Pharmacogenovigilance: Has the time come?

Pharmacogenovigilance: Has the time come?

Last Updated on August 26, 2022 by Joseph Gut – thasso

August 26, 2022 – Traditionally, pharmacovigilance (PV), is the pharmaceutical science relating to the “collection, detection, assessment, monitoring, and prevention” of adverse drug reactions (ADRs) with pharmaceutical products and associated therapies. Pharmacovigilance is based on information about ADRs received from patients and healthcare providers via pharmacovigilance agreements, as well as other sources such as the medical literature. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authorities and adhere to. very strikt worldwide laws, regulations, and guidances. ( Adverse Events Peporting).

Millions and millions if not milliards of patient data entries worldwide into PV databases, fulfilling regulations of regulatory bodies. However, the gain of knowledge remains somewhat limited.

The classical pharmacovigilance reporting is based on observed clinical adverse reactions (phenotypes) after drug treatment. However, this reporting usually not include any information on the genetic background of affected patients and their possibly existing genetic susceptibilities for producing exactly the observed adverse effect. Genetic factors determine individual susceptibility to both dose-dependent and dose-independent ADRs. Determinants of susceptibility include kinetic factors, such as gene polymorphisms in cytochrome P450 enzymes, and dynamic factors, such as polymorphisms in drug targets (see an early review here). Also thasso has already had a couple articles of  predispositions of patients for adverse effects, such as in serious  lupus,  in fatal skin reactions with Keytruda, on problems with Tetrazepan-containing medicines, or on predisposition on drug toxicity in general, besides many others.

The events illustrate that the time has come to include genetic background data of patients into pharmacovigilance reporting, giving rise to the all new concept of “Pharmacogenovigilance“. Pharmacogenovigilance aims at integrating patient related pharmacogenomic data into a pharmacovigilance reporting. The fact that genes play a vital role in variability in response to medicines makes pharmacogenomic data related to adverse drug reactions (ADRs) very essential. Genetic variations do significantly affected the drug action  (indented or non-intended, i.e., adverse) in many patients, and at times predisposes a fraction of patients to unforeseeable, sometimes even fatal ADRs that are not seen in a large majority of

The answer to above question is: Yes, it does. It is time to redo pharmacovigilance under inclusion of individual patients genetic predispositions for ADRs in a new approach: Pharmacogenovigilance.

patients. In the epoch of precision and personalized medicine, pharmacogenetics may provide cleaner path to individualized use of medicines, making, among others, drug safety and efficacy studies more safe and effective when genetic polymorphism are taking into account.

Over all, in order to explore these potential benefits of until now rather unused knowledge on genetic backgrounds of individual, integration such knowledge in to clinical practice and public health systems, and as a consequence, into of pharmacogenovigilance has become necessary. It is imperative for every medical practitioner to consider genetic factors in order to prescribe the best medication to his patients. In a recent article by Prof. Nordin Bin Simbak published in the Research Journal of Pharmacy and Technology , the concept of pharmacogenovigilance has extensively been eluded to and presented the impact of literature searches using terms such as “genetic biomarkers”, “application of pharmacogenetics and pharmacogenomics”, and “influence of pharmacogenetics on pharmacovigilance”  in systems such as PubMed, PharmGKB, as well as in many US FDA and WHO websites. Several challenges facing drug safety and pharmacovigilance were highlighted and proposed pharmacogenomics approaches in solving them. In any case, it turns out that it has become imperative for every medical practitioner to consider genetic factors in order to prescribe the best medication to his patients and also to possible freeze who could be a candidate for severe, if not fatal, adverse reactions, which may include genetic testing of patients before treating them with medications known out of pharmacogenovigilance to carry critical (genetic) risk factors.

Pharmacogenovigilance: The time has come? Or, is it simply overdue?

The purpose of this article was to justify the new discipline of pharmacogenovigilance as an essential tool for drug safety and efficacy while providing the most feasible way for its successful integration into the cycle of patients care. In conclusion, considerable progresses have been recorded on the potentials of pharmacogenovigilance in drug safety and efficacy study during post-marketing surveillance, and based on the provided evidences, the right time for pharmacogenovigilance is now. Having a long-time carrier as an scientific expert on the genetic backgrounds of drug-induced effects in individual patients, and having worked on part-time projects in pharmacovigilance, the author of this post may simply state that tharrival of  pharmacogenovigilance is far from “in time” but was overdue, since many many years even.

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Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.

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