Atovaquone

Atovaquone and proguanil hydrochloride are antimalarials. They work by killing the parasite. 

Decision-making process for supply

Step one: request a full travel itinerary. When people come to you seeking antimalarials, it’s important to first ask them for their full travel itinerary, including travel between areas. This is to ensure they receive the correct prevention against malaria. 

People revisiting an area should not assume that they will require the same antimalarial as before – for information on repeat supplies, see the section on quantity to supply and repeat requests.

Step two: check which antimalarials are required and suitable for the location and person requesting. Not all antimalarials will suit everyone. The following factors will determine the most appropriate antimalarials:

• Age of person/people travelling
• Area of travel
• Current medicines (interactions)
• Existing medical conditions
• Preference
• Pregnancy and breastfeeding status
• Time of year of travel
• How long they are staying in each area

To check which antimalarial(s) are suitable for the area of travel, you should use the most up-to-date resources. Malaria-endemic areas vary by season and over time, and resistant strains are spreading. You may find the following resources and tools helpful: 

• TravelHealthPro (England and Wales).
• UK Malaria Expert Advisory Group (UKMEAG) malaria prevention guidelines for travellers from the UK include a template for risk assessment and a summary of advice given, which pharmacists may find helpful when carrying out patient consultations.
• Maloff Protect educational risk minimisation materials, including a screening questionnaire, are available from the electronic medicines compendium (emc).

The choice of antimalarial will depend on the malaria species common in the area to be visited and whether there is resistance to any of the available medicines.

If bite avoidance and malaria prophylaxis and more than one antimalarial option is available, you should discuss all options with the person – see alternative treatments.

If bite avoidance alone is required, provide bite avoidance advice and travel advice where appropriate. 

Step three: follow the process for supply below where atovaquone 250mg/proguanil hydrochloride 100mg OTC is recommended.

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 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’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 over 40kg? 
• Is the person hypersensitive to any of the active ingredients or excipients in atovaquone 250mg/proguanil hydrochloride 100mg OTC? 
• Do they have any health or medical conditions and are they taking any medicines?
  • Check for contraindications, interactions and any reason for referral.  
• Have they already been supplied atovaquone 250mg/proguanil hydrochloride 100mg 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 any other antimalarials 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.  
• 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 Maloff Protect has published risk materials including a pharmacy checklist, pharmacy guide, pharmacy screening questionnaire and explanatory sheet, which you may find useful. For further information, see the relevant product summary of product characteristics (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, see the SPC. For example, the manufacturer of Maloff Protect recommends that: 

• The maximum daily dose is one tablet.
• Maloff Protect can be supplied without prescription for a maximum of 12 weeks (approximately three months).
• If the person needs Maloff Protect for longer than 12 weeks, you should refer them to a prescriber.

Ensure you provide the correct pack(s) of medicine to cover the required course length. You may also find the Maloff Protect pack-size calculator useful which can be found under risk materials under further information.

Repeats 

People revisiting an area should not assume that they will require the same antimalarial as before.

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.

Requests for repeat supplies for antimalarials within a short timeframe may be required as an exception. For example, the person may have an unplanned extension to a holiday and not obtained enough medicine OTC initially, therefore need a further supply to cover the full holiday period.

You would need to use your professional judgement on a case-by-case basis in these scenarios to determine if a repeat supply is suitable or if they’ll need a full consultation. People may not have evidence of previous supplies so this shouldn’t be the only deciding factor when making a repeat supply.

These questions may help you assess continued suitability: 

• Where are they travelling to? Check the itinerary of all travellers needing the medicine.
  • If it is for a different destination – they would require a new consultation, follow the steps in the section on decision-making process for supply.
  • If it is for the same destination, check the same medicine and recommendations still apply – follow steps one, two and then three (if applicable) in the section on the decision-making process for supply. 
• If it is the same destination, when did you last go to that area?
  • For example, they could have stopped taking the medication because they left the area and after a short break returned to the area and need to start them again.
• Requests for antimalarials for a separate period of travel would require a new consultation. 
• Have there been any changes in their health or medical conditions since your last supply (see the when to refer section)?
  • Have there been any changes to your medicines (including prescribed, OTC, herbal products, complementary, vitamins, dietary supplements, recreational, alcohol and tobacco) since your last supply (see the interactions section)?
• Have you been experiencing any side effects?
  • Serious side/adverse effects may require immediate withdrawal and referral to the prescriber. 

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

If you feel the supply is suitable, provide counselling.

Supply to the person’s representative

Atovaquone 250mg/proguanil hydrochloride 100mg 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 medicines.
• 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 an adult and using it for the prevention of malaria. 

Counselling 

Advise the person to read the PIL and packaging as a reminder of key safety messages. You may also find the Maloff Protect risk materials under further information useful to support with counselling, which includes a pharmacy checklist, pharmacy guide and user reminder card.

Discuss the following: 

• The medicine – what it is, how it works and how to use it.
• Adherence – remind the person of the importance of taking antimalarials regularly and completing the course to reduce the risk of resistance. 
• 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). 
• Effects on driving – may cause dizziness. If affected, don’t drive, operate machinery or undertake activities where this may put themselves or others at risk.
• Vomiting and diarrhoea – see the section on vomiting and diarrhoea. 
• Missed dose – see the section on missed dose.
• Sharing of medicines – advise people that the medicine supplied is for the sole use of those the consultation was completed for.
• Bite avoidance – provide information on bite avoidance (see the section on bite avoidance).
• Change of travel plans – advise people that if their travel plans change, they will need to seek updated travel advice, as their current antimalarial may no longer be a suitable medicine.
• Malaria awareness – advise people on the risk of malaria if travelling to endemic areas by checking the most up-to-date resources before travel:
  • Acquired immunity – settled immigrants or long-term visitors to the UK may be unaware that any immunity acquired while living in the endemic area is lost rapidly after migration to the UK. The area they lived in before may not have been malarious at the time but may be now.
  • Standby treatment – if the person is travelling to remote, malarious areas for prolonged periods, and are likely to be away from medical assistance for more than 24 hours, you should advise that they carry standby treatment in case they become infected (refer to a prescriber for supply).
• Diagnosing malaria and seeking help early – educate people on the symptoms of malaria and when to seek medical assistance. You should advise them to seek medical assistance immediately if they experience any symptoms of malaria while travelling, within one year (and especially three months) of return from a malarial area and to inform the doctor of possible exposure to malaria (see the section on malaria).
• Provide full travel advice – see the section on travel advice. If you are unable to provide this, refer to a provider that can, including advice on vaccinations.
• Further supplies – make sure the 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 logos). 
• Storage and 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 (see the GPhC guidance on providing pharmacy service at distance, including on the internet, and GPhC standards for registered pharmacies).
• 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: 

• Details such as the travel itinerary
• Product supplied
• 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 atovaquone 250mg and 100mg proguanil hydrochloride for supply as P medicines.

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	– Preventing plasmodium falciparum malaria (especially recommended if the patient resistant to other antimalarials). – For use in adults over 18 years old, weighing more than 40kg.
Dose	– Take a maximum of one tablet daily. – Start one to two days before entering the malaria endemic area and continue for the duration of the stay and for seven days after leaving the area. – Take at the same time daily. – Take with food or a milky drink, but can also take on an empty stomach if food isn’t tolerated (reduced absorption). – Should preferably be taken whole and not be crushed. – Can be used for up to 12 weeks.
Vomiting and diarrhoea	– If the person vomits within one hour of taking a dose, the dose should be taken again. – If the person has diarrhoea, normal dosing should be continued. – In addition, use bite avoidance measures (repellents and bed nets), as the medicine’s absorption and effectiveness may be reduced.
Missed dose	– If the person forgets to take a dose, they should take it as soon as they remember then continue the course as planned. – Advise people not to take two tablets together as this could increase the chance of side effects. – It’s important not to miss a dose to maintain effective levels in the bloodstream.
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:   – Has a contraindication. – Experiences any side effects. – Is pregnant, planning to become pregnant or breastfeeding. – Is taking or using medicine(s) which has a clinically significant interaction. – If there is any doubt a person is suitable for supply. – Has a history of depression or seizures. – Has tuberculosis. – Needs quantities to cover longer than 12 weeks’ travel. – Weighs less than 40kg.
Contraindications	– Atovaquone 250mg/proguanil hydrochloride 100mg OTC is not recommended in the following and the person should be referred: – If the person has renal impairment of any severity. – If the person has hepatic impairment of any severity. – If the person is under 18 years old (children and adolescents). – If the person has hypersensitivity or allergies to atovaquone/proguanil hydrochloride or any of the other ingredients.
Side/adverse effects	Very common: – Headache – Nausea and vomiting – Abdominal pain – Diarrhoea Common: – Anaemia – Allergic reaction – Hyponatraemia – Anorexia – Abnormal dreams – Depression – Insomnia – Dizziness – Pruritus – Rash – Fever – Cough Report any suspected side effects via the Yellow Card scheme as appropriate – you may find our guide on the Yellow Card scheme helpful.
Interactions	People should be aware if taking:  – Etoposide – atovaquone increases levels of etoposide. – Rifampicin or rifabutin – reduces levels of atovaquone (not recommended). – Metoclopramide – reduces levels of atovaquone. – Warfarin or other oral anticoagulants – proguanil may increase the effect of oral anticoagulants, which may increase the risk of bleeding. Dose adjustments may be needed during use or after its withdrawal, based on international normalised ratio results. – Tetracycline – reduces levels of atovaquone. – Indinavir. – Zidovudine – atovaquone increases levels of zidovudine. – Efavirenz, boosted protease inhibitors – reduces levels of atovaquone (avoid).
Pregnancy and breastfeeding	– Cannot be used while breastfeeding. – Cannot be used in pregnancy – an increased risk of developing severe malaria and a higher risk of fatality in people who are pregnant compared with non-pregnant.

Malaria

Malaria is a serious disease caused by plasmodium parasites. The parasites are passed to humans by the bite of an infected mosquito, which passes them into the bloodstream. If malaria is not diagnosed and treated promptly within 24 hours, it can quickly lead to organ failure and be fatal.

Malaria symptoms include:

• Diarrhoea
• Headaches
• High temperature (fever)
• Muscle pains
• Sweats and chills
• Tiredness
• Vomiting

Pharmacists should refer anyone they think may be infected with malaria to seek immediate medical assistance.
There is a risk of misdiagnosing malaria as influenza or other viral illness, such as viral hepatitis (if jaundice is present), gastroenteritis (if diarrhoea is evident) or lower respiratory tract infection (cough may be a non-specific symptom). Advise patients to be cautious and treat any such symptoms as potential malaria symptoms.

For further information on the condition and symptoms, see the National Institute for Health and Care Excellence’s (NICE) Clinical Knowledge Summaries (CKS) page.

Bite avoidance

There’s still a risk that people will get malaria, even if they take antimalarial medicines. It’s very important that people also take steps to prevent getting bitten by mosquitoes.

Bite avoidance measures:

• Stay somewhere that has effective air conditioning and screening on doors and windows. If this is not possible, make sure the doors and windows close properly.
• Use a knockdown spray or insecticide vaporiser to clear the room before sleeping.
• If you are not sleeping in a sealed, air-conditioned room, sleep under an intact mosquito net that has been treated with insecticide.
• Use insect repellent on exposed skin. Remember to reapply it frequently. If visiting areas where mosquito-borne diseases are endemic, use a product containing 50% diethyltoluamide (DEET) as the first choice, although alternatives are available.
• Wear light, loose-fitting trousers rather than shorts, and wear shirts with long sleeves. This is particularly important during early evening and at night, when mosquitoes prefer to feed.

For further information on bite avoidance, see the NHS website.

Travel advice

You should also provide general advice and information on other medicines or products that patients may require on their trip, e.g.: 

• Bite avoidance measures (insect repellents, mosquito nets, insect bite cream and antihistamines).
• Rehydration sachets, anti-diarrhoeal medicine, or water purification tablets.
• Sun protection cream.
• Travel first aid kit.
• Travel sickness tablets.
• Vaccinations.

Alternative treatments

People should be advised on both prescription-only (POM) and P antimalarial options available (see below) when making their choice, even if the pharmacist is unable to make the POM supply and referral is appropriate. You should consider the person’s preference when deciding on the most appropriate antimalarial. For example, they may prefer the dosage regimen or side effect profile of one option over another.

P antimalarials

• Maloff Protect
• Avloclor 250mg (now rarely used due to the development of resistance)

POM antimalarials

• Atovaquone with proguanil (Malarone or generic)
• Doxycycline
• Mefloquine hydrochloride (Lariam)

POM antimalarials may be available via a prescription from a prescriber or via a patient group direction (PGD).

These services may be available from other pharmacies (via a PGD or travel clinic), GP surgeries and non-pharmacy travel clinics. You should refer where appropriate and relevant. 

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 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 the 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 travel services and clinics. 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 antimalarials.  

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

• Maloff Protect – pack size calculator
• Maloff Protect – pharmacy checklist
• Maloff Protect – pharmacy guide
• Maloff Protect – pharmacy screening questionnaire and explanatory sheet
• Maloff Protect – user reminder card

Further information

• emc – SPC, PIL, and risk materials

Clinical 

• NICE CKS
• NHS
• Patient
• BNF
• World Health Organization

Travel advice

• TravelHealthPro
• UKMEAG

Consultation skills 

• Centre for Pharmacy Postgraduate Education
• Health Education & Improvement Wales
• NHS Education for Scotland
• RCPharm – confidence in consultation skills
• RCPharm – counselling people on the use of medicines