Consultation outcome

Summary of responses to consultation - Gina 10 microgram vaginal tablets

Updated 20 July 2022

1.Background to public consultation

1.1

A consultation document which summarises the proposal on the prescription only (POM) to pharmacy (P) reclassification of Gina 10 microgram vaginal tablets containing estradiol hemihydrate for the treatment of vaginal atrophy due to oestrogen deficiency in postmenopausal women aged 50 years and above, who have not had a period for at least 1 year, was posted on the GOV.UK website on 2 February. The deadline for comments was 23 February 2022.

1.2

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)

1.3

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 application for Gina against the criteria for prescription control to determine the suitability for pharmacy availability. The CHM has advised that none of the criteria apply to Gina as risks can be managed through the product information and pharmacist training. Following this advice, a public consultation was conducted to seek views on the reclassification proposal for Gina from prescription only medicine to pharmacy availability.

2.Summary of responses

2.1

In response to the consultation, 1229 responses were received which is unprecedented for a reclassification consultation. There was overwhelming support for this consultation with 88% of responses (1082) in support of the proposal. 7% of responses (85) did not support the proposal and 5% (62) were unsure about the proposal.

2.2

Of the 1082 responses in support of the proposal, 14 had a pharmacy interest which included pharmacy bodies such as the Royal Pharmaceutical Society (RPS), the National Pharmacy Association (NPA) and practising pharmacists, 133 had a medical interest, which included the Royal College of Obstetricians and Gynaecologists (RCOG), the Dispensing Doctors Association, British Menopause Society (BMS), Faculty of Sexual and Reproductive Healthcare (FSRH), Medicines and Pharmacy Team (Healthcare Improvement Scotland), Pharmacy Forum NI, Community Pharmacy Northern Ireland (NI), consultants in gynaecology, GPs and nurses and 935 of the responses were from the public.

2.3

Of the 86 respondents who did not support the proposal, 22 had pharmacy interest which included working pharmacists, 7 were from those with a medical interest, which included consultants in gynaecology and GPs, and 57 responses were from patients and the public.

2.4

Of the 62 who were unsure about the proposal, 4 had a pharmacy interest and included working pharmacists, 8 had a medical interest and included the Royal College of General Practitioners, GPs and nurses with a special interest in the menopause, and 50 were from patients and the public.

2.5

All the responses received have been carefully considered. Due to the large number of responses 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 Gina as a pharmacy medicine

3.1

The respondents who were in favour of the proposal recognised the rationale for reclassification supported by the CHM.

Public Assessment Report

3.2

The general themes raised in support of the reclassification of Gina 10 microgram vaginal tablets were:

• Improving access to a treatment for vaginal atrophy and choice around how to access local hormone replacement therapy (HRT) which should serve to remove barriers to healthcare
• Increasing convenience of obtaining Gina 10 microgram vaginal tablets from a pharmacy instead of getting it prescribed
• Freeing up GP appointments for other issues
• Gina 10 microgram vaginal tablets work locally therefore there are less risks and adverse events associated with it
• Increasing awareness for vaginal atrophy amongst post-menopausal women

4.Main issues raised

4.1

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

The target population for Gina 10 microgram vaginal tablets as a P medicine

4.2

Some of those who responded to the consultation raised concerns about the population that Gina is indicated for (women aged 50 years and above who have not had a period for at least one year). This target population has been chosen so that pharmacists can identify a woman’s post-menopausal status in a pharmacy environment, and also avoids the need to provide contraceptive advice to women, which simplifies the supply of Gina from pharmacies. The conditions of supply such as the target population of a medicine are often more restrictive in a P setting than in a POM setting. Women aged under 50 years or who still have a period will be better treated under medical supervision, and will still be able to obtain this medicine on prescription.

4.3

There is no upper age limit for the supply of Gina from pharmacies.

Inequality of access

4.4

Many responders raised concerns about pharmacy supply of locally acting Gina 10 microgram vaginal tablets 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 hormone replacement therapy (HRT) not being prescribed on the NHS. The aim of supply of Gina 10 microgram vaginal tablets as a Pharmacy medicine to be sold over-the-counter is to provide further choice to women on how they access HRT and to increase access. Locally acting estradiol 10 microgram vaginal tablets and other forms of HRT will continue to be available on the NHS through GPs in the same way as they are now.

Training of pharmacists to supply Gina 10 microgram vaginal tablets from pharmacies

4.5

Some of those who responded to the consultation raised concerns over whether pharmacists will have the correct training and knowledge to correctly diagnose vaginal atrophy in a pharmacy. This was considered by CHM. Vaginal atrophy is currently diagnosed based on symptoms alone and without the need, in most women, for any physical examination, making it suitable for a pharmacy setting.

4.6

Additional resources in the form of pharmacy training materials will be provided for pharmacists which include a Pharmacy Guide and a Pharmacy Checklist.

4.7

The Pharmacy Guide provides information to pharmacists on the safe use of Gina ensuring it is only supplied when suitable, with appropriate counselling and advice. The guide covers supply to women who have never previously used a local oestrogen therapy, supply to women switching from a prescription locally acting low dose vaginal oestrogen product, and supply to women receiving hormonal therapy, including systemic HRT, whose GPs have confirmed suitability for treatment with locally acting estradiol. Other symptoms, conditions and concurrent medications which require a GP to confirm suitability for treatment before Gina can be supplied are also listed in the guide.

4.8

The checklist acts as an aide memoire and allows the pharmacist to check the suitability of Gina during consultations. The pharmacy checklist includes appropriate questions to be used during the pharmacy consultations to help identify whether there has been a change in a woman’s health when they return for a supply of Gina from the pharmacy. It also provides a reminder of symptoms which would require medical advice to be sought, and counselling advice to provide to the woman.

4.9

The pharmacy training materials have been tested thoroughly amongst community pharmacists, which tested pharmacists’ knowledge on different aspects of supplying Gina through pharmacies, e.g. instances when a woman would need to be referred to a doctor instead of being supplied Gina.

4.10

Some symptoms of vaginal atrophy may also be features of other underlying conditions. However, the risk of misdiagnosing vaginal atrophy is considered to be low and is likely to be managed by asking the appropriate questions which are listed in the training materials. These materials also include a list of other symptoms which may indicate a different underlying condition, which would require a referral to a doctor.

Risks associated with HRT

4.11

Some of those who responded to the consultation were concerned that HRT carries a number of risks and therefore specific advice may need to be provided from a GP/specialist. Gina 10 microgram vaginal tablets are a form of local hormone replacement therapy (HRT). Unlike systemic HRT medicines (HRT medicines which are absorbed into the bloodstream such as oral tablets and patches (transdermal patches) and gels which are put on the skin), Gina works locally, which means it works directly where it is applied with very little absorption into the bloodstream. The risks associated with systemic HRT have been carefully considered, and as Gina is a local form of HRT, these risks are less likely to apply. However, as Gina is a form of HRT, warnings and information related to HRT is included in the product information, so that these risks can be considered by users, alongside their personal history and risks for these conditions, prior to and during use of Gina. The product information also advises users to speak to their doctor or pharmacist if they are concerned.

Reviews with GPs

4.12

Some of those who responded to the consultation considered that regular check-ups or reviews would be required by a GP, for example to discuss the risks and benefits of continuing treatment, and to check whether a woman’s symptoms are improving from using Gina. This issue has been considered as part of the assessment. Pharmacists are well placed to monitor the progress of symptoms of vaginal atrophy at each consultation. These reviews will provide pharmacists with the opportunity at every supply to check for progress in symptoms, contraindications and changes to personal and family medical history at every visit. These regular pharmacy reviews replace the recommendation in the POM Summary of Product Characteristics (SmPC) for treatment to be reviewed every 12 months.

Increased workload for pharmacists

4.13

Some of those who responded to the consultation raised concerns about the increased workload this will add to community pharmacists, especially due to the current pressures within community pharmacies from staffing issues and vaccination services. In particular, concerns were raised over the time required for consultations to take place to supply Gina safely. The sale and supply of P medicines does not fall within the terms of the Pharmacy NHS contract. The decision to stock and sell a pharmacy medicine is a business decision and would not be taken into account when the Licensing Authority considers the suitability of a medicine for P classification.

Use of single-use plastic

4.14

Some of those who responded to the consultation raised concerns about Gina 10 microgram vaginal tablets using single-use plastic applicators instead of reusable applicators. This factor is not part of the assessment against the criteria for P classification.

Name of the product

4.15

Some of those who responded to the consultation raised concerns about the name of the product (Gina 10 microgram vaginal tablets) as ‘Gina’ is also a woman’s name. The MHRA assesses each invented name in accordance with the legislation, specifically the Human Medicines Regulation 2012, which requires that an invented name should not be liable to confusion with the common name or the name of any other existing medicinal product. In addition, invented names should not be misleading with respect to the therapeutic effects of the product, the composition of the product and the safety of the product. Therefore, as ‘Gina 10 microgram vaginal tablets’ is not likely to be confused with another medicinal product, and there is no risk to the public health, the name is considered to be acceptable.

Discussion of symptoms in a pharmacy environment

4.16

Some of those who responded to the consultation raised concerns about the discussion of vaginal symptoms in a pharmacy, and considered that a pharmacy environment is not discreet enough to talk about menopausal issues, especially as some pharmacies do not have consultation rooms. Whilst the facilities available in a pharmacy for consultation cannot be considered by the Licensing Authority, it is noted that over 95% of pharmacies have a consultation room. Women will still be free to choose whether they wish to continue to obtain estradiol 10 microgram vaginal tablets on prescription or buy Gina in a pharmacy and whether they are comfortable obtaining it in the pharmacy environment. It is of note that P medicines are already supplied from pharmacies for personal medical conditions, e.g. emergency hormonal contraception or erectile dysfunction, therefore pharmacists are accustomed to conducting consultations in a discreet and sensitive manner.

Notifying GPs of using Gina from pharmacies

4.17

Some of those who responded to the consultation considered that there should be greater emphasis on notifying the woman’s GP once they have started using Gina which has been bought from a pharmacy. It is acknowledged that pharmacists will not be able to enter information on supply of Gina into a patient’s medical records. The carton label includes the statement ‘You should inform your doctor at your next appointment that you are using Gina’. The Pharmacy Guide also includes references to remind women to inform their GP they are using Gina. The Pharmacy Checklist has also been strengthened, so that pharmacists remember to include this as part of their advice during the consultation.

Difference between Vagifem and Gina

4.18

Some of those who responded to the consultation queried the difference between Vagifem 10 microgram vaginal tablets which is available as a prescription only medicine, and Gina 10 microgram vaginal tablets which is now available as a pharmacy medicine. Both Vagifem and Gina contain the same medicine, but Gina will only be available from pharmacies for a restricted and clearly defined group of women that is appropriate for supply under the supervision of a pharmacist. Consequently, a new name (Gina) has been accepted for this medicine when supplied as a pharmacy medicine. Vagifem 10 microgram vaginal tablets will remain available on prescription for other women under the same conditions that it is currently available.

Use in transgender population

4.19

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.

5.Pharmacy checklist, Patient Information Leaflet and Label

5.1

There were a lot of positive comments on the pharmacy checklist, patient information leaflet and label. There were comments that these materials are comprehensive, clear, informative and easy to understand. A number of points were raised, which are discussed below.

Patient Information Leaflet

5.2

There were comments that the leaflet should not refer to Gina 10 microgram vaginal tablets as HRT, and risks related to systemic HRT should be removed. General information regarding key safety risks are required to be listed in the SmPC and patient information of all HRT products. This information is derived from data for systemic HRT. As there is very little absorption of oestrogen into the bloodstream with Gina 10 microgram vaginal tablets, these risks are less likely to apply. However, as this product is a form of HRT, information about them is included in the SmPC and PIL, so that these risks can be considered by users, alongside their personal history and risks for these conditions, prior to and during use of Gina. This information is the most up-to-date version which is common amongst the product information of all HRT products, and is kept under review.

5.3

There were some comments about the distinction between local and systemic HRT in the leaflet. The applicant has conducted user testing of the leaflet which specifically demonstrated that individuals can identify the difference between local and systemic HRT and can also identify that Gina 10 microgram vaginal tablets is form of local vaginal HRT.

5.4

There were some comments about the inclusion of the risk of breast cancer in the leaflet. Regarding the risk of breast cancer, although it is not known if Gina can be safely used in women who had breast cancer in the past, recent evidence suggests that using Gina does not increase the risk of breast cancer in women who had no breast cancer in the past. This new information is reflected in the product information for Gina.

5.5

There were comments requesting information to be included in relation to whether intrauterine systems can be used whilst using Gina. Intrauterine systems (IUS) are indicated as a contraceptive or to reduce menstrual blood flow if a woman suffers from heavy periods. Women taking an IUS for these conditions would not be suitable for supply of Gina from a pharmacy as it is only indicated for women aged 50 years and above who have not had a period for at least one year. Some intrauterine systems are used in conjunction with an oestrogen as part of a hormone replacement therapy (HRT) regimen to protect the lining of the womb. In this scenario, women would be using a systemic oestrogen HRT. The questions in the pharmacy checklist ensure women are asked if they are taking any other medicines, including systemic HRT, which would determine whether it is suitable to supply Gina or not.

5.6

There was a request to change the wording of the target population from ‘…not had a period for at least one year’ to ‘…no vaginal bleeding for than a year’. The target population of women aged 50 years and above who have not had a period for at least one year makes it easier for pharmacists to identify the post-menopausal status of women in a pharmacy setting.

5.7

There was also a call to include a reference to smear tests and an explanation that these may be painful as a result of vaginal atrophy. Smear tests may be very painful for a number of reasons, which should be investigated by a GP. Therefore, this information would be inappropriate to include in the product information or the training materials.

5.8

There was a call to clarify whether herbal menopause tablets can be taken at the same time as Gina. The leaflet cannot recommend specific medications to be taken together, however any medicines including herbal medicines which are currently being taken should be discussed with the pharmacist before being supplied with Gina.

5.9

There was also a request to include factors which may increase the risk of a blood clot. This information is already present in the leaflet and is also included in the pharmacy training materials.

5.10

There was a concern that some of the warnings, e.g. related to venous thromboembolism (VTE) or dementia are outdated and should be updated. All of the warnings in the leaflet have been carefully considered and are aligned with the product information with other HRT medicines which are reviewed regularly.

5.11

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.

5.12

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 Gina and the key information for safe use.

Label

5.13

There was a comment to reduce the information on the label and instead direct women to read the leaflet. The information on the label is necessary and meets the requirements for the labelling and leaflet of a Pharmacy (P) product as set out in The Human Medicines Regulations 2012 number 1916 [SI 2012/1916] and Annex III(A) of the Quality Review of Documents (QRD) product information template (version 10.1).

5.14

There was a comment requesting the inclusion of thrush as an example of a vaginal infection on the label, however as vaginal infections are not only limited to thrush the label has not been updated to reflect this. Thrush is currently treated in a P setting, so pharmacists will know how to identify this.

Pharmacy Checklist

5.15

There were some comments raised in relation to the length and detail included in the pharmacy checklist. The checklist is split into three sections: Section 1: Women who have never previously used Gina (first visit to the pharmacy), Section 2: Women who are returning for their second visit (7 weeks) or first 3-monthly visit and Section 3: Women who are returning for their ongoing 3-monthly visits. Therefore, pharmacists will only need to use whichever section is relevant to their consultation. The detail within each section is necessary to ensure the correct diagnosis of vaginal atrophy, and to ensure that Gina would be a suitable treatment for the woman.

5.16

A concern over the sensitive nature of some of the questions in the pharmacy checklist was raised. To address this, the applicant was requested to include an opening question at the beginning of the checklist which ensures that women feel comfortable to proceed with the consultation.

5.17

There was a request to change the title of the Pharmacy Checklist to ‘Pharmacist Clinical Aide’. As the purpose of this document is to use the list of questions to check whether Gina would be suitable to supply, the original name of the document is acceptable.

5.18

There was a comment to include tick boxes in the checklist to allow for ease of recording. As a result, the applicant was requested to update the pharmacy checklist to ensure pharmacists can use the tick boxes during consultation.

5.19

There was a call for the checklist to include symptoms which may be indicative of thrush. The pharmacy checklist includes questions about vaginal discharge which is the predominant symptom of thrush. Thrush is currently treated in a P setting, so pharmacists will know how to identify this. The advice in the checklist reminds pharmacists that Gina cannot be supplied if there is a current vaginal infection.

5.20

There was a comment which requested information to be included about other local HRT options, such as oestrogen cream, or other ways to manage their symptoms, such as lubricants, and how women would be able to obtain this. The Pharmacy Guide includes information about other local oestrogen therapies which are available on prescription which may be more suitable for women to use to manage their symptoms. The guide also includes information about lubricants or moisturisers.

5.21

There was a query about whether the checklist provides advice to women switching from another local oestrogen therapy. There is a section in the checklist which provides specific advice for this population, including the recommended dosage.

5.22

There were some comments about how pharmacists will know when to refer to a GP. The Pharmacy Guide and the checklist include symptoms and conditions which would require referral to a doctor. The checklist also includes questions on a woman’s progress with Gina, and if symptoms have worsened or have not improved after a certain time point, pharmacists will refer to a doctor.

5.23

There was a concern over the time period that a pharmacist would use to refer to a doctor if there has been no improvement in symptoms. The time taken for an improvement in symptoms has been carefully considered. The pharmacy training materials advise pharmacists to review treatment at each purchase. They encourage pharmacists to check whether symptoms have worsened after completion of the first pack. This is to check that their symptoms are caused by vaginal atrophy and not a different underlying condition. Likewise, the materials also encourage pharmacists to check whether there has been some improvement in symptoms after completion of the second pack, as women should expect to experience some improvement in symptoms after this time if their symptoms are due to oestrogen deficiency-related vaginal atrophy.

6.Conclusion

6.1

Careful assessment of the responses to consultation on the reclassification of Gina 10 microgram vaginal tablets containing estradiol hemihydrate for the treatment of vaginal atrophy due to oestrogen deficiency in post-menopausal women aged 50 years and above who have not had a period for at least one year 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 this product as risks can be managed through the product information and pharmacist training.

6.2

We anticipate that pharmacy availability of Gina will provide a valuable option to women enabling easier access to a local form of HRT. Making this more accessible will increase the awareness of vaginal atrophy in post-menopausal women.

6.3

In conclusion, it is considered that the benefit of increasing access to this local vaginal HRT 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 Gina 10 microgram vaginal tablets containing estradiol hemihydrate.