Off-Label Medicine Use in Pediatric Care

OSPAP Programme: Paediatric Medicines, Vaccines, and OTC

• The lecture aims to improve understanding of challenges of young patients, childhood ailments/diseases, complex diseases, OTC treatments, and special considerations.

Licensing of Medicines in Children

• Marketed medicines require a product license, referring to individual Summaries of Product Characteristics (SPCs) for details on indication, route, dose, and age.
• Many medicines lack a specific license for use in children, leading to 'off-label' use, for which the Medicines Act makes provision.
• Common examples of 'off-label' medicines include salbutamol for children under 2 years and paracetamol for infants younger than 2 months.
• BNF-Children should always be used for paediatric queries.
• Sources of information include Patient Information Leaflets/SPC.

Children's National Service Framework

• National guidelines for England set standards for children's care, with Standard 10 focusing on medicines.
• Children, young people, parents, and healthcare professionals should make informed decisions on medicines based on risk and benefit.
• Access to safe & effective medicines prescribed on available evidence.

Giving Medicines to Children

• Medicines can be administered through various routes.
• Oral liquids - suspensions, solutions, syrups, elixirs
• Oral solids - tablets, capsules, granules, lozenges
• Inhaled – MDI (with a spacer), powder devices, nebules.
• Ear/Eye/Nose - drops (solutions, suspensions), ointments
• Skin - creams, ointments, sprays, lotions
• Injection - sub-cut, im, iv, it
• Rectal - suppositories, solutions, enemas, ointments

Considerations

• Age of the child should be considered when choosing between a syringe or spoon.
• Care should be taken to not administer the dose too quickly, especially when administering orally
• Accuracy of the dose.
• The stability, length and taste of treatment should be considered
• Medicines should never be mixed in a baby's bottle.
• Tablets/capsules are not usually given to children under 5-7 years, but some can be crushed/opened and mixed with soft food or yogurt.
• Enteric-coated or sustained-release preparations shouldn't be crushed.
• Soluble tablets may be considered.
• For nasogastric/nasojejunal tubes, liquids are preferable and use Newt Guidelines (secondary care).
• Tablets may be mixed with water per BNF/SmPC (Summary of Product Characteristics).
• Stop continuous feeding 15 minutes before administering medicine, as some medicines may mix with continuous feeding.
• Eye preparations must be sterile, preserved products should be discarded 4 weeks after opening, while unpreserved products have a 7 day shelf life. Some products may require refrigeration. Tilt head back, drop into corner of eye, mop up excess, and apply ointment to the inner lower lid (may need 2 adults).
• Rectal administration is suitable for young children but less acceptable for older children.
• Suppositories may be lubricated before use, and splitting is not recommended.

Dose Calculation

• Children's doses are typically standardized by weight (kg) or body surface area (m²).
• Young children may need higher doses per kilogram due to higher metabolic rates.
• Use ideal weight, related to height and age.
• Body surface area (BSA) estimates are sometimes preferable to body-weight
• Body surface area can be estimated from weight, refer to BNF for Children for info.

Patient Information & Counselling

• Providing detailed instructions on how to administer the medication.
• The information should be on the label and verbally explained/shown to the parent.
• Ensure that 'What the medicine is used for' is stated
• Potential cautions should be discussed (e.g., imipramine for nocturnal enuresis).
• What happens if a dose is missed should be discussed, including how the dose can be changed at school to avoid medication.
• How long the medicine to be taken for should be discussed
• Storage of all medicines should be out of child’s reach
• Child-resistant containers
• Storage needs to be in its original container.
• Any refrigeration needs

Medicines at School

• Giving medication is a parental responsibility, though school staff may be asked.
• May vary depending on short or long-term medication and the child’s age
• Required education for staff
• Medicines require to be labelled with full details
• Policies vary as the administration may be a legal issue
• Schools should have medication policies.
• The dosing schedule may be changed according to avoid medicine during school.

Immunisation

• Recommendations are based on advice from the Joint Committee on Vaccination and Immunisation (green book).
• Updates are communicated to professionals by the CMO, with guidance from DH and WHO.
• Most children are immunized unless there are contra-indications; immunization levels had dropped.
• See https://www.nhs.uk/conditions/vaccinations/nhs-vaccinations-and-when-to-have-them/ for information.

Immunisation Schedule

• At 8 weeks, vaccinations include the 6-in-1 vaccine (diphtheria, tetanus, pertussis, polio, Hib, hepatitis B), rotavirus vaccine (oral), and MenB.
• At 12 weeks, vaccinations include a 2nd dose of the 6-in-1 and rotavirus vaccines, plus pneumococcal (PCV) vaccine (1st dose).
• At 16 weeks, vaccinations include a 3rd dose of the 6-in-1 vaccine and MenB.
• At 1 year, vaccinations include Hib/MenC (single jab), MMR (1st dose), pneumococcal (PCV) vaccine (2nd dose), and Men B (3rd dose).
• Between 2 and 15 years, the flu vaccine is administered annually via nasal delivery.
• At 3 years and 4 months, MMR (2nd dose) and 4-in-1 pre-school booster (diphtheria, tetanus, pertussis, polio) are given.
• Between 12 and 13 years, the HPV vaccine
• At 14 years, the 3-in-1 teenage booster (tetanus, diphtheria, polio) and MenACWY vaccines are administered.
• As of Nov 2023, a universal varicella (chickenpox) vaccination program (2 doses at 12 and 18 months using MMRV) is proposed for the routine childhood schedule but not yet implemented.

Immunisation - Contraindications

• Unless there are overriding clinical circumstances, immunisation is contra-indicated in cases of acute illness or previous severe reaction to the vaccine or constituent.
• Live vaccines are not given to immunosuppressed patients
• Vaccination information is documented in Child Health Record.
• Educational Leaflets are available from community pharmacies, clinics, GP, DH web-site

Rotavirus

• It is the commonest cause of gastroenteritis among infants and children.
• The Diarrhoea and vomiting is associated with this
• It may cause severe dehydration and results in the number of admittance of people to hospital each year
• The Virus is highly infections being transmitted through the faecal route
• Peaks are prevalent January- March in the UK
• Infection is present usually at 3 years old
• There are symptoms that persist from 3-8 days.

Rotavirus Vaccine Administration

• Live vaccine given via the oral route at 8 weeks.
• It has no restrictions on food or drink consumption before, but there are restrictions after.
• It may not need to be postponed if the illness is minor.
• Effectiveness is reduced if it passes too quickly through the intestine.
• Postpone if diarrhoea is present.
• First dose must be given 6-15 weeks

Fluenz

• Nasal flu vaccines for 2–16.
• LAIV strains of vaccine are genetically altered by 3 mechanisms
  • Cold adapted to work with the immune system in the cooler temperature in the nose
  • Temperature Sensitive
  • Attenuated-replicates to simulate immune system without the affect of symptoms.
• The child may breathe normally and is not made to sniff
• Patients with blocks or runny nose have to clear symptoms before taking vaccines.
• Contraindications-immunocompromised, age under 2, aspirin or salicylates, egg/gelatin allergy, those who are pregnant or have severe asthma.

Men B Vaccine

• Bexsero was added in 2015 on the schedule for immunisation
• The injection is given in the thigh
• There risks of higher increased fever when Bexsero is administered.
• Recommendations- paracetamol is needed
• Government recommendation should be given as prophylactic measure on the side effects.
• Paracetamol 3 dose has to be given for up to 6 hours.

General Immunisation Issues

• Most adverse reaction are not serious
• There is also pain and swelling that may reside up to 24 hours but needs medical assessment If more prolonged
• Paracetamol is not needed for a vaccine unless Bexsero is given
• For paracetamol that has to be given with Bexsero has to be 4-6 hours
• Rare Fainting -Hyperventilation
  • Anaphylaxis

MMR Brief History

• Since 1998
• The safer record of this according to the WHO stands to be exemplary
• 1998 there was discredited information by Dr. Wakefield stating autistic children had bowel symptoms- Scientist stated there was no links.
• Publicity gave the impression of a link
• Regressive symptoms start around the time of the dose
• Autosome is not common in children
• No effect on autosome after vaccine.

2013 Measles Outbreak

• The number of measles in the UK in the year 2013
• Falls dramatically in taking vaccines
• 94%-78%-68%
• A number of 32,000 children across London may at risk catching measles
• 92% is not been vaccinated.

Explore implications and guidelines for off-label medicine use in pediatrics. Understand the factors influencing dosage and the role of Summary of Product Characteristics (SPC). Learn why many medicines lack specific licenses for children.