Editorial

Genetic and pharmaceutical care a synergy in improving clinical outcome reducing costs

Author m .luisetto pharm.d. , specialist in pharmacology, European specialist in lab medicine

Maurolu65@gmail.com Italy

Keywords: genetic, genomics, pharmacology , clinical pharmacy, clinical outcomes

Introduction

Today more than past the relationship between pharmacotherapy and genetics is very strictly.

This make possible to achieve more clinical outcomes levels and at the same time reducing healthcare costs.

This method is classified as Personalized therapy .

The pharmacogenetics sciences studies the role of pharmaco-genetics in drug response and with the term pharmacogenomics we mean to predict the therapy drug response based on the individual genetic profile .

The clinical pharmacist works added in medical team gives the improve in clinical outcomes as we can easy see in Scientific works on biomedical database. (1) luisetto et. Al 2015 .

A new discipline named CLINICAL PHARMACEUTICAL CARE (2) is an instrument to achieve clinical and economic goals. This new management discipline add the positive caractheristic of clinical pharmacy with a pharmaceutical care approach .( from population to single patient need) as a kind of personalized pharmacotherapy.

But as we can see in some field the pharmacological therapy can be improved a lot (3)and using the genetic patient data we can use the right drug to the right patient with more rational approach .

In this way we can obtain less resitances to the therapy.

We can see for example therapy of CML with phyladelphia cromosome ( bcr-abl) and The old and new TK INIBITORS, or what happen in the therapy of virus as HCV and HIV.

Iperexpression of receptor ( her 2 ), EGFR, ormonal receptor profile and many other examples show a great variability in drug response according the single genetic profile.

Other example can be : warfarin therapy, many antiepileptic drugs, many TK inibitors, many MABS used in oncotherapy, anti depress agent and more other examples

Of the genetic profile effect on methabolism, toxicity or efficacy .

The genetic profile, the mutation added to the classic clinical and pathological data make possible to have the right stadiation with more information about sensibility or resistance to a pharmacologicval therapy.

Clinical data added to family history, med lab results in genetic profile , imaging , drug responces and other drive the pharmacological therapy in correct way.

The citocrome profile or specific mutation or other genetic condition in many situation are responsible of failure of some pharmaco therapy .( lower or fast metabolizer condition , inducer or inhibiting drugs ,drug toxicity level due to some genetic profile )

If a drug is not indicate by the genetic profile we can have a problem : a inefficacy drugs is used and other drug is not

Correctly used.

Is a simply consideration but not so clear since today to all healthcare professionals , institution or patients.

In last years some drugs registrative indication are specifically directed to a specific genetic profile but not in all cases there is a genetic specific indications to differentiate responder from non responder .

This was not in some drugs registered in example 10-20 years ago due to the low level of scientific knowledge in pharmacogenomics.

I some countries ( Italy ) the public reimboursement of some innovative drugs are under evaluation of the real clinical effect obtained after the use in clinical condition and if not responce is not fully payed .( payment by results, risck sharing and other procedure ).

The pharmacogemonics is oriented to study the single patient response to drugs and the new drugs registerd in example in oncology show sometimes a large variety of efficacy.

The medical team that is involved in this terapy must include clinicians, pathologist, radiologist , molecular biologist but also clinical pharmacist .

The evolution of clinical pharmacy approach in medical equipe in last centuries demostred continuous positive effect (4)

The same we can see the effect of polymorphism in single patien drugs methabolism and the effect produced on the therapy goal ( clinical effect, ADR, toxicity )

Extensive, ultra rapide or poor methabolizer status is importat to know for drugs with little therapeutic range, or related with high toxicity condition.

In example we can see what happen with some immunosupprive drugs usend in transplant due to the methabolic Process and other drugs interactions.

An under dosage can lead to loss the transplanted organs while high plasma level we can have toxicity.

TDM -therapeutic drugs monitoring give a great help but having the genetic profile information added to

The right information in drugs ( methabolism , toxicity, kinetics, pharmacodynamics) can make more easy and efficacy to shift to other class drug if not response is

Demonstrated.

The same way we can see positive effect when clinical pharmacist are permanent member in some relevant

medical teams with reducing for example in mortality rate ( ICU )(5)

This was related to the specific pharmaceutical and pharmacological knowledge of the pharmacist in field of pharmacotherapy.

So we can think that pharmacokinetics management (6) , added to pharmacodynamics but with the genetic data can be useful instrument in drug terapy as well as in researching of new CLASS drugs .

Genotype/phenotype profile , mutations, wild type conditions and other must be used to drive the therapy when the clinical outcome require it to be obtained .

Molecular biology, pathology, imaging data drive the therapy choice.

To make clear this consideration we report other bibliography involved :

Liming Weng et al writed that : large advances have been made in the anticancer therapy., US FDA has updated the package inserts of about 30 anticancerdrugs s including PGx information.

This information are useful in improving therapeutic efficacy and reducing toxicity and side effects. (7)

And according to Mary V. Relling et al :from pharmacogenomics ,discovery to clinical implementation as an EBM strategy TO improve the use of drugs , for a precision medicine”(8)

Allison B. et al said “Diseasepathology progression and drug response may differ significantly between patient to patient., targeting in drug development and monitoring of the clinical effect of therapy in order to f apply precision medicine in clinic filed (9)

And U Subrahmanyeswara Rao et al writed the sequencing of the human genome and the related pharmacogenomics knowledge are in use for the practice of precision medicine.

However, this knowledge is not fully tranfered in clinical practice.among the healthcare professionals... (10)

As we have see (1) the permanent presence of clinical pharmacist in medical equips make possible to improve clinical outcomes and we can write also when the patient genetic profile is strictly realted with

Clinical outcomes of some relevant pharmacotherapy.

Conclusion

The personalization of the pharmacological therapy Is next golden end point and we think that the clinical pharmacist precence in medical team that is universally recognized as the expert f drugs for excellence

( also in pharmacogenomics and genetics ) added to the genetist and patoglogist can give the right instrument to the clinicians.

The clinical pharmaceutical care approach can be a golden endpoint to improve clinical outcomes since the level of single patient ( personalized therapy ) and its genetic profile .

A last question : is ethical not to use genetic data when this information is crucial in the obtaining of good clinical effect?

References

1)Luisetto M, Francesca C, Giovanni B, Behzad NA (2015) Pharmacist CognitiveService and Pharmaceutical Care: Today and Tomorrow Outlook UK Journal ofPharmaceutical and Biosciences 3: 67-72.

2)Luisetto M, Sahu R (2015) Clinical Pharmaceutical Care: A New ManagementHealth Care Discipline in 2016 UK Journal of Pharmaceutical and Biosciences 4: 63-64.

3)Luisetto M. Editorial efficacy of oncologic drug therapy: Some to rethink in the management of the system? Journal of Business Management and Economics. 2016;4:07

4)Luisetto M, Nili-Ahmadabadi B, Cabianca L, Ibne Mokbul M (2016) Stepsand Impacts of Pharmaceutical Care and Clinical Pharmacy Developmenton Clinical Outcomes 2016: A Historical Analysis Compared with Results,Clinicians Teamwork 1: 4-8.

5)Pharmaceutical Care and Toxicology, a Synergy in High Risk SituationLuisetto, J App Pharm 2016, 8:4

6)Nili-Ahmadabadi B, Luisetto M, Nili-Ahmadabadi H, Nasser H, Mashori GR,et al. (2016) Clinical Impact of Pharmacist Presence in ICU Medical Team onMortality Rate. Clinicians Teamwork 1: 15-33.

7) Pharmacogenomics. Pharmacogenomics. 2013 Feb; 14(3): 315–324.Pharmacogenetics and pharmacogenomics: a bridge to individualized cancer therapyLiming Weng,1 Li Zhang,2 Yan Peng,3 and R Stephanie Huang1,*

8) Nature. Author manuscript; available in PMC 2016 Jan 13.Nature. 2015 Oct 15; 526(7573): 343–350.Pharmacogenomics in the clinicMary V. Relling1 and William E. Evans1

9) Precision medicine: from pharmacogenomics to pharmacoproteomics Allison B. ChamblissEmail

author and Daniel W. ChanClinical Proteomics201613:25

10) Pharmacogenomics June 2015 ,Vol. 16, No. 8, Pages 905-911 , ReviewStrategies for implementation of an effective pharmacogenomics program in pharmacy educationU Subrahmanyeswara Rao*,1, Susan L Mayhew2 & Prema S Rao1