Clinical pharmacy specializations at a school of pharmacy: Development and implementation.

BACKGROUND AND PURPOSE: Specializations within doctor of pharmacy (PharmD) programs allow student pharmacists to advance their knowledge and expertise in a specific area of pharmacy. The purpose of this manuscript is to expand the knowledge of pharmacy specializations within a PharmD program by describing two patient care specializations at a school of pharmacy and their assessment strategies. EDUCATIONAL ACTIVITY AND SETTING: A pediatric pharmacotherapy and acute care pharmacotherapy specialization are described. The development of the specializations and assessment strategies are discussed. Student feedback in addition to postgraduate training and employment in specialization area are used to continually assess the specializations. FINDINGS: Sixty students completed the patient care specializations by completing the specialization coursework, which included extra assignments and a research project. A total of 34 students (57%) who completed the specializations also completed postgraduate year one training. SUMMARY: Patient care specializations allow students to develop skills used in specialty areas, and these added skills may help them be successful in finding postgraduate training related to the specialization. Creating detailed specialization requirements and assessment strategies may ensure that the specialization is of appropriate rigor to enhance specialty-specific skills and knowledge. This report can help other schools of pharmacy with their plans for developing a specialization at their institution.

Patient Weight Should Be Included on All Medication Prescriptions.

Medication prescriptions for both children and adults often require the patient's current weight to determine a safe and effective dose. Medication orders in the inpatient setting typically require a patient weight be recorded prior to order verification. However, in the ambulatory setting a very different standard exists; weights are not required on prescriptions and are rarely provided by practitioners. Without this information, the community pharmacist must either ask the caregiver, who may not know an accurate weight, or simply assume that the prescriber used a current and accurate weight and calculated the dose correctly. Standard doses are prescribed for most adult prescriptions, which makes it possible for the pharmacist to identify a dosing error. Without a current patient weight, the pharmacist is not able to provide the same level of patient care to pediatric patients or adults whose prescriptions require weight-based doses. The Pediatric Pharmacy Association recommends that patient weight, recorded in kilograms, be required on all medication prescriptions in both the inpatient and outpatient settings.

The use of elexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis postliver transplant: A case series.

INTRODUCTION: Cystic fibrosis (CF)-related liver disease (CFLD) manifests as a wide spectrum of hepatobiliary disease and can progress to need liver transplantation. Elexacaftor/tezacaftor/ivacaftor (elx/tez/iva) is a cystic fibrosis transmembrane conductance regulator modulator that has superior efficacy compared to previously approved modulators. Use of elx/tez/iva, should be approached with caution in individuals with CFLD or following liver transplantation due to possible increases in liver function tests (LFTs) and drug-drug interactions with several immunosuppressant medications. OBJECTIVE: The purpose of this case series is to explore if the use of elx/tez/iva is safe and tolerable in patients with CF postliver transplantation. METHODS: A retrospective case series including patients prescribed elx/tez/iva following liver transplantation and an immunosuppressive regimen consisting of drug therapy metabolized by P-glycoprotein was completed. RESULTS: Ten patients at six CF centers with a median age of 22.1 years (range 14-43.4 years) and the median time from the transplant of 6.9 years (range 0.6-22 years) were included. Most patients (8, 80%) received a reduced or full dose of elx/tez/iva for a mean duration of 10.4 months (range 7-12 months). Fluctuations in LFTs occurred in all patients (10, 100%) and led to therapy discontinuation in two patients (20%). Elx/tez/iva initiation resulted in elevations in tacrolimus trough concentration in seven patients (70%). Most patients who tolerated elx/tez/iva had symptomatic and quality of life improvement, increased body mass index, and maintained or improved lung function. CONCLUSION: Initiation of elx/tez/iva in patients with CF who received liver transplantation may be safe with clinical benefits.

Presumed adrenal insufficiency in neonates treated with corticosteroids for the prevention of bronchopulmonary dysplasia.

OBJECTIVE: To determine if extremely preterm (EPT) neonates receiving dexamethasone for the prevention of BPD have a higher incidence of presumed adrenal insufficiency (PAI). STUDY DESIGN: Retrospective cohort study of neonates <28 weeks gestation examining PAI after dexamethasone use and PAI after intratracheal budesonide with surfactant administration. RESULT: Of 332 neonates, 38% received dexamethasone. The incidence of PAI was higher in neonates who had received dexamethasone (20.8% vs 2.9%, p < 0.001). However, for intubated babies receiving surfactant, dexamethasone was not independently associated with increased PAI after adjusting for gestational age, birthweight, and race (aOR 2.92, 95% CI: 0.79-10.85). Dexamethasone was independently associated with increased PAI in infants previously receiving budesonide/surfactant treatment (aOR 5.38, 95% CI: 1.38-20.90). CONCLUSION: The use of dexamethasone alone was not associated with increased PAI, when adjusted for prematurity-related factors. The combination of budesonide with dexamethasone was significantly associated with increased PAI.

Joint Statement on Pediatric Education at Schools of Pharmacy.

Providing health care for children is a unique specialty, and pediatric patients represent approximately 25% of the population. Education of pharmacy students on patients across the lifespan is required by current Accreditation Council for Pharmacy Education standards and outcomes; thus, it is essential that pharmacy students gain a proficiency in caring for children. A collaborative panel of pediatric faculty members from schools and colleges of pharmacy was established to review the current literature regarding pediatric education in Doctor of Pharmacy curricula and establish updated recommendations for the provision of pediatric pharmacy education. This statement outlines five recommendations supporting inclusion of pediatric content and skills in Doctor of Pharmacy curricula.

Key Potentially Inappropriate Drugs in Pediatrics: The KIDs List.

OBJECTIVES: The safe use of medications in pediatric patients requires practitioners to consider the unique pharmacokinetics and pharmacodynamics of drugs prescribed in this age group. In an effort to create a standard of care for the safe use of medications in this population, a list of drugs that are potentially inappropriate for use in pediatric patients has been developed and titled the "KIDs List." METHODS: A panel of 7 pediatric pharmacists from the Pediatric Pharmacy Association were recruited to evaluate primary, secondary, and tertiary literature; FDA Pediatric Safety Communications; the Lexicomp electronic database; and product information for drugs that should be considered potentially inappropriate for use in pediatric patients. Information was rated using predefined criteria. A PubMed search was conducted using the following terms: adverse drug events OR adverse drug reactions. The search was limited to humans; age <18 years; case reports, observational studies, or clinical trials; and English language. No date range was used. Results were used to create an evidence-based list of candidate drugs that was then peer-reviewed and subjected to a 30-day public comment period prior to being finalized. RESULTS: A PubMed search yielded 4049 unique titles, of which 210 were deemed relevant for full review. Practitioner recommendations highlighted an additional 77 drugs. FDA Pediatric Safety Communications and the Lexicomp database yielded 22 and 619 drugs, respectively. After critical analysis, peer review, and public review the final KIDs List contains 67 drugs and/or drug classes and 10 excipients. CONCLUSIONS: This extensive effort led to compilation of the first list of drugs that are potentially inappropriate for prescribing in all or in a select subgroup of pediatric patients. If avoidance is not clinically possible, the drug should be used with caution and accompanied by appropriate monitoring.

Off-label use of intravenous antimicrobials for inhalation in patients with cystic fibrosis.

Management of infections in patients with cystic fibrosis (CF) presents challenges for healthcare providers, including the eradication of initial acquisition, treatment of acute exacerbations, and chronic infection with suppressive therapy. Inhaled antimicrobial therapy for infections in patients with CF has been used in these capacities, often in an effort to achieve optimal concentrations in sputum for antimicrobial efficacy while mitigating potential toxicities associated with systemic therapy. Unfortunately, there are few commercially available products formulated for inhalation, resulting in the off-label use of other formulations, such as intravenous products, administered via nebulization. This review aims to examine the evidence supporting the efficacy of these off-label formulations for management of acute and chronic infections associated with CF, as well as adverse effects associated with their use.

An Evaluation of Vancomycin Area Under the Curve Estimation Methods for Children Treated for Acute Pulmonary Exacerbations of Cystic Fibrosis Due to Methicillin-Resistant Staphylococcus aureus.

The prevalence of pulmonary methicillin-resistant Staphylococcus aureus infections in patients with cystic fibrosis (CF) has increased over the last 2 decades. Two concentrations-a postdistributive and a trough-are currently used to estimate the area under the curve (AUC) of vancomycin, an antibiotic routinely used to treat these infections, to achieve the target AUC/minimum inhibitory concentration of ≥400 mg·h/L in ensuring optimal dosing of this drug. This study evaluated precision and bias in estimating vancomycin AUCs obtained either from a population pharmacokinetic (PK) model by using a single trough concentration or from standard PK equation-based 2-point monitoring approach. AUCs were either obtained from a single trough concentration-fitted model or derived from a model fitted by 2 concentration points. Children ≥2 years of age with CF received intravenous vancomycin at 2 centers from June 2012 to December 2014. A population PK model was developed in Pmetrics to quantify the between-subject variability in vancomycin PK parameters, define the sources of PK variability, and leverage information from the population to improve individual AUC estimates. Twenty-three children with CF received 27 courses of vancomycin. The median age was 12.3 (interquartile range [IQR] 8.5-16.6) years. From the individual vancomycin PK parameter estimates from the population PK model, median AUC was 622 (IQR 529-680) mg·h/L. Values were not significantly different from the AUC calculated using the standard PK equation-based approach (median 616 [IQR 540-663] mg·h/L) (P = .89). A standard PK equation-based approach using 2 concentrations and a population PK model-based approach using a single trough concentration yielded unbiased and precise AUC estimates. Findings suggest that options exist to implement AUC-based pediatric vancomycin dosing in patients with CF. The findings of this study reveal that several excellent options exist for centers to implement AUC-based pediatric vancomycin dosing for patients with CF.

Nebulized Gentamicin as an Alternative to Nebulized Tobramycin for Tracheitis in Pediatric Patients.

OBJECTIVES: Tracheitis is an infection of the lower respiratory tract and is defined by the US Centers for Disease Control and Prevention (CDC) based on signs and symptoms with no radiographic evidence of pneumonia. One method of treatment involves the use of tobramycin given by nebulizer. The purpose of this study was to compare the safety and efficacy of nebulized gentamicin with nebulized tobramycin. METHODS: This study was conducted in patients under 21 years of age who received greater than or equal to 1 day of gentamicin, 80 mg, or tobramycin, 300 mg, given twice a day by nebulization within the 14-month study period. The primary endpoint was amount of time until the patient no longer met the CDC definition of tracheitis. RESULTS: There were 19 patients who presented with 60 separate encounters. The average age of the patients within the gentamicin group was 7.2 and 5 years old within the tobramycin group. The average duration of time for the gentamicin treatment encounters to be free of the CDC definition of tracheitis was 3.36 days compared to 3.17 days with tobramycin. No adverse effects were observed that were attributable to aminoglycoside nebulization. CONCLUSIONS: No differences were detected between the safety and efficacy of intravenous gentamicin administered twice a day by nebulizer and that of tobramycin inhalation solution given twice daily in children without cystic fibrosis.

Cystic Fibrosis Foundation pulmonary guideline. pharmacologic approaches to prevention and eradication of initial Pseudomonas aeruginosa infection.

DESCRIPTION: The Cystic Fibrosis (CF) Foundation developed clinical care guidelines for the prevention of Pseudomonas aeruginosa infection, the treatment of initial P. aeruginosa infection, and the use of bronchoscopy to obtain routine airway cultures in individuals with CF. METHODS: A multidisciplinary committee developed questions about the prevention and treatment of initial P. aeruginosa infection and the use of bronchoscopy to obtain routine airway cultures. The outcome measure of interest was cultures without P. aeruginosa growth. Systematic reviews of PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials were conducted in May 2012 and August 2013. Searches combined controlled vocabulary terms and text words for CF and terms relevant to each question. The entire committee reviewed the evidence, and final recommendation statements were graded using the U.S. Preventive Services Task Force system. Recommendation 1: The CF Foundation strongly recommends inhaled antibiotic therapy for the treatment of initial or new growth of P. aeruginosa from an airway culture (certainty of net benefit, high; estimate of net benefit, substantial; grade of recommendation, A). The favored antibiotic regimen is inhaled tobramycin (300 mg twice daily) for 28 days. Recommendation 2: The CF Foundation recommends against the use of prophylactic antipseudomonal antibiotics to prevent the acquisition P. aeruginosa (certainty of net benefit, moderate; estimate of net benefit, zero; grade of recommendation, D). Recommendation 3: The CF Foundation recommends routine oropharyngeal cultures rather than bronchoalveolar lavage cultures obtained by bronchoscopy in individuals with CF who cannot expectorate sputum to determine if they are infected with P. aeruginosa (certainty of net benefit, moderate; estimate of net benefit, moderate; grade of recommendation, B).

Population pharmacokinetics of intermittent vancomycin in children with cystic fibrosis.

BACKGROUND: Vancomycin is the drug-of-choice for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in children with cystic fibrosis. However, no studies have characterized the pharmacokinetic profile of vancomycin among pediatric cystic fibrosis patients. OBJECTIVE: To evaluate the pharmacokinetics of intermittent vancomycin administration in children with cystic fibrosis and identify covariates that significantly influence vancomycin efficacy and safety. METHODS: Therapeutic drug monitoring data were obtained from two cystic fibrosis care centers that identified children < 18 years who received vancomycin treatment for an acute pulmonary exacerbation from 2005 to 2010. Trough and peak serum concentrations were determined before and after the third or fourth dose. Nonlinear mixed effects models were developed to evaluate the population pharmacokinetics of vancomycin. RESULTS: Among the 67 children (mean age 12.1 ± 5.3 years), the mean vancomycin dose was 17.4 ± 4.4 mg/kg. The mean trough concentration (Cmin ) was 10.3 ± 3.8 mg/L. The mean daily area under the serum concentration time curve (AUC24 ) was 282.5 ± 816.9 mg·hour/L. A one-compartment model with first-order elimination best described the data. Weight significantly influenced vancomycin clearance (p<0.001). In the final model, clearance was estimated as 5.57 L/hour/70 kg, and the volume of distribution was 44.1 L/70 kg. The between subject variability for clearance and volume of distribution were 27% and 40%, respectively. CONCLUSIONS: Using a one-compartment model to evaluate the pharmacokinetic properties of vancomycin in children with cystic fibrosis, clearance increased with body weight. Pharmacodynamic studies are needed to establish an optimal vancomycin dosing regimen for the treatment of pediatric exacerbations of cystic fibrosis.

Cystic fibrosis pulmonary guidelines. Chronic medications for maintenance of lung health.

RATIONALE: Cystic fibrosis (CF) is an autosomal recessive disease characterized by abnormal airways secretions, chronic endobronchial infection, and progressive airway obstruction. The use of medications to slow the progression of lung disease has led to significant improvement in survival. An evidence review of chronic medications for CF lung disease was performed in 2007 to provide guidance to clinicians in evaluating and selecting appropriate treatment for individuals with this disease. We have undertaken a new review of the literature to update the recommendations, including consideration of new medications and additional evidence on previously reviewed therapies. A multidisciplinary committee of experts in CF pulmonary care was established to review the evidence for use of chronic medications for CF lung disease and make treatment recommendations. Published evidence for chronic lung therapies was systematically reviewed and resulting treatment recommendations were graded based on the United States Preventive Services Task Force scheme. These guidelines provide up-to-date evidence of safety and efficacy of chronic treatments of CF lung disease, including the use of novel therapies that have not previously been included in CF pulmonary guidelines.

Smoking cessation treatment for adolescents.

Cigarette smoking in the adolescent population remains a public health concern. A significant portion of the adolescent population currently uses tobacco. Nicotine is particularly addicting in adolescents, and quitting is difficult. The goals for adolescent cigarette smoking efforts must include both primary prevention and smoking cessation. Bupropion and nicotine replacement therapies-including nicotine patches, gum, and nasal spray-have been studied to a limited extent in the adolescent population. Varenicline has not been evaluated as a treatment modality in adolescents. Long-term quit rates in the pharmacotherapy trials have not been optimal; however, decreases in cigarettes smoked per day have been observed. Several evidencebased guidelines include recommendations for smoking cessation in adolescents that include counseling and pharmacotherapy. Pharmacotherapy may be instituted for some adolescents in addition to counseling and behavioral interventions. Therapy should be individualized, based on smoking patterns, patient preferences, and concomitant disease states. Smoking cessation support for parents should be instituted as well. The pharmacist can play a large role in helping the adolescent quit smoking. Further studies evaluating pharmacotherapy options for smoking cessation in adolescents are necessary. If pharmacotherapy is used, it should be individualized and combined with psychosocial and behavioral interventions.

Oral baclofen and clonidine for treatment of spasticity in children.

Few data exist in the literature to support the use of high dosages of oral baclofen and clonidine that are frequently required to treat children with spasticity. This study was a retrospective chart review of baclofen and clonidine dosages used in children diagnosed with cerebral palsy or traumatic brain injury. The primary objective was to calculate the mean dosages of baclofen and clonidine based on the duration of spasticity postinjury. Secondary objectives included determining correlations between dosage and age, injury type, location of spasticity, comorbid seizures, or concomitant antispasticity medications. Eighty-seven children receiving baclofen and/or clonidine were included in this study. Mean dosages of 40 mg/day (n = 86) and 0.4 mg/day (n = 31) were required for baclofen and clonidine, respectively. The maximum dosage was 240 mg/day for baclofen and 3.6 mg/day for clonidine. Duration postinjury, age, and concomitant antispasticity medications were the most predictive variables for baclofen dosage as a model (r = .522; P = .000). Duration postinjury and location of spasticity were the most predictive variables for clonidine dosage as a model (r = .523; P = .000). The average dosages of baclofen and clonidine used in this population of children with cerebral palsy or traumatic brain injury were similar to those reported in the literature, with higher maximum dosages found in this investigation.

Prevalence and treatment of metabolic syndrome in adolescents with type 2 diabetes.

BACKGROUND: The incidence of obesity and type 2 diabetes among adolescents has risen dramatically in recent years, and it is likely that many of these adolescents also have metabolic syndrome. OBJECTIVE: To investigate the prevalence of metabolic syndrome in the patient population enrolled in a children's hospital type 2 diabetes clinic and to describe baseline pharmacologic treatment and adherence patterns. METHODS: In this retrospective cohort study, the medical charts of 52 adolescents were reviewed. A data collection instrument was used to collect demographic data, laboratory values, medication lists, and documented adherence patterns from the patient's initial clinic visit. Data collected were used to identify patients with metabolic syndrome. Data were entered into a database and analyzed using SPSS 13.0. RESULTS: Data were collected for 52 patients; of these, 40 (76.9%) had characteristics of metabolic syndrome meeting 3 or more of the 5 criteria, although only 8 (15.4%) were diagnosed with the metabolic syndrome. Among patients with characteristics of metabolic syndrome, 92.5% were taking a glucose-lowering drug, with 85% of those receiving metformin. Sixteen (40%) patients were receiving a blood pressure-lowering medication at baseline, and 4 (10%) were taking a lipid-lowering agent. Forty-three percent of these patients reported nonadherence to their prescribed drugs. CONCLUSIONS: Given these treatment patterns, pharmacologic management of metabolic syndrome in adolescents with type 2 diabetes may be suboptimal and may impact cardiovascular outcomes. It is important for clinicians to be aware of the incidence of type 2 diabetes and metabolic syndrome in adolescents so that treatment with lifestyle modifications and pharmacologic therapy may be implemented earlier.

Long-term follow-up of survivors of childhood cancer.

OBJECTIVE: This study was designed to improve the long-term follow-up of childhood cancer survivors by developing standard monitoring for adverse effects; Providing concise treatment summaries for each patient and identifying already existing adverse effects; Determining patient risks for long-term adverse effects; and providing individualized 10-year of plans for follow-up. METHODS: A retrospective chart review of long-term childhood cancer survivors followed by the institution's pediatric oncologists was performed. Criteria for review included being at least 5 years from diagnosis and 2 years off chemotherapy. Patients are followed annually by the pediatric oncologists. RESULTS: At the time of review, there were 26 long-term survivors of childhood cancers enrolled at the clinic. Their charts have been reviewed and treatment summaries formulated. Fifty-four adverse effects have been detected. 74% of the patients have long-term adverse effects from receiving cancer therapy. The most common were growth hormone deficiency, hypothyroidism, seizures, and hearing loss. Ten year follow-up plans have been devised for each patient. CONCLUSION: The presence of long-term adverse effects is common in childhood cancer survivors. The pediatrician is pivotal in helping assure their patients are receiving adequate follow-up to detect these complications as well as assisting in the transition to care as an adult.

Are antidepressants safe to use in children and adolescents?

The Food and Drug Administration is investigating 10 antidepressants to determine possible increase of depression or suicidality in children and adolescents while on the medication. Results of the data analysis should be available in the summer of 2004.