Early this year, in anticipation of the possible removal of emergency hormonal contraception (EHC) from prescription-only control, the Royal Pharmaceutical Society convened an advisory group to identify best practice for pharmacists in the supply of EHC as a pharmacy medicine. Its membership included experts in family planning and sexual health and representatives of the Department of Health, the Centre for Pharmacy Postgraduate Education and the Medicines Control Agency.
In October, the Council approved five professional standards for the sale of EHC as a pharmacy medicine (PJ, October 14, p546). These set the mandatory requirements to be adopted by all pharmacists. To help pharmacists meet these standards, the Society has produced guidance on best practice, based on the recommendations of the expert group. This guidance 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 standards. As with any pharmacy medicine, pharmacists need to be in a position to exercise their own judgment about how best to conduct individual consultations with those requesting this product.
An amendment to the Prescription Only Medicines (Human Use) Order is expected to come into effect on January 1, 2001, allowing the sale of levonorgestrel-containing EHC to women aged 16 and over. Supplies of the pharmacy pack are unlikely to be available until mid to late January at the earliest. Pharmacists will need to explain to potential clients why the pharmacy product is not yet available and refer them to local sources of the POM product in the meantime.
Leading Article, p871; News, p872; Council report, p882
1.1 This document provides guidance on best practice in relation to the supply of emergency hormonal contraception (EHC) as a pharmacy (P) medicine. It is based on the recommendations of an expert advisory group and is intended to support the professional standards, adopted by the Council in October, 2000 (reproduced in section 2). It complements the training and support being made available from national bodies such as the Centre for Pharmacy Postgraduate Education, the Welsh Centre for Postgraduate Pharmaceutical Education, the Scottish Centre for Post Qualification Pharmaceutical Education, the FPA (formerly the Family Planning Association) and manufacturers of pharmacy-only EHC products.
1.2 The availability of levonorgestrel as a P medicine means that there are now three possible routes by which clients can obtain emergency hormonal contraception:
•As a prescription-only product via primary care, family planning clinics, hospital genito-urinary medicine clinics or some accident and emergency centres
•As a prescription only medicine through patient group directions via NHS walk-in centres, family planning clinics and some community pharmacies
•As a pharmacy medicine
1.3 The efficacy of EHC has been found to decrease with time. It will only be effective if taken within 72 hours of intercourse (see also section 4.1.2). It is essential therefore that clients are able to obtain treatment as soon as possible. The pharmacy supply route will help to improve timely access to EHC and thus reduce unwanted pregnancies.
2.1 Pharmacists in personal control of a pharmacy must ensure that the following standards are observed in the supply of emergency hormonal contraception 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 health care 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.
3.1 Training on the supply of EHC as a P product should be extended to involve all staff. It is important for everyone in the pharmacy to be aware of the key issues regarding the supply of EHC to ensure that all staff respond sensitively and appropriately to inquiries about EHC. In particular staff should recognise that EHC requests should be referred to the pharmacist early on in the consultation.
4.1 Sufficient information should be obtained to assess whether it is appropriate for EHC to be supplied. Pharmacists should be aware of the client's competence to receive and understand information. Clients with special needs, eg, 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 the type of information that will be necessary when considering a supply.
4.1.1 Is the client presenting in person? Sales to third parties should normally only be carried out in exceptional circumstances (eg, 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. Supplies to third parties should not normally be made where the pharmacist suspects abuse or non-consensual sex.
4.1.2 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. (Current evidence indicates that levonorgestrel-based EHC will prevent 95 per cent of expected pregnancies if taken within 24 hours of unprotected sex, 85 per cent between 24-48 hours and 58 per cent if used within 48-72 hours.) An intrauterine device (copper coil) can be fitted up to 120 hours (five days) after unprotected sex. Clients who may need an IUD must be advised to contact a GP or family planning service as a matter of urgency.
4.1.3 Is the client already pregnant or likely to be pregnant? That is: Is the 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 client had unprotected sex at any time before this occasion?
If it is suspected that a 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, eg, 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 should be considered for referral.
4.1.4 Has EHC been used since the last period? If appropriate, clients may 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 strongly encouraged to seek advice about more reliable methods of contraception and should be provided with information on local contraceptive services.
4.2 Pharmacists should be aware of the following contraindications and drug interactions and refer to a GP or family planning service as appropriate.
4.2.1 The following drugs interact with levonorgestrel:
| Carbamazepine | Rifampicin |
| Phenytoin | Rifabutin |
| Primidone | Griseofulvin |
| Phenobarbitone | St John’s wort |
| Phenylbutazone | Cyclosporin |
| Ritonavir | |
4.2.2 The medicines listed above may increase the rate of metabolism of levonorgestrel, thus reducing drug levels and efficacy. This may also occur with certain herbal remedies, eg, St John's wort. Levonorgestrel may increase the risk of toxicity with cyclosporin due to possible inhibition of cyclosporin metabolism.
4.3 In the event of any 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.
4.3.1 Does the client have any condition that might affect absorption of EHC, eg, vomiting, severe diarrhoea or Crohn's disease? Doses of levonorgestrel will need to be altered if clients have conditions associated with malabsorption.
4.3.2 Has the client previously experienced severe allergic reactions to progestogen-containing contraceptives? Allergy to levo- norgestrel is rare but is a contraindication to taking progestogen-containing EHC.
4.3.4 Does the client have severe hepatic dysfunction? The use of progestogen-containing EHC is not recommended in such clients.
4.4 Pharmacists may consider, having obtained and assessed the relevant information, that EHC is not needed. However, if the client perceives herself to be at risk of pregnancy and despite the pharmacist's professional advice still wishes to take EHC then, in the absence of any obvious contraindication, pharmacists should consider supplying. EHC poses very little safety risk to clients, even if taken when not necessary, provided the relevant information is first obtained as above and the appropriate advice given. (This does not apply to requests for supplies in advance of need, see section 12.)
* 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.
5.1 Pharmacists may wish to consider using a printed card as an assessment tool for use in EHC consultations (see appendices 1 and 2).
6.1 One tablet is taken as soon as possible (and not later than 72 hours) after unprotected sex or contraceptive failure, followed by the second tablet 12 hours later.
6.2 As outlined in 4.1.2, EHC has higher efficacy the sooner it is taken after unprotected sex. However, it is also important to ensure an interval of 12 hours (and no longer than 16 hours) between tablets. Pharmacists should advise on the timing of the first dose that will enable the client to take the second dose in 12 hours time. This must allow the first tablet to be taken within the 72-hour period.
•Vomiting is possible but unlikely with progestogen-only EHC. If the client vomits within three hours after taking the first tablet she should take the second tablet in the pack straight away. She then needs to obtain another pack of EHC and take one tablet 12 hours later
•Emergency contraceptive pills do not provide protection against pregnancy for the rest of the menstrual cycle. Other contraceptive measures such as careful use of a barrier method are needed
•Emergency contraceptive pills will not bring on a period straight away but can alter the timing of the next menstrual period, which may start early or late but usually within three days of the expected time
•Repeated use of emergency contraceptive pills is likely to cause disruption to the menstrual cycle and is less effective than other forms of oral contraception
8.1 Clients seeking EHC because they have missed one or more of their oral contraceptive tablets should be advised to continue taking their normal oral contraceptive for the remainder of the cycle. They should also be advised to use barrier methods of contraception until the next period.
8.2 Clients who are breastfeeding should be advised that very small amounts of levonorgestrel may appear in breast milk. This is not thought to be harmful to the baby but if clients are concerned the tablets should be taken immediately after a breast feed. In this way tablets are taken well before the next breast feed thus reducing the amount of active ingredient the baby may take in with the breast milk.
8.3 Where appropriate, clients 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. 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.
9.1 Clients should be advised that EHC is not 100 per cent effective. They should be strongly encouraged to seek follow-up advice from a GP or family planning service approximately three weeks after taking EHC in any of the following circumstances:
•If the next period is light, more than three days late, or unusual in any way (to establish whether the client is pregnant)
•If it is considered that a client 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
9.2 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, eg, health authority or health board.
10.1 A pharmacist's duty of confidentiality is outlined in Part 2 of the Code of Ethics. Clients of all ages, including those who are aged under 16, are entitled to a confidential consultation with their pharmacist, although not all potential clients will be aware of this. Pharmacists may therefore consider advertising that all advisory services and consultations are confidential.
10.2 Pharmacists are encouraged to display a notice in the pharmacy encouraging clients 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.
11.1 EHC is licensed as a P medicine for women aged 16 and over. As is already the case with other non-prescription medicines pharmacists should use their professional judgment to decide whether they believe the supply is both necessary and in the client's best interest.
11.2 Pharmacists should make every reasonable effort to satisfy themselves that clients are aged 16 or over. Pharmacists should ensure that where they believe a client to be under 16 the request is dealt with sympathetically and the client is offered appropriate help and support to enable her to obtain EHC by another route, ie, authorised supply of a POM product.
12.1 Supply of EHC via the pharmacy in advance of 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.
13.1 As far as record keeping is concerned, EHC products should not be treated differently from any other P products. Some clients seeking EHC will wish to remain anonymous and in such cases attempting to record client details could be counter-productive.
14.1 Pharmacists may wish to display a nationally approved sign indicating that EHC is available.
15.1 It is important that all health care professionals involved in sexual health advice provide consistent information to clients. 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 agencies to produce leaflets containing lists of local services and contact points.
15.2 The availability of national resources (eg, the FPA and manufacturer helplines or websites) as well as local resources, including NHS Direct (where available), should be explored. The quality of support available to pharmacists will be determined by the links made with these services.
16.1 Pharmacists who choose not to supply EHC on the grounds of moral or religious beliefs should treat the matter sensitively and advise on an appropriate local source of supply available within the time period for EHC to be effective (ie, within 72 hours of unprotected sex).
17.1 Pharmacists may be concerned about their professional liability if, despite their supply of EHC in good faith after satisfying themselves that the above criteria are met, the client is already pregnant. If a client 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.
Certain information will need to be obtained by the pharmacist in order to be sure that emergency hormonal contraception is safe to take.
Clients aged under 16 should normally seek emergency hormonal contraception from a GP or family planning service.
The pharmacist needs to know if the answer to either of the following two questions is "no".
1. Is the consultation with the client herself?
2. Has there been unprotected sex/intercourse within the last 72 hours (three days)?
The pharmacist needs to know if the answer to any of questions 3 to 8 is "yes".
3. Is it possible that pregnancy has already occurred, ie:
3a. Is the period late? If so, how late?
3b. Was the last period lighter or shorter than usual?
3c. Was the last period unusual in any other way or different from normal?
3d. Since the last period, has there been unprotected sex at any time before this occasion?
4. Has emergency contraception 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: eg, vomiting/being sick, severe diarrhoea or a condition that can cause diarrhoea, eg, Crohn's disease?
7. Are there severe liver problems?
8. Has there previously been an allergy or other reaction to the main ingredient in this medicine (levonorgestrel)?
This aide-mémoire is intended to help pharmacists to elicit the necessary information to
determine whether the pharmacy supply of emergency hormonal contraception 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 (ie, 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 (copper coil) can be fitted up to 120 hours (5 days) after unprotected sex. Clients who may need an IUD must be advised to contact a GP or family planning service as a matter of urgency.
3. Pregnancy: (3a) Is the period late? If so, how late? (3b) Was the last period lighter or shorter than normal? (3c) Was the last period unusual in any other way? (3d) Since the last period, has there been unprotected sex at any time before this occasion? These questions are to determine how likely it is that a client might already be pregnant. Pregnancy is a contraindication to taking EHC and clients should be referred. In addition, pharmacists should be aware there are some conditions, eg, 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 emergency contraception 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, including over-the-counter or herbal remedies, being taken? Some medicines and herbal remedies interfere with the dose of levonorgestrel required and clients will need to be referred, eg:
Carbamazepine
Ritonavir
Phenytoin
Rifampicin
Primidone
Rifabutin
Phenobarbitone
Griseofulvin
Phenylbutazone
St John's wort
Clients taking cyclosporin will also need to be referred, since levonorgestrel may increase the risk of toxicity with cyclosporin (see guidance, section 4.2).
6. Are there any problems that may affect the absorption of EHC, eg, 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? Levonorgestrel-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 the ingredient in this medicine (levonorgestrel)? Allergy to levonorgestrel is rare but is a contraindication to taking progestogen-containing EHC.