Evaluation of outcomes in converting from intravenous ondansetron to oral granisetron: an observational study.

OBJECTIVE: To describe a systematic evaluation of the outcomes associated with revising institutional guidelines for the prevention of acute chemotherapy-induced nausea and vomiting (CINV) to promote cost-effective use of the serotonin (5-HT3) antagonists. METHODS: The 5-HT3 antagonist of choice in the antiemetic guidelines was revised from intravenous ondansetron to oral granisetron in August 1995. Patient assessments were conducted immediately prior to (Period 1) and after (Period 2) guideline revision using validated questionnaires. The effectiveness of the two 5-HT3 antagonists were compared and reported to the prescribing oncologists. Outcomes were assessed one year after guideline revision (Period 3) using identical methods. RESULTS: No difference was found in the rate of total control (no emesis, no nausea) between patients receiving oral granisetron (60%) and intravenous ondansetron (56%) (p = 0.408, Period 1 vs. 2). Nausea severity, the number of emesis episodes, and use of rescue antiemetics were also equivalent. Prescriber compliance with using the 5-HT3 antagonist of choice and dose increased from 48% to 61% following adoption of oral granisetron. By Period 3, compliance increased to 78%, and satisfactory control of acute CINV was again documented. The costs for prevention of acute CINV decreased from $107 in Period 1 (intravenous ondansetron only) to $65 in Period 3 (oral granisetron). CONCLUSIONS: Outcomes associated with use of oral granisetron and intravenous ondansetron were equivalent in this patient population. Guideline revision and outcome documentation by the oncology pharmacists resulted in increased compliance with institution guidelines and a 40% cost savings.

Synagis: an anti-RSV monoclonal antibody.

Palivizumab is a new anti-RSV monoclonal antibody product indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of developing RSV disease ("Synagis," 1998). Palivizumab was evaluated in a single, large clinical trial (IMpact) (Connor et al., 1998). In this trial, RSV hospital admissions were reduced by 55% in children 24 months of age with BPD or in infants born prematurely (35 weeks gestation). Additionally, the severity of illness was also reduced as evidenced by a decrease in total days of RSV hospitalization and decreased incidence of RSV intensive care unit admissions. Palivizumab is expensive--with an estimated cost for a season ranging from $3,500-$10,700 per infant, depending on the child's weight and length of RSV season in the area where the child resides. Although palivizumab prophylaxis has been shown to reduce hospital admissions, the cost effectiveness of using this product needs to be formally evaluated. The AAP has provided guidance to determine the best candidates for RSV prophylaxis.

Anagrelide, a selective thrombocytopenic agent.

The pharmacology, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of anagrelide are reviewed. Anagrelide is a selective thrombocytopenic agent with FDA-approved labeling for the treatment of essential thrombocythemia. Clinical trials have shown that the drug may have a role in the treatment of other chronic myeloproliferative disorders, including polycythemia vera, chronic myeloid leukemia, and agnogenic myeloid metaplasia. The mechanism by which anagrelide reduces platelet count is not yet clear. The current hypothesis is that anagrelide affects the late (postmitotic) phases of megakaryocyte development. Anagrelide has a large volume of distribution and is extensively metabolized; less than 1% is recovered unchanged in the urine. Plasma half-life after a 0.5-mg dose is 1.3 hours. Anagrelide's efficacy and safety have been evaluated in open-label, noncomparative trials, in which the response rate was 60-93%. Adverse effects include headache, diarrhea, edema, palpitations, and abdominal pain. Patients with renal or hepatic dysfunction need to be closely monitored for signs of toxicity. The recommended starting dosage is 0.5 mg four times a day or 1 mg twice a day, with dosage adjustment to the lowest effective amount required to reduce and maintain platelet count below 600 x 10(9)/L. The wholesale acquisition price for 0.5-mg capsules is $350 per 100. Whether anagrelide will replace hydroxyurea as first-line therapy in some or all patients remains to be determined. Anagrelide is effective in the treatment of essential thrombocythemia and may have a role in the treatment of other myeloproliferative disorders.

RespiGam: an RSV immune globulin.

Respiratory syncytial virus immune globulin has been shown to prevent or attenuate RSV lower respiratory tract infection in infants under 24 months of age with BPD or who were born prematurely (< or = 35 weeks gestation). The use of RSV-IG is expensive. The estimated average cost of prophylaxis for a season is $4,000 to $5,000 per infant. Because of the cost of RSV-IG, and because viral transmission is possible when any blood product is administered, careful consideration of which children should receive RSV-IG is warranted.