1. NSI (Needle stick injuries) & PEP (Post Exposure Prophylaxis)
Needle stick injury and its prevention by post exposure prophylaxis are the most important topics of discussion especially from the point of view of the treating physician and his or her protection from this occupational hazard. This presentation will sensitize the delegates and doctors how not to get worried while handling the potentially infective patient, how to protect one’s self and last but not the leats, how not to hide the needle stick injury and in stead what to do immediately after such a exposure. Time is precious in such exposure as one has to start the prophylaxis treatment as soon as possible.

2. HCW/HCP EXPOSURE – NSI
An exposure that might place HCP at risk for HBV, HCV, or HIV infection is defined as
a per-cutaneous injury (e.g., a needle-stick or cut with a sharp object) or
contact of mucous membrane or non-intact skin (e.g., exposed skin that is chapped, abraded, or afflicted with dermatitis)
with blood, tissue, or other body fluids that are potentially infectious .
Description of the types of injury and exposure which can put us at a risk of getting infected with blood borne pathogens like HBV, HCV and HIV.
CDC-MMWR June 29, 2001 / Vol. 50 / No. RR-11
– Updated US PHS Guidelines for Management of Occup Exposure to HBV,HCV and HIV and Recommendations for PEP

3. Worldwide, the first documented case of HIV transmission from patient to HCW was a UK nurse who sustained a needle-stick injury whilst obtaining blood from the arterial line of an African patient with AIDS.
(Anon., Lancet, 1984, ii:1376-7)
Photograph of poorly introduced cannula and reference to HIV in healthcare workers

4. Infections transmitted by Sharps injury (source: Collins & Kennedy, 1987 )
Blastomycosis Malaria
Brucellosis Mycobacteriosis
Cryptococcosis Mycoplasmosis
Diphtheria Rocky Mountain fever
Ebola fever Scrub typhus
Gonorrhoea Staphylococcus aureus
Hepatitis B Streptococcus pyogenes
Hepatitis C Syphilis
Herpes Toxoplasmosis
HIV Tuberculosis
Leptospirosis
List of infections that can be transmitted by sharps injury. One needs to stress that not only HIV but a host of other infections can be potentially transmitted by needle stick injury including HCV and HBV which are 10 & 100 time more potent in their eficacy of transmission percutaneously. We are only now aware and afraid of needle stick injury though HBV and HCV is known to the mankind for many decades before we knew of HIV.

5. **Simonsen et al WHO bulletin 77,1999
Estimated Risk of Infection Following a Needle-stick from an Infected Source-Patient
35%
30%
**Simonsen et al WHO bulletin 77,1999
30%
25%
20%
15%
10%
Graph showing the estimated risk of infection by the commonest three blood borne pathogens from an infected source to healthcare professional. If the source was infected with HBV then there is a 30% chance that the healthcare professional will develop Hepatitis B infection. The same is for Hepatitis C and HIV. But the fear in our minds is converse more for HIV and less for Hepatitis B & C. 5% 3%
0.30% 0%
Hepatitis B Virus
Hepatitis C Virus
HIV

6. Determinants of Risk Of Transmission
Prevalence of virus in patient population
Type of exposure – percutaneous/ muco-cutaneous
Extent of injury – superficial/deep
Type of device – hollow bore/solid needle
Plasma viraemia of source
Immune status of HCW
Immediate aftercare and use of PEP
Description of the causes increasing risk of transmission of blood borne pathogens due to NSI. It is important to note that the risk of transmission depends on so many variables and hence it is important to elicit details of the type of exposure which will help us decide the type of post exposure prophylaxis to be started after such an exposure.

7. At risk type of exposures
At risk type of exposures. In a Percutaneous injury the risk is more from hollow needles with visible blood if the injury is deep or the device is introduced directly into the vein or Artery. In a splash on a non intact skin or mucous membrane has the highest risk. The risk is high if the exposure is to large volume of blood and body fluids or the injury is severe.

8. Line diagram showing different types of infectious body fluids
Line diagram showing different types of infectious body fluids. It is important to stress that the common misunderstanding that urine, stools, tears, saliva, sweat or vomits can lead to chances of transmission is not true unless these are contaminated visibly by blood. It also stresses the need of taking universal precautions while handling other body fluids.

9. Needlestick Injuries Inappropriate disposal
Most frequently during & after an injection
Recapping, carrying needles and syringes
Patient movement (children)
Inappropriate disposal
NSI occur most commonly when we are trying to recap needles either before injection or after injection. When we carry needles in a tray from one point to another without the cap on due to sudden movement of patients in an attempt to withdraw away we prick ourselves or any other person standing nearby. Inappropriate disposal like throwing away casually in the dustbin or in isolated corners can prick us or any other person who steps on them. It is dangerous to try to bend or recap the needle and the best is to dispose it by standard method i.e. cutting the needle and the needle hub in a syringe cutter or putting the used syringe with needle in a puncture proof container.

10. Prevent Needlesticks
Organizing the physical layout of the Injection work area
Minimize handling of injection equipment
Do not carry, Do not Recap or bend
Cleaning the Injection environment – Before and after injections
Safe disposal to Prevent injuries to public
The basic interventions which can prevent needle stick are having a proper layout of the injection OPD or our office area. Minimizing the handling of injection equipment by not carrying them from one point to another in bare hands by not recapping and trying to bend the needle after giving the injection. Proper cleaning of the OPD pre and post can also minimize the chances of infection being spread. Safe disposal as per GOI recommendations is also imperative.

11. STANDARD PRECAUTIONS Barriers Protection Hand washing Safe techniques
Safe handling of
Sharp items
Specimens
Spill of blood / body fluids
Use of Disposable / Sterile items
Standard precautions for safety of self and primary prevention of needle stick injury are thorough hand washing before each procedure taking care that the web spaces and creases are properly cleaned. Barrier protection using gloves gives added protection. Studies have shown that the incidences of NSI is the same with a single pair of gloves or no gloves, it is with the double gloves that the incidence dramatically falls. Proper techniques of giving injections minimize NSI to a great degree. Safe handling of all Sharps (broken glass, blades, needles, etc) and Biological specimens including blood and body fluids (peritoneal fluids, urine, etc), and usage of disposable or pre-sterile equipment minimizes the chances of spread of blood borne pathogens.

12. Immediate Management of NSI
IMMEDIATELY clean Exposure site – The most important part of PEP
Skin wounds should be washed with soap and running water
No evidence that antiseptics are useful and caustic agents (bleach) may do more harm than good
Mucous membranes flushed thoroughly with water(no soap)
Eyes irrigated with a liter of saline
Immediate management of NSI is one of the most important steps in the long process of efforts to minimize chances of spread of BBV due to sharps injury. Immediate cleaning of the injury site followed by washing of skin wounds with soap and running water for 15 minutes (by the clock literally) is of paramount importance. Mucous membranes are flushed thoroughly with water and eyes irrigated with a liter of saline at least. There is no evidence that antiseptics and disinfectants have any role.

13. Post Exposure Prophylaxis Guidelines
Immediate first aid
Report incident
Risk assessment
Counselling
Decision regarding use of PEP
Follow-up
A general guide line for PEP is given in this slide and will be dealt in detail in following slides. A common mistake done by the person exposed is to hide or ignore the incidence out of fear, carelessness or shame. This only delays the first dose of drugs like anti-retroviral agents which must be started as early as possible, preferably within first hours of exposure. It is better to behave like a patient and leave the decisions to your physician friend who is competent to like such decisions and not to self treat as you may under-treat or over-treat yourself!

14. NSI :Hepatitis B - Risk of Disease depends on the HBeAg status
This slide shows the risk of Hepatitis B after an NSI and is dependant on the HBeAg status of the source. Incidence of clinical Hepatitis will be high if both ‘s’ and ‘e’ antigens are positive. Percentage of seroconversion is higher when both are positive and a bit low when only surface antigen is positive. It is also known that the hepatitis B virus can survive and remain active in a dried blood clot for up to a week at room temperatures. It is also highly sensitive to commonly available disinfectants and sterilization procedures.
HBV Remains active in dried blood at Room Temperature for at least 1 Week
Can be a major cause of transmission
CDC-MMWR June 29, 2001 / Vol. 50 / No. RR-11
– Updated US PHS Guidelines for Management of Occup Exposure to HBV,HCV and HIV and Recommendations for PEP

15. Hepatitis B Vaccination in HCP
GOOD NEWS
Those HCP’s who have been vaccinated; the vaccine offers virtually complete protection to responders.
Hence all HCP should be HB vaccinated
BAD NEWS
Most HCP’s are NOT vaccinated
6-10% of vaccinees do NOT develop antibody
Repeat vaccine series – 30-50% respond
Really bad news: CDC estimates that HCW die from Hep B each year
The good news about Hep B immunization in health care professionals is that those who have taken all the doses of vaccine at the right interval and have responded to the immunization have virtually complete protection. The bad news is that a lot of health care professionals are still not immunized. The level of response to the antigen comes down with increasing age. 6 to 10 percent of vaccines do not develop antibodies, in these it is imperative to repeat the vaccine series still only 30 to 50 percent of non responders develop immunity. CDC in the US estimate that 50 to 75 health care professional die every year due to complication of Hep B infections acquired due to sharps injury.

16. Exposure To Hep B – HCP Management
HCP Vaccinated
HCP Not Vaccinated
Antibody >10 iu/ml
Antibody <10 iu/ml
Immediate Vaccine – (within 7 days) Along with HBIg (0.06 ml/Kg)
No Addl T/T
Pt HBs Ag -ve
Unknown Source
Pt HBsAg +ve
Management of health care professionals exposed to Hep B infection is as follows:
1) All vaccinated health care professionals have to get a serum antibody titer done. If it is more than 10 mIU/ ml no additional treatment is required; if the titers are below this and the source patient is HBsAg negative a new series of vaccines is given. If the source person is HBsAg positive then a complete series of vaccine is started with initial dose of HB immunoglobulin and booster given later.
2) If not vaccinated than immediate vaccine series to be started within seven days of injury along with the HB immunoglobulin in the dose of 0.06 ml/Kg body weight to a maximum of 5.0 ml. HBIg should be given as early as possible, preferably within hours along with the vaccine at a separate site. However if the HBIg is delayed due to any reason, it can be still be given up to 7 days beyond its efficacy is doubtful.
HCP:Booster dose or Complete series
HCP:Booster dose or Complete series + HBIg

17. POST EXPOSURE MANAGEMENT
HEPATITIS C –
POST EXPOSURE MANAGEMENT
Blood Test immediately and at 6 mths
LFT and Anti HCV at 4 – 6 Mths
Interferon not recommended for prophylaxis
No Active Prophylaxis-Immunoglobulins not effective
Determine status of Source (Anti-HCV)
PEP of Hep C is relatively simple as immunoglobulins are not very effective and interferons have not been recommended for prophylaxis. The anti HCV status of source should be determined if possible and HCP tested immediately and at 6 months for both LFT and anti HCV. Really speaking there is no effective anti-HVC prophylaxis treatment available and hence it is all the more important to prevent this infection avoiding needle stick injury.

18. POST EXPOSURE COUNSELLING - CDC
6 Mths
Blood Test No
Blood Donation
Pregnancy
Breast feeding
Modification of Sexual practices
Risk to infant and Partner
Factors
Yes
Low
Hep B
Hep C
CDC has proposed post exposure counseling of all HCP who have been exposed Hep B or C due to NSI. The given chart is self explanatory.

19. POST EXPOSURE PROPHYLAXIS FOR HIV
The rationale for PEP is to block the dendritic cells before they can get infected with HIV and halt viral replication before it becomes systemic. Studies have shown that the risk of seroconversion is significantly lower in HCP who have taken immediate PEP. In case of a pregnant female HCP, mother to child transmission is also negligible if immediate treatment is started.
PEP should be started within 2 to 8 hours of exposure for maximal benefit. Delays in starting PEP may prove costly in the long run. The risk of HIV infection depends on the type of exposure. The highest incidences is because of NSI and 0 incidence if contact with intact skin. NACO has for purposes of scientific management of NSI coded the type and severity of exposure to infected blood and body fluids into three. They have also classified the source of infection based on the HIV status, CD4 counts and viral load into three. A combination of the severity and type of exposure coupled with the HIV status of the source patient determines what treatment regime has to be followed.
The Available antiretrovirals are grouped in to two regimes the basic regimes and the expended regime. Generally the basic regime is two drug regime given for a period of 4 to 6 weeks. The expanded regime adds one more drug to the basic regime. Improper and intermittent treatment has started to throw up resistance to the PEP .In pregnant HCP PEP started immediately to stop any chances of mother to child transmission. Of those who do not take post exposure prophylaxis or fail to respond and become infected with HIV, seroconversion occurs within 6 to 12 weeks; co infection with HCV delays seroconversion to HIV. The average time from exposure to symptoms is 2 to 6 weeks but in 50 to 90% cases acute symptomatic seroconversion may develop.

20. Rationale for HIV PEP
HIV infects dendritic cells (DC) then regional lymph nodes before becoming systemic
AZT blocks infectivity of HIV infected DC
Goal of PEP : halt viral replication before systemic infection is established
Retrospective study : Risk of Seroconversion: 81% lower in HCP’s who took AZT PEP.(NEJM 1997;337:1485)
Several animal studies showing efficacy
Peri-natal prophylaxis has been effective

21. FOR HIV-VIRUS Time is ESSENCE
Animal studies show that PEP should be given within 2-8 hours of exposure for maximal effect
(JID 1991;163:625 - Within 2 hrs optimal)
(JID 1993;168:825 - Within 8 hrs optimal)
PEP may have some benefit up to 36 hrs but seems to be ineffective if given later

22. Mucous membrane exposures (0.09%risk of HIV infection).
The exposures that pose the greatest risk are: Contaminated needle stick injuries (0.3% risk of HIV infection)
Mucous membrane exposures (0.09%risk of HIV infection).
Non-intact skin contact with contaminated blood (similar risk as mucous membrane exposure).
No documented transmission has taken place from intact skin contact.
Bell DM. Occupational risk of human immunodeficiency virus infection in healthcare workers: an overview. Am J Med 1997;102(suppl 5B):9–15.
Ippolito G, Puro V, De Carli G, Italian Study Group on Occupational Risk of HIV Infection. The risk of occupational human immunodeficiency virus in health care workers. Arch Int Med 1993;153:1451–8.

23. PEP-HIV Classification of Exposure - NACO
Exposure code (EC)
Exposure
EC 1
Mucous Membrane / skin integrity compromised , Small Vol, Few drops Short Duration
EC 2
Mucous Membrane / skin integrity, large volume,long duration (several minutes or more )
Percutaneous Exposure ,Less severe (solid needle/Superficial scratch)
EC 3
Percutaneous, more severe
Hollow needle, major wound , bloody device

24. PEP-HIV Classification of Source -NACO
Source Code (SC)
HIV status of Source
SC 1
HIV +ve , Low Titer Exposure, asymptomatic with High CD4 Counts
SC 2
HIV +ve, High Titer Exposure ( Advanced AIDS, Primary HIV infection/High Viral load or Low CD4 Counts)
UnKnown
Status or Source is Unknown

25. PEP-HIV Treatment – NACO
Exposure code (EC)
Source Code (SC)
Treatment
EC 1
SC 1
PEP may be warranted*
SC 2
Consider Basic Regime
EC 2
Recommend Basic Regime
( most exposures in this category)
Recommend Expanded Regime
EC 3
SC 1or2
2/3
Unknown
Consider basic regime

26. ANTIRETROVIRALS FOR PEP
Reverse transcriptase inhibitors RTI
Nucleoside Reverse Transcriptase Inhibitors (NRTI) - Ziduvidine, Lamuvidine
Non nucleoside (NNRTI) - Nevirapine (not recommended)
Protease inhibitors (PI)-Nelfinavir,Indinavir
Single drug v/s multiple drugs for PEP - no direct supportive evidence
Theoretical advantage of adding an agent at a different level

27. PEP HIV - DRUG REGIMENS BASIC REGIMEN ZIDOVIDINE 200 mg tid plus
LAMIVUDINE
150 mg bid
for 4 weeks
EXPANDED REG
Basic Regimen +
INDINAVIR
800 mg tid or
NELFINAVIR
750 mg tid or
Selquinavir (softgel)
1200 mg tid

28. HIV PEP Resistance
Significant problem now : many patients on Treatment
Important to take history :both recent & remote
PEP should NOT be delayed for want of Full medical history.
Data from maternal transmission studies shows viral resistance does not preclude benefit

29. HIV PEP Resistance Issues
Consultation with HIV specialist recommended in cases where HIV resistance is possible
PEP may need to be modified once more history is available
Resistance testing is too slow to be of use right now

30. HIV PEP and Pregnancy
Women of child bearing age :offered a pregnancy test before starting PEP
BUT, recommendations on starting PEP should NOT change just because HCW is pregnant
Contraindicated drugs
d4T, ddI: severe lactic acidosis
Efavirenz: is teratogenic in primates
Indinavir: causes hyperbilirubinemia in newborns if given near time of delivery

31. HIV: Health Care Professional Time to Seroconversion
6-12 weeks (median time :46 days)
95% by 6 months; 100% by one year
Co-infection with HCV may delay HIV seroconversion
Acute Symptomatic sero-conversion develops in 50-90% of cases
Exposure to symptoms : average time 2-6 weeks
ANY HCP who develops a flu-like illness in the follow up period should be encouraged to get HIV RNA testing

32. Conclusion Ensure reporting setup Update oneself on all aspects of PEP
Ensure supply of (Start up packs) PEP medications in your setup.
People react very differently to exposures - be prepared for anything!
The psychological impact of an exposure can be enormous
Your patience and understanding may be the best PEP of all
The conclusion that can be drawn from this presentation is that all health facilities should have are reporting set up we have to keep updating ourselves on all aspects of PEP. Start up packs should be available with the nearest reporting centre and these are provided by NACO on demand.The psychological impact of the NSI is enormous so we should be prepared for type of reaction. Patience and understanding is one of the best PEP available.

33. Be Needle Smart Do NOT recap Do NOT bend Do NOT remove
Do NOT transport
Do NOT re-use
Finally to reiterate LET ALL BE NEEDLE SMART.

34. Thank you