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This Patient Group Direction (PGD) must only be used by registered Community Pharmacists who have been named and authorised by their organisation to practice under it. The most recent and in date final signed version of the PGD should be used.

Patient Group Direction

for the supply and/or administrationof

Ulipristal Acetate 30mg tablet

(ellaOne®)

by registered Community Pharmacists for

Emergency Hormonal Contraception (EHC)

in Cheshire and Merseyside

Version number:1.0

Change history

Version number / Change details / Date
1.0

PGD development

Name / Job title and / Signature / Date
Lead doctor (or dentist) / Dr Nicola Mullin
Lead pharmacist / Helen Stubbs
Representative of other professional group using PGD / Jayne Fortune
Other members of the PGD working group / Dr Ifeoma Onyia
Dr Jane Wilkinson
Dr Joanna Cartwright
Melanie Carroll

PGD authorisation

Name / Job title and organisation / Signature / Date
Senior doctor
Senior pharmacist
Senior representative of professional group using the PGD
Person signing on behalf of authorising body

Training and competency of registered Community Pharmacists

Requirements of registered Community Pharmacists working under the PGD
Qualificationsand professional registration / Community Pharmacists currently registered with the General Pharmaceutical Council (GPhC), who are working in a pharmacy contracted to NHS England (Mersey) or NHS England (Cheshire, Warrington and Wirral)
Initial training / The Pharmacist must have completed the following Continuing Pharmacy Post Graduate Education (CPPE) open learning packs:
Safeguarding: a guide for the pharmacy team
Contraception
Emergency Hormonal Contraception
Undertake appropriate training for working under Patient Group Directions (PGDs) for the supply and administration of medicines.
Must handle all requests for emergency hormonal contraception in a sensitive and non-judgmental manner, and act in accordance with guidance issued by the General Pharmaceutical Council on consent, raising concerns and confidentiality.
Competency assessment / The pharmacist must satisfy the requirements of CPPE Self-Assessment of Competence for Community Pharmacy for Emergency Contraception
The Pharmacist must have achieved the competency levels specified in the NICE Competency Framework for Health Professionals using Patient Group Directions

Ongoing training and competency / Provide a regular self assessment declaration of competency every two years or sooner if appropriate. It is the responsibility of the pharmacist to keep up-to-date with Continued Professional Development.

Clinical condition

Clinical condition or situation to which this PGD applies / Prevention of pregnancy from unprotected sexual intercourse (UPSI) e.g. no contraception or failure of usual method.
Inclusion criteria /
  • Woman of child bearing age presenting within 72 to 120 hours of unprotected sexual intercourse (UPSI)
  • Failure of the normal method of contraception See appendixE
  • Severe vomiting and diarrhoea which may have reduced oral contraceptive efficacy
  • Penetration without ejaculation, or ejaculation on external genitals
For patients using Qlaira® tablets, NuvaRing® vaginal delivery system or Evra® patches please refer to the manufacturer’s current Summary of Product Characteristics to determine whether the patient is at risk of a decreased contraceptive efficacy
  • Progestogen-only contraceptive injection overdue by more than two weeks
  • Potential intrauterine contraceptive failure, e.g. lost threads
  • Patient has received ulipristal emergency contraception but has vomited within three hours of taking it (provided they are still within 120 hours of UPSI)
  • Post partum patients must be more than 21 days post-partum
  • Following termination of pregnancy, consider the date of termination as the last menstrual period
  • Under 18 year olds a risk assessment should be undertaken to ensure the child is not at risk of harm. If a risk is identified, a referral to social services should be made in line with the Child Protection Procedures of the Commissioning Organisation.
  • Under 16 year olds are included provided they meet the criteria of the Fraser Guidelines on consent to medical treatment.
  • In addition, if patient is under 13 years of age a referral to social services should be made in line with the Child Protection Procedures of the Commissioning Organisation.

Exclusion criteria /
  • Patient is pre-pubertal
  • Less than 72 hours after UPSI. Advise patient that levonorgestrel (Levonelle® 1500) _ is recommended - refer to levonorgestrel PGD
  • Confirmed pregnancy
  • Previous use of ulipristal within this menstrual cycle
  • A second supply for patients who vomit within 3 hours of taking ulipristal (provided the repeat dose is still within 120 hours of UPSI) IS allowed under this PGD.
  • Previous use of levonorgestrel containing emergency hormonal contraception (Levonelle® 1500) within this menstrual cycle
  • A supply of ulipristal is allowed under this PGD for women who vomit within 2 hours of taking levonorgestrel if this takes the woman to over 72 hours since UPSI (provided the ulipristal dose is still within 120 hours of UPSI).
  • Any earlier episodes of UPSI which took place more than 120 hours ago and within this menstrual cycle.
  • Known hypersensitivity to ulipristal or any excipients, or patient has previously experienced any severe clinical problems with hormonal contraception.
  • Currently taking any medicine which induces hepatic enzymes:
  • Anti-epileptics
Carbamazepine
Eslicarbazepine
Oxcarbazepine
Phenobarbital
Phenytoin
Primidone
Rufinamide
Topiramate
  • Antimicrobials:
Rifampicin
Rifabutin
Also
Antiretrovirals
St John’s Wort
Bosentan
Modafinail
Aprepitant
For enzyme inducers this exclusion also covers women who have stopped the medicines listed that induce hepatic enzymes within the last 28 days.
  • Uncontrolled severe asthma (where asthma is not controlled despite oral corticosteroid treatment)
  • Hepatic impairment
  • Concomitant use of medicinal products reducing gastic acid eg H2receptor antaganists and PPIs
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption are excluded from treatment with ulipristal (ellaOne®▼) under this PGD, as this medicine contains lactose monohydrate.
  • Patients lacking competence to consent to treatment
  • Post partum patients (within 21 days) are not considered at risk of pregnancy and so are excluded from treatment.
  • Medicines that are P-glycoprotein transporters:due to a theoretical interaction where ulipristal may affect these medicines patients prescribed the medicines listed below are excluded from treatment with ulipristal (ellaOne®) under this PGD. Patients may be eligible for treatment with levonorgestrel (Levonelle 1500®)- see levonorgestrel PGD.eg
Dabigatran etexilate
Digoxin
Cautions (including any relevant action to be taken) /
  • Severe intestinal malabsorption syndromes
e.g. Crohn’s disease
The FRSH advise that oral contraception may be less reliable in women with malabsorption due to severe small bowel disease or resection. Women with these conditions should be encouraged to consider an IUD as the preferred method of emergency contraception.
  • Breast feeding For women who are breast feeding inform them that breast feeding is not recommended for 7 days after taking ulipristal (ellaOne®▼). The manufacturers advise that women who are breast feeding should feed their baby immediately before taking the tablet, then pump and discard the milk for 7 days after taking the ulipristal (ellaOne®▼). Breast feeding can be resumed after 7 days. If the woman is unable or unwilling to comply with this advice she is excluded from treatment with ulipristal (ellaOne®▼) under this PGD- refer to GP or Community Sexual Health Clinic.

Arrangements for referral for medical advice / Know the referral pathway into local sexual and reproductive health services or how to contact the local lead doctor for sexual and reproductive health for medical advice.
Action to be taken if patient excluded /
  • Discuss reasons for exclusions
  • Consider the supply and administration of levonorgestrel 1500mg (refer to levonorgestrel PGD)
  • Refer immediately to Community Sexual Health Clinic or GP if appropriate. An intrauterine device (IUD) may be fitted up to 5 days after unprotected intercourse or up to 5 days after likely ovulation.
  • Provide an emergency supply of condoms

Action to be taken if patient declines treatment /
  • Discuss reasons patient declines treatment
  • Consider the supply and administration of levonorgestrel (Levonelle®) 1500mg (refer to levonorgestrel PGD)
  • Refer immediately to Community Sexual Health Clinic or GP if appropriate

Details of the medicine

Name, form and strength of medicine / Ulipristal acetate 30mg tablet
(ellaOne®)
Legal category / POM
Indicate any off-label use (if relevant) / Not applicable
Route/method of administration / Oral
The earlier in the 120 hour period ellaOne® taken the greater the efficacy.
It is recommended that the woman takes the tablet(s) whist in the pharmacy
If the tablet(s) are not taken in the pharmacy:
Advise the woman to take the tablet(s) as soon as possible
Highlight the presence of a patient information leaflet in the pack(s)
The pack(s) should be labelled with the woman’s name, date of issue, directions for use, the pharmacy address and ‘keep out of reach of children’.
Dose and frequency / ONE x 30 milligram tablet to be taken as soon as possible no later than 120 hours after UPSI.
If patient vomits within 3 hours of taking the dose, then a second pack may be issued if the patient is able to take the repeated dose within 120 hours following UPSI.
Administration while the patient is present should be encouraged and supported, although this is voluntary.
Quantity to be administered and/or supplied / One pack containing one Ulipristal 30mg tablet
Maximum or minimum treatment period / See dose and frequency section above
Adverse effects / Side effects may include;
  • Nausea, vomiting, diarrhoea or abdominal pain
  • Dizziness
  • Fatigue
  • Headache
  • Temporary disturbance of menstrual cycle (bleeding, spotting, next period early or late)
  • Back pain
  • Muscle spasms
  • Less commonly; tremor, hot flush, uterine spasm, breast tenderness, dry mouth, blurred vision, pruritis and rash
No treatment is recommended to manage side effects other than simple analgesia as required.
Records to be kept /
  • A consultation proforma for the “Supply and Administration of EHC” mustbe fully completed and signed for all consultations, irrespective of whether a supply is made. The following details will be recorded:
  • That valid informed consent has been given
  • Patient’s name, address (optional) and date of birth
  • Name of GP
  • Dose given
  • Date of supply
  • Manufacturer, brand, batch number and expiry date
  • A record of the counselling about encouragement to consider an IUD
  • Advice given
  • Advice given if patient excluded or declines treatment
  • Details of any ADRs and actions taken
  • Signature, GPHC number and name of pharmacist who administered or supplied the medication
  • Document if the dose is administered on the premises
  • The supply must be entered in the Patient Medication Record (PMR)
  • All records should be clear, legible and contemporaneous.
This can be a paper or electronic version (or both)
A “Fraser Ruling Assessment of Competency” form must be completed for all women under 16 years of age
Consultation and Fraser Ruling proformas must be signed by the pharmacist and the woman

Patient information

Written information to be given to patient or carer / The Product Information leaflet must be given to the woman
Give patient emergency contraception leaflet and before supplying discuss;
  • Method of taking. The dose must be taken as soon as possible after supply
  • For patients presenting less than 72 hours after UPSI. Advise patient that levonorgestrel 1500mg is recommended - refer to levonorgestrel PGD.
  • Side effects. Discuss side effects with patient. Some women experience dizziness, drowsiness, blurred vision and/or disturbance in attention: advise patient not to drive or use machines if they experience these symptoms.
  • Failure rate. Ulipristal (ellaOne®) is not 100% effective, of 100 women receiving ulipristal (ellaOne®) up to 5 days after UPSI, approximately 2 will become pregnant.
  • Risk to foetus if already pregnant. Discuss with the patient that ulipristal (ellaOne®) is a newly licensed treatment and so experts do not know the effects on the unborn baby. Explain to the patient that if she does become pregnant after taking this medicine it is important that she informs her doctor.
  • Intra-uterine device (IUD) as an alternative. An IUD is more effective than hormonal emergency contraception especially when there are multiple risks or the patient is towards the end of the 120 hour time limit.
  • Future contraception.Discuss with the patient future contraception. Emphasise that the tablet is for emergency use only and is not as effective as a regular method of contraception. Remind the patient that the use of ulipristal (ellaOne®) does not provide ongoing contraceptive protection and that she must continue to use another method for the remainder of the cycle.
  • Advise that the next period may be early or late
  • Advise to seek medical advice if they suffer any abdominal pain
  • Breast feeding. See special precautions section of this PGD.
  • Sexually transmitted infections
Advise that the patient may be at risk of sharing sexually transmitted infections (STIs). Patients may be asymptomatic. Further advice, screening and treatment can be accessed from Community Sexual Health Services or their GP.
  • Patients taking oral contraceptives. Those taking combined oral contraceptives (COC) or progestogen only pills (POP) should be advised to continue taking their pills but to also use additional barrier method contraceptive precautions until their next period. This is because ulipristal (ellaOne®) may reduce the efficacy of regular hormonal contraception.

Follow-upadvice to be given to patient or carer / Woman should be offered a pregnancy test after 3 weeks to check for failure of EHC

Appendices

AppendixA Key references

  1. Emergency Contraception Guidelines, Faculty of Sexual & Reproductive Health Clinical Effectiveness Unit (2012)
  2. Faculty of Sexual & Reproductive Healthcare Guideline “Missed pill recommendations” May 2011
  3. GPhC Guidance – Consent 2012, Raising Concerns 2012 , and Confidentiality 2012
  4. Summary of Product Characteristics for ellaOne® available accessed 3rd February 2013.
  5. Current BNF chapter 7.3.1
  6. Drug Interactions with ellaOne® Faculty of Sexual & Reproductive Healthcare Clinical Guidance (updated 2012)
  7. NICE Good Practice Guidance on Patient Group Directions and the Competency framework for healthcare professionals using Patient Group Directions

Appendix B

Community Pharmacist’s agreement to practiseunder the Ulipristal 30mg Patient Group Direction for Community Pharmacists

I have read and understood the Patient Group Direction and agree to supply and/or administer this medicine only in accordance with this PGD.

Full Name (print)
GPhC number
Signature
Date

Appendix C - Clinical Condition Notes

A relevant medical history must include:

  • Age
  • Date of first day of last menstrual period, and normal cycle length
  • Number of hours since intercourse and day of cycle on which unprotected intercourse took place (first day of period = day 1 of cycle)
  • Any other episodes of unprotected intercourse since last period
  • Past medical history, current medication
  • Pregnancy tests if suspected

Reasons for usual method failure may include:

  • Misplaced / dislodged diaphragm / incorrect insertion / torn / removed too early.
  • Condom breakage /leakage /ejaculation on external genitalia.
  • IUD failure – complete or partial expulsion or removal considered necessary
  • Miscalculation of fertility awareness method
  • Reduced contraceptive protection because of e.g. severe diarrhoea and vomiting which may have reduced oral contraceptive efficacy
  • Missed or late contraceptive pill COC or Progestogen only contraceptive (POP) (further notes available in BNF chapter 7.3.1)
  • If the combined vaginal ring (CVR) (NuvaRing ®)
  • Has been left in for more than 4 weeks
  • A new ring has not been inserted following the 7day break
  • If the ring has been expelled from the vagina either spontaneously or during intercourse and not replaced within 3 hours
  • Expelled more than once per cycle
  • Allowed more than 14 weeks (98 days) to elapse since the last medroxyprogesterone acetate (Depo Provera) contraceptive injection.
  • Has vomited within 2 hours of taking levonorgestrel 1500microgram tablet (see use outside Product Licence)
  • Using contraceptive patch which becomes partially or fully dislodged or missed the change day (refer to current SPC for further advice)
  • Barrier method failure in women on the COC/POP/Progestogen implants or CVR who are also taking liver enzyme inducing drugs (and for 28 days after stopping the liver enzyme inducing drugs).

Appendix D

Advice to Young People Under 16

In considering the provision of advice or treatment on contraception, doctors and other professional staff need to take special care not to undermine parental responsibility and family stability. The doctor or other professional should therefore always seek to persuade the young person to tell the parents or guardian (or other person in loco parentis), or to let her inform them, that contraceptive advice is being sought and the nature of any advice or treatment that is given. It should be most unusual for a doctor or other professional to provide advice or treatment in relation to contraception to a young person under 16 without parental knowledge or consent.

Exceptionally, there will be cases where it is not possible to persuade the young person either to inform the parents or to allow the doctor or other professional to do so. This may be, for example, where family relationships have broken down. In such cases, a doctor or other professional would be justified in giving advice and treatment without parental knowledge or consent, provided he followed the Fraser Guidelines.

FRASER GUIDELINES

In law young people under 16 years are entitled to confidentiality in the same way as over 16 year olds. In 1985 Lord Fraser established the current legal position that a doctor or other professional can give contraceptive advice or treatment to a person under 16 without parental consent providing they are satisfied that:

The young person will understand the risks and benefits of the treatment offered and the advice given.

The young person cannot be persuaded to tell his or her parents or allow a health professional to inform them that he or she is seeking contraception advice.

The young person is likely to begin or continue having intercourse with or without contraceptive treatment.