Providing over-the-counter vaginal oestrogen in New Zealand: a cross-sectional study of pharmacists’ views
Tylah Maniapoto 1 , Amber Young
1 * , Alesha Smith 1
1
Abstract
Genitourinary symptoms of menopause (GSM) affect a large proportion of women and can worsen over time if left untreated. In New Zealand, effective treatment with low-dose vaginal oestrogen is available only by prescription, limiting timely access. Internationally, such treatments have been reclassified for supply by pharmacists, but there are no studies examining New Zealand pharmacists’ perspectives on this.
This study aimed to determine pharmacists’ confidence in treating GSM and their perspectives on supplying an over-the-counter (OTC) vaginal oestrogen.
A cross-sectional survey was distributed by the research team to 2762 registered pharmacists. The survey explored confidence in GSM management, opinions on OTC vaginal oestrogen supply, perceptions of patient preferences, and barriers and facilitators to service delivery. Quantitative data were analysed descriptively, and open-ended responses were reviewed using descriptive thematic analysis.
A total of 299 pharmacists responded (response rate 10.8%). While only 46.8% felt confident in recommending currently available OTC products for GSM, 61.2% reported they would be confident supplying low-dose vaginal oestrogen OTC. Pharmacists believed that supplying OTC oestrogen would improve accessibility, reduce the burden on general practice, and support patient-centred care. Key barriers included cost to patients, lack of specific knowledge of GSM, and limited time or resources in the pharmacy setting.
Pharmacists in New Zealand support expanding their role to supply low-dose OTC vaginal oestrogen for GSM, provided that appropriate tools and training are implemented. This service could improve access, address health disparities, and significantly enhance menopause care in New Zealand.
Keywords: community pharmacy services, genitourinary symptoms, hormonal therapy, menopause, oestrogen, pharmacy, postmenopause, urogenital symptoms, vuvlovaginal atrophy, woman’s health, womens health.
| WHAT GAP THIS FILLS |
| What is already known: Many women experience genitourinary symptoms of menopause and use low-dose vaginal oestrogen to manage symptoms. This treatment is only available with a prescription in New Zealand, but in other countries it can be supplied over-the-counter following consultation with a pharmacist. |
| What this study adds: Pharmacists in New Zealand would like to be able to provide their patients with low-dose vaginal oestrogen to manage genitourinary symptoms of menopause. Pharmacists believe that being able to offer low-dose vaginal oestrogen is within their scope of practice and would improve medicine access for women in the community. |
Introduction
Menopause is the natural cessation of menstrual periods usually occurring between 45- and 55-years of age.1 During menopause the production of female sex hormones from the ovaries, including oestrogen, significantly decreases. Approximately 85% of women experience some symptoms related to menopause, and these can be variable in type and severity,2 substantially impacting women’s quality of life (QOL) over many years.3 Genitourinary symptoms of menopause (GSM) are caused by vaginal atrophy with thinning and reduced elasticity in the vaginal tissue, and decreased production of natural lubricant. Resulting symptoms include vaginal dryness and itching, dysuria, dyspareunia, recurrent infections of the vagina and lower urinary tract, and general discomfort. These symptoms affect around 50% of postmenopausal women, can severely impact sexual function and enjoyment, and will progressively worsen over time if left untreated or upon treatment cessation.4,5
If women are only experiencing troublesome GSM, without vasomotor or other symptoms, then vaginal oestrogen application is considered the most effective treatment option.6 Unlike systemic oestrogen, vaginal oestrogen can be used long-term beyond the menopause transitional period because of the long-term duration of symptoms and perceived safety.4,5 The only vaginal oestrogen treatments for GSM available in New Zealand are estriol pessaries or vaginal cream7 and can only be obtained with a prescription. In New Zealand, 100,899 women were prescribed topical estriol (Ovestin) between May 2022 and April 2023.8 The age of menopause onset does not differ between Māori and non-Māori women, nor does experiences of GSM.9 However, only 5.83% (n = 5887) of estriol prescriptions across all ages were Māori women. The cause of the discrepancy between Māori and non-Māori estriol prescriptions are unknown and warrants further investigation, but may be related to health inequities and reduced access to health services for Māori in New Zealand.
New Zealand currently has minimal evidence-based over-the-counter (OTC) treatment options for the relief of GSM symptoms. Available OTC treatment options include oral complementary and alternative medicines (CAMs) such as black cohosh, red clover, and ashwagandha. However, these CAMs have limited efficacy and supporting data for menopause symptom relief,10–13 particularly for GSM.14 Furthermore, some herbal remedies have been linked to severe adverse events, such as hepatotoxicity with black cohosh.15,16 Other options available OTC are vaginal lubricants, intended for short term use during sexual intercourse,17 and moisturisers that mimic natural vaginal secretions to improve hydration in the vaginal area and decrease vaginal dryness.18 However, vaginal moisturisers and lubricants often have varying pH and osmolarity ranges outside of the recommendation from the World Health Organization (WHO),19,20 which can contribute to the vaginal atrophy symptoms of menopause and increase risk of infection.21
In July 2022, the United Kingdom Medicine Regulatory Agency (the MHRA) reclassified a vaginal oestrogen tablet from prescription only to pharmacy medicine. This reclassification allows women in the UK over 50 years old who have not menstruated for 12 consecutive months to receive treatment from a pharmacy instead of requiring a doctor’s prescription.22 A detailed checklist for pharmacists to use when supplying the low dose vaginal oestrogen was also created to assist pharmacist’s consultations and contains a series of questions that differ for the different stages of treatment. The checklist also contains additional information to assist pharmacists in individual cases.23 As mentioned, New Zealand has no effective OTC treatment options to alleviate GSM, and people requiring effective options need to have this treatment prescribed. Community pharmacists in New Zealand can provide a range of other treatments OTC, some of which used to be classified as prescription only, such as the emergency contraceptive pill and oral contraceptives, and treatments for urinary tract infections (UTIs) and erectile dysfunction.24 To date, there are no studies investigating pharmacists’ perspectives of supplying OTC hormone therapies for menopause symptoms in New Zealand. It is unknown whether registered pharmacists in New Zealand would be confident in supplying OTC hormone therapy and would want to do this in a pharmacy setting.
The aim of this study is to determine pharmacists’ confidence in treating genitourinary symptoms of menopause and their perspectives on supplying an OTC topical vaginal oestrogen.
Methods
Survey design
This was a cross-sectional mixed-method study utilising a survey instrument drafted by the research team. The questions included in the survey were adapted from the literature25 to align with the study objectives. Participants were asked questions about their confidence in supplying treatment for menopause symptoms, their opinions on supplying OTC low dose vaginal oestrogen for the relief of GSM, and perceptions of patient preferences for menopausal therapy. Participants were also asked demographic questions. The survey questions consisted of multiple-choice questions, Likert scale responses, checklist questions, and open-ended questions, allowing participants to express their opinions. A pilot version of the survey was sent to three pharmacists who were personal contacts of the research team, and the survey was adapted for clarification based on feedback provided. The final survey consisted of 28 questions, see Supplementary material S1.
Participants
We aimed to recruit participants that reflect all registered pharmacists in New Zealand. The survey was emailed to a list of registered pharmacists obtained from the Pharmacy Council New Zealand (Te Pou Whakamana Kaimatū o Aotearoa) from their database of pharmacists who indicated that they are open to research. It was intended for registered pharmacists working in a community pharmacy setting to participate; however, two participants indicated that they work in hospital pharmacy and wanted to contribute to the study, so their responses were retained.
Survey administration
This project was approved by the University of Otago Human Ethics Committee (Non-Health) (reference D22/351). Participation in the survey was voluntary, and completion of the survey was taken as consent.
The participants were emailed an invitation, an information sheet, and a link to the web-based survey platform Qualtrics to complete the survey in February 2023. Two follow up reminder emails were sent at fortnightly intervals. The survey closed in April 2023.
Statistical methods
An exploratory descriptive statistical analysis was conducted using Excel with the quantitative data received. Open-ended responses were analysed using descriptive thematic analysis.26 These were triangulated against the quantitative findings to gain a deeper understanding of the results and to identify additional concepts raised by participants.
Results
Participant demographics
The survey was sent to 2762 registered pharmacists across New Zealand. Of these, 299 pharmacists participated in the survey, giving a response rate of 10.8%. Almost 75% of participants had worked in a community pharmacy setting for more than 10 years. The majority of the participants in this study were female (71.4%), which is consistent with the Pharmacy Workforce Demographic 2022 statistics27 that found that 67% of New Zealand practising pharmacists are female. Just over half of our survey participants (53.66%, n = 151) were aged between 41 and 60 years old. In contrast, the largest cohort of practicing pharmacists in New Zealand are under 40 years of age.27 Therefore, the participants in our cohort are not a direct representation of registered pharmacists in New Zealand. For a full list of demographics, see Table 1.
| Participant characteristics | n (%) | |
|---|---|---|
| Highest level of education | ||
| Bachelor of Pharmacy | 121 (43%) | |
| Bachelor of Pharmacy with Honours | 49 (17%) | |
| Postgraduate certificate | 17 (6%) | |
| Postgraduate diploma | 44 (16%) | |
| PharmD | 2 (1%) | |
| Masters | 20 (7%) | |
| PhD | 2 (1%) | |
| Other | 28 (10%) | |
| Years worked in a community pharmacy | ||
| <5 years | 36 (13%) | |
| 5–10 years | 35 (12%) | |
| >10 years | 212 (75%) | |
| Demographic and comparison to 2022 pharmacy workforce data 27 | |||
|---|---|---|---|
| Participants in study | Pharmacists in New Zeland | ||
| N (%) | N (%) | ||
| Age | |||
| 20–30 years old | 41 (15%) | 1005 (24%) | |
| 31–40 years old | 50 (18%) | 1283 (31%) | |
| 41–50 years old | 78 (28%) | 743 (18%) | |
| 51–60 years old | 73 (26%) | 621 (15%) | |
| 61+ years | 41 (15%) | 466 (12%) | |
| Gender | |||
| Male | 81 (29%) | 1343 (33%) | |
| Female | 202 (71%) | 2775 (67%) | |
Confidence in supplying treatment options
Participants were asked about their confidence in recommending and supplying treatments for GSM and the suitability of current options, see Table 2 for responses.
| Question | Strongly agree | Agree | Neither agree nor disagree | Disagree | Strongly disagree | Total | |
|---|---|---|---|---|---|---|---|
| % (n) | % (n) | % (n) | % (n) | % (n) | (n) | ||
| I feel confident recommending treatments currently available for GSM | 15% (46) | 31% (94) | 23% (69) | 23% (70) | 7% (20) | 299 | |
| I would feel confident in supplying a low-dose oestradiol vaginal tablet (Gina® 10 μg) for relief of GSM | 23% (68) | 38% (115) | 15% (45) | 20% (59) | 4% (12) | 299 | |
| There are current suitable options available over the counter for symptom relief of GSM | 1% (4) | 6.0 % (19) | 19% (55) | 62% (182) | 12% (35) | 295 | |
| I would like to have a checklist to use if I was supplying low-dose oestradiol (Gina® 10 μg) | 67% (199) | 29% (88) | 3% (8) | <1% (1) | 1% (3) | 299 | |
| I would feel confident in counselling women about a low-dose oestradiol (Gina® 10 μg) treatment for their GSM | 32% (96) | 40% (119) | 15% (45) | 11% (34) | 2% (5) | 299 |
Just under half of the participants either strongly agreed or agreed (15%, n = 46 and 31%, n = 94 respectively) that they feel confident recommending treatment options currently available for GSM. In open text responses, numerous participants indicated they feel confident in supplying treatment options currently available because these are considered ‘safe’.
I think the products that are currently available OTC are generally non-medicated so pose little risk. (P18)
Other participants were confident because of personal experience and/or research on menopause and related topics.
Almost one-third of participants (30%, n = 90) indicated that they were not confident in supplying treatment options currently available. In open text response, a few participants described how being a younger male makes it harder to supply treatment as they find women embarrassed to discuss their GSM symptoms. Some participants doubted the efficacy of current OTC treatment options.
As far as I am aware, treatments currently available from a pharmacy fall into the herbal/natural category. While these treatments do help some people with their symptoms, I feel uncomfortable supplying treatments that are not proven to be effective in clinical trials. (P32)
Almost three-quarters of participants (74%, n = 217) thought that there are insufficient over-the-counter treatment options available. Some pharmacists expressed that this left them feeling unable to support patients in their symptom management.
[I] feel bad when menopause symptoms queries arise in the pharmacy setting as there are limited options on what to supply without a prescription. (P116)
Over half of the participants (61%, n = 183) agree that they would feel confident in supplying OTC low dose vaginal oestrogen, with one participant stating:
I think we, as well-trained pharmacists, should start trusting our training, knowledge, and expertise to claim our rightful place in the health provider sector. (P10)
To facilitate provision of this medicine, almost all the participants (96%, n = 287) would like to have a checklist to support this service, as is used in the UK and for some other OTC treatments in New Zealand, eg for the emergency contraceptive pill.
Most participants (72%, n = 215) indicated that they would feel confident in counselling women about OTC low dose vaginal oestrogen. Reasons for this were explored in open text responses, where pharmacists considered the medicine safe to use OTC because it was applied and exerted its effect topically, it was low dose, and had low risk of systemic side effects.
It’s a low-dose topical product, and systemic side effects are unlikely to happen. Also, when it’s used locally, the effect is straightforward, if it’s not working, the customers can stop using it anytime without worrying about the systemic side effects. It is a safer option I believe. (P172)
Expanding patient care
Responses to questions about whether participants thought providing treatment OTC for GSM would improve patient care and be beneficial for pharmacy practice are in Table 3.
| Question | Strongly agree | Agree | Neither agree nor disagree | Disagree | Strongly disagree | Total | |
|---|---|---|---|---|---|---|---|
| % (n) | % (n) | % (n) | % (n) | % (n) | (n) | ||
| Supplying over-the-counter low-dose vaginal oestradiol (Gina® 10 μg) for symptom relief is something I am interested in | 46% (137) | 43% (128) | 7% (21) | 3% (8) | 1% (3) | 297 | |
| Supplying over-the-counter low-dose vaginal oestradiol (Gina® 10 μg) is within a pharmacist scope of practice | 41% (122) | 44% (130) | 13% (38) | 1% (4) | 1% (3) | 297 | |
| Introducing over-the-counter menopausal symptom relief would advance the profession’s goals of providing more pharmacist-directed patient care | 68% (201) | 28% (84) | 2% (7) | 1% (3) | 1% (2) | 297 | |
| Supplying over-the-counter vaginal oestradiol for symptom relief for menopausal women will improve accessibility | 47% (140) | 47% (140) | 4% (12) | 1% (2) | <1% (1) | 295 | |
| Patients would feel comfortable in disclosing their genitourinary symptoms to a pharmacist | 23% (69) | 50% (147) | 21% (62) | 6% (17) | 0% (0) | 295 | |
| My patients would prefer to receive treatments for genitourinary symptoms from their doctor | 2% (5) | 11% (32) | 60% (177) | 24% (71) | 3% (10) | 295 |
Most participants were interested in supplying OTC low dose oestrogen for symptom relief of menopause (89%, n = 265) and believe this service is within a pharmacist’s current scope of practice (85%, n = 252). Furthermore, almost all participants (96%, n = 285) believed that being able to supply this OTC would advance the profession’s goals of providing pharmacist-directed patient care. In open text responses, one participant stated:
[OTC supply of low-dose topical oestrogen] is something we can do to reduce the burden on other primary health care providers. (P47)
Some participants identified that this proposed service is similar to other services pharmacists already provide for genitourinary issues, such as nitrofurantoin provision for UTIs or sildenafil for erectile dysfunction.
It increases access for another group of patients needing help in a particular area, we [pharmacists] already counsel on sildenafil. (P250)
Almost all participants (95%, n = 280) believe that this service will improve accessibility to treatment for women experiencing GSM. One participant stated:
Pharmacists are well placed to provide treatment as has been demonstrated for many years. Providing a guide/algorithm means standardised consultations across the board. Given the dire state of access to GP [General Practitioners; family physicians], this would be welcomed by many women, I’m sure. Pharmacists are also very good at referring patients if medication is not suitable. (P89)
Regarding patient uptake of pharmacist’s supplying vaginal oestrogen OTC, almost three-quarters of participants (73%, n = 216) agreed or strongly agreed that patients would feel comfortable with seeking support from their pharmacist for their symptoms. When asked if they believed patients would prefer to receive treatments for genitourinary symptoms from their doctor, most participants (60%, n = 177) neither agreed nor disagreed and more than one-quarter of participants strongly disagreed or disagreed (3%, n = 10 and 24%, n = 71 respectively), indicating they thought that women would feel comfortable receiving treatment for genitourinary symptoms from pharmacists, without a prescription.
Benefits and barriers of supplying OTC low-dose topical oestrogen
Benefits of supplying OTC low-dose vaginal oestrogen identified in open text responses included improving accessibility and equity, improving QOL, relieving pressure from GP clinics, access to treatment in a more timely manner, expanding a pharmacist’s scope of practice, improving pharmacist–patient relationships, increasing the conversation around menopause, removing the stigma around menopause, and the potential to decrease medicine misuse (reduction of antibiotic supply for UTI treatment).
Women would be empowered to take charge of their health, knowing that there is easy access to their pharmacist for help and support. (P224)
Some barriers to pharmacists providing OTC topical oestrogen were identified by participants. The barriers most identified were cost to the patient, lack of knowledge around GSM, and being unaware of associated risks of supplying OTC low dose oestrogen (Table 4).
| Barrier | % (n) | |
|---|---|---|
| Cost to the patient | 19% (219) | |
| Lack of knowledge around genitourinary symptoms of menopause | 16% (186) | |
| Unaware of the associated risks of supplying OTC low dose oestrogen | 15% (178) | |
| Limitations on pharmacist time | 15% (175) | |
| Limitations on pharmacist resources (consultation rooms, information pamphlets, etc) | 8% (97) | |
| Liability concerns | 7% (85) | |
| Cost to the pharmacist | 6% (73) | |
| Accessibility | 5% (60) | |
| Increased responsibility | 6% (67) | |
| Other | 2% (19) |
In open-ended text responses, several participants indicated that patients may feel uncomfortable disclosing their genitourinary symptoms to their pharmacists.
I don’t think many woman would feel comfortable talking about this in a pharmacy setting. (P17)
Other barriers participants identified included inadequate training, inability to access patient medical history/records, financial barriers (including lack of subsidies and cost of training), and differential diagnosis.
Of those who selected ‘other’ (n = 19), some indicated there are no barriers to this proposed service or that the identified barriers can be easily overcome, such as a short training module to educate about menopause.
Discussion
This study provides valuable insights into New Zealand pharmacists’ perspectives and confidence in supplying low-dose topical oestrogen OTC for the treatment of GSM. Our findings show that most pharmacists are confident in counselling and supplying this treatment with the aid of a checklist, and that there is widespread support for expanding the scope of practice to improve access for women experiencing GSM. This aligns with international trends, such as the reclassification of vaginal oestrogen tablets in the United Kingdom, which has enabled pharmacists to play a greater role in menopause care.
Other studies have shown that patients perceive pharmacists to have adequate knowledge about menopause and menopausal treatments.28–31 Furthermore, discussions with patients regarding menopause and related topics are often appreciated,29,30,32–34 and women recommend pharmacy-based menopausal services to their friends and family.33 However, this study identified that more menopause-specific training would be welcomed by pharmacists to improve confidence in supplying vaginal oestrogen OTC for GSM. Participants in our study identified that this could be achieved by using a checklist (similar to the checklist the UK pharmacists use).
Prior to reclassification in the UK, 88% (n = 1082) of respondents (cohort consisted of pharmacy bodies, medical associations, consultants, and the general public) were highly supportive of the reclassification. Similar themes from this survey were identified from the UK’s respondent cohort, which included improved accessibility, more convenience for women to access treatment, decreasing wait time to see GPs, and increasing awareness about vaginal atrophy and menopause.22 In our study, cost to the patient was considered the most significant barrier to pharmacists supplying vaginal oestrogen OTC, and was also identified as a potential barrier in the UK.22 Time constraints are often considered a barrier to expanding pharmacy services, and international studies have found that this may be problematic for menopausal services in a pharmacy setting.34 Similarly, in this study, a lack of time was identified as one of the main barriers to providing this service. The UK cohort shared other similar barriers, including risks associated with treatment and lack of resources in a pharmacy setting (eg consultation rooms). However, participants in the UK cohort identified additional barriers including cost-related inequality of access, packaging consisting of single-use plastics (and environmental impact), inability to notify GPs when a patient starts using treatment, and the use of inclusive language for the transgender population.22 Concerns about potential risks with unopposed vaginal oestrogen were also raised;22 however, systemic absorption of low/ultra low-dose vaginal oestrogens is minimal35 and side effects counselling and risk evaluation can be undertaken in a pharmacy setting with appropriate training.22
Currently, there are minimal opportunities for pharmacists to supply menopause care in New Zealand. New Zealand has minimal effective treatment options that pharmacists can supply without a prescription, despite menopause being a well-defined condition that potentially affects a large proportion of the population. Pharmacists are one of the more accessible forms of health care. Expanding the role to provide tailored care has been demonstrated to improve patient outcomes36 and is desired by community pharmacists in New Zealand.37 A study investigating women’s experiences through the menopausal period identified that the stigma around menopause is due to numerous factors, such as menopause being a sign of aging, and therefore society seeing them as ‘less valuable’.38 Women often feel there is a general lack of support and understanding around menopause.38,39 This study found that pharmacists have the ability to provide support to menopausal women in a pharmacy setting, and this support can help destigmatise the menopausal narrative.
Limitations
The treatment (Gina® 10 μg oestradiol hemihydrate) this study is investigating is not currently available in New Zealand, which somewhat challenges the applicability of supplying OTC treatment for GSM in New Zealand. The only topical hormone treatment therapy for GSM available in New Zealand is a 500 μg oestriol pessary or a 1000 μg oestriol vaginal cream (which delivers 500 μg per dose);24 although oestriol is considered a weaker oestrogen and is much less potent than oestradiol.40 Other limitations in this study include the low response rate (10.8%), potentially affecting the generalisability of the results. However, low response rates are common in surveys among health professionals and in web-based surveys, even when actions to encourage participation, such as reminders, shortening survey to 10 min, and prize draws, are incorporated as was done in this study.41,42 Therefore, analysis with simple descriptive statistics was considered appropriate. There may also be some responding biases. Participants with an interest in expanding pharmacy services to include menopausal therapy are more likely to respond, resulting in selection bias. Furthermore, most respondents were over 40 years of age and may be more aware of menopause treatment and symptoms and more comfortable providing it OTC.
This study was also limited in that it did not enquire about location of practice, and there may be differences in opinions based on rurality of workplace regarding medicine access. Future research is needed to look at expanding the scope of pharmacy practice in urban vs rural settings. Another limitation was the limited scope of this study, with the possibility of transgender men also experiencing GSM following long-term testosterone therapy. More research is needed to investigate the potential of OTC oestrogen to manage these symptoms in this patient group.
Conclusion
This study identified that many pharmacists would like to be able to provide vaginal oestrogen over-the-counter (OTC) for the relief of genitourinary symptoms of menopause (GSM). Participants acknowledged that this service has the potential to help decrease the workload of GP services and other primary healthcare services and improve access to treatment for a large proportion of the population. Participants were interested in upskilling and expanding pharmacists’ scope of practice. Overall, supplying OTC vaginal oestrogen for GSM is a service pharmacists could provide in New Zealand.
Declaration of funding
Funding for this project was received from the He Rau Kawakawa ki Ōtākou Whakaihu Waka (School of Pharmacy, University of Otago) as part of the Honours research programme.
Acknowledgements
The authors acknowledge the pharmacists who participated in the survey, Thelma Fisher, the Division of Health Sciences Subject Librarian, Ōtākou Whakaihu Waka (University of Otago), and the anonymous peer reviewers who provided feedback to improve the manuscript.
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