Document Control Sheet Rationale To enable patients, presenting for emergency contraception to be treated in a consistent and timely manner by suitably trained pharmacists in community pharmacies within the CCG, without the need for a doctor’s prescription Documents replaced or superseded by this PGD. CP PGD2 For supply or administration of Post-Coital Contraceptive Pills by registered pharmacists: Cambridgeshire & Peterborough CCG Issued February 2011 Expiry February 2013 Development & Consultation: Developed by the Cambridgeshire and Peterborough CCG Medicines Management Team in consultation with: Dr Lynne Gilbert Associate Specialist in Sexual Health and Reproductive Health Rita Bali Community Pharmacist and Local Pharmaceutical Committee Representative Dissemination Community Pharmacies and Community Pharmacists Local Pharmaceutical Committee Family Planning services, GP Practices, Out of Hours services, for information Accessibility Cambridgeshire County Council and Pharmaceutical Committee websites Implementation Each registered pharmacist authorised to supply and/or administer medication this PGD must have read, understood and signed it and completed the agreement to practice form before attempting to work according to it Training See PGD Audit See PGD Review Review should be initiated 6 months before the expiry date unless a review is required in response to a change to the medicine(s) covered by this PGD Equality and Diversity The Medicine Safety and Governance Group has carried out a Rapid Equality & Diversity Impact Assessment and concluded the document is compliant with the CCG Equality and Diversity Policy. Standards for Better Health Domain How? Safety PGD documentation provides consistent approach to patient care. This document sets out the information specified in law as that required for a Patient Group Direction. Attention is drawn to professional guidelines on child protection and contact details for local child protection lead professionals. Professionals working under a patient group direction must fulfil the training requirements set out in it, and be working within their own competence.
3. Medicine to be supplied under this Patient Group Direction 3.1 Name, strength and form of medicine(s) Levonorgestrel 1500microgram tablet (Levonelle® 1500) 3.2 Legal Status POM 3.3 triangle NO Black triangle drugs (see BNF) are newly licensed medicines that are closely monitored by the MHRA. All suspected reactions should be reported using yellow cards (see below Adverse Drug Reactions) 3.4 PGD covering use outside terms of Summary of Product Characteristics (SPC)? Levonorgestrel 1500microgram is not licensed for women under 16 years of age. The use of 2 x Levonorgestrel 1500microgram tablets if the patient is taking drugs (see Section 2.3 above) is an unlicensed indication. However, this is the recommendation in the current BNF. Use between 72 and 96 hours after UPSI EHC with Levonorgestrel 1500mcg may be considered for use between 72 and 96 hours after UPSI, but women should be informed of the limited evidence of efficacy and that such use falls outside the licence of the product. If >72 hours but <less 120 hours from UPSI, advise that the option of an insertion of an IUD is the recommended first – line treatment but that EHC is supported by evidence from a World Health Organisation trial. Use of EHC does NOT stop a woman from having the IUD fitted as well but may ensure some protection whilst more effective protection is sought. Provision of Ulipristal acetate (which is licensed for up to 120 hrs) could be another alternative which would require referral to a medical practitioner to consider Use more than once in a cycle The product SPC advises against this because of the possibility of disturbance of the However, use more than once is supported by guidance from the Faculty of Sexual and Reproductive Healthcare. But, if a second act of UPSI has occurred within 12 hours of taking Levonorgestrel 1500mcg an additional dose is not necessary If Ulipristal has been used in this cycle then hormonal contraception will be affected. See SPC. Women seeking EHC in these circumstances should be advised to see a medical practitioner as an IUD would be the recommended first line treatment. If they
Appendix 1 Advice for women missing combined oral contraceptives (30-35mcg and 20mcg ethinylestradiol formulations) If one pill has been missed (more than 24 and up to 48 hours late) If two or more pills have been missed (more than 48 hours late) Continuing contraceptive cover The missed pill should be taken as soon as it is remembered. The remaining should be continued at the usual time. Minimising the risk of pregnancy Emergency contraception (EC) is not usually required but may need to be considered if have been missed earlier in the packet or in the last week of the previous packet. Continuing contraceptive cover The most recent missed pill should be taken as soon as possible. The remaining pills should be continued at the usual time. Condoms should be used or sex avoided until seven consecutive active pills have been taken. This advice may be overcautious in the second and third weeks, but the advice is a backup in the event that further pills are missed. Minimising the risk of pregnancy If pills are missed in the first week (Pills 1–7) If pills are missed in the second week (Pills 8–14) If pills are missed in the third week (Pills 15–21) EC should be considered if unprotected sex occurred in the interval or in the week of pill taking. No indication for EC if the pills in the preceding 7 days have been taken consistently and correctly (assuming the pills thereafter are taken correctly and additional contraceptive precautions are used). OMIT THE INTERVAL by finishing the pills in the current pack (or discarding any placebo tablets) and starting a new pack the next day. Adapted from Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. Faculty Statement from CEU CEU Statement (May 2011)