1. Viva case presentation Assessment 3 785 2014 jmit016

2. Patient Profile 3 year old preschooler presents to ED with vomiting, fever, rash and pulling at right ear. PMhx: Bilateral Otitis media with effusion, Acute otitis media in infancy, delayed speech, constipation. No hx of Renal or Liver impairment, no cardiac history Commenced on oral Erythromicin (E-MYCIN) today for ongoing right ear infection by GP. Antibiotic changed from Cefaclor to Erythromicin today due to rash, starts vomiting today post administration of antibiotics. Has vomited 2 doses.

3. History of Present Illness Cough, rhinorrhea 5 days Pulling at right ear 4 days Fever 3 days, GP visit 3 days ago diagnosis of Acute Otitis Media right ear. Left ear ongoing Otitis Media with Effusion (OME) Commences Cefaclor prescribed. Revisits GP as develops rash and has fever GP prescribes Erythromicin.

4. Demographics European Up to date immunisations No known drug allergies/sensitivities Attends day care 5 days a week Caregiver smokes outside Caregiver has car, phone Nil recent overseas travel

5. Life Span Considerations Preschooler with delayed speech No known drug or food allergies No known renal or hepatic problems Children are therapeutic orphans At preschool age pharmacokinetic/ pharmacodynamic differences to adults and infants (Bartelink, Rademaker,, Schobben, & van den Ankers 2006) (Gutierrez, 2008)

6. Medication History Treatment with amoxicillin x 4 courses for AOM lasting 5 days to 7 days each in the last year. Last course 3 weeks ago, mother reports “it no longer works.” Ciprafloxicin drops 7/7 day course left ear 2/12 ago Previously on lactulose for constipation now resolving with diet. Paracetamol for pain prescribed elixer150mg every 6 hours with this illness

7. Current Drug Regime & Observations Erythromicin 250mg three times a day (vomited) Paracetamol 150mg every 4-6 hours OTC vitamins 1 daily purchased from supermarket Weight 15.4kg Observations: Heart rate 134 Temp 38.4C, RR 32, 02 sats 99% air Rash maculopapular non pruritic, non petechial noted on trunk and back.

8. Physical Examination Normal heart sounds Normal respiratory examination no crackles/ wheeze, stridor HEENT bulging red right TM/ left TM perforated with otorrhoea, throat red. Nil exudate on tonsils, rhinorrhoea, nil conjunctivitis, nil apthous ulcers. Nil oral thrush. Nil neck stiffness or photophobia. Abdomen soft non tender nil signs of peritonism GU NAD / Urine MSU positive ketones. –ve Leucs and nitrites Skin/ Lymph blanching papular macular rash trunk and back, no angiooedema, urticaria. Shotty cervical nodes palpated

9. Erythromicin ethylsuccinate Macrolide antibiotic Inhibits protein synthesis of susceptible organsims Many strains of H Influenzae are resistant Usually efficacious against gram +ve organisms such as C diptheriae, C minutissimum, Listeria monocytogenes, Staph aureus, Strep pneumoniae, Strep pyogenes. Gram –ve organisms Strep viridans, Moraxella catarrhalis Has several drug interactions which must be avoided important drug history and OTC therapies NZ Data sheet MOH downloaded 9/9/2014, (Gutierrez, 2008), (Bryant, Knight & Salerno 2010)( Chahine, Johnson & Costanzo 2014) (Quorral,et al, 2012)

10. Dosage in Children Usual dosing regimen Erythromicin base 30mg to 50mg per kg per day in equally divided doses every 6 hours, however there are alternate regimens of 12 hourly dosing or every 8 hours Dosage for Alice is 50mg/kg = 750mg/ day given in doses of 250mg three times a day. (NZ Data sheet MOH)

11. Paracetamol Antipyretic analgesic Exact mechanisms of action unclear Normal doses safe analgesia for children Rapidly absorbed peak serum levels in 15-60minutes Undergoes phase 2 metabolism using glucuronidation and sulphatylation to harmless metabolites in normal doses with normal liver function NZ Data sheet MOH downloaded 9/9/2014, (Gutierrez, 2008), (Bryant, Knight & Salerno 2010)

12. Paracetamol Dosing in Children Single dose 15mg/ kg per dose 4-6 hourly no more than 4 doses in 24 hours

13. Clinical Reasoning Analysis Is the current treatment safe, efficacious and appropriate?

14. Pharmacotherapy process 1. “What are the desired outcomes and what is reasonable?” 2. “Based on evidence/guidelines/literature what therapeutic endpoints are needed to achieve outcomes?” 3. “Are there potential medication related problems that prevent end points from being achieved?” 4. “What patient self/family care and medication changes are needed to address medication problems?” 5.” What monitoring parameters are needed to verify the achievement of goals, side effects and toxicity how often should these be monitored?” (Yarborough, 2003) (Boivon, Carey & Levy 2003) (Gonzalez Caroca and Paris 1998)

15. Are there pharmaceutical issues ? 1. Treatment failure due to ongoing vomiting? 2. Is there an adverse reaction to current drug? Interindividual response? 3. Is the vomiting from current illness? 4. Is the rash from a prior drug reaction or current illness? 5. How can we resolve the current medication issue? 6. How can we optimise the patients current drug regime? 7. Do we need to change the drug, reduce the dose? what other options are there? (Feucht,& Patel, 2011) (Cipole, Strand, & Morely 2004)

16. Adverse Effects of Erythromicin Most common is gastrointestinal which include poor appetite, nausea, vomiting and abdominal pain with or without diarrhoea. Hepatic dysfunction including abnormal liver tests Pseudomembranous colitis Pyloric stenosis in infants CNS symptoms including seizures and hallucinations confusion, syncope. (Boivon, Carey & Levy 2003) ( NZ data sheet MOH) ( Gutierrez, 2008)

17. Paracetamol Currently receiving only 10mg/kg/dose Optimisation of pain relief needed

18. Treatment/Drug Therapy Care Plan Swab left ear for microculture and sensitivity as has current otorrhoea. Treat pain with optimal dose of paracetamol 15mg/kg per dose 6 hourly. Give mother paracetamol advice sheet and explain. May need to give dose in ED rectally if still vomiting. Consider adding NSAID. Provide parent with accurate measure device on discharge (oral syringe) Oral rehydration therapy in department using pedialyte. Ketones in urine indicating dehydration recheck urine post hydration. If still symptomatic IV and U&E and FBC and IV fluids. Consider treating vomiting with an antiemetic (Boivon, Carey & Levy 2003) (Lieberthal et al 2013) ( Ramakrishnan, Sparks, & Berryhill 2007)

19. Treatment/Drug Therapy Care Plan cont… Stop erythromicin, consider stopping antibiotics however indication from evidence tx needed Consider admission overnight and review by paediatric team if symptoms do not improve In this case I would want to introduce another antibiotic using evidence from current guidelines to inform decision of antibiotic choice and arrange ongoing follow-up at discharge. I would discuss smoking cessation with mother as this is contraindicated in recurrent Otitis media (Boivon, Carey & Levy 2003) (Lieberthal et al 2013) ( Ramakrishnan, Sparks, & Berryhill 2007) ( Venekamp, Sanders, Glasziou & Rovers 2014)

20. Ongoing Monitoring Review sensitivities of organisms after micro-culture and sensitivities of ear swab. Observation in ED for oral rehydration and resolution of vomiting before discharge. Advised to return to ED if concerning symptoms emerge. Arrange referral to Ear Nose and Throat clinic for specialist input. Acute illness referred to home nursing service for next day visit to monitor hydration and observations. GP requested to examine child in 2-3 days time. (Guttierez, 2008)

21. Patient/ Family Education Give analgesia regularly as prescribed at the dose prescribed to optimise pain relief. Education around the medications prescribed and why will help with adherence. If prescribed another antibiotic, give as prescribed and finish the course even if child appears well and symptoms abate. No lying supine with bottles of milk or drinks explain simply anatomy of ear and tympanic membrane. Advise and education around the signs and symptoms of allergic reaction. (Chahine, Johnson & Costanzo 2014)

22. References Bartelink, I.,Rademaker, M.A, Schobben, F.A., van den Ankers, J. (2006) Guidelines on Paediatric Dosing on the Basis of Developmental Physiology and PharmacokineticConsiderations. Clin Pharmacokinet, 45(11), 1077-1097. Boivin, M. A., Carey, M. C., Howard Levy, B. S. (2003) Erythromicin accelerates gastric emptying in a dose response manner in healthy subjects. Pharmacotherapy, 23(1) 1-5. Retrieved from http://www.medscape.com/viewarticle/448278_print Bryant, B. J., Knights, K. M., & Salerno, E. (2010). Pharmacology for health professionals (3rd ed.). Chatswood, NSW, Australia: Mosby Elsevier. Chahine, E. B., Johnson, A.N., & Costanzo A. (2014) Update on the management of pediatric acute otitis media. US Pharm, 39(7), 27-30. Retrieved from http:/www.uspharmacist.com/home/> Cipole, R. J., Strand, L. M., & Morely P.C. (2004) Pharmacotherapeutic work up notes. Pharmaceutical Care Practice: The clinicians guide, New York, USA McGraw Hill. Retrieved from http://www.pharmacy.umn.edu/img/assets/10745/Assessment_Pharmacotherapy_Notes.pdf http://www.pharmacy.umn.edu/img/assets/10745/Assessment_Pharmacotherapy_Notes.pdf

23. References cont Conroy, S. (2003). Paediatric pharmacy - Drug therapy. Hospital Pharmacist, 11(2), 49-57. Feucht, C., & Patel, D. R. (2011). Principles of pharmacology. Pediatric Clinics of North America, 58(1), 11-19. http://dx.doi.org/10.1016/j.pcl.2010.10.005 Gutierrez, K. (2008). Pharmacotherapeutics: Clinical reasoning in primary care (2nd ed). St. Louis, MO: Saunders Elsevier Holmes, E., & Miller, J. (2014). Adverse reactions of medications in children:The need for vigilance, a case study. Journal of Clinical Chiropractic Pediatrics14(2), 1125-1130. Retrieved from Lieberthal, A.S., Carroll, A.E., Chonmaitree, T., Ganuats, T.G., Hoberman, A., Jackson, M.A., et al. (2013) The diagnosis and management of acute otitis media. Pediatrics, 131(3), 964-999. doi:10.1542/peds.2012-3488 New Zealand data sheet E-Mycin. Retrieved from www.medsafe.govt.nz/profs/datasheet/dsform.asp on 9 September 2014www.medsafe.govt.nz/profs/datasheet/dsform.asp New Zealand data sheet Junior Parapaed. Retrieved from www.medsafe.govt.nz/profs/datasheet/dsform.asp on 9 September 2014www.medsafe.govt.nz/profs/datasheet/dsform.asp Porter, G. A., & Bennett, W. M. (1981). Nephrotoxic acute renal failure due to common drugs. American Journal of Physiology, 241(1), F1-8. Qorraj-Bytyqi, H., Hoxha, R., Krasniqi, A., Bahturu, E., & Kransuqi, V. T. (2012) The incidence and clinical relevance of drug interactions in pediatrics. Journal of Pharmacology and Pharmacotherapeutics 3(4) 304-307. doi:10.4103/0976-500X.103686 Ramakrishnan, K., Sparks, R., & Berryhill, W. (2007) Diagnosis and treatment of otitis media. Am Fam Physician,76(11) 1650-1658.

24. References Rylance, G. (1981) Clinical Pharmacology: Drugs in children. British Medical Journal, 282(1), 50-51. Valsalakumari P.K., Rajalakshmi G.R. and William H. (2014). A study of adverse reactions on pediatric patients. Int. J. Pharm. Life Sci., 5(3):3394-3399. Retrieved from http://www.ijplsjournal.com/issues%20PDF%20files/2014/march-2014/8.pdfhttp://www.ijplsjournal.com/issues%20PDF%20files/2014/march-2014/8.pdf Venekamp, R. P.,, Sanders, S., Glasziou, P. P., Del Mar C, B., & Maroeska R. M. (2013). Antibiotics for acute otitis media in children (Review). The Cochrane Collaboration DOI: 10.1002/14651858.CD000219.pub3 Yarborough, P. (2003) Case study: A patient with type 2 diabetes working with an advanced practice pharmacist to address interacting comorbidities. Diabetes Spectrum, 16(1), 41-48.