Abstract
Objective
To evaluate whether testosterone could be prescribed safely in General Practice by appropriately trained primary care clinicians.
Methods
We audited testosterone prescribing in four GP surgeries across the Northwest against standards extrapolated from current guidance. We then introduced a structured EMIS template and protocol and then re-audited our prescribing against the same standards 6 months later.
Results
Initiating and prescribing of testosterone after our interventions met all our standards to 100%.
Conclusion
Our protocol and template facilitated safe prescribing of testosterone within a primary care setting.
Keywords
Introduction
There are currently many barriers for menopausal women having access to a conversation/being prescribed testosterone as part of their HRT regime for treatment of hypoactive sexual desire disorder (HSDD). A variety of factors contribute to this including long waiting times to access specialist secondary care services, 1 differing opinions in General Practice about the prescription of testosterone and who should prescribe and over see this and local prescribing limitations. We aimed to assess whether we could provide safe prescribing and monitoring in general practice of testosterone with a view to this being a reproducible model. Where the audit was completed, we followed the Cheshire and Merseyside prescribing guidelines and testosterone therapy for women with HSDD is amber initiated, meaning it should be initiated by a menopause specialist.
When asked how they managed a patient with HSDD for whom the addition of testosterone as part of an HRT regime could be beneficial: • 34% advised they would start testosterone • 25% of doctors advised they would refer to a colleague within the surgery who has a specialist menopause interest • 24% advised they would refer to a specialist menopause clinic • 11% advised they could not prescribe • 6% advised they would discuss on the local menopause weekly drop-in session run by a menopause specialist at the local tertiary hospital
Aim
To show that testosterone can be prescribed safely in General practice following standards taken from the British Menopause Society (BMS) guidance for Testosterone replacement in menopause.
Method
Four practices across the Northwest of England took part in our Audit. These practices were chosen as were known to have GP’s completing specialist menopause training. Prior to the introduction of our protocol/EMIS template, we audited the current testosterone prescribing against the standards we felt needed to be met to ensure safe prescribing of testosterone. We then introduced an EMIS template, an information leaflet and a protocol to follow and re-audited the prescribing of testosterone 6 months later.
The EMIS template was distributed throughout the surgeries and complemented the protocol below. Work had been done to produce a patient information leaflet regarding testosterone as part of a HRT regime with the Liverpool Women’s Foundation Hospital Trust and we were given consent to use this to provide written information for our patients. The protocol was developed with support from our local specialist menopause specialists.
Protocol
Standards chosen for audit
Standard 1: Women should be on a transdermal estrogen
Both the BMS and NICE guidance highlight the importance of patients being on transdermal estradiol since oral estradiol therapy can increase the sex hormone binding globulin which binds to testosterone and may make it less inactive. By ensuring that patients are taking on a transdermal preparation it follows that there may be more free testosterone which may aid libido.2,3
Standard 2: The indication for testosterone therapy should be HSDD
The guidelines advise considering the initiation of testosterone therapy should be for HSDD after excluding other biopsychosocial causes when HRT alone is not effective.2,3 Some studies cite other benefits of testosterone therapy 4 but as per our guidelines HSDD is the only advised current indication.
Standard 3: Advice women that the use of testosterone is off licence
As an unlicensed medication here in the UK, we need to follow prescribing guidelines and ensure that we appropriately counsel our patients about why a medication is unlicensed, the risks of the medications, and why it is used out of licence so they can make an informed decision and our advice should be documented.5,6
Standard 4: Women should be advised of the potential side effects of testosterone therapy
As with the prescribing of any medications, in line with good practice, we should inform patients of potential side effects, and this should be documented. 7
Standard 5: Women should be given written information regarding testosterone therapy
As per good prescribing guidelines patients should be referred to reliable sources of information. 7
Standard 6: Baseline testosterone should be checked prior to initiation of testosterone
The BMS, NICE, and our local prescribing guidelines all stipulate that an initial testosterone level should be checked prior to commencing therapy to ensure it meets the criteria to safely initiate testosterone therapy.2,3,8
Standard 7: Testosterone levels should be rechecked 6–12 weeks after initiation of testosterone
The BMS, NICE guidance, and our local prescribing guidelines advise the testosterone levels are rechecked at 6–12 weeks.2,3,8
Standard 8: Women should have a clinical review at 3 months
The BMS guidance advises it can take 3–6 months to see a benefit from testosterone therapy 2 so we felt a review at 3 months with the patient was an appropriate time to review compliance, side effects, and efficacy when laboratory results would also be available for monitoring purposes.
Standard 9: Women should have a clinical review at 6 months
As if can take up to 6 months to see a benefit from testosterone therapy 2 a review at 6 months was a good interval to be able to reflect and see if there had been an improvement and if not the opportunity to discontinue the medication. The 6 month review is in line with guidance to assess response.
Results
For the patients initiated on testosterone over the previous 6 months an anonymous survey was sent out to them. Of the 13 patients, 7 completed the online questionnaire. All seven answered positively that they were happy seeing their GP for testosterone therapy and were happy with the service they received. We also asked a free text question about any things you were happy/ not happy with respect to seeing your GP about testosterone treatment and the replies were as follows: • ‘Very happy everything was explained clearly to me and feel I am in safe hands. I am also glad someone is listening to me’ • ‘All explained clearly and willing to try again with slightly different combination of HRT’ • ‘My GP was very understanding. I did have to try another type/course of HRT for 3 months in advance, but outcome was as expected and she was really kind and thorough. Happy to start the new testosterone and have a review after 3 months’ • ‘I actually felt listened to. People underestimate the impact of menopause even though it is talked about. For the first time I felt someone understood and appreciated it is not just something you have to go through, More GP’’s should have this specialist knowledge’ • ‘Very happy with my GP’s knowledge in relation to testosterone and HRT and her understanding’
Discussion
Our audit prior to any intervention showed that the counselling, information given to women, documentation, and monitoring when prescribing testosterone did not adhere to local and national guidelines in all cases and that patient care could be improved. Certain topics may have been discussed, for example, side effects and testosterone being off license but were not documented.
With the introduction of a structured EMIS template along with a protocol all standards were met to 100%. The feedback from patients was positive, those who replied to the survey were happy being reviewed in primary care and were happy with the treatment they received.
From a practitioner’s point of view the EMIS template is straight forward and easy to use. The protocol is clear and also easy to follow, and this was informally feedback from the clinician’s involved in the audit.
It is important to note the small numbers in the audit. Over 6 months across the practices, we only had 13 patients started on testosterone therapy and not all patients at the time of audit had been on the treatment for 6 months. However, for those patients, we were able to provide a good standard of care and prescribe testosterone safely. We wondered whether the numbers initiated on testosterone were lower than we expected because we were addressing the other multifactorial elements involved in HSDD and with fuller discussion and consideration of other contributory factors, testosterone was less oftenindicated.
We had slightly biased circumstances in that all four surgeries involved in the audit had someone competing/completed the PPMC so had an interest in menopause care. Testosterone should be initiated by a menopause specialist and so we choose practices which had access to someone with the relevant qualifications.
The EMIS template covers monitoring up to 6 months and our protocol advises prescribers should revert back to GP’s HRT monitoring protocol. The ongoing standard for testosterone therapy is that testosterone levels should be measured 6–12 monthly 2 and we did not cover this in our audit. The template could be amended to include a yearly review including monitoring testosterone levels.
Conclusions
The introduction of a protocol and structured EMIS template showed an improvement with respect to all our standards around testosterone prescribing. We only had a small number of patients in our repeat audit but we showed that the standards could be met and testosterone can be prescribed safely by a Primary Care Clinicians with appropriate menopause qualifications within Cheshire and Merseyside.
Footnotes
Acknowledgements
We would like to thank Dr Rebecca Saadian and Dr Jennifer Peter’s for participating in our audit and Dr Jane Wilkinson for her guidance. Thank you to Ms Abbie Stirling, Lead Primary Care Network Pharmacy Technician for her support in creating the EMIS template. We would also like to thank Dr Rachel Barnes and the Liverpool Women’s Hospital for allowing us to use their patient information leaflet around testosterone use in the menopause.
Contributorship
KJ and HK worked together across all areas.
Declaration of conflicting interests
The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The authors received no financial support for the research, authorship, and/or publication of this article.
Guarantor
Dr Katie Jenkins and Dr Helen Kini
