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This document is designed to provide guidance to pharmacists on a range of issues including appropriate and effective processes, desired behaviour of good practice, how professional responsibilities may be best fulfilled, and expected outcomes. At all times, pharmacists must meet any legislative requirements and are expected to exercise professional judgment in adapting the guidance provided here to presenting circumstances.
Guidance for provision of a Pharmacist Only medicine Approved indication: emergency contraception A Professional standardsB PrivacyC Duty of CareD DocumentationE Where timely referral is possible, refer if:
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Where timely referral possible, refer if: Supply and referral may be considered when: M Adverse effectsN Possibility of sexual assaultO Ongoing contraceptive adviceP A. Professional standards
standards and obligations, supply is not consistent As such, EC may be accessed by all women of with regulations or approved product information, child-bearing potential after unprotected intercourse, The Professional Practice Standards (PPS)1 outline the and requires the pharmacist to document and retain irrespective of the time within the menstral cycle at appropriate actions to be taken by pharmacists and trained pharmacy staff in response to a direct product- informed consent. Using a checklist can assist the consultation process. PSA’s informed consent form and checklist can be downloaded from www.psa.org.au G. Time since intercourse
B. Privacy
Pharmacists should advise patients there is clear E. Supply to a third party
Pharmacists must meet their obligations in relation evidence that EC is not 100% effective. The time to respecting the patient’s privacy and confidentiality When EC is requested through a third party, elapsed since intercourse is a critical factor and relates in the provision of Pharmacist Only medicines and pharmacists should use their professional judgment to percentage of expected pregnancies prevented as:5 and consider whether the required information is available to ensure supply is appropriate. Pharmacists C. Duty of care
are encouraged to provide the service according to the In the event that an out of stock situation or moral PPS (See Standard 6: Indirect pharmacy services).1 belief of a pharmacist leads to the nonsupply of Efficacy continues to decline with time after 72 hours. a product or service, the pharmacist must accept F. Stage of menstrual cycle
Overall, the frequency of unintended pregnancy with responsibility for ensuring continuity of care – that During a natural menstrual cycle, the risk of pregnancy EC taken within 72 hours of unprotected sex is 1.5%. is, timely access to the required medicine or service. from unprotected intercourse is greatest during the This can be compared with the frequency of pregnancy This may involve the use of initiative to identify another ovulatory phase of the cycle. However, predicting after unprotected sex without EC, which varies during reasonably available source for the required medicine when a woman is ovulating and her risk of pregnancy the menstrual cycle from 2–4% to 20–30%.6 or service, particularly in rural or remote areas or in is complicated by irregular cycles; variations in cycle Product Information for Australian registered products other situations where access to alternate service length; the woman’s ability to recall the date of her last indicates the product is for use within 72 hours menstrual period and the exact timing of intercourse. of unprotected sex. However, there is evidence D. Documentation
For women who are using oral contraceptives, the risk that there is some efficacy up to 96 hours after Pharmacists are encouraged to document the service of pregnancy is related more to which pill(s) have intercourse, with efficacy declining significantly after provided according to the PPS (See Standard 1: been compromised rather than the stage of the cycle. 96 hours.7 If levonorgestrel is supplied for use in a Fundamental pharmacy practice).1 This is of particular (See the Australian Pharmaceutical Formulary and woman >72 hours after intercourse, the pharmacist importance where, in order to meet professional Handbook4 for further guidance on missed pills).
should firstly discuss the evidence for off-label use and any potential risks (e.g. reduced effectiveness) reduction in efficacy of EC due to reduced absorption. general ectopic pregnancy rates.17 Regardless, patients to allow the woman to make an informed decision. As evidence is lacking for the effectiveness of using experiencing lower abdominal pain should be referred.
The pharmacist should then document and retain EC in individuals with malabsorption disorders, it may There are no known reports of adverse effects on fetal informed consent and recommend that the woman be advisable to refer the patient to a sexual health seek medical review as soon as possible.
or family planning clinic or to a medical practitioner. H. Advance provision
In such cases it is part of a pharmacist’s duty of N. Possibility of sexual assault
care to assist with arranging an urgent appointment EC may be requested for a future incident of Where sexual assault is suspected, the pharmacist unprotected intercourse (advance provision), should offer support and assistance with reporting e.g. where timely access might not be possible. Breastfeeding: The use of levonorgestrel for EC
the incident to the police and facilitating a referral to a Advance provision has not been shown to impact is safe for breastfeeding mothers.6,14 It does not sexual assault referral centre or medical practitioner for negatively on sexual and reproductive health interfere with lactation, and the small amounts more comprehensive help and advice. One suggested behaviours and outcomes.8 Pharmacists should be excreted in breastmilk have no known effect on a approach if an assault is suspected is for the pharmacist aware there may be a greater need to provide written breastfed infant’s growth or development.14 to ask if the sexual intercourse was consensual.
information regarding appropriate use, proper storage K. Drug interactions
Requirements for mandatory reporting of suspected and awareness of the expiry date on the pack.
Liver enzyme inducing drugs: Medicines such as
cases of child abuse vary across Australia and rifabutin, rifampicin, phenytoin, phenobarbitone, pharmacists must therefore consider applicable state- Information regarding age should only be sought to carbamazepine, and St John’s wort can increase the fulfil the pharmacist’s own professional obligations to metabolism (and therefore reduce the efficacy) of O. Ongoing contraceptive advice
levonorgestrel. A copper IUD may be used as an alternative method of emergency contraception. There is no limit to the repeated use of EC, even within Supply to females under 16 years of age requires However if levonorgestrel for EC is requested by consideration of state-based legislation.
an individual taking liver enzyme inducing drugs, However, overall, the use of levonorgestrel for EC is less While there is limited data available regarding the use clinical guidelines9 recommend increasing the effective at preventing pregnancy than other methods of levonorgestrel for EC in females of child-bearing levonorgestrel dose (to 2.25 mg if taking 750 mcg of contraception used regularly. As such, repeated potential aged 14–16 years, there is no medical reason tablets, or to 3 mg if taking 1.5 mg tablets). use is not recommended as a ‘routine’ method of for the use of levonorgestrel EC to be restricted on the As evidence is lacking for this approach, it may be preferable to refer the patient to a family planning Further, a course of EC does not provide ongoing It may be advisable to refer someone who is under clinic or medical practitioner. In such cases it is protection against pregnancy. Abstinence or using a 16 years of age to a children’s hospital, sexual health part of a pharmacist’s duty of care to assist with contraceptive method (e.g. barrier method, continuation or family planning clinic or medical practitioner of her arranging an urgent appointment for the patient.
of the oral contraceptive pill within 12 hours of taking choice. In such cases it is part of a pharmacist’s duty Warfarin: There has been a case report of the use of
of care to assist with arranging an urgent appointment EC) must be employed until the next menstrual period levonorgestrel for EC being associated with a marked starts and regular contraception can be instituted. increase in INR within three days of administration.15 Where timely referral is not possible, the pharmacist Close monitoring of INR is recommended and Depending on the method of hormonal contraception adjustment to the dose of warfarin may be required.
used, a pregnancy test three weeks following the dose of emergency contraception may be appropriate to t
The patient is mature enough to understand the L. Dosage
EC can be taken at any time during the menstrual t
The patient is likely to begin or continue to have sex cycle. There are two approved regimens for EC: Where appropriate, the pharmacist should offer the patient general information about the appropriate t
One tablet containing 1.5 mg of levonorgestrel t
The pharmacist has tried to persuade the patient use of contraception or facilitate referral to a (or two tablets each containing 750 mcg of to inform her parents or to allow the pharmacist to medical practitioner or to a sexual health or family levonorgestrel taken as a single dose) to be taken orally as soon as possible and within 72 hours of t
The patient’s health would suffer without treatment P. Risk of sexually transmissible infection
t
One tablet containing 750 mcg of levonorgestrel The use of levonorgestrel for EC does not protect t
The patient’s best interests require the pharmacist to be taken orally as soon as possible and within against sexually transmissible infections (STIs). 72 hours of unprotected intercourse, followed Undiagnosed or untreated STIs can lead to serious J. Contraindications and precautions
a second 750 mcg tablet 12 hours after the complications (including infertility) and/or the need for more intensive treatment after diagnosis.20 Product Information for the Australian registered products list unexplained vaginal bleeding, current There is no clinically significant difference in efficacy Most STIs are asymptomatic in the earlier stages breast cancer and pregnancy/suspected pregnancy as between the two approved regimens.16 If the two and individuals may not be aware that they have an contraindications for the use of levonorgestrel for EC.11 dose regimen is supplied, the doses should be timed STI. For this reason, everyone who requests the EC for optimum convenience to the patient in order to (who has had unprotected sex without a condom) Levonorgestrel for EC does not interrupt an established minimise the risk of missing the second dose.
should be encouraged to have a sexual health check pregnancy or harm a developing embryo.12 As such, within 2–3 weeks after unprotected intercourse. PSA’s this contraindication reflects a lack of benefit rather M. Adverse effects
checklist includes possible symptoms associated with The most commonly reported side effects are some STIs, and can be used to indicate when referral The pharmacist should assess the likelihood of the nausea (23%) and vomiting (5–6%).5 Less common patient already being pregnant (e.g. menstruation side effects include breast tenderness, vaginal is late or was lighter than normal). If in doubt, a Q. Follow up advice/referral
pregnancy test can be undertaken prior to the No clinically significant differences in side effects The patient’s menstrual period should occur around provision of EC, or the patient can be referred to a between the two dosing regimens have been the (previously) anticipated date but can be up to medical practitioner or to a sexual health or family observed, except for more cases of headache with one week earlier or later. If menstruation does not the single-dose regimen.16 If the patient vomits occur within one week after the expected date or if Where contraindications exist and timely referral is not within two hours of taking a tablet, EC is unlikely to the period is lighter than normal or intermittent, the possible, the pharmacist may consider that the World be effective. In this case the ‘lost’ dose needs to be patient should conduct a pregnancy test and/or consult Health Organization does not identify any conditions a sexual health or family planning clinic, or a medical for which the risks outweigh the benefits of EC use.13 Recent evidence indicates that the rate of ectopic Malabsorption disorders, e.g. Crohn’s disease,
pregnancy in pregnancies that do occur after using Provision of a CMI leaflet and other printed information or acute diarrhoea or vomiting: There may be a
levonorgestrel for EC, is lower or comparable to Frequently asked questions
Contacts
clinics which would be more convenient for the patient Additional information on the guidance provided in this The contact details for Sexual Health and Family supply protocol, and use of PSA’s checklist, is available Planning member organisations can be found online at The telephone numbers for sexual assault centres are www.shfpa.org.au, or www.psa.org.au. Pharmacists may also find local sexual health or family planning Pharmaceutical Society of Australia Ltd, July 2011. This document may only be reproduced with permission of the Society. 1. Pharmaceutical Society of Australia. Professional Practice Standards v4. 9. Faculty of Family Planning and Reproductive Health Care Clinical 15. Ellison J, Thomson A, Greer I. Apparent interaction between Effectiveness Unit. FFPRHC Guidance: Emergency contraception. warfarin and levonorgestrel used for emergency contraception. 2. Pharmaceutical Society of Australia. Professional Practice and the Journal of Family Planning and Reproductive Health Care 2006;32(2):121–8. Accessed at www.ffprhc.org.uk/admin/ 16. Cheng L, Gülmezoglu A, Piaggio G, et al. Interventions for emergency 3. Position statement: Ethical issues in declining supply. Canberra: uploads/449_EmergencyCONTRACEPTIONCEUguidance.pdf contraception. Cochrane Database of Systematic Reviews 2008, Issue Pharmaceutical Society of Australia, 2003 Oct.
2. Art. No.: CD001324. DOI: 10.1002/14651858.CD001324.pub3.
4. Sansom L (ed). Australian Pharmaceutical Formulary and Handbook, 10. Brahams D. House of Lords rules DHSS guidance on contraception 17. Cleland K, et al. EC and ectopic pregnancy: what’s really the risk? International Consortium for Emergency Contraception 5. Task force on postovulatory methods of fertility regulation. Randomised 11. eMIMS. Sydney: UBM Medica Australia, 2010 Nov.
Conference. New York; 2009 Sept. In: Fact sheet on the controlled trial of levonorgestrel versus the Yuzpe regimen of combined 12. Fact sheet on the safety of levonorgestrel-alone emergency safety of levonorgestrel-alone emergency contraceptive pills. oral contraceptives for emergency contraception. Lancet 1998; contraceptive pills. Geneva: World Health Organization, 2010. Accessed Geneva: World Health Organization, 2010.
at http://whqlibdoc.who.int/hq/2010/WHO_RHR_HRP_10.06_eng.pdf 18. Higgins D, et al. Resource sheet: Mandatory reporting of child abuse. 6. Rossi S (ed). Australian Medicines Handbook. Adelaide: AMH Pty Ltd, Australian Institute of Family Studies, 2010 Aug. Accessed at 13. Medical eligibility criteria for contraceptive use – 4th edn, 2009. www.aifs.gov.au/nch/pubs/sheets/rs3/rs3.html on 5/2/11.
7. Piaggio G, Kapp N, von Hertzen H. Effect on pregnancy rates of Geneva: World Health Organization, 2010. Accessed at 19. Contraception: an Australian clinical practice handbook, 2nd edition. the delay in the administration of levonorgestrel for emergency http://whqlibdoc.who.int/publications/2010/9789241563888_eng.pdf Sydney: Sexual Health and Family Planning Australia, 2008.
contraception : a combined analysis of four WHO trials. Contraception 20. Second National Sexually Transmissible Infections Strategy 14. Pharmacy Department, Royal Women’s Hospital. Pregnancy and 2010–2013. Canberra: Commonwealth of Australia, 2010. Accessed at 8. Polis C, Grimes D, Schaffer K, et al. Advance provision of emergency breastfeeding medicines guide. Melbourne: The Royal Women’s www.health.gov.au/internet/main/publishing.nsf/Content/ohp-national- contraception for pregnancy prevention. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD005497. DOI: 10.1002/14651858.CD005497.pub2.
Pharmaceutical Society of Australia Ltd, July 2011. This document may only be reproduced with permission of the Society.

Source: http://www.shfpa.org.au/sites/shfpa.drupalgardens.com/files/201306/PSA%20Guidelines%20on%20EC.pdf