Template for Trust Policies



Policy and procedure for post exposure prophylaxis (PEP) following occupational and sexual exposure (PEPSE) to human immunodeficiency virus (HIV) Target audience:All Trust staffMain author: Consultant in Genito-Urinary Medicine and HIVContact details: 01622 225713/01622 225707Other contributors: Consultant Microbiologist / Director Infection Prevention and ControlConsultant Microbiologist HIV Specialist Pharmacist Lead Nurse Occupational Health Executive lead:Medical DirectorDirectorate:Women’s and Sexual Health ServicesSpeciality:Genito-Urinary Medicine (Sexual Health)Supersedes:Antiretroviral Chemoprophylaxis after Occupational Exposure to HIV (Version 2.0: July 2012)Antiretroviral Chemoprophylaxis after Occupational Exposure to HIV (Version 2.1: September 2015)Approved by:Infection Prevention and Control Committee, 17th August 2017Ratified by: Policy Ratification Committee, 13th February 2018Review date: 13th February 2022Disclaimer:?Printed copies of this document may not be the most recent version. The master copy is held on Q-Pulse Document Management SystemThis copy – REV3.0Document historyRequirement for document: HIV Post Exposure Prophylaxis is recommended after high risk exposure to HIV infected blood or bodily fluids. This policy aims to provide information on the assessment of risk and the drugs recommended following occupational exposure (PEP) and sexual exposure (PEPSE) and is written using UK guidance on HIV Post Exposure Prophylaxis from the Department of Health Expert Advisory Group on AIDS (2008) and the guideline for the use of Post exposure prophylaxis following sexual exposure by the British Association for Sexual Health and HIV (2015). This policy must exist alongside the Trust Policy on Management and Prevention of Sharps/Splash Injuries (2011).Cross references (external): Department of Health Expert Advisory Group on AIDS (2008). UK guidance on HIV Post Exposure ProphylaxisBritish Association of Sexual Health and HIV (BASHH) UK guideline for the use of post exposure prophylaxis for HIV following sexual exposure (2015) Expert Advisory Group on AIDS (EAGA) Change to recommended regimen for post exposure prophylaxis (September 2014) BASHH/EAGA Position statement on HIV window period (November 2014)General Medical Council. Good Medical Practice (2013)Associated documents (internal):Infection Control Policy and Procedure [RWF-OPPPCSS-C-PATH15]Sharps/Splash Injuries Policy and Procedure (incorporating Bloodborne Virus Exposure), Management and Prevention of [RWF-OPPPCS-C-WF5]Policy and Procedure for the Care of Patients with Bloodborne Infections [RWF-OPPPCSS-C-PATH7]Incident Management Policy and Procedure [RWF-OPPPCS-NC-CG22]Serious Incidents (SI) Policy and Procedure [RWF-OPPPCS-NC-CG23]Keywords: PEP- Post Exposure prophylaxisOccupational exposure to HIVNeedle-stick injuryHIV - Human Immunodeficiency virusPEPSE - Post Exposure Prophylaxis after Sexual ExposureHIV transmissionVersion control: Issue:Description of changes:Date:1.0First iteration of documentNovember 20052.0Reviewed and amendedJuly 20122.1Amended Appendix 6 Unique IDSeptember 20153.0Reviewed and amended to include recommendations for the most appropriate use of HIV post exposure prophylaxis following sexual exposure February 2018Summary forPolicy for post exposure prophylaxis (PEP) following occupational and sexual exposure (PEPSE) to human immunodeficiency virus (HIV)-571565405The purpose of this policy is to support the most appropriate use of HIV post exposure prophylaxis following a significant, or potentially significant, high risk exposure to HIV infected blood or body fluids. This policy provides information on management following either occupational exposure (PEP) or sexual exposure (PEPSE) for Maidstone and Tunbridge Wells NHS Trust (MTW).The policy aims to provide information on assessing risk of HIV transmission, timing of PEP and PEPSE, preferred drug regimen, drug to drug interactions and follow-up within Level 3 GUM services to adults aged 16 years and older.00The purpose of this policy is to support the most appropriate use of HIV post exposure prophylaxis following a significant, or potentially significant, high risk exposure to HIV infected blood or body fluids. This policy provides information on management following either occupational exposure (PEP) or sexual exposure (PEPSE) for Maidstone and Tunbridge Wells NHS Trust (MTW).The policy aims to provide information on assessing risk of HIV transmission, timing of PEP and PEPSE, preferred drug regimen, drug to drug interactions and follow-up within Level 3 GUM services to adults aged 16 years and older.Procedure Post exposure prophylaxis (PEP) following occupational and sexual exposure (PEPSE) to human immunodeficiency virus (HIV) TOC \o \h \z \u 1.0 Introduction, purpose and scope PAGEREF _Toc514841286 \h 52.0Definitions / glossary PAGEREF _Toc514841287 \h 63.0Duties PAGEREF _Toc514841288 \h 74.0Training / competency requirements PAGEREF _Toc514841289 \h 85.0Key information PAGEREF _Toc514841290 \h 85.1Risk of transmission PAGEREF _Toc514841291 \h 85.2Calculating risk of HIV transmission PAGEREF _Toc514841292 \h 105.3When to start PAGEREF _Toc514841293 \h 105.4What to use PAGEREF _Toc514841294 \h 115.5Other considerations PAGEREF _Toc514841295 \h 116.0Procedure PAGEREF _Toc514841296 \h 126.1Occupational exposure PAGEREF _Toc514841297 \h 126.2Sexual exposure PAGEREF _Toc514841298 \h 146.3Access to PEP/PEPSE PAGEREF _Toc514841299 \h 166.4Current recommended HIV post exposure prophylaxis regime PAGEREF _Toc514841300 \h 176.6HIV testing of the source patient PAGEREF _Toc514841301 \h 196.7Incident involving an unknown source PAGEREF _Toc514841302 \h 206.8Monitoring and advice for patients who require HIV PEP/PEPSE PAGEREF _Toc514841303 \h 206.9HIV antibody testing after exposure to HIV PAGEREF _Toc514841304 \h 21APPENDIX 1 PAGEREF _Toc514841305 \h 23Process requirements PAGEREF _Toc514841306 \h 23APPENDIX 2 PAGEREF _Toc514841307 \h 24CONSULTATION ON: Policy and procedure for post exposure prophylaxis (PEP) following occupational and sexual exposure (PEPSE) to human immunodeficiency virus (HIV) PAGEREF _Toc514841308 \h 24APPENDIX 3 PAGEREF _Toc514841309 \h 25Equality impact assessment PAGEREF _Toc514841310 \h 25FURTHER APPENDICES PAGEREF _Toc514841311 \h 261.0 Introduction, purpose and scopeThe risk of acquiring HIV following an exposure to HIV infected blood is LOW but the risk can vary depending on the type of exposure to the recipient and whether the source is at high risk of HIV.An occupational exposure is high risk if the injury is deeply penetrating and contaminated with blood or blood stained bodily fluids1.A sexual exposure is considered high risk2 if:unprotected anal sex has occurredunprotected receptive vaginal sex has occurred following a sexual assault Sources with a higher risk of HIV are2:men who have sex with menpersons who inject drugs or share injecting equipment those from a higher prevalence group i.e. Black African. a known HIV positive person who has an HIV viral load of 200 copies per ml or moreRisk of transmission can be calculated and is recommended when the risk of HIV transmission is thought to be greater than 1:1000 (see Table 1).Prophylaxis treatment for both occupational exposure (PEP) and sexual exposure (PEPSE) is the same and consists of a 28 day course of 3 antiretroviral drugs currently licensed to treat HIV positive patients. Where PEP/PEPSE is recommended the first dose should be issued within 24 hours but can be taken up to 72 hours after exposure.PEP/PEPSE is available 24 hours a day within the Trust. PEP/PEPSE is available from the Rubin Clinic, Department of Sexual Health (Tel 01622 225713 to confirm working hours) .Outside of working hours please refer the patient to Emergency Department (A&E) either at Maidstone Hospital or Tunbridge Wells Hospital to commence a 5 day starter pack. Advise the patient to attend the Rubin Clinic, Department of Sexual health at Maidstone Hospital for follow-up the next working day or within 72 hours of commencing a starter pack.PEP/PEPSE cannot be prescribed by GPs and patients must attend the Rubin Clinic, Department of Sexual Health for further treatment.PEP/ PEPSE starter packs should be issued in Emergency Department (A&E) if the first point of contact and recipients should not be advised to attend GUM the next day to commence it. Failure to attend for PEP/PEPSE could result in a missed opportunity to reduce acquisition of HIV.If PEP/PEPSE is required for anyone under the age of 16 years please consult with the on-call Consultant for Paediatrics. 2.0Definitions / glossaryAntiretroviral therapy: a drug or combination of drugs given to suppress viral replicationExposure: contact of skin (percutaneous), mucous membranes (mucocutaneous) or genital tract with blood or blood-stained body fluids HAART: Highly Active Antiretroviral Therapy – combination therapy used to treat HIV infectionHIV: Human Immunodeficiency VirusHIV Post exposure prophylaxis (HIV PEP): a combination of antiretroviral medications given to prevent HIV infection developing in an individual following a high risk occupational exposure to HIVHIV Post exposure prophylaxis after sexual exposure (HIV PEPSE): a combination of antiretroviral medications given to prevent HIV infection developing in an individual following a high risk sexual exposure to HIVHIV Seroconversion: the period of time during which HIV antibodies develop and become detectable. Seroconversion generally takes place within a few weeks of initial infection. It is often, but not always, accompanied by flu-like symptoms including fever, rash, muscle aches and swollen lymph nodes.HIV viral load: quantitative measure of HIV in 1ml of blood and reported as copies per ml. Levels of HIV viral load measured below 200 copies per ml are accepted as ‘undetectable’ and risk of HIV transmission is considered to be low risk. Poor adherence to medication and known HIV drug resistance may affect the suppression of HIV viral load level and should be checked in a source patient who is known to be HIV positive.Patient source: the person whose blood/body fluid is present on the item that caused the sharps / splash injury / sexual exposureRecipient: the person who has received a significant occupational or sexual significant exposure to blood / blood stained bodily fluids/ genital tract secretions.Sexually transmitted infection (STI): an infection that can be passed on from one person to another through sexual contact (including vaginal, oral and anal intercourse). Examples of important STIs that can facilitate HIV transmission include Chlamydia, Neiserria gonorrhoea, Trichomonas vaginalis, Herpes simplex infection, infectious Syphilis (primary or secondary stage)Significant occupational exposure: percutaneous injury (from needles, instruments, bone fragments, significant bites which break the skin etc.); exposure of broken skin (abrasions, cuts, eczema etc.); exposure of mucous membranes including the eyeSignificant sexual exposure: sexual exposure (unprotected insertive and receptive anal sex, unprotected receptive vaginal sex) from a known HIV positive person or someone from a high prevalence group.3.0Duties3.1 Genito-Urinary Medicine (GUM) staffAll staff should ensure that recipients are able to access this in a timely manner to avoid delay in commencing this treatment where possible. Administration staff should also be able to arrange appropriate follow-up for those started on PEP / PEPSE from Emergency Department (A&E) using GUM PEP/PEPSE pathway.Consultants and trained staff should be able to advise when HIV post exposure prophylaxis may be considered appropriate Consultants and trained staff must provide clinical care, management and follow-up to recipients who require HIV PEP/PEPSE within services provided by The Rubin Clinic, Department of Sexual Health, Maidstone Hospital, First Floor, Green Zone.All staff must be aware of the potential of HIV prophylaxis to interact with other prescribed and non-prescribed medications and how to seek further advice when necessary. Drug interactions can also be checked on hiv- Consultants and trained staff must be able to discuss with recipients requiring HIV PEP/PEPSE the risk of antiretroviral medication in pregnancy and to seek advice when necessary. Consultants and trained staff must liaise with Occupational Health Departments when necessary and provide timely written information of follow-up.The Lead Consultant for the Rubin Clinic Department of Sexual Health, has a responsibility to formulate this policy and procedure and to update this regularly.3.2Microbiology consultantsAdvise on management of sharps / splash injuries where HIV is known or thought to be a significant risk (out of normal working hours)Be able to recommend when HIV post exposure prophylaxis may be considered appropriate and to ensure that patients are provided this in a timely manner to avoid delay in commencing this treatment where possible. To liaise with Occupational Health Departments when necessary following Occupational exposure and GUM services following Sexual Exposure.To be aware of the potential of HIV prophylaxis to interact with other prescribed and non-prescribed medications and to seek advice from Trust on-call pharmacist out of hours when necessary. Drug interactions can also be checked on hiv- Aware of the potential risk of using HIV antiretroviral medication in pregnancy and to seek advice when necessary from Chelsea and Westminster HIV on-call registrar (contactable via Switchboard)3.3Manager responsibilitiesAll managers have a duty of care toward the staff for whom they are responsible. They should:Ensure that staff receive training on prevention and management of sharps / splash injuries.Ensure staff know the correct procedure to follow in the event of an incidentEnsure member of staff sustaining an injury report to Occupational Health the same day (Emergency department out of core hours) or next working day.Ensure that incident is investigated, steps to minimise reoccurrence are taken and that an incident report is completed.Ensure that risk assessments are undertaken to minimise the risks of sharps / splash injuries occurring.3.4Employee responsibilitiesEmployees have an individual responsibility to ensure that sharps are always handled safely, that they are disposed of correctly and safely and should be aware that it is a criminal offence to discard an item in such a way as to cause injury to others. They should:Report all needlestick incidents / percutaneous exposures to the ward/department manager and ensure that they have completed an incident report. Procedure described in Incident Management Policy and ply with preventative strategies for the protection of themselves and others, including universal precautions as well as the safe use/ disposal of sharps (see Prevention and Management of Sharps / Splash Injuries Policy and Procedure) Ensure adequate risk assessments have been undertaken prior to the commencement of their work and for ensuring safe working practices.Always seek assistance when dealing with any patient whose condition or mental state may increase the risk of a sharps/splash injury occurring.4.0Training / competency requirementsStaffTraining for all Trust staff regarding the action required in the event of a sharps / percutaneous incident will form part of the Trust’s mandatory training package.The author of these guidelines disseminates this document to the lead consultants in Microbiology, Occupational Therapy, Emergency Department (A&E) and Sexual Health. It is also available on the Trust Intranet Policies & guidelines page (Q-Pulse).It is the responsibility of directorate and departments to ensure that relevant staff are aware of any new or newly revised policies.5.0Key information5.1 Risk of transmissionRisk can be calculated (see Section 1.2) and depends on whether the source is known HIV positive, or from a higher prevalence risk group, and the type of exposure. Any risk calculated greater than 1 in 1000 is accepted as being significant and PEP/PEPSE would be recommended2. 5.1.1 If a source is known HIV positive the risk of transmission is dependent on the level of HIV viral load. Any source on treatment with an undetectable viral load for at least 6 months is deemed low risk. PEP would not be necessary if the viral load was less than 200 copies per ml regardless of what type of exposure occurred. However this must be verified with the source’s HIV care team as soon as possible and PEP could be initiated while sourcing this information if a delay of >24 hours is expected3.If a source is known to be HIV positive and not on treatment then the HIV viral load level is likely to be >200 copies per ml. The risk of HIV transmission will then also depend on the type of exposure (see Table 1). Risk of HIV transmission from a known positive source not on treatment following a needlestick injury is 1 in 333, from unprotected receptive anal intercourse is higher at 1 in 90 but from unprotected receptive or insertive oral intercourse is much lower at <1 in 10,000 (See Table 1). PEP/PEPSE is only recommended where the risk is > 1 in 1000.Table 1: Risk of HIV transmission per exposure from a known HIV positive individual not on HAARTType of occupational exposureEstimated risk from known HIV positive individual not on HAARTBlood transfusion1 in 1Needlestick1 in 333Sharing injecting equipment (including chemsex)1 in 149Human bite< 1 in 10,000Type of sexual exposureEstimated risk from known HIV positive individual not on HAARTReceptive anal intercourse 1 in 90* With ejaculation1 in 65 Without ejaculation1 in 170Insertive anal intercourse 1 in 666** Not circumcised1 in 161 Circumcised1 in 909Receptive vaginal intercourse1 in 1000Insertive vaginal intercourse1 in 1219Semen splash to eye< 1 in 10,000Receptive oral sex (giving fellatio)< 1 in 10,000Insertive oral sex (receiving fellatio)< 1 in 10,000*use this figure if not able to ascertain if ejaculation occurred** use this figure if not able to ascertain if circumcised or not5.1.2 Where the source HIV status is unknown or unconfirmed the prevalence of HIV can help establish the likelihood of a source having HIV. The prevalence of HIV in the UK is highest in men who have sex with men (MSM) and those from Africa. In MSM aged 15-59, the prevalence is 5.9% but areas of higher prevalence occur and should be taken into consideration (see Table 2). The prevalence in those of African ethnicity is 4.1% in men and 7.1% in women compared to the UK population prevalence of 2.8% so careful consideration of each individual circumstance must be given when assessing the need to commence PEP/PEPSE.Table 2: Estimated HIV prevalence (diagnosed and undiagnosed infection) in adults15-59 years in UK 2014 (see Appendix 5)GroupEstimated HIV seroprevalence GroupEstimated HIV seroprevalence General populationPer 1000Kent areasPer 1000UK2.8Dartford1.72Kent1.12Gravesham1.63Medway1.40Ashford1.56Heterosexual%Thanet1.43Black African Male4.1Shepway1.30Black African Female7.1Sevenoaks1.16Non Black African Male0.06Maidstone1.15Non Black African Female0.06Swale1.09MSM%Dover 1.00UK5.9Canterbury0.94London12.5Tunbridge Wells0.87Brighton13.7Tonbridge and Malling0.45Manchester8.6Female commercial sex workers (%)Elsewhere in UK2.8Western Europe<1Injecting drug users%Central Europe1-2All0.6-1.1Eastern Europe2.5-85.2 Calculating risk of HIV transmissionThe potential risk of exposure to an individual is calculated by multiplying the risk per exposure (see Table 1) and the risk that the source is positive (see Table 2)For example if an MSM presents for PEPSE following unprotected receptive anal intercourse with ejaculation with a male partner of unknown HIV status in London. The risk of transmission = 1 in 65 x 12.5% = 1/65 x 12.5/100 = 1/520. The risk in this case is higher than 1/1000 so PEPSE would be recommended.5.3 When to startIf required for the reasons below initiation of HIV PEP/PEPSE should commence as quickly as possible and is now recommended to commence within the first 24 hours, but can be initiated within 72 hours after a significant exposure.Where significant exposure may have occurred published evidence suggests that the virus may take 48-72 hours before becoming detectable in regional nodes and up to 5 days before being detectable in blood. This gives a 72 hour window of opportunity after exposure during which HIV PEP/PEPSE if initiated may prevent HIV seroconversion.Use of Zidovudine (AZT) monotherapy has been shown to reduce occupational HIV transmission by 79% if started within 72 hours and taken for 28 days (1). As a standard three drug combination of antiretroviral therapy is more potent in suppressing HIV replication in HIV infected individuals, a similar drug combination is also recommended for PEP/PEPSE. Recipients receiving PEP/PEPSE should be made aware that whilst use of these drugs as prophylaxis in HIV negative people is unlicensed current joint guidance from Public Health England and the British Association of Sexual Health and HIV recommend the use of these medications following significant exposure to prevent HIV transmission. Patients should be issued PEP/PEPSE when assessed necessary. If deemed necessary the initiation of PEP/PEPSE should never be delayed / deferred until the next day at the first point of contact with Trust services, or whilst source testing is being done, or while awaiting a source patient result. 5.4 What to useCurrent HIV post exposure prophylaxis for occupational (PEP) and sexual exposure (PEPSE) consists of: Truvada one tablet once a day (Tenofovir 245mg and Emtricitabine 200mg) plus Raltegravir 400mg twice a day for 28 days (4). Tenofovir is a non-nucleotide reverse transcriptase inhibitor, Emtricitabine is a non-nucleoside reverse transcriptase inhibitor and Raltegravir is an integrase inhibitor.5.5 Other considerationsWhen assessing each case the probability of HIV transmission and correct use of post exposure prophylaxis may depend upon factors other than the type of exposure and the HIV risk of the source.Source characteristicsExposure to a drug resistant virus – baseline HIV drug resistance is 7.2% among HIV positive men who have sex with men and is declining. Amongst heterosexuals baseline drug resistance is stable at 6%. No baseline drug resistance has been detected for integrase inhibitors (Raltegravr/Dolutegravir) but data is limited. Whilst use of this class of drug to treat HIV increases this may change but data does not support that this is likely currently. HIV drug resistance is also more likely to develop in a known positive patient on treatment and who is not regularly adherent to HIV medication. Drug resistance due to poor adherence can be suspected in a known HIV positive patient if:there is a reported history of poor adherencethe source has a history of HIV treatment being prescribed and either known or suspected loss to follow-upreports history of detectable viral load and / or drug resistance testing resulting in a change of medication in last 6 monthsDiscuss with HIV clinician if resistance is suspected to any of the drugs used as first line – an alternative to regime could be Combivir one tablet twice day (Zidovudine 600mg and Lamivudine 300mg) and Kaletra (Lopinavir/ Ritonavir) two tablets twice a day if this is suspected.The genital viral load level can be increased in the presence of a coexisting STI in the source at the time of sexual exposure. It is therefore useful following sexual exposure to ascertain if possible when the source last had an STI screen.5.5.2 Recipient characteristicsPost exposure prophylaxis is not 100% effective and there have been cases of HIV acquisition whist on PEP and 24 cases of occupational HIV transmission have still occurred despite using HIV PEP and PEPSE (2).The risk of HIV acquisition in the host may be increased by the following:Delayed initiation – if deemed necessary PEP must be started as soon as possible and within 24 hours and delay must be avoided. Variable host absorption from the gastrointestional tract – if PEP/PEPSE is supplied anti-emetics and anti-diarrhoea medication should be supplied to minimise poor absorption. Adherence to medication - in the UK completion of PEP has been shown to be poor (42-82%) and reiteration of good adherence with medication should be stressed when initiated. Failure of adherence has also been known to allow HIV seroconversion to occur in those commenced on PEPSE. Written information should be supplied to patient of all medications prescribed and a discussion on timings of treatment emphasised to ensure constant therapeutic levels. 6.0Procedure6.1Occupational exposure Immediate action and risk assessment (see Appendix 5 and 6)All staff involved in an occupational exposure to blood / body fluids should report this to their manager immediately for risk assessment (see Management and Prevention of Sharps/Injuries Policy and Procedure) and then to the Occupational Health (OH) Department promptly even if risk assessment is low risk. If out of OH working hours the member of staff should report the incident to them the next working day. Occupational HIV exposure may be higher if the risk of the source having HIV is high, or that HIV virus level is detectable in the blood in a known positive patient, and the exposure is significant.Risk that the source has HIV includes: the source patient is from a high prevalence group (see Table 2)Risk that the HIV virus level is detectable in a known positive patientthe source patient is known HIV positive and not on HAARTthe source patient is known HIV positive, is on HAART and has an HIV viral load level of or greater than 200 copies per mlLow risk occupational exposures are listed below and PEP is no longer recommended:Human bites - risk is likely to be low, although actual risk is not known. In rare situations risk may be considered higher if there is trauma and bleeding to the oropharynx, the wound is very deep, and the source has advanced disease or a high viral load. Only in extreme cases should PEP should be considered and discussed first with Microbiology or GUM munity needlestick injuries - it is not usually possible to determine whether the needle has been used, what it has been used for and when use occurred. HIV is not viable within a couple of hours once dried, and if found in small amounts in syringes is non-viable after 24 hoursFluids, including blood, fall onto intact skin Exposure to saliva unless associated with dentistryExposure to urine, faeces, tears, sweat and nasal secretions unless visibly blood stainedExposure from a known HIV positive source, on treatment with a viral load of < 200 copies per ml for at least 6 months - the risk of HIV is low and PEP/PEPSE is not recommended ( confirmed by source’s clinic wherever possible)High risk occupational exposure includes (see Tables 3 and 4):source blood is clearly visible on the device or in the fluid that caused the injury the needlestick injury is deeply penetrating dental treatment where sharp instruments are being used and mucus membrane trauma may have occurred bodily fluids such as amniotic fluid, pericardial fluid where HIV virus may be detectableTable 3: Recommendations for PEP following occupational and community exposure and HIV status of sourceSource statusSource HIV positive (see Table 2)Source HIV unknownType of exposureKnown HIV positive with detectable viral load of or greater than 200 copies per mlKnown HIV positive with undetectable viral load of less than 200 copies per mlHigh prevalence country (e.g. Sub-Saharan Africa)or high risk group (e.g. MSM)Low prevalence country or low risk groupNeedlestickRecommendedNot recommendedConsider if fresh blood onlyNot recommended if in communityNot recommendedSharing IVDU equipmentRecommendedNot recommendedConsiderNot recommendedHuman biteNot recommendedNot recommendedNot recommendedNot recommendedFluid type (high prevalence group / Known HIV positive & VL>200 copies)PercutaneousMucus membranesBroken skinAmniotic fluid RecommendedRecommendedRecommendedBloodRecommendedRecommendedRecommendedCSFRecommendedRecommendedRecommendedHuman breast milkRecommendedRecommendedRecommendedPericardial fluidRecommendedRecommendedRecommendedPleural fluidRecommendedRecommendedRecommendedSaliva in association with dentistry onlyRecommendedRecommendedRecommendedSynovial fluids RecommendedRecommendedRecommendedVaginal secretionsRecommendedRecommendedRecommendedUnfixed human tissue or organsRecommendedRecommendedRecommendedExudative or other tissue fluid from burns or skin lesionsRecommendedRecommendedRecommendedTable 4: Risk assessment of type of occupational exposure to bodily fluids and the recommendation to take PEPAll exposures assessed as high risk for HIV transmission and require HIV PEP must be referred for this as a matter of priority to GUM (working hours) and A&E out of hours.6.2Sexual exposureImmediate action and risk assessmentAny recipient of potential sexual exposure to HIV seen in A&E must be triaged urgently and seen as soon as possible. If sexual assault has occurred, any life threatening injuries must be attended to immediately, and assessment for PEPSE can occur after these have been dealt with. The sexual assault referral centre (SARC) is available for collection of forensic samples if a patient reports non-consenting sexual intercourse. Sexual HIV exposure may be higher if the risk of the source having HIV is high, or a known HIV positive source has detectable HIV viral load in the blood, and the exposure is significant (see Table 5). Risk that the source has HIV includes: the source patient is from a higher risk groupRisk that the HIV virus level is detectable in a known positive patientthe source patient is known HIV positive and not on HAARTthe source patient is known HIV positive, is on HAART and has an HIV viral load level of or greater than 200 copies per mlLow risk sexual exposures are listed below and PEPSE is not usually recommended:After oral sex even with ejaculation unless exacerbating factors are present such as oro-pharyngeal trauma, ulceration and/or a source who is seroconverting for HIVAfter a semen splash in the eye as no documented transmission has occurred.Exposure from a known HIV positive source, on treatment with a viral load (<200 copies per ml) for at least 6 months ( this must be confirmed wherever possible with source HIV care centre)High risk sexual exposure includes (see Table 5):Unprotected anal sex has occurred (with or without ejaculation) with someone from a higher risk groupejaculation occurred into a body cavity of the recipient (vagina/anus) from someone in a higher risk groupTable 5: Recommendation for PEP following Sexual Exposure and HIV status of sourceSource HIV positive (see Table 2)Source HIV negative (see Table 3)Type of sexual exposureKnown HIV positive with detectable viral load of or greater than 200 copiesKnown HIV positive with undetectable viral load less than 200 copiesHigh prevalence country (e.g. Sub-Saharan Africa)or high risk group (e.g. MSM)Low prevalence country or low risk groupReceptive analRecommendedNot recommendedVL confirmed less than 200 copies per ml for 6 monthsRecommendedNot recommendedInsertive analRecommendedNot recommendedConsiderNot recommendedReceptive vaginalRecommendedNot recommendedConsiderNot recommendedInsertive vaginalConsiderNot recommendedConsiderNot recommendedSexual assault RecommendedNot recommendedConsiderNot recommendedReceptive oral with ejaculation Not recommendedNot recommendedNot recommendedNot recommendedInsertive oral with ejaculationNot recommendedNot recommendedNot recommendedNot recommendedCunnilingusNot recommendedNot recommendedNot recommendedNot recommendedSemen splashNot recommendedNot recommendedNot recommendedNot recommendedExacerbating sexual risk factors may increase the risk of sexual transmission and include:presence of mouth or genital ulcer disease in the recipient causing breaches in the mucosal barrier at the time of sexual exposure presence of a known concomitant STI in the recipient or source at the time of sexual exposure menstruation or other bleeding at the time of sexual exposure could also theoretically increase risksexual exposure was aggravated ie post sexual assault or multiple individuals involved Lack of circumcision is not a risk factor in itself but non-circumcision in a recipient exposed to known HIV has been shown to increase the risk of HIV acquisition in both heterosexuals and men who have sex with men at high risk of HIV compared to those who have been circumcised.6.3Access to PEP/PEPSEThose at risk who require PEP/PEPSE should be referred to GUM (within working hours) and to Emergency Department (A&E) outside of working hours. PEPSE should be issued at Department (A&E) if the first point of contact especially if out of hours.HIV PEP 5 day treatment starter packs are available at the following sites:Emergency Department (A&E) at Maidstone Hospital Emergency Department (A&E) at Tunbridge Wells Hospital The Rubin Clinic at Maidstone Hospital (9-5pm)Additional starter packs are available in the Emergency drug cupboard at each Hospital site. Contact the Site Practitioner to access these (see next page). LocationMaidstone Hospital contactTunbridge Wells Hospital contactRubin Clinic Department Sexual Health, HIV and contraceptionReception 01622 225713Admin room 01622 225711Processing Room 01622 225726Emergency Department (A&E)ReceptionTel 01622 226000/1/2ReceptionTel 01892 635170Emergency Drug CupboardContact site practitionerContact site practitionerMaidstone HospitalDuring working hours:Recipients should be referred to the Rubin Clinic, Department of GU Medicine Maidstone Hospital, First Floor, Green Zone. Telephone: 01622 225713 / mtw-tr.rubinclinic@ Out of hours:Recipients should be referred to the Emergency Department (A&E) to commence HIV PEP/PEPSE (in the case of occupational exposure please state ‘priority case requiring HIV PEP following occupational exposure A&E category 2’ to avoid delay).Those recipients who identify as attending for HIV PEP/PEPSE or assessment for HIV PEP/PEPSE at the Emergency Department (A&E) reception must be assessed promptly to avoid any delay in obtaining their first dose of medication. In the event of a delay recipients should request to be seen by the ‘Nurse in charge’Tunbridge Wells HospitalDuring working hours and out of hours:Recipients should be referred to Emergency Department (A&E) immediately to commence HIV PEP/PEPSE to avoid delay in travelling to the GUM clinic at Maidstone Hospital. Recipients of an occupational exposure should state as having been assessed as a ‘priority case requiring HIV PEP following an occupational exposure A&E category 2’ Those recipients who identify as attending for HIV PEP/PEPSE or assessment for HIV PEP/PEPSE at the Emergency Department (A&E) reception must be assessed promptly to avoid any delay in obtaining their first dose of medication. In the event of a delay recipients should request to be seen by the ‘Nurse in charge’6.4Current recommended HIV post exposure prophylaxis regime (see Appendix 4): NameDoseFrequency Total durationTruvada? (Tenofovir 245 mg + Emtricitabine 200 mg)One tablet(blue)Once a dayWith food to increase absorption28 daysIsentress? film-coated tablets 400mg(Raltegravir)One tablet(pink)Twice a day Every 12 hoursWith or without food but do not chew, crush or split28 daysDomperidone 10mg three times a day and Loperamide 4mg four times a day can be prescribed if necessary.Current medication should be listed including vitamins, over the counter medication, herbal remedies and recreational drugs. Drug interactions should be checked using hiv- to avoid sub-therapeutic levels of prescribed medication and / or PEP/PEPSE treatment (see PEP Patient information leaflet).When HIV PEP/PEPSE is recommended recipients they should be advised to avoid sexual intercourse and blood donation until reviewed in GUM Clinic. 6.4.1 Alternative PEP/PEPSE regimeModification of the above regime may be required if drug resistance to Truvada and Raltegravir is suspected. Attempts should be made to establish a recent HIV viral load, drug resistance profile and treatment history from the source. Urgent advice should be sort from the source HIV clinic, or the GUM consultant (9am to 5pm) or Microbiology consultant on-call (5pm to 9am). Further discussion with an HIV consultant on-call at Chelsea and Westminster Hospital (contact via Switchboard) can occur if concerns exist before issuing a starter pack.In the event of suspected resistance to Truvada or Raltegravir an alternative regime is suggested below:NameDoseFrequency Total durationCombivir? film coated tablet(Zidovudine 300 mg + Lamivudine 150 mg)One capsule(white)Twice a dayWith or without food 28 daysKaletra? film-coated tablets(Lopinavir 200 mg/ Ritonavir 50mg) *Two tablet(yellow)Twice a day Every 12 hoursWith or without food but do not chew, crush or split28 days*Alternatives to Kaletra include Darunavir 800mg / Ritonavir 100mg once a day, Atazanavir 300mg / Ritonavir 100mg once a day or Dolutegravir 50mg once a day.6.4.2 Completion of PEP/PEPSEAll recipients commenced on an HIV PEP/PEPSE starter pack should be advised to attend the Rubin Clinic within 72 hours for further assessment and on-going PEP/PEPSE prescription. Recipients should be advised to attend follow-up as a matter of priority so as to complete a 28 day course and that interruption to therapy may affect efficacy and should be avoided. In exceptional circumstances recipients may be issued two starter packs instead of one to ensure no interruption to medication dosing occurs if they report a potential delay in attending for follow-up. On-going prescription of HIV PEP/PEPSE can only be issued at the Rubin Clinic. Patients should not be advised to attend their GP for further prescriptions.The Rubin Clinic offers walk in clinic services occur between 9-11am Monday to Friday (except Wednesday morning) and recipients commenced on HIV PEP/PEPSE can attend these clinics without an appointment. If an appointment is required please advise them to contact the clinic on 01622 225713 or refer to mtw-tr.rubinclinic@ 6.5Assessment of sharps incidentIn the guidance “Good Medical Practice 2013” the General Medical Council (GMC) says that doctors who know or suspect they have a serious communicable condition that they could pass on to their patients such as a bloodborne virus should not rely on your own assessment of the risk to patients. It is important that any health professional informs their manager immediately of any such an event. Any doctor is bound to take all proper steps to safeguard the interests of their patients and this would include ensuring that following an exposure incident they cooperate fully with those conducting the risk assessment, providing all necessary information about their own infection status or risk behaviour. Similar guidance for other health professionals should be followed by practitioners.6.6HIV testing of the source patient Following significant exposure to HIV, establishing the HIV status of the source is strongly recommended. 6.6.1 Testing the source following occupational exposureThis should be done by Occupational Health liaising with the inpatient team responsible for the source patient. The source patient should not be tested by the staff recipient and the staff recipient should not be asked to arrange the testing of the source patient.The source should be informed of the incident and their HIV status established using the following:Review of healthcare records of the source patient to check for evidence of established HIV infectionAsking the source if they are known to have HIV and obtaining the name of HIV care provider if known positive. If known HIV positive attempts to determine HIV viral load, treatment history and resistance profile should be made at the earliest opportunity from the HIV care team.Asking the source for the date of any previous negative HIV testIf no evidence of HIV infection can be found, the consent of the source patient should be obtained to test for HIV (only verbal permission is required to test for HIV). Testing of the source blood should be done urgently and a result should be available within 24 hours, and ideally within 8 hours. Request the HIV test as ‘urgent’ on the pathology request form sent to the laboratory and inform Microbiology of this request by telephone. The source should be informed of the result as soon as possible. 6.6.2 Testing the source following sexual exposureThis recipient should be encouraged to contact the sexual partner wherever possible to ascertain their HIV status. If HIV negative, the date of last negative HIV test and brief sexual history since last the HIV test can be helpful but it is recognised that this may not always be possible. The source should be asked to attend for an HIV test as soon as possible but again it is recognised that this may not always be able to be completed in the next 72 hours (or be reliable).If known HIV positive then the result of any HIV viral load tests in the last 6 months, treatment regime and adherence to medication should be established. The name and location of their HIV care team should be documented and contact made at the earliest opportunity. Any resistance profile should be obtained when available. 6.6.3 Source testing and / or information sharing If the source does not agree to testing, or does not give permission to contact their HIV clinic team for information if known positive, the difficulties for the exposed healthcare worker situation should be fully explained to the source:the unnecessary exposure for the recipient to potential side effects of antiretroviral medication could be avoided the opportunity to benefit from HIV PEP may be missed if important information is not known6.7Incident involving an unknown sourceIf the source patient cannot be identified and if there has been a significant exposure a risk assessment should be made. Circumstances of the exposure will need to be carefully reviewed as well as the epidemiological likelihood of HIV in the source. A decision to commence PEP should be assessed on each individual basis, but is often unlikely in the majority of cases. A community needlestick injury is not likely to be high risk for HIV or require PEP but unprotected sexual exposure with a man who has sex with men of unknown HIV status may require PEPSE due to the greater risk of HIV in the source.6.8Monitoring and advice for patients who require HIV PEP/PEPSEPatients commenced on PEP/PEPSE require the tests listed below at baseline and on completion of PEP/PEPSE. Results of baseline tests will be reviewed in GUM within 7 days. 6.8.1Baseline tests in those requiring HIV PEP/PEPSESerum save – this will be stored for 2 yearsFull blood count and differentialUrea, electrolytes, creatinine, estimated GFRLiver functionUrinalysis for proteinuria (send urine protein / creatinine if proteinuria)Hepatitis B surface antibody levels if appropriate6.8.2 Review in GUM within 7 daysAssessment of riskAssessment of adherence to medicationReview of results from baseline investigations Urinalysis for proteinuria (send urine protein / creatinine if proteinuria)BBV screening if appropriateSTI screening if appropriate6.8.3 Review at 28 daysUrea, electrolytes, creatinine, estimated GFRUrinalysis for proteinuria Urine protein/creatinine ratio if persistent proteinuriaSTI screening if appropriateGUM staff can provide valuable support patients while on HIV PEP/PEPSE includingemotional and psychological support adherence supportadvice in managing side effects of medicationadvising on minimising HIV transmission to others during this timeprovision of barrier contraceptionInterruption to PEP regimeIf interruption of PEP/PEPSE occurs the following advice should be given:If < 24 hours has elapsed since the last dose the patient should take the missed dose as quickly as possible and continue doses at usual time. If 24 to 48 hours have elapsed since last dose patient should continue with PEP at usual time If > 48 hours have elapsed since last dose patient should be advised to stop PEP.On-going high risk sexual exposure while on PEP/PEPSEPatients should be advised to avoid sexual intercourse while on PEPSE but if ongoing unprotected exposure occurs in the last 48 hours of treatment course they should be advised to continue with PEP for an additional 48 hours.6.9HIV antibody testing after exposure to HIV HIV testing should be done using a 4th generation HIV antigen / antibody serology test.6.9.1 Testing after a High risk HIV exposureAll individuals who have had a High risk exposure should be tested at 8 weeks (i.e. 4 weeks after completion of PEP/PEPSE). Occupational exposure - follow-up HIV testing for can be arranged in the GUM or Occupational Health (Trust staff only) departments depending on the individual’s needs and preferences. For those followed up in GUM letters should be sent to the Occupational health department with test results to complete staff records Sexual exposure - following high risk exposure recipients can receive follow-up with GUM services or their GP depending on choice6.9.2 Testing after a Low risk HIV exposureHIV antibody testing for those at low risk of HIV is recommended 4 weeks after exposure.Occupational exposure - all Trust staff who have an occupational exposure but who did not require HIV PEP should be followed up by Occupational Health. Non-Trust staff can receive follow-up with local Occupational Health departments, the GUM service, or their GP for HIV testing depending on choice.Sexual exposure - recipients following low risk sexual exposure can receive follow-up for HIV testing with GUM services or their GP depending on choice6.10Special considerations6.10.1Healthcare worker who refuses a blood testIn the event that a patient receives a significant exposure from a member of staff a request for the staff member to be tested for HIV will be made. It would be unlawful to compel a healthcare worker to take a blood test however an employer may take appropriate steps to protect patients from a worker who refuses to undergo a test following an incident, such as restricting the healthcare worker thereafter from performing exposure-prone procedures. A healthcare worker who unreasonably refuses a blood test may be in breach of their ethical and legal duty of care to patients if it results in the patient receiving post-exposure prophylaxis unnecessarily. Whilst a healthcare worker could allege that their right to respect for private life under article 8 (1) of the European Convention on Human Rights is infringed as a result of being asked to undergo a test and to action being taken if they refuse, it is considered that any infringement would be justifiable under article 8 (2) in the interests of protecting the health of others.6.10.2The unconscious patientIn accordance with the GMC Guidance Good Medical Practice 20135 post-exposure prophylaxis should not be withheld from an unconscious patient on the grounds that they are unable to consent. if clinical judgement deems it to be in their best clinical interest.Testing for HIV in an unconscious source patient is not routinely recommended and in these cases it is recommended that such cases must be discussed first with a GUM consultant or Microbiology consultant. PregnancyPregnancy should not alter the use of post-exposure prophylaxis if felt necessary. Whilst HIV antiretroviral therapy is not licensed in pregnancy the risk of seroconversion, with a high plasma viral load, would be likely to result in intrauterine infection. The ARV pregnancy register however has shown that so far no increase in birth defects has occurred in pregnant people exposed to Truvada including in the first trimester. Expert advice should be sought from the GUM consultant if PEP is considered for a recipient who is pregnant. If the Trust GUM consultant is not available advice should be sought from the on-call Microbiologist, who may wish to contact another on call GUM consultant for advice (Chelsea and Westminster Hospital via Switchboard)APPENDIX 1Process requirements 1.0Implementation and awarenessOnce ratified, the Chair of the Policy Ratification Committee (PRC) will email this policy/procedural document to the Corporate Governance Assistant (CGA) who will upload it to the Trust Policy database on the intranet, under “Policies & guidelines”.A monthly publications table is produced by the CGA which is published on the Trust intranet under “Policies & guidelines”. Notification of the posting is included on the intranet “News Feed” and in the Chief Executive’s newsletter.On reading of the news feed notification all managers should ensure that their staff members are aware of the new publications.2.0Monitoring compliance with this documentPrescribing of HIV PEP will need to be audited to assess the following:HIV PEP prescribed to only those with a high risk exposure to HIVCompletion of 28 days of HIV PEP Completion of HIV testing of all health care workers and those attending for sexual exposure prescribed HIV PEPIncident reporting of sharps/splash injuries to assess the use of recommended procedures to prevent avoidable/unnecessary blood/bodily exposureThe annual audit report and action plan will be submitted to the Clinical Audit Department. Having been approved, the project will appear on the Trust Clinical Audit Programme.3.0ReviewThis policy and procedure and all its appendices will be reviewed at a minimum of once every 4 years.4.0ArchivingThe Trust approved document management database on the intranet, under “Policies & guidelines”, retains all superseded files in an archive directory in order to maintain document history.APPENDIX 2CONSULTATION ON: Policy and procedure for post exposure prophylaxis (PEP) following occupational and sexual exposure (PEPSE) to human immunodeficiency virus (HIV)Please return comments to: Consultant in Genito-Urinary Medicine,Rubin Clinic, Department of GU Medicine, First Floor, Green Zone, Maidstone Hospital. By date: 10/03/2017Job title: Date sentdd/mm/yyDate reply receivedModification suggested?Y/NModification made?Y/NThe following staff MUST be included in ALL consultations:Corporate Governance Assistant01/03/1710/03/17YYChief Pharmacist and Formulary Pharmacist27/03/17Formulary Pharmacist27/03/17Staff-Side Chair27/03/17Emergency Planning Team27/03/1728/3/2017NHead of Staff Engagement and Equality 27/03/1710/4/2017YYHealth Records Manager 27/03/17All individuals listed on the front page of this documentAll members of the approving committee:Infection Prevention and Control Committee11/8/201717/8/2017NNOther individuals the author believes should be consultedConsultant Microbiologist / Director Infection Prevention and Control08/11/201623/11/2016YYOccupational Health Lead Nurse 08/11/201613/1/2017YYHIV Specialist Pharmacist 03/11/201608/11/2016NNAccident and Emergency (Dr AS)08/11/201613/1/2017NNRisk and Governance Manager (Women and Children’s08/11/2016NNRisk and Compliance Manager27/03/17The following staff have given consent for their personal names to be included in this policy and its appendices:APPENDIX 3Equality impact assessmentThis policy includes everyone protected by the Equality Act 2010. People who share protected characteristics will not receive less favourable treatment on the grounds of their age, disability, gender, gender identity, marital or civil partnership status, maternity or pregnancy status, race, religion or sexual orientation. The completion of the following table is therefore mandatory and should be undertaken as part of the policy development, approval and ratification process.Title of policy or practicePolicy and procedure for post exposure prophylaxis (PEP) following occupational and sexual exposure (PEPSE) to human immunodeficiency virus (HIV)What are the aims of the policy or practice?To safeguard the health, safety and welfare of staff and patients by ensuring that:Staff and patients are aware of how to proceed following a significant potential occupational exposure to HIVStaff and patients have appropriate and timely access to HIV PEP in the event of a significant exposure to blood or blood stained body fluids.Staff are aware of their responsibilities with regards to reporting of such eventsIs there any evidence that some groups are affected differently and what is/are the evidence sources?NoAnalyse and assess the likely impact on equality or potential discrimination with each of the following groups.Is there an adverse impact or potential discrimination (yes/no).If yes give details.Gender identityNoPeople of different agesNoPeople of different ethnic groupsNoPeople of different religions and beliefsNoPeople who do not speak English as a first language (but excluding Trust staff)NoPeople who have a physical or mental disability or care for people with disabilitiesNoPeople who are pregnant or on maternity leaveNoSexual orientation (LGB)NoMarriage and civil partnershipNoGender reassignmentNoIf you identified potential discrimination is it minimal and justifiable and therefore does not require a stage 2 assessment? N/AWhen will you monitor and review your EqIA?Alongside this document when it is reviewed.Where do you plan to publish the results of your Equality Impact Assessment?As Appendix 3 of this documentFURTHER APPENDICESThe following appendices are published as related links to the main policy /procedure on the Trust approved document management database on the intranet (Trust policies, procedures and leaflets):No.TitleUnique IDTitle and unique id of policy that the appendix is primarily linked to4Recommendations for chemoprophylaxis following occupational exposure to HIVRWF-OPG-WC100This policy5Post exposure to HIV: information sheet regarding chemoprophylaxisRWF-OPG-WC101This policy6Sharps and mucus membrane injuries – recording and risk assessment formRWF-OWP-APP554Management & Prevention of Sharps/Splash Injuries Policy and Procedure (Incorporating Bloodborne Virus Exposure) [RWF-OPPPCS-C-WF5] ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download