Acute Otitis Media — No Antibiotics Does Not Equal No Treatment!
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Volume 18, Number 8 September 2004 Drugs & Therapy B � U � L � L � E � T � I � N PRESCRIBING FORMULARY UPDATE The Pharmacy and Therapeutics Acute otitis media — Committee met August 18, 2004. 4 drugs were added in the Formulary and 2 drugs were deleted. 4 drugs No antibiotics does not equal were designated nonformulary and not available. 1 drug was evalu- no treatment! ated and designated a high-priority nonformulary drug. cute otitis media (AOM) is the hours, antibiotics should be instituted A most commonly treated bacterial immediately. infection in children. Treatment ac- Observation of AOM should not ◆ ADDED counts for greater than 50% of pediatric equal no treatment. All patients should Azacitidine (Vidaza® by antibiotic prescriptions and as much receive adequate analgesics, especially Pharmion)* as $5 billion annually.1 Studies show during the fi rst 24 hours after diagno- that the spontaneous resolution rate of sis.3 Although various treatments for Bortezomib (Velcade® by AOM is between 70-90%, and only 1 in otalgia have been used, none are well Millennium Pharmaceuticals)* 7-14 children with AOM benefi ts from studied. Eplerenone (Inspra® by Pfi zer) treatment with antibiotics.2 Acetaminophen and ibuprofen are In May of 2004, The American Acad- the mainstay of treatment for pain Progesterone Suppositories emy of Pediatrics and the American associated with AOM due to their ef- (Compounded) Academy of Family Physicians pub- fective analgesia for mild-to-moderate lished evidence-based clinical practice pain.1 The usual dosage of ibuprofen in *Restricted to chemotherapy guidelines for the diagnosis and man- infants and children in 4-10 mg/kg/dose prescribers AND approval by an agement of AOM in children between orally every 6-8 hours, not to exceed oncology pharmacist 2 months and 12 years of age with 30 mg/kg/day.4 The usual dosage of uncomplicated AOM. The guidelines acetaminophen is 10-15 mg/kg/dose ◆ DELETED recommend that observation without orally given every 4-6 hours as needed Beef Lung Heparin use of antibacterial agents in a child for pain, with a maximum of 5 doses in (Beef Lung Heparin by Upjohn)** with uncomplicated acute otitis media 24 hours. Topical agents such as ben- is an option for selected children based zocaine (Auralgan® otic) have limited Prochlorperazine Syrup on diagnostic certainty, age, illness, se- usefulness, as there is no evidence (Compazine® Syrup by SmithKline verity, and assurance of follow-up. This supporting their use over systemic Beecham)** “observation option” refers to defer- analgesics. Other treatments for otalgia ring antibacterial treatment of selected in AOM include narcotic analgesics, **Nonformulary and not available children for 48-72 hours and limiting which are effective for moderate or management to symptomatic relief. Ap- severe pain. However, these agents ◆ NONFORMULARY AND NOT propriate and adequate management of may be more problematic than acet- AVAILABLE symptoms such as otalgia (ear pain) is aminophen and ibuprofen due to their Hydroxyprogesterone Caproate essential during this time period. adverse effect profi le, which includes Injection (Compounded) Once AOM is diagnosed, the decision respiratory depression, altered men- must be made to observe or treat the tal status, gastrointestinal upset, and Venlafaxine Immediate-Release patient. Based on guideline recommen- constipation.4 Tablets (Generic) dations, observation should be limited (continued on page 3) to otherwise healthy children 6 months ◆ EVALUATED, BUT NOT ADDED to 2 years of age with non-severe ill- Botulism Immune Globulin ness at presentation and an uncertain ® diagnosis, and to children 2 years of (BabyBIG by California Depart- ◆ ment of Health Services)*** age and older without severe symp- toms at presentation or with an un- INSIDE THIS ISSUE ***Cannot be stocked, but designated certain diagnosis. Observation allows a high-priority nonformulary drug the patient time to improve without ◆ P&T Actions instituting antibacterial therapy. If the (continued on next page) patient does not improve within 48-72 Formulary update, from page 1 suggest that bortezomib is a possible larger absolute risk reduction of 11% Azacitidine is a pyrimidine nucleo- option for the outpatient management (NNT= 9). Although approximately side analog that is used in the treat- of refractory multiple myeloma. Bort- 50% of the patients in the RALES trial ment of myelodysplastic syndromes. ezomib plus dexamethasone may offer had ischemic heart failure, these pa- Myelodysplastic syndromes (MDS) benefi t to patients who are refractory tients were not in the immediate post- are a heterogeneous group of clonal to dexamethasone alone. MI setting, like the eplerenone trial. hematological disorders character- The most serious adverse reactions Spironolactone use in males with ized by cytopenia and death from associated with bortezomib include congestive heart failure is associated bleeding, infection, or progression to thrombocytopenia, asthenia, peripheral with gynecomastia in about 10% of acute myelogenous leukemia (AML). neuropathy, neutropenia, anemia, nau- patients. It is also associated with im- There is no standard therapy for sea, vomiting, and diarrhea. Asthenia potence and menstrual irregularities in MDS and treatment options are (fatigue, malaise, weakness) occurs in women. These may be less problem- determined by the patient’s age and most patients. Over 40% of patients atic with eplerenone because of less prognostic factors. Most patients experience thrombocytopenia. affi nity for progesterone and andro- with MDS receive supportive care A typical course of therapy will cost gen receptors, but this has not been (ie, hematopoietic growth factors and approximately $20,000. In August 2003, proven in a head-to-head study. cytokines, transfusions, and antibi- bortezomib was reviewed by the P&T Hyperkalemia is the most trouble- otics). The only curative therapy is Committee and designated nonformu- some adverse effect associated with stem cell transplantation and most lary and not available for inpatient and the use of eplerenone. Excessive patients do not qualify for this option. outpatient use because it was expen- dosages or use with drugs that inhibit Chemotherapy is an alternative to sive and both inpatient and outpatient the metabolism of eplerenone may in- supportive therapy. Azacitidine is the reimbursements did not cover this crease the risk of hyperkalemia. Some only drug with a labeled indication added expense. diseases and drugs (eg, ACE inhibi- for the treatment of MDS. Bortezomib was a reason for a tors) may independently increase the A phase III trial has shown that change in federal reimbursement risk of hyperkalemia. A recent time azacitidine had signifi cantly higher rules. The FDA approved bortezomib, series analysis showed increased mor- response rates, improved quality of yet reimbursement was not provided bidity and mortality associated with life, reduced risk of leukemia trans- for its labeled indication. Regulations hyperkalemia in patients treated with formation, and improved survival now require that all drugs, including spironolactone for heart failure. Similar compared with supportive care. bortezomib, be a covered expense for problems are expected with eplere- Response rates of 60% (7% complete) its labeled indication in the outpatient none unless appropriate monitoring is were dramatically better than with setting. done. supportive care (ie, 5% response rate In the inpatient setting, however, Serum potassium should be mea- and 0% complete response). The reimbursement is “covered” by fi xed sured before the institution of eplere- time to transformation to leukemia reimbursement. Therefore, use should none, within the fi rst week of therapy, or death occurred in a median of 21 be outpatient or in rare instances when and after 1 month after the start of months versus 12 months for sup- a patient is hospitalized and requires therapy. Serum potassium should be portive care. These results were ap- continuation of therapy. Since patients measured “periodically” thereafter. parent despite 53% of the supportive must pay a co-pay in the outpatient set- It should be re-measured within 1 care arm crossing-over to the treat- ting, there is potential for patients to be week and at 1 month after a dosage ment arm because of lack of effect. inappropriately admitted to avoid this change (or the addition of a mediation Myelosuppression is the most expenditure. Thus, an oncology phar- that may decrease the metabolism of common toxicity seen with azaciti- macy specialist must approve inpatient eplerenone). Eplerenone is contrain- dine. Toxicity is diffi cult to assess, use of bortezomib. dicated in patients with a creatinine however, because of the underlying Eplerenone is a selective aldosterone clearance less than 30 mL/min and cytopenias associated with MDS. receptor blocker with labeled indications patients with a serum potassium Azacitidine is expensive. A typical for hypertension and heart failure post greater than 5.5 mEq/mL at initiation 7-day course will cost over $11,000. myocardial infarction (MI). It is similar to of therapy. Usually this drug will be adminis- spironolactone, but pharmacologically it There is insuffi cient evidence to tered as an outpatient; however, is more specifi c for aldosterone recep- support the use of eplerenone for the there will be instances when pa- tors and has less effect on progesterone treatment of hypertension or heart fail- tients will be admitted for complica- and androgen receptors.