One in three drugs approved in Europe includes a genetic marker
One third of the total approved drugs in Europe by the European Medicines Agency (EMA) include at least include at least a genetic marker in their data sheet in their data sheet.
When a drug is going to be registered, it is analyzed if having or not a specific gen could increase its certainty and allow identifying in each case when it would be more effective.
In this context, Spain will develop the first database in Spanish and one of the first in Europe that will allow the identification of the genes to be analyzed in each condition.
It will centralize its operations at the AEMPS, the Spanish Agency of Drugs and Medical Devices, according to Adrian Llerena,
vice-president at Spanish Society of Clinical Pharmacology and at Spanish Society of Pharmacogenetics and Pharmacogenomics,
and one of the eight members on the committee of pharmacogenomics of the EMA.
Llerena said it’s important to homogenize the tools of genetic analysis used nowadays, saying that pharmacogenetic tests made by some companies
“are designed based on arbitrary criteria”. At present, Llerena coordinates a European project that chase to combine the implementation of Personalized Medicine,
in order to unify all these tests under the program Horizonte 2020.
The importance of including the genotype of patients in clinical records
During the 12th Congress of the European Association of Clinical Pharmacology and Therapeutics, Llerena said,
“20% of emergencies at hospitals are produced by adverse effects of drugs, being considered the sixth leading cause of death.
It would be an achievement to reduce that percentage or to reduce some of the causes of death due to genetic analysis”.
According to his words, “drugs save lives, but also make damage. The strategies we have in pharmacovigilance could be supplemented,
from epidemiological level in the sense that it is quantified what happens,
the active strategies supplemented by the inclusion of the genotype of patients in their clinical recordsto make sure the prescriber could take a more informed decision at the time to prescribe a certain drug.
We are not going to prevent all adverse reactions, but we can prevent an important part individually”.
Regarding to the words of Adrian Llerena, The Extremadura Health system has launched a pioneering proposal in Europe that would allow the implementation of personalized medicine in Public Health Systems.
This project called Medea allowsthe doctor to be guided in the prescription through the genetic analysis included in the Health Card with the final purpose of reducing the risks and optimizing their effectiveness.