Quality Use of Medicines in Children

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1 Welcome to Allied Health Telehealth Quality use of medicines in children To receive an attendance certificate please complete your online evaluation at: Quality Use of Medicines in Children Pathma D Joseph Medicine Information and Quality Use of Medicine The Pharmacy Department The Children s Hospital at Westmead 3 November

2 "A person's a person, no matter how small." -Dr. Seuss Overview Unique medicine needs of children. Medicines related to harm. Prescribing and dosing principles. Administration of medicines. Paediatric medicine information resources. 2

3 Unique medicine needs of children Therapeutic orphans - inadequate safety and efficacy evaluation through clinical trials. Children are not little adults : Pharmacokinetic and pharmacodynamic differences. Physiological, developmental, psychological and pharmacological specificities. Paediatric disease presentation and pathophysiology differs from adults. Diseases that may be specific to children. Medicine associated harm in children FDCA amendment: drugs effective in population marketed Propofol long-term, high IV doses - metabolic acidosis and myocardial failure E-Ferol IV vitamin E supplement - ascites, thrombocytopenia, liver and renal failure, and death 1957 Thalidomide treatment of morning sickness - birth defects (phocomelia) Food, Drug and Cosmetic Act(FDCA): adequate directions for use Chloramphenicol gray baby syndrome in neonates Sulfanilamide elixir solvent diethylene glycol 34 children died 3

4 Medication errors in children Inconsistent presentation and interpretation of information. Use of medicines not labelled for use in children ( off-label ). Lack of familiarity with paediatric doses. Complex calculations. Therapeutic challenges Paucity of safety and efficacy evidence. Off-label use of medicines. Lack of small dose strengths of tablets - requiring dividing tablets into halves or quarters. Lack of child-friendly formulations. Dosing inconsistencies when using non-marketed formulations. 4

5 Children are a vulnerable population and need to be protected from harm of medicines through evidence-based prescribing, administration and monitoring! Age classification 5

6 Dosing considerations in children Most doses are expressed in terms of body weight. Some medicines are dosed by body surface area (mg/m 2 ). Confusion may arise with mg/kg/dose and mg/kg/day in divided doses. Do NOT exceed the adult maximum dose (40kg). Dosing considerations in obese children Volume of distribution of the medicine. Therapeutic range of the medicine. Side effect profile of the medicine. Ideal body weight related to height and age or 50th percentile weight is used to calculate certain medicine doses for obese patients eg. gentamicin. 6

7 Administration of medicines Can be challenging in children. Important to select the appropriate formulation. Switching formulations may alter the bioavailability, efficacy and side-effect profile. Remember to give: Correct medicine Correct time Correct dose Correct route Medicine formulations Oral medicines (by mouth or enteral feeding tube) eg. oral liquids, lozenges, wafers and meltlets, tablets or capsules Inhaled medicines eg. sprays, nose drops, nebulisation Topical Transdermal patches, topical creams and ointments Ear drops/ointments Ear drops/ointments Rectal eg. ointments, suppositories Injections (intravenous, intramuscular) 7

8 Child with swallowing difficulties Child may be trained to swallow tablets or capsules. Disperse/crush tablets or capsules-may have an unpleasant taste or numb the mouth. Taste of medicines may be masked by mixing with suitable food or drink. Caution: food and medicine interactions eg. dairy products Don t rush to crush Information to consider before giving a medicine to a person who cannot swallow or has an enteral feeding tube. Individual medicine monographs with specific guidelines. Available to order from: Reference: Society of Hospital Pharmacist of Australian (SHPA), Don t Rush To Crush Handbook, Second edition,

9 Do not rush to crush : also available via e-mims General Information Administration guidelines for medicine Swallowing difficulties or enteral feeding tube consider: Oral liquids or dispersible tablets May need to dilute viscous or high osmolarity liquid medicines. Sorbitol can cause diarrhoea. Dispersing tablets and capsule contents Use a closed system eg. oral dispenser. Less hazardous and less loss of medicine. Crushing tablets For tablets that do not readily disperse. 5-10% dose is lost when using a pestle and mortar to crush. Formulations that dissolve in the mouth Eg. fastabs, melts, wafers, orally disintegrating tablet. Give the injection orally if suitable e.g. vancomycin 9

10 Do NOT crush Delayed-release formulations initials EC or EN in the product name enteric coating of tablet, beads or pellets in capsules dissolves in small intestine Extended-release formulations Contin, Slow release, Slow, Duro, Mono or the letters ER, SR, LA, SA, XR, MR, CD, XL, CR or HBS in name Release medicine over a prolonged time Cytotoxic/immunosuppressant medicines Buccal and sublingual tablets Alternative oral formulations options Different route of administration. Changing to a different liquid or dispersible medicine. Extemporaneously prepared liquid formulation. Importing a product available overseas (Special Access Scheme). 10

11 Children with enteral feeding tube Evaluate: Type of enteral feeding tube Location in the gastrointestinal tract Effects of food on absorption of medicine Use liquid medicines whenever possible. Suspensions are viscous- may need to be diluted to prevent the tube from blocking. Disperse effervescent tablets or powders in ~ 50mL water allows effervescing gases to escape. Monitor for consistency of administration, side effects and effectiveness of medicines. Prevent enteral tubes blockage Select most appropriate dose form. Finely crush and disperse medicine well. Give medicines one at a time, flushing in between. Avoid drug interactions with feeds and other medicines. Avoid acidic liquids. Consider the tube size. Flush tube before and after administration of medicines. 11

12 Guiding principles to crushing or dispersing oral medicines Review medicines Necessary and appropriate. Availability of more suitable formulations and medicines. Follow instructions Both the background information and the individual medicine monograph. Ensure that the medicine is prepared the same way each time, using the correct equipment - minimises the risk of harm. Document changes Always document changes made to a medicine. Minimises variation in preparation, administration and dose of the medicine. Important if adverse event occur. Give medicines Never use an IV syringe to prepare or give oral medicines. Always use an oral dispenser or medicine cup to give crushed, dispersed or liquid medicines. Injectable Medicines Considerations Stability: prepare immediately prior to administration using aseptic technique. Diluents: for reconstitution or dilution must be sterile and suitable for injection, preservative free where possible. Displacement volume: volume that the powder component of a drug takes up upon reconstitution: Volume of diluent to reconstitute a vial + displacement volume of drug powder = Final volume of vial Single Use Injections: When only a portion of the dose is required unused medication should be discarded. No ampoule or vial should be shared between patients. 12

13 Paediatric Injectable Medicines Handbook, available via CIAP Trissel's 2 IV compatibility on Micromedex. Caution: compatibility is usually under specific conditions, duration and concentration 13

14 Problem excipients in medicines Excipient Possible effects Glucose and sucrose Benzyl alcohol Ethanol Aspartame Polyoxyl castor or arachis (peanut) oils Propylene glycol Colourants (e.g. tartrazine) Carbohydrate content Obesity, and tooth decay if taken orally A gasping syndrome in neonates (in large quantities) CNS effects A source of phenylalanine in patients with phenylketonuria Severe anaphylactoid reactions CNS effects especially in neonates and children under 4 years Hypersensitivity and behavioural disturbances Carbohydrate content needs to be minimised in a ketogenic diet (for patients with refractory seizures). Reference: SHPA, Australian Medicines Information Training workbook, 1 st ed Acceptable abbreviations Caution: Do not abbreviate drug names Follow guidelines for approved abbreviations Australian Commission on safety and quality of health care: Recommendations for Terminology, Abbreviations and Symbols used in the Prescribing and Administration of Medicines 14

15 Alarm bell medicines Aspirin - Reyes Syndrome (except for Kawasaki s disease and low-dose anticoagulation) Vigabatrin visual field toxicity (except last line anticonvulsant) Tetracyclines <8 years permanent teeth discolouration Ceftriaxone in neonates- precipitates with calcium containing products severe reaction + death Medicine Information Resources Australian Medicines Handbook Children s Dosing Companion British National Formulary for Children CHW Paediatric Injectable Medicines Handbook Paediatrics Manual: The Children s Hospital at Westmead NSW Kids + Families. Policy Directives/Guidelines UpToDate Pediatric & Neonatal Dosage Handbook PemSoft BMJ Best Practice 15

16 Medicine Information Resources Australian Don t Rush to Crush Handbook e-mims Micromedex Toxinz Australian Immunisation Handbook Joanna Briggs Institute Maternity and Infant care Neonatal Formulary. Drug use in pregnancy and the first year of life Neofax AAP Pediatrics Journal Useful Paediatric websites Children s Healthcare Australasia: Cochrane Child Health: Medicines for Children About Kids Health 16

17 Recommendations for practice Children are not little adults and there are particular peculiarities that need to be considered when prescribing and administering medicines. There is a great need for advocacy of more clinical trials to test the safety and efficacy of medicines in children to support evidence-base practice. It is important to synthesise existing evidence to inform the therapeutic needs of children and protect them from harm. References Society of Hospital Pharmacist of Australian (SHPA), Don t Rush To Crush Handbook, Therapeutic options for people unable to swallow solid oral medicines, 2 nd ed SHPA NSW Medicines Information Specialist Interest Group. Paediatric Chapter. Australian Medicines Information Training Workbook. 1 st ed,

18 "Children are one third of our population and all of our future." - Select Panel for the Promotion of Child Health,