Patient Group Direction For Supply Of Emergency Hormonal Contraception By Community Pharmacists November 2005 City & Hackney TPCT PGD for EHC Version printed: November 2005 Page 1 of 5 Patient Group Direction For Supply Of Emergency Hormonal Contraception By Community Pharmacists Rationale To enable a pharmacist working in City and Hackney, who has received specific training and has been assessed as competent, to supply emergency hormonal contraception in accordance with the following patient group direction (PGD). Professionals to whom this patient group direction may apply Qualifications Required Additional Requirements Pharmacist (registered with RPSGB or PSNI) Access to: British National Formulary, latest edition Levonelle 1500® summary of product characteristics City and Hackney Teaching PCT medicines policies, if appropriate Information about services available to young people Continuing Training Requirements It is the responsibility of the individual pharmacist to ensure that they and their staff are competent in all aspects of supply and administration of emergency hormonal contraception and are updated on current medicines policies. THIS PATIENT GROUP DIRECTION WILL BE SUBJECT TO REGULAR REVIEW IN LINE WITH CURRENT CLINICAL PRACTICE AND AT TIMES OF MAJOR CHANGE Date of overall review of this document – November 2007 City & Hackney TPCT PGD for EHC Version printed: November 2005 Page 2 of 5 Patient Group Direction for the supply/administration of to LEVONORGESTREL 1500 MCG TABLETS FEMALE CLIENTS FOR EMERGENCY HORMONAL CONTRACEPTION 1. Clinical Condition Define situation/condition Criteria for inclusion Prevention of pregnancy from unprotected sexual intercourse (UPSI) in women under 26 years of age*. UPSI defined as follows: Penetration with or without ejaculation, or ejaculation on external genitals and no contraceptive method used Barrier method failure Missed pills without alternative methods used More than 89 days have elapsed since the last medroxyprogesterone injection More than 21 days post-partum if not breastfeeding More than 42 days post-partum if fully breastfeeding Potential Intra Uterine Contraceptive Device (IUCD) failure, e.g. lost threads *Treatment may be given to women over 26 in exceptional circumstances, e.g. at weekends, after normal GP practice opening hours Women presenting within 72 hours of UPSI as defined above, or women who have: Severe diarrhoea and vomiting which may have reduced oral contraceptive efficacy Also been taking broad-spectrum antibiotic with a combined oral contraceptive pill and have failed to use additional barrier method during the course of the treatment Received levonorgestrel emergency contraception (e.g. from GP, purchased over-the-counter, PUCC), but have vomited within 3 hours of taking the dose (provided it is still within 72 hours of UPSI) Fraser Ruling: the Fraser ruling concluded that there is no lower age limit for young women to understand sexual health issues. For clients known/thought to be under 16 years of age, discussion with the young person should explore their understanding of the advice given, and they should be encouraged to involve their parents. The following should also be considered: Adverse effect on the physical or mental health of the young person if advice or treatment withheld Supply is in the best interests of the young person The young person is likely to continue with sexual activity without advice or treatment Criteria for exclusion City & Hackney TPCT PGD for EHC Version printed: November 2005 Child protection: an assessment of risk of harm should be made for clients under 16, including age of partner. Contact appropriate authorities if there are any concerns – refer to the information provided. UPSI more than 72 hours ago Known hypersensitivity to levonorgestrel or any ingredient Page 3 of 5 Action if excluded Action if patient declines 2. Description of treatment Name of Medicine POM/P/GSL Dose/s Route Method Frequency Total dose number Follow up Advice Records City & Hackney TPCT PGD for EHC Version printed: November 2005 contained in the product Suspected pregnancy Unexplained or unusual vaginal bleeding Acute severe liver disease Active acute porphyria Severe intestinal malabsorption syndromes, e.g. Crohn’s Disease Clients taking enzyme-inducing drugs If more than 72 hours since episode of UPSI, a post-coital IUCD is an alternative option Refer to family planning clinic or GP for advice about regular contraception Document refusal/action taken in client’s record. Levonorgestrel 1500 microgram tablets (Levonelle 1500®) POM One tablet to be taken as soon as possible, preferably within 12 hours and no later than 72 hours of UPSI Oral Single episode of treatment 1500 microgram tablet x 1 Clients should be provided with information and advice about regular contraception – an information pack should be provided to all clients, whether included or excluded Clients should be given 3 condoms Client may require follow-up by GP or family planning clinic e.g. for missed or abnormal period If a sexually transmitted infection is suspected, refer to genitourinary medicine clinic Explain treatment and administration including advice if vomiting occurs Discuss side-effects and administration with the client and provide a manufacturer’s patient information leaflet Advise client that she could still become pregnant. If menstrual periods are delayed by more than 5 days or are abnormal in any way (light, heavy or painful), client should seek medical advice If a pregnancy has occurred, following failure of levonorgestrel treament, the client should contact GP/Family planning clinic for follow-up to ensure that it is not ectopic Seek medical advice if there is any lower abdominal pain Stress need to use a reliable barrier method, e.g. condom, diaphragm or cap, until the next menstrual period, or abstain from sexual intercourse Client’s name or initials, date of birth and GP details, if they are willing to share these details. The first part of the post-code and the number from the 2nd part should be recorded for analytical purposes Reason for inclusion Advice given to patient Batch number and expiry date Name of pharmacist who supplied the medication Details of any adverse drug reaction and actions taken including documentation in the client’s medical record via GP Page 4 of 5 Patient Group Direction For Supply Of Emergency Hormonal Contraception By Community Pharmacists DECLARATION DECLARATION by City & Hackney Teaching Primary Care Trust: This PGD has been authorised by: Enquiries relating to this PGD should be addressed to: Head of Pharmacy & Prescribing, City & Hackney tPCT, St Leonard’s, Nuttall Street, London N1 5LZ. Tel: 020 7683 4454 Fax: 020 7683 4464 Date of review: November 2007 This PGD is available on the tPCT intranet {click on ‘Departments’, then click on ‘Primary Care Dev.’, then click on ‘Prescribing’, then click on ‘Patient Group Directions’} I have been appropriately trained to understand the criteria listed and the administration required to supply emergency hormonal contraception in accordance with this Patient Group Direction. I confirm that I am competent to undertake administration of these medicines. Pharmacist Name:……………………………. Pharmacy stamp: RPSGB/PSNI registration number: Signature:………………….. City & Hackney TPCT PGD for EHC Version printed: November 2005 Date:………………………. Page 5 of 5