What does the HIV Pharmacy Team need to know about PEP

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1 What does the HIV Pharmacy Team need to know about PEP Rosy Weston Senior Lead Pharmacist Sexual Health and HIV St. Mary s Hospital Imperial College Healthcare NHS Trust London November 2008

Objectives Describe the key pharmacy issues from the PEP guidelines List the medicines which should be included in a PEP/PEPSE starter pack Describe options for

2 Objectives Describe the key pharmacy issues from the PEP guidelines List the medicines which should be included in a PEP/PEPSE starter pack Describe options for 24-hour access to PEP Describe potential interactions with PEP and other meds Share unusual requests for advice. Summarise the role for the HIV pharmacy team in PEP

3 So why do we need to know about PEP? At St. Mary s April 2008 November we have issued 297 PEP kits Majority PEPSE Issued from our walk-in GUM clinics Occupational exposure often require discussion with senior medical colleagues and access to non standard drugs e.g. raltegravir, T-20 No longer recapping needles No longer high risk iv access e.g. IVDU with no veins Splash injury Canullation of paediatric patients

4 Starter packs Currently most HIV units/centres offer PEPSE and all NHS Trusts are advised to have direct access and advice for hospital based occupational PEP. April 2004, September 2008 DH London Consortium tendering for starter packs (adults and adolescents 5-day starter packs Truvada 1 tablet OD Kaletra 2 tablets BD (can be followed up with 4 tablets OD if well tolerated) Agents for side effects Metoclopramide not recommended in young people due to increased incidence of dystonic reactions. Information leaflet PILS

6 PEPSE Antiretroviral choice 2NRTI + PI* or boosted PI NRTI combinations AZT+3TC D4T +3TC 3TC+ TDF TDV + FTC * = Nelfinavir Boosted PI Lopinavir Fosamprenavir (700mg/100 BD, 1400mg/200mg OD) Saquinavir Nelfinavir Pre-withdrawal Fosamprenavir 1400mg BD Kaletra capsules with food, fridge storage Suggested starter packs 3-5 days

8 DH Document offers guidance on 1. Assessing the risk to the healthcare worker of acquiring HIV infection following occupational exposure 2. When to recommend PEP 3. The choice of drugs 4. How to ensure that all healthcare workers have immediate, 24-hour access to advice on PEP, to drugs and appropriate support 5. Devising local PEP policies and protocols 6. Appropriate support arrangements for healthcare workers seconded overseas, including medical students on electives 7. Provision of PEP occurring outside of the hospital setting 8. Antiretroviral drug resistance 9. Laboratory workers who may be exposed to unusual or highly resistant virus 10. Considerations about PEP for women who are or maybe pregnant 11. PEP for patients after possible exposure to an infected healthcare worker

9 DH recommend Truvada and Kaletra preferred option Does state Combivir and Kaletra an option lack availability of prepacks with suitable stability data (written 2007) Stability testing data available 1 year data. National QC data Still a number of requests re use of desiccant, plastic container and closure Pan London tendering of pre-packs and proposed tariff.

10 Other drugs In situations where additional advice/consultation required Give standard starter pack and modify following advice Never recommend or use NNRTI Would not recommend abacavir Paediatrics Specialist advice

11 Side effects Over the last 15 years tolerability of antiretrovirals has improved significantly 1996 protocol for needlestick injuries Combivir 1 tablet BD Indinavir 800mg TDS (on an empty stomach and with an additional 2-3 litres of water) Very few staff members completed the course with the 3 drugs High levels of anxiety Additional clinical support Don t prescribe benzodiazepines

12 Side effects Rash Lamivudine Kaletra 1. Review by medical staff 2. Consider antihistamine chlorphenamine 4mg TDS cetirizine 10mg BD 3. Switch drug

13 Side effects Diarrhoea Kaletra Loperamide provided in pack Specific advice re dose 4mg after initial loose stool and repeat if necessary Codeine phosphate Consider darunavir Limited experience in PEP

14 Side effects Nausea, vomiting Common Ritonavir AZT Advise on correct use of domperidone. Advise on what do if vomit Alterative anti-emetics Levomepromazine 12.5mg Prochorperazine 5mg tds Cyclizine 50mg tds Caution risk of sedation and drowsiness

15 Legal requirements Prescription only medicines Not licensed- duty to let recipient know So how can the pharmacy team ensure access to drugs/advice On call/residency pharmacist May need to call specialist HIV pharmacist Emergency drug cupboards- PEP packs and full range of ARVs Special PEP packs Individuals with highly resistant virus Paeds packs with patient during transport Adolescent broken condom Standard packs Casualty Occ Health GUM walk-in clinic Wards paeds and infections disease Sexual assault clinics

17 I would therefore ask you to ensure that PEP is part of the spectrum of sexual health services for your local populations. Provision of PEP for non-occupational exposure is not a replacement for evidence-based HIV health promotion, but it can have a contribution to make in preventing transmission of HIV. SIR LIAM DONALDSON CHIEF MEDICAL OFFICER 6 th April 2006

18 Costings PEPSE funded from GUM budget and charged to recipient s PCT PEP occupational should be funded from separate budget Proposed London consortium tariff for Truvada+ Kaletra for 30 days Pharmacy 1. Need to have mechanism in place for recording PEP use 2. Needs to include both starter packs and follow up

19 Drug interactions Accurate drug history for all recipients of PEP. Need to explain what we mean by drug or medicine Many people do not include oral contraceptives, herbal preparations, recreational or medicines received during procedures. Ritonavir potent inhibition of cytochrome P450 Inhibitors fast on and fast off effect CYP 3A4 Toxicity of drugs metabolised via CYP3A4 Kaletra substrate of cytochrome P450 Inducers slow on and slow off effect Failure to achieve effect levels to inhibit viral replication Managed through Stopping the offending drug(s) often not possible Increasing Kaletra dose to 3 tablets BD

20 Always check additional sources of information pharmacist, drug interaction websites This information provided from the HIV Pharmacy Team Brighton and Sussex University Trust NHS Hospitals

21 Always check additional sources of information pharmacist, drug interaction websites This information provided from the HIV Pharmacy Team Brighton and Sussex University Trust NHS Hospitals

22 Case scenarios St John s wort Recreational drugs Sport injury

23 In summary PEP is important part of the HIV service BHIVA standards Pharmacy plays an essential role in procurement of PEP (starter packs, and follow up) provision of advice regarding management of potential drug interactions provision of advice and dispensing out of hours for non standard PEP ensuring the PEP service complies with legal requirement e.g. prescriptions Ensuring drugs are correctly accounted for and charged appropriately.

MANAGEMENT OF SEXUAL EXPOSURE TO HIV: PEPSE

Sandyford Protocols MANAGEMENT OF SEXUAL EXPOSURE TO HIV: PEPSE www.hiv-druginteractions.org If you require information on occupational exposure to blood borne viruses, including HIV, please refer to the