Andrews Revised Pharmacologic Management of Otitis …sohnnurse.com/...Andrews-Revised-Pharmacologic-Management-of-Otitis... · 9/20/2013 1 Pharmacologic Management of Otitis Externa

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Pharmacologic Management of Otitis Externa and the Draining

Tympanostomy TubeBecky Andrews FNP-BC, CORLN

Richmond ENT8700 Stony Point Parkway

Richmond, Virginia 804 330 5501

∗ No real or perceived conflicts of interest related to this presentation

Disclosures

∗ Antiseptic preparations that have been used in otitis externa will be discussed

∗ A study on using mupirocin to treat MRSA otorrhea will be reviewed.

∗ The use of Tacrolimus 0.1% for the treatment of COE will discussed.

Off Label Use

∗ Distinguish proper pharmacologic management of acute and chronic otitis externa

∗ Analyze when pain medication for otitis externa is appropriate

∗ Develop a treatment plan for the draining tympanostomy tube

∗ Participate in an interactive discussion on pharmacologic management of otitis externa and the tympanostomy tube otorrhea

Objectives

Pharmacologic management of acute and chronic otitis externa

∗ Definition of acute otitis externa- Diffuse inflammation of the external auditory canal which may also involve the auricle or tympanic membrane.

∗ Definition of chronic otitis externa- Incomplete resolution or inflammation lasting > 3 months

Definitions of acute and chronic otitis externa

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∗ In America affects 4 out of 1000 per year

∗ Netherlands incidence has been reported to be significantly higher with 12-14 per 1000 per year

∗ United Kingdom incidence greater than 10 per 1000 per year

∗ Increases at the end of the summer (May be due to delayed seeking of treatment)

I

Interventions for acute otitis externa. The Cochrane Collaboration 2010.

Otitis Externa- AKA Swimmer’s ear, hot weather ear, tropical ear

∗ Exposure of ear to heat, humidity, maceration, absence of cerumen (a natural barrier against moisture and bacteria), loss of acidity (Cerumen creates a slightly acidic PH)

∗ Decreased acidity shown to be proportionate to the degree of infection

∗ Edema of stratum corneum resulting in blockage of apopilosebaceous units.

∗ Bacterial overgrowth leads to progressive edema and increased pain

∗ Current Diagnosis and Treatment Otolaryngology Head & Neck Surgery p 650

Pathogenesis of otitis externa

∗ 98% of OE in North America is bacterial

∗ Most common pathogen

∗ Pseudomonas aeruginosa

∗ Staphylococcus Aureus

∗ Rarely gram negative organisms other than P Aeruginosa

Fungal involvement is uncommon in primary acute OE

Rosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006

Pathogenesis of otitis externa

∗ Debridement of the canal avoiding trauma

∗ Ear wick for severe stenosis of canal

∗ Water protection

Nonpharmacologic Treatment

Ear wick Water Protection

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∗ Antiseptic preparations∗ Acetic and boric acids

∗ Ichthammol – “Drawing Salve”

∗ Phenol- Oticin ear drops

∗ Aluminum acetate drops (not available in US)

∗ Gentian violet

∗ Thymol

∗ Thimerosol

∗ Cresylate

∗ Alcohol

Pharmacologic management

∗ Antibiotic preparations∗ Ofloxacin

∗ Ciprofloxacin

∗ Colistin-polypeptide antibiotic

∗ Polymyxin B

∗ Neomycin

∗ Chloramphenicol

∗ Gentamycin

∗ Tobramycin

Pharmacologic management

∗ Bacterial resistance less of a concern with topical antibiotics. High local concentrations of antibiotic in the canal will usually eradicate both susceptible bacteria and those with marginal resistance


Pharmacologic management with topical antibiotics

∗ Corticosteroids

∗ Fluocinolone otic

∗ Found in combination products

∗ Ciprodex otic-ciprofloxacin/dexamethasone otic

∗ Cipro HC otic- ciprofloxacin/hydrocortisone

∗ Cortisporin- neomycin/polymyxin B/hydrocortisone

∗ Hydrocortisone/acetic acid otic

Pharmacologic Management with Topical Steroids

∗ Topical antimicrobials with steroids have been found to be more effective than placebo

∗ Topical antimicrobials with steroids more effective than acetic acid in terms of cure rate at 2-3 weeks

∗ No clinically meaningful differences found in cure rates between the various topical agents reviewed. The Cochrane review found that any antimicrobial or antiseptic drops with or without steroids had similar efficacy and treatment response (they noted limited exception)

∗ Evidence of steroid-only drops is very limited and further investigation needed


Which ototopical is most effective based on studies?

∗ Preferred choice of topical treatment may need to be determined by other factors∗ Risk of ototoxity

∗ Risk of contact sensitivity

∗ Risk of developing resistance

∗ Availability

∗ Cost

∗ Dosing Schedule


How to choose which agent you prescribe?

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∗ Proper delivery is very important

∗ Educate the patient/parent/spouse on correct administration of ototopical agents

Don’t forget to educate

∗ Warm drops by holding in hand several minutes

∗ Gently shake bottle

∗ Do not touch tip of bottle to ear

∗ Lie down or tilt head to one side

∗ Gently pull and hold ear up and back for adult or down and back for children

∗ Gently squeeze bottle and insert number of prescribed drops

∗ Press on tragus and keep head tilted for several minutes

Proper administration of ototopicals

∗ Systemic Antimicrobial Therapy-

Should be used only for infection extending beyond ear canal or presence of specific host factors that would indicate need for systemic treatment

Oral antibiotics are over used for acute OE (20-40% of patients receive oral antibiotics often in addition to topical antibiotics)

Oral antibiotics selected are usually inactive against P aeruginosa and S aureusRosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006

Pharmacologic Management with Systemic Antibiotics

∗ Diabetics

∗ HIV infection

∗ Other immunocompromised state

∗ History of radiation therapy

∗ TM perforation

∗ Tympanostomy tube

∗ Rosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006

Medical History that May Warrant use of Systemic Antibiotics

∗ Most people with OE do not need oral antibiotics!!!

∗ Cipro 250 to 750 mg PO BID for 10 days (dose, duration vary with severity). Not FDA approved for use in children.

∗ Culture directed antibiotic therapy recommended for children

Systemic Antibiotics

∗ Sensitization/secondary contact otitis can occur from prolonged or recurrent use of topical antibiotics

(Most common with neomycin)

Otoxicity with neomycin if tympanic membrane perforation or tympanostomy tube present

Otomycosis can result from prolonged use of topical antibiotics

Risks of Topical Antibiotic use

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∗ Significant adverse events that can include diarrhea, vomiting, allergic reactions, development of bacterial resistance

∗ Societal consequence of spreading resistant pathogens

∗ Many of antibiotics chosen ineffective against usual pathogens in otitis externa

∗ Rosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006

Risk of Oral Antibiotics in Otitis Externa

∗ Inflammatory process of the external ear caused by fungi

∗ Responsible for 9% of otitis externa

∗ Most common pathogens include Aspergillus and Candida

∗ Usually presents with pruritus

∗ Current Diagnosis and Treatment Otolaryngology Head & Neck Surgery p 650

Otomycosis

Otomycosis

∗ Nonspecific antifungal agents- thimerosal and gentian violet

∗ Specific antifungals- clotrimazole, Nystatin , ketoconazole.

∗ CSF powder (cholamphenicol, sulfamethoximazole, and fungizone)

∗ No FDA approved antifungal otic preparation Ototopical antifungals and otomycosis: a review. International Journal of Pediatric Otorhinolaryngology, (2008)72, 453-459.

Pharmacologic Management of Otomycosis

∗ An inexpensive “home remedy” for persistantotomycosis

∗ 1:1 preparation of rubbing alcohol and white vinegar. Apply 3-4 drops BID for a week

∗ Do not use with TM perforations

Pharmacologic Management of Otomycosis

Malignant Otitis Externa

∗ Immunocompromised

∗ DM, HIV, XRT

∗ Granulation tissue

∗ Necrotic Bone

∗ Oral ciprofloxacin

∗ Consider IV aminoglycosides

∗ Hyperbaric oxygen therapy

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∗ Inflammatory condition of the ear canal skin.

∗ Cause is unknown

∗ Possibly allergic or autoimmune

∗ Effects 3-5 % of the population

∗ Bilateral in at least half of patients

∗ Kesser, Bradley. Assessment and management of chronic otitis externa. Curr Opin Otolaryngology & Head and Neck Surgery 2011, 19:341-347.

Chronic Otitis Externa

∗ History- pruritis, clear or seromucinous drainage, and aural fullness.

∗ Examination- lack of cerumen, clear drainage, and flaky, dry, scaly inflamed ear canal skin.


Chronic Otitis Externa

Identify underlying cause

Systemic autoimmune disease, contact allergen, fungal infection, dermatophytid reaction

Control inflammation

Avoid water, q-tips, careful debridement and topical therapy

Kesser, Bradley. Assessment and management of chronic otitis externa. Curr Opin Otolaryngology & Head and Neck Surgery 2011, 19:341-347.

Chronic Otitis Externa Treatment

∗ Topical therapies include choloromycetin-sulfanilamide-fungizone-hydrocortisone (CSF-HC) powder, topical steroid creams of varying potency, antibiotic-steroid ototopical preparations, immunosuppressive agent (e.g. tacrolimus) and acetic acid/alcohol drops.


Chronic Otitis Externa Treatment

∗ Nonsteroidal immunosuppressant mainly used for allogeneic organ transplantation

∗ Efficacy seen in atopic dermatitis and more recently in noninfectious chronic otitis externa

∗ Insert a wick containing 0.1% tacrolimus into the ear canal. Change every 2-3 days for 9-12 day.


Tacrolimus 0.1%

∗ Pain assessment should be included in OE management

Don’t forget the pain

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Mild to Moderate pain- acetaminophen or NSAIDS given alone or in combination with an opioid (acetaminophen with codeine, oxycodone, or hydrocodone; ibuprofen with oxycodone)

Rarely parental analgesia may be necessary to control painRosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006

Pain Management for Otitis Externa

∗ Topical preparations

∗ Benzocaine otic solution with or without pyrine

∗ No clinical trials show efficacy in AOE

∗ May mask progression of underlying disease due to suppression of pain

∗ Benzocaine may cause contact dermatitis

∗ If prescribed reexamine in 48hours∗ Rosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006

Pain Management of Otitis Externa

∗ Nonpharmacologic therapies-

Heat, cold, relaxation, and distraction have unproven value


Pain Management of Otitis Externa

∗ Definition- Discharge from the middle ear through the tube, usually caused by AOM or external contamination of the middle ear from water entering the ear canal (swimming, bathing, washing hair).

∗ Rosenfeld et al ., Clinical Practice Guideline: Tympanostomy Tubes in Children. 2013

The Draining Tympanostomy Tube

∗ Tympanostomy tube placement is the most common surgical procedure performed in children

∗ By 3 years of age nearly 6.8% of children will have tympanostomy tubes and this increases by 2 fold with daycare participation

∗ Most studies show post tympanostomy tube otorrhea (PTTO) at a rate of 16% although it can range from 1.7 to 74%.

∗ Rosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006∗ Rosenfeld et al., Clinical Pracitce Guideline: TympanostomyTubes in Children. 2013

The Draining Tympanostomy Tube

∗ Streptococcus pneumoniae

∗ Haemophilus influenzae

∗ Moraxella catarrhalis

∗ Staphylococcus aureus

∗ Pseudomonas aeruginosa

∗ Concomitant viral infection found in as many as 70%∗ Rosenfeld et al ., Clinical Practice Guideline: acute otitis externa. 2006

Microbiology of PTTO

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∗ Topical Flouroquinolones with or without corticosteroids preferred to systemic antibiotics

∗ Advantages-

∗ Can be applied directly to middle ear through patent tube

∗ Higher concentration of medication which can overcome antibiotic resistance

∗ Do not carry the risk of ototoxicity associated with aminoglycosides

∗ Decreased systemic adverse reactions

Pharmacologic Management of PTTO

∗ Ciprodex Otic 4 gtts in draining ear BID for 7 days∗ Bactericidal and anti inflammatory action∗ Minimal/no systemic absorption

∗

∗ Ofloxacin Otic 5-10 gtts in draining ear BID for 10-14 days∗ Bactericidal∗ Minimal systemic absorption∗ Minimal metabolism in the liver

Pharmacologic Management of PTTO

∗ Ciprodex Otic

∗ $184.40 (7.5ml bottle)

∗ Not covered by Medicaid and certain HMOs

∗ Higher out of pocket expense compared to Ofloxacin

Ofloxacin Otic

∗ $148.99 (10ml bottle)

∗ Preferred by Medicaid

∗ Lower out of pocket cost/lower tiered copay

Expense of Topical Antibiotics

∗ 4-8% of children with PTTO treated with quinolones require treatment with oral antibiotics for persistent symptoms

∗ Occur when topical antibiotics cannot reach middle ear space∗ Clean ear before administering drops by blotting the canal

opening, using infant nasal aspirator, q-tip soaked in hydrogen peroxide (for use around EAC opening), or suction using open head otoscope or binocular microscope

∗ “Pump” tragus several times after drop has been instilled

∗ Avoid water in ears during period of otorrhea∗ Clinical Practice Guideline: Tympanostomy Tubes in Children, Otolaryngology-head and Neck Surgery July 2013

Failure of Ototopical Antibiotic Therapy

∗ Culture drainage- Frequently organisms are identified that are susceptible to topical quinolones

∗ Remember that sensitivity results from otorrhea cultures usually relate to serum drug levels achieved from systemic antibiotics . Antibiotic concentration at the site of infection with topical agents can be up to 1000 fold higher and can overcome resistance

∗ Clinical Practice Guideline: Tympanostomy Tubes in Children, Otolaryngology-head and Neck Surgery July 2013

Failure of Ototopical Antibiotic Therapy

∗ Children with complicated otorrhea

∗ Cellulitis of adjacent skin

∗ Concurrent bacterial infection requiring antibiotics (sinusitis, Group A strep throat)

∗ Immunocompromised

∗ Rosenfeld et al., Clinical Practice Guideline: TympanostomyTubes in Children. 2013

Exceptions to ototopical agents as firstline

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∗ Earplugs, headbands, avoidance of swimming and water sports recommended during active episodes of PTTO, recurrent or prolonged PTTO and those with a history of problems with prior water exposure.

∗ Rosenfeld et al., Clinical Practice Guideline: TympanostomyTubes in Children. 2013

Water Precautions with PTTO

∗ Steady increase in MRSA otorrhea

∗ External ear may be a site of colonization and infection

∗ Study-

∗ Mupirocin ointment (0.6mg) was applied locally to TM and promontory around and through perforation with its adjacent ear canal. Applied 1-4 times for 2-3 weeks. Complete cure in 100% of patient’s studied.

∗ Ofloxacin group used drops BID for 2-3 weeks at home. Only a 20% cure rate.

∗ Furukawa, et al’. Clinical Effectiveness of Ototopical Application of Mupirocin Ointment in Methicillin-Resistant Staphylococcus aurues Otorrhea. Otology & Neuroltoogy, 2008; 29:676-678.

MRSA otorrheaStudy in Japan compared Ofloxacin

to Mupirocin

Otorrhea Algorithm http://raleighent.com/Images/otorrheaGrid.gif

∗ 70 yo male c/o left ear itching and pain for 5 days which is getting progressively worse

∗ History of SNHL and has been wearing hearing aids for 3 years

Case Study #1

Case Study #1 exam

∗ HEENT– Patient wearing bilateral hearing aids. Small amount of cerumen in right EAC with TM clear and mobile. Left EAC obstructed by white debris and fungal hyphae. Canal inflamed. TM not visible.

∗ After cleaning with suction the left TM is clear and mobile

Case Study # 1 physical exam

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∗ Debridement of canal

∗ Consider ear wick

∗ Antimycotic solution (Gentian Violet, Acetic Acid, CSF powder, etc.)

∗ Keep hearing aid out of affected ear until resolved

Case Study #1 Treatment plan

∗ 2 yo female with history of recurrent AOM

∗ 2 weeks s/p insertion of tympanostomy tubes.

∗ Mother reports child has had yellow drainage from both ears for 3 days

∗ Medication- None

∗ NKDA

Case Study #2

www.entusa.com

Case Study- Physical Exam

∗ Afebrile

∗ HEENT- Bilateral EAC- purulent drainage, Tubes in place and draining. Nose patent without drainage. Tonsil 3+ without erythema.

∗ Neck- No LAD

∗ Lungs- CTAB A & P

Case Study- Physical Examination

∗ Suction ears as tolerated

∗ Ciprodex Otic 4 gtts AU BID for 7 days or

∗ Floxin Otic 5 gtts in AU BID for 10 days

∗ Follow-up in a week if not improving for culture and suctioning if necessary

Case Study- Treatment

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Andrews Revised Pharmacologic Management of Otitis …sohnnurse.com/...Andrews-Revised-Pharmacologic-Management-of-Otitis... · 9/20/2013 1 Pharmacologic Management of Otitis Externa