Challenges to Implementation of the Co-Curriculum in Accredited Pharmacy Programs.

Objective. To determine areas of concern, and challenges to implementing and assessing the co-curriculum in accredited Doctor of Pharmacy programs, along with how confident programs are in their ability to meet the co-curriculum requirement as mandated by the Accreditation Council for Pharmacy Education (ACPE).Methods. A survey was administered to all ACPE-accredited pharmacy programs to collect information regarding areas of concern, challenges, and confidence in their ability to meet the co-curriculum requirement. The frequency of responses to items are presented along with comparisons based on characteristics, including institution type, cohort size, most recent ACPE accreditation review, and supporting offices.Results. The most common concerns centered on the documentation and assessment process. The most commonly reported challenges were lack of enthusiasm or buy-in from faculty, staff, and students; lack of a clear definition of co-curriculum; and faculty time and insufficient staff. Overall, programs had a high level of confidence in their ability to meet the requirements for co-curriculum. The only differences found were related to supporting offices and cohort size.Conclusion. The results suggest that having supporting offices may reduce the co-curriculum burden. Similarly, student cohort size may have an impact on the challenges for some programs, particularly those with moderate-sized cohorts reporting challenges related to faculty and staff. Further research is needed to determine how programs address these critical issues, and to explore whether programs report differently on these areas after completing an accreditation review. The study results may be useful to members of the Academy when evaluating co-curriculum.

Co-Curriculum Implementation and Assessment in Accredited Doctor of Pharmacy Programs.

Objective. To determine how accredited Doctor of Pharmacy programs implement and evaluate the co-curriculum requirement as mandated by the Accreditation Council for Pharmacy Education (ACPE). Methods. A survey was administered to all ACPE-accredited pharmacy programs to collect information regarding how co-curriculum models were being implemented, including types of activities, structure, learning outcomes, oversight, and assessment. The frequency of responses to items were presented to describe the general features of co-curriculum models. Results. The types of co-curricular activities reported by programs were generally consistent, with the majority of programs categorizing these activities and allowing students to choose which they would engage in. Most respondents reported that the program mapped co-curricular activities to learning outcomes, primarily ACPE Standards 1-4. The structural oversight of the co-curriculum typically included a co-curriculum committee, subcommittee, or task force, and supporting offices. The most common offices/departments involved in the co-curriculum were assessment, student affairs/services, experiential education, and academic/curricular affairs. The most common assessments were reflections, self-assessment surveys, and checklists. Conclusion. In most programs, implementation of the co-curriculum was a joint effort among various individuals, committees, and offices. Given the developing nature of programs, descriptive studies should be repeated to identify how programs develop and enhance co-curriculum models. The study results may be useful to members of the Academy when evaluating the current state of co-curriculum implementation and potential areas for program development.

Topiramate for migraine prophylaxis in pediatric patients.

OBJECTIVE: To evaluate the currently published data pertaining to the efficacy and safety of topiramate for prophylaxis of classic and common migraine in pediatric patients. DATA SOURCES: The literature was identified via PubMed (through April 2013) and Iowa Drug Information System (through April 2013). References from identified articles were also reviewed. STUDY SELECTION AND DATA EXTRACTION: Data were included from studies of efficacy and safety in pediatric patients experiencing migraine (with or without aura), as defined by the International Headache Society. Studies including patients with more specific types of migraine, such as basilar migraine, were excluded. DATA SYNTHESIS: Eight publicatons were identified, including 3 randomized controlled trials (RCTs), a subgroup analysis, and 4 observational studies. These studies reported a decrease in headache frequency ranging from 63% to 100% for doses of 100 mg/d and 65% for 200 mg/d. Response to therapy, defined as ≥50% reduction in migraine rate, was also reported in 83% to 95% of patients receiving topiramate. Topiramate is generally well tolerated. Adverse effects were dose related and included paresthesias, weight loss, and cognitive adverse effects. CONCLUSION: Topiramate is an effective and well-tolerated prophylactic therapy for use in pediatric migraine patients. Doses of 100 and 200 mg/d (1.47-2.0 mg/kg/d) effectively decrease the frequency of migraine headaches, with 100 mg/d providing optimal benefit-to-risk ratio. Additional randomized, double-blind, placebo-controlled studies are needed to determine the impact of the drug on quality-of-life outcomes, such as school function, and migraine severity and duration.

Efficacy of tamsulosin with extracorporeal shock wave lithotripsy for passage of renal and ureteral calculi.

OBJECTIVE: To review the evidence for the safety and efficacy of adjunctive tamsulosin in enhancing the efficacy of renal and ureteral stone clearance when used with extracorporeal shock wave lithotripsy (ESWL). DATA SOURCES: A search of MEDLINE (1950-January 2008), PubMed (1950-January 2008), and the Iowa Drug Information System (1966-January 2008) was performed using the search terms tamsulosin and extracorporeal shock wave lithotripsy. MeSH headings included lithotripsy and adrenergic alpha-antagonists. Additional references were found by searching bibliographic references of resulting citations. STUDY SELECTION AND DATA EXTRACTION: All studies utilizing tamsulosin therapy after a single session of ESWL or after the development of steinstrasse, an accumulation of stone fragments that obstructs the ureter, were included. DATA SYNTHESIS: To date, 5 prospective studies have evaluated the efficacy of tamsulosin combined with ESWL in enhancing the passage of renal and ureteral stones. In one trial, 12-week renal stone clearance was 60% in the control group compared with 78.5% in the tamsulosin group (p = 0.037). Among trials that evaluated overall ureteral stone clearance, efficacy rates were 33.3-79.3% in the control groups compared with 66.6-96.6% in the tamsulosin groups. Reports of pain and supplemental analgesic dosing were consistently lower with tamsulosin, but data on the incidence of subsequent retreatment with ESWL or ureteroscopy was rarely reported. Adjunctive tamsulosin particularly enhanced the passage of renal stones 10-24 millimeters in diameter. Overall, tamsulosin was well tolerated. CONCLUSIONS: Overall, evidence suggests that adjunctive tamsulosin therapy combined with ESWL is safe and effective in enhancing stone clearance in patients with renal stones 10-24 millimeters in diameter. Evidence regarding ureteral stone clearance is inconclusive, although adjunctive tamsulosin has been reported to reduce painful episodes. Larger prospective trials evaluating different dosages and stone locations, as well as the ability of tamsulosin to reduce repeat ESWL or more invasive methods such as ureteroscopy should be performed.

Amantadine enhancement of arousal and cognition after traumatic brain injury.

OBJECTIVE: To determine the role of amantadine therapy for early arousal and improved cognition in traumatic brain injury (TBI). DATA SOURCES: Literature was accessed through MEDLINE (1950-August 2007) using the MeSH terms amantadine, brain injuries, cognition, and arousal. PubMed (through August 2007) terms included amantadine, traumatic brain injury, and cerebral injury. STUDY SELECTION AND DATA EXTRACTION: All studies of amantadine (used <6 mo after injury) for enhancement of arousal or cognition in patients with TBI were reviewed. DATA SYNTHESIS: Many cases of TBI are associated with frontal lobe injury. As a dopamine agonist, amantadine is thought to be involved in frontal lobe stimulation. Two case reports, 3 retrospective studies, and 2 randomized, double-blind, controlled trials of amantadine therapy for early arousal in TBI were identified and reviewed. Limitations of the available studies include open design, retrospective design, and heterogeneous brain injury types. Results have been inconsistent between studies, largely due to variability in designs, heterogeneity in patient populations, time following injury, and use of numerous different outcome measures. Despite these limitations, improvements in arousal and cognition, as documented by the Glasgow Coma Scale and other measures, have been observed in patients with TBI when amantadine has been initiated 3 days to 5 months after injury. CONCLUSIONS: At doses of 200-400 mg/day, amantadine appears to safely improve arousal and cognition in patients with TBI. Additional prospective controlled studies with homogeneous patient populations will better define the role of amantadine for early arousal.

Pharmacologic expulsive treatment of ureteral calculi.

OBJECTIVE: To evaluate the role of nifedipine and the alpha(1)-adrenoreceptor antagonists tamsulosin, terazosin, and doxazosin in the expulsive treatment of ureteral calculi. DATA SOURCES: Literature was searched via MEDLINE (1966-February 2006) with subsequent bibliographic review. MeSH headings included ureteral calculi, nifedipine, doxazosin, and adrenergic alpha-antagonists. Key terms were ureteral calculi, nifedipine, tamsulosin, terazosin, and doxazosin. STUDY SELECTION AND DATA EXTRACTION: Trials evaluating nifedipine, tamsulosin, terazosin, and doxazosin for expulsion of ureteral stones were reviewed. All were published in English-language, peer-reviewed journals. DATA SYNTHESIS: Several trials have evaluated the effects of nifedipine and tamsulosin on ureteral stone passage rates and mean time to stone passage in stones no larger than 15 mm. In 28 day trials, the rates of ureteral stone passage were 35-70% in the control groups compared with 77.1-80% in patients treated with nifedipine and 79.3-100% in patients treated with tamsulosin. Average number of days to stone passage in the control groups was 4.6-20, and the time to stone passage was only 5-9.3 days in patients receiving nifedipine and 2.7-7.9 days in those receiving tamsulosin. The stone passage rates and time to stone passage appeared to be similar in one trial that compared tamsulosin with terazosin and doxazosin. Limited data suggest that these agents may have a role as adjuncts to shock wave lithotripsy. Adverse drug reactions were uncommon. CONCLUSIONS: Nifedipine, tamsulosin, terazosin, and doxazosin are safe and effective options in enhancing ureteral stone expulsion in selected patients with uncomplicated presentations.

Clearance of linezolid via continuous venovenous hemodiafiltration.

BACKGROUND: Linezolid is being used increasingly for life-threatening vancomycin-resistant infections in critically ill patients. Limited data suggest that linezolid is cleared by intermittent hemodialysis. However, information on clearance of linezolid by continuous renal replacement therapy is limited. A patient undergoing continuous venovenous hemodiafiltration (CVVHDF) was evaluated to determine linezolid clearance through CVVHDF. METHODS: A 33-year-old man with necrotizing fasciitis and acute-on-chronic renal failure requiring CVVHDF was treated with linezolid, 600 mg every 12 hours, for a vancomycin-resistant urinary tract infection. The study was performed on day 4 of therapy after a 1-hour infusion of linezolid. A series of blood samples and all urine and diafiltrate were collected during a 12-hour period. Linezolid concentrations were determined by using high-performance liquid chromatography assay. Linezolid clearance through CVVHDF was determined by using 2 methods. Method 1 evaluated the amount of drug recovered in diafiltrate. Method 2 evaluated plasma drug concentrations in prefilter and postfilter (PAN-10 Hemofilter; Asahi Medical Co, Tokyo, Japan) samples. RESULTS: Clearance of linezolid through CVVHDF was 15.6 mL/min by method 1 and 21.6 mL/min by method 2. Total-body clearance was 189 mL/min. The amount of linezolid recovered in diafiltrate was 50 mg (8.3% of the dose). CONCLUSION: Clearance of linezolid through CVVHDF in this patient was marginal. It does not appear that supplemental dosing of linezolid is necessary in patients undergoing CVVHDF.

Impact of ginkgo biloba on the pharmacokinetics of digoxin.

Many medications are known to alter digoxin pharmacokinetics, including the herbal medication St. John's wort. An open-labeled, randomized, crossover trial was conducted in eight healthy human volunteers to determine if ginkgo biloba (GB) also alters the pharmacokinetics of digoxin. On two occasions separated by 2 weeks, subjects ingested digoxin, 0.5 mg. One week prior to each study phase, half of the volunteers were randomly initiated on GB therapy, 80 mg three times daily, that continued until the end of the study phase. Immediately prior to and for 36 hours following digoxin ingestion, multiple blood samples were collected for digoxin plasma concentration determination. No significant difference between treatments was observed with respect to AUC(0- infinity ) (digoxin alone: 21.0 +/- 8.6 [ng/mL] x h; digoxin + GB: 25.6 +/- 13.2 [ng/mL] x h). Additionally, no significant difference between therapies was observed with respect to C(max), T(max), or Cl(o). In six subjects, k(e) and t(1/2) were able to be determined. These parameters also did not differ significantly between treatments. In conclusion, within the context of the specific GB product used during this investigation, the concomitant use of GB and digoxin did not appear to have any significant effect on the pharmacokinetics of orally administered digoxin in healthy volunteers.

Erythromycin in the Treatment of Diabetic Gastroparesis.

The macrolide antibiotic erythromycin has been known to be associated with increased gastrointestinal motility since its introduction more than 35 years ago. Investigators have, thus, sought to take advantage of this side effect in patients with gastric stasis secondary to long-standing insulin-dependent diabetes mellitus (IDDM). The hormone motilin induces phase 3 contractions of the migrating motor complex (MMC) to induce peristalsis and facilitate gastric emptying in normal subjects. Patients with diabetic gastroparesis lack adequate phase 3 activity to effectively empty gastric contents. Exogenous motilin administered to animals and patients with diabetic gastroparesis has proven useful for promoting gastric emptying. However, motilin is expensive to produce and must be given intravenously. Erythromycin has been shown to induce premature phase 3 activity via stimulation of motilin receptors, so investigators evaluated its efficacy for the treatment of diabetic gastroparesis. Early studies in animals with experimental gastroparesis indicated that erythromycin may be a useful prokinetic agent. Human studies of both intravenous erythromycin and chronic oral erythromycin in patients with diabetic gastroparesis resistant to other prokinetic agents showed that gastric retention was indeed reduced and symptomatic improvement achieved. Even though erythromycin lost some of its prokinetic activity with chronic oral dosing, gastric retention was still significantly reduced compared to placebo or baseline. Although prokinetic agents like metoclopramide, domperidone and cisapride are effective for the treatment of patients with diabetic gastroparesis, tachyphylaxis and adverse effects are obstacles to their use. Erythromycin appears to be both effective and well tolerated in clinical studies. At this time it should be reserved for the treatment of patients with diabetic gastroparesis who are resistant to or intolerant of other prokinetic agents. Future research on erythromycin's long-term safety and comparative efficacy will further define its role.

Effect of Single Dose Fluoxetine on Theophylline Serum Concentrations.

Fluoxetine has been previously reported to elevate plasma concentrations of several hepatically metabolized medications. Eight healthy male volunteers received intravenous aminophylline (approximately 6 mg kg(minus sign1)) on two occasions separated by 2 weeks. A 40-mg dose of oral fluoxetine was administered 8 h prior to the second administration of fluoxetine. Blood samples were collected and assayed for theophylline. Fluoxetine administration was not associated with any significant differences with respect to peak theophylline serum concentration, total body clearance, or half-life. Possible explanations include the fact that only a single dose of fluoxetine was administered and low fluoxetine serum concentrations were present at the time of aminophylline administration. The most likely explanation, however, is the fact that fluoxetine inhibits cytochrome P450 2D6 activity, whereas theophylline is predominately metabolized by cytochrome P450 1A2. In summary, a single 40-mg dose of fluoxetine failed to alter the plasma concentrations of theophylline when administered intravenously as aminophylline.