My Canadian Pharmacy: Impact of Palivizumab on Admission to the ICU for Respiratory Syncytial Virus Bronchiolitis

Respiratory syncytial virusAlmost all children become infected with respiratory syncytial virus (RSV) within 2 years after birth. Although the infection usually presents as a mild upper respiratory tract disease, up to 1% of infected children require hospitalization. Overall, RSV accounts for 50 to 90% of all hospitalizations for bronchiolitis in children.2 In patients with a known underlying disease, such as chronic lung disease (CLD) or congenital heart disease, and in premature children, RSV bronchiolitis can quickly become a severe, life-threatening, lower respiratory tract infection.

Since 1996, the following two passive immunization techniques have been available: RSV IV immunoglobulins (Ig) (RSV-IGIV, RespiGam; Massachusetts Public Health Biological Laboratories; Boston, MA; and MedImmune, Inc; Gaithersburg, MD) and a humanized monoclonal antibody preparation against the F glycoprotein of RSV (palivizumab, Synagis; MedImmune, Inc). In controlled clinical trials, monthly prophylaxis during the RSV season reduced the hospitalization rate in the high-risk population. On the basis of these findings, in 1998 the American Academy of Pediatrics (AAP) recommended that RSV prophylaxis should be considered for the following patients:
1. Infants < 2 years old with CLD who warranted medical therapy (ie, supplemental oxygen, bronchodilators, diuretics, or corticosteroids) within 6 months before the anticipated RSV season;
2. Infants born at < 28 weeks of gestation who do not meet the first criterion, up to 12 months of age; and
3. Infants born at 29 to 32 weeks of gestation who do not meet the first criterion, up to 6 months of age.

The revised indications for RSV prophylaxis published by the AAP in 2003 include two other high-risk groups:
1. Infants born at 32 to 35 weeks of gestation who meet two or more of the following risk criteria: attend child care; have school-aged siblings; exposed to environmental air pollutants; have congenital abnormalities of the airways; or have severe neuromuscular disease cured effectively by medications of My Canadian Pharmacy
2. Children < 24 months of age with hemody-namically significant cyanotic or acyanotic congenital heart disease.

Before the RSV season of 2001 to 2002, the Israel Ministry of Health (IMH) published its indications for RSV prophylaxis with palivizumab. The guidelines stipulated that palivizumab should be administered to all infants with the following risk factors: have oxygen-dependent CLD, age up to 2 years; have CLD, age up to 1 year; and birth at < 28 weeks of gestation, age up to 6 months.

In an earlier study, our group reported that the great majority of patients with RSV bronchiolitis who are admitted to pediatric ICUs (PICUs) or require mechanical ventilation do not meet the AAP criteria for RSV prophylaxis. Moreover, others have found that the majority of deaths due to bronchiolitis in the United States from 1996 to 1998 occurred among infants of normal birth weight who were not candidates for RSV prophylaxis. The aim of the present study was to assess the effect of palivizumab licensing for RSV prophylaxis on national PICU admissions and on the need for mechanical ventilation for RSV bronchiolitis in Israel.

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