Dosage Calculation Research Articles

RF16 | PSUN204 Improving Inpatient Insulin Management amongst Internal Medicine Residents with a Multi-Media Structured Educational Program

Abstract Introduction Approximately 1 in 4 patients admitted to the hospital carry a diagnosis of diabetes mellitus1 and 1 in 10 patients are admitted due to diabetes complications.2 Although Internal Medicine residents comprise the primary care team for the vast majority of patients admitted to major academic hospitals, there is a paucity of resources and standardized training for inpatient diabetes management, specifically designed for residents. Methods We developed a structured resident education program consisting of a mobile/web application ("EndoApp") as an accessible resource combined with a series of short lectures. The EndoApp is comprised of checklists, guidelines, and calculators based on the most recent American Diabetes Association (ADA) and American Association of Family Physicians (AAFP) recommendations. The application addresses five major areas of inpatient insulin management—i) insulin pharmacokinetics, ii) admission dosage calculation, iii) inpatient insulin regimen adjustment, iv) management of diabetic emergencies, and v) equipment and prescription management at discharge. The confidence level of residents for each of the five areas were surveyed at months 0, 1, and 3, after the start of the program on a scale of 1-5. Results Our 3-month interim analysis showed that the confidence of residents in all five areas of inpatient insulin management improved over the study period. Increased confidence was seen in post-graduate year (PGY) 1, 2, and 3 residents. The Admission Insulin Dosing Calculator was the most frequently used function (45% of residents), followed by DKA/HHS helper (23% of residents), and Inpatient Dosage Adjustment Guidelines (21% of residents). Residents who used the Admission Insulin Dosing Calculator had greater increase in provider confidence compared to those who did not use the function. Subjective feedback from residents included expanding functions to include hypoglycemia and non-emergent hyperglycemia management, as well as having recordings of supplementary lectures available on the application. Conclusion Structured resident education in inpatient insulin management utilizing a mobile/web application and lectures as supplementary material is a promising approach to improve resident education and confidence in inpatient diabetes management.

Molecular markers of cytotoxicity induced with copper-contained pesticides

The applying copper sulphate is a cheap, however it leads to global the environment contamination. Especially, the contamination of the water sources is crucial for fish harvesting and farming. The copper contamination in some areas are caused by decades. The impact of copper ions is dependent on the inhibition of invasive aquatic plants, many microorganisms and protozoa. The family of copper-contained chemicals is frequently used as algaecides in swimming pools. Despite the copper ions are well known as a high toxic for fish in freshwater ponds, the copper sulphate remains one of the prevalent pesticides in fish farming everywhere. High cytotoxicity and accumulation of the copper ions in the sediments require studying and calculation of the optimal dosage to use it as an antiseptic agent that should prevent the detrimental effect in various tissue types of aquatic organisms. The main depicted mechanism, which is associated with cytotoxicity is the generation of oxidative stress.
 Neural tissue cells are extremely susceptible to oxidative damages. Neural damaging is important cause of the CNS disfunction as well as is the critic to the organism vitality. Glial cells maintain the structure and many vital functions of neuronal cells. Glial fibrillary acidic protein (GFAP), transcriptional nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and poly(ADP-ribose) polymerase (PARP) are critic regulators in a cell response to the environment toxicity. Based on this fact, it could be applied as the boimarkers of heavy metal toxicity. In presented study, we investigated the effects of copper ions on PARP, NF-kB, and GFAP expression in the rainbow trout (Oncorhynchus mykiss) brain tissue. For 96 hours the fishes were exposed to the copper sulphate sublethal concentrations 380 µg/L, estimated as 1/4 of the LC50 value. Western blot analysis of GFAP, NF-kB and PARP was used to assess further effects in the brain tissue.
 The modulatory effect of copper ions on the expression of GFAP was detected in fish brain. Reciprocal changes were observed in respect with 24 hours exposure in compare to both 48 hours and 96 hours treatment. Obtained results demonstrated meaningful disturbance in the expression of transcriptional factor NF-kB in the brain of fish group exposed to copper in compare to control group. Furthermore, the time-depended effect in a range 24 – 96 hours was detected. However, the short time exposure to copper ions initiated no effect in fish group treated 24 hours while in compare to both 48 hours and 96 hours treatment. The similar changes of PARP content in the brain of fish were determined as well. It deserves to be mentioned that all of aforementioned changes of GFAP, NF-kB and PARP expression were accompanied by increasing in reactive oxygen species content. Thus, copper ions cytotoxic effect could be initiated with oxidative injury in a brain tissue.
 On the other hand, the observed effect of copper in the fish brain evidences the unspecific toxicity of this ion in brain tissue cells.
 The results showed that copper ions could induce astroglial response accompanied by modulations of NF-kB and PARP-1 expression. Obtained in presented study data suggest that copper sulphate has significant effect on astrogliosis and DNA damage in the fish brain.

Understanding plant to extract ratios in botanical extracts.

Dietary supplement current good manufacturing practice (cGMP) requires establishment of quality parameters for each component used in the manufacture of a dietary supplement to ensure that specifications for the identity, purity, strength, composition, and limits on contaminants are met.* Compliance with botanical extract ingredient specifications is assured by using scientifically valid methods of analysis, the results of which are reported on certificates of analysis (CoAs). However, CoAs routinely include additional data that are not amenable to verification through methods of analysis. Such descriptive information may include Plant to Extract ratios, which are ratios of the quantity of botanical article used in the manufacture of the extract to the quantity of extract obtained. Plant to Extract ratios can be misleading when their meaning is not clearly understood.Plant to Extract ratios do not completely describe botanical extracts because other important factors influence the make-up of final extracts, such as the quality of the raw starting material (as can defined by pharmacopeial standards), extraction solvent(s) used, duration and temperature of extraction, and percentage and type of excipients present. Other important qualitative descriptions may include constituent “fingerprinting.” Despite these issues, Plant to Extract ratios are often used as a measure of extract strength for dosage calculations. This article defines and clarifies the meaning of Plant to Extract ratios and their proper use in describing and labeling botanical extract ingredients and finished products containing them.

Pharmacokinetics and pharmacodynamics of isopropoxy benzene guanidine against Clostridium perfringens in an intestinal infection model.

This study aimed to evaluate the antibacterial activity of isopropoxy benzene guanidine (IBG) against C. perfringens based on pharmacokinetics/pharmacodynamics (PK/PD) modeling in broilers. The PK parameters of IBG in the plasma and ileal content of C. perfringens-infected broilers following oral administration at 2, 30, and 60 mg/kg body weight were investigated. in vivo PD studies were conducted over oral administration ranging from 2 to 60 mg/kg and repeated every 12 h for 3 days. The inhibitory Imax model was used for PK/PD modeling. Results showed that the MIC of IBG against C. perfringens was 0.5–32 mg/L. After oral administration of IBG, the peak concentration (Cmax), maximum concentration time (Tmax), and area under the concentration-time curve (AUC) in ileal content of broilers were 10.97–1,036.64 mg/L, 2.39–4.27 h, and 38.31–4,266.77 mg·h/L, respectively. After integrating the PK and PD data, the AUC0 − 24h/MIC ratios needed for the bacteriostasis, bactericidal activity, and bacterial eradication were 4.00, 240.74, and 476.98 h, respectively. For dosage calculation, a dosage regimen of 12.98 mg/kg repeated every 12 h for 3 days was be therapeutically effective in broilers against C. perfringens with MIC ≤ 2 mg/L. In addition, IBG showed potent activity against C. perfringens, which may be responsible for cell membrane destruction. These results can facilitate the evaluation of the use of IBG in the treatment of intestinal diseases in broilers caused by C. perfringens.

A National Survey of Medication Dosage Calculation Teaching Methods and Competency Criteria on Nursing Student Success: Recommendations for Nurse Educators.

The purpose of this study was to synthesize the current landscape of medication dosage calculation (MDC) education for prelicensure nursing students in the United States. There is little consistency in the format of MDC education and evaluation in prelicensure nursing education, yet consequences of not passing MDC exams can affect the number of graduating nurses. Consequences can include withdrawal from the course, delayed progression of a semester or more, or dismissal from the nursing program. An electronic survey was emailed to prelicensure administrators of 1,620 associate, bachelor's, and master's entry programs in the United States. Surveys were received from 210 programs. Results confirmed inconsistent methods used to teach and evaluate MDC competency. Inconsistent teaching methods and competency criteria can affect retention and subsequent growth of the nursing workforce. Based on the characteristics associated with MDC success, recommendations are made for nurse educators.

Pediatric dosage calculations for undergraduate nursing students using digital-physical reality

Accurately calculating safe dosages for medications is an essential skill for every nurse. Although new nurse graduates are hired for pediatric settings, they may be unprepared to safely administer medications to children due to limited experience offered during pediatric clinical rotations. To bridge this gap, undergraduate nursing and new graduate orientation programs can design simulated experiences that contextualize pediatric medication calculations and provide a safe environment for students to practice and learn from mistakes.

Intravenous Medication Errors Among ICU Nurses: Differences In Knowledge Attitudes And Behavior

Background: Intravenous (IV) medication errors can lead to serious complications for ICU patients. ICU nurses' knowledge, training, attitudes, and behaviors toward medication errors are insufficiently investigated. Objectives: This study aims at investigating knowledge, behaviors, training, and attitudes among ICU nurses during the preparation and administration of IV medications and examining their differences according to certain variables. Methods: A cross-sectional-correlational design was used in this study. A convenience sampling technique included 206 ICU nurses from different types of hospitals in Jordan. The knowledge, attitudes and behavior related to medication errors questionnaire were used to collect data. Descriptive statistics, t-test, Pearson correlation, and Kruskal-Wallis H test were used to analyze the data. Results: ICU nurses showed adequate knowledge regarding IV medication preparation and administration, with gaps in basic professional behaviors. About 81.6% of the ICU nurses considered dosage calculation of intravenous drugs to reduce preparation errors. 81.1% of respondents agreed that clinical skills about the safe management of drug therapy should be regularly evaluated. Only (87.9%) of the ICU nurses agreed that handwashing is necessary before drug preparation and administration. Despite that 90.8% received training related to the preparation and administration of IV medications during undergraduate study, about 23.3% didn’t receive topics related to the preparation and administration of IV drugs treated during the POST-basic courses. This study showed a strong positive correlation between ICU nurses' knowledge, attitudes, and behaviors. Conclusion: Education is essential to nurses’ feeling safe at administering medications, especially in critical care units, which may affect their attitudes and behaviors. Continuous education that meets the needs of nurses is essential, along with continuous monitoring and evaluation of clinical practices to maintain safe and efficient medication practices and reduce related errors.

Simulations of aluminum dosage and H2O-H2 flow in a pre-pilot twelve-cell electrocoagulation stack

This paper investigates the aluminum dosage generation and H2O-H2 flow simulations in a pre-pilot twelve-cell stack electrocoagulation (EC) reactor in continuous operation mode. Each cell contains two aluminum plate electrodes. The electrochemical reactor is open to the atmosphere at the top to facilitate the H2 release produced at the cathodes, while aluminum oxidation occurs at the anodes. The two-phase (H2O-H2) flow simulations were performed by solving the Navier-Stokes (NS) equations for the continuous (H2O) phase and the bubbly flow model for the dispersed (H2) phase. Since H2 formation is promoted at the cathode due to H2O reduction, the momentum and Laplace's equations were simultaneously solved. The aluminum dosage calculations were attained by solving the diffusion-convection equation. The influence of volumetric inflow rate (8.3 ≤ Q ≤ 33.3 cm3 s−1) and applied current density (4 ≤ j ≤ 8 mA cm−2) on the coagulant dosage, current distribution, and H2O-H2 flow dispersion was systematically examined. The H2 volume fraction showed a typical bubble curtain profile close to the cathode surface. Homogeneous current distribution along the electrodes was obtained due to the well-engineering cell design, guaranteeing even wear of the sacrificial electrodes. There was an excellent agreement between the experimental and theoretical data for residence time distribution (RTD) curves and aluminum dosage generation.

An Innovative Approach to Teaching Dosage Calculations Using Mirror Technology.

An Innovative Approach to Teaching Dosage Calculations Using Mirror Technology.

Anesthcalc™ is Associated with Superior Accuracy and Faster Accomplishment in Simulation-based Anesthesia Drugs Dosage Calculation

Abstract Background: Medication error is one of the barriers to achieving sustainable patient safety. We aim to determine the efficacy and reliability of a smartphone dosage calculator application (AnesthCalc™) when compared with the manual calculation of various anesthetic drugs to prevent medication error. Materials and Methods: This is a pre-test–post-test intervention study. There are 52 participants who included residents in anesthesiology, which is divided into two groups. Each group performed two simulation cases in which they had to calculate drugs dosage in anesthesia settings. One set of cases was performed with the app and the other set was performed manually. The order of drugs and simulation patients was randomized. The accuracy and the deviation of administered drug doses were recorded. Accuracy of dosage was categorized as either accurate (80–100% of target dose) or inaccurate (less than 80%), whereas the deviation of dosage was categorized as either deviant (<50% or >200% of target dose) or safe (between the range). Results: There is a significant increase in the accuracy of calculation between the manual group and that using the app group (from 46% to 92%, a mean increase of 18.29%, P < 0.005). There is a significant decrease in the duration of calculation between without using the app group and with using the app group (from 32.92 to 18.79 s, a mean decrease of 30.55 s, P = 0.001). Conclusion: AnesthCalc™ is a valid and reliable instrument as it increases users’ accuracy and shortens calculating time. AnesthCalc™ may be the potential to reduce calculation errors and may increase patients’ safety.

Clinical pharmacokinetics of kavalactones after oral dosing of standardized kava extract in healthy volunteers

Ethnopharmacological relevancePiper methysticum G. Forst. (Piperaceae), commonly known as kava, has been used as a traditional beverage for centuries for its relaxing properties. Kavalactones are considered to be the major constituents responsible for kava's beneficial effects. Despite the extensive use of kava, clinical pharmacokinetic data is not available in the literature; therefore, the findings of this study will be critical for the dosage calculations for future clinical evaluation of kava. Aim of the studyThe aim of the current study is to examine the clinical pharmacokinetics of six major kavalactones following oral dosing of flavokavain A/B-free standardized kava extract capsules in healthy volunteers using two dosage regimens. Materials and methodsA sensitive, reliable, and specific ultra-high pressure liquid chromatography-mass spectrometry (UPLC-MS/MS) method was developed and validated for the simultaneous quantification of six major kavalactones (kavain, dihydrokavain, methysticin, dihydromethysticin, yangonin, and desmethoxyyangonin) and two flavokavains (A and B) in human plasma. Pharmacokinetic profiles were assessed in ten healthy volunteers after oral doses of standardized kava product, and plasma samples were analyzed for six kavalactones and two flavokavains using the validated UPLC-MS/MS method. Concentration-time data was subjected to pharmacokinetic analysis. ResultsThe systemic exposure of the kavalactones was found to be in the following order: dihydrokavain > dihydromethysticin > kavain > methysticin > yangonin. Desmethoxyyangonin was quantifiable only at a couple of time points, while flavokavain A and flavokavain B were not present in any of the plasma samples. Fast absorption of five kavalactones was observed with time to reach the maximum plasma concentration of 1–3 h. A dose proportionality in pharmacokinetics was established from 75 to 225 mg of kavalactone doses. In the multiple-dose study, a significant reduction in the extent of absorption of kavalactones with food was observed. ConclusionSingle and multiple-dose clinical pharmacokinetic studies for kava were performed in healthy volunteers, and higher exposure to the kavalactones was observed after single-dosing (225 mg), while a longer duration of exposure was observed after three times a day (3 x 75 mg) dosing.

Medication dosage calculation among nursing students: does digital technology make a difference? A literature review

BackgroundPatient safety is a major part of nursing care and following patients’ medication orders is considered one of the greatest responsibilities of individual nurses and nursing Failure to make safe drug calculations poses serious risks to patient safety. It is therefore important to strengthen nursing students’ numeracy skills and conceptual abilities during their education. Research suggests that digital technologies play an increasingly important role in promoting nursing students’ knowledge and medication dosage calculation (MDC) skills. The present review aims to identify and critically evaluate research investigating how the use of digital technologies informs the development of nursing students’ MDC skills.MethodsA systematic literature review was performed within Scopus (Elsevier), Academic Search Elite (Ebsco), Cinahl (Ebsco), ERIC (Ebsco), Web of Science and PubMed. Research papers on MDC using digital technologies were considered for inclusion. Starting from 2843 sources, eighteen research articles met the inclusion criteria.ResultsThe results show that use of digital technologies can reduce nursing students’ medication errors. Interestingly, web-based courses were the most commonly used digital technologies aimed at developing nursing students’ MDC skills. However, such courses had limited impacts the development of these skills.ConclusionThe present review concludes by mapping the current knowledge gaps and making suggestions for further research.

Progression Rates Among Rural Junior-I Pre-licensure Nursing Students Using a Math Academic Coaching Program

Purpose: Math competency is a content area in which some rural pre-licensure baccalaureate nursing students struggle, contributing to lower completion rates. The purpose of this project was to determine if a Math Academic Coaching Program (MACP) can increase first semester nursing student success with math proficiency in medication dosage calculations. Sample: First semester Bachelor of Science nursing students at a rural, public university in the Southeastern United States participated in this study. Method: Six online learning modules were provided. A quantitative, quasi-experimental approach was used to measure successful completion of the Medication Dosage Competency Exam (MDCE) and Junior-I progression using frequency distributions and means to compare MACP group to the traditional teaching math group. Participation was voluntary. Findings: The MACP improved MDCE scores and progression rates compared to previous semesters of students who did not complete the MACP. Conclusion: The MACP was an effective way to teach math skills to rural first-semester nursing students, assist them in success in the MDCE, and increase patient safety through proper medication calculations and dosing. Keywords: nursing students, drug dosage calculations, academic success, rural nursing education DOI: https://doi.org/10.14574/ojrnhc.v22i1.688

Stem Cells in Mammary Health and Milk Production.

Adult stem cells like mammary and mesenchymal stem cells have received significant attention because these stem cells possess therapeutic potential in treating many animal diseases. These cells can be administered in an autologous or allogenic fashion, either freshly isolated from the donor tissue or previously cultured and expanded in vitro. The expansion of adult stem cells is a prerequisite before therapeutic application because sufficient numbers are required in dosage calculation. Stem cells directly and indirectly (by secreting various growth factors and angiogenic factors called secretome) act to repair and regenerate injured tissues. Recent studies on mammary stem cells showed in vivo and in vitro expansion ability by removing the blockage of asymmetrical cell division. Compounds like purine analogs (xanthosine, xanthine, and inosine) or hormones (progesterone and bST) help increase stem cell population by promoting cell division. Such methodology of enhancing stem cell number, either in vivo or in vitro, may help in preclinical studies for translational research like treating diseases such as mastitis. The application of mesenchymal stem cells has also been shown to benefit mammary gland health due to the 'homing' property of stem cells. In addition to that, the multiple positive effects of stem cell secretome are on mammary tissue; healing and killing bacteria is novel in the production of quality milk. This systematic review discusses some of the studies on stem cells that have been useful in increasing the stem cell population and increasing mammary stem/progenitor cells. Finally, we provide insights into how enhancing mammary stem cell population could potentially increase terminally differentiated cells, ultimately leading to more milk production.

Outcomes of a simplified, fixed surgical dosage calculation for uncomplicated, horizontal, concomitant strabismus in adults.

Purpose:The aim of this study was to evaluate the outcomes of a simplified, fixed surgical dosage calculation for uncomplicated, horizontal, concomitant strabismus in adults.Methods:Outcomes analysis of a fixed-dose calculation method for uncomplicated, horizontal, concomitant strabismus in adults (≥18 years) wherein 1-mm recession/resection equals 2 PD for lateral rectus and 3 PD for medial rectus. This was a retrospective case series.Results:The mean age of the patients was 28.50 ± 8.43 years, the mean amount of preoperative deviation was 35.16 ± 9.97 PD, the mean expected correction was 36.26 ± 9.49 PD, and the mean correction achieved was 35.92 ± 10.74 PD. There were 22 monocular exotropias, six monocular esotropias, eight alternate divergent squints, and two alternate convergent squints. There were 20 cases of sensory strabismus (54.28%). There was no statistically significant difference between the expected correction and correction achieved (P = 0.519), meaning that our fixed-dose calculation method was effective. Thirty-five out of 38 patients had successful outcomes as per our criteria of less than 10-PD deviations from straight in primary position. Therefore, the success rate achieved by this procedure was 92.10%. There was no statistically significant correlation between age and the amount of deviation (P = 0.611)Conclusion:Our case series had a high postoperative success rate in terms of motor alignment. It is hoped that this simplified, fixed-dosage calculation method would help the numerous novice strabismus surgeons, make their starting steps easier and give them the confidence to do strabismus surgeries. They can modify the dosages later as per their own experiences.

Predictive factors for the efficacy of 131I therapy with formulated dosage calculation on Graves' disease.

To analyse predictive factors to ensure the efficacy of iodine-131 (131I) therapy on Graves' disease (GD). Graves' disease patients from three tertiary medical centers were enrolled. Serological data, thyroid mass estimation, thyroid radioactive iodine uptake, thyroid texture and thyroid murmurs (bruits) were recorded. Iodine-131 treatment was performed by applying a formulated calculation method. After one year of follow-up, GD patients with euthyroidism and hypothyroidism were classified as the cured group, and the other thyroid function status refers to the uncured group. These analyses were performed by using SPSS17.0 software. A P value of less than 0.05 was considered statistically significant. A total of 970 GD patients, of which 540 patients (55.7%) belonged to the cured group, and 430 patients (44.3%) belonged to the uncured group, participated in the current analyses. Multivariate logistic regression analysis was performed. Moreover, estimated thyroid mass, thyroid murmurs (bruits), prescribed 131I dosage, FT3 and FT4 have independent prognostic value for 131I efficacy, and their odds ratios are 1.368, 2.283, 1.326, 1.467 and 1.419, respectively. Graves' disease patients who are undergoing 131I therapy using the formulated dosage calculation could be influenced by thyroid mass, thyroid murmurs, 131I dosage and thyroid function.

Lactose hydrolysis in milk using a commercial recombinant β-galactosidase (lactase) from Bifidobacterium bifidum

We have identified the most relevant properties of a commercial recombinant lactase from Bifidobacterium bifidum (RBBL, Saphera 2600 L) for milk hydrolysis, with a yeast neutral lactase (GODO-YNL2) being used for comparison. Both products were characterized according to their lactase and invertase activities, protein profiles by sodium-dodecyl-sulfate-polyacrylamide-gel electrophoresis, and Kms for lactose. RBBL exhibited properties that permitted milk hydrolysis over a broader range of conditions than YNL: apparently, milk’s ionic composition was not an activity-limiting property, an optimum temperature range between 45 and 50 °C and a considerable activity at pH 4.5, which would permit lactose hydrolysis in acidic dairy products. Like YNL, the bacterial lactase retains a considerable activity under refrigeration (3-7 °C). To describe the lactose-hydrolysis time course, an empirical model was used in which the glucose obtained was expressed as a function of the standard activity per unit volume and the reaction time. This model proved adequate to describe the glucose-formation kinetics at 7 °C and 45 °C, up to a 95% hydrolysis and to facilitate calculation of the volumen-based enzyme dosage to obtain a certain degree of hydrolysis – a fundamental consideration in evaluating the costs of applying the enzyme

A Reevaluation of Prazosin Pharmacokinetics in a Two-Compartment Model, the Apparent Volume of Distribution and Comparative Simulations in the One-Compartment Model

Published clinical data of Prazosin were reevaluated pharmacokinetically using explicit solutions to drug concentration as a function of total time for IV bolus injection, intermittent intravenous infusion and oral routes of administration in an open two-compartment model. In a novel way, the apparent volume of distribution was estimated from a two-compartment model and found to be close to the total body water suggesting that Prazosin is distributed in all tissues both extracellularly and intracellularly. In addition, extracting the value of the apparent volume of distribution from a two-compartment model allowed comparative simulations in the one-compartment model. It is shown that dosage calculations of Prazosin intermittent infusion can be safely performed using the simpler one-compartment model equations. Lastly, several additional time-dependent pharmacokinetic parameters e.g., the peak time in the central and peripheral compartment and non-steady state and steady state peak concentration and AUC were determined using series equations for all three routes of administration, as a function of dose number and total time upon multiple drug administrations in the two-compartment model. It is also the first time that steady-state plasma drug concentration equations were derived in a two-compartment mammillary model.

Značaj farmakokinetike u doziranju lekova kod pedijatrijskih pacijenata

Optimizing the dosing of medicines for pediatric patients in routine clinical practice and determining the dose for clinical trials is still a challenging task. Children differ from adults in their response to drugs due to inherent differences in pharmacokinetics and/or pharmacodynamics, and responses may also vary among pediatric patients of different ages. However, the greatest disparities compared to adult pharmacokinetic profiles are observed in children below 2 years of age. The maturation of the liver and the kidneys, as well as the variation in body composition, are considered to be the main sources of pharmacokinetic variability. Hence, besides specific pharmacodynamic features, understanding age-related changes in drug absorption, distribution, and elimination is fundamental for optimizing drug efficacy and avoiding toxicity. This paper summarizes the pharmacokinetic changes throughout the childhood, along with the effect of developmental changes on drug dosage calculation. In clinical practice, age and body weight-based dosing regimens are usually used. In spite of dosing recommendations based on age and/or body weight, variabilities in pharmacokinetics and pharmacodynamic response remain, implying a need to monitor patients and optimize the dosing regimen according to physiological characteristics, disease characteristics and therapy.

CE Accreditation and Barriers to CE Marking of Pediatric Drug Calculators for Mobile Devices: Scoping Review and Qualitative Analysis.

BackgroundPediatric drug calculators (PDCs) intended for clinical use qualify as medical devices under the Medical Device Directive and the Medical Device Regulation. The extent to which they comply with European standards on quality and safety is unknown.ObjectiveThis study determines the number of PDCs available as mobile apps for use in the Netherlands that bear a CE mark, and explore the factors influencing the CE marking of such devices among app developers.MethodsA scoping review of Google Play Store and Apple App Store was conducted to identify PDCs available for download in the Netherlands. CE accreditation of the sampled apps was determined by consulting the app landing pages on app stores, by screening the United Kingdom Medicines and Healthcare products Regulatory Agency’s online registry of medical devices, and by surveying app developers. The barriers to CE accreditation were also explored through a survey of app developers.ResultsOf 632 screened apps, 74 were eligible, including 60 pediatric drug dosage calculators and 14 infusion rate calculators. One app was CE marked. Of the 20 (34%) respondents to the survey, 8 considered their apps not to be medical devices based on their intent of use or functionality. Three developers had not aimed to make their app available for use in Europe. Other barriers that may explain the limited CE accreditation of sampled PDC apps included poor awareness of European regulations among developers and a lack of restrictions when placing PDCs in app stores.ConclusionsThe compliance of PDCs with European standards on medical devices is poor. This puts clinicians and their patients at risk of medical errors resulting from the largely unrestricted use of these apps.