Hull EHC Plus Service Introduction of Ulipristal Acetate 24 September 2014 Caroline Hayward Professional Development Pharmacist Community Pharmacy Humber LPC

Aims of the event Update / Reinforce EHC knowledge Outline the Hull EHC Plus service specification Highlight the Patient Group Directions considerations applicable to Levonorgestrel and Ulipristal Acetate Point out changes to the Levonorgestrel PGD Understand the clinical decision tree and be able to apply it Introduce the new client record form / PharmOutcomes platform Outline pharmacist training requirements/ registration

Sue Turner CHCP –Clinical nurse specialist Sexual Health Expert speaker Sue Turner CHCP –Clinical nurse specialist Sexual Health Update / Reinforce EHC knowledge EHC clinical decision process Case Studies

What is the EHC Plus service? Hull Pharmacies only Only Hull pharmacies currently accredited to provide the EHC service can provide the EHC+ service (ERoY will hopefully introduce + service in January 2015 TBC) Provision of either Levonorgestrel or Ulipristal Acetate EHC under Patient Group Direction depending on the client circumstances/ clinical appropriateness Supply of Ulipristal acetate is limited to 3 scenarios where efficacy of Levonorgestrel may not be adequate: If client presents between 72 - 120 hours post UPSI If client is within 3 days before or 2 days after EDO If client is unsure of date of last period or has irregular cycle, making it impossible to predict the EDO

Hull EHC Plus service spec Client must take medication on site Must discuss the superior efficacy of the IUD during all consultations All counselling points must be covered as detailed in the CRF Must outline LARC and its availability / provide leaflets –Angela King CHCP Must Raise awareness of STI and encourage screening Must complete an excluded client form if applicable Must provide every client with a client information sheet relevant to product supplied Must provide manufacturers PIL to client Can provide condoms to clients of ALL ages (Hull scheme only) (reimbursement £2.00 / pack) BMI considerations removed – insufficient evidence Angela King CHCP angela.king9@nhs.net leaflets

Hull EHC Plus service spec All consultations MUST be recorded on the PharmOutcomes platform and clients PMR Every pharmacist providing the service in Hull must enrol on the EHC PharmOutcomes platform and declare their qualifications / competency before they are able to use the platform to deliver the service. Platform will allow enrolment in advance of a consultation. Data will be saved and retrievable across all Hull Pharmacies. Delivery of a consultation: Platform will split into two halves. Recording of consultation info Recording of product choice List of pharmacists declaring their competency on the platform will be held by LPC and available for viewing by commissioners and pharmacy contractors if requested New PharmOutcomes platform.. Live from1st October. This is when the Ulipristal PGD is valid from Pharmacists must Register themselves onto the platform before they can use it and provide the service. Enrolment only required once

Service Fees Consultation fee: £15.75 Drug cost reimbursed at Tariff price plus 5%VAT: Levonorgestrel: Current tariff price: £5.20 Ulipristal Acetate: Current tariff price: £16.95 Condom provision: £2.00 per pack supplied

PGD considerations Every pharmacist must read and sign the current PGD held within every pharmacy they work from. Must work within the PGD’s and be aware of: Inclusion criteria No age restrictions but MUST be Fraser competent Exclusion criteria (Levonorgestrel and Ulipristal) See Pharmacist Reminder Sheet Changes to Levonorgestrel PGD: Double dose (two tablets - 3mg) can be supplied to clients taking enzyme inducing medication – or taken within the last 28 days. This provision is Off-License. You must explain to client this is outside of the product license. They must consent to treatment – Record consent Hull CC sending both PGD’s and service spec out to sites this week. Enzyme induction may last for up to 4 weeks (28 days) following the withdrawal of enzyme inducing medication INCLUDING Rifampicin and Rifabutin. – no longer 3 month recommendation for Rifampicin… see BNF 4 week effect/ extra precautions.

Common Exclusion criteria applicable to both Ulipristal Acetate and Levonorgestrel PGD’s Lack of valid consent or Fraser competency Previous use of EHC within the same menstrual cycle Pregnancy or suspected pregnancy Hypersensitivity to the active substance or to any of the excipients listed in the product SPC Acute Porphyria Severe hepatic dysfunction Unexplained vaginal bleeding Severe active malabsorption syndromes, such as Crohn's disease Less than 21 days postpartum Women who are not able to attend the pharmacy in person Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Exclusion criteria for Hull and ERoY Levonorgestrel PGD (Identical PGD) Unprotected sexual intercourse occurred more than 72 hours ago. Previous UPSI more than 72 hours earlier within the same menstrual cycle Active trophoblastic disease Unusual vaginal bleeding Interacting medicines EXCEPT enzyme inducing medications (double dose provision allowed – Off-License supply – Record Consent)

Exclusion criteria For Hull Ulipristal Acetate PGD (No ERoY PGD as yet) Unprotected sexual intercourse occurred more than 120 hours ago. Renal impairment Current persistent vomiting Uncontrolled severe asthma (insufficiently controlled by oral steroids) Taking drugs that increase gastric pH (e.g. antacids, histamine H2 antagonists and PPI’s Taking Liver enzyme-inducing drugs (e.g. rifampicin, long term ritonavir, phenytoin, phenobarbital, carbamazepine, efavirenz, fosphenytoine, nevirapine, oxcarbazepine, primidone, rifabutine, St John's wort) either currently taking or within 28 days of completing treatment Enzyme induction may last for up to 4 weeks (28 days) following the withdrawal of enzyme inducing medication INCLUDING Rifampicin and Rifabutin. – no longer 3 month recommendation for Rifampicin… see BNF 4 week effect/ extra precautions.

Decision Tree Considerations Timing of UPSI e.g. relative to Ovulation, and since UPSI event Medical contraindications e.g. Severe Asthma Drug interactions / contraindications e.g. Raised gastric pH : PPI’s, H2 receptor antagonists, antacids Use of Enzyme inducing medication Patient choice e.g. Breastfeeding Is the client unwilling to expressed and discard milk for 7 days?

Emergency Contraception Decision Guide for Community Pharmacists Assess eligibility for Emergency Contraception Discuss with local sexual health service if unsure Consider UPA if IUD is unacceptable and: Client presents within 72- 120 hours since all episodes of UPSI UPSI occurred within 3 days before and 2 days after date of expected ovulation (i.e. 5 days around expected date of ovulation) Client presents between 0 - 120 hours following UPSI whose cycle is so irregular that it is not possible to calculate the date of expected ovulation. Do not give Ulipristal if: Client takes or has taken enzyme inducing drugs in last 28 days Client is a severe asthma insufficiently controlled by oral glucocorticoids Client takes medication which increases the gastric pH Discuss all three options: unless a method of EC is clearly contraindicated Consider IUD if: <120 hours since UPSI or < 5 days since earliest expected date of ovulation Wants most effective method Wants Cu-IUD as ongoing contraception LNG and UPA contraindicated or unavailable Consider LNG if IUD unacceptable and: <72 hours since all episodes of UPSI Breastfeeding and not wishing to stop for 7 days after taking UPA Client is taking enzyme inducing medication or has taken within last 28 days (advise 3mg dose) Discuss IUD and where / when it can be accessed. Offer an appropriate method of oral EC as a backup method Signpost / refer to IUD service provider Supply or signpost to LNG provider if unable to supply under local PGD or product licence (i.e. if multiple episodes of UPSI outside of 72 hour window; previous use of LNG during this cycle.) Supply or signpost to UPA provider if pharmacy supply not possible Discuss STI Testing, Discuss future contraception. Discuss / Supply condoms and Signpost to GP or other contraception provider for continued contraception Abbreviations: Cu-IUD copper intrauterine device; EC Emergency contraception; FSRH Faculty of Sexual & Reproductive Healthcare; LNG levonorgestrel; UPA Ulipristal acetate; UPSI unprotected sexual intercourse

Client record form See sample form (Delegate packs) New client record form: Can use during the consultation then enter onto PharmOutcomes platform retrospectively OR Can provide the consultation using the revised PharmOutcomes platform Under 16 years: Must also complete Fraser competency assessment form. (Download from PharmOutcomes platform) Must take into account any safeguarding considerations: Remember any client under 13 years is too young to consent to any sexual activity (classed as rape) Must be referred to the safeguarding team. (can be treated with EHC, but a referral must be made)

Pharmacist ‘accreditation’ Hull From 1st October 2014 Hull Council has adopted the CPPE Declaration of Competency model for Community Pharmacy Services as introduced by CPPE in April 2014. What does this mean? Must read and complete the DoC model on CPPE website Each pharmacist is responsible for assessing and achieving the necessary competencies to deliver the EHC service. Each pharmacist wishing to provide the service must complete their own DoC statement, provide a copy to each pharmacy contractor they work for and retain a personal copy for inspection by commissioner DoC process must be completed at least every 3 years The DoC will form the basis for the enrolment onto the PharmOutcomes platform False declarations will be subject to GPhC consideration – honesty expected and inherent in professional registration

Paperwork All revised paperwork relevant to the Hull EHC Plus service will be available on Community Pharmacy Humber LPC website by 1st October: http://communitypharmacyhumber.org/ Client Record Form Client information sheet –Ulipristal Acetate Client Information sheet – Levonorgestrel Excluded client referral form IUD guide for pharmacists Safeguarding contact details and referral pathway Ulipristal PGD Levonorgestrel PGD Hull service specification