Decision-making process and flowchart 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 prescreening, education and supply. Explore the person’s situation by considering and asking the following:

• Who is requesting a supply? Is it the person who needs the medicine or a representative?
  • Supply to the person needing the medicine – is the person needing the medicine of childbearing potential and age? Ensure you are supplying the medicine in accordance with the marketing authorisation.
  • Supply to the person’s representative – see the section on supplying to a person’s representative.
• Are they already on any other form of contraception?
  • Consider whether the person can switch to desogestrel or whether they should continue with their current contraception method.
• Have they already been prescribed desogestrel?
  • Desogestrel can still be purchased over the counter (OTC) 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) (see our guide on emergency supply). 
• Have they already been supplied desogestrel 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 desogestrel 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 it is a reason for referral.
• Are they aware of all the other options available to them, including long-acting reversible contraceptives (LARCs)?
  • See the section on alternative contraception options and sexual health advice.

If you and the person requesting the medicine are happy to continue with the supply, use our decision-making flowchart for supplying desogestrel 75 microgram film-coated tablets.

Decision-making flowchart

Use our short and easy-to-read flowchart. This can help you with questions and you may consider it appropriate to assess suitability of supply. You can also print it out to use as an aide-memoire.

The flowchart can also be used in combination with the following sections in this guide to help support you to develop your consultation skills: 

• Decision-making process for supply
• Summary of product information
• Counselling

For requests for a repeat supply see repeat supply requests.

Note: For useful practical tips on having a good consultation, you may want to refer to confidence in consultation skills.

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 Lovima and Hana (desogestrel) has published risk materials, including pharmacy guides, checklists, a supply algorithm and a pregnancy exclusion tool, which you may find useful. For further information, see the relevant product SPC and product information leaflet (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

For details on maximum quantities you can sell, see the relevant product SPC. For example, the manufacturer of Lovima and Hana advises:

• First supply – up to three months could be supplied.
• Repeat supply – up to 12 months could be supplied.
• People of childbearing potential under the age of 18 – up to three months could be supplied.

Repeats

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

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. This will determine if a repeat supply is suitable or not.

Consider the following questions to assess continued suitability: 

• Have there been any changes in their health or medical conditions since their last supply?
  • Have there been any changes to their medicines (including prescribed, OTC, herbal products, complementary, vitamins, dietary supplements, recreational, alcohol and tobacco) since their last supply?
• Have there been any changes in their periods that concern them?
• Have they 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.

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 to maintain the confidentiality of the person.

Consider the following:

• Who is requesting on the person’s behalf and why – are there any potential safeguarding issues raised? See the section on vulnerable adults and children.
• How will you ensure that the treatment is clinically appropriate for the person needing the medicine (e.g. check contraindications, referrals, medical history and existing medicines)?
• How can you get in touch with the person to assess suitability and determine whether the request is appropriate and genuine (e.g. phone call)?
• Be careful not to disclose to the representative what was previously discussed, unless you have consent from the person needing the medicine to do so.
• Are you supplying the medicine within the marketing authorisation (e.g. ensure that the person is of childbearing potential and age, using it as oral contraception and that pregnancy is ruled out with reasonable certainty)?

Counselling

Advise the person to read the PIL and packaging as a reminder of key safety messages. You may also find the Hana resources and Lovima risk materials under further information useful to support counselling, which includes pharmacy checklists and guides.

Discuss the following:

• The medicine – what it is, how it works, how to use it (including the importance of adherence) and pros and cons.
• Side/adverse effects and risks – make sure the person is aware of what signs and symptoms to look out for and when to seek medical attention and advice.
• Missed pill rules – make sure the person is aware of what to do if pills are missed.
• Diarrhoea and vomiting – make sure the person is aware of what to do if diarrhoea or vomiting occurs.
• Contraception options – make sure the person is aware of all contraception method options available to them, including LARCs, provide written information if requested and refer to a prescriber or family-planning clinic if the person is interested in LARCs.
• Sexual health – provide sexual health advice where appropriate, including sexually transmitted infections (STIs), condom use, the importance of breast examination, cervical screening and where to signpost to.
• Health promotion – provide general lifestyle and wellbeing advice where appropriate, including diet, exercise, smoking cessation, weight and blood pressure (BP) management (consider taking a baseline body mass index and BP measurement as good practice).
• Further supplies – make sure the person is aware of how to obtain further supplies.
• Interactions – make sure the person knows to check interactions with a pharmacist before starting any new medicines.
• Referrals – make sure the person is aware of when to see a prescriber.
• Advising prescriber – make sure the person is aware that they need to inform their prescriber that they are on Lovima/Hana as soon as possible, so that their medical records can be updated to support future prescribing and check 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 
• 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 by a reputable provider before purchasing (see the General Pharmaceutical Council’s (GPhC) guidance on providing pharmacy services online). 
• Storage and disposal – advise the person to return any unused medicines to a pharmacy for disposal.
• Online pharmacies – online pharmacies need to meet GPhC regulatory standards for providing services at a distance. For further information, see GPhC guidance on providing pharmacy service at a distance, including on the internet and GPhC standards for registered pharmacies.
• Delivering and posting medicines – the Medicines, Ethics and Practice (MEP) guide covers some additional points about 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:

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

If you decide to make a record, make sure you get the person’s consent. You may also find our pharmacy guide on clinical documentation useful.

Summary of product information

The table below provides some product information on desogestrel 75 microgram film-coated tablets for supply as a P medicine. 

Make sure to refer to the full up-to-date product details and risk information in the relevant SPC and the British National Formulary, found under further information.

Indication	– Lovima: oral contraception for people of childbearing age, including adolescents, who are not pregnant and where pregnancy is ruled out with reasonable certainty. – Hana: oral contraception for people of childbearing age, who are not pregnant and where pregnancy is ruled out with reasonable certainty. The SPC for Lovima and Hana advises there is no data on safety and efficacy in adolescents under 18 years, and so the benefits and risks of supplying under this age group should be carefully considered.
Dose	– Take one tablet at the same time daily (every 24 hours). – Take continuously without breaks between packs.
Administration	New: start on day one of period. Can start on days two to five, but will need to use an additional barrier method (e.g. condom) for first seven days. Continue: start taking the day after, without a break from the previous pack. After education, health and care: – Levonorgestrel: Start straight away and use an additional barrier method (e.g. condom) for seven days. – Ulipristal: Wait five days after taking ulipristal (desogestrel can stop ulipristal working) and use an additional barrier method (e.g. condom). Then start desogestrel and continue using an additional barrier method for a further seven days (12 days of additional barrier-method use in total). After childbirth: if periods have started, start as ‘new’. – More than 21 days after delivery – start straight away. – Less than 21 days after delivery – first exclude pregnancy. If pregnancy is ruled out with reasonable certainty, start straight away and use an additional barrier contraception (e.g. condom) for the first seven days. After miscarriage or abortion: start straight away or within five days of miscarriage or abortion.
Switching	From the following to desogestrel: – Combined oral contraceptive – start taking day after the last active tablet – Vaginal ring, cap, patch – start day of removal. Use an additional barrier method (e.g., condom) for seven days if desogestrel started during the break in the above methods. – POP – start taking day after – Long-acting reversible contraception – start taking on day of removal or when next injection due.
Diarrhoea and vomiting	– If the person vomits within three to four hours of taking a dose, follow missed pill rules. – If vomiting or diarrhoea persists, use an additional barrier method (e.g. condom) for as long as the vomiting or diarrhoea lasts, and for seven days after it stops.
Missed pill	<12 hours: If the person misses a pill and is less than 12 hours late, they should take the pill immediately. They are still protected and do not need to use additional methods of contraception. >12 hours: If the person is more than 12 hours late, they are no longer protected against unwanted pregnancy. They should take the missed pill as soon as they remember and then take their next pill as normal (even if that means taking two in one day). They will need to use an additional barrier method (e.g. condom) for the next 48 hours.
When to refer	People should be referred to a clinician/prescriber if there is any doubt that the medicine is suitable for them and there are no other alternative OTC products available, or if the person: – Is pregnant. – Has a contraindication. – Is taking a medicine that causes a clinically relevant interaction in your professional judgement. – Is concerned with their bleed pattern.  – Has a history of thrombosis or breast cancer. – Has diabetes. – Has uncontrolled hypertension. – Experiences any serious side effects or signs and symptoms of adverse effects (e.g. depression, thrombosis, allergy, liver disease, breast cancer or ectopic pregnancy). – Is due to have surgery or is immobile. – If there is any doubt the person is suitable for supply (e.g. the person has previously tried POP, it didn’t suit them, and they can’t remember why, but they would like to try it again).
Contraindications	Desogestrel 75 microgram tablets OTC is not recommended in the following, and the person should be referred if they: – Have an active thrombosis (blood clot). – Have an active or history of liver disease or liver cancer. – Have an active or suspected sex-steroid sensitive cancer, e.g., breast, uterine or ovarian cancer. – Have any undiagnosed vaginal bleeding. – Are allergic or intolerant to any of the ingredients, including lactose, soya or peanut (please note: Hana does not contain soya bean oil. However, Lovima does contain soya bean oil and should therefore not be taken by people with soya or peanut allergy). – Are pregnant. For further information, see the relevant product SPC and educational risk materials.
Side/adverse effects	Common: – Irregular bleed patterns (reassure the person that irregular bleeding is normal and temporary, but if it is severe or persists or they are concerned then to see their prescriber). – Altered mood – Depressed mood – Libido decreased  – Headaches  – Nausea – Acne – Breast pain/tenderness (reassure the person that breast tenderness is normal and temporary but if it is severe or persists or they are concerned then to see their prescriber). – Amenorrhoea – Weight changes Uncommon: – Vaginal infection – Contact lens intolerance – Vomiting – Hair loss – Dysmenorrhoea – Ovarian cyst – Fatigue Rare: – Rash – Urticaria Other risks include ectopic pregnancy and increased breast cancer risk.
Interactions	People taking the following could be at increased risk of systemic side effects – CYP3A4 inhibitors and hepatic enzyme-inducing medicines such as: – Anti-convulsants – St John’s-wort – Antibiotics and antivirals – Endothelin receptor antagonists List is not exhaustive. For further information, see the BNF, Stockley’s Drug Interactions, and relevant product SPC and educational risk materials. It would be best practice to use your professional judgement to regularly check interactions with people’s concurrent medicines (including prescribed, OTC, herbal, complementary, vitamins, dietary supplements and other topical products) in case they are of clinical relevance and they need referral to a prescriber.
Pregnancy and breastfeeding	– Can be used while breastfeeding. – Cannot be used in pregnancy – pregnancy must be ruled out with reasonable certainty before supply.
Age	Lovima is licensed as oral contraception for people of child-bearing age and potential, including adolescents. Hana is licensed as oral contraception for women of child-bearing age. The SPC for Lovima and Hana advises there is no data on the safety and efficacy in adolescents under 18 years and so the benefits and risks of supplying under this age group should be carefully considered. See the vulnerable adults and children section for more information.

Alternative contraception options and sexual health advice

Types of contraception

There are many contraception options available, including both hormonal and non-hormonal contraceptives. See the latest National Institute for Health and Care Excellence (NICE) guidance on the different methods of contraception, including their advantages and disadvantages, and NICE’s comparison of the effectiveness of different contraception methods.

When discussing contraception, it’s important to discuss all options of contraception available and their advantages and disadvantages, including LARCs.

Consider the following when supporting people to choose the right contraception for them:

• Effectiveness
• Adherence
• Benefits and risks
• Side effects
• How to use
• Personal preference
• Future plans for pregnancy
• Comorbidities and concurrent medicines that might affect the method of contraception

Pharmacists may find the College of Reproductive and Sexual Healthcare (CoSRH, formerly the Faculty of Sexual and Reproductive Healthcare) UK Medical Eligibility Criteria for Contraceptive Use (UKMEC) document useful to see what contraceptives could be safely recommended based on the person’s medical condition(s).

Ensure the person has enough information to make an informed choice about the options available to them. The following resources may also support you with these discussions:

• Family Planning Association – to buy patient leaflets on contraception for the pharmacy.
• World Health Organization Contraception – factsheets for patients in different languages.

Sexual health

When discussing contraception, you should consider using this as an opportunity to discuss general sexual health, where appropriate.

LARCS, diaphragms and caps, oral hormone pills, patches and rings don’t protect against STIs and HIV. Only condoms help to protect from some STIs.

You and your teams should be aware of, and provide information on, local services offering advice on contraception, free contraceptive services, follow-up care, testing and screening for STIs.

You and your teams could also use this as an opportunity to promote chlamydia, cervical smear and breast checks, where appropriate.

Moral beliefs

If your religious or moral beliefs impact your willingness to supply oral contraception, inform your employer, your locum agency and the colleagues you will be working with as soon as possible.

GPhC guidance on religion, personal values and moral beliefs describes the factors to consider if a person requests a supply of oral contraception and the questions you should ask yourself so you can ensure person-centred care. 

Referral is an option, but it may not always be possible. The GPhC has outlined factors to consider when deciding whether a referral is appropriate. Employers and pharmacy professionals need to work together to consider a broad range of situations.

Vulnerable adults and children

You should be aware of important issues, such as abuse (non-consensual intercourse), child protection, vulnerable adults, consent and confidentiality.

In some circumstances, requests for oral contraception could be linked to non-consensual intercourse of children or vulnerable adults. 

If questioning during a consultation leads you to believe that a child or adult has a safeguarding issue, refer to your local safeguarding policy. You may also find our pharmacy guide on safeguarding useful.

The Department of Health and Social Care has published a document called Responding to domestic abuse: a resource for health professionals, which provides practical advice on dealing with domestic abuse, keeping records, confidentiality and sharing information.

The Department for Education has published a guidance document called Working together to safeguard children: statuary guidance, which includes sections for healthcare professionals (HCPs) on referral.

The supply of Lovima or Hana to under 16s is not contraindicated by the manufacturer. The SPCs of Lovima and Hana advise there is no data on the safety and efficacy in adolescents under 18 years, and so the benefits and risks of supplying this age group should be carefully considered. However, you may wish to consider the following additional factors:

• Children under the age of 13 are legally too young to consent to any sexual activity. Instances should be treated seriously and reported to social services, unless there are exceptional circumstances backed by documented reasons for not sharing information.
• Sexual activity with children under the age of 16 is also an offence, but may be consensual – the law is not intended to prosecute mutually agreed sexual activity between young people of a similar age, unless it involves abuse or exploitation.
• You can provide contraception or sexual health advice to a child under 16, and the general duty of confidentiality applies.
• Where there is a decision to share information, consent should be sought whenever possible prior to disclosing information. This duty is not absolute, and information may be shared if you judge on a case-by-case basis that sharing is in the child’s best interest (e.g. to prevent harm to the child or where the child’s welfare overrides the need to keep information confidential).
• Remember that it is possible to seek advice from experts without disclosing identifiable details of a child and breaking confidentiality – where there is a decision to share information, this should be proportionate.

Confidence in consultation skills 

Some people 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 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. Referrals should also be covered in the standard operating procedure (SOP).

To support these conversations, good communication is essential. Develop your confidence with practical tips and information in our confidence in consultation skills pharmacy guide. You may also find our resource on facilitated self-selection of pharmacy (P) medicines helpful.

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, family planning and sexual health clinics. Consider keeping a list in the pharmacy to refer to for signposting.

You and your teams may want to practise roleplay scenarios to gain confidence and familiarise yourselves with the consultation process for oral contraception.  

Further information and educational materials can be found in the relevant product SPCs and further information section, which includes:

• Lovima HCP training guide 
• Lovima pharmacist checklist 
• Hana pharmacy training guide 
• Hana online pharmacy training 
• Hana pharmacy supply aid checklist.
• Hana pharmacy supply algorithm
• Hana pregnancy exclusion tool
• Hana contraceptive options leaflet
• Hana point-of-sale materials.

Further information

Hana

• Hana
• Lovima:
  • electronic medicines compendium
  • Lovima HCP website
  • Lovima risk materials

Clinical

• CoSRH
• CoSRH POP guideline
• CoSRH – UKMEC
• CoSRH – Contraception for Women Aged over 40 Years.
• NICE – Contraception
• NICE Clinical Knowledge Summaries (CKS) Contraception – assessment.
• NICE CKS Contraception – progestogen-only methods.

Consultation skills 

• Centre for Pharmacy Postgraduate Education
• Health Education & Improvement Wales
• NHS Education for Scotland
• RCPharm confidence in consultation skills

Safeguarding

• RCPharm safeguarding

Health promotion

• RCPharm – statement on women’s health

Breast awareness

• NHS
• Breast Cancer Now
• Coppafeel!

Cervical screening

• NHS

Chlamydia

• NHS

General lifestyle and wellbeing advice

• NHS