Progestogen-only pills (POPs) are a popular contraceptive method. The Clinical Effectiveness Unit (CEU) of the Faculty of Sexual and Reproductive Healthcare (FSRH) regularly updates and develops national UK clinical guidelines relating to contraception. The updated FSRH progestogen-only pills (POP) guideline was published in August 2022 (FSRH, 2022a). It is essential that practice nurses stay up to date with the latest evidence and advice. This article will highlight what is new or important in the guideline and how to relate the recommendations to clinical practice to provide safe and comprehensive care.
What types of progestogen-only pills are available?
There will soon be four different POPs available in the UK. Most clinicians will be familiar with the desogestrel (DSG) 75 µg POP and the two ‘traditional’ POPs, levonorgestrel (LNG) 30 µg and norethisterone (NET) 350 µg. A new drospirenone (DRSP) 4 mg POP is expected to be available in the UK soon and has been included throughout the POP guideline (FSRH, 2022a).
‘Traditional’ POPs (levonorgestrel and norethisterone)
Traditional POPs are taken daily within 3 hours of their scheduled time. Their contraceptive effect relies on the effect on cervical mucus (Rivera et al, 1999), the endometrium and tubal motility (rather than inhibition of ovulation), which could theoretically offer less robust contraception. The bleeding pattern with traditional POPs (as with all POPs) is unpredictable (Collaborative Study Group, 1998).
Desogestrel POP
Desogestrel POPs are taken daily within 12 hours of their scheduled time. The contraceptive effect primarily relies on inhibition of ovulation (Duijkers et al, 2015) and the bleeding pattern is unpredictable (Collaborative Study Group, 1998).
Drospirenone POP
The drospirenone POP is different to other POPs because there are 24 active pills which contain 4 mg of the progestogen drospirenone. These 24 days of active pills are then followed by 4 placebo pills — a 4-day hormone free interval (HFI). It is taken daily within 24 hours of the scheduled time and the contraceptive effect primarily relies on inhibition of ovulation (Duijkers et al, 2015). Suppression of ovulation is maintained during the HFI.
The HFI is designed to try to trigger a regular scheduled monthly withdrawal bleed. This does happen for some users, but not all. There is often unscheduled bleeding in addition to the scheduled bleeding (Palacios et al, 2020).
Effectiveness of POPs
All POPs are very user-dependant and rely on correct use for their contraceptive effectiveness. If pills are taken correctly then the POP may be 99% effective; however, with typical use the estimated failure rate is 9% (Trussell, 2011). It is essential that clinicians advise users of the 9% typical-use failure rate of POPs and the superior effectiveness of long acting reversible contraception (LARC), so that users can make an informed decision about their contraceptive choice.
As well as adherence to correct use, effectiveness of all POPs can also be affected by:
- Concomitant use with enzyme-inducing drugs. The British National Formulary (BNF) drug interaction checker (Joint Formulary Committee, 2022) is an excellent resource for checking interactions with medication. The CEU have recently published the updated Drug Interactions with Hormonal Contraception guidance (FSRH, 2022b), which includes information on enzyme-inducing drugs and other relevant interactions to consider
- Malabsorption (eg vomiting, diarrhoea and bariatric surgery). When there is concern about malabsorption, non-oral methods of contraception should be considered.
The available evidence suggests that the effectiveness of POPs is not affected by body weight or body mass index (BMI) and double-dose POP is not required for these individuals (FSRH, 2022a).
Who can and cannot use POP?
There are few medical contraindications to the use of traditional and desogestrel POPs.
All POPs can be used (by medically eligible individuals) between menarche and age 55. The UK Medical Eligibility Criteria (UKMEC) (FSRH, 2016) gives guidance about the use of POPs by people with various medical conditions, and relates to all POPs.
The UKMEC recommends that use of all POPs is contraindicated if someone currently has breast cancer (UKMEC category 4). POP should generally be avoided by people who have previously had breast cancer, people with ischaemic heart disease or ischaemic stroke that occurred during use of a POP, and people with severe liver disease (UKMEC category 3) (FSRH, 2016). See Table 1 for definition of UKMEC categories.
Table 1. Definition of UKMEC Categories
| UKMEC | Definition of UKMEC category |
|---|---|
| Category 1 | A condition for which there is no restriction for the use of the method |
| Category 2 | A condition where the advantages of using the method generally outweigh the theoretical or proven risks |
| Category 3 | A condition where the theoretical or proven risks usually outweigh the advantages of using the method. The provision of a method requires expert clinical judgement and/or referral to a specialist contraceptive provider, since use of the method is not usually recommended unless other more appropriate methods are not available or not acceptable |
| Category 4 | A condition which represents an unacceptable health risk if the method is used |
Note that UKMEC category 3 does not absolutely contraindicate the method: use may be considered if safer effective contraceptive methods are unavailable or unacceptable. Discussion with a specialist sexual and reproductive health (SRH) service should be considered.
There are no restrictions to the use of POP for people with a history of ectopic pregnancy or a history of ovarian cysts (provided they do not have other contraindications).
Additional considerations for drospirenone POP use
In addition to the UKMEC restrictions for POP use, there are some extra considerations for drospirenone POP. Drospirenone is a spironolactone derivative and an aldosterone antagonist (Duijkers et al, 2015), so its use can increase serum potassium levels. For most users this will not be an issue, but for susceptible individuals there is a concern about possible hyperkalaemia (Kimble et al, 2020). Therefore, drospirenone POP should not be used by:
- Individuals with severe renal insufficiency or acute renal failure
- Individuals with known hyperkalemia or untreated hypoaldosteronism (eg Addison's disease)
- Individuals currently using potassium sparing diuretics, aldosterone antagonists or potassium supplements.
Drospirenone POP should be used with caution by:
- Individuals with mild/moderate renal insufficiency
- Individuals with treated hypoaldosteronism (eg treated Addison's disease)
- Individuals using angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor antagonists.
For people with significant risk factors for chronic kidney disease, particularly those aged 50 or over, clinicians may wish to check urea and electrolytes and blood pressure prior to prescribing the drospirenone POP (this is not required for traditional and desogestrel POP and not routinely required for drospirenone POP) (FSRH, 2022a).
Are there any health risks associated with POP use?
The limited published evidence suggests that use of POP does not increase the risk of venous thromboembolism (VTE), thrombotic stroke, myocardial infarction or breast cancer (FSRH, 2022a).
What should be done during a POP consultation?
Included in the new guideline (FSRH, 2022a) is a suggested checklist to help guide clinicians when starting or continuing someone on POP. The following aspects are the suggested minimum criteria for a consultation.
Assessing medical eligibility
It is important to check if the POP will be safe for someone to use. A comprehensive medical history should be taken, specifically thinking about UKMEC 3 and 4 conditions and considerations for drospirenone POP.
Drug history and allergies
It is important to take a full drug history including non-prescribed and herbal remedies. Clinicians should check if their patient is taking any enzyme-inducing drugs that would make a POP less effective or a teratogenic medication where a LARC method would be recommended rather than POP.
Check if the patient has any allergies: some brands of the desogestrel POP contain soya and there may be a cross allergic reaction for someone who has a peanut allergy (FSRH, 2022a).
Assessing risk of pregnancy, need for emergency contraception and for additional contraceptive precautions
Clinicians should assess any current risk of pregnancy and any requirement for emergency contraception. If a pregnancy cannot be excluded (if there has been unprotected sex in the last 21 days) but a pregnancy test is negative, a POP can be ‘quick started’ as per the FSRH Quick Starting guidance (FSRH, 2017). The need for emergency contraception would also be assessed.
If a patient is quick starting a POP then additional precautions (eg condoms) are required for 2 days for traditional and desogestrel POPs, and for 7 days for drospirenone POP. A follow up pregnancy test would be required 21 days after the last episode of unprotected sex.
If a patient is starting desogestrel POP or a traditional POP during days 1–5 of a natural menstrual cycle, then they can be advised that no additional contractive precautions are required.
If a patient has decided to use drospirenone POP, they could only start on day 1 of a natural menstrual cycle without the need for additional contraceptive precautions.
The POP guideline (FSRH, 2022a) includes comprehensive tables for starting POP which can really help in practice. If a user was switching from another method there are tables to help guide clinicians in various switching situations. Contraceptives have different modes of action and this is why there is different advice when switching between certain methods. Drospirenone POP is different to other POPs due to insufficient evidence of time to cervical mucus effect and therefore 7 days of condoms is required.
Full discussion of POP including:
Contraceptive effectiveness (perfect and typical use)
It is really important that users are advised of the typical-use failure rate so that they can make an informed decision about their contraceptive choice and consider more effective methods.
How to take pills
Patients should be advised how to take their pills, reminding them that effectiveness relies on correct pill taking.
Management of late/missed pills
Patients should receive information about what they should do if they miss pills. They can be directed to the FPA online leaflet which includes missed pill rules (FPA, 2022).
Clinicians can use the ‘missed pill’ guidance in the new POP guideline (FSRH, 2022a) to help advise patients about what to do next and to make decisions about the requirement for emergency contraception.
The missed pill rules for drospirenone POP are different to the other POPs, and a bit more complicated because of the 4 day HFI and the 24-hour window for taking pills.
Users should be advised that a traditional POP is considered missed if it is taken more than 3 hours late, a desogestrel POP if taken more than 12 hours late and a drospirenone POP if more than 24 hours late.
Interaction with medicines/herbal remedies
During a consultation, all patients should be informed that enzyme-inducing drugs can affect the effectiveness of POP (even if they are not currently taking any medications). They may be started on a new medication or start taking a herbal remedy and it is important that they are aware of possible interactions.
If they start an enzyme-inducing drug (eg topiramate, carbamazepine, St John's wort) then they should be advised that the contraceptive effect of their POP could be reduced (while they are taking the enzyme inducer and for 28 days after stopping), and therefore a method that is unaffected by enzyme inducers should be considered (eg Depo-Provera injectable or intrauterine contraception).
If they start a teratogenic medication (eg topiramate, roaccutane, methotrexate) then a highly effective (non-user dependant) method of contraception is recommended (eg contraceptive implant or intrauterine contraception).
Potential bleeding patterns
Unpredictable bleeding is common with the use of all POPs and is a common reason for discontinuation (Collaborative Study Group, 1998). However, it is important to exclude other possible causes (eg pregnancy, infection, pathology).
Individuals considering use of any POP should be advised that the bleeding pattern is unpredictable; the bleeding will be irregular, can change at any time and will be different for each individual. The overall total number of bleeding days with desogestrel and drospirenone POPs is very similar (FSRH, 2022a).
If someone is having problematic bleeding with one POP, they might want to try another one to see if it is different for them.
Other potential side effects
Users of POP (or any hormonal contraceptive method) might report symptoms of mood change, headache, acne, weight gain or an effect on libido. Although the current evidence does not confirm that it is the POP itself causing these symptoms (FSRH, 2022a). However, if patients are unhappy with what they feel are side effects it is important that these are acknowledged, other possible causes explored and a discussion of alternative contraception is had if appropriate.
As drospirenone has some mild anti-androgenic effects it could theoretically be useful for acne or mood. But there have been no studies looking specifically at this, so the POP guideline (FSRH, 2022a) advises that it might have a different side effect profile to other POPs and therefore potentially is a useful alternative.
Alternative contraceptive methods, including LARC
A POP consultation is an opportunity to find out how satisfied the user is with their contraceptive method and also to discuss other methods, including non-user dependant methods.
Accessible information or a link to a trusted online resource should be provided to support safe, effective POP use (FPA, 2022).
Duration of POP prescription
A 12-month supply of all types of POP can be provided to medically eligible individuals (FSRH, 2022a). Clinicians might feel that some users require review earlier than 1 year.
Remote prescribing and review
POP users should generally be reviewed annually and this can achieved with a remote consultation. Remote providers still need to ensure that they have the same discussion, assessment and signposting as they would do in a face to face consultation (FSRH and British Association for Sexual Health and HIV, 2020), but remote prescribing might help to facilitate access to contraception. POP lends itself well to remote provision without the need for a face-to-face consultation because there are generally no tests or procedures that are required before providing POP.
During the review clinicians should recheck medical eligibility, update the drug history, check if the individual is missing pills, and ask if they are happy with the method or if they having any side effects. This is also a good opportunity to consider other contraceptive methods.
Pharmacy provision of POP
Two specific new brands of the desogestrel POP, Lovima and Hana, are now available as Pharmacy medicines (FSRH, 2021). This means that users can purchase these brands from a pharmacy, without a prescription, under the supervision of the pharmacist. They are not on the general sales list and cannot be bought ‘off the shelf’ but pharmacy provision offers a convenient alternative to prescription and online purchase to those able to afford it. These new brands of desogestrel POP are just the same as the desogestrel pills that we currently have and the desogestrel POP is still available free on prescription.
Supporting tools for clinicians
The POP guideline (FSRH, 2022a) is a long and comprehensive document that gives key information, recommendations, guidance and supporting evidence. For busy clinicians it can be difficult to navigate such a large document and therefore the Key Information Points and Recommendations are listed at the beginning of the document, where there is also a summary of the guideline that includes all the changes to previous guidance.
For FSRH members, there is a Quick Reference Guide with all the basic information and tables that clinicians might need to refer to in the context of a busy clinic. Members also have access to a version of the guideline with the evidence sections relocated to help with ease of reading the document.
Conclusion
Nurses working in general practice need to make sure they stay up to date with changes to relevant guidelines. The FSRH POP guideline provides key information, recommendations and guidance for nurses to refer to when providing contraceptive services.
KEY POINTS:
- There will soon be four progestogen-only pills (POPs) available in the UK
- All POPs are very user-dependant and rely on correct use for their contraceptive effectiveness
- All POPs can be used (by medically eligible individuals) between menarche and age 55. Practice nurses need to be aware of the medical contraindications and cautions for POPs
- Unpredictable bleeding is common with the use of all POPs and is often a reason for discontinuation
CPD REFLECTIVE PRACTICE:
- How can you determine whether a patient is eligible for progestogen-only pills (POPs)? What resources could you use?
- How would you explain the potential bleeding pattern side effects that patients may experience with POPs?
- Are you comfortable with reviewing patients remotely? What things should you consider?