Transcript Hull EHC Plus Service Introduction of Ullipristal Acetate 30mg

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
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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
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
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 info
2. 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 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
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
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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 Considerations
1.
Timing of UPSI
e.g. relative to Ovulation, and since UPSI event
2.
Medical contraindications
e.g. Severe Asthma
3.
Drug interactions / contraindications
e.g. Raised gastric pH : PPI’s, H2 receptor antagonists, antacids
4.
5.
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
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
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
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)
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.)
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
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
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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