To support the POM to P switch of the oral contraceptive desogestrel, we summarise the key points, signpost to useful tools and highlight good practice for pharmacists
Pharmacists already have well developed consultation skills built up over 20 years of safely supplying emergency hormonal contraception — so the OTC supply of desogestrel is a natural extension of this important public health role.
Desogestrel OTC is a progesterone-only pill (POP), which is taken at the same time every day. It inhibits ovulation and increases the volume and viscosity of cervical mucus, preventing sperm from entering the uterus. If used consistently and correctly it is more than 99 per cent effective.
Desogestrel is thought to be more effective than traditional POPs such as norethisterone and levonorgestrel, especially with typical use, because ovulation is suppressed more consistently, and it has a longer ‘missed pill window’ (12 rather than three hours). It can be used in women up to 55 years of age.
Lovima 75mcg film-coated tablets (from POM to P specialist Maxwellia) and Hana 75mcg tablets (manufactured by HRA Pharma) have both now been launched as P medicines.
Responding to a request for Hana or Lovima
Just as pharmacists did with EHC, you will develop a conversational way of getting the information you need and gradually become more efficient at managing consultations. A woman may ask for a specific brand of OTC desogestrel, for “the new pill” or even “the mini-pill”.
Presenting the consultation in three linked parts, each with a specific purpose, we provide suggested questions to help with this approach.
Part 1: Can OTC desogestrel be considered?
This will save time by helping you to decide whether to proceed further. For example:
“I need to ask you some questions before I can sell it to you. Would you like to go into the consulting room so that we have more privacy? Some of the questions may seem personal but I have to make sure that this pill is right for you. Are you OK for me to go ahead? First, do you mind me asking you the year when you were born?”
- Hana pharmacy supply algorithm with decision tree for under-16s and over-16s
- Lovima age and safeguarding considerations
- RPS – Vulnerable Adults and Children.
Then: “I need to ask whether you’re aware of your different contraceptive options?”
- Lovima types of contraception.
You could show a list here and might also want to mention the cost of desogestrel OTC in case it is not affordable for this woman.
“Next I need to check – could you possibly be pregnant?”
If pregnancy cannot be ruled out “with reasonable certainty”, desogestrel OTC should not be supplied.
- Hana – pregnancy exclusion tool
- Lovima – ‘Could she be pregnant?’ resource.
Part 2: Is referral needed?
This rules out the small number of occasions when referral might be necessary.
- Lovima – Six key questions & pharmacy consultation checklist
- Hana pharmacy supply aid checklist
- RPS decision flowchart for supply.
“Next I need to ask you some questions to check that it will be OK for you to take the OTC pill”
1. “Do you have any medical conditions?” (If yes, you might want to use a card with the questions listed below. Refer if the answer to any of these is yes.)
- Do you currently have a thrombosis (blood clot) and have you ever had one in the past?
- Do you currently have or have you ever had severe liver disease or liver cancer?
- Do you currently have breast cancer or cancer of the uterus or ovaries? Have you ever had any of these?
- Do you have diabetes and/or high blood pressure that is not under control?
2. “Do you ever have bleeding between periods or that happens regularly after sex and, if you do, have you seen a doctor or nurse about it?” (If yes, refer)
3. “Are you taking any medicines or herbal products?” (checking for those with a clinically important interaction with desogestrel, in which case refer)
4. “Have you ever had an allergic reaction or intolerance to peanuts, soy or lactose?” (Lovima contains soya bean oil; both Hana and Lovima contain lactose.) If referral is not needed, proceed to counselling and supply desogestrel OTC.
Part 3: Counselling and supply of OTC desogestrel
Make sure you are familiar with the patient information leaflet for both Hana and Lovima. Use the PIL to point out the relevant information. Let’s now break down the consultation further.
Explaining how to take desogestrel
Table 1 highlights some of the circumstances why a woman may be requesting desogestrel.
The training materials for Lovima and Hana deal with each of these situations and also include specific instructions on starting contraception after childbirth or after a miscarriage or abortion.
Advice for all desogestrel OTC users:
- Take the pill at the same time each day. Make use of phone reminders or an app to remind you and record taking it
- When the pack is finished go straight onto the next pack without a break.
A detailed explanation of side-effects and adverse effects is included in the training materials from both companies.
Use the PIL and point out the relevant section. The commonest side-effect is altered bleeding patterns, likely to be experienced by up to half of women taking desogestrel OTC.
Young women in particular may be concerned about changes if they are not adequately counselled. Bleeding may become more frequent in 20-30 per cent of women and less frequent or totally absent in 20 per cent. In the former group bleeding tends to become less frequent and settle after a few months.
Things that reduce pill efficacy
Use the PIL to show how the pill’s efficacy can be reduced (see table 2).
Note: Drugs that are moderate or strong inhibitors of CYP3A4 liver enzymes and are being taken long-term can reduce the clearance of desogestrel and may increase the risk of an adverse effect (see RPS guidance/Hana and Lovima training).
Sexual health advice
Pharmacists are well used to offering sexual health advice alongside supply of EHC. The Hana and Lovima training materials cover this well.
Future supplies of OTC desogestrel
First supply – up to three months, with repeat of up to 12 months next time. If the woman is aged under 18 years, give up to three months’ supply for initial and repeat supplies. You might want to offer reminders when the next supply date is due and discuss the most convenient way to receive future supplies from your pharmacy.
Frequently asked questions by pharmacists...
- Do I need to go through a full consultation every time a woman requests a repeat supply?
You will need to use your professional judgement when dealing with repeat supply requests,
for example by asking (or using a list of questions on a card):
“Has anything changed...
- in your health or medical conditions since you last got the pill?
- in your medicines (on prescription; bought OTC), herbals or supplements since last time?”
“Have there been any changes in your periods that concern you?”
“Have you been experiencing anything that you think might be a side-effect?”
- Can I supply OTC POP to a young woman who is under 16 years of age?
In the same way as for EHC, this will be based on your professional judgement and subject to guidance about vulnerable adults and children.
(Guidance: RPS Vulnerable Adults and Children; Faculty of Sexual and Reproductive Health Contraceptive Guidance for Young People).
- Can I supply to the person’s representative?
Yes – if in your professional judgement this is appropriate. (Guidance: RPS Supply to the Person’s Representative).
- Should I measure the woman’s blood pressure before supplying?
Pharmacists are not expected to check blood pressure before the first supply or at repeat requests but it has been suggested that this would be good practice. Uncontrolled hypertension would be a reason for referral.
- If the woman requests EHC and also asks about the OTC contraceptive pill, can I supply both?
Yes, but bear in mind that if ulipristal is taken concurrently with desogestrel POP, then the efficacy of both may be reduced (because both bind to progesterone receptors).
If you recommend ulipristal, the desogestrel POP should be started five days after taking the EHC and barrier contraception should be used until then and for a further seven days until the desogestrel contraceptive effect is established.
Desogestrel POP can be started or restarted on the same day as emergency contraception containing levonorgestrel.
- Do I need to keep a record of supply for reference at repeat requests?
There is no expectation that pharmacists will make a record of OTC POP supplies. The RPS
suggests that it is good practice for pharmacists to measure baseline BP and BMI, and record these with the patient’s consent (Guidance RPS – Counselling).
There is currently no evidence suggesting a relationship between the POP and weight gain, although it is a commonly reported side-effect. The RPS also advises that pharmacists who wish
to make records for audit purposes can do so with the woman’s consent.
- Do all women with diabetes who request desogestrel have to be referred to the GP?
Yes, as a safety precaution. Although there is no evidence that the therapeutic regimen in diabetes (type 1 or type 2) needs changing during POP use, there is some evidence that progestogens can decrease glucose tolerance. The patient’s prescriber should therefore keep an eye on the diabetes during the first months of POP use.
- Will local surgeries be aware of the OTC supply of desogestrel?
As always with POM to P switches it is good practice to let your local surgeries know about the switch, and when and why you will be referring patients to them. Manufacturers’ training materials state that pharmacists should advise the woman to let her GP know that she is taking an OTC desogestrel POP so that they can take potential interactions into account. The RPS suggests that pharmacists ask the woman if she would like them to inform the GP on her behalf.
- What should I say about confidentiality of information if I make a supply to someone who is under 16 years of age?
Your general duty of confidentiality applies. This duty is not absolute and information can be shared if in your professional judgement it is in the person’s best interest (see RPS Guidance Vulnerable Adults and Children).
- Can desogestrel OTC be bought online?
Yes. The Hana and Lovima websites provide access to online pharmacy supply.
- Can I use this desogestrel OTC training for revalidation?
In a reflective account the training can showcase your leadership, communication and professionalism skills. Overseeing the training and involvement of your team members, developing your pharmacy’s consultation framework and liaising with local GP practice/s might be elements you could include.