East Region Formulary

Prescribing Notes:

Most contraceptive failures are due to poor adherence which is strongly influenced by acceptability. It is important therefore to accept that women may prefer one particular method of contraception and even one particular brand to another despite similar or identical composition.
Discontinuation rates of all methods of contraception are high and many women change to a less effective method. Good counselling about risks, side effects and benefits should improve continuation. Long-acting reversible contraception methods (LARC) particularly implants and intra-uterine methods, have higher continuation rates and are independent of adherence for their effectiveness.
NICE CG30 (2019) advises that all currently available LARC methods are more cost effective than the combined oral contraceptive pill, even at 1 year of use, that intrauterine devices, intrauterine systems and implants are more cost effective than the injectable contraceptives, and that increasing the uptake of LARC methods will reduce the numbers of unintended pregnancies.
LARC methods should be actively encouraged and always discussed in any contraceptive consultation.
When hormonal contraception is used for management of gynaecological conditions, such as heavy menstrual bleeding or pain, the risk/benefit balance changes and it may be prescribed for women who would have relative contra-indications if they were using it solely for contraception.
Drug interactions must be considered when prescribing hormonal contraception. Enzyme inducing drugs, (such as antiepileptic preparations and rifampicin and rifabutin), may impair the efficacy of hormonal contraception. For further information on drug interactions see BNF and Faculty of Sexual and Reproductive Healthcare (FSRH) guidance.
The FSRH advises that it is essential that women of reproductive age who are taking known teratogenic drugs (e.g. methotrexate, some antiepileptic drugs and retinoids) or drugs with potential teratogenic effects should always be advised to use highly effective contraception (such as copper intrauterine devices (IUD), levonorgestrel intrauterine system and progesterone-only implant) both during treatment and for the recommended timeframe after discontinuation. A pregnancy prevention plan should be in place to ensure there is no risk of conception.
The FSRH recommends that long-acting reversible contraception should be used for a woman of child-bearing age requiring treatment with valproate.
Valproate should not be used in any woman or girl able to have children unless she has a pregnancy prevention programme in place. This includes the completion of a signed risk acknowledgment form with specialist review, at least annually.
Refer to MHRA guidance on valproate use by women and girls and “Valproate medicines: Pregnancy prevention Programme” materials online.
There is an association between all COC and metabolic changes, including changes in lipids.
Different progestogens have different side-effect profiles associated with their androgenicity.

History Notes

18/05/2022

East Region Formulary content agreed.

High efficacy: less than 0.05 unintended pregnancies per 100 users per year.

Consult product literature for insertion and removal instructions.

Prescribing Notes:

Nexplanon insertion and removal requires specialist training.
Nexplanon is a low dose long-acting progestogen which suppresses ovulation in all women. Its contraceptive effect lasts for 3 years.
Approximately 20% of women will experience amenorrhoea; the rest may have unpredictable but light bleeding. Occasionally women may experience prolonged bleeding. This point should be carefully covered during counselling. Combined oral contraception can be given to regulate bleeding. FSRH Clinical Guideline: Problematic Bleeding with Hormonal Contraception has further advice for clinicians when a combined oral contraceptive may be contraindicated.
Nexplanon is more cost effective than either the combined pill or condoms even if used for only one year.
Nexplanon is affected by concomitant use of enzyme-inducing drugs. An alternative contraceptive method should be sought.
Return of fertility may be delayed after stopping treatment with Depo-Provera but not after using Nexplanon.

History Notes

18/05/2022

East Region Formulary content agreed.

High efficacy: 0.2 unintended pregnancies per 100 users in 1 year.

See BNF for dose and duration.

See BNF for dose and duration and product literature for instructions.

See BNF for dose and duration.

Prescribing Notes:

In the 3-6 months following IUD insertion, women may experience irregular, prolonged or frequent bleeding but menstrual bleeding patterns tend to improve with time. At one year infrequent bleeding is usual with levonorgestrel intrauterine device and some women will experience amenorrhoea. Patients should be counselled accordingly.
Systemic absorption may cause side effects e.g. acne or greasy skin. The incidence of this is low.
Refer to the BNF and the Faculty of Sexual and Reproductive Healthcare (FSRH) resources for additional prescribing guidance.
It is recommended to prescribe IUDs by brand name in order to avoid any confusion in preparation selection.
Women wishing to use intrauterine contraception should undergo risk assessment for sexual transmitted infections (STIs) and if appropriate should be offered testing for STIs.

History Notes

19/12/2024

Updated prescribing information, ERFC Dec 2024.

20/11/2023

Addition of Benilexa (ERFC March 2023).

18/05/2022

East Region Formulary content agreed.

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High Efficacy: 0.8 unintended pregnancies per 100 users per year.

Minimum uterine length 5cm. Replacement every 5 years.

Minimum uterine length 6.5cm. Replacement every 5 years.

Minimum uterine length 5cm. Replacement every 5 years.

Minimum uterine length 6.5cm. Replacement every 10 years.

Prescribing Notes:

IUD insertions should be performed by trained healthcare staff who have been regularly updated and perform frequent insertions (recommendation is 12 or more per year).
Copper IUDs provide long acting highly effective contraception for at least 5 years and do not rely on adherence for their efficacy. Devices which contain less than 300mm of copper should no longer be used as they are less effective.
TT380 Slimline is marginally more effective than UT380 and should be the IUD of choice. TT380 Slimline is a wider device and technically it may only be possible to fit a UT380 in some women. The UT380 Short should only be used if the cavity is <6.5cm.
The most effective copper IUDs have at least 380mm² of copper and are banded, i.e. have copper on the arms as well as the stem. However, unbanded devices with copper on the stem only are slightly easier to fit and may need to be considered if the cervix is very narrow.
Pain on insertion of device may be alleviated by a NSAID e.g. Ibuprofen, 30 minutes before insertion.
Fertility declines with age and therefore a copper IUD which is fitted in women over the age of 40 may usually be retained until the menopause. Refer to latest FSRH guidance.

History Notes

18/05/2022

East Region Formulary content agreed.

Medium efficacy: 6 unintended pregnancies per 100 users per year.

By deep intramuscular injection, 150mg within first 5 days of cycle or within first 5 days after parturition; for long-term contraception, repeated every 13 weeks (+/- 1 week); if interval greater than 14 weeks exclude pregnancy before next injection and advise patient to use additional contraceptive measures (e.g. barrier) for 7 days after the injection.

By subcutaneous injection, 104mg within first 5 days of cycle or within first 5 days after parturition; for long term contraception repeat every 13 weeks (+/- 1 week) if interval greater than 14 weeks exclude pregnancy before next injection and advise patient to use additional contraceptive measures (e.g. barrier) for 7 days after the injection.

Prescribing Notes:

Medroxyprogesterone acetate is available as two formulations to be given via different routes, Depo-Provera via intramuscular injection and Sayana Press via subcutaneous injection. Choice of preparation will depend on individual patient factors and service provision.
Depo-Provera has been approved locally for off-label use as contraception in the immediate post-natal period.
FSRH guidance recommends that women should be advised to return every 13 weeks for a repeat injection of intramuscular or subcutaneous medroxyprogesterone acetate. This is outside the product licence for intramuscular medroxyprogesterone acetate (Depo-Provera).
FSRH guidance recommends that an injection of depot medroxyprogesterone acetate can be administered up to 7 days late (up to 14 weeks after the last injection) without the need for additional contraceptive precautions. This is outside the product license for intramuscular medroxyprogesterone acetate (Depo-Provera).
Medroxyprogesterone acetate can cause menstrual dysfunction and weight gain. By the end of the first year of use, 80% of women will have become amenorrhoeic or have scanty infrequent periods.
When medroxyprogesterone acetate is stopped ovarian activity can take up to a year to recover.
Medroxyprogesterone acetate is associated with hypoestrogenism and amenorrhoea. Bone mineral density decreases slightly during the first two years of method use and these effects are reversible on discontinuation. There is no evidence for an increased risk of osteoporosis or fracture either during use or in later life.
Medroxyprogesterone acetate is only indicated in adolescents (12-18 years), when other contraceptive methods are considered unsuitable or unacceptable, due to unknown long-term effects of bone loss associated with medroxyprogesterone acetate injection during the critical period of bone accretion. Young women often find adherence with condoms or oral contraceptives difficult.
Medroxyprogesterone acetate injection use should be reviewed after 2 years in women of all ages.
The effectiveness of medroxyprogesterone acetate is unaffected by enzyme-inducing drugs and the inter-injection interval need not be altered.
Sayana Press can be useful in obese woman due to administration subcutaneously rather than intramuscularly.

History Notes

18/05/2022

East Region Formulary content agreed.

Medium efficacy: 9 unintended pregnancies per 100 users per year. 1st Generation combined hormonal contraception.

1 tablet once daily for 21 days; subsequent courses repeated after hormone-free interval, withdrawal bleeding occurs during the hormone-free interval. A missed pill is one that is 24 or more hours late.

2nd Generation combined hormonal contraception.

1 tablet once daily for 21 days; subsequent courses repeated after hormone-free interval, withdrawal bleeding occurs during the hormone-free interval. A missed pill is one that is 24 or more hours late.

3rd Generation combined hormonal contraception.

1 tablet once daily for 21 days; subsequent courses repeated after hormone-free interval, withdrawal bleeding occurs during the hormone-free interval. A missed pill is one that is 24 or more hours late.

Prescribing Notes:

Logynon and TriRegol are triphasic combined oral contraceptive pills. Triregol tablets are approved for restricted use only, in patients when 1st, 2nd or 3rd choice pills have been not tolerated or are unsuitable.
Different doses of oestrogen may be associated with different side effect profiles in individual women. For most, a pill containing 30micrograms oestrogen is recommended.
All women can consider extended pill taking regimes (off-label), for example tricycling- 63 active pills in a row followed by a 4 to 7-day pill free interval. This may reduce the incidence of unwanted side effects related to fluctuations in hormone levels. Faculty of Sexual and Reproductive Healthcare provides guidance to clinicians advising on continuous pill regimens.
The risk of cardiovascular disease (including venous thromboembolism) is higher with pills containing 50micrograms oestrogen, but there is no evidence for a difference in cardiovascular risk between 20 and 30micrograms.
The MHRA has stated that while evidence suggests that combined oral contraceptives have a higher risk of venous thromboembolism, the absolute risk of venous thromboembolism is small. The relative risk of venous thromboembolism in healthy non-pregnant women taking combined oral contraceptives of second generation progestogens is about 3 times that of non-users of combined oral contraceptives (COC) or 5 times for combined oral contraceptives of third generation progestogens. Any increase in risk is greatest in the first year of use. However, the absolute risk is considerably smaller than that associated with pregnancy. Provided that this is made clear to the user, there is no restriction on prescription of these pills.
Women with acne often benefit from the oestrogen component of combined hormonal contraception. If acne is a particular problem, choose a pill containing a less androgenic progestogen e.g. desogestrel, (Cimizt 30/150 or Marvelon 30/150) or consider co-cyprindol 2000/35.
Co-cyprindol 2000/35 (composed of cyproterone acetate 2mg, ethinylestradiol 35micrograms) is a treatment for severe acne that has not responded to oral antibiotics or for moderately severe hirsutism and only in those patients may it also be used as an oral contraceptive - see acne pathways in the Skin chapter of the formulary. Most acne improves with any combined oral contraceptive; co-cyprindiol is more expensive and recent evidence suggests an increased risk of venous thromboembolism. Some women with acne or hirsutism requiring contraception may benefit. This is a good example of the need to consider a risk-benefit in women with relative contraindications.
In accordance with MHRA guidance, co-cyprindiol 2000/35 should be withdrawn 3-4 cycles after the treated condition has completely resolved. For acne, substitution with another combined oral contraceptive is likely to maintain the improvement but hirsutism is likely to recur. A combined oral contraceptive containing a less androgenic progestogen e.g. desogestrel, Cimizt 30/150 or Marvelon 30/150 could be substituted if effective.
In women with severe hyperandrogenism, symptoms usually recur when treatment with co-cyprindiol is stopped. In these women treatment may be continued until the symptoms are judged unlikely to recur. The decision of when to stop should be judged on a case-by-case basis.
Yasmin (ethinylestradiol 30micrograms, drospirenone 3mg) and Qlaira are not approved for use in NHS Scotland by the SMC.
Bimizza 20/150 and Mercilon 20/150 (ethinylestradiol 20micrograms, desogestrel 150micrograms) contain a lower dose of oestrogen and may be associated with a better side effect profile in women complaining of oestrogenic symptoms such as nausea or breast enlargement/mastalgia.
Women who do not wish to change from a combined method while on short term treatment with an enzyme inducing drug (and for 28 days after stopping treatment) may opt to continue using a combined oral contraceptive containing at least 30micrograms ethinylestradiol, the patch or ring along with additional contraception. An extended or tricycling regimen should be used and the hormone-free interval shortened to 4 days. Additional contraception should be continued for 28 days after stopping the enzyme inducing drug.
With the exception of the very potent enzyme inducers, rifampicin and rifabutin, women who are taking an enzyme-inducing drug and who do not wish to change from a combined oral contraceptive or use additional precautions may increase the dose of combined oral contraceptive to at least 50micrograms ethinylestradiol (maximum 70micrograms ethinylestradiol) and use an extended or tricycling regimen with a pill-free interval of 4 days.
Women taking lamotrigine (except in combination with sodium valproate) should be advised that due to the risk of reduced seizure control whilst on combined hormonal contraception (CHC) and the potential for toxicity in the CHC-free week, the risks of using CHC may outweigh the benefits.
Women aged up to 50 years can be advised that no contraceptive method is contraindicated by age alone and that CHC can be used unless there are co-existing diseases or risk factors.
Women prescribed combined oral contraceptives should be reviewed annually. This is an opportunity to assess any changes to medical, family and sexual health history together with checking blood pressure and weight.
It is advised that multi-ingredient products for example combined oral contraceptives are prescribed by brand name. As there is no established way of describing them generically and there can be variation in the description of content on packaging or within prescribing literature of these preparations, there is risk in prescribing these generically.

History Notes

18/05/2022

East Region Formulary content agreed.

Medium efficacy: 9 unintended pregnancies per 100 users per year.

Apply 1 patch once weekly for 3 weeks, apply first patch on day 1 of cycle, change patch on days 8 and 15; remove third patch on day 22 and apply new patch after a patch-free interval to start subsequent contraceptive cycle, subsequent courses repeated after a patch-free interval (during which withdrawal bleeding occurs).

Prescribing Notes:

The SMC has advised that Evra patches should be restricted for use in women who may have difficulties adhering to combined oral contraceptives.
Side effects, risks and benefits are likely to be the same as those for the combined oral contraceptive pill. Evidence suggests that the transdermal route for combined hormonal contraception may have an increased risk of VTE compared to standard combined oral contraceptives. This is in contrast to HRT preparations where the risk if VTE is thought to be lower than with the transdermal route.

History Notes

18/05/2022

East Region Formulary content agreed.

Medium efficacy: 9 unintended pregnancies per 100 users per year.

1 unit, insert the ring into the vagina on day 1 of cycle and leave in for 3 weeks; remove ring on day 22; subsequent courses repeated after 7-day ring free interval (during which withdrawal bleeding occurs).

Prescribing Notes:

NuvaRing may be considered as a combined hormonal contraceptive in specific circumstances. It produces good cycle control and user acceptability. Some users have reported less nausea, acne, irritability and depression than pill users, but studies suggest they experience more vaginal irritation and discharge.
Side effects, risks and benefits are likely to be the same as those for the combined oral contraceptive pill. Evidence suggests that the contraceptive vaginal ring is as effective as combined oral contraceptives.

History Notes

18/05/2022

East Region Formulary content agreed.

Medium efficacy: 9 unintended pregnancies per 100 users per year.

75micrograms daily, dose to be taken at same time each day, starting on day 1 of cycle then continuously, if administration delayed for 12 hours or more it should be regarded as a ‘missed pill'.

350micrograms daily, dose to be taken at same time each day, starting on day 1 of cycle then continuously, if administration delayed for 3 hours or more it should be regarded as a ‘missed pill'.

Prescribing Notes:

Progesterone-only pills (POPs) are associated with irregular bleeding in up to 40% of users. Bleeding patterns do not tend to improve with time and are not likely to be any different with a different progestogen.
In line with East Region Formulary Policy on branded generic prescribing, POP should be prescribed by their generic drug name, not the brand name.
The traditional POP is suitable for all women over the age of 40 years.
Desogestrel may have better efficacy in women who have difficulty with consistent and correct use of POPs as they are still protected up to 12 hours after missing a pill, compared to only 3 hours with other POPs.
It is no longer recommended that women who weigh over 70kg are prescribed two POPs a day. The efficacy of the POP will be affected by enzyme inducing medicines and an alternative contraceptive method should be sought.
Progestogen only contraceptives may be more suitable than combined oral contraceptives for a variety of patients; clinicians are directed to advice from Faculty of Sexual and Reproductive Healthcare.
Some brands of desogestrel tablets contain soya oil and may not be suitable for patients with nut or soya allergies; please see product literature for further information.

History Notes

18/05/2022

East Region Formulary content agreed.

Low efficacy: 12 unintended pregnancies per 100 users per year. A spermicide should always be used with a diaphragm. No medicinal forms of nonoxinol spermicide are available, seek advice on a suitable alternative from Sexual and Reproductive Health Services.

Prescribing Notes:

Sexual and Reproductive Health Services can provide general advice and information about diaphragms to patients and support when there are supply problems.
Diaphragms should be used with careful counselling, only, when other methods of contraception are not appropriate.
Caya diaphragms are the preferred brand of diaphragms currently as patients can fit the diaphragm and one size fits all.
While nonoxinol-9 has been shown to be toxic to HIV in vitro, concerns have been raised regarding a damaging effect on vaginal mucosa leading to a possible increase in the risk of HIV transmission.
Spermicidal contraceptives are useful safeguards for use with barrier methods but do not give adequate protection when used alone.
The concomitant use of condoms should be encouraged to prevent sexually transmitted infections.

History Notes

08/11/2023

Gygel discontinued and removed, ERWG Sept 23.

18/05/2022

East Region Formulary content agreed.

Low efficacy: 18 unintended pregnancies per 100 users per year.

Prescribing Notes:

Condoms are available free of charge from Sexual and Reproductive Health Services. Other locations include:
- Borders: C Card scheme providers, including School Nurses, Youth Groups, some pharmacies and GPs.
- Fife: Free Condoms Fife, which offers a free postal service; and some GPs.
- Lothian: Caledonia Youth; Healthy Respect and MYPAS clinics; C:card outlets, including community pharmacies, or postal service; and some GPs.
Condoms are proven to protect against sexually transmitted diseases including HIV. Condom users should be informed about emergency contraception.

History Notes

18/05/2022

East Region Formulary content agreed.

Where service available. Insert within 120 hours of unprotected sexual intercourse or up to 5 days after predicted day of ovulation.

Minimum uterine length 5cm. Replacement every 5 years.

Minimum uterine length 6.5cm. Replacement every 5 years.

Minimum uterine length 5cm. Replacement every 5 years.

Minimum uterine length 6.5cm. Replacement every 10 years.

Where Copper IUD service not available/not appropriate. If unprotected sexual intercourse up to 120 hours (5 days) ago.

1 tablet (30mg) to be taken as soon as possible following unprotected intercourse, but no later than 120 hours.

Where Copper IUD service not available/not appropriate. If unprotected sexual intercourse up to 72 hours ago.

1 tablet (1.5mg) to be taken as soon as possible, preferably within 12 hours, and no later than 72 hours after unprotected intercourse.

Prescribing Notes:

All eligible women presenting within 120 hours of unprotected sexual intercourse (UPSI) or up to 5 days after earliest expected date of ovulation should be offered a copper IUD as it is the most effective method; available evidence suggests that oral emergency contraception administered after ovulation is ineffective.
If IUD insertion is not available locally then ideally women should be referred to a service which can provide insertion of IUD. Oral emergency contraception can be provided in the interim.
If a copper IUD is not appropriate or not acceptable, women should be advised that oral emergency contraception should be taken as soon as possible if there has been UPSI within the last 5 days.
Levonorgestrel emergency contraception may be used between 72-96 hours after UPSI, efficacy declines and it is ineffective if taken more than 96 hours after UPSI.
Levonorgestrel is available in community pharmacies via a Patient Group Direction for no charge. Levonorgestrel can also be purchased in community pharmacies under the brand name Levonelle One Step. Ulipristal is also available in community pharmacies for no charge or can be purchased. Both medicines are part of the public health service provided by community pharmacy.
If vomiting occurs within 2 hours of taking levonorgestrel or 3 hours of taking ulipristal, a replacement dose can be given.
Women who require emergency contraception while using enzyme-inducing drugs should be advised that a copper IUD is the preferred option. Those that prefer to take a hormonal emergency contraceptive may be advised to double the dose of levonorgestrel i.e., two tablets of levonorgestrel 1.5mg (off-label). It is not known if the efficacy of ulipristal acetate is reduced by enzyme-inducing drugs but increasing the dose is not recommended.
Women with a BMI greater than 26kg/m² or total body weight greater than 70kg require a double dose of levonorgestrel. No dose adjustment is required for ulipristal acetate.
There is no evidence that hormonal emergency contraception is teratogenic. It has no effect if a woman is already pregnant. Before emergency contraception is prescribed or sold, pregnancy should be excluded on the basis of the menstrual history; pregnancy testing is only indicated if suspected on clinical grounds.
Ulipristal is not suitable in women taking drugs that affect gastric pH i.e. antacids, H2 antagonists and proton pump inhibitors
If emergency contraception has been required due to missed pills, women should continue their pill without delay. Additional contraceptive precautions will be required depending on method of both emergency and regular contraception. Check summary of product characteristics or the Faculty of Sexual and Reproductive Healthcare guidance for details.
Women presenting for emergency contraception should be encouraged to consider regular contraceptive options, if not already using. Women may opt for LARC methods and bridging with a progesterone-only pill can be considered until a LARC method is organised. Guidance regarding quickstart and bridging can be found on the Faculty of Sexual and Reproductive Healthcare website.
Women should be advised to wait 5 days after taking ulipristal emergency contraception before starting suitable hormonal contraception and should be made aware that they must use condoms reliably or abstain from sex during the 5 days waiting and then until their contraceptive method is effective.
After taking levonorgestrel emergency contraception, women should be advised to start suitable hormonal contraception immediately and should be made aware that they must use condoms reliably or abstain from sex until contraception becomes effective.
Guidance on the use of ulipristal and levonorgestrol in the same cycle is available from Faculty of Sexual and Reproductive Healthcare.
Ulipristal acetate is the most effective hormonal emergency contraception (EC). Consider as 1st line if unprotected sexual intercourse (UPSI) was 96-120 hours ago, or if UPSI was in the 5 days prior to ovulation.
Levonorgestrel should be considered as 1st line hormonal EC if UPSI is unlikely to have occurred in a fertile period and quick starting of ongoing hormonal contraception is planned.

History Notes

18/05/2022

East Region Formulary content agreed.