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1.
Am J Health Syst Pharm ; 81(9): e210-e219, 2024 Apr 19.
Article in English | MEDLINE | ID: mdl-38146826

ABSTRACT

PURPOSE: The purpose of this review is to summarize the management of asthma in children and to highlight different guideline-based approaches. This review also discusses literature regarding the use of corticosteroids, both inhaled and systemic, as well as biologic agents, in asthma management. SUMMARY: Asthma is a common chronic respiratory condition in the pediatric population and has evolved into a highly patient-specific disease. Of the 2 main asthma guidelines, one developed by the National Asthma Education and Prevention Program was recently published as a focused update in 2020. The other, from the Global Initiative for Asthma, focuses on a global strategy for management and prevention, with the most recent update in 2023. Both reports discuss diagnosis, assessment, and treatment of asthma in adults and children. Treatment is designed as a stepwise approach in both reports, although there are key differences. This article focuses on gaps in these guidelines, including the use of bronchodilators and inhaled corticosteroids with single maintenance and reliever therapy and long-acting muscarinic antagonists in children. It also reviews treatment in children under 5 years of age, although recommendations are limited due to a lack of evidence in this age group. Finally, this review discusses considerations for emerging treatments, including biologics, for patients who are difficult to treat. CONCLUSION: New treatment strategies and agents have emerged in the treatment of pediatric asthma. Pharmacists play a key role in providing education about, dispensing, and recommending the newest evidence-based treatment options for children.


Subject(s)
Anti-Asthmatic Agents , Asthma , Adult , Child , Humans , Child, Preschool , Anti-Asthmatic Agents/therapeutic use , Pharmacists , Asthma/diagnosis , Asthma/drug therapy , Bronchodilator Agents , Adrenal Cortex Hormones/therapeutic use , Administration, Inhalation
2.
J Pediatr Pharmacol Ther ; 28(3): 222-227, 2023.
Article in English | MEDLINE | ID: mdl-37303765

ABSTRACT

OBJECTIVE: As a result of recent legislative changes allowing for increased access to marijuana products, there have been increasing rates of cannabis abuse among adolescents and subsequent diagnoses of cannabinoid hyperemesis syndrome (CHS). Most available literature on this syndrome exists within the adult population and describes benzodiazepines, haloperidol, and topical capsaicin as potentially efficacious in the management of CHS. The objectives of this study were to identify antiemetics and compare their efficacy and safety in the management of pediatric CHS. METHODS: A retrospective review of Penn State Children's Hospital electronic health record was performed to identify patients 18 years or younger who had an emergency department or inpatient encounter, a cannabis hyperemesis-related diagnosis code, and met diagnostic criteria for CHS. Antiemetic efficacy was determined using subjective patient perception of nausea and objective documentation of vomiting. Benzodiazepines, haloperidol, and topical capsaicin were classified as nontraditional antiemetics, whereas all other antiemetics were classified as traditional. RESULTS: Nontraditional antiemetic medications appeared to be more effective in resolving patient symptoms compared with traditional antiemetics. Analysis of all ordered antiemetics demonstrated a gap in partial or full symptom resolution between nontraditional and traditional agents. Reported adverse effects were minimal. CONCLUSIONS: Cannabinoid hyperemesis syndrome is an underrecognized and underdiagnosed condition characterized by cyclic vomiting related to chronic cannabis use. Abstinence from cannabis remains the most effective approach to mitigating morbidity associated with CHS. Medications such as lorazepam or droperidol may have benefit in managing toxidrome symptoms. Traditional antiemetic prescribing remains a key barrier to effective management of pediatric CHS.

3.
Curr Pharm Teach Learn ; 15(5): 444-454, 2023 05.
Article in English | MEDLINE | ID: mdl-37198091

ABSTRACT

INTRODUCTION: Academic dishonesty (AD) continues to be an area of concern in pharmacy education. While studies have been conducted evaluating various forms and interventions to address AD, few have looked at faculty experiences and perceptions of AD in doctor of pharmacy (PharmD) programs in the United States. METHODS: A 52-item survey was distributed electronically to pharmacy faculty at 129 colleges of pharmacy (COP). Faculty perceptions and experiences related to AD were recorded using a six-point Likert-type scale. Data were reported as the percentage of respondents for each level of agreement in addition to the mean and SD of the agreement level for each survey item. RESULTS: Responses were received from 775 faculty from 126 COP (14.2% response rate). Faculty agreed that AD was an issue in pharmacy education in general (76%) and at their institution (70%), however respondents also agreed that AD was quickly addressed by their institution (72%) and were confident in their institution's ability to manage AD infractions (68%). Faculty agreed that it is both difficult (82.5%) and frustrating (75.2%) to report AD infractions at their institution. Female faculty (P = .006) and those who spent more time in classroom (P < .001) agreed more that they witnessed AD in the classroom. Findings were further stratified by gender, faculty rank, time in class, and terminal degree. CONCLUSIONS: AD was perceived as an issue in pharmacy education. Transparency in the AD handling process and increased student education about AD were identified as potential solutions to reduce AD occurrences.


Subject(s)
Education, Pharmacy , Students, Pharmacy , Humans , Female , United States , Faculty, Pharmacy , Faculty , Surveys and Questionnaires
4.
Am J Health Syst Pharm ; 80(7): 412-422, 2023 03 21.
Article in English | MEDLINE | ID: mdl-36610740

ABSTRACT

PURPOSE: The aim of this article is to provide an overview of the current literature for direct-acting oral anticoagulant (DOAC) use in pediatric patients and summarize ongoing trials. SUMMARY: In treatment of venous thromboembolism (VTE) in pediatric patients, evidence supports use of both dabigatran and rivaroxaban. Dabigatran has been shown to be noninferior to standard of care (SOC) in terms of efficacy, with similar bleeding rates. Similarly, treatment with rivaroxaban in children with acute VTE resulted in a low recurrence risk and reduced thrombotic burden, without increased risk of bleeding, compared to SOC. Treatment of pediatric cerebral venous thrombosis as well as central venous catheter-related VTE with rivaroxaban appeared to be both safe and efficacious and similar to that with SOC. Dabigatran also has a favorable safety profile for prevention of VTE, and rivaroxaban has a favorable safety profile for VTE prevention in children with congenital heart disease. Many studies with several different DOACs are ongoing to evaluate both safety and efficacy in unique patient populations, as well as VTE prevention. CONCLUSION: The literature regarding pediatric VTE treatment and prophylaxis is growing, but the need for evidence-based pediatric guidelines remains. Additional long-term, postauthorization studies are warranted to further elucidate safety and efficacy in clinical scenarios excluded in clinical trials. Additional data on safety, efficacy, and dosing strategies for reversal agents are also necessary, especially as the use of DOACs becomes more common in the pediatric population.


Subject(s)
Rivaroxaban , Venous Thromboembolism , Humans , Child , Rivaroxaban/adverse effects , Anticoagulants/adverse effects , Factor Xa Inhibitors/adverse effects , Dabigatran/adverse effects , Venous Thromboembolism/drug therapy , Venous Thromboembolism/prevention & control , Hemorrhage/chemically induced , Administration, Oral
5.
J Pediatr Pharmacol Ther ; 26(4): 339-345, 2021.
Article in English | MEDLINE | ID: mdl-34035677

ABSTRACT

With significant increases noted in adolescent marijuana use across the United States, perhaps as a result of legislative changes over the past half-decade, clinicians must be increasingly aware of the potential negative health effects. One such effect that warrants concern is cannabinoid hyperemesis syndrome (CHS) in the pediatric population. A systematic review of the literature was performed to determine the safety and efficacy of management strategies for CHS using PubMed, Scopus, the Cumulative Index of Nursing and Allied Health (CINAHL), Web of Science, and Cochrane Library databases. Search terms used in each database were "pediatric OR child OR children OR adolescent" AND "cannabinoid OR marijuana" AND "hyperemesis OR cyclic vomiting OR vomiting" NOT "seizure OR chemotherapy OR pregnancy OR cancer OR AIDS OR HIV." Fourteen pieces of literature that described either effective, ineffective, or supportive management strategies for pediatric CHS were included in this review. Benzodiazepines were the most reported efficacious agents, followed by topical capsaicin cream and haloperidol. A total of 9 of the 14 studies described intravenous fluid resuscitation and hot bathing rituals as supportive measures, and 7 cases reported traditional antiemetics were ineffective for CHS. The heterogenicity of reported data, combined with the limited number of encounters, make it difficult to ascertain whether a definitive treatment strategy exists. Clinicians should be cognizant of pharmacotherapy agents that are efficacious, and perhaps more importantly, avoid using traditional antiemetic therapies that do not provide benefit.

6.
Curr Pharm Teach Learn ; 13(5): 576-584, 2021 05.
Article in English | MEDLINE | ID: mdl-33795114

ABSTRACT

BACKGROUND: The Accreditation Council for Pharmacy Education Standards 2016 emphasize the incorporation of a co-curriculum in pharmacy education. However, how students perceive the value of these activities is still unclear. The objectives of this study were to (1) describe how students perceive co-curricular involvement, (2) identify barriers that impede student engagement in co-curricular activities, and (3) assess the influence of co-curricular activities on academic performance. METHODS: A literature search was conducted using the Cumulative Index of Nursing and Allied Health Literature, Academic Search Complete, PsycInfo, Web of Science, Scopus, PubMed, and ProQuest Central databases. Search terms used within each database were "co-curricular" AND "pharmacy learning OR pharmacy education OR pharmacy student." Studies were included in the review if they addressed pharmacy student perceptions of or barriers to co-curricular activity. RESULTS: Eleven studies met the criteria for inclusion. Student perceptions of co-curricular activities were consistently positive, reflecting perceived improvement in self-confidence and abilities. Barriers to student engagement included voluntary participation and student's limited scope of practice. Engagement in co-curricular activities also improved academic performance and clinical knowledge. IMPLICATIONS: Co-curricular activities have a perceived positive impact on student confidence and abilities as practitioners. Participation in co-curricular activities provides benefits to students in their academic, professional, and personal development in ways that are not always supported in a didactic curriculum. Incorporating co-curricular activity is justified from the student perspective in the framework of pharmacy student development and maturation.


Subject(s)
Education, Pharmacy , Pharmacy , Students, Pharmacy , Curriculum , Humans , Perception
7.
Ann Pharmacother ; 55(5): 666-676, 2021 05.
Article in English | MEDLINE | ID: mdl-32864984

ABSTRACT

OBJECTIVE: The objective of this study is to comprehensively review the efficacy and safety data of low-molecular-weight heparins (LMWHs) and fondaparinux in pediatric patients with obesity. DATA SOURCES: A comprehensive literature search of PubMed, SCOPUS, CINAHL, Academic Search Complete, PsycInfo, Cochrane Library, and Web of Science databases was conducted (1900 to July 2020). Search terms utilized included LMWH, low-molecular-weight heparin, enoxaparin, dalteparin, tinzaparin, fondaparinux, pediatric, child, children, obese, obesity, overweight. No limits or timeline restrictions were imposed. STUDY SELECTION AND DATA EXTRACTION: Studies that reported pediatric patients with described overweight or obesity and utilized LMWHs or fondaparinux were considered. DATA SYNTHESIS: Of 207 studies screened, 12 were included. Average dose reductions of 12.9% to 37.3% from the starting dose were observed with treatment indications of enoxaparin and increased up to 27.3% for prophylactic indications. Trends could not be concluded in the dalteparin and fondaparinux studies. Four thrombotic and 15 bleeding events were reported in the studies. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Pediatric patients with obesity may initially be underdosed or overdosed with enoxaparin compared with children with healthy body weight, depending on the indication. CONCLUSION: Pediatric patients with obesity may benefit from proactively adjusting enoxaparin dosing on initiation of therapy. Further studies are needed for dalteparin and fondaparinux in these populations. Clinical controversy exists with the relevance of monitoring these high-risk medications for therapeutic and prophylactic indications. Thrombotic and hemorrhagic events were similar to reported adult outcomes.


Subject(s)
Anticoagulants/administration & dosage , Factor Xa Inhibitors/administration & dosage , Fondaparinux/administration & dosage , Heparin, Low-Molecular-Weight/administration & dosage , Obesity/drug therapy , Anticoagulants/adverse effects , Child , Child, Preschool , Fondaparinux/adverse effects , Hemorrhage/chemically induced , Heparin, Low-Molecular-Weight/adverse effects , Humans , Obesity/epidemiology , Retrospective Studies , Thrombosis/drug therapy , Thrombosis/epidemiology , Venous Thromboembolism/drug therapy , Venous Thromboembolism/epidemiology
8.
Curr Pharm Teach Learn ; 13(1): 81-90, 2021 01.
Article in English | MEDLINE | ID: mdl-33131623

ABSTRACT

BACKGROUND: Colleges of pharmacy are currently required to implement a remediation program within their curricula, but no specifications are provided on the ideal methodology. While the need for successful remediation strategies continues to grow, literature describing positive or negative outcomes of different approaches is significantly lacking. The objective of this literature review was to describe and evaluate remediation methodologies in pharmacy education. METHODS: This literature review was completed following PRISMA criteria. A search of the PubMed, Cochrane Library, Cumulative Index of Nursing and Allied Health, Academic Search Complete, PsycInfo, Scopus, and ProQuest Central databases was conducted in July 2019. Studies were included if they involved pharmacy student education and described either remediation or reassessment. RESULTS: The evaluated studies discussed a range of course types being remediated, a large variety of remediation strategies and timeframes, and differing overall outcomes. No studies provided comparison of remediation techniques or provided details on the implementation of their chosen approaches. A consistent finding within the evaluated studies was the inclusion of prevention strategies to attempt to avoid the need for remediation preemptively. Overall outcomes for each remedial program were inconsistent and no clear patterns were evident other than an improvement in student performance following remediation. IMPLICATIONS: Remediation strategies included course repetition, summer restudy, reassessment, and individualized plans. Outcomes varied significantly between studies, making methodology comparisons difficult. Future studies that include more detail and consistency in the reported outcomes would be beneficial to students and help clarify remediation for colleges of pharmacy.


Subject(s)
Education, Pharmacy , Pharmaceutical Services , Students, Pharmacy , Curriculum , Educational Measurement , Humans
9.
J Pediatr Pharmacol Ther ; 25(5): 390-400, 2020.
Article in English | MEDLINE | ID: mdl-32641909

ABSTRACT

Experiential education conducted in the pediatric practice setting provides student pharmacists the opportunity to learn about a unique patient population. For many students, experiential rotations may be the only form of pediatric education they receive in pharmacy school. Providing quality pediatric experiences is essential to stimulate students' interest in this practice area and train those with goals to become pediatric pharmacists. It is also important to ensure graduating pharmacists have exposure to fundamental pediatric pharmacy concepts. Although pediatric practice areas and institutions differ in patient populations and services, a well-rounded rotation experience should be provided for the pharmacy student. Preceptors must decide what concepts to teach and what activities students should be incorporated into during this experiential period. This article provides goals and activities for student pharmacists that can be included in newly designed introductory pharmacy practice experiences and advanced pharmacy practice experiences within various pediatric settings.

11.
Curr Pharm Teach Learn ; 12(9): 1150-1161, 2020 09.
Article in English | MEDLINE | ID: mdl-32624146

ABSTRACT

BACKGROUND: Pharmacy services have evolved to include direct patient care and a greater role within the community. Service learning (SL) is a specific pedagogy that can provide pharmacy students with live patient interaction and foster community engagement. Although SL is recommended by educational standards, it is not clearly known if students or patients recognize the benefits of these activities. The objectives of this review are to assess student and patient perceptions of SL in the literature, evaluate the different approaches to SL, and describe interprofessional education (IPE) within SL. METHODS: A literature search was conducted using the Scopus, PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ProQuest, Cochrane Review, Academic Search Complete, PsycInfo, and Google Scholar databases. Search terms included "service learning" AND "pharmacy education OR learning" AND "perceptions." Studies were included if they described perceptions of SL in pharmacy education. No timeline restrictions were made. RESULTS: Fourteen studies were included with SL occurring in didactic, co-curricular, and experiential pharmacy education. Student perceptions were consistently positive and expressed improvements in confidence, knowledge, and abilities. Patient perceptions, when evaluated, were also positive. SL provided a strong and trusting learning environment for IPE. IMPLICATIONS: SL is a beneficial component in all aspects of pharmacy education. Student and patient perceptions suggest that SL can enhance knowledge and improve overall health outcomes. Incorporating IPE into SL offers benefits to all healthcare professional students.


Subject(s)
Education, Pharmacy , Students, Pharmacy , Humans , Learning , Perception , Problem-Based Learning
12.
Curr Pharm Teach Learn ; 12(3): 307-312, 2020 03.
Article in English | MEDLINE | ID: mdl-32273068

ABSTRACT

BACKGROUND AND PURPOSE: The Indiana Pharmacy Teaching Certificate Program (IPTeC) offered a live, two-day conference to pharmacy residents, fellows, and preceptors in Indiana, while simultaneously live-streaming to participants in Doha, Qatar. Participants engaged in longitudinal activities for a one-year period. The purpose is to evaluate this pilot extension of a teaching and learning curriculum (TLC) to experienced preceptors in a global partnership and determine whether global and local participants perceive similar quality of programming. EDUCATIONAL ACTIVITY AND SETTING: Upon completion of the two-day conference, all pharmacists from two years of the program were encouraged to complete the standard course evaluations, consisting of nine items, in order to obtain continuing education (CE) credit. Evaluations of the program were analyzed by location cohort. FINDINGS: A total of 206 eligible pharmacists attended the program, with 154 completing the course evaluations (response rate 75%). "Good" or "outstanding" median ratings were given to each learning objective by both location cohorts, with domestic participants more likely to give "outstanding" ratings (6/9 items versus 0/9 items). SUMMARY: This pilot extension was successful in providing educational content satisfying learning objectives from the perspective of domestic participants and remote participants in Qatar. This type of global collaboration can meet the needs of trainees and experienced preceptors to advance pharmacy education and training.


Subject(s)
Curriculum/trends , Education, Pharmacy/methods , Curriculum/standards , Education, Pharmacy/trends , Education, Pharmacy, Graduate/methods , Humans , Indiana , Internationality , Qatar
13.
Am J Health Syst Pharm ; 77(4): 254-258, 2020 02 07.
Article in English | MEDLINE | ID: mdl-31907520

Subject(s)
Pharmacists , Workload , England , Humans
14.
Am J Health Syst Pharm ; 76(24): 2041-2047, 2019 Dec 02.
Article in English | MEDLINE | ID: mdl-31789351

ABSTRACT

PURPOSE: To evaluate residency applicant (RA) and residency program director (RPD) perceptions of Phase II of the Match process since its inception in 2016. METHODS: An online survey was issued to all Match-registered RAs and RPDs for the 2016, 2017, and 2018 Match periods. Study participant demographics, participant designation (RA or RPD), the year(s) and Phase(s) of the Match participated in were measured using categorical ranges, and overall perceptions of the Match process since Phase II of the Match was implemented were captured with 5-point Likert scales. RESULTS: A total of 2,599 individuals (RA and RPD) completed the survey for an overall survey response rate of 12.6%. The majority of RAs were female (73.2%), under the age of 30 (87.4%), Caucasian (67.4%), and recently graduated (90.9% graduated between 2016 and 2018). Most RAs participated in the 2018 Match period (61%), and overall 82% successfully matched to a residency position. RA perceptions relating to process cost-effectiveness and perceived fairness to all applicants differed significantly from RPD perceptions (2.23 versus 3.71 and 2.80 versus 3.67, respectively; p < 0.001 for each). There were no differences between RA and RPD perceptions related to the submission/review process. CONCLUSION: The Phase II of the Match process has demonstrated improved organization and satisfaction from the RPD perspective compared to the previous process. RAs have identified several areas for improvement in the process. It is imperative that efforts are made to continue expanding program and position offerings as much as possible.


Subject(s)
Perception , Personnel Selection/methods , Pharmacy Residencies/methods , Surveys and Questionnaires , Adult , Female , Humans , Male , Middle Aged , Personnel Selection/organization & administration , Pharmacy Residencies/organization & administration , Young Adult
15.
J Pediatr Pharmacol Ther ; 24(6): 465-472, 2019.
Article in English | MEDLINE | ID: mdl-31719807

ABSTRACT

Traumatic brain injury remains a leading cause of morbidity and mortality in children. The use of hyperosmolar therapy to offset increased intracranial pressure (ICP) is described in pediatric guidelines, yet some controversy remains regarding which option to select. A search was conducted using the PubMed, MEDLINE, Cumulative Index of Nursing and Allied Health, Academic Search Premier, PsycInfo, and Cochrane Library databases. Studies were included if they described the hyperosmolar therapy use, involved severe traumatic brain injury (TBI), and patient age was 0 to 18 years. A total of 331 studies published between 1987 and 2017 were retrieved; of these, 9 met the inclusion criteria. Included studies were evaluated for the type and concentration of hyperosmolar therapy, associated mortality outcomes, ICP and coronary perfusion pressure (CPP) measurements, concurrent medications, and reported serum sodium and serum osmolarity or osmolality values. Hypertonic saline was the most commonly reported hyperosmolar therapy. Mannitol was less studied, but collectively demonstrated a higher incidence of mortality than hypertonic saline. There were several studies that did not report monitoring outcomes associated with serum sodium and/or serum osmolarity, despite the use of hyperosmolar therapies. Inconsistencies were noted between the studies in the overall study design as well as reported monitoring parameters and length of stay. Hypertonic saline appears to be safe and efficacious at several concentrations for treatment of increased ICP associated with severe TBI in pediatric patients. The limited available data regarding the use of mannitol do not allow a strong conclusion to be made regarding its use.

17.
Pharmacy (Basel) ; 7(2)2019 Apr 13.
Article in English | MEDLINE | ID: mdl-31013900

ABSTRACT

PURPOSE: To describe a unique pharmacy intern program in a group of federally qualified health center (FQHC) outpatient primary care provider clinics. SUMMARY: A pharmacy intern program was created at the North Central Nursing Clinics in Indiana, a group of four FQHC outpatient primary care provider facilities. Intern-performed tasks included: Prior authorization (PA) requests, medication assistance program (MAP) applications, sample procurement and inventory, and contraceptive devices for implantation inventory management. Interns interacted with clinic administration, nurse practitioners, and medical staff to complete their assigned responsibilities. Over a one-year period, the interns completed documentation on more than 2000 charts during a combined 12 h a week. Interns identified the interprofessional interactions as the most beneficial experience, while providers acknowledged no difference in the processing of paperwork during the transition of duties from pharmacy fellow to intern. CONCLUSION: This unique pharmacy intern program was successfully created and implemented in a primary care provider office, resulting in learning opportunities for pharmacy interns, as well as operational efficiencies to fellows, providers, and the organization.

18.
Curr Pharm Teach Learn ; 11(2): 145-154, 2019 02.
Article in English | MEDLINE | ID: mdl-30733010

ABSTRACT

OBJECTIVE: To describe the relationship between the use of a teaching objective structured clinical examination (TOSCE) and student confidence in a pharmacy skills laboratory. METHODS: To develop students' abilities in providing recommendations and patient education on selected drug products, third-year pharmacy students participated in a TOSCE in a men's and women's health laboratory. A 19-item, 5-point Likert scale survey was administered longitudinally to assess student confidence (1 = not all confident to 5 = extremely confident). An additional seven items (1 = strongly disagree to 5 = strongly agree) were added to the original 19-item survey to measure changes in confidence and attitude before and after a problem-based assessment. RESULTS: Seventy-two students completed all five surveys administered throughout the semester. Students' confidence improved in multiple areas within the clinical skills and interpersonal communication skills categories. Students also indicated their confidence in using primary literature, electronic drug references, and package inserts to answer medication-related questions improved after the TOSCE implementation. Students agreed that the feedback they received from the TOSCE was beneficial to their performance on a problem-based assessment. CONCLUSIONS: A TOSCE is a formative assessment that has the potential to improve student confidence in core competency areas immediately after an activity. However, its benefit may be short-term when a time gap exists. Further study is needed to assess long-term sustainability in student confidence over multiple laboratory activities throughout a semester.


Subject(s)
Clinical Competence/standards , Education, Pharmacy/standards , Self Efficacy , Students, Pharmacy/psychology , Adult , Clinical Competence/statistics & numerical data , Education, Pharmacy/methods , Education, Pharmacy/statistics & numerical data , Educational Measurement/methods , Female , Humans , Male , Middle Aged , Students, Pharmacy/statistics & numerical data , Surveys and Questionnaires , Teaching/psychology , Teaching/standards , Teaching/statistics & numerical data
19.
Paediatr Drugs ; 21(1): 47-58, 2019 Feb.
Article in English | MEDLINE | ID: mdl-30484072

ABSTRACT

OBJECTIVES: Half of prescription drugs commonly given to children lack product labeling on pediatric safety, efficacy, and dosing. Two drugs most widely used off-label in pediatrics are azithromycin and fentanyl. We sought to determine the risk of serious adverse events (SAEs) when oral azithromycin or intravenous/intramuscular fentanyl are used off-label compared to on-label in pediatric intensive care units (ICUs). STUDY DESIGN: Six pediatric hospitals participated in a retrospective chart review of patients administered oral azithromycin (n = 241) or intravenous/intramuscular fentanyl (n = 367) between January 5, 2013 and December 26, 2014. Outcomes were SAEs by drug and labeling status: off-label compared to on-label by Food and Drug Administration (FDA)-approved age and/or indication. Statistical analysis was performed using logistic regression to estimate odds ratios (ORs) and Cox regression to estimate hazard ratios (HRs). RESULTS: Twenty-one (9%) children receiving azithromycin experienced SAEs. Off-label use of azithromycin was not associated with a higher risk of SAE (OR 0.87, 95% CI 0.27-2.71, p = 0.81). Ninety-five (26%) children receiving fentanyl experienced SAEs. Fentanyl off-label use by both age and indication was not associated with a higher risk of overall SAEs compared to on-label use (OR 1.99, 95% CI 0.94-4.19, p = 0.07). However, the risk of the SAE respiratory depression was significantly greater when fentanyl was used off-label by both age and indication (OR 5.05, 95% CI 1.08-23.56, p = 0.044). Results based on HRs were similar. CONCLUSIONS: Azithromycin off-label use in pediatric ICUs does not appear to be associated with an increased risk of SAEs. Off-label use of fentanyl appears to be more frequently associated with respiratory depression when used off-label by both age and indication in pediatric ICUs. Prospective studies should be undertaken to assess the safety and efficacy of fentanyl in the pediatric population so that data can be added to the FDA labeling.


Subject(s)
Analgesics, Opioid/adverse effects , Anti-Bacterial Agents/adverse effects , Azithromycin/adverse effects , Drug-Related Side Effects and Adverse Reactions/etiology , Fentanyl/adverse effects , Intensive Care Units, Pediatric , Off-Label Use , Administration, Intravenous , Administration, Oral , Adolescent , Child , Child, Preschool , Drug-Related Side Effects and Adverse Reactions/epidemiology , Female , Hospitals, Pediatric , Humans , Infant , Infant, Newborn , Male , Prescription Drugs , Prospective Studies , Retrospective Studies , United States , Young Adult
20.
Pharmacotherapy ; 37(11): 1458-1468, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28891099

ABSTRACT

Pediatric opioid and benzodiazepine withdrawal are avoidable complications of pain and sedation management that is well described in the literature. To prevent withdrawal from occurring, practitioners regularly use a steady decrease of pain and sedation medications, also known as a weaning or tapering schedule. The weaning schedule is highly variable based on clinician preference and is usually dependent on the clinician. The purposes of this review are to evaluate the current literature on the process of opioid and benzodiazepine weaning in pediatric patients and to assess the various standardized protocols used to decrease withdrawal occurrences. We conducted a search of the PubMed, MEDLINE, Cochrane Library, Cumulative Index of Nursing and Allied Health (CINAHL), Academic Search Premier, and PsycInfo databases. Studies were included if they described a wean or taper in pediatric patients aged 18 years or younger. Studies describing neonatal abstinence syndrome were excluded from the review. A total of 97 studies published between 2000 and 2014 were retrieved; of those, 15 studies met the inclusion criteria. Studies were evaluated for selection of withdrawal assessment tool, wean protocol summary, preferred weaning agents, benzodiazepine withdrawal, and wean-at-home regimen. The most common opioid-weaning protocol approaches described a 10-20% dose decrease per day. Benzodiazepine weaning was not regularly standardized or described. The use of a standardized opioid-weaning protocol reduced withdrawal rates compared with nonstandardized weaning plans. Benzodiazepine weaning was inconsistently evaluated and may have affected study outcomes. Identified areas of improvement include the use of newer withdrawal assessment tools validated in the older pediatric population and standardized withdrawal assessment and reporting.


Subject(s)
Analgesics, Opioid/administration & dosage , Benzodiazepines/administration & dosage , Substance Withdrawal Syndrome/prevention & control , Adolescent , Analgesics, Opioid/adverse effects , Benzodiazepines/adverse effects , Child , Child, Preschool , Drug Administration Schedule , Humans , Infant , Infant, Newborn , Pain/drug therapy
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