Intercoder Reliability of Mapping Between Pharmaceutical Dose Forms in the German Medication Plan and EDQM Standard Terms.

A nationally uniform medication plan has recently been part of German legislation. The specification for the German medication plan was developed in cooperation between various stakeholders of the healthcare system. Its' goal is to enhance usability and interoperability while also providing patients and physicians with the necessary information they require for a safe and high-quality therapy. Within the research and development project named Medication Plan PLUS, the specification of the medication plan was tested and reviewed for semantic interoperability in particular. In this study, the list of pharmaceutical dose forms provided in the specification was mapped to the standard terms of the European Directorate for the Quality of Medicines & HealthCare by different coders. The level of agreement between coders was calculated using Cohen's Kappa (κ). Results show that less than half of the dose forms could be coded with EDQM standard terms. In addition to that Kappa was found to be moderate, which means rather unconvincing agreement among coders. In conclusion, there is still vast room for improvement in utilization of standardized international vocabulary and unused potential considering cross-border eHealth implementations in the future.

Single-dose Pharmacokinetic Properties and Relative Bioavailability of a Novel Methylphenidate Extended-release Chewable Tablet Compared With Immediate-release Methylphenidate Chewable Tablet.

PURPOSE: A novel methylphenidate hydrochloride extended-release chewable tablet (MPH ERCT) was developed to potentially address an unmet need for patients with attention-deficit/hyperactivity disorder, especially children, who cannot or will not swallow tablets or would prefer the convenience of a chewable tablet. This randomized, open-label, crossover trial compared the pharmacokinetic properties and relative bioavailability of MPH ERCT with an MPH chewable immediate-release tablet (IR MPH) formulation in healthy adults. METHODS: Healthy men and women 18 to 55 years of age were randomly assigned to MPH ERCT 40 mg or 40 mg IR MPH administered in 2 equal doses of 20 mg 6 hours apart with a 7-day washout period. Plasma concentrations of MPH at selected time points up to 24 hours were measured, and pharmacokinetic parameters were determined using a noncompartmental approach in the SAS (Version 9.2) PROC general linear model procedure. FINDINGS: A total of 33 participants were enrolled in the study; 31 participants were included in the pharmacokinetic analysis. The exposure ratios for MPH ERCT and IR MPH (MPH ERCT/IR MPH) for area under the analyte concentration versus time curves (AUC) from time zero to the last measurable analyte concentration (AUC0-last) (87.64%; 95% CI, 84.96-90.41) and AUC0-∞ (89.11%; 95% CI, 86.57-91.73) were within the standard 80% to 125% bioequivalence acceptance criteria. Mean Cmax for MPH ERCT and IR MPH was 12.51 ng/mL and 15.57 ng/mL, respectively; mean time to Cmax was 4.16 hours and 6.43 hours, respectively. The mean Cmax of MPH ERCT was 80% of the Cmax of IR MPH due to a higher peak concentration that occurs after the second dose of IR MPH. All adverse events were mild in severity. IMPLICATIONS: The relative bioavailability of MPH ERCT 40 mg, based on the exposure (AUC), was comparable to that of IR MPH 40 mg administered in 2 equal doses of 20 mg 6 hours apart. Both formulations were generally well tolerated.

Carência de preparações medicamentosas para uso em crianças no Brasil / Lack of drug preparations for use in children in Brazil

OBJETIVO: Identificar medicamentos que apresentam dificuldades para seu uso pediátrico no Brasil. MÉTODOS: Estudo descritivo envolvendo a composição de uma listagem nacional de medicamentos não-licenciados ou não-padronizados para uso em crianças (medicamentos problema em pediatria, MPP), através de revisão bibliográfica, comparação com fontes do mercado farmacêutico brasileiro e inquérito com pediatras. Os medicamentos foram codificados pela classificação anatômica, terapêutica e química (Anatomic Therapeutic Chemical Classification System, ATC) e analisados quanto ao licenciamento no país e indicação/ recomendação em pediatria, tendo como referências básicas o bulário da ANVISA (2005), Dicionário de Especialidades Farmacêuticas (2005/06/07) e o site de bulas. RESULTADOS: Foram identificados na literatura 126 MPP e excluídos 24 não referidos nas fontes nacionais investigadas. A listagem foi complementada com 24 outros medicamentos referidos pelos pediatras. Do total de 126 MPP, 23 não tinham registro no país para o uso em crianças e 24 dos 103 licenciados apresentavam restrições de faixa etária. A lista envolveu 42 grupos terapêuticos e 68 subgrupos. Os grupos com maior número de MPP foram os antibacterianos de uso sistêmico (15), antiepilépticos (8), antiasmáticos (7) e analgésicos (7). Os problemas mais frequentes foram: dosagem inapropriada (43), forma farmacêutica inadequada (35), não-licenciamento para uso pediátrico (28), restrições de faixa etária (23). CONCLUSÕES: A carência de medicamentos desenvolvidos para uso em crianças envolve ampla gama de produtos clinicamente importantes. Algumas dessas formulações e dosagens já comercializadas em outros países não são disponibilizadas no mercado brasileiro sem nenhuma justificativa plausível.

OBJECTIVE: To identify drugs which are not suited for pediatric use in Brazil. METHODS: A descriptive study involving the development of a national list of unlicensed and off-label medications for pediatric use (problem drugs in pediatrics, PDP) through a literature review, a comparison among sources of the Brazilian pharmaceutical industry, and a survey with pediatricians. Drugs coded at the Anatomic Therapeutic Chemical (ATC) classification system were analyzed regarding licensing status in Brazil and recommendations/indications in pediatrics, based on the following reference sources: the list of licensed drugs of the Brazilian National Health Surveillance Agency (2005), the Brazilian Dictionary of Pharmaceutical Specialties (2005-2007) and the website www.bulas.med.br. RESULTS: Our literature search returned 126 PDP, but 24 drugs were excluded due to absence of national reference. To compose the final list, 24 other drugs referred by pediatricians were added. Of the 126 PDP, 23 drugs were not licensed in the country for use in children; and of the 103 licensed drugs, 24 presented age-related restrictions for pediatric use. The pharmaceutical list included 42 therapeutic groups and 68 subgroups. The groups containing larger numbers of PDP were: antibiotics for systemic use (15), antiepileptics (8), antiasthmatics (7), and analgesics (7). The most frequent problems were: inappropriate dosage (35), unlicensed for pediatric use (28), age-related restrictions (23). CONCLUSIONS: The lack of pediatric drug formulations in Brazil shows a profile similar to that observed in other countries, which involves a wide range of clinically important products. This study brings a contribution to the evaluation of the needs and priorities that support the development of suitable medicines for the pediatric patient.