Safer medicines for children

From the EACPT Focus Meeting on How to Assess Medicines, Opatija, 6-9 October 2016. 

In this video, Donald Singer discusses with speaker Suzana Mimica Matanović evaluation of drugs in the pediatric population.

Discussants
Suzana Matanović: Assistant Professor of Clinical Pharmacology, School of Medicine, University of Osijek, Croatia and PCO alternate delegate at the European Medicines Agency.

Professor Donald Singer: member of the Executive Committee of the European Association for Clinical Pharmacology and Therapeutics and EACPT delegate on the European Medicines Agency Health Professionals Working Party.

 

The next EACPT biennial congress will be held in Prague Congress from 24th - 27th June 2017. The programme will provide an international scientific and educational forum for discussion of clinical pharmacology and therapeutics, including personalised pharmacotherapy. See more on our website. 

Anyone from anywhere in the world with a professional interest in clinical pharmacology and therapeutics can now join the EACPTas an Individual Associate member.

Membership benefits include:

* Access to videos of talks from EACPT Meetings
* Discounted registration fees for EACPT meetings
* Online access to the Official EACPT Journal - Clinical Therapeutics
* Access to the EACPT’s worldwide network of Individual Associate Members
* Active involvement in EACPT  

The EACPT was founded 24 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.

WEB-RADR - innovative use of mobile technology and social media to monitor safety of medicines

The European Medicines Agency is today hosting an update workshop on the 3 year

Innovative Medicines Initiative WEB-RADR project, which was launched in September 2014.
 The project includes a series of work packages for partner organisations in Europe and the USA aimed at developing and evaluating use of mobile technology and social media as tools to monitor the safety of medicines.
 
Patients experiencing suspected adverse reactions to medicines can report these to their physician or pharmacist. In the UK and since 2014 throughout the European Union, patients can now also report suspected drug reactions direct to their national medicine safety authority. However reporting is inconsistent and important adverse side-effects may not be detected until a large number of patients have already been exposed to risk from a medicine.

Three countries in Europe - the UK, the Netherlands and Croatia - are now to evaluating a WEB-RADR mobile app for reporting suspected adverse drug reactions (side effects). The app allows patients and health professionals to reports suspected adverse drug reactions securely to the relevant National Medicines Regulatory Authority.

The Workshop is reporting on experience so far of app-based safety reporting, perspectives and expectations from patients and health professionals and data protection issues.

Clinical drug-drug interaction studies: methods, pitfalls and interpretation

From the EACPT Focus Meeting on How to Assess Medicines, Opatija, 6-9 October 2016. In this video, Donald Singer discusses with Janne Backman from Helsinki how to identify and minimise risk of drug-drug interactions.

Discussants
Janne Tapio Backman: Professor in Clinical Pharmacology and Individual Medicine, University of Helsinki, Finland
Professor Donald Singer: member of the Executive Committee of the EACPT and member  of the European Medicines Agency Health Professionals Working Party.

Here is a summary of the key points from Professor Backman's  talk at the EACPT Focus Meeting in Opatija: 

Drug-drug interactions can either markedly reduce or enhance the therapeutic or adverse effects of drugs by causing alterations in the pharmacokinetics or pharmacodynamics of drugs. If such interactions are not understood or accounted for in patient care, they can have harmful, even hazardous clinical consequences. 

Drug-drug interactions have been a major cause of drug withdrawals from the market. Regulatory agencies, including the European Medicines Agency (EMA) have therefore published guidance documents that are designed for the industry to guide their DDI studies during drug development. In particular, detailed scientific recommendations can be given concerning pharmacokinetic interactions, because such interactions can be mediated via mechanistic changes in absorption, distribution, metabolism and excretion of drugs. 

Specific approaches are suggested concerning cytochrome P450 enzymes (CYPs), non-CYP enzymes and membrane transporters. In addition, current guidance also recommends use of modelling approaches, such as physiologically based pharmacokinetic (PBPK) models to design and extend the interpretation of preclinical and clinical drug-drug interaction studies. For designing clinical drug-drug interactions studies, detailed preclinical in vitro and early clinical pharmacokinetic information is necessary. 

Despite detailed guidelines, there are many challenges in characterization of the interaction potential of a drug, both as a perpetrator and as a victim of the interaction. Such challenges arise from complex interaction mechanisms, eg, simultaneous involvement of transporters and drug metabolizing enzymes, autoinhibition and autoinduction of metabolism, time-dependent inhibition and involvement of major drug metabolites. 

Understanding the challenges and pitfalls of drug-drug interaction studies is thus necessary in interpretation of the results of studies. In this lecture, basic methods of clinical drug-drug interaction studies will be reviewed, with examples of potential pitfalls and basic principles of interpretation.
  
The next EACPT biennial congress will be held in Prague Congress from 24th - 27th June 2017. The programme will provide an international scientific and educational forum for discussion of clinical pharmacology and therapeutics, including personalised pharmacotherapy. See more on our website. 

Anyone from anywhere in the world with a professional interest in clinical pharmacology and therapeutics can now join the EACPT as an Individual Associate member.

Membership benefits include:

* Access to videos of talks from EACPT Meetings
* Discounted registration fees for EACPT meetings
* Online access to the Official EACPT Journal - Clinical Therapeutics
* Access to the EACPT’s worldwide network of Individual Associate Members
* Active involvement in EACPT  

The EACPT was founded 24 years ago and now includes as members all national organisations for clinical pharmacology in Europe, as well as organisations from further afield internationally. The EACPT aims to provide educational and scientific support for the more than 4000 individual professionals interested in clinical pharmacology and therapeutics throughout the European region, with its congresses attended by a global audience. The EACPT also advises policy makers on how the specialty can contribute to human health and wealth.