2/19/2014. Erika Clark, PharmD, BCPS. Palmetto Health Children s Hospital Columbia, SC. Erika W. Clark Nothing to Disclose

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1 Erika Clark, PharmD, BCPS Palmetto Health Children s Hospital Columbia, SC Erika W. Clark Nothing to Disclose Understand the updated acute otitis media guidelines Review newest update to the guidelines for treatment of Streptococcal pharyngitis. Understand the treatment options for head lice and new formulations on the market. 1

2 Infection in middle ear (AOM) Cochrane Database Syst Rev. 2010;9:CD Image: Most common illness of early childhood 10% of children have episode of AOM by 3 months of age Peaks 6-15 months of age High morbidity, low mortality Higher incidence in young children & infants due to immature immune system & differences in eustacean tube Kerschner, JE. Nelson Textbook of Pediatrics, 18th ed

3 Signs & Symptoms + middle ear effusion with inflammation Irritability, sleep difficulty +/- fever, +/- ear pain, +/- purulent otorrhea (tympanic membrane rupture), +/- URI symptoms Kerschner, JE. Nelson Textbook of Pediatrics, 18th ed update - American Academy of Pediatrics Update to guidelines published in 2004 Children ages 6-12 years of age with uncomplicated AOM Addresses proper diagnosis, initial treatment, pain management, antibiotic agents, and preventative measures, and recurrence in healthy children Does not apply to any underlying condition that may alter the natural course of AOM: Presence of tympanostomy tubes Anatomic abnormalities, including cleft palate Genetic conditions with craniofacial abnormalities, including Down syndrome Immune deficiencies Cochlear implants 3

4 Moderate to severe bulging of the TM or new onset of otorrhea not due to acute otitis externa (Grade B; recommendation) Mild bulging of the TM and recent (< 48hrs) onset of ear pain or intense erythema of the TM (Grade C; recommendation) Clinicians should NOT diagnose AOM in children who do not have middle ear effusion (MEE) (Grade B; recommendation) AOM will resolve in many children without antibiotic treatment ~ ½ of children younger than 2-3 years old Observation strategies reduce risk of antibiotic side effects 4

5 Pathogens Usually bacterial pathogens (~65-70%) Streptococcus pneumoniae Nontypable Haemophilus influenzae Moraxella catarrhalis Viral Pathogens Rhinovirus Respiratory syncytial virus (RSV) No way to clinically differentiate between pathogens Introduction of PCV7 vaccine in 2000 More non-pcv7 serotypes of S.pneumoniae More resistance = more recurrence or initial treatment failure PCV13 will likely cause additional shifts in nasopharyngeal colonization patterns Age Otorrhea with AOM 6 mo to 2 yrs Antibiotic therapy >/= 2 years Antibiotic therapy Unilateral or bilateral AOM with severe sx Antibiotic therapy Antibiotic therapy Bilateral AOM without otorrhea Antibiotic therapy Antibiotic therapy or additional observation Unilateral AOM without otorrhea Antibiotic therapy or additional observation Antibiotic therapy or additional observation 5

6 First line Amoxicillin 90 mg/kg/day No amoxicillin in last 30 days No purulent conjunctivitis No PCN allergy Grade B, Recommendation Amoxicillin-clavulanate 90 mg/kg/day if: Amoxicillin in last 30 days Concurrent conjunctivitis Hx of recurrent AOM unresponsive to amoxicillin Grade C, recommendation Use ES formulation! Alternatives for 1 st line treatment if PCN allergic: Cefdinir 14 mg/kg/day 1-2 x daily Counsel patients about changes in stool color Cefuroxime 30 mg/kg 2 x daily Compliance challenges due to taste Cefpodoxime 10 mg/kg 2 x daily Compliance challenges due to taste Ceftriaxone 50 mg/kg/dose IM or IV 3 days is better than 1day < 2 years old & severe symptoms 10 days 2-5 years Mild or moderate symptoms 7 days 6 years & older Mild or moderate symptoms 5-7 days 6

7 Reassess at hrs if sx have worsened or failed to respond Grade B, recommendation Routine reassessment after clinical improvement is not necessary 60-70% have persistent middle ear effusion at 14 days After hrs of treatment with 1 st line agent Amoxicillin/clavulanate 90 mg/kg/day bid Use ES formulation Ceftriaxone 50 mg/kg/day IV or IM x 3 days Alternatives: Clindamycin +/- 3 rd gen cephalosporin Clindamycin has no efficacy against H. influenzae Not effective against multi-drug resistant S. pneumoniae Do NOT use: Macrolides (azithromycin, erythromycin, clarithromycin) Limited efficacy against H. influenzae & S. pneumoniae Trimethoprim/sulfamethoxazole or erythromycin/sulfamethoxazole Substantial resistance from S. pneumoniae 7

8 Management of AOM should include an assessment of pain. If present, treatment should be recommended. (Grade B, strong recommendation) Antibiotic therapy does not relieve pain in the first 24 hours Persistent pain/fever present after 3-7 days in ~30% < 2 years Analgesics should be used regardless of antimicrobial treatment Treatment Acetaminophen, ibuprofen Home remedies (distraction, heat/cold, oil drops in external canal) Topical agents benzocaine, procaine, lidocaine naturopathic agents Homeopathic agents Narcotic analgesia with codeine or analogs Comments Effective for mild-moderate pain Limited effectiveness Additional but brief benefit over APAP in children over 5 Comparable to amethocaine/phenazone drops in patients older than 6 y. No controlled studies that directly address pain Effective for moderate or severe pain. Requires prescription; risk of significant side effects 8

9 Prophylactic antibiotics are NOT recommended (grade B; recommendation) All children should receive the flu vaccine yearly (grade B; recommendation) All children should receive the pneumococcal vaccine as recommended by ACIP, AAP & AAFP (grade B; strong recommendation Encourage breastfeeding for at least 6 months (grade B; recommendation) Encourage avoidance of tobacco smoke exposure (grade B; recommendation) Birch sugar alcohol Available as chewing gum, lozenge or syrup 2011 Cochrane Review: Prevention of recurrent AOM 25 % reduction in risk of AOM in children in child care centers vs control group Chewing gum & lozenges were more effective than syrup Must be given 3-5 times daily to be effective 9

10 Amoxicillin should be used as the 1 st line agent in most cases Ear pain should be treated & continued until at least 72 hours of antibiotics Prophylactic antibiotics are not recommended EC is an 18 month old female with 2 day history of fever, irritability, & ear tugging. She has bilateral middle ear effusion, & her TM are red and bulging. She has no other symptoms and this is only her 2 nd ear infection. 10

11 EC is an 18 month old female with 2 day history of fever, irritability, & ear tugging. She has bilateral middle ear effusion, & her TM are red and bulging. She has no other symptoms and this is only her 2 nd ear infection. Amoxicillin 90 mg/kg/day divided bid x 10 days Treat ear pain as long as needed One of most common childhood diseases throughout the world 7 million outpatient visits each year Top 20 diagnoses for ED visits $224-$539 million per year US Pharmacist 2013; 38(7):

12 Most commonly caused by respiratory viruses: Adenovirus Parainfluenza Influenza Coxsackie A Group A Streptococcus (S. pyogenes) Most common bacterial cause 20-30% of cases in children 5-15% of cases in adults Up to 30% of cases during winter months US Pharmacist 2013; 38(7):51-56 Children ages 5-15 years Usually occurs in winter to early spring Usual initial presentation sore throat difficulty swallowing fever Abrupt onset of sore throat Fever, headache Abdominal pain N & V Exudative pharyngitis Enlarged tender anterior cervical lymph nodes Palatal petechiae Inflamed uvula Scarlatiniform rash History of exposure 12

13 Absence of fever Conjunctivitis Common cold symptoms Cough Horseness Oral ulcerative lesions Rash Diarrhea ; N Engl J Med. 2011; 364: Important to determine correct cause Prevention of overuse use of antibiotics Reduction in duration and severity of symptoms Prevention of complications and acute rheumatic fever Prevention of disease transmission Rapid antigen detection test (RADT) Children > 3 years: Negative RADT follow up with culture (strong, high) < 3 years: not recommended unless other risk factors (strong, moderate) Anti-streptococcal antibody titers not recommended (strong, high) Reflective of past exposure 13

14 Follow up testing after abx is not recommended (strong, high) Testing or treatment of unsymptomatic household contacts is not recommended (strong, moderate) Usually a self limiting disease 1-3 days Goal of antibiotic treatment Prevent complications Mastoiditis, cervical lymphadenitis, peritonsilar abscess, etc Prevent progression to acute rheumatic fever Penicillin 250 mg bid-tid x 10 days Penicillin resistant GAS has never been documented Very cost effective Low incidence of side effects Amoxicillin 50 mg/kg daily x 10 days Equal efficacy Suspension is more palatable Once daily dosing 14

15 Penicillin G benzathine IM Preferred for patients unlikely to complete 10 day course 1 st generation cephalsporin x 10 days Clindamycin x 10 days Taste! Clarithrmycin x 10 days GI side effects Azithromycin x 5 days Resistance 6-8% Tetracyclines Very high rate of resistance in the US Sulfonamides Do not eradicate GAS in patients with acute pharyngitis Ciprofloxacin Limited activity against GAS Other fluoroquinolones Unnecessarily broad spectrum 15

16 NSAIDS/APAP may be used for treatment of pain or fever Aspirin should be avoided in children Corticosteroids are not recommended Topical sprays/lozenges may provide temporary relief Warm salt water rinses have not been studied Patients with frequent recurrent episodes may be carriers GAS colonization with viral pharyngitis Antibiotic treatment usually not recommended Unlikely to spread to close contacts Little to no risk of complications CID 2012; 55: Treatment may be necessary if: Community outbreak of acute rheumatic fever, acute post-streptococcal glomerularnephritis, or invasive GAS Family or personal history of acute rheumatic fever Outbreak of GAS in closed community If tonsillectomy is being considered due to being a carrier 16

17 Clindamycin mg/kg/day tid x 10 days Penicilllin + rifampin Penicillin VK 50 mg/kg/day 4x daily x 10 days Rifampin 20 mg/kg/dose qd on last 4 days of treatment Amoxicillin-clavulanate 40 mg amoxicillin /kg/day tid x 10 days Benzathine penicillin G + rifampin Penicillin G IM: <27 kg 600,000 units x 1 dose 27 kg: 1,200,000 units x 1 dose Rifampin PO 20 mg/kg/day bid x 4 days Prophylactic treatment not recommended unless previous history of acute rheumatic fever Very important to differentiate between viral pharyngitis & bacterial pharyngitis Negative rapid test should be confirmed with culture in children >3 years 1 st line agents: penicillin or amoxicillin 17

18 SC is a 6 year old with several day history of sore throat, difficulty swallowing, abdominal pain, and fever. Her RADT Strep test is negative. SC is a 6 year old with several day history of sore throat, difficulty swallowing, abdominal pain, and fever. Her strep RADT is negative. Follow up RADT with culture Start amoxicillin 50 mg/kg/day divided bid x 10 days 18

19 Common in children ages 3-12 years Providers have not always been involved Diagnosis by non-healthcare personnel Easy access to safe & effective OTC treatments Emergence of resistance Improper diagnosis Improper use of OTC products 19

20 All socioeconomic groups are affected Males less susceptible than females In US, black children less affected Do not transmit any disease Itching caused by sensitization to components of insect saliva Survive < 1 day away from the scalp at room temperature Lice cannot hop or fly, only crawl Transmission usually from head to head contact Rarely from inanimate objects Brushes, combs, hats, pillowcases 20

21 Should find live louse on the head Use louse comb Nits can be confused with dandruff, hair casts, hairspray droplets, scabs, dirt, other hair debris 21

22 Ideal agent: Completely safe Free of harmful chemicals Readily available without a prescription Easy to use inexpensive Permethrin (1%) lotion Least toxic topical agent, available OTC (Nix ) Apply to damp hair, leave on for 10 min, rinse off Reapply in 7-10 days if live lice are seen Side effects: Puritis, erythema, edema Resistance has been reported, but prevalence is not known $ Pyrethrins + piperonyl butoxide Naturally derived from chrysanthemums Neurotoxic to insects Apply to dry hair (shampoo & mousse formulations), leave on 10 min & rinse out No residual effect Do not kill newly laid eggs 20-30% remain viable Retreatment in 7-10 days Significant resistance seen in some areas $ 22

23 Malathion (0.5%) Organophosphate, high ovicidal activity Rx only (OVID ) Apply to dry hair, leave on 8-12 hrs then wash off High alcohol content = highly flammable No hair dryers, curling irons, etc! Contraindicated in children < 2 years Safety & efficacy not proven for children < 6 years $$$ Benzyl alcohol 5% Approved in 2009 for children > 6 months Rx only (Ulesfia ) Kills lice by asphyxiation, not ovicidal Apply topically for 10 min, repeat in 7 days Side effects: Puritis, erythema, pyoderma, ocular irritation $$ All treatments can be repeated in 7-10 days studies have shown that day 9 is the ideal window Alternative schedule Days 0, 7, and

24 Lindane (1%) Organochloride available Rx only since 1951 Neurotoxicity in humans Cases of severe seizure reported in children No longer recommended by the AAP, banned in California FDA warning stating it should only be used in patients who have failed other treatments and should not be used in children Wide spread resistance Spinosad (Natroba ) 0.9% topical suspension Kills lice & eggs Approved for children 4 years old Apply to dry hair & rinse off after 10 min; may repeat in 7 days Rx Only Side effects: Skin or eye irritation $$$$ Ivermectin (Sklice )0.5% lotion Antihelmintic; kills louse & eggs Approved for children 6 months & older Apply to dry hair for 10 min & rinse off Side effects: Burning, dry skin, dandruff, conjunctivitis $$$$ 24

25 Off label oral treatments for resistant cases Oral ivermectin Sulfamethoxazole-trimethoprim Whole household should be examined Bedmates should be prophylactically treated Wash clothing & linen used within 48 hrs of treatment in hot water or dry in high heat dryer (temps at least 130 degrees) Items that cant be washed: Dry clean Seal in plastic bag for 2 weeks Vacuum carpets & furniture that infested person sat or laid on Spraying home with pediculicide is not recommended 25

26 Head lice is very common in children & is a visual diagnosis 1 st line agents: permethrin or pyrethrins Malathion, benzyl alcohol, spinosad, or topical ivermectin are acceptable alternatives Treatment failure may occur due to reinfestation or lack of proper initial treatment Which of the following should not be used to treat head lice in children? a) Benzyl alcohol b) Spinosad c) Lindane d) Malathion e) All of the above are safe and effective treatments for head lice in children 26

27 Which of the following should not be used to treat head lice in children? a) Benzyl alcohol b) Spinosad c) Lindane d) Malathion e) All of the above are safe and effective treatments for head lice in children Erika Clark, PharmD, BCPS Palmetto Health Children s Hospital Columbia, SC 27