or
e mail.
 PEP must be initiated as soon as possible after exposure, preferably within 2 hours
and certainly within 72 hours as it is less beneficial if started beyond 72 hours.
 The first dose of PEP should be administered as soon as possible, without waiting
for
the test results and the subsequently dose should be given at bed time with clear
instruction to take it 2-3 hours after dinner and to avoid fatty food in dinner.
 Counselling: Provide psychological support. Explain possible side effects,
adherence
to medicines, and follow up protocol. Explain that PEP is voluntary. Explain that the
risk of HIV infection after needle stick exposure is around 0.3% and mucus
membrane splash to eyes, oro-nasal is 0.09%. There is a small risk of transmission
even after PEP. Document the exposure. Obtain consent for PEP. Give the
information sheet to HCP.
Refer for Expert opinion if
 Delay in reporting > 72 hours
 Unknown source
 Known or suspected pregnancy (initiate PEP), Breast feeding mothers (initiate PEP)
 Source patient on ART
 Major toxicity of PEP
 When in doubt or complicated cases ( eg major psychological problem)
Follow up :
 Every week. Adherence counselling and drug toxicity monitoring
 Medical evaluation for any febrile illness within 3-6 weeks of exposure ( acute sero
conversion illness). If suspected refer to ART centre
 Avoid blood/semen/organ donation
 Avoid pregnancy . Sexual abstinence/use of latex condom. Avoid breast feeding,
 Lab testing : Complete blood count at week 2 and week 4
 HIV testing at 6 weeks, 3 months and 6 months.
 HBV and HCV testing at month 3 and month6

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