scholarly journals Better medicines for children: clinical investigation of medicinal products in the paediatric population - a QA perspective

2007 ◽  
Vol 11 (2) ◽  
pp. 123-127 ◽  
Author(s):  
Gerhard Fortwengel ◽  
Herwig Ostermann ◽  
Roland Staudinger
Keyword(s):  
Clinical Investigation ◽  
Paediatric Population ◽  
Medicinal Products ◽  
Medicines For Children

More medicines for children: impact of the EU paediatric regulation

2018 ◽  
Vol 103 (6) ◽  
pp. 557-564 ◽  
Author(s):  
Sofia Nordenmalm ◽  
Paolo Tomasi ◽  
Chrissi Pallidis
Keyword(s):  
Product Information ◽  
Positive Impact ◽  
The European Union ◽  
Medicinal Products ◽  
Paediatric Regulation ◽  
Line Extension ◽  
Pharmaceutical Form ◽  
Paediatric Drug Development ◽  
Medicines For Children ◽  
The Eu

IntroductionThis paper focuses on the authorisation of new medicines, new indications and new pharmaceutical forms or strengths for use in children and also on the availability of paediatric information in the product information of centrally authorised medicinal products following the enforcement of the Paediatric Regulation on 26 January 2007.ObjectivesTo investigate whether the Paediatric Regulation has led to more medicines available for children in the European Union (EU) and if more information on paediatric use is now available in the product information of medicines authorised via the centralised procedure.Materials and methodsWe retrospectively analysed the centrally authorised medicinal products in the EU that had an approval for an initial marketing authorisation, a type II variation, or a line extension during the years 2004–2006 and 2012–2014. Medicinal products not subjected to the obligations of the Paediatric Regulation were excluded.ResultsIn 2004–2006, 20 new medicines and 10 new indications were centrally authorised for paediatric use compared with 26 new medicines and 37 new indications in 2012–2014. The number of medicines with a new pharmaceutical form or strength for use in children was eight in 2004–2006 and seven in 2012–2014. There was a huge increase in the number of products with changes of paediatric relevance in the summary of product characteristics in 2012–2014 compared with 2004–2006.ConclusionsThe entry into force of the Paediatric Regulation has had a positive impact on paediatric drug development with more medicines available for children in the EU and substantially more information available for clinicians on paediatric use in the product information.

scholarly journals Pharmaco-epidemiological research on herbal medicinal products in the paediatric population: data from the PhytoVIS study

2019 ◽  
Vol 179 (3) ◽  
pp. 507-512
Author(s):  
Karen Nieber ◽  
Esther Raskopf ◽  
Johanna Möller ◽  
Olaf Kelber ◽  
Robert Fürst ◽  
...  
Keyword(s):  
Adverse Events ◽  
Common Cold ◽  
Sleep Disturbances ◽  
Skin Diseases ◽  
Herbal Medicines ◽  
Paediatric Population ◽  
Clinical Effects ◽  
Medicinal Products ◽  
Herbal Medicinal Products ◽  
Herbal Medicinal

AbstractIn paediatrics, clinical study data are limited, especially on herbal medicinal products. To address this gap, 2063 datasets from the paediatric population were evaluated in the PhytoVIS data base. By screening for paediatric data, information on indication, gender, treatment, co-medication and tolerability were evaluated. The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety. The perceived effect of the therapy was rated in 84% of the patients as very good or good without adverse events. The data shed light on a still neglected field of phyto-pharmacotherapy by giving information on the use of herbal medicines in an unselected cohort of paediatric patients. The results confirm the good clinical effects and safety of herbal medicinal products in this patient population and show that they are widely used in Germany.What is Known:• In Germany, about 85% of children receive one or more herbal medicinal products per year.• Despite international initiatives to promote clinical research in paediatrics, there are still many gaps of knowledge in the use of drugs in paediatrics.What is New:• The PhytoVIS project evaluated 2063 data sets from the paediatric population using herbal medicinal products.• The majority of patients was treated because of common cold, fever, digestive complaints, skin diseases, sleep disturbances and anxiety, and 84% of the patients rated the therapy as very good or good without adverse events.

scholarly journals P107 How significant is the lack of formulations for paediatric inpatients?

2019 ◽  
Vol 104 (6) ◽  
pp. e62.2-e62
Author(s):  
J Zahn ◽  
W Rascher ◽  
A Neubert
Keyword(s):  
Descriptive Analysis ◽  
Hospital Setting ◽  
List Type ◽  
Medicinal Products ◽  
Oral Medications ◽  
Emergency Department Nurses ◽  
Safety Risks ◽  
German Children ◽  
Medicines For Children ◽  
Dosing Accuracy

BackgroundPharmacotherapy in children is complex requiring individual dosages of an active substance which are often not compatible with commercially available medicinal products.1–2 Manipulations of medicinal products, e.g. splitting or mortaring of tablets are common practice and often unavoidable although they entail risks for the patient as they can affect dosing accuracy, bioavailability and integrity of the dosage form.3–4In this study we aim to determine how many medicines have to be manipulated before administration in a hospital setting in Germany.MethodsA prospective observational approach was used to determine all manipulations of drugs orally administered on two wards of a German children´s hospital. A pharmacist systematically observed the nurses and documented all steps of the medication preparation processes for 7 days. Data was analysed using descriptive analysis. Types of manipulations were evaluated on the basis of the relevant summary of product characteristics (SmPC).ResultsDuring the pilot phase 170 medication preparation processes were monitored. In 36,5% (n=62) of the observed processes medicines had to be manipulated. 54,3% (n=19) of the patients were affected by at least one manipulation. 48,4% (n=30) of all manipulations were unauthorized by the relevant SmPC affecting 37,1% of the patients. In 60,0% the reason for unauthorized manipulation was unsuitable strength of the available formulation. Dosage forms affected by unauthorized manipulations were tablets (n=28) and granules (n=2). Active substances most frequently involved in unauthorized manipulations were Omeprazole (n=11), Phenobarbital (n=7) and Topiramat (n=3).ConclusionOverall, these results reveal that manipulations to medicines prior to administration are frequent on paediatric wards in Germany. About half of the manipulations are unauthorized indicating that no suitable paediatric formulation is available. Further investigation is needed to determine the preventability and the risks associated with the overall aim of improving safety of drug therapy in children.ReferencesSchirm E, Tobi H, de Vries TW, Choonara I, De Jong-van den Berg LT. Lack of appropriate formulations of medicines for children in the community. Acta paediatrica(Oslo, Norway:1992) 2003;92(12):1486–9.Richey RH, Craig JV, Shah UU, Nunn AJ, Turner MA, Barker CE, et al. MODRIC - Manipulation of drugs in children. International journal of pharmaceutics. 2013;457(1):339–41.Bjerknes K, Boyum S, Kristensen S, Brustugun J, Wang S. Manipulating tablets and capsules given to hospitalised children in Norway is common practice. Acta paediatrica(Oslo, Norway: 1992) 2017;106(3):503–8.Paparella S. Identified safety risks with splitting and crushing oral medications. Journal of emergency nursing: JEN: official publication of the Emergency Department Nurses Association 2010;36(2):156–8.Disclosure(s)Nothing to disclose

Medicines for children licensed by the European Agency for the Evaluation of Medicinal Products

2002 ◽  
Vol 58 (8) ◽  
pp. 495-500 ◽  
Author(s):  
Ceci A. ◽  
Felisi M. ◽  
Catapano M. ◽  
Baiardi P. ◽  
Cipollina L. ◽  
...  
Keyword(s):  
Medicinal Products ◽  
Medicines For Children ◽  
European Agency

scholarly journals Phytotherapy in the Management of Diabetes: A Review

2017 ◽  
Author(s):  
Paolo Governa ◽  
Giulia Baini ◽  
Vittoria Borgonetti ◽  
Giulia Cettolin ◽  
Daniela Giachetti ◽  
...  
Keyword(s):  
Herbal Medicine ◽  
Medicinal Plants ◽  
Clinical Investigation ◽  
Clinical Effectiveness ◽  
Mechanisms Of Action ◽  
Evidence Based ◽  
Medicinal Products ◽  
Key Points ◽  
Treatment Of Diabetes ◽  
Alpha Glucosidase

Phytotherapy has long been a source of medicinal products and many attempts to use herbal medicine for the treatment of diabetes has been done over the years. Several medicinal plants and their preparations demonstrated to act in key points of glucidic metabolism. The most common mechanisms of action found include the inhibition of α-glucosidase and of AGE formation, the increase of GLUT-4 and PPARs expression and the antioxidant activity.Despite the large amount of literature available, the actual clinical effectiveness of medicinal plants in controlling diabetes related symptoms is still controversial and there is a crucial need for stronger evidence-based data. In this review, an overview of the medicinal plants, which use in the management of diabetes is supported by authoritative monograph, is provided. References to some species which are currently under growing clinical investigation are also reported.

scholarly journals Phytotherapy in the Management of Diabetes: A Review

2017 ◽  
Author(s):  
Paolo Governa ◽  
Giulia Baini ◽  
Vittoria Borgonetti ◽  
Giulia Cettolin ◽  
Daniela Giachetti ◽  
...  
Keyword(s):  
Antioxidant Activity ◽  
Medicinal Plants ◽  
Clinical Investigation ◽  
Clinical Effectiveness ◽  
Mechanisms Of Action ◽  
Evidence Based ◽  
Medicinal Products ◽  
Key Points ◽  
Treatment Of Diabetes ◽  
Alpha Glucosidase

Phytotherapy has long been a source of medicinal products and many attempts to use herbal medicine for the treatment of diabetes has been done over the years. Several medicinal plants and their preparations demonstrated to act in key points of glucidic metabolism. The most common mechanisms of action found include the inhibition of α-glucosidase and of AGE formation, the increase of GLUT-4 and PPARs expression and the antioxidant activity. Despite the large amount of literature available, the actual clinical effectiveness of medicinal plants in controlling diabetes related symptoms is still controversial and there is a crucial need for stronger evidence-based data. In this review, an overview of the medicinal plants, which use in the management of diabetes is supported by authoritative monograph, is provided. References to some species which are currently under growing clinical investigation are also reported.

Sign in / Sign up

Export Citation Format

Share Document