Indicators of Evaluation and Monitoring of Drug Claims
December 8, 2015Virtual Meeting of RedETSA Members
June 8, 2016Construction of a model for the optics of two new medications
The Pharmacoepidemiology Research on Essential Medicines seminar, held by the Oswaldo Cruz Foundation, included the participation of Brian Godman This recent study presents two challenges faced by the accelerated introduction and incorporation of new medications, how this phenomenon impacts its users and what approaches have been identified to prevent or mitigate these potential damages.
Titled “Dabigatran – a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs” , Godman employs as an example of these technologies in advancing dabigatrana, um two new anticoagulants orais, very popular medicine in recent years in decorrência of its apparent benefits in comparison with warfarin.
It has been identified that in many countries the population in the use of medication differs in clinical trials, depending on age, gender proportion or presence of other comorbidities. Allied to this fact is the occurrence of some cases of prescription that do not correspond to the recommendations of the studies, such as, for example, cautious use based on the patient's kidney function.
This study is not related to the experience of some countries that refers to the process of introducing medicines and how the rational prescription of this medicine is promoted. I propose a model to base the optimization and management of new medicines on the basis of stakeholders, from a pre-incorporation phase to post-introduction validation of health technology; This material may be available for free access to all.
Link to the article “Dabigatran – a continuing exemplar case history demonstrating the need for comprehensive models to optimize the utilization of new drugs”
News about the ROCKET-AF study
In the same area, two new anticoagulants are some recent news regarding Rivaroxabana, for the ROCKET-AF study, I placed in check the results obtained for myself. It has been identified that the International Normalized Relation (INR) reporting devices are subject to recall due to a fault, as they show values lower than those demonstrated by laboratory tests on our standards. This suggests that participants taking their doses of warfarin unnecessarily modified, potentially to levels higher than the ideal, thereby increasing the risk of bleeding in the arm using this medication was not studied.
This fact is also associated with the previous criticisms about the study that corresponds to the short time that patients presented within the faixa terapêutica da warfarina. However, given that the controls are not effective as was inferred, these data would be subject to benefiting the effects and security proposed by the use of rivaroxaban.
More information is available in material from the British Medical Journal Data on trial of anticoagulant is to be reanalyzed after discovery that investigators used faulty device