PRACTICE GUIDANCE ON THE SUPPLY OF EMERGENCY HORMONAL CONTRACEPTION AS A PHARMACY MEDICINE

Transcription

1 PRACTICE GUIDANCE ON THE SUPPLY OF EMERGENCY HORMONAL CONTRACEPTION AS A PHARMACY MEDICINE This guidance was prepared on behalf of the Practice Division of the Royal Pharmaceutical Society of Great Britain (RPSGB). Additional paper copies may be requested by contacting: Lorraine Fearon Practice Division Royal Pharmaceutical Society of Great Britain 1 Lambeth High Street London SE1 7JN Telephone: lorraine.fearon@rpsgb.org All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means - electronic, mechanical, photocopying, recording or otherwise - without the prior written permission of the Royal Pharmaceutical Society of Great Britain. September

2 1. Introduction This document provides guidance on best practice in relation to the supply of emergency hormonal contraception (EHC) as a pharmacy medicine and replaces the Royal Pharmaceutical Society s original practice guidance developed in It continues to complement the training and support that is available from national bodies such as the Centre for Pharmacy Postgraduate Education, the Welsh Centre for Postgraduate Pharmaceutical Education, NHS Education for Scotland Pharmacy (Scottish Centre for Post Qualification Pharmaceutical Education), fpa (formerly the Family Planning Association) and manufacturers of pharmacy-only EHC products. This guidance aims to support pharmacists implementation of the Royal Pharmaceutical Society s five professional standards for the sale of EHC as a pharmacy medicine (reproduced in section 3). It should not be read as a protocol for pharmacists to follow but sets out to address the specific issues that should be explored with the client to ensure safe and appropriate supply in accordance with the required professional standards. Revised dosage instructions have been incorporated into this practice guidance. 1.1 Effectiveness of EHC versus IUD An earlier clinical study indicated that levonorgestrel-based EHC taken as two tablets (2 x 0.75mg) with a 12 hour interval, prevented 85% of expected pregnancies. Efficacy appeared to decline with time of start of treatment after intercourse. 1 A recent clinical study has shown that two tablets (2 x 0.75mg) of levonorgestrel taken at the same time (and within 72 hours of unprotected sex), did not differ significantly compared to when the tablets were taken 12 hours apart. 2 Taking both tablets at the same time prevented 84% of expected pregnancies compared with 79% when the tablets were taken 12 hours apart. The results indicate that a single dose of 1.5mg levonorgestrel can substitute two 0.75mg doses of levonorgestrel 12 hours apart. The study did not however confirm the significant trend in failure rates with delay in treatment and we await publication of meta-analyses of the results obtained for levonorgestrel-based EHC. An IUD can be fitted up to 120 hours (5 days) after unprotected sex or within five days of expected ovulation and is over 99% effective. Women who may need an IUD for emergency contraception must be advised to contact a GP or family planning service as a matter of urgency. 3 Pharmacists should direct women to a local service known to provide IUDs. 1.2 Advance provision of EHC Supply of EHC via the pharmacy in advance of clinical need is not currently recommended. Clients requesting advance supplies should be advised that some, but not all, doctors and family planning services may prescribe EHC for advance situations. Pharmacists should ensure that they know if and where this is provided locally so that the information can be offered to clients. 2. Routes of EHC supply There are three possible routes by which women can obtain EHC: 2

3 As a pharmacy (P) medicine; As a prescription-only medicine (POM) via primary care, family planning, hospital genito-urinary medicine clinics, or some accident and emergency centres; As a POM through patient group directions, via NHS Walk-in Centres, family planning clinics and some community pharmacies. 3. Professional standards Pharmacists in personal control of a pharmacy must ensure that the following standards are observed in the supply of EHC as a pharmacy medicine. As with all medicines, pharmacists must have sufficient knowledge of the product to enable them to make an informed decision when requests are made. a) Pharmacists must deal with the request personally and decide whether to supply the product or refer the patient to an appropriate healthcare professional. b) Pharmacists must ensure that all necessary advice and information is provided to enable the patient to assess whether to use the product. c) Requests for emergency hormonal contraception should be handled sensitively with due regard being given to the customer s right to privacy. d) Only in exceptional circumstances should pharmacists supply the product to a person other than the patient. e) Pharmacists should, whenever possible, take reasonable measures to inform patients of regular methods of contraception, disease prevention and sources of help. 4. Practice Guidance 4.1 Training Training on the supply of EHC should involve all pharmacy staff. It is important for everyone in a pharmacy to be aware of the key issues regarding the supply of EHC to ensure that all staff respond sensitively and appropriately to enquiries about EHC. In particular, staff should recognise that all requests for EHC should be referred to the pharmacist early on in the consultation. Training and support is available from the national centres for pharmacy postgraduate education (CPPE, NES Pharmacy [SCPPE], WCPPE), family planning association (fpa) and the Faculty of Family Planning and Reproductive Health Care (FFPRHC) of the Royal College of Obstetricians and Gynaecologists Clinical Effectiveness Unit: CPPE: NES Pharmacy (SCPPE): WCPPE: fpa: FFPRHC: Information is also available from manufacturers of pharmacy-only EHC products. 3

4 4.2 Indications EHC is indicated for emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method. EHC is licensed as a pharmacy medicine for women aged 16 or over. EHC is available to women of all ages as a POM product on prescription. It may also be supplied as a POM through patient group directions but supply to women under 16 may only be made if this is specified in the patient group direction. 4.3 Obtaining information before a supply is made Sufficient information should be obtained to assess whether it is appropriate for EHC to be supplied. Pharmacists should be aware of the woman s competence to receive and understand information. Women with special needs e.g. those whose first language is not English, whose literacy levels are low, who have hearing difficulties, have visual impairment, or who may be suffering from a mental health problem, should be dealt with appropriately. Outlined below is information that will be necessary when considering a supply. Is the client presenting in person? Supplies to third parties should not normally be made where the pharmacist suspects abuse or non-consensual sex. Sales to third parties should normally only be carried out in exceptional circumstances (e.g. where the client is housebound through disability or illness). When considering making a supply in such circumstances, pharmacists should be satisfied that the criteria for supply set out below are met. Telephone contact with the client may be useful for establishing this. Has the client been placed at risk of pregnancy in the last 72 hours because of unprotected sex, contraceptive failure or missed contraceptive pills *? EHC will only be effective if taken within 72 hours of unprotected intercourse and its efficacy has been found to decrease dramatically with time. Evidence 1 indicates that levonorgestrel-based EHC will prevent 95% of expected pregnancies if taken within 24 hours of unprotected sex, 85% between hours and 58% if used within hours). An IUD can be fitted up to 120 hours (5 days) after unprotected sex or within five days of expected ovulation. Clients who may need an IUD must be advised to contact a local service (eg GP or family planning service) known to provide IUDs as a matter of urgency. Is there a possibility that the client may already be pregnant? i.e. Is her period late? If so, how late? Was the last period lighter or shorter than normal? Was the last period unusual in any way? Since the last period, has the woman had unprotected sex at any time before this occasion? * Where necessary pharmacists are advised to seek further information to ensure that they are knowledgeable about the respective risks of missing different types of oral contraceptive pills. 4

5 If it is suspected that the client might already be pregnant she must be advised to contact a GP or family planning service as soon as possible. There are some conditions, e.g. chlamydial infections, which can cause bleeding between periods and therefore could be confused with pregnancy or miscarriage. A client who answers yes to any of the questions above regarding pregnancy should be considered for referral. Has EHC been used since the last period? If appropriate, women can be given more than one supply of EHC within the same menstrual cycle but should be advised about possible cycle disruption. They should also be encouraged to seek advice about more reliable methods of contraception and should be provided with information about local contraceptive services Drug interactions Pharmacists should be aware of the following drug interactions and refer to a GP or family planning service as appropriate. The following drugs interact with levonorgestrel: Carbamazepine Griseofulvin Phenobarbital Phenylbutazone Phenytoin Primidone Rifabutin Rifampicin Ritonavir St John s wort Ciclosporin The medicines listed (except ciclosporin) may increase the rate of metabolism of levonorgestrel thus reducing drug levels and efficacy. This may also occur with certain herbal remedies, e.g. St John s wort. Levonorgestrel may increase the risk of toxicity with ciclosporin due to possible inhibition of ciclosporin metabolism Contraindications In the event of the following contraindications levonorgestrel-based EHC should not be supplied and the client should be advised to seek advice from a GP or family planning service. Does the client have any condition that might affect absorption of EHC, eg vomiting, severe diarrhoea, Crohn s disease? Doses of levonorgestrel will need to be altered if clients have conditions associated with malabsorption. Does the client have severe hepatic dysfunction? The use of progestogen-containing EHC is not recommended in such clients. Has the client previously experienced severe allergic reactions to progestogencontaining contraceptives? Allergy to levonorgestrel is rare but is a contraindication to taking progestogen-containing EHC. 5

6 Pharmacists may consider, having obtained and assessed the relevant information, that EHC is not needed. If the woman, however, perceives that she is at risk of pregnancy and, despite the pharmacist s professional advice, still wishes to take EHC then, in the absence of any obvious contraindication, a pharmacist should consider supplying. EHC poses very little safety risk to women, even if taken when not necessary, provided the relevant information is first obtained as outlined above and the appropriate advice given Use of a printed card to assist with consultations Pharmacists may wish to consider using a printed card as an assessment tool for use in EHC consultations (see appendices 1 and 2). Instructions on use of EHC (see section 4.4 below) could be incorporated into a card as practice points to consider when recommending EHC. 4.4 Instructions on use of EHC Dosage The dose timing of EHC has changed. A single dose of 1.5 mg levonorgestrel (equating to two x 0.75mg tablets) should be taken, as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected intercourse Side effects The most commonly reported side effect is nausea. Some women may also vomit after taking EHC. If vomiting occurs within three hours of taking the tablets, another single dose of 1.5mg levonorgestrel-based EHC (equating to two x 0.75mg tablets) should be taken immediately. The woman should contact her doctor, family planning clinic or pharmacist for advice and more tablets. EHC can alter the timing and type of bleeding of the next menstrual period, which may start early or late but usually within 3 days of the expected time. Repeated use of EHC is likely to cause disruption to the menstrual cycle, and is less effective than other forms of oral contraception Additional counselling points Pregnancy EHC does not provide protection against pregnancy for the rest of the menstrual cycle. Other contraceptive methods such as careful use of a barrier method are needed Missed oral contraceptive pills Women seeking EHC because they have missed one or more oral contraceptive pill(s) should be advised according to the oral contraceptive they are taking. Full advice can be found in the British National Formulary. 6

7 Breastfeeding A small amount of levonorgestrel may appear in breast milk. This should not be harmful to the baby but women can be advised to take the tablets immediately after a breast feed, thus reducing the amount of levonorgestrel the baby may take in at the next feed How EHC works Where appropriate, women should be given advice on how EHC works so that those who believe that life begins at fertilisation can make an informed choice. EHC does not cause abortion. 4 Depending on when it is given in the menstrual cycle it is thought to work by preventing or delaying ovulation, preventing fertilisation or preventing implantation of a fertilised egg Follow up Women should be advised that EHC is not 100% effective. A single dose of 1.5mg levonorgestrel-based EHC (taken as two x 0.75mg tablets) will prevent about 84% of pregnancies when taken within 72 hours of unprotected intercourse. 2 Women should be strongly encouraged to seek follow-up advice from a GP, practice nurse or family planning service approximately three weeks after taking EHC in any of the following circumstances: If the next period is light, more than 3 days late, or unusual in any way (to establish whether the client is pregnant); If it is considered that a woman would benefit from a referral to obtain contraceptive advice, particularly if a more reliable method of contraception is needed or if contraception is not regularly used; If more general information about contraception is sought. Women should also be advised to refer promptly to their doctor if any lower abdominal pain occurs because this could signify an ectopic pregnancy (ie a pregnancy that develops outside the womb, usually in a fallopian tube). It is recommended that information on local family planning services, including location, hours of opening and services provided, is made available in every pharmacy. This information can be obtained from local health agencies. Information should also be available on local GUM clinics and other local services where testing and screening for sexually transmitted infections is provided (see section 5: linking with local networks). 4.5 Terms of marketing authorisation (pharmacy medicine) EHC is licensed as a P medicine for women aged 16 or over. As is already the case with other non-prescription medicines pharmacists should use their professional judgement to decide whether they believe the supply is both necessary and in the woman s best interest. 7

8 Pharmacists should make every reasonable effort to satisfy themselves that women are aged 16 years or over. Pharmacists should ensure that where they believe a woman to be under 16 the request is dealt with sympathetically and the woman is offered appropriate help and support to enable her to obtain EHC by another route, i.e. authorised supply of a POM product on prescription or via a patient group direction that specifies this age group. The Department of Health s Best practice guidance for doctors and other health professionals on the provision of advice and treatment to young people under 16 on contraception, sexual and reproductive health 5 recommends that health professionals (including pharmacists who supply EHC as a POM under a patient group direction) should give young people the time and support needed to make informed choices. 4.6 Pharmacists who choose not to supply EHC Pharmacists who choose not to supply EHC on the grounds of religious or moral beliefs should treat the matter sensitively and advise women on an appropriate local source of supply available within the time for EHC to be effective (i.e. within 72 hours of unprotected sex). 5. Linking with local networks It is important that all health care professionals involved in sexual health advice provide consistent information. Pharmacists are therefore encouraged to take the lead in linking community pharmacies into existing local networks for family planning services. This may involve local pharmaceutical advisers. Simple mechanisms should be established to enable community pharmacists to feed back family planning issues arising from the pharmacy supply route. Pharmacists should consider working with other local agencies to produce leaflets containing lists of local services and contact points. The availability of national resources (e.g. fpa and manufacturers leaflets, websites and help lines) as well as local resources such as NHS Direct, NHS24 and local GUM clinics should be explored. The quality of support available to pharmacists will be determined by the links made with these services. 6. Record keeping EHC products should not be treated any differently from any other P products. Some women seeking EHC may wish to remain anonymous and this should be respected, even if the pharmacist usually records P medicine sales on their PMRs. 7. Liability Pharmacists may be concerned about their professional liability if, despite their supply of EHC, after satisfying themselves that all the above criteria are met, the woman is already pregnant. If a woman inadvertently takes EHC when she is already pregnant she should be reassured that EHC is not an abortifacient, does not appear to pose a risk to pregnancy, nor does it appear to harm the baby. It is important to note that no guarantee can be given about any pregnancy whether EHC is used or not. 8

9 8. Communication 8.1 Privacy and confidentiality A pharmacist s duty of confidentiality is outlined in Part 2 of the Code of Ethics. Pharmacy users of all ages, including those who are under 16 years, are entitled to a confidential consultation with their pharmacist, although not all pharmacy users will be aware of this. Pharmacists may therefore consider advertising that all advisory services and consultations are confidential and that a private area is available. Pharmacists are encouraged to display a notice in the pharmacy encouraging pharmacy users to inform a member of staff if they require a more private consultation for any purpose. The dispensary should not be used for this purpose because of security risks in relation to medicines and patient information. 9

10 References 1. Task force on postovulatory methods of fertility regulation (1998). Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency. Lancet 352: von Hertzen H, Piaggio G, Ding J, Chen J, Song S, Bártfai G, Ng E et al. (2002). Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet 360: Trussell J, Ellertson C (1995). Efficacy of Emergency Contraception, Fertility Control Review 4 : Department of Health. Judicial review of emergency contraception. London: Department of Health, Department of Health. Best practice guidance for doctors and other health professionals on the provision of advice and treatment to young people under 16 on contraception, sexual and reproductive health. London, Department of Health,

11 Appendix 1 EHC Consultation Card Certain information will need to be obtained by the pharmacist in order to be sure that emergency hormonal contraception is safe for the woman to take. Women aged under 16 should normally seek emergency hormonal contraception from a GP, NHS Walk-in Centre or family planning service etc, where there is no provision for supply to this age group via a pharmacy PGD. The pharmacist needs to know if the answer to the following two questions is no : 1. Is the consultation with the client? 2. Has there been unprotected sex/intercourse within the last 72 hours (3 days)? The pharmacist needs to know if the answer to any of questions 3-8 is yes 3. Is it possible that you are already pregnant? Is your period late? If so, how late? Was your last period lighter or shorter than usual? Was your last period unusual in any other way or different form normal? Since your last period, have you had unprotected sex at any time before this occasion? 4. Has EHC been used since the last period? 5. Are any medicines or pills being taken, including over the counter or herbal remedies? 6. Are there any problems that might affect the absorption of EHC, e.g. vomiting, severe diarrhoea or a condition that can cause diarrhoea e.g Crohn s disease? 7. Do you have severe liver problems? 8. Has there previously been an allergy or other reaction to emergency contraception or to levonorgestrel? 11

12 Example aide-memoire for pharmacists Appendix 2 This aide-memoire is intended to help pharmacists to elicit the necessary information to determine whether the pharmacy supply of EHC would be appropriate. Pharmacists are reminded that they should satisfy themselves that the client is aged 16 or over early in the consultation. 1. Is the consultation with the client? Sales to someone else (i.e. third parties) should normally only be carried out in exceptional circumstances. 2. Has there been unprotected sex/intercourse within the last 72 hours (3 days)? Efficacy of EHC decreases with time and will only be effective if taken within 72 hours (3 days) of unprotected sex. An IUD can be fitted up to 120 hours (5 days) after unprotected sex or within five days of expected ovulation. Clients who may need an IUD must be advised to contact a local service (eg GP or family planning service) known to provide IUDS as a matter of urgency. 3. Is there a possibility that the woman may already be pregnant? Is her period late? If so, how late? Was the last period lighter or shorter than normal? Was the last period unusual in any way? Since the last period has the woman had unprotected sex before this occasion? Pregnancy is a contraindication to taking EHC and clients should be referred. In addition, pharmacists should be aware that there are some conditions, for example, chlamydial infections, which can cause bleeding between periods and therefore could be confused with pregnancy or miscarriage. Any client who answers yes to any of the questions in 3 should be considered for referral. 4. Has EHC been used since the last period? More than one course of EHC can be taken safely within the same menstrual cycle but a client may need to seek advice about more reliable methods of contraception and advised about cycle disruption. 5. Are any medicines or pills being taken, including over the counter or herbal remedies? Some medicines and herbal remedies interfere with the dose of levonorgestrel required and clients will need to be referred, e.g.: Carbamazepine Griseofulvin Phenobarbital Phenylbutazone Phenytoin Primidone Rifabutin Rifampicin 12

13 Ritonavir St John s wort Clients taking ciclosporin will also need to be referred since levonorgestrel may increase the risk of toxicity with ciclosporin (see guidance, section 4.3.1). 6. Are there any problems that may affect the absorption of EHC, e.g. vomiting, severe diarrhoea, Crohn s disease? The dose of levonorgestrel required may need to be changed if there are problems with absorption. Clients will need to be referred. 7. Are there severe liver problems? Levonorgestel-containing EHC is not recommended in clients with severe hepatic dysfunction. Clients will need to be referred. 8. Has there previously been an allergy or other reaction to emergency contraception or to levonorgestrel? Allergy to levonorgestrel is rare but is a contraindication to taking progestogencontaining EHC. PRACTICE POINTS TO CONSIDER WHEN RECOMMENDING EHC If a decision has been made to supply EHC, pharmacists should consider providing advice on the use of EHC (see section 4.4 for further details). The following points may be highlighted in consultations with women requesting EHC: Emergency use EHC is for emergency use after unprotected sex and is not as effective as using other regular methods of contraception How to take A single dose of 1.5 mg levonorgestrel (equating to two x 0.75mg tablets) should be taken, as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected intercourse. Side effects The most commonly reported side effect is nausea; some women may also vomit after taking EHC. Irregular bleeding and spotting may occur until the next period. Vomiting If the client vomits within three hours of taking EHC, she should take another single dose of 1.5mg levonorgestrel-based EHC (equating to two x 0.75mg tablets) immediately (contact GP, family planning clinic or pharmacist for advice and more tablets). Ectopic pregnancy If any severe lower abdominal pain occurs after taking this medicine the client should refer to her doctor promptly as this could signify an ectopic pregnancy. 13

14 Continued contraception EHC does not provide protection against pregnancy for the rest of the menstrual cycle. Other contraceptive methods such as careful use of a barrier method are needed. Clients seeking EHC because they have missed one or more oral contraceptive pill(s) should be advised according to the oral contraceptive they are taking. Full advice can be found in the British National Formulary. Breastfeeding Small amounts of levonorgestrel may appear in breast milk. This should not be harmful to the baby but women can be advised to take EHC immediately after a breast feed, thus reducing the amounts of levonorgestrel the baby may take in at the next feed. Next period EHC can alter the timing and type of bleeding of the next menstrual period, which may start early or late but usually within three days of the expected time. Follow up Suggest follow-up advice from a GP, practice nurse or family planning service approximately three weeks after taking EHC if the next period is light, more than 3 days late, or unusual in any way (to establish whether the client is pregnant). STIs EHC does not protect against sexually transmitted infections (STIs), only condoms do this. Consider providing information (eg leaflets) on sexual health and STIs Local networks Consider providing information on local services offering advance supplies, advice on contraception, sexual health, follow-up care, testing and screening for STIs. fpa leaflets on STIs are available in England from DH Publications or if ordering from elsewhere in the UK the leaflets are available from fpa direct 14