Children's Medicine Licensing Quiz

OSPAP Programme

• This programme covers paediatric medicines, vaccines, and over-the-counter (OTC) treatments.
• Presented by Kathryn Davison and Deanne Marshall.

Aims

• Improve understanding of challenges in treating young patients.
• Cover common minor ailments of childhood.
• Discuss common infectious diseases of childhood.
• Cover complex diseases requiring referral.
• Detail how to treat minor conditions using OTC medications.
• Highlight important considerations.

Licensing of Medicines in Children (1)

• All marketed medicines must have a product license with specific details documented.
• Key elements of the product license include indication, route, dosage, and age.
• Many medications lack licensing for use in children; this is often referred to as "off-label" use.
• The Medicines Act addresses this use.

Licensing of Medicines in Children (2)

• Salbutamol in children under 2 years.
• Paracetamol in children under 2 months.
• The British National Formulary for Children (BNF-Children) is a frequent source of information for paediatric queries.
• Patient Information Leaflets and Summary of Product Characteristics (SPC) are useful resources.

Children's National Service Framework

• National guidelines (for England) set standards for care.
• Standard 10 focuses on medicines for children.
• The Department of Health (DH) website provides further details.
• Decisions on medicines should be based on sound information regarding risk and benefit.

Giving Medicines to Children

• Routes
  • Oral liquids (suspensions, solutions, syrups, elixirs)
  • Oral solids (tablets, capsules, granules, lozenges)
  • Inhaled medications (MDIs with spacers, powder devices, nebules)
  • Ear, eye, or nose drops/ointments
  • Skin creams/ointments/sprays/lotions
  • Injections (subcutaneous, intramuscular, intravenous, intra-thecal)
  • Rectal suppositories/solutions/enemas/ointments.
• How to use a spacer with a mask for a baby or child is important (Asthma UK guidelines)

Considerations

• Important considerations when administering medication to children include the child's age, dosage accuracy, ensuring the medication is formulated appropriately avoiding fast delivery, checking sugar content, and treatment stability.
• Never mix medications in a baby bottle.
• For tablets/capsules avoid dispensing (<5-7 years), consider crushing and mixing in soft foods or yogurt.

Giving Medicines to Children (NG/NJ tubes)

• For nasojejunal (NG/NJ) tubes, administering liquids is preferred.
• Follow up Newt guidelines.
• Some tablets need mixing with water (see BNF/SPC).

Giving Medicines to Children (Eye)

• Eye preparations must be sterile.
• Discard preserved eye drops 4 weeks after first opening.
• Unpreserved eye drops should be used within 7 days
• Some medications may need to be refrigerated.
• Tilt the head back and drop in corner of the eye.
• Mop up excess, apply ointment to the eye lid.

Giving Medicines to Children (Rectal)

• Rectal administration is suitable for very young children, less so for older children.
• Lubricate suppositories prior to use.
• Avoid splitting suppositories.

Dose Calculation

• Child's dosages are usually standardized by weight or body surface area (BSA)
• Infants often require higher dosages per kilogram compared to adults due to their higher metabolic rates.
• Use ideal weight, related to height and age, if administering an unusually high dose - see the BNF for guidance.

Patient Information - Counselling

• Primarily provide clear instructions on how to administer the medication.
• Ensure all important information is on the label and comprehensively explained to the patient.
• Discuss the medication's usage, cautionary notes, implications of missed medication, dosing frequency.
• Important information regarding storage. (out of reach of children, child-resistant containers, refrigeration if required, avoid mixing medicines in the same bottle, keep in original container)

Medicines at School

• Medication administration at school is a parental responsibility, but school staff may be involved in certain situations.
• Considerations include the type of medication, child's age and medication duration/frequency, education requirements for staff.
• School policies differ so local education authorities should be consulted.

Immunisation

• Recommendations are based on Joint Committee on Vaccination and Immunisation advice (green book).
• Updates are given by the Chief Medical Officer (CMO) and the Department of Health and WHO.
• Most children are immunised unless there are specific contraindications.
• Website address for further information provided.

Immunisation (First Year Ages)

• Detailed chart including specifics vaccines and associated ages for each.

Immunisation (1-15 years)

• Comprehensive chart including specifics vaccines and associated ages for each.

Immunisation Issues

• Immunisation should not be given to an unwell child.
• Live vaccines are not for immunocompromised children.
• Immunisation recording is crucial and should be included in the child's health record.
• Further details regarding specific cases are available through community pharmacies, clinics and GP's. More detailed specifics available from DH websites.

Rotavirus

• Rotavirus is a frequent cause of gastroenteritis in babies and young children.
• The virus is highly contagious, predominantly spread faecal-orally but respiratory transmission also exists.
• Rotavirus incidences show seasonality with the greatest incidence shown from January to march.
• Symptoms usually resolve within 3-8 days.

Rotavirus Administration

• Rotavirus vaccine is a live vaccine given orally at 8 weeks of age.
• No dietary restrictions are required prior to or after the vaccine administration.
• Postpone administration if the child is experiencing diarrhoea or other gastrointestinal issues.
• The first dose needs to be given between 6 to 15 weeks of age.
• A second dose, ideally given prior to 16 weeks of age, ensures effective protection.

Fluenz

• Fluenz is a nasal influenza vaccine offered to children (ages 2-16).
• The vaccine contains strains of the influenza virus that are genetically altered via 3 mechanisms.
• The vaccine is cold-adapted to work effectively in the nose, avoids lung infection and a full immune response is still generated.

Contraindications (Fluenz)

• For patients/ children generally, immunosuppressed patients, children under 2 years of age.
• Children actively wheezing or with severe asthma should not get the fluenz injection.

Men B Vaccine

• The Men-B vaccine is injected into the left thigh of babies.
• The additional vaccination schedule may carry an increased risk of fever.
• Guidelines from PHE for additional paracetamol given following the immunisation to avoid fever.

Using Paracetamol after MenB Vaccination

• Guidance on different dosages of paracetamol based on age.

Case Studies (Tom)

• Case study involving a child with a history of anaphylaxis who has a sister with leukaemia.
• Question asked was if the child could receive the scheduled flu vaccination.

Case Study (Jess)

• Case study regarding a child with eczema and suspected childhood asthma who is due a flu vaccination, question asked is if the child could receive the scheduled flu vaccination.

Case Study (Mo)

• A case study about a child due to receive the scheduled vaccines.
• The child's mother asks if paracetamol can be given immediately after the Rotavirus vaccine.

General Immunisation Issues

• Most adverse reactions to immunisation are minor.
• Localised reactions usually resolve within 24 hours.
• Prolonged swelling will require medical review.
• Fever following immunisation may require paracetamol.
• Seek medical advice if the child’s fever persists.
• Rare cases of complications exist including fainting, hyperventilation, and true anaphylaxis.

MMR - Brief History

• MMR vaccination first given in 1988.
• The effectiveness of the MMR vaccine is well-documented.
• One study linking MMR to autism was discredited.
• Evidence for an autism connection was flawed and is not medically supported.
• MMR vaccinations are still important to prevent outbreaks of measles.

2013 Swansea Measles Epidemic

• In 2013, Swansea experienced a large measles outbreak.
• Low MMR vaccine uptake was a factor in the epidemic.
• The outbreak spread from a holiday camp and was linked to low vaccination rates.
• A significant number of hospitalisations and fatalities occurred.

2023 - NHS England Update

• Measles outbreaks affecting London in 2023, linked to low MMR vaccination rates.
• Vaccination uptake is below the target rate set by WHO and this led to severe outbreaks.

Common Childhood Illnesses

• A general overview of common childhood illnesses.
• The difficulty in obtaining a comprehensive history when dealing with childhood illnesses.

Pyrexia

• Pyrexia is a common symptom in children.
• Various underlying causes exist, ranging from teething to meningitis.
• Essential to establish the causes accurately.
• Accurate measurement is crucial (e.g., rectal, underarm).

Pyrexia Issues

• Establishing the child’s health.
• Understanding the parent’s overall perception of their child’s state.
• Check for other symptoms and remember UTIs can cause mild pyrexia.

Differential Diagnosis (Pyrexia)

• Common differential diagnoses: URTI, UTI, Meningitis
• Establishing accurate diagnosis is crucial for treating the condition effectively and avoiding potential risk of more serious conditions.

Treatment (Pyrexia)

• Paracetamol is established for treating fevers and pain, often used for post-immunisation fevers
• It's usually licensed from 2 months.
• Ibruprofen is also often used for treating pyrexia and pain and is licensed from 3 months of age and over 5kg.
• Alternating between paracetamol and ibuprofen may be used, but further research is needed to establish efficacy.
• Appropriate hydration is essential.

Ibuprofen and Chickenpox

• NSAIDs, including ibuprofen, are generally not recommended for chickenpox, as risk of complications exists.
• Paracetamol is a suitable alternative pain and fever reliever.

Doses (Paracetamol and Ibuprofen)

• Standard doses for paracetamol and ibuprofen are based on age.
• Important to take age and weight into account for appropriate dosage.

Atopic Eczema

• Typical onset occurs between 2-6 months.
• One-fifteenth of the population will be affected (1-15%).
• Most cases improve as children age.
• Family history of allergy or asthma often present.

Atopic Eczema (Incidence)

• Incidence is rising, potentially links to environmental issues.
• Connection exists to house dust mites, pets, and choice of food.
• Environmental factors such as central heating and air conditioning are implicated in exacerbating the condition.

Atopic Eczema Diagosis

• Diagnosis includes a history of the skin condition (scratching, etc), a history of atopic illness in relatives.
• Onset prior to the age of two (2)
• Visible eczema in flexes

Atopic Eczema Lesions

• Lesions can be moist and weepy or skin thickened (lichenified).
• In darker skin tones this may cause papules.
• Scratch marks or bacterial infections may be present.

Atopic Eczema (Differential Diagnoses)

• Seborrhoeic Dermatitis
• Psoriasis
• Hives/urticaria
• Other allergic conditions
• Contact dermatitis.

Atopic Eczema (Referrals)

• Severe cases of eczema, suspicion of complications (e.g., eye involvement), or treatment failure warrant referral to specialist services.

OTC Treatments (Eczema)

• Emollients/substitutes for soap
• Antihistamines
• Corticosteroids (generally not OTC for under 10 years)

Emollients (Use)

• Used to improve dry skin conditions.
• Often added to bathwater as a soap substitute.
• Avoid any emollient that stings on application.
• Look for warning if the medicine may dry out skin.

Antihistamines

• Often prescribed to treat itching associated with eczema.
• Some antihistamines cause sedation and should be used at night time to assist and avoid sleep disruption.
• Hydroxyzine is suitable for use in children aged six months +.

Cough and Cold Preparations

• Refer to a separate OTC respiratory lecture.
• In 2009, guidelines were issued for the safe use of cough/cold medicines for children under 12, by the Committee on Medicines for Human Use.
• Typical medications included: Chlorphenamine/Diphenhydramine, Dextromethorphan, Guaifenesin/Ipecacuanha, and others.
• Safety concern exists for use under 2 yrs.

Cough and Cold Preparations (Reviews)

• The 2009 MHRA review and Cochrane review on efficacy for under 12-year-olds showed poor evidence in some preparations.

Suitable OTC for under 6 years

• List of specific OTC medications to address coughs, colds, and pain relief under six years of age

Teething

• Teething typically occurs between 3 months and 3 years of age.
• Teething can cause discomfort and irritation, associated with pain, swollen gums, redness, excessive drooling.
• Topical gels containing local anaesthetics, (e.g., Lidocaine in Anbesol), are commonly used as a first-line treatment for relieving pain.

Colic

• Colic refers to excessive crying or fussiness in infants, often present between 3 weeks and 4 months of age (usually in the evening).
• Causes are varied, including immature digestive systems, milk/lactose intolerance, excessive gas swallowed, or potentially, undiagnosed conditions.
• Treatments may include medication or advice on the feeding method.

Colic-Treatment

• The evidence base for colic treatment is weak/varied.
• Dimethicone, found in products like Infacol, is a surface acting agent and is thought to assist with smaller gas bubbles to pass easily.
• Lactase-based supplements can alleviate lactose intolerance.
• Important to ensure baby's feeding method is correct.

Constipation

• Constipation is fairly common in children.
• Often related to changes in diet and hydration.
• Typically linked to psychological trauma, so supportive and preventative methods are important in managing the condition.

Threadworms

• Threadworms are a common cause of itching around the anorectal region.
• The most common cause is the transmission resulting from faecal oral route.
• Mebendazole is the standard treatment, used on the entire family.
• Hygiene measures are vital for those affected and important to avoid spread.

Differential Diagnosis (Threadworms)

• Roundworms and tapeworms are unlikely in children and can be detected if found in the stool samples.
• Secondary bacterial perianal infections can also lead to itching.
• Referrals for treatment failure or secondary infections are required.

Head Lice

• Head lice are contagious.
• Transfer occurs via direct contact.
• Treatment often involves using appropriate topical lotions, shampoos.
• Avoid alcoholic based lotions if the child is asthmatic.
• Treat all household members to prevent spread.

Infective Diseases of Childhood

• Overview of common infectious diseases in children.
• Discussion concerning recent MMR vaccine uptake concerns.

Impetigo

• Highly contagious bacterial skin infection.
• Common causes are S. aureus or S. pyogenes.
• Presents on the face and develops into yellowish crust formation.
• Treatment often involves using hydrogen peroxide solutions.

Pharmacy First – Impetigo

• Adults and children over one year can be treated at the pharmacy.
• Important to differentiate between bullous and non-bullous impetigo.
• Treatment and self-care guidelines given to the client.

Slapped Cheek Syndrome

• Mild viral disease affecting primarily young children.
• Initial symptom is a distinctive red rash on the cheeks("slapped cheeks").
• Symptoms generally resolve within 1-2 weeks without further treatment.

Hand, Foot, and Mouth Disease

• Viral infection that causes mouth ulcers and skin rash.
• Most common in children under 10 years of age.
• Symptoms generally resolve within 10 days, usually resolving without further treatment.

Scarlet Fever

• Bacterial infection caused by Streptococcus pyogenes.
• Characterised by flu-like symptoms (fever, sore throat), and develops a blanching rash 12-48 hours later.
• The rash is sandpaper-like.
• The tongue develops a red or 'strawberry' appearance.

Measles

• Highly contagious viral infection.
• Measles features include flu-like symptoms, and a generalised rash that develops over 2-4 days.
• Complications can result if secondary bacterial infections occur.
• Crucial to consult with a GP if measles is suspected.
• Measles is a notifiable disease.

German Measles/Rubella

• Symptoms are generally mild compared to measles but are potentially harmful to pregnant women and their foetus.
• Incubation is typically 14-21 days before rash develops.
• The rash does not spread in the same way as measles.

Chickenpox

• Viral infection that causes an itchy rash of blisters, generally occurring over 1-2 weeks.
• Infectious period is prior to and during development, usually within 1 – 2 weeks.
• Avoid NSAIDs (ibuprofen, etc) in order to avoid potential risks.
• Treatment should be focused on symptom relief, including topical creams/lotions, and antibiotics for secondary infection.

Chickenpox Complications

• Secondary bacterial skin infections are common.
• Severe chickenpox is associated with a higher morbidity risk of complications.
• Potential rare serious complications can occur. (scarlet fever, toxic shock syndrome, encephalitis, thrombocytopenia).

Differential Diagnosis - Molluscum Contagiosum

• A viral skin infection causing spots on the body.
• Usually resolves without treatment and will generally occur in children.
• Avoid transmission to others during the infection period.

Meningitis

• Highly infectious bacterial and viral disease affecting brain membranes.
• Common symptoms include fever, headache, stiff neck, nausea, and vomiting.
• Early diagnosis and treatment are crucial for preventing serious complications such as sepsis. (refer to GP immediately is condition suspected).

Whooping Cough

• Caused by Bordatella Pertussis.
• A highly contagious infection leading to paroxysmal coughing fits followed by a whooping sound.
• Significant morbidity exists for those affected.

Mumps

• Caused by a virus, primarily affecting the salivary glands resulting in swelling
• Vaccine available is highly successful in reducing outbreaks.
• Potential for fertility complications exist for those affected predominantly in adults.

Summary

• General overview of the various subjects covered in the presented program.

Explore the critical aspects of licensing medicines for pediatric patients with this quiz. Test your knowledge on the challenges, off-label usage, and regulatory factors involved in treating children. Perfect for healthcare professionals and students in the medical field.