Decision-making process for supply

You’ll need to use your professional judgement when dealing with requests (see our professional judgement guide). 

It’s important to share information about the process of supply with the person requesting. Explain that you’ll need to ask some questions to make sure the medicine is suitable for them, and that you may need to refer them to a prescriber if you identify contraindications or if investigations are required. 

You may want to use the following questions to support with diagnosis, prescreening, education and supply. Explore the person’s situation by considering and asking the following:  

• Who’s requesting a supply? Is it the person who needs the medicine or a representative? 
• Is the person needing the medicine aged 18 years or older and female? 
• Does the person have signs and symptoms of heavy menstrual bleeding (see the section on heavy menstrual bleeding)?
  • What is the trigger, onset, duration and frequency of their bleed (etc.)? 
  • Are there any other symptoms, (e.g.) pelvic pain/pressure, intermenstrual or postcoital bleeding, anaemia, acne, hirsutism, dyspnoea or fatigue, that may indicate differential diagnosis or require referral for further investigation?
• Ask about their menstrual cycle – (e.g.) pattern, duration, date of last period and number of period supplies used daily.
• Ask about the impact of heavy bleeding on their quality of life.
• Is the person hypersensitive to any of the active ingredients or excipients in tranexamic acid tablets OTC? 
• Do they have any health or medical conditions and are they taking any medicines which may impact the choice of treatment and identify underlying causes?
  • Check for contraindications, interactions and any reason for referral.  
• Have they already been supplied tranexamic acid OTC?
  • Check if they experienced any side/adverse effects that would require referral to the prescriber and see the repeat supply section.
• Have they requested tranexamic acid in the past and been refused, or had to stop treatment for any reason?
  • Find out why and use your professional judgement to decide if that’s a reason for referral.  
• Have they already been prescribed tranexamic acid?
  • Tranexamic acid can still be purchased OTC if more practical, (e.g., they are unable to get a suitable appointment with their prescriber). But consider if an emergency supply of the person’s prescribed medicine is more appropriate (e.g., if they are being prescribed off-licence or are taking an alternative dose or strength). See our guide on emergency supply.

Use your professional judgement to decide on suitable action:

• If you feel the supply is suitable and the person requesting the medicine is happy to continue, provide counselling and relevant information using the section on summary of product information .
• If you feel the supply isn’t suitable, if in doubt of suitability or if medical attention, investigations or a referral is required, then refer to a prescriber. 

The manufacturer of Evana Heavy Period Relief 500mg Tablets (tranexamic acid) has published training materials on its healthcare professional website, including a checklist and pharmacy training guide which you may find useful.

For further information, see the relevant SPC and PIL, found under further information.  

Quantity to supply and repeat requests 

You should use your professional judgement on a case-by-case basis to decide if frequent or multiple-pack supply to the same person is appropriate.

Quantity 

There is no limit on the number of packs that you can sell. 

However, Evana recommends that: 

• The maximum daily dose is two 500mg tablets three times a day, which can be increased if there is very heavy bleeding to a maximum dose of eight tablets a day for four days.
• You should refer the person if their symptoms worsen or do not improve after three menstrual cycles after they use the medicine. 

Repeats 

You need to be satisfied that the medicine is still clinically appropriate and suitable on each occasion, and check if anything has changed since the last supply. You can ask to see if the person has evidence of the initial/previous consultation or supply (e.g., a slip to confirm where and when the consultation took place). This will determine if a repeat supply is suitable or if they’ll need a full consultation. 

Consider the following questions to assess continued suitability: 

• How often do they need to use this medicine, and is there any improvement with use?
  • Refer the person if their symptoms don’t improve or worsen.
• Have there been any changes in their health or medical conditions since their last supply (see the referral section)?
• Have there been any changes to their medicines (including prescribed, OTC, herbal, complementary, vitamins, dietary supplements, recreational, or alcohol and tobacco use) since their last supply (see the interactions section)?
• Have they been experiencing any side effects?
  • Serious side/adverse effects may require immediate withdrawal and referral to the prescriber. 

Supply to the person’s representative  

Tranexamic acid can be supplied to a representative. However, it is important that you only supply the product:  

• Within the marketing authorisation.
• If you’re satisfied it’s a genuine request.
• If the treatment is clinically appropriate for the person.  

You’ll need to use your professional judgement with requests from representatives. 

Consider the following:  

• Who is requesting on the person’s behalf and why?  
• How will you ensure that the treatment is clinically appropriate for the person needing the medicine (e.g., check contraindications, referrals, previous medical history and existing 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 .
• Are you supplying the medicine within the marketing authorisation (e.g., ensure that the person is female and aged 18 or over and it’s used for the treatment of heavy menstrual bleeding (menorrhagia)?

Counselling 

Advise the person to read the PIL and packaging as a reminder of key safety messages. 

Discuss the following: 

• The medicine – what it is, how it works and how to use it (importance of adherence).
• Side/adverse effects and risks – make sure the person is aware what signs and symptoms of adverse effects to look out for and when to seek medical attention and advice. 
• Referrals – make sure the person is aware of when to see a prescriber.
• Interactions – make sure the person knows to check interactions with a pharmacist before starting any new medicines (see the section on interactions).
• Health promotion – provide lifestyle and wellbeing advice (NHS website) where appropriate including diet, exercise, smoking cessation, as well as reducing alcohol, stress, weight and controlling blood pressure. 
• Alternative treatments – provide information on alternative treatments (see the alternative treatments section).
• Condition – explain the condition and what causes it to empower the person to have an understanding of their condition.
• Offer sexual health advice – if required, see the NHS.UK website on sexual health.
• Further supplies – person is aware how to obtain further supplies. 

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

Other considerations: 

• Record-keeping – see the section on record-keeping. 
• Quantity to supply – see the section on quantity to supply and repeat requests.
• Online purchases – highlight the risks of purchasing medicines online:
  • If buying from unregulated resources, the medicines may not be tested for safety or effectiveness.
  • Advise the person to check that the medicine is being supplied from a reputable provider before purchasing (see the General Pharmaceutical Council (GPhC) guidance on internet pharmacy). 
• Storage and disposal – advise the person to return any unused medicines to a pharmacy for disposal (see the section on storage). 
• Online pharmacies – will need to meet GPhC regulatory standards for providing services at a distance (see the GPhC guidance on providing pharmacy service at distance, including on the internet, and GPhC premises standards).
• Delivering and posting medicines – the Medicines, Ethics and Practice page covers some additional points about delivering and posting medicines to patients. 

Record-keeping 

There is no legal requirement to record the supply of a P medicine. However, professionally, you may decide to record the following for audit purposes: 

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

If you decide to make a record, make sure you get the person’s consent (see the GPhC’s guidance on confidentiality and consent). 

Our pharmacy guide on clinical documentation may also be useful.

Summary of product information

The table below provides some product information on tranexamic acid 500mg for supply as P medicine. 

Refer to the full up-to-date product details and risk information in the relevant SPC and the British National Formulary (BNF), which can be found under further information.

Indication	– Treatment to reduce menorrhagia in people with regular (21–35 day) cycles and where their cycle duration does not vary by more than three days each month. – For use in women over 18 years of age.
Dose	– Take two 500mg tablets three times a day only when heavy bleeding starts.  – The dose can be increased if there is very heavy bleeding. – Maximum dose is eight tablets a day.  – Maximum duration of use is four days.
When to refer	People should be referred to a clinician/prescriber if there is any doubt the medicine is suitable for them and there are no other alternative OTC products available, or if the person:  – Experiences any side effects. – Has a contraindication. – Is taking or using medicine(s) that has a clinically significant interaction with tranexamic acid.  – Has no improvement of symptoms after taking tranexamic acid for three menstrual cycles or if symptoms worsen. People should check with their prescriber if taking tranexamic acid OTC would be suitable, if they:  – Are breastfeeding – Are obese – Are over 45 years old – Have been taking certain medicines (e.g., oral contraceptives, unopposed oestrogen or tamoxifen) – Have diabetes – Have an unknown cause for their irregular menstrual bleeding – Have polycystic ovary syndrome – Have a history of endometrial cancer in a first-degree relative (e.g., parent or sibling)
Contraindications	Tranexamic acid OTC is not recommended in the following and the person should be referred if:  – Taking warfarin, other anticoagulants or oral contraceptives – In people under 18 years old – In people who are pregnant Or in people with:  – Mild to moderate renal insufficiency or severe renal impairment. – Active thromboembolic (blood clot) disease, previous thromboembolic event and a family history of thrombophilia (blood disorder) – only use under medical supervision. – Haematuria (blood in urine). – Irregular menstrual bleeding (i.e., more than three days variability in each cycle or if the cause is unknown). – Fibrinolytic conditions following disseminated intravascular coagulation (abnormal blood clotting throughout blood vessels). – A history of convulsions (fits and seizures). – Hypersensitivity or allergies to tranexamic acid or any of the other ingredients.
Side/adverse events	Common: – Nausea – Vomiting – Diarrhoea Uncommon: – Allergic skin reactions If the person experiences the following symptoms, they should be advised to stop taking tranexamic acid and immediately referred to a prescriber:  – Eye – visual disturbance, impaired vision or loss of vision. – Thromboembolic events (blood clots) – throbbing pain or swelling in the legs or arms, sudden breathlessness, sharp chest pain, coughing up blood. – Convulsions. Very rare: – Hypersensitivity including anaphylaxis – Gastrointestinal disorders Report any suspected side effects via the Yellow Card scheme as appropriate.
Interactions	People should be aware if taking:   – Other fibrinolytics – counteracts the thrombolytic effects of other fibrinolytics. – Warfarin or other anticoagulants. – Oral contraceptives – may increase the risk of thrombosis. Refer anyone with a clinically relevant interaction to their prescriber, using your professional judgement.
Pregnancy and breastfeeding	– If breastfeeding, see your prescriber first. – Cannot be used in pregnancy.
Age	– For use in adult women over 18 years old.
Storage	– Store below 25°C and keep in the original packaging.

Heavy menstrual bleeding

Menorrhagia is excessive menstrual blood loss which interferes with a woman’s physical, social, emotional and/or material quality of life. It can occur alone or in combination with other symptoms. It can be normal for a person to have heavy periods and they may be heavy at certain times, e.g. (at the start of your period, after pregnancy or during menopause.

Research has shown that the average menstrual blood loss is 30ml to 40ml each cycle, however, women who experience heavy bleeding may lose 80ml or more. As this is impractical to measure and often does not correlate with the impact on quality of life, heavy bleeding will often be determined by the patient.

Some signs of heavy bleeding may include:

• Bleeding through clothes or bedding.
• Frequently needing to change sanitary towels, tampons or empty menstrual cups (e.g., every 1–2 hours). 
• Needing to use more than one type of sanitary product at once (e.g., tampons and pads).
• Passing large blood clots (e.g., more than 2.5cm).
• Impact on normal daily activities (e.g., exercise and work). 

Some possible causes may include:

• Polycystic ovary syndrome
• Fibroids and polyps 
• Endometriosis and adenomyosis 
• Pelvic inflammatory disease
• Some medicines (e.g., anticoagulants and chemotherapy, antiplatelets, non-steroidal anti-inflammatory drugs, selective serotonin reuptake inhibitors) and herbal supplements (such as ginseng, ginkgo and soya)
• Stress and depression
• Coagulation disorders (e.g., von Willebrand disease)

Heavy bleeding can often be a cause of iron-deficiency anaemia. Patients that present with signs or symptoms of this should be referred to their prescriber. 

Pharmacists should be aware that irregular bleeding, abnormal bleeding, bleeding between periods or over prolonged periods could be a sign of endometrial cancer. Bleeding between periods, pain during sex, bleeding after sex and bleeding after menopause could be signs or symptoms of cervical cancer.

Alternative treatments  

People should also be made aware of all the treatment options available in addition to tranexamic acid, as something else may be more suitable. Consider referring the person to their doctor if alternate treatments are more suitable. 

Other drug treatments and non-medical treatments include: 

• Hormonal treatments (e.g., oral progestogens, combined oral contraceptives and levonorgestrel-releasing intrauterine system)
• Non-hormonal treatments (e.g., nonsteroidal anti-inflammatory drugs)
• Surgical treatments

The choice will depend on the cause, the individual and their response to treatment.

For further information on alternative treatments, see NHS England’s decision support tool: making a decision about managing heavy periods document and the National Institute for Health and Care Excellence’s (NICE) Clinical Knowledge Summaries (CKS) page.

Confidence in consultation skills 

Discussing symptoms of heavy menstrual bleeding may be uncomfortable for some people, who may feel nervous approaching the pharmacy team. To ensure comfort and confidence, you and the pharmacy team should always be discreet, non-judgemental and put the person at ease. 

You can supply P medicines or supervise their supply. If the request needs to be referred to you by counter staff, they’ll need suitable training to handle such circumstances (see the section on education for pharmacy teams), since they’re usually the first point of contact. Referral should also be covered in your standard operating procedure (SOP). 

To support these conversations, good communication is essential. Develop your confidence with practical tips and information in our consultation skills pharmacy guide.

Education for pharmacy teams 

Ensure the pharmacy team is trained and has read any relevant SOPs and training guides.  

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

You and your team may want to practise roleplay scenarios to gain confidence and familiarise yourselves with the consultation process for tranexamic acid.  

Further information 

Clinical 

• NICE CKS
• NHS.UK
• Patient
• BNF
• electronic medicines compendium – SPC and PIL
• Evana – pharmacy checklist/guide

Consultation skills 

• Centre for Pharmacy Postgraduate Education.
• Health Education and Improvement Wales.
• NHS Education for Scotland
• RCPharm – confidence in consultation skills
• RCPharm – counselling patients guide