Personalized medicines

Role of Pharmacists in Patient
care and Personalized
Medication
Dr. Kamal Singh Rathore
BN College of Pharmacy, BN university, Udaipur
Presented Online with Alwar Pharmacy College , Alwar-Raj.
On
May 10, 2021
5/13/2021 1

One Size Doesn’t Fit All..
• Every year in the USA 2 million people die due to adverse drug effects
• Drug efficacy is only in 60 % of the population
• Other 40 % have poor drug effects or no effect at all 3
5/13/2021 2

The answer is.. Pharmacogenomics/Precision
Medicines/Personalized Medicines/Individualized
medicine/stratified medicine /P4 medicines
in 1902. Sir Archibald Garrod
5/13/2021 3
The tailoring of treatment
to patients dates back at
least to the time of
Hippocrates

Pharmacogenomics and Pharmacogenetics
• Genomics – The study of the entire set of genetic instructions found in a cell (DNA)
• Pharmacogenetics (PGt) — The effect of genetic variation on drug response. A discrete inherited
trait related to drug absorption and disposition
• Pharmacogenomics (PGx)— The application of genomics to the study of human variability in drug
response. [The application of genome-wide SNP scans and gene expression analyses]
• Importance !! Made-to-Order Drugs
• Pharmacogenomics shows how genes determine individual variability to drug response and for
Pharmacists it would be easy to predict how a patient may respond to drug, with the help of a
genetic test before prescribing a drug
5/13/2021 8

Human Genome Diversity
• As humans, all of us have a similar genetic code, which is nearly 99.9% similar.
The 0.1% difference is what makes us different influences the response to drugs
• SNPs
• These differences are due to change in the DNA sequence, sometimes a mere
change of one alphabet. This is called as Single Nucleotide Polymorphisms or
SNPs. The effect of one alphabet change can be variable; some could have a
profound change in the meaning/function while others may have minimal or no
effect, as shown below:
• e.g. Cattle – Battle; Tumour – Tumor
• SNPs are powerful Tools
• SNPs screening will help in prescription
• “Right drug at the right dose in the right patient”
5/13/2021 13

What Makes it Possible?
• Human genome sequencing
• New technologies facilitate handling of data
• A lot of investment in public and private sector
• The future of medicine – so called Personalized Medicine
5/13/2021 17
In personalised medicine, diagnostic testing is often employed for
selecting appropriate and optimal therapies based on the context of
a patient's genetic content or other molecular or cellular analysis.
The use of genetic information has played a major role in certain
aspects of personalized medicine (e.g. pharmacogenomics), and the
term was first coined in the context of genetics, though it has since
broadened to encompass all sorts of personalization measures,
including the use of proteomics, imaging analysis, nanoparticle-based
theranostics, among others.

Ongoing Research on CYP
• Cytochrome P450 superfamily of enzymes
Important drug metabolozing enzymes
Bioactivation and metabolism of approximately 75% of drugs gives
CYPs prominence in pharmacogenetics research
Here’s My Sequence ...
More Business in Future..
• Develop new therapies
• Incorporation of genetic information into the diagnosis
of disease and prescription of drugs
5/13/2021 18

The route to a new medicine … is a long one
… and an expensive one !!
5/13/2021 21

Role of Pharmacists
• The field of personalized medicine affords multiple opportunities to
pharmacists, and pharmacists have specific knowledge, skills and
abilities that make them uniquely suited to advance the use of
personalized medicine as a clinical tool.
• The pharmacy profession as a whole, however, has been slow to
embrace the concept of clinical pharmacogenetics and is now facing a
critical juncture that can potentially redefine the professional identity
of the pharmacist.
5/13/2021 33

Are pharmacists ready for the challenge of
personalized medicine?
• When assessing the readiness of pharmacy for personalized medicine,
one must consider factors that are specific to the individual
pharmacist as well as systematic considerations that allow
pharmacists to successfully integrate personalized medicine into their
individual practice area.
• These include factors such as education and training, competency, an
attitude of engagement and adequate support and guidance.
Personnel, information technology and laboratory infrastructure are
also critical elements that are required, and financially sustainable
practice models must be developed.
5/13/2021 34

Important areas required for implementation
of clinical pharmacogenomics
Such as :
• Pharmacy informatics,
• Clinical decision support tool development,
• Database management,
• Development of medication use policies and processes,
• Logistics of genetic testing,
• Research and clinical guideline development.
5/13/2021 35

• Pharmacy is a constantly changing profession that requires
pharmacists to adapt their skills as scientific advances continue to
transform the practice of medicine.
• Over the last 100 years, the profession of pharmacy has evolved from
a dispensing model focused on the formulation and delivery of a drug
product to a patient care model focused on individualizing drug
therapy and delivering direct patient care.
5/13/2021 37

• The Clinical Pharmacogenetics Implementation Consortium (CPIC), an international
working group of pharmacists, scientists and other health care professionals, has
developed evidence-based clinical guidelines for 35 actionable gene– drug pairs.
• Over the last two decades, the US Food and Drug Administration has added “black box”
warnings for several medications (e.g., abacavir, clopidogrel, carbamazepine),
incorporated genotype-guided dosing algorithms into product labeling and added
pharmacogenetic information to the labels of >150 medications.
• There are even drugs, such as simeprevir for hepatitis C and mipomersen for
homozygous familial hypercholesterolemia, that require pharmacogenetic testing before
they can be prescribed. The costs of genetic testing continue to decrease and
comprehensive genetic tests can be performed for less than $250 US dollars and are
offered in 7% of hospitals in the US. Direct-to-consumer (DTC) genetic testing kits are
also readily available in community pharmacies, and the first DTC test for determining
breast cancer risk was just approved by the US Food and Drug Administration in March
2018.
5/13/2021 38

What do pharmacists need to be ready for
personalized medicine
• Education and training
• Demonstrated competency
• Attitude of engagement
• Support and guidance
• Resources and infrastructure
• Evidence of benefit
• Strengths, weaknesses, opportunities and threats [SWOT Analysis]
• Creating a path forward
5/13/2021 39

5/13/2021 42
23 and Me, Nevigenics, Illymina these are Pvt. Co. provide
facilities of direct-to-customer genome sequencing to the
public

Lab-on-a-chip
• A physician wants to initiate a specific medication according to the
patient's genotype. All he needs is a drop of patient's blood on a
microchip and in a few minutes the SNP of the patient and the
suitable medication is displayed on the screen [lab on chip]
5/13/2021 44

HOW CAN WE IMPLEMENT PERSONALIZED MEDICINE?
The human genome was completely sequenced in 2003. The technology for DNA sequencing is
improving and becoming cheaper. Currently, it would cost Rs. 4.00 to 5.00 lakhs to do a whole
genome sequencing. However, in 5–10 years time, this is expected to fall to Rs.50,000 or less. Thus,
every newborn can have his/her blood sample collected soon after birth and the whole genome
sequencing done. This will then help in the following ways:
To identify diseases which the baby is likely to be predisposed to during his/her lifetime. This will
help in initiating strategies to prevent the development of the disease or reduce that risk
substantially.
To identify drugs which are likely to be toxic/cause severe side-effects, so that these drugs can be
flagged in the baby’s record and avoided if there be a need later.
To identify drugs which are more likely to be effective for diseases manifested later during life,
and with minimal side-effects.
To tailor the treatment, based on the biological characteristics of the cancer, if one were to
develop it later in spite of preventive strategies. This will ensure that the most effective drugs
targeted to the specific cancer are given, increasing the cure rates with minimal side-effects.
Thus, instead of casting a traditional horoscope soon after birth, it would be possible and prudent
to get the Genomic Horoscope done for the baby.
5/13/2021 45

PM encompasses all sorts of personalization
measures:
• Use of genomics, proteomics, metabolomics for genome,
transcriptomics, protein RNA/DNA sequencing, HTS, phenotyping
screening
• Imaging analysis: fMRI, CT, PET, SPECT, fluorescent markers (QD),
Radiotracers, HR-LCMS
• Nanoparticles based theranostics etc.: deep learning algorhithm,
Fluorescent in-situ hybridization (FISH)
• 3D printing for drug development
• Coding, WES, WGS , Next gen sequencing (NGS) leads to genome
medicines till 2025.
5/13/2021 46

Conclusion
• While pharmacists might not be completely ready for the challenge of
pharmacogenetics, they are most certainly up to facing the challenge.
The time is right and the stage is set for pharmacy to embark on
another transformative journey – a journey that will redefine the role
of the pharmacist and will secure a place for pharmacy in the era of
personalized medicine and beyond.
• Individualize drug therapy opens up exciting new opportunities for
pharmacists to expand their clinical roles and responsibilities.
• Personalized medicine has been identified as a key and prospective
approach to “achieve optimal individual health decisions”, therefore
overcoming the challenge of “Engineer better medicines”
5/13/2021 47

Personalized medicines

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