Consultation outcome

A public consultation on reclassifying two medicines containing desogestrel from prescription only (POM) to pharmacy (P)

Updated 8 July 2021

A public consultation on reclassifying two medicines containing desogestrel from prescription only (POM) to pharmacy (P)

1. Background to public consultation

Consultation document for ARM 99, which summarises the proposals on the prescription only (POM) to pharmacy (P) reclassification of Lovima 75 microgram film coated tablets and Hana 75 microgram film coated tablets both containing desogestrel for the prevention of pregnancy in women of childbearing age, were posted on the GOV.UK website on 12 February. The deadline for comments was 5 March 2021. ARM 99 documents can be accessed via the following link: (https://www.gov.uk/government/news/views-sought-on-making-the-oral-contraceptive-pill-desogestrel-available-from-pharmacies)

To be reclassified from POM to P a medicine must:

*be unlikely to be a direct or indirect danger to human health when used without the supervision of a doctor, even if used correctly

• be generally used correctly (i.e. not frequently or to a wide extent used incorrectly)

• not contain substances or preparations of substances where the activity of the product or its side effects require further investigation

• not normally be prescribed by a doctor for injection (parenteral administration)

In the UK, these criteria are laid down in the Human Medicines Regulations 2012, regulation 62(3). Prior to starting the public consultation, advice was sought from the Commission on Human Medicines (CHM) (the Government’s independent advisory committee on medicines safety), on the assessment of the applications for Lovima and Hana against the criteria for prescription control to determine the suitability for pharmacy availability. The CHM has advised that none of the criteria apply to Lovima and Hana as risks can be managed through the product information and pharmacist training. Following this advice, a public consultation (ARM 99) was conducted to seek views on the reclassification proposal for Hana and Lovima from prescription only medicine to pharmacy availability.

2. Summary of responses

In response to the consultation, 493 responses were received which is unprecedented for an ARM reclassification consultation. There was overwhelming support for this consultation with 82% of responses (402) in support of the proposal. 15% of responses (75) did not support the proposal and 3% (16) were unsure about the proposal.

Of the 402 responses in support of the proposal, 18 had a pharmacy interest which includes pharmacy bodies such as the Royal Pharmaceutical Society (RPS), the Company Chemists Association (CCA) and practising pharmacists, 2 had an industry interest, which included the Proprietary Association of Great Britain (PAGB), 131 had a medical interest, which included the Royal College of Obstetricians and Gynaecologists (RCOG), the Faculty of Sexual and Reproductive Health (FSRH) Clinical Effectiveness Unit, consultants in gynaecology and sexual and reproductive health, GPs and sexual health nurses and 251 of the responses were from patients and the public.

Of the 75 respondents who did not support the proposal, 6 worked in a pharmacy, 8 were from those with a medical interest, which included doctors from various backgrounds and medical students, and 61 responses were from patients and the public.

Of the 16 who were unsure about the proposal, 2 had a pharmacy interest and included the British Pharmacological Society and a pharmacist, 1 had a medical interest and 13 were from patients and the public.

All the responses have been carefully considered. Due to the large number of responses received a decision has been made not to publish individual responses and this document provides a high-level summary. A thematic analysis has been conducted and the key themes that were raised are set out and discussed below.

3. Responses in support of the proposal to reclassify desogestrel as a pharmacy medicine

The respondents who were in favour of the proposal recognised the rational for reclassification supported by the CHM (https://www.gov.uk/government/consultations/hana-75-microgram-film-coated-tablets-desogestrel-public-consultation/outcome/hana-public-assessment-report)

The general themes raised in support of the reclassification of desogestrel were:

• Improving access to contraception and choice around how to access contraception, which should serve to remove barriers to healthcare

• The potential to reduce the risk of unplanned pregnancies and subsequent abortion

• The well-known safety profile of desogestrel, its ease of use and the few contraindications to its use

• Freeing up GP appointments for other issues

4. Main issues raised

The main issues raised in the consultation from those opposed to the consultation and from those in support are set out below:

4.1 Risk of side effects particularly mental health side effects such as depression

Some of those who responded to the consultation raised concerns about the risk of side effects, particularly around mental health such as depression. Mood changes and depressed mood are recognised side effects with desogestrel and are highlighted in the patient information leaflets with advice for the patient to contact their doctor should this occur. However, in light of the comments received in response to the consultation the pharmacy checklist has been strengthened to encourage the pharmacist to counsel the woman about mood changes and depression and advise them to speak to their doctor if they experience this. This will increase the likelihood that women are aware of the risk and know what to do should they experience a change in their mood.

4.2 Continuity of care, long term monitoring and lack of access to medical records

Some of those who responded to the consultation raised concerns about the continuity of care since pharmacists do not need to keep records of supplies of pharmacy medicines and do not need to inform a person’s GP that they are using a pharmacy medicine. Concern was also raised about pharmacists not having access to a person’s medical records and reliance on the person to provide the correct information about their past medical history and concomitant medication. Part of the issue also included concerns over long term monitoring of women on desogestrel such as their blood pressure. In light of this some responders expressed concern that a consultation with a pharmacist would not be as thorough as a consultation with a GP.

Firstly, it is important to note that use of desogestrel requires little ongoing monitoring and specifically does not require blood pressure to be monitored as progesterone only pills have not been shown to affect blood pressure. Pharmacists will initially provide a 3-month supply and after this if the woman is happy and remains eligible, then up to 12 months supply can be given. This means that follow up pharmacy supply and consultations are at least as frequent as they are with supply via a GP. Pharmacists are trained practitioners who are experienced in checking eligibility for all the products they supply. Community Pharmacists have access to the Summary Care Record, so they are able to see what medications a person is being prescribed. Ensuring eligibility for desogestrel will be done in partnership with the woman, and studies have shown that women are able to accurately self-screen for contraindications. Furthermore, women should be trusted to make decisions around their own health.

With regards to accessing medical records and sharing information with a patient’s GP, it is acknowledged that pharmacists will not be able to enter information on supply of desogestrel into a patient’s medical records. Currently there is already variation in the amount of feedback to GPs when women receive contraception via a sexual health clinic and in the case of private prescriptions, there is also variation as patients can be given the choice as to whether their GP is informed. The pharmacy training materials reminds pharmacists to encourage patients to inform their GP that they are taking desogestrel in the same way they do when they supply other pharmacy medicines.

Overall, the benefits to women of having access to desogestrel via a pharmacy and reducing the risk of an unplanned pregnancy and abortion is considered to outweigh any risks of a woman not informing her GP of desogestrel use and not revealing all information about her medical history and concomitant medication.

4.3 Safeguarding/exploitation and supply to those under 18

Some of those responding to the consultation raised concerns about supplying desogestrel as a pharmacy medicine to those under 18 and in particular to those under 16. Concerns were raised around vulnerable women and young girls being exploited and abused and coerced into seeking desogestrel. Pharmacists are already familiar with safeguarding and consent, through the provision of emergency contraception services. All pharmacy professionals in England are required to attain level 2 safeguarding status and the training and the checklist ensure pharmacists are reminded of how to safely supply contraception to girls under 18, and especially those under 16. Pharmacists are encouraged to provide no more than a 3-month supply of desogestrel to ensure there is opportunity for girls to be followed up and reassessed in terms of safeguarding and exploitation. An unplanned pregnancy in a young woman/girl is a very poor outcome and is likely to have negative effects on both physical and mental health. The benefits of avoiding an unplanned pregnancy and the ongoing consequences of this are considered to far outweigh any risk of supply.

4.4 Inequality of access

Many responders raised concerns about pharmacy supply of desogestrel having to be paid for, which would introduce a barrier to access for those unable to afford to pay and would result in increased health inequalities. There was also a concern that this reclassification would ultimately result in removal of free of charge contraception from the NHS. The aim of supply of desogestrel via a pharmacy is to provide further choice to women on how they access contraception and to increase access. Desogestrel and other contraceptives will continue to be available on the NHS through GPs and sexual health clinics in the same way as they are now.

4.5 Sexually Transmitted Diseases

Concern was expressed that pharmacy supply of desogestrel would lead to an increase in sexually transmitted infections (STIs). Whilst there is a risk that women who switch from a barrier method of contraception to desogestrel may no longer use the barrier method and risk exposure to STIs, the risk is no higher than supply via a GP. Advice about sexual health should automatically occur as part of discussions around contraception, including reminders that only barrier methods of contraception protect against STIs. Any woman with symptoms of an STI or at potential risk, should be referred to sexual health services. A reminder about sexual health is included in the product information and further information and guidance is included in the pharmacy training materials. Pharmacists are already experienced in advising on sexual health given that some pharmacies engage in the chlamydia screening programme.

4.6 Moral concerns

Concern was expressed that pharmacy supply of desogestrel would encourage promiscuity by making it easier for younger girls to access contraception. Moral concerns are not a matter for the regulator. As set out above, an unplanned pregnancy is a very poor outcome and allowing greater access to contraception should help to reduce the risk of an unplanned pregnancy.

There was also a misconception that desogestrel is an abortifacient when in fact its primary mechanism of action is to inhibit ovulation. This information is also included in the pharmacy training material and patient information leaflet.

4.7 Encouraging use of desogestrel rather than other more suitable contraceptive options such as Long Acting Reversible Contraception (LARC)

Concern was expressed that pharmacy supply of desogestrel may result in reduced contact with the GP and the opportunity to discuss wider sexual and other health issues. There was also concern that pharmacy supply of desogestrel may encourage women to choose this method out of convenience, when it may not be the most appropriate choice of contraception for them. The pharmacy training materials encourage pharmacists to discuss all methods of contraception with a woman before she makes a choice to ensure she is using the method most suitable for her. Therefore, although the only regular contraceptive available from the pharmacy will be desogestrel, all other methods will be discussed, and women referred on if they would prefer a different method, or in the pharmacist’s view desogestrel may not be the most appropriate method of contraception for that woman, following a conversation with the woman.

The pharmacy training materials ensure the pharmacist conducts a holistic consultation with women requesting contraception, including all elements of sexual health and all available contraceptive methods. Pharmacists already have relevant knowledge and experience to be able to do this. This should help to address this risk by ensuring women are informed about all contraceptive options.

5. Pharmacy checklist, Patient Information Leaflet and Label

There were a lot of positive comments on the pharmacy checklist, patient information leaflet and label. There were comments that the checklist for pharmacists was important and should not be optional. From a regulatory perspective, a condition of this reclassification is that the applicant is required to ensure that the checklist and training materials are made available as support materials for all pharmacists. Whether the pharmacist uses the materials or not is a professional decision.

As a result of some comments about the risk of mental health side effects such as depression outlined above, the applicant has been asked to strengthen the pharmacy checklist to encourage the pharmacist to counsel the woman about mood changes and depression and advise that they speak to their doctor if they experience this. Mood changes and depressed mood are recognised side effects with desogestrel and are highlighted in the patient information leaflet with advice for the patient to contact their doctor should this occur.

There was also a call for clarity on whether desogestrel could be supplied to those under 18. Desogestrel is indicated for women of childbearing age and as outlined above, the pharmacy training materials provide clarity on supply to those under 18.

In addition, there were comments that the checklist did not cover quick starting (the immediate initiation of contraception rather than awaiting the start of the next menstrual period), , safeguarding issues, wider advice on fertility, sexual health and the menstrual cycle, supply to those under 18 and the Fraser guidelines, and use in those over 55 years of age. The pharmacy checklist is not intended to be comprehensive and all these issues are covered in the pharmacy training.

There were also comments that the patient information leaflet should be available in other languages. The leaflet which accompanies all medicines is intended to supplement the discussion with the healthcare professional supplying the medicine and there is no legal requirement for leaflets for any medicine to be available in different languages. The pharmacy consultation will be important in this regard as the pharmacist will explain to the patient, if they are eligible for supply, how to use desogestrel and the key information for safe use.

There were some comments that the product information is not completely aligned with the Faculty of Sexual and Reproductive Healthcare FSRH guidance in terms of missed pill advice in that it is unnecessarily cautious in advisingadditional contraceptive measures for 7 days as opposed to 2 days. The missed pill advice is, however, in line with the medicine which is available on prescription. There was also concern that a 3-month supply for those under 18 is too restrictive, however, this follows advice of the CHM to ensure adequate and frequent follow up in this age group. In addition, there were a few comments questioning the referral to a doctor of those with diabetes. The pharmacy model requires referral to GP in the first instance for monitoring of blood glucose before, supply of desogestrel may be made in the pharmacy.

With regards to drug interactions, there was a comment that modafinil, which is reported to be used off label in young people, is an enzyme inducer which may interact with desogestrel to reduce its effectiveness. Pharmacists will already be familiar with these interactions. The product information has been strengthened with regard to drug interactions to ensure the information is comprehensive. The pharmacy training materials and check list make it clear that pharmacists should check all the medication (including over the counter and herbal products) a woman is taking for interactions with desogestrel. Clinically relevant interactions will necessitate referral to a doctor for discussion of contraceptive options. Pharmacists are encouraged in the training to counsel women on the importance of informing other healthcare professionals that they are taking desogestrel. The risk of a woman failing to disclose to a pharmacist that they take modafinil is no higher than supply through a GP or sexual health clinic.

Finally, there were comments that transgender inclusive language should be used in these materials and that there should be guidance on use in the transgender population. This is an issue for all medicines of all classifications that are indicated for male or female only.

6. Differences between the two products being reclassified

A key difference between the two products is that Lovima contains soya bean oil and should therefore not be taken by people with soya or peanut allergy. Hana does not contain soya bean oil. There was concern that there may be a risk if a patient that is allergic to soyabean oil or has a peanut allergy changes between Lovima and Hana and does not realise that Lovima contains soyabean oil. There is an excipient warning in the Lovima PIL and on the label regarding peanut or soya allergy and this is highlighted in the pharmacy checklist.

There were comments that there should be consistency between the product information and checklists for both products being reclassified. This consultation was on two different desogestrel products from two different marketing authorisation holders (MAHs) and it is the responsibility of the individual MAHs to draft the product information and checklist for pharmacists to accompany their product. As long as there is consistency in the safety messaging, the language, style and layout can be different.

7. Conclusion

Careful assessment of the responses to consultation on the reclassification of two products containing desogestrel for continuous oral contraception has revealed no new issues of concern in addition to those already considered by CHM and on which CHM was reassured. The responses to consultation support the MHRA and CHM’s view that the POM criteria do not apply to these products as risks can be managed through the product information and pharmacist training.

We anticipate that pharmacy availability of desogestrel-containing oral contraception will provide a valuable additional option to women enabling easier access to a safe and effective contraceptive. Making this more accessible will reduce the risk of unplanned pregnancies, which may have significant negative effects on both mental and physical health. Patients can easily be assessed for suitability by a pharmacist as there are few contraindications to use and no ongoing monitoring requirements in terms of blood pressure measurements.

In conclusion, it is considered that the benefit of increasing access to this oral contraception will outweigh any risks. Following advice from CHM and careful consideration of the response to consultation, the Licensing Authority has taken the decision that the POM criteria no longer apply and the MHRA has approved the pharmacy (P) legal status for for two products containing desogestrel.