Introduction of Ulipristal Acetate24 September 2014

Caroline HaywardProfessional Development Pharmacist

Community Pharmacy Humber LPC

Aims of the eventUpdate / Reinforce EHC knowledge Outline the Hull EHC Plus service specificationHighlight the Patient Group Directions considerations

applicable to Levonorgestrel and Ulipristal AcetatePoint out changes to the Levonorgestrel PGDUnderstand the clinical decision tree and be able to

apply it Introduce the new client record form /

PharmOutcomes platform Outline pharmacist training requirements/

registration

Expert speakerSue Turner

CHCP –Clinical nurse specialist Sexual Health

Update / Reinforce EHC knowledge EHC clinical decision processCase 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

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.

1. Recording of consultation info2. 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

Service FeesConsultation fee: £15.75Drug cost reimbursed at Tariff price plus

5%VAT:Levonorgestrel: Current tariff price: £5.20Ulipristal Acetate: Current tariff price: £16.95

Condom provision: £2.00 per pack supplied

PGD considerationsEvery 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 competentExclusion 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

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

Decision Tree Considerations1. Timing of UPSI

e.g. relative to Ovulation, and since UPSI event

2. Medical contraindicationse.g. Severe Asthma

3. Drug interactions / contraindicationse.g. Raised gastric pH : PPI’s, H2 receptor antagonists,

antacids

4. Use of Enzyme inducing medication5. Patient choice

e.g. Breastfeeding

Is the client unwilling to expressed and discard milk for 7 days?

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Assess eligibility for Emergency ContraceptionDiscuss with local sexual health service if unsure

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)

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 pHDiscuss IUD and where / when it can be

accessed.Offer an appropriate method of oral EC as a backup methodSignpost / 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

Emergency Contraception Decision Guide for Community Pharmacists

Client record formSee sample form (Delegate packs)New client record form:Can use during the consultation then enter onto PharmOutcomes platform retrospectivelyORCan 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’ HullFrom 1st October 2014Hull 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 yearsThe DoC will form the basis for the enrolment onto the PharmOutcomes platformFalse declarations will be subject to GPhC consideration – honesty expected and inherent in professional registration

PaperworkAll 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 FormClient information sheet –Ulipristal AcetateClient Information sheet – LevonorgestrelExcluded client referral formIUD guide for pharmacistsSafeguarding contact details and referral pathwayUlipristal PGDLevonorgestrel PGDHull service specification