The pharmacist's role in pediatric care is critical for the provision of safe medication use secondary to differences in physical development, frequent off label use of medications, need for dose calculations, and the lack of standard dosage forms. Many regulatory agencies, health care organizations, and professional societies support the pharmacist as a member of the interdisciplinary team. However, specific details showcasing how pharmacists impact the care of pediatric patients in a quantifiable and meaningful way have not been well described. The purpose of this article is to provide a review of evidence demonstrating measurable clinical outcomes directly resulting from pharmacist participation in pediatric patient care. This report is an opinion paper of The American College of Clinical Pharmacy (ACCP) Pediatrics Practice and Research Network and has been endorsed by the Pediatric Pharmacy Association (PPA). This article represents the opinion of the Pediatrics Practice and Research Network of ACCP. It does not necessarily represent an official ACCP commentary, guideline, or statement of policy or position.

The use of mother’s own breast milk during initial hospitalization has a positive impact not only in reducing potential serious neonatal morbidities but also contribute to improvements in neurodevelopmental outcomes. Mothers of very preterm infants struggle to maintain a supply of breast milk during their infants’ prolonged hospitalization. Galactogogues are medications that induce lactation by exerting its effects through oxytocin or prolactin enhancement. Domperidone is a potent dopamine D2 receptor antagonist which stimulates the release of prolactin. Small trials have established its ability in enhancing breast milk production. EMPOWER was designed to determine the safety and efficacy of domperidone in mothers experiencing an inadequate milk supply.

OBJECTIVE:The objective of this observational study was to evaluate the safety and effectiveness of discharging stabilized neonates to complete their oral morphine weaning at home.STUDY DESIGN:This retrospective cohort study evaluated neonates treated with oral morphine at two hospitals in London, Ontario, Canada. Neonates who completed their morphine wean in hospital were compared with neonates who completed their morphine wean following discharge from hospital (at home).RESULTS:There were 80 neonates treated with oral morphine at two hospitals from 2006 to 2010. The majority (65%, 52/80) of neonates completed their morphine weaning after hospital discharge and were significantly less likely to return to hospital for further withdrawal treatment (1/52 vs. 4/28, p < 0.05). Neonates who were treated at home remained on morphine for more days (32 vs. 19 days, p < 0.01).CONCLUSIONS:We present the first North American cohort of neonates weaned with morphine at home for neonatal abstinence syndrome (NAS). We found that more days on oral morphine resulted in fewer returns to hospital for continued withdrawal management. There was no evidence of increased effectiveness, measured by the number of returns to hospital for further NAS management with in-hospital weaning. The estimated cost savings of continued weaning upon discharge was approximately $11,000 per patient (Canadian dollars). While further prospective research is necessary, in some cases morphine weaning at home may present a safe and cost-effective strategy for NAS management.

The sixth Ivey Chair Symposium, held at the University of Western Ontario in October 2011, was dedicated to an update on the complex issues surrounding opioid dependent mothers and their newborns. The day commenced with Loretta Finnegan who provided a historical overview of the complex issues surrounding the addicted mother and her baby suffering from neonatal withdrawal syndrome. It is remarkable that the tool devised by Dr Finnegan forty years ago is in wide use today, capturing accurately the severity of NAS and the need for follow up and treatment. She stressed that comprehensive approach to the care of pregnant drug-dependent mothers and their babies significantly reduces maternal and infant's morbidity. The risk of low birth weight and severe withdrawal can be reduced substantially when both patients in this dyad are optimally cared for. The seven speakers following her provided an update on the medicinal and non drug approach to treat the opioid-dependent mother and her newborn, including new Canadian guidelines which were just released.

BACKGROUND:The benefits of breast milk to the newborn infant are well established. The Canadian Paediatric Society recommends exclusive breastfeeding for the first 6 months of life for healthy, term infants. Mothers of premature newborns, however, may have difficulty providing an adequate supply of breast milk. Domperidone is officially used as a prokinetic agent. However, it is used widely around the world as a galactogogue. Despite its widespread use as a galactogogue, only a small number of investigators have studied domperidone for this indication.AIMS:The purpose of this study was to determine an optimal dosage of domperidone as a galactogogue.METHODS:Eligible subjects were randomized to receive domperidone 10 mg 3 times daily or domperidone 20 mg 3 times daily for 4 weeks. At week 5, the frequency was decreased to twice daily in both groups, and finally once daily for week 6.RESULTS:Over the entire first 4-week period, there was a significant increase in daily milk volumes within each group (P < .01). The between-group difference over this period, although not statistically significant, was clinically significant. Additionally, there was no significant within- or between-group difference during weeks 5 and 6.CONCLUSION:A dose of domperidone of 20 mg, 3 times daily instead of 10 mg, 3 times daily was associated with a clinical, but not statistically significant, increase in milk production.

Although most drugs are used to treat chronic or pregnancy-induced conditions during pregnancy and lactation, very few are studied in pregnant or breastfeeding women. The information we have on drugs taken during pregnancy and lactation is usually obtained after market approval through published case reports or case series and from pregnancy exposure or retrospective birth defect registries. Furthermore, generic drugs approved for use in this vulnerable population may be approved based on results from a male trial population. This disregards the changes that can occur during pregnancy which can affect the pharmacokinetics of drugs. In an effort to improve the information provided to prescribers, in 2008 the United States Food and Drug Administration proposed a change in product labelling where information from pregnancy exposure registries would be required. As of 2009, European Medicines Agency requires additional statements on use during pregnancy within drug labelling information. In Canada, it is anticipated that the efficacy and safety of drugs in pregnancy will be included under the Drug Safety and Effectiveness Network initiative, and that this will offer a unified approach for such assessments. Pregmedic, a non-profit organization for the advancement of safe and effective use of drugs in pregnancy, has presented a number of proposals and draft guidelines to Health Canada on the inclusion of pregnant women in pharmacokinetic studies and the establishment of registries for women who take drugs during pregnancy. Pregmedic advocates for ensuring that drugs indicated for women are studied in women.

OBJECTIVES:The primary objective of this study was to compare the use of opioid infusions to that proposed in guidelines published in an in-house medication handbook. Secondary objectives were to assess the documented use of a standardized neonatal pain assessment tool and to describe the supplemental use of opioids concurrent with an opioid infusion.METHODS:A retrospective chart review was performed for all patients in the NICU who received opioid infusions between November 1, 2005, and November 30, 2006. Data collected included patient characteristics, opioid infusion dosing and duration, supplemental opioid use, and pain assessment documentation.RESULTS:Of the110 neonates who received morphine or fentanyl during the study period, 65 patients met inclusion criteria. Reasons for starting an opioid infusion included nonsurgical sedation and/or analgesia (51%), postoperative pain (17%), and procedural pain (1%). No reason was documented for 31% of patients. Thirtyeight percent of neonates received a loading dose of opioid before initiation of the infusion. The median dose was 100 mcg/kg (IQR=48.2) for morphine and and 1 mcg/kg (IQR=0.8) for fentanyl. The mean ± SD starting rates of morphine and fentanyl infusions were 12.3 ± 4.7 mcg/kg/hr and 1.5 ± 1.7 mcg/kg/hr, respectively. Supplemental opioid doses were given to 46% of neonates during the infusion period. Supplemental doses were given for procedures (69%) and pain/agitation/sedation (26%). No reason was documented for 5% of patients. The Neonatal Pain, Agitation and Sedation Scale scores were only documented 9% of the time for each day that the patient received an opioid infusion.CONCLUSIONS:Dosing of opioids generally was within the recommendations that are described in the in-house medication handbook. A substantial percentage of neonates received supplemental opioid doses while on opioid infusions, mostly for procedural pain management. Documentation of the reason for using opioid infusions and the assessment of neonatal pain was poor.

Appropriate dosage forms of medication are often not available for use in newborns, infants, and young children. This is a worldwide phenomenon, but especially in developing countries. The WHO’s ‘Make medicines child size’ campaign emphasizes this shortcoming. Professional organizations, industry, and government from the international arena have the resources to address this and need to work together to create solutions.

Introduction: Enoxaparin is the current anticoagulant of choice for neonatal thrombosis. Present neonatal treatment guidelines of 1.5 mg/kg every 12 hours (q12 h) are extrapolated primarily from an earlier study with 9 infants less than 2 months of age. More recent studies indicate an increased dose requirement for neonates.Materials and methods: Relevant data from articles and abstracts were identified by searching MEDLINE and pediatric and hematology conference proceedings.Results: Publications between 1996 and 2007 included 8 papers, 4 abstracts and 1 review article with primary research documenting enoxaparin use in 240 neonates. The mean maintenance dose of enoxaparin ranged from 1.48 to 2.27 mg/kg q12 h for all infants, but was higher for preterm neonates at 1.9-2.27 mg/kg q12 h. The efficacy of enoxaparin, causing either complete or partial resolution was between 59 and 100%. Minor side effects were common and adverse events (major bleeding) occurred in 12 patients (0-19%).Conclusions: Increased experience with enoxaparin use in neonates in the past decade has indicated higher doses to achieve accepted target anti-factor Xa values. The long-term use of indwelling catheters (Insuflon(R) catheter) for enoxaparin administration may need to be reevaluated in ELBW infants. Suggested starting doses of enoxaparin are 1.7 mg/kg q12 h for term neonates and 2.0 mg/kg q12 h for preterm neonates if there is no considerable bleeding risk. However, further prospective studies are needed to validate an increased initial dose of enoxaparin. (C) 2007 Elsevier Ltd. All rights reserved.

There are several pharmacy and clinical pharmacology organizations in which pediatrics is one of many special interest groups and a few whose focus is entirely pediatric drug therapy. Recently the foundation for the establishment of an International Network of Paediatric Pharmacists has been laid. This paper describes that network.

Study Objective. To evaluate the effectiveness and safety of enoxaparin therapy in a neonatal intensive care unit (NICU).Design. Retrospective chart review.Setting. Level III NICU in a Canadian academic center.Patients. All neonates treated with enoxaparin while in the NICU between January 1, 1998, and June 1, 2006.Measurements and Main Results. Data abstracted included patient demographics, diagnosis of thrombosis and its progression, enoxaparin dosages with corresponding antifactor Xa levels, and adverse events. Sixteen neonates (four term, 12 preterm) were treated with enoxaparin at a mean +/- SD initial subcutaneous dose of 1.41 +/- 0.15 mg/kg every 12 hours. The target therapeutic range (antifactor Xa level 0.5-1.0 U/ml) was achieved by 12 infants at a mean SD dose of 1.92 +/- 0.43 mg/kg every 12 hours, after a mean of 5.6 days (range 1-15 days). Preterm infants required a higher dose (per kilogram) compared with term infants to maintain therapeutic antifactor Xa levels (mean SD 1.94 +/- 0.39 vs 1.65 +/- 0.14 mg/kg every 12 hrs, p < 0.001). Enoxaparin doses were more strongly correlated to antifactor Xa levels in term infants (r(2)=0.51, p < 0.001) compared with preterm infants (r(2)=0.20, p < 0.001). Ten (71%) of 14 thromboembolic events resolved, either partially or completely, at a mean of 39 days (range 8-61 days) of enoxaparin therapy Nine infants (56%) experienced minor local adverse effects at the site of the indwelling subcutaneous catheter (induration, bruises, hematomas, or leakage). Systemic adverse events that were possibly related to enoxaparin therapy included osteopenia (one infant), scleral hemorrhage (one), and minor gastrointestinal tract bleeding (three) found in gastric feeding tubes. No adverse effects were associated with antifactor Xa levels greater than 1.0 U/ml.Conclusion. Enoxaparin may be effective in the treatment of neonatal thrombosis. An initial dosage of 1.5 mg/kg every 12 hours is likely inadequate to obtain therapeutic antifactor Xa levels rapidly and differs for term and preterm neonates. Therapeutic levels in preterm infants may be more variable, and the pharmacokine tics of this drug in preterm infants requires further evaluation. Future studies in neonates should prospectively evaluate a higher starting dose of enoxaparin to document effectiveness, acceptance, compliance with treatment guidelines, and adverse effects.

There are several case reports and case series that have examined the acute effects of selective serotonin reuptake inhibitors (SSRIs) on the newborn. There is considerable controversy whether the reported symptoms represent withdrawal from the SSRI or toxicity caused by the SSRI. A case of an infant who was exposed to paroxetine during pregnancy is presented. This case supports the notion of serotonin toxicity and is believed to be the first report that substantiates clinical symptoms with serum levels of the offending SSRI.

1Physicians were advised to taper the dosage of antidepressants in pregnant women during the last trimester so that the fetus receives no drug for at least 7–10 days before delivery. A month later, Health Canada followed suit; the Canadian advisory 2 similarly suggested that “Physicians may consider slowly decreasing the dose of these medications in the third trimester.” These advisories were based on “reports reveal[ing] that some newborns whose mothers took these medications during pregnancy have developed complications at birth.” 2 These complications were seen as consistent with withdrawal symptoms or a direct adverse effect by the antidepressant on the baby. We believe those recommendations are only partially evidence-based and may put the depressed mother-to-be and her baby at an unreasonable health risk. This paper presents a brief discussion of the pattern of neonatal symptoms observed after maternal use of selective serotonin or serotonin–norepinephrine reuptake inhibitors (SSRIs or SNRIs, respectively).

Many women of reproductive age take the nonsteroidal antiinflammatory drug celecoxib. No data exist, however, regarding its transfer into human breast milk and safety for breastfed infants. We had the opportunity to obtain such data when a woman who was breastfeeding her infant daughter underwent emergency surgery to remove a gangrenous appendix. She received four doses of oral celecoxib 100 mg and did not breastfeed her daughter for 48 hours after taking the last dose. We analyzed samples of her breast milk and found a concentration of 133 ng/ml at approximately 5 hours after a 100‐mg dose and an elimination half‐life of 4.0–6.5 hours. This initial report, which should be substantiated and expanded, provides information that can help counsel parents about breastfeeding and celecoxib.