Pediatric Pharmacy Research Articles

Safety of infliximab treatment in pediatric patients with inflammatory bowel disease.

Infliximab appears to be efficacious in the treatment of pediatric Crohn disease (CD). There are few large-scale pediatric studies on the complications of infliximab therapy. A retrospective review of all infliximab infusions administered to IBD patients at a tertiary children's hospital was undertaken. Data was obtained from an infliximab infusion database maintained in the section of Pediatric Gastroenterology, pharmacy records and patient charts. 594 infusions were administered to 111 IBD patients (88 CD and 23 UC; 55 male and 56 female; ages 4 to 20 years; mean age, 13.4 years). The number of infusions ranged from 1 to 24 with a mean of 5.4/patient. Infusion reactions occurred in 8.1% of patients (seven early and two delayed) and in 1.5% of all infusions. Reactions occurred more frequently in female patients (14% versus 2%; P = 0.03). All reactions were mild and responded rapidly to treatment. Four patients had infections deemed unusual, including three cutaneous tinea infections and one case of shingles. Infliximab is safe in pediatric IBD patients with a low incidence of generally mild reactions that respond rapidly to intervention. Infusion reactions are more common in female patients. Our patients had no serious infectious complications, although cutaneous tinea infection may represent a newly reported associated complication.

Enterobacter cloacae bloodstream infections in pediatric patients traced to a hospital pharmacy.

The sources of an outbreak of Enterobacter cloacae bloodstream infections in a pediatric hospital were investigated, as were the risk factors for acquiring the infection: Two retrospective case-control studies were conducted. The study sample included all patients admitted to the general pediatric wards from February 5 through March 30, 2001, who had a positive blood culture for E. cloacae. Pediatric ward and pharmacy infection-control practices were reviewed, personnel and environmental cultures were obtained, and pulsed-field gel electrophoresis (PFGE) molecular typing of the bloodstream isolates was conducted. Four subjects were identified. These infants were more likely than control patients to receive i.v. ranitidine (p < 0.01). Among patients receiving i.v. ranitidine, subjects were more likely than controls to receive i.v. ranitidine prepared by a pharmacist. No environmental or personnel cultures yielded E. cloacae. Patients' E. cloacae isolates had four different PFGE patterns, suggesting environmental rather than point-source contamination. Ranitidine multidose vials were kept connected to an automatic compounding machine for up to 48 hours at room temperature after the first dose was drawn, contrary to manufacturer recommendations. Further, preparation of ranitidine infusions was not conducted in accordance with recommendations for risk level 2 sterile i.v. products. The use of contaminated ranitidine multidose vials was the most likely cause of an outbreak of E. cloacae. However, a combination of other factors such as inadequate hand-washing techniques, presence of E. cloacae in the environment, noncompliance with guidelines for the preparation of sterile infusions and medications, and a susceptible population may have contributed to the infections.

Medicines for children—the last century and the next

Paediatricians, neonatal/paediatric pharmacists, and chief executives of hospital trusts recently received a position statement on the use of unlicensed medicines, produced by the Joint Standing Committee on Medicines of the...

Initial Experience with a Paediatric Pharmacy E‐Mail Network

Background: The unique characteristics associated with paediatric pharmacy practice led to the launch of an e‐mail network in January 1999. It aimed to facilitate communication and timely exchange of information between pharmacists on paediatric‐related issues.Aim: To outline the utility and assess the activity of the e‐mail network over the first 18 months of operation and to determine the future direction of the group.Method: A retrospective review of electronic activities was performed to assess the activity of the e‐mail list for the first 18 months of operation. User satisfaction was determined by an e‐mail survey of all subscribers and the future direction of the network drawn from analysis of this information.Results: For the first six months the network consisted of 15 New Zealand (NZ) based pharmacists, with 23 new enquiries and 60 replies circulated. After 18 months, 65 practitioners subscribed with representatives from NZ (22), Australia (42) and England (1). A corresponding increase in activity was noted over the 12‐ to 18‐month period with 80 new enquiries and 170 associated replies. Of the 148 new enquiries over the 18‐month period, the most frequently raised topics related to dosage and administration (27%), formulation (19%), useful resources and information (15%) and availability and supply of medicines (14%). Nearly 60% related to off‐label or unlicensed use of medicines. The majority of respondents to the user satisfaction survey indicated that they found the network convenient, useful and valuable. To ensure rapid communication with archiving of messages, use of a mailing list named ‘Paedpharm’ has been established. Future developments being considered are inclusion of individual members overseas and links with other established paediatric groups.Conclusion: The paediatric pharmacy e‐mail network has grown into a convenient, valuable and useful tool for informal exchange of information with paediatric colleagues.

Participating in an International Pharmacist Exchange Program

This paper describes an exchange between two paediatric pharmacists in Australia and the UK. Main areas of interest are highlighted and similarities and differences between paediatric pharmacy practice in the two countries are discussed.

Pediatric Pharmacy Education for U.S. Entry-Level Doctor of Pharmacy Programs

Pediatric Pharmacy Education for U.S. Entry-Level Doctor of Pharmacy Programs

Sterility of filgrastim (G-CSF) in syringes.

To determine if the sterility of filgrastim (G-CSF) is maintained for up to 7 days when aseptically transferred from the vial to tuberculin syringes in a laminar air flow environment. The study was conducted in two phases: a validation and an experimental phase. The method was validated by inoculating samples of sterile filgrastim solution with common bacterial and fungal skin contaminants. Samples were aseptically drawn into syringes in a class 100 horizontal laminar air flow hood and refrigerated. The samples were equally divided and transferred to microbiology culture media at times 0, 24 hours, 48 hours, and 7 days; incubated; and the organisms identified and quantitated. In the experimental phase, samples of filgrastim were aseptically drawn into syringes, separated into three groups, and refrigerated. At 24 hours, 48 hours, and 7 days, the samples were transferred to broth, incubated, and observed for the development of turbidity. A class 100 laminar air flow hood in a pediatric hospital pharmacy and a home-infusion pharmacy class 100,000 clean room. The sterility of filgrastim in syringes was determined by comparing experimental broth culture tubes to a control tube and observing for the development of turbidity. Filgrastim demonstrated the ability to support the growth of intentionally inoculated skin contaminants, both qualitatively and quantitatively. However, when aseptically transferred to syringes and refrigerated, all tested filgrastim samples remained sterile for at least 7 days. Syringes of filgrastim remain sterile for 7 days when prepared in a class 100 laminar air flow hood, using aseptic technique, and stored under refrigeration. This change in practice can result in significant cost savings.

Pediatric Pharmacy: Therapy and Practice

Pediatric Pharmacy: Therapy and Practice

Providing Pharmaceutical Care to the Pediatric Patient

The purpose of this article is to provide the pharmacist with direction in providing pharmaceutical care to pediatric patients. A major component of the provision of pharmaceutical care is minimizing the risk for adverse drug effects such as medication errors. Dosage calculation errors are the most common type of medication error encountered in pediatric pharmacy practice. It is imperative that the pharmacist verify the dosages for all medication orders with appropriate dosage references. Establishing basic procedures for the processing of pediatric medication orders can reduce the risk for medication errors. One of the challenges in pediatric pharmacy practice is providing a drug product that is suitable for administration to infants and small children, because many of the commercial products are not. This may entail preparing a liquid formulation from a solid dosage form or instructing the caregiver on how to extract the contents out of a liquid-containing capsule. Providing the caregiver with suggestions on ways to improve the palatability of the medication can make a significant impact on patient compliance. The pediatric population is a very dynamic group of individuals who are constantly changing from the time of conception through adolescence. The physiological changes that occur with normal growth and development alter the pharmacodynamics and pharmacokinetics of therapeutic agents. The pharmaceutical care team must be versed in the unique aspects of these patients to best meet their drug therapy needs and achieve the desired therapeutic outcomes. As the expert in pharmacotherapy and pharmaceutics, the pharmacist is a key member of the pharmaceutical care team. Copyright © 1996 by W.B. Saunders Company

Multicenter postmarketing surveillance of ondansetron therapy in pediatric patients.

To identify prescribing patterns of ondansetron, to provide a general overview of the therapeutic responses and possible adverse effects to ondansetron in selected children's hospitals, and to evaluate this methodology of surveillance and assess its effectiveness as a means to collect postmarketing experience with a drug in pediatric patients. This survey examined the use of ondansetron in 210 children. Complete drug and medical histories, indications, doses, possible ondansetron-associated adverse reactions, and daily responses to ondansetron therapy were recorded by a study pharmacist for each patient. Patients were followed until discharged from the clinic or hospital and/or until ondansetron therapy was discontinued. The survey was conducted in seven free-standing children's hospitals across the US. Hospitals ranged in size from 100 to 331 beds (average 234). One hospital was located on the West coast, one on the East coast, one in the Rocky Mountain region, one in the Southwest region, and three in the Midwest. The selection of study participants was limited to member free-standing children's hospitals of the Pediatric Pharmacy Administrative Group. Selection was based on geographic location and availability of a pharmacist to coordinate the study. One pharmacist at each study site served as surveillance coordinator. Each pharmacist monitored without intervention the use of ondansetron in 30 children. Patients were enrolled consecutively from physicians' orders for ondansetron. Enrollment was open to clinic and hospital patients. Patients were excluded if more than 48 hours of retrospective review was required. The survey queried patient demographics, type of antineoplastic therapy administered, indications and dosing regimen(s) for ondansetron, additional antiemetic agents administered, and clinical response. Adverse drug reactions and prescriptions for ondansetron on discharge were recorded. An evaluation of response rates in hospital patients based on exposure to antineoplastic regimens causing acute (within 24 h) or delayed emesis (after 24 h) was formulated after data collection. Off-label use was summarized. Surveys from 197 of the 210 patients enrolled were complete for evaluation. Ondansetron was used to treat chemotherapy-induced emesis in 88 percent of the patients and 12 percent received it for various other indications. Ondansetron dosing was off-label in 15 percent and 73 percent prior to and after an emetogenic exposure, respectively. Twenty-six percent of the patients were younger than four years. Dosages ranged from 0.15 to 0.45 mg/kg, given in various schedules. The injectable form was given both intravenously and orally. There was a significant difference in the mean number of doses in hospital (9 +/- 7.3) versus clinic (2 +/- 1.5) patients (p < 0.0001). Eighty-seven percent of all patients had a complete or major overall response. Possible ondansetron-associated adverse reactions were similar to those of previous reports for all patients, although some recorded reactions are not currently included in package labeling. This study documents off-label use of ondansetron in children. Further study of ondansetron use in children less than four years of age, and for indications other than chemotherapy-induced emesis, is needed. Additional evaluation into the most cost-effective dosing of ondansetron would also be valuable.

Comprehensive Pharmaceutical Services for Pediatric Patients

The development of comprehensive pharmaceutical services for pediatric patients at a tertiary-care teaching hospital is described. A team of three staff pharmacists, a clinical specialist, and supportive personnel was formed. A pediatric pharmacy, operating from 0800 to 2100 daily, was created in a separate area of the central pharmacy to focus on potential problems with pediatric dosage calculations and drug administration. The team staffs the pediatric pharmacy for 75% of its day and evening shifts. The pharmacy prepares the 24-hour unit dose supply for each nursing unit, processes new orders, and provides drug information and problem-solving services. Clinical services are provided by the decentralized pharmacist, a rotating member of the team who makes rounds each day to the pediatric nursing units to review patient charts, provide medication information, and answer questions. The pediatric clinical specialist conducts educational programs, provides consultations, maintains reference materials, monitors pharmacokinetic evaluations, reviews medication communication forms, and assists in developing medication administration procedures. The creation of a pediatric pharmacy and a pediatric pharmacy team that coordinates both dispensing and clinical functions has made it possible to provide comprehensive pharmaceutical services to pediatric patients.

Justification for a pediatric satellite pharmacy at a tertiary-care institution

The justification for a pediatric satellite pharmacy is described. Of the 742 inpatient beds in a tertiary-care medical center, 150 are dedicated to pediatric patients. The pharmacy department provides services to both adult and pediatric patients from a central pharmacy. However, unit dose drug distribution services are not provided to the nurseries. Furthermore, the department lacks a core of pharmacists specializing in pediatric practice. As a result, the ability of the pharmacy to support pediatric drug use has been compromised, and medication errors and infection control problems have occurred that can be attributed to this situation. A pediatric satellite pharmacy was proposed to improve the quality of pediatric care. Service objectives were established, and benefits were identified. A financial analysis was included in the proposal that documented a total gain attributable to a pediatric satellite pharmacy of approximately $285,000 over five years. The satellite pharmacy was approved by hospital administration. The pharmacy department's quality assurance committee will monitor the satellite's impact. The justification for a proposed pediatric satellite pharmacy included indications that the satellite could correct medication-related problems and improve pediatric care and that implementation would have a positive effect on finances.

Catering to Pediatric Patients: Rebecca Wheeler's pediatric pharmacy practice is characterized by thorough patient counseling, an understanding of parent needs, and a large dose of learning and fun.

Catering to Pediatric Patients: Rebecca Wheeler's pediatric pharmacy practice is characterized by thorough patient counseling, an understanding of parent needs, and a large dose of learning and fun.

Pediatric Pharmacy Practice Guidelines. Pediatric Pharmacy Administrative Group Committee on Pediatric Pharmacy Practice

Pediatric patients are unique because of age-specific differences in metabolic capacity, disease processes that may make commercially available pharmaceutical preparations unacceptable for use, a lack of published information on the effects of many new pharmacotherapeutic agents in this population, and changes in population demographics caused by new diseases (e.g., AIDS) and new technologic applications. Comprehensive pharmaceutical services are essential for maximizing the benefits--while avoiding or minimizing adverse effects--of pharmacotherapy and new technologies. Comprehensive pharmaceutical services can help maximize the use of health-care resources in the pediatric population and assist in the development, implementation and evaluation of new methods of treatment that will benefit children everywhere.

Justifying a pediatric critical-care satellite pharmacy by medication-error reporting

As a part of an evaluation of the need for a satellite pharmacy to serve two pediatric critical-care units, an observational study was conducted to determine the incidence of medication errors in the units. A pharmacist observed nurses preparing and administering medications in 18 12-hour shifts. Of the nine shifts observed in each unit, five were day shifts and four were night shifts. Five nurses were observed per shift in the intensive-care nursery (ICN) and three nurses per shift in the pediatric intensive-care unit (PICU). The classification of errors was based on the definitions established by the American Society of Hospital Pharmacists. The total error rate was 17.4% in the ICN and 38.0% in the PICU. When the error rates were calculated excluding wrong-time errors, they were 7.1% in the ICN and 11.7% in the PICU. Of 147 errors, 124 (84.4%) occurred with medications with a high potential for serious consequences. The error rates were similar on the day and night shifts in the PICU (42.1% and 31.3%, respectively), but they were significantly higher on the day shifts than the night shifts in the ICN (24.5% and 8.4%, respectively). The number of medication errors in the two units was substantial, and steps were taken to implement a 24-hour pediatric critical-care satellite pharmacy with unit dose drug distribution to reduce the incidence of errors.

ASHP supplemental Standard for residency training in pediatric pharmacy practice

Journal Article ASHP supplemental Standard for residency training in pediatric pharmacy practice Get access American Journal of Hospital Pharmacy, Volume 41, Issue 2, 1 February 1984, Pages 334–337, https://doi.org/10.1093/ajhp/41.2.334 Published: 01 February 1984

An Elective Didactic Course in Pediatric Pharmacy

An Elective Didactic Course in Pediatric Pharmacy

Pharmacist administration of intravenous medications in a pediatric service

The establishment and operation of a pediatric intravenous medication administration program is described. A program was developed in which a team of pharmacists rotate between assignments in a pharmacy satellite providing unit dose distribution for 87 pediatric beds and an intravenous medication administration program serving a 15-bed pediatric isolation unit. Staffing patterns, pharmacy responsibilities, and a six-week training program for pharmacists are described. The i.v. medication administration program has been well received by nurses and physicians, and pediatric pharmacy personnel view themselves as functioning, productive members of the health care team. Audits indicate the pharmacy-controlled i.v. medication administration program has favorably affected patient care.

Curd and whey proteins in the nutrition of low birthweight babies.

Some animals thrive more satisfactorily on a milk that contains whey and curd protein. For this reason human milk protein (which contains about 40% whey) may have some advantages over cows' milk protein (which contains about 15% whey) and so infants feeding formulae based on demineralised whey in which the protein has been modified to achieve a curd:whey ratio similar to that in human milk may also thrive more satisfactorily. As the exact situation in the human newborn is unclear, the effects of feeding a formula containing unmodified cows' milk protein (mainly curd) and one containing the same amount of modified cows' milk protein (curd and whey) were studied in 57 low birthweight babies during the first 3 months of life. During the early weeks of life the curd and whey group grew bigger, absorbed more nitrogen, and excreted proportionately less urea. These results suggest that a curd and whey formula has advantages in the protein nutrition of low birthweight babies, especially the preterm ones. We feel it would be unwise to reduce the protein content of a formula based on cows' milk below 15 g/1 unless it was modified to achieve a larger proportion of whey protein and hence, among other qualities, more cysteine. Although some of the qualities of human milk protein can be mimicked by the use of demineralised whey formulae, others cannot.