Incidence of Cytomegalovirus DNAemia in Pediatric Post-Renal Transplant Patients Receiving Weight-Based vs Body Surface Area-Based Valganciclovir Chemoprophylaxis.

OBJECTIVE: To determine the incidence of cytomegalovirus (CMV) DNAemia and disease, identify potential risk factors, and assess the safety and efficacy of weight-based valganciclovir dosing in pediatric post-renal transplant patients. METHODS: This single-center, retrospective study included patients ≤21 years who received a kidney transplant between January 1, 2011, and November 1, 2019, with 3 to 24 months of follow-up data. Demographics and clinical characteristics were collected to assess for potential risk factors. Descriptive statistics and logistic regressions were used to determine rates of CMV DNAemia considering clinical characteristics and chemoprophylaxis. RESULTS: Fifty-seven patients were included. The incidence of CMV DNAemia was 43.9%. Cytomegalovirus seropositive status was associated with increased risk of CMV DNAemia. Patients receiving valganciclovir for <150 days had 8.33 (95% CI, 1.68-41.29) greater odds of developing CMV DNAemia than patients receiving valganciclovir for 180 ± 30 days, p = 0.01. The median time to detectable CMV PCR after transplant was 140 days (range, 12-511 days). Cytomegalovirus DNAemia was not statistically different between those receiving weight-based vs FDA-approved valganciclovir dosing; however, patients receiving the FDA-approved dosing were more likely to develop neutropenia. Among the intermediate-risk group, the adjusted relative risk of CMV DNAemia was 0.62 (95% CI, 0.36-1.09) for those not receiving chemoprophylaxis compared with those who did. CONCLUSIONS: Risk of CMV DNAemia is higher among patients receiving valganciclovir for <150 days. Further exploration of weight-based valganciclovir dosing for CMV chemoprophylaxis in high- and intermediate-risk post-renal transplant patients is needed to minimize adverse drug effects while maintaining efficacy.

Comparison of Clinical Outcomes and Medication Use of Obese Versus Nonobese Children Admitted to the Pediatric Intensive Care Unit.

Background: Few studies have compared clinical outcomes and medication use between obese and nonobese children in the pediatric intensive care unit (PICU). Objectives: The primary objective was to compare clinical outcomes including mortality, PICU length of stay (LOS), and mechanical ventilation (MV) requirement between obese and nonobese children. Secondary objectives included analysis of factors associated with these outcomes and medication use between groups. Methods: This retrospective study included children 2 to 17 years old admitted to the PICU over a 1-year time frame. Patients were categorized as obese, body mass index (BMI) ≥ 95th percentile, and nonobese (BMI < 95th percentile). Three binary regression models assessed the impact of obesity on clinical outcomes. Results: There were 834 admissions, with 22.1% involving obese children. There was no difference in mortality, MV requirement, or PICU LOS between groups. There were no associations with obesity and clinical outcomes found, but an association was noted for medication classes and receipt of continuous infusions on clinical outcomes. There was no difference noted in the median number (interquartile range [IQR]) of medications between obese and nonobese children, 8 (6-13) versus 9 (6-15), P = .38, but there was a difference in patients receiving a continuous infusion between obese and nonobese children, 24.4% versus 8.8%, P < .01. The 15 most used medications in both groups included analgesics, antimicrobials, corticosteroids, bronchodilators, and gastrointestinal agents. Conclusions: One-fifth of all admissions included obese children. Obesity was not associated with mortality, PICU LOS, and MV requirement, but the number of medication classes and continuous infusions were associated with these outcomes.

Publication Rates of Pediatric-Focused Resident Research Projects Presented at The Pediatric Pharmacy Association Bruce Parks Memorial Residency Showcase.

OBJECTIVES: The primary objective was to identify the number of residency projects presented at the Pediatric Pharmacy Association (PPA) Bruce Parks Memorial Residency Showcase that were subsequently published. Secondary objectives included a comparison of subsequent publications after residency completion between those who did and did not publish their residency project and an analysis of factors associated with subsequent publications. METHODS: This was a descriptive study including all pediatric-focused resident projects presented at the PPA Bruce Parks Memorial Residency Showcase from 2006 to 2015. Literature searches for all the pediatric-focused residency projects and any subsequent publications were performed. Data collection included residency type (i.e., postgraduate year 1 [PGY1], postgraduate year 2 [PGY2]), project category, and initial position after residency. A zero-inflated Poisson regression was used to analyze subsequent publication status while controlling for other factors. Statistical analyses were performed using SAS/STAT, with a priori p value < 0.05. RESULTS: There were 434 projects presented by 401 residents. Seventy-four (17.1%) were published, with the majority being PGY2s (74.3%). Subsequent publications were identified for 162 residents (40.4%), with a higher percentage in those who published their pediatric-focused residency project versus those who did not, 59.5% versus 32.8%, p < 0.001. Factors associated with subsequent publications were those who published their residency project, initial position in academia, and PGY2s. CONCLUSIONS: Of the residency projects presented at the showcase <20% were subsequently published. Those who published their residency research project were more likely to have subsequent publications. Future efforts should be taken to ensure that residents have the tools/confidence to independently publish their research/scholarship.

Descriptive study of discharge medications in pediatric patients.

BACKGROUND: Limited studies have evaluated medications in children discharged from hospitals. Knowledge of the number of medications and dosage forms could provide a baseline to establish a medication discharge prescription program. OBJECTIVES: To identify the median number of discharge prescriptions per patient. Secondary objectives included an evaluation of the dosage formulations and frequency, and comparisons of the prevalence of unrounded medication doses between service type (medical vs surgical) and physician provider level (trainees vs attendings). METHODS: This retrospective study included children <18 years receiving >1 discharge prescription during 4 selected months over a 1-year time frame. Comparisons were made via Pearson's chi-square tests, Fisher's Exact tests, and Kruskal-Wallis nonparametric rank tests as appropriate with a priori p value of <0.05. RESULTS: A total of 852 patients were evaluated, with most (78.8%) on a medical service. The median (interquartile range) number of new medications at discharge was 2 (1-3), with the median total number of discharge medications of 3 (2-6). There was no difference in the net change of the median number of home medications stopped and new medications started between service types. The majority (72.2%) received >1 oral liquid medications. There was no difference in prescribing rates per service type and provider level. There was a difference in the number of unrounded doses between trainees versus attendings, 17.8% versus 9.5%, p = 0.048. CONCLUSION: Patients were discharged on a median of three medications, and most received >1 oral liquid medications. These data can be used to target children who would benefit from medication discharge prescription programs.

Hyponatremia With Intravenous Sulfamethoxazole/Trimethoprim in Children.

Background: Intravenous (IV) sulfamethoxazole/trimethoprim (SMX/TMP) has been associated with hyponatremia in adults. Objective: The primary objective was to identify the number of patients with a serum sodium <135 mEq/L. Secondary objectives between the hyponatremic versus nonhyponatremic groups included demographic comparisons, median serum sodium concentrations, SMX/TMP cumulative dose, number of diuretics, and other medications causing hyponatremia. Methods: This was a retrospective study of children <18 years receiving IV SMP/TMX. Comparisons were conducted via Mann-Whitney-Wilcoxon and Mantel-Haenszel χ2 tests with an a priori P value <0.05. Results: Sixty-one patients received 66 total courses; 20 courses (30.3%) were associated with hyponatremia with a decrease in the median nadir serum sodium concentration of 133 and 138 mEq/L in the hyponatremic and nonhyponatremic groups, respectively (P<0.001). The median age (interquartile range) was lower in the hyponatremic versus nonhyponatremic group, but this was not statistically significant: 0.6 (0.1-5.5) versus 3.9 (0.3-11.0) years; P=0.077. There was no significant difference in the median cumulative dose (mg/kg) between groups; P=0.104. In addition, there was a significant difference in the number of children in the hyponatremic versus nonhyponatremic groups receiving diuretics (16 [80.0%] vs 23 [50.0%], P=0.023) and other medications that cause hyponatremia (7 [35.0%] vs 5 [10.9%], P=0.034), respectively. Furosemide was noted to be the medication most associated with hyponatremia. Conclusion and Relevance: Approximately one-third administered IV SMX/TMP developed hyponatremia. Concomitant furosemide administration was one of the most common risk factors. Clinicians should be aware of this potential adverse event when initiating IV SMX/TMP in children.

A survey of pediatric degree option program graduates in a doctor of pharmacy curriculum: Confidence and initial employment position.

BACKGROUND AND PURPOSE: Graduates from the pediatric degree option program (PDOP) were tracked to identify confidence with pediatric pharmacotherapy and categorize initial employment following graduation. EDUCATIONAL ACTIVITY AND SETTING: The PDOP was established in 2011 and requires 16 credits of pediatric-focused didactic coursework and advanced pharmacy practice experiences. Thirty PDOP graduates completed a 30-item questionnaire to assess confidence in pediatric pharmacotherapy knowledge and skill statements and employment position following graduation. Responses were compared between those completing post-graduate pediatric pharmacy training and those who did not. FINDINGS: Nineteen (63.3%) graduates responded. All expressed "very high" or "high" confidence with dose calculations, first-line treatment selection for otitis media, and counseling caregivers on medications. However, <75% expressed "very high" or "high" confidence with identification of pharmacokinetic differences in neonates vs. children, utilization of growth charts, and counseling children. Ten (52.6%) respondents completed post-graduate training, and the remainder had an initial position in community or hospital pharmacy. There were no significant differences in pharmacotherapy skill and knowledge statements between those completing residency vs. those who did not. The most beneficial experiences reported were gaining clinical experience in pediatric pharmacy and medication safety. SUMMARY: Overall, PDOP graduates noted high confidence in pediatric pharmacotherapy skills and knowledge. Most felt that the PDOP influenced their initial career plans and made them more competitive for their initial position following graduation. The PDOP was well received and provided an opportunity for additional knowledge and skill development for students interested in pediatrics.

Prescribing Patterns of Continuous Infusions in Nonobese versus Obese Children Admitted to the Pediatric Intensive Care Unit.

This retrospective study compared the continuous infusions prescribed for obese and nonobese children. Ninety-five (13.2%) received an infusion. A greater percentage of obese ( n = 42/168) versus nonobese (53/552) children received infusions, p < 0.01. No difference was noted in the median number of infusions between the obese and nonobese groups, 2 versus 2, p = 0.975. The top 20 prescribed infusions included ten (50%) for sedation/analgesia or neuromuscular blockade and six (30%) for hemodynamic support. A literature search was performed for these 20 agents to determine pharmacokinetics, pharmacodynamics, and dosing in obese children and revealed six studies evaluating fentanyl ( n = 2), midazolam ( n = 1), and propofol ( n = 3).

Disulfiram-like Reaction With Metronidazole: An Unsuspected Culprit.

The association of disulfiram-like reaction with concomitant use of metronidazole and alcohol has been reported in the literature; however, alcohol containing oral liquids may not always be identified as a culprit. A case of a 14-year-old patient who experienced a possible disulfiram-like interaction while receiving metronidazole and Prednisone Intensol solution is reported. Metronidazole oral suspension was initiated for treatment of Clostridium difficile-associated diarrhea. Later, a 5-day course of oral Prednisone Intensol solution was initiated. On day 2 of concomitant metronidazole and steroid therapy, the patient experienced severe discomfort and abdominal distention accompanied by new onset tachycardia. A disulfiram-like reaction between the steroid solution and metronidazole was suspected; therefore, the Prednisone Intensol was discontinued. The patient's mother reported that, following discontinuation, the patient slept well for the first time in 2 days. Use of the Naranjo Adverse Drug Reaction Probability Scale indicated a possible relationship (score of 4) between the concomitant medication use and the gastrointestinal discomfort and tachycardia. If this interaction between metronidazole and alcohol containing medications occurs, it may be initially unrecognized, potentially resulting in patient discomfort or harm. It is important for healthcare professionals to identify these potential drug-drug interactions so that alternative medications may be utilized and offending agents can be avoided or replaced.

Description of a pediatric degree option program in a doctorate of pharmacy curriculum and its impact on pediatric-focused advanced pharmacy practice experience rotations and faculty scholarly productivity.

PURPOSE: To describe the development of a Pediatric Degree Option program and its impact on pediatric-focused advanced pharmacy practice experiences (APPEs) and faculty scholarly productivity. EDUCATIONAL ACTIVITY: The Pediatric Degree Option program was established in 2011 and requires 16 h of didactic coursework and APPEs. The number of pediatric-focused APPEs and mean number of APPEs per pediatric faculty per year was compared pre- (2005-2010) and post-implementation (2011-2016). In addition, the median number of scholarship activities per student pre- and post-implementation was compared. The initial position obtained by graduates completing the degree option was collected. FINDINGS: Thirty students have completed the program. There were 146 pediatric-focused APPEs for the pre-implementation period and 259 post-implementation. However, there was an increase in pediatric faculty during the post-implementation, so there was no difference in the mean number of pediatric-focused APPEs per pediatric faculty in the pre- versus post-implementation period, 8.4 + 2.7 versus 6.9 +1.0, p = .224. A significant increase in the median number of pediatric-focused scholarly activities per student was observed pre-versus post-implementation, 3 (2-5) versus 5 (3-7), p = .005. Twenty-six (86.7%) students in the post-implementation period participated as a research assistant or coauthor in an original research or manuscript writing project. Students accepted a variety of positions after graduation including twelve (40%) accepting a PGY1 residency and eight (36.7%) as community pharmacists. SUMMARY: Although the number of pediatric-focused APPEs increased in the post-implementation, this did not result in an increase in the mean number of mean pediatric-focused APPEs per pediatric faculty member. However, it did allow a unique opportunity for 30 students with interest in pediatrics and allowed for content and skill development. The Pediatric Degree Option program allowed students to gain experience with pediatric-focused scholarly activities that also enhanced faculty productivity in scholarship and research.

Efficacy and tolerability of magnesium plus protein for managing hypomagnesemia in pediatric kidney transplant patients.

We sought to investigate whether magnesium oxide bound to soy protein (MGP) increases serum magnesium concentrations with less diarrhea compared to commonly prescribed magnesium salts. Subjects were switched to MGP at a near-equivalent daily elemental magnesium dose. Mean serum magnesium levels were compared. If magnesium levels remained <1.7 mg/dL after switching to MGP, subjects were enrolled into Part 2 and received a one-time MGP dose adjustment. The MGP daily dose was increased by 266 mg. For both parts 1 and 2, subjects recorded the number and quality of their stools to assess gastrointestinal (GI) tolerability of MGP. Twelve pediatric kidney transplant recipients completed Part 1. Mean serum magnesium levels increased from 1.61 (SD 0.1) on standard MG to 1.69 (SD 0.1); t(11) = 2.6, P = .02 on MGP. Five subjects completed Part 2, and all achieved serum magnesium ≥1.7 mg/dL (mean 1.75 mg/dL, SD 0.06; t(4) = 2.7, P = .06). Subjects reported the same number of, but looser bowel movements with MGP; however, individuals did not perceive intolerable GI symptoms with MGP therapy and all chose to remain on MGP at the end of the study. At an equivalent mg/kg/d dose of elemental magnesium, serum magnesium levels on MGP were significantly higher.

Prevalence of Unrounded Medication Doses and Associated Factors Among Hospitalized Pediatric Patients.

OBJECTIVES: This study aims to determine the prevalence and factors associated with unrounded doses ordered via a computerized prescriber order entry (CPOE) system among children during a 1-week reference period. METHODS: This retrospective, cross-sectional study included children younger than 18 years admitted during a 7-day period. An unrounded dose was defined as an unrounded actual dose (eg, dose calculated to the tenths place for non-neonatal intensive care (non-NICU) patients and dose calculated to the hundredth place for NICU patients) or unrounded volume per dose [eg, <0.1 mL for non-NICU patients and <0.01 mL for NICU patients]. A multilevel logistic regression model was used to determine the prevalence and factors associated with unrounded doses via a CPOE system with adjustment for clustering effects. RESULTS: A total of 395 patients were admitted with 391 receiving medications. The overall prevalence of unrounded doses was 30% among the 2426 doses administered. Patients on the NICU team had the highest prevalence of unrounded doses. The odds of an unrounded dose were 4% (adjusted odds ratio, 0.96; 95% confidence interval, 0.94-0.98) lower with each additional kilogram increase in weight after controlling for age, route, scheduled versus as-needed administration, and cluster effects. CONCLUSIONS: The prevalence of unrounded doses was higher than in previous studies. It was higher in smaller children after controlling for age, medication-related variables, and clustering. Future studies should focus on the role of CPOE in preventing unrounded and unmeasurable doses and if these strategies affect clinical outcomes (eg, adverse drug events).

Applicability of the Schwartz Equation and the Chronic Kidney Disease in Children Bedside Equation for Estimating Glomerular Filtration Rate in Overweight Children.

STUDY OBJECTIVE: To determine if significant correlations exist between glomerular filtration rate (GFR) prediction equation values, derived by using the original Schwartz equation and the Chronic Kidney Disease in Children (CKiD) bedside equation with a 24-hour urine creatinine clearance (Clcr ) value normalized to a body surface area of 1.73 m(2) in overweight and obese children. DESIGN: Prospective analysis (20 patients) and retrospective analysis (43 patients). SETTING: Pediatric inpatient ward and pediatric nephrology clinic at a comprehensive academic medical center. PATIENTS: Sixty-three pediatric patients (aged 5-17 years), of whom 27 were overweight (body mass index [BMI] at the 85th percentile or higher) and 36 were not overweight (BMI lower than the 85th percentile [controls]) between 2007 and 2012. METHODS AND MAIN RESULTS: Data from the overweight patients were compared with nonoverweight controls. GFR values were calculated by using the original Schwartz equation and the CKiD bedside equation. Each patient's 24-hour urine Clcr value normalized to a body surface area of 1.73 m(2) served as the index value. A Pearson correlation coefficient model was used to determine association between the 24-hour urine Clcr value (index value) with the Schwartz and CKiD GFR estimations. Significant correlation was found to exist between the Schwartz and CKiD bedside GFR estimations relative to the 24-hour urine Clcr in the control subjects (r = 0.85, p<0.0001, and r = 0.85, p<0.0001, respectively). Significant correlation was also found to exist between the Schwartz and CKiD bedside GFR values with the 24-hour urine Clcr value in overweight subjects (r = 0.86, p<0.0001, and r = 0.86, p<0.0001, respectively). The Schwartz equation estimated average GFR 21.75 ml/minute/1.73 m(2) higher than 24-hour urine Clcr (p<0.0001) in overweight children with a kidney disorder. The CKiD bedside GFR estimations were not significantly different compared with 24-hour urine Clcr values for the overweight group with kidney disorder (p=0.85). CONCLUSION: The Schwartz and CKiD bedside estimations of GFR correlated with 24-hour urine Clcr values in both overweight and nonoverweight children. Compared with the Schwartz equation, which tended to overestimate renal function, the CKiD bedside equation appeared to approximate 24-hour urine Clcr more closely in overweight children with kidney disorder.

Increased enoxaparin dosing is required for obese children.

Weight-based dosing for enoxaparin is recommended in the 2008 American College of Chest Physicians (ACCP) guidelines for venous thromboembolism (VTE) prophylaxis. Enoxaparin 0.5 mg/kg per dose administered subcutaneously every 12 hours is recommended for this indication in children. There is no established upper dosing limit of enoxaparin for prophylaxis in children, and the US Food and Drug Administration-approved enoxaparin dose for adults for VTE prophylaxis is 30 mg subcutaneously every 12 hours or 40 mg subcutaneously daily. Therefore, we assumed that the upper limit for children is 40 mg subcutaneously daily. We reviewed 3 cases of obese adolescent boys who required large doses of enoxaparin to achieve the ACCP-recommended anti-factor Xa range of 0.1 to 0.3 IU/mL for the prevention of VTE. All 3 patients required doses of enoxaparin that are higher than that recommended for adults for VTE prophylaxis: patient A (BMI: 105.9) required >0.28 mg/kg per dose, patient B (BMI: 95.7) required 0.15 mg/kg per dose, and patient C (BMI: 29.9) required 0.49 mg/kg per dose. The desired anti-factor Xa range was achieved when enoxaparin was administered every 12 hours in each patient with no reported episodes of VTE. One patient had minor bruising, but no other adverse events were noted. Because of the variability in dose requirements and unpredictability in patient responses demonstrated in our 3 adolescents, prospective studies are needed to provide definitive recommendations on dosing of enoxaparin for VTE prophylaxis in this subset of obese pediatric patients.

Intensive vs. conventional insulin management initiated at diagnosis in children with diabetes: should payer source influence the choice of therapy?

Intensive insulin management (IIM) in type 1 diabetes facilitates improved glycemic control and a reduction in long-term diabetes complications. We hypothesized that IIM can be started at diagnosis without deleterious effects on hemoglobin A1c (A1c), body mass index (BMI), and severe hypoglycemia regardless of payer source. Type 1 diabetes patients aged 0-18 yrs, in an academic endocrinology practice were identified for a retrospective chart review. Fifty-four patients on conventional insulin management (CIM) were compared to 51 on IIM. Insulin regimens, payer, and A1c values were compared at baseline, 12, 15, and 18 months. Secondary analyses included BMI changes and hypoglycemia frequency. Overall mean A1c values for the IIM group (8.15 +/- 1.41) were lower across all time periods compared to the CIM group (8.57 +/- 1.52). Repeated measures anova revealed a significant treatment group effect (p = 0.01) with no time effect (p = 0.87) or interaction (group by time) effect (p = 0.65). Private insurance patients had lower mean A1C values than Medicaid patients (chi(2) = 4.5186, p < 0.05), regardless of regimen. A1c values between IIM and CIM were not statistically different within the Medicaid group. BMI changes between groups were not different. Chi-square analysis for severe hypoglycemia revealed no group differences. In conclusion, IIM had improved glycemic control. Private insurance vs. Medicaid patients had lower mean A1c values regardless of treatment group. Considering Medicaid patients only, IIM was not inferior, and for those with private insurance, IIM was superior. IIM, initiated at diagnosis, is a reasonable approach for newly diagnosed children with diabetes regardless of payer source.

EP2 receptor mediates PGE2-induced cystogenesis of human renal epithelial cells.

Autosomal-dominant polycystic kidney disease (ADPKD) is characterized by formation of cysts from tubular epithelial cells. Previous studies indicate that secretion of prostaglandin E2 (PGE2) into cyst fluid and production of cAMP underlie cyst expansion. However, the mechanism by which PGE2 directly stimulates cAMP formation and modulates cystogenesis is still unclear, because the particular E-prostanoid (EP) receptor mediating the PGE2 effect has not been characterized. Our goal is to define the PGE2 receptor subtype involved in ADPKD. We used a three-dimensional cell-culture system of human epithelial cells from normal and ADPKD kidneys in primary cultures to demonstrate that PGE2 induces cyst formation. Biochemical evidence gathered by using real-time RT-PCR mRNA analysis and immunodetection indicate the presence of EP2 receptor in cystic epithelial cells in ADPKD kidney. Pharmacological evidence obtained by using PGE2-selective analogs further demonstrates that EP2 mediates cAMP formation and cystogenesis. Functional evidence for a role of EP2 receptor in mediating cAMP signaling was also provided by inhibiting EP2 receptor expression with transfection of small interfering RNA in cystic epithelial cells. Our results indicate that PGE2 produced in cyst fluid binds to adjacent EP2 receptors located on the apical side of cysts and stimulates EP2 receptor expression. PGE2 binding to EP2 receptor leads to cAMP signaling and cystogenesis by a mechanism that involves protection of cystic epithelial cells from apoptosis. The role of EP2 receptor in mediating the PGE2 effect on stimulating cyst formation may have direct pharmacological implications for the treatment of polycystic kidney disease.

Salicylate toxicity associated with administration of Percy medicine in an infant.

Percy Medicine is a nonprescription gastrointestinal suspension containing bismuth subsalicylate as the active ingredient (1050 mg/10-ml dose). A 3-month-old infant with colic developed salicylate toxicity requiring hospitalization in the pediatric intensive care unit (PICU) as a result of continued administration of this medicine. Bismuth subsalicylate has an aspirin equivalency conversion factor of 0.479 (approximately half the strength of aspirin). For 3.5 weeks the infant's parents administered the medicine, which provided the equivalent of aspirin 57-84 mg/kg/day with no reported problems. However, on the day of admission the baby presented with central nervous system depression and respiratory distress. Assessment at a local emergency facility revealed metabolic acidosis; his serum salicylate concentration was 747 mg/L. After acute management, the patient was transferred to our hospital, where he was treated with whole bowel irrigation and alkalinization therapy. Subsequently, the baby required 4 days of management in the PICU and 2 additional days of observation in a general nursing unit before he was discharged home without incident. The parents had chosen Percy Medicine based on the picture of a baby on the front of the package and because of its placement on the shelf next to a drug their family physician had recommended previously. Salicylate-containing products are not routinely recommended for children aged 1 year or younger. The general public may assume that over-the-counter products are safe because they do not require a prescription. Health care professionals must be responsible for educating the public regarding risks associated with over-the-counter products and the need to read and follow label directions.