Over-the-counter HRT: Why design matters
The recent move by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), to enable women to pick up hormone replacement therapy (HRT) treatment from a pharmacy without a prescription should be applauded. If rubber-stamped, thousands of women over the age of 50 who suffer from vaginal dryness will no longer need a trip to their doctor for treatment. However, a successful move from prescription (Rx) to over-the-counter (OTC) drug isn’t just a case of administrative reclassification; design also plays an essential part in mitigating risks.
What has design got to do with the success of over-the-counter HRT?
On February 2 2022, the MHRA opened consultation on a proposal to make the prescription-only estradiol vaginal tablet, Gina10, available as a pharmacy medicine. To qualify, a drug must fulfill the following:
- It 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.
- It must not contain substances or preparations of substances where the activity of the product or its side effects require further investigation.
- It must not normally be prescribed by a doctor for injection (parenteral administration).
- It must generally be used correctly (i.e. not frequently or to a wide extent used incorrectly).
This last item isn’t a factor of the medicine’s efficacy but mainly of how it is used. The task of helping meet this criterion falls to design. In the absence of a prescribing doctor, factors such as packaging usability, information, instructions, and labeling must step in to support the pharmacist and empower the consumer to make safe and informed choices.
The move to self-health
The commercial opportunity enabled by such redesign is growing – the global Rx to OTC switch market was valued at US$ 33 billion in 2020 and is predicted to expand by over 5% each year between 2021 and 2031.
This will require an industry mindset shift from relying on doctors to pharmacists or consumers themselves. As demonstrated by the widespread adoption of home lateral flow tests during the COVID-19 pandemic, design can be an enabler. Suddenly, the public was expected to carry out and report on a process that previously (most likely) would have been the domain of a medical professional.
We became de facto lab technicians overnight, swabbing younger patients and recording results at the kitchen table. Design was central to the scheme’s success, from letterbox-sized kits to step-by-step graphical instruction books. Lateral Flow Technology made in-home results that would once have been the domain of well-equipped labs, available in minutes.
Their user-friendliness was improved in design iterations, with the introduction of nose-only swab kits and all-in-one buffer solution tubes. Of course, if the tests had been rolled out without the time and cost pressures of a global pandemic, the intuitiveness and usability of the product-pack experience could have been improved. For example, the ever-confusing ‘C’, which clearly means ‘Control’ to scientists, raises the risk of erroneous reporting if interpreted as ‘COVID-19’ by others.
The good news for most pharma companies considering an Rx to OTC switch is that there is time to optimize this experience, thanks (or no thanks) to an often-lengthy reclassification process.
The evolution of the over-the-counter experience
The evolution of the OTC user experience can be demonstrated by another landmark for women’s health: the reclassification of the morning-after pill. When the pill became available in UK pharmacies in 2001, women had to endure a face-to-face interview with a pharmacist in a private side room (which only made the whole process more indiscreet and potentially a barrier to freedom of health choices.) Today, people can order online from multiple consumer-friendly websites for next-day delivery.
Telehealth website ForHims, founded in 2017, achieves the same for men seeking treatment for highly emotive personal problems such as hair loss and erectile dysfunction. An easy-to-navigate website encourages users to fill out a five-minute questionnaire sent to a clinician to approve the requested treatment. Available drugs include Sildenafil and Viagra Connect, which became OTC treatments in the UK in 2018.
A joint effort
The ability to zip into a pharmacy and pick up HRT will be life-changing for many women. There are many candidate drug opportunities with the potential to ‘switch’ in the future, which can only be a good thing for consumers. The design industry will play a critical role working in pharma and regulatory partnerships to ensure this evolving landscape and the packaging and surrounding experience are optimized to best inform and empower those it seeks to benefit.
Head of Consumer Healthcare
A landmark for women’s health innovation
There were two victories in the MHRA’s announcement that it’s seeking to reclassify Gina10, an HRT treatment for vaginal dryness, as a non-prescription drug.
The first is that the medical industry is waking up to accessibility needs in healthcare, particularly for women. This group has significantly less free time than men to organize and attend a doctor’s appointment. OTC treatment will make a difference to the 80% of menopausal women who contend with the impact of vaginal dryness on their quality of life.
The second is the medical industry’s increasing willingness to develop a product that addresses the sexual wellness of menopausal women, a traditionally taboo subject. Moreover, the media are willing to talk about this advance for women constructively without the titillating headlines we might have seen in the past.
Both these points mark substantial progress in advancing equality in women’s healthcare.
- Proposal to make Gina 10 microgram vaginal tablets (Estradiol) available from pharmacies [Internet]. GOV.UK. 2022 [cited 8 February 2022]. Available from: https://www.gov.uk/government/consultations/consultation-on-proposal-to-make-gina-10-microgram-vaginal-tablets-estradiol-available-from-pharmacies
- Rx-to-OTC Switches Market [Internet]. Futuremarketinsights.com. 2021 [cited 8 February 2022]. Available from: https://www.futuremarketinsights.com/reports/rx-to-otc-switches-market
- Men enjoy five hours more leisure time per week than women – Office for National Statistics [Internet]. Ons.gov.uk. 2018 [cited 8 February 2022]. Available from: https://www.ons.gov.uk/peoplepopulationandcommunity/wellbeing/articles/menenjoyfivehoursmoreleisuretimeperweekthanwomen/2018-01-09
FemTech Lead and Associate Insights Researcher
Head of Consumer Healthcare