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

2. 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

3. 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

4. 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 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

5. 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 leaflets

6. 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

7. 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

8. 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.

9. 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

10. 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)

11. 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.

12. 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?

13. 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 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 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

14. 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)

15. 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

16. Paperwork
All revised paperwork relevant to the Hull EHC Plus service will be available on Community Pharmacy Humber LPC website by 1st October:
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