Improving Pediatric Adverse Drug Event Reporting through Clinical Pharmacy Services.

OBJECTIVES: The purpose of this study was to summarize adverse drug event (ADE) reporting and to characterize the type of healthcare practitioners involved in reporting over a 10-year period at a 120-bed university-affiliated children's hospital. METHODS: The University of Virginia Children's Hospital ADE database was analyzed for records involving pediatric patients. Data from patients <18 years of age who were admitted to the University of Virginia Children's Hospital between January 1, 2000, and December 31, 2009, were analyzed. Data collected included drug name and therapeutic class of the suspected causative agent, description of the event, severity, causality, outcome, and the type of healthcare practitioner reporting the event. RESULTS: A total of 863 ADEs were reported over the 10-year period. The 5 most common types reported were extravasation injury (10%), rash (8%), hypotension (5%), pruritus (5%), and renal failure (3%). A total of 196 (21%) cases were categorized as mild, 436 (47%) cases as moderate, and 296 (32%) cases as severe. Further characterization of extravasations was performed to identify trends relating to potential causes. In 45 (57%) reports, parenteral nutrition was identified as the causative agent. Full recovery was documented in 21 (47%) extravasations. Of the total events reported, 83% were reported by pharmacists, 16% by nurses, and <1% by other healthcare practitioners. CONCLUSIONS: Results of this study are consistent with those of previous studies involving ADE reporting in children's hospitals. This consistency is due in part to system design and use of unit-based pharmacists as the primary reporters.

Zoster vaccine live.

Herpes zoster is a neurocutaneous disease caused by the varicella-zoster virus and is associated with significant morbidity and long-term sequelae in older adults. Until recently, treatment options for these complications have been primarily targeted at disease state management and symptom relief. Zoster vaccine live is the first vaccine approved for the prevention of herpes zoster. The vaccine was approved by the United States Food and Drug Administration for adults aged 60 years or older. Results of the Shingles Prevention Study demonstrated that in older individuals, administration of zoster vaccine live reduces the burden of illness associated with herpes zoster by 61.1%, the frequency of herpes zoster pain and discomfort by 51.3%, and the frequency of postherpetic neuralgia by 66.5%. Overall, adverse events reported in clinical trials of zoster vaccine live were classified as mild. Events that occurred more frequently in zoster vaccine live recipients than in placebo recipients included injection site reactions, headache, respiratory infections, fever, flu syndrome, diarrhea, rhinitis, skin disorders, respiratory disorders, and asthenia. The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recently recommended universal vaccination for those 60 years of age and older, including those who have experienced previous episodes of shingles.

Trivalent intranasal influenza vaccine, live.

OBJECTIVE: To review human data on the efficacy, safety, and clinical use of trivalent intranasal influenza vaccine, live (TIIVL). DATA SOURCES: A MEDLINE search (1966-3rd week of January 2004) using the terms influenza vaccine, intranasal administration, and FluMist was conducted. References from pertinent articles were also reviewed. STUDY SELECTION AND DATA EXTRACTION: Studies conducted in humans and published in English were selected. Double-blind, controlled trials evaluating the efficacy and safety of TIIVL were evaluated. DATA SYNTHESIS: Administration of TIIVL results in mucosal and humoral immunity to influenza. Results of clinical trials in children and adults have demonstrated that TIIVL reduces the incidence of influenza. In children, TIIVL was also associated with a decrease in febrile illness and febrile otitis media. In adults, reductions in workday absences and medical visits due to febrile upper respiratory tract illness were also documented. TIIVL is well tolerated, with rhinorrhea or nasal congestion and sore throat occurring more frequently than with placebo. CONCLUSIONS: TIIVL is an alternative to intramuscular inactivated influenza vaccine in healthy individuals between 5 and 49 years of age. However, the vaccine is contraindicated in the majority of patient populations for whom annual influenza vaccination is recommended.

Excessive somnolence from aripiprazole in a child.

A 9-year-old girl was hospitalized with prolonged somnolence that began 3.5 hours after a single 15-mg dose of aripiprazole. After extensive workup, physical examinations were unremarkable, and all laboratory test results were within normal limits. The patient's extreme somnolence was attributed to aripiprazole, a new atypical antipsychotic prescribed for oppositional defiant disorder. In clinical trials, somnolence has been reported with a frequency of approximately 11%. However, the somnolence experienced by this child was severe, requiring 24-hour hospitalization for observation. Although a recent dose-finding study in 22 pediatric patients (> or = 6 yrs old) described weight-based dosages that were safe and well tolerated, dosing of aripiprazole in children has not been well established. Further studies are needed to identify optimal dosing of aripiprazole in pediatric patients.

Possible anaphylaxis after propofol in a child with food allergy.

OBJECTIVE: To report a case of anaphylaxis due to propofol in a child with allergies to egg and peanut oil. CASE SUMMARY: A 14-month-old boy with a history of reactive airway disease was hospitalized for treatment of respiratory symptoms. The patient had documented allergies to egg, peanut oil, and mold. Within the first few hours after admission, acute respiratory decompensation occurred, and arrangements were made to transfer the patient to our tertiary-care hospital. Prior to transfer, he was emergently intubated under sedation and paralysis with propofol and rocuronium. When emergency air transport arrived, the patient was hypotensive and tachycardic. His symptoms of anaphylaxis were managed throughout the flight and, upon arrival at our institution, the patient was admitted to the Pediatric Intensive Care Unit. He improved over a 5-day hospital course, and his caregivers were instructed to avoid propofol in the future. The patient's anaphylactic reaction following propofol was rated as a possible adverse drug reaction using the Naranjo probability scale. DISCUSSION: The use of propofol in pediatric patients for procedural sedation has gained increased favor. Since the propofol formulation contains both egg lecithin and soybean oil, its use is contraindicated in patients with hypersensitivities to these components. Several other drugs have a food component, resulting in contraindications and warnings in product labeling. CONCLUSIONS: Propofol should be avoided in patients with allergies to egg and/or soybean oil, if possible. Clinicians should consider the potential for adverse drug events in patients with select food allergies.

Clopidogrel-associated leukopenia.

OBJECTIVE: To report a case of leukopenia in a patient receiving clopidogrel following intracoronary stent placement. CASE SUMMARY: A 58-year-old white man presented to the emergency department (ED) with fever and chills. Seven days prior to presentation, he underwent intracoronary stent placement and clopidogrel 75 mg once daily was initiated. In the ED, laboratory evaluation revealed leukopenia with negative blood and urine cultures. The patient was released but returned the following day with fever and sweating. Infectious complications were ruled out, and clopidogrel was discontinued. Leukopenia resolved within 7 days, and the patient has experienced no further hematologic complications. Based on the Naranjo probability scale, the leukopenia was rated as a probable reaction to clopidogrel. DISCUSSION: Ticlopidine and clopidogrel are the 2 commercially available thienopyridine antiplatelet agents. Risk of myelotoxicity with ticlopidine is well known and requires frequent hematologic monitoring. Clopidogrel is better tolerated, less toxic, and has more extensive indications, including use in acute coronary syndrome. These factors have resulted in the replacement of ticlopidine by clopidogrel. The 4 previously published reports of clopidogrel-associated white blood cell (WBC) toxicity are described. The mechanism of myelotoxicity with clopidogrel is not known. CONCLUSIONS: Better tolerability, reduced toxicity (particularly hematologic), and the convenience of once-daily dosing have resulted in the replacement of ticlopidine with clopidogrel. WBC toxicity associated with clopidogrel therapy is very infrequent and has occurred weeks to months following therapy initiation. Clinicians should be aware of the potential for this adverse effect.