Decision-making process and flowchart

Use your professional judgement when dealing with requests.

Communicate the process of supply to the person requesting the medicine and that you will need to ask some questions to make sure the medicine is suitable for them.

Explain to the person requesting the medicine that referral to a prescriber may be needed if contraindications are identified or if further investigations are required.

Explore the person’s situation by considering the following:

• Who is requesting a supply? Is it the person who needs the medicine or a representative?
• Are there any safeguarding issues identified?
• What are the symptoms? Is there a cause for referral?
• Are they on any other form of vaginal oestrogen? Consider whether the person should continue with their current vaginal oestrogen or if they wish to switch to oestradiol 10mg vaginal tablets – see section on switching.
• Have they already been prescribed oestradiol 10mg vaginal tablets? Oestradiol 10mg vaginal tablets can still be purchased from a pharmacy as a P medicine if more practical (e.g. they are unable to get a suitable appointment with their prescriber).
• Consider if an emergency supply of the person’s prescribed medicine is more appropriate (e.g. if they are being prescribed off-licence).
• Have they already been supplied oestradiol 10mg vaginal tablets as a P medicine OTC? See section on repeat supply requests.
• Have they requested oestradiol in the past and been refused or have they had to stop treatment for any reason? Find out why and use your professional judgement to decide if it is a reason for referral.
• Are they aware of all the other options available to them (e.g. counselling)?

Decision-making flowchart

This flowchart below can help you with questions you may consider appropriate to assess suitability of supply.

This flowchart is designed to be used with the following sections in this guide. To help support you to develop your own consultation skills: 

• Decision-making process
• Summary of product information
• Counselling
• Confidence in consultation skills

Further tools such as the relevant summary of product characteristics (SPC) and educational risk minimisation materials can be found under further information.

Quantity to supply 

Pharmacists should use their professional judgement on a case-by-case basis to decide if supply of multiple pack purchases or frequent supplies to the same person is appropriate, in the same way they would for all other P medicines.

The manufacturer of Gina doesn’t recommend a quantity to supply. However, it does recommend the person returns to the pharmacy for review: 

• After seven weeks if they are using the initial dose for the first time. 
• Every three months thereafter if they using the maintenance dose.  

Therefore, only one pack may be supplied each time.  

Repeat supply requests

When a person requests a repeat supply, it will be up to the pharmacist to exercise their professional judgement to decide whether a full consultation is required again.

You’ll need to ensure you are satisfied that the medicine is still clinically appropriate and suitable on each occasion. Check if anything has changed since the last supply. This will determine if a repeat supply is suitable or not.

Questions you may consider appropriate to ask the person requesting oestradiol to assess continued suitability:

• Have there been any changes in their health or medical conditions since their last supply?
• Have there been any changes in their or their family’s medical history (e.g. cancer, blood clots)?
• Have there been any changes to their medicines (including prescribed, OTC, herbal, complementary, vitamins, dietary supplements, recreational, alcohol and tobacco) since their last supply?
• Have there been any changes in their symptoms that concern them?
  • Refer if symptoms have worsened, or not improved, or if symptoms other than dryness, soreness, itching, burning, irritation and painful sexual intercourse occurs, or if any newly onset contraindications arise.
• Have you been experiencing any side effects or signs and symptoms of adverse effects? 
  • Serious side/adverse effects may require immediate withdrawal and referral to the prescriber.

Use your professional judgement to decide on suitable action.

• If you feel the supply is suitable then provide counselling.
• If you feel the supply is no longer suitable, if in doubt of suitability, or if medical attention, investigations or referral is required, then refer to a prescriber.

Supply to the person’s representative

You will need to use your professional judgement with requests from representatives due to the sensitive nature of the medicine and the issue of maintaining confidentiality.

Consider the following:

• Who is requesting on the person’s behalf and why? If you suspect any potential safeguarding issues, you may find our pharmacy guide on safeguarding useful.
• How will you ensure you are satisfied that the treatment is clinically appropriate for the person needing the medicine?
• How can you get in touch with the person to assess suitability and determine whether the request is appropriate and genuine (e.g. by telephone)?
• Be careful not to disclose to the representative what was previously discussed, unless you have consent from the person needing the medicine.

Counselling

Advise the person to read the patient information leaflet and packaging, as a reminder of key safety messages.

Discuss the following:

• The medicine — what it is, how it works, how to use it (including the importance of adherence).
• Side/adverse effects and risks — make sure the person is aware what signs and symptoms to look out for and when to seek medical attention and advice. Risks and benefits should also be discussed.
• Other options — make sure the person is aware of all options available to them including other treatment options (lifestyle, non-hormonal and other hormonal treatments). Refer to a prescriber where other hormonal medicine treatments are requested. Provide written information if requested.
• Signpost – to supporting organisations such as charities and networks.
• Health promotion— provide general lifestyle and wellbeing advice where appropriate including diet, exercise, smoking cessation, caffeine control, alcohol reduction, weight reduction, fluid intake, sleep hygiene, relaxation, bone health and other screening programmes.
• Further supplies — person is aware of how to obtain further supplies.
• Interactions — person is aware to check interactions with their pharmacist before starting any new medicines.
• Referrals — person is aware when to see a prescriber.
• Advising prescriber — person is aware to inform their prescriber that they are on oestradiol 10mg vaginal tablet as soon as possible, so that their medical records can be updated to support future prescribing and checking interactions. Discuss with the person if they are happy for you to inform their prescriber on their behalf.

You may also find our pharmacy guide on counselling people on the use of medicines useful.

Other considerations:

• Record-keeping — see section on record-keeping.
• Quantity to supply — see section on quantity to supply.
• Online purchases — highlight the risks of purchasing medicines online:
  • If buying from unregulated sources the medicines may not have been tested for safety or effectiveness.
  • Advise the person to check that the medicine is being supplied from a reputable provider before purchasing — see guidance from the General Pharmaceutical Council (GPhC) on internet pharmacy logos.
• Disposal — advise the person to return any unused medicines to a pharmacy for disposal.
• Online pharmacies – will need to meet GPhC regulatory standards for providing services at a distance. For further information see GPhC guidance on providing pharmacy service at distance, including on the internet and GPhC premises standards.
• Delivering and posting medicines – there are some additional points for consideration in the Medicines, Ethics and Practice page (MEP) guide under delivering and posting medicines to patients.

Record-keeping

There is no legal requirement to make a record of the supply of a P medicine.  

However, professionally, you may decide to make a record of the following for audit purposes: 

• Referrals
• Discussions
• Reasons for the advice that you gave
• Advice you gave in terms of when and how to seek help if needed (i.e. safety netting)
• Repeat sales
• If person has asked you to contact their prescriber
• Interaction checks

If you decide to make a record, you need to ensure you have gained consent to do so. See GPhC guidance on confidentiality and consent. You may also find our pharmacy guide on clinical documentation useful.

Summary of product information

The table below provides a summary highlighting some useful product information relating to oestradiol 10mg vaginal tablets for supply as a P medicine.

Refer to the full up-to-date product details in the relevant SPC, found under further information.

For further information see the National Institute for Health and Care Excellence’s (NICE) Clinical Knowledge Summaries (CKS) website and NHS.UK. 

Indication	– Treatment of VA symptoms (dryness, soreness, itching, burning, irritation and painful sexual intercourse). – Can only be used in postmenopausal women over 50 years old, who haven’t had a period for at least one year, with or without a uterus.
Dose	– Initiation – insert one (10mg) tablet intravaginally daily for two weeks. – Maintenance – Insert one (10mg) tablet intravaginally twice a week. – Can be started on any day.
When to refer	– If the person has any contraindications. – If the person experiences any side effects. – Currently on another local HRT for more than three months but wants to switch. – If you suspect someone’s symptoms may indicate a condition other than VA. – Where oestradiol vaginal tablets should be used only under medical supervision.  Symptoms to refer (red flags) to confirm diagnosis include:  – Vaginal – undiagnosed bleeding, smelly or unusual discharge, severe itching. – Vulva – changes to the look, texture or colour (e.g. soreness, lumps, rashes, itching). – Pain – pelvic, when passing urine. – Lower abdominal pain, bloating or swelling. When assessment by a prescriber is required before supplying OTC: – People with a history of endometriosis – can supply if no recent symptoms, local oestrogen previously prescribed and no changes to health since last supply.  – People with a history of endometrial hyperplasia – can supply if local oestrogen previously prescribed and no changes to health since last supply or has had a hysterectomy. – People with current undiagnosed vaginal infection – can supply if treated first. – People taking existing systemic HRT and have never used a local HRT concurrently or have been using a local HRT for less than three months – can supply if prescriber confirms suitability or a local oestrogen previously prescribed for concurrent use and no changes to health since last supply. Where oestradiol should be used only under medical supervision: – People with contraindications such as breast cancer, blood clots, heart disease, stroke. – People with undiagnosed genital bleeding. – People with untreated endometrial hyperplasia. – Women over 50 whose last period was less than one year ago. – Women under the age of 50. Women with an intact uterus previously treated with unopposed systemic oestrogens. After starting treatment refer people: – If VA symptoms worsen or don’t improve at the seven-week review. – If the person experiences any side effects.
Contraindications	– Acute or previous liver disease. – Angina, heart attack, ischaemic stroke (current, recent). – Cancer – breast cancer, ovarian cancer, endometrial cancer (current, previous or suspected and family history). – Deep vein thrombosis or pulmonary embolism (current, previous and family history). – Hypersensitivity or allergies to oestradiol or any of the excipients. – Porphyria. – Thrombophilic disorders. – Undiagnosed genital bleeding. – Untreated endometrial hyperplasia (thickening of the uterus). – Untreated vaginal infection, severe itching. – Vulval dermatoses and rashes.
Side/adverse effects	This list is not exhaustive. For further information see Stockley’s Drug Interactions, the SPC and educational risk minimisation materials under further information. Common: – Headache – Stomach pain – Vaginal bleeding, discharge or discomfort Uncommon: – High blood pressure – Hot flush – Infection – Nausea – Rash – Weight gain Very rare: – Cancer – breast, endometrial – Deep venous thrombosis – Diarrhoea – Endometrial hyperplasia – Fluid retention – Hypersensitivity reactions – Insomnia – Urticaria and rash – Vaginal irritation and pain – Worsened migraines Other risks: Advise to stop immediately and refer if the person experiences: – Allergy symptoms – sweating, swelling, vomiting, breathing difficulty, palpitation, dizziness. – Blood clot symptoms – symptoms to look out for include leg swelling, sudden chest pain, difficulty breathing. – New onset of contraindications, including any red flag symptoms. – Jaundice symptoms – yellow skin or whites of eyes. – Hypertension symptoms – high blood pressure, new onset migraine, headaches. The risks below are lower with local vaginal HRT than systemic HRTs (oral tablets, patches, gels) due to reduced absorption into the bloodstream. These risks are mentioned below to aid discussions where people are concerned: – Breast cancer – local oestradiol doesn’t increase the risk in people who have never had breast cancer. The risk is unknown for people who have had breast cancer. – Ovarian cancer – systemic oestradiol slightly increases the risk of ovarian cancer. – Blood clots – risk is higher in HRT users compared to non-users and in those with risk factors (e.g. immobility for long periods, obesity, previous or family history, taking anticoagulants for blood clot treatment). – Heart disease – systemic oestradiol doesn’t increase the risk of heart disease. – Stroke – systemic oestradiol increases the risk of stroke compared to non-users. Report any suspected side effects, as appropriate, via the Yellow Card scheme on the Medicines and Healthcare products Regulatory Agency website. See our Yellow Card scheme guide for further details.
Interactions	– Check all medicines the person is taking (including prescribed, OTC, herbal, complementary, vitamins, dietary supplements, recreational drugs, alcohol, and tobacco). – Clinically relevant medicine interactions are unlikely. However, check interactions with other locally applied vaginal medicines. – Refer anyone with a clinically relevant interaction to their prescriber, using your professional judgement.
Missed doses	– Use as soon as remembered but don’t double dose.
Pregnancy and breastfeeding	– Cannot be used while breastfeeding. – Cannot be used in pregnancy.
Age	– Can only be used by women aged 50 or above.
Switching	All three of these points must be adhered to before switching: – Current local vaginal oestrogen has been used at the recommended dose for more than three months. – Symptoms are controlled. – No changes in health condition since last supply.

Education for pharmacy teams  

Ensure the pharmacy team is trained and has read any relevant standard operating procedures (SOPs) and training guides. 

It would also be good practice for the pharmacy team to be aware of local services and consider keeping a list of these services in the pharmacy to refer to for signposting. 

Pharmacists and pharmacy teams may want to carry out roleplay scenarios in advance of their first request for oestradiol. This can help you gain confidence and familiarise yourselves with the consultation process. 

Confidence in consultation skills

Discussing menopause can be challenging for some people and they may feel nervous approaching the pharmacy team. To ensure comfort and confidence, the pharmacy team should always be discreet, non-judgemental, and put the person at ease. 

Pharmacists can supply P medicines or supervise their supply. If the request needs to be referred by counter staff to the pharmacist, then the pharmacy team will also need suitable training to handle such circumstances, since they’re usually the first point of contact. Referral should also be covered in the SOP.

To support these conversations, good communication between yourself and the patient is essential. We have a pharmacy guide with practical tips and information that could be used to help develop your confidence in consultation skills.

Further information

RCPharm

• Clinical documentation
• Counselling people on the use of medicines
• Emergency supply
• MEP
• Professional judgement
• Safeguarding
• Yellow Card scheme
• Position statement on women’s health

Clinical

• NICE (NG23)
• NICE CKS
• electronic medicines compendium – SPC and product information leaflet
• Gina website
• The Pharmacy Network
• Stockley’s Drug Interactions

Consultation skills

• Centre for Pharmacy Postgraduate Education
• Health Education and Improvement Wales
• NHS Education for Scotland

Breast awareness and checks

• NHS
• Breast Cancer Now
• CoppaFeel!

Cervical screening

• NHS.UK

General lifestyle and wellbeing advice

• NHS.UK

Menopause information and support for the public

• NHS.UK
• Rockmy
• Menopause Matters
• Women’s Health Concern
• The Royal College of Obstetricians and Gynaecologists