The role of pharmacists in personalization of therapy in light of Globalization

THE ROLE OF PHARMACISTS IN
PERSONALIZATION OF THERAPY IN THE
LIGHT OF GLOBALIZATION
Dalia A. Hamdy
BSc.(Pharm), MSc., PhD, RPh., MBA, MRSC
Founder and Manager of AbEx Health Services LTD.
Assistant Clinical Professor, FoPPS, University of Alberta
dhamdi@ualberta.ca

outline
➢Identifying Globalization and its impact on healthcare system
➢Identifying Precision medicine and Pharmacogenomics
➢Pointing out how the world is working to tackle down the
challenges towards PGX implementation
➢Some preliminary data and research activities by my research
teams
➢Examples of how a pharmacist can implement precision medicine
to solve drug-gene interactions
2Dalia A. Hamdy (precision medicine -November 2020)

Globalization
The process in which people, ideas and goods spread throughout the world, spurring more
interaction and integration between the world's cultures, governments and economies.
3
Dalia A. Hamdy (19 November 2020)

Globalization and Healthcare systems
New terms have emerged due to the ease of migration and travel
➢Medical tourism
➢Diversity and the changes in many population demographics in many countries
Dalia A. Hamdy (19 November 2020) 4
Challenges! 1. Quality of healthcare systems
2. Healthcare Cost/medication cost
3. Personalized/Precision Medicine!

Precision Medicine
“is the tailoring of medical treatment to the individual characteristics
of each patient”
The Age of Personalized Medicine
“The science of individualized prevention and therapy”
National Institute of Health 5

Precision Medicine
One Size fits all
medicine
(empiric therapy)
Vs.
Precision medicine

Precision Medicine
Pharmacists Roles:
Therapy initiation :Medication doses (Loading and Maintenance doses)
Therapy Monitoring
Empiric vs. tailored!
Therapeutic drug monitoring (narrow therapeutic index drugs)
Special population considerations
Drug-Drug and Drug disease interactions
Are we using precision
medicine?
What is New?!

Polymorphism and Drug-Gene Interaction
Different types of genetic variants/polymorphism or mutations
Single Nucleotide Polymorphism (SNP)
=SNV that exist in 1-2% of the
population

Pharmacogenetics (PGX)
The study of the effect of variations in DNA sequence (genetic
differences) on drug response in terms of both the
metabolism/clearance (PK) and action (PD) of the drug delivered

How to apply PGX in precision medicine?
➢Technology
➢Cost
➢Ethical and legal considerations
➢Healthcare professional Knowledge
➢General population awareness
➢Resources
Challenges?

Technology/Cost
Two types of testing
-Genetic testing for diagnostic purposes
-Genetic testing for therapy management (PGX)
Challenges?

Technology/Cost
Genetic testing for therapy management (PGX)
Testing the polymorphs or the genetic alleles of
Transporters
Enzymes
Receptors
Commercial kits are now available
(150 to 500$)
US labs,Australian labs, European labs
Challenges?

Technology/Cost
Genetic testing for therapy management (PGX)
Testing the polymorphs or the genetic alleles of
Transporters
Enzymes
Receptors
Commercial kits are now available
(150 to 500$)
US labs,Australian labs, European labs
Challenges?
Genes Alleles
CYP1A2 *1C, *1C, *1E,*1F, *1J, *1K, *1L, *1V, *1W, *6, *7, *8, *15
CYP2B6 *2, *4, *5, *6, *7, *8, *9, *13, *16, *18, *22, *34
CYP2C19 *2, *3, *4, *4B, *6, *8, *10, *17
CYP2C9 *2, *3, *4, *5, *6, *8, *9, *11, *12, *18, *27
CYP2D6 *2, *2A, *3, *4, *5, *6, *7, *9, *10, *14, *14A, *17, *29, *4N, *4M, *5, *6, *6C, *7, *8, *9, *10, *11,
*12, *13, *14A, *14B, *15, *17, *18, *19, *29, *31, *34, *35, *36, *39,*41, *42, *63, *64, *68, *69,
*70, *91, *109
CYP3A4 *1B, *3, *6, *11, *12, *16, *17, *18, *19, *22
CYP3A5 *2, *3A, *3B, *6, *7
COMT VAL158MET
DPYD *2A, *4, *5, *6, *9A, *13, rs7376798A
DRD2 PROMOTER VARIANT -241A>G
F2 20210G>A
F5 ARG534GLN (LEIDEN, 1691G>A)
GRIK4 NON-CODING (INTRONIC) T>C VARIANT
HTR2A INTRON 2, T>C VARIANT
HTR2C PROMOTER VARIANT -759C>T
IFNL3 rs1297860 C/T
IL28B (IFNL4) NON-CODING (INTRONIC) C>T VARIANT
NUDT15 ARG139CYS
OPRM1 ASN40ASP, A118G
SLC6A4 C,-1810A>G; -1791_-1749DEL43
SLCO1B1 *1B, *5, *9, *15, *31
TPMT *2, *3A, *3B, *3C, *4, *8
UGT1A1 *6, *27, *38, *60, *80
VKORC1 c.-1639G>T, A and G variants

Ethical and legal considerations
Countries started placing regulations for genetic data management and access to prevent
Genetic Discrimination :
Genetic stigmatization :
Also healthcare service needs to follow the general ethical rules: Justice, Beneficence,Autonomy
etc.
Challenges?

Ethical and legal considerations
North America!
GNA 2017 (Canada)
The Genetic Non-Discrimination Act: critical for promoting health and science in Canada
GINA 2008 (USA)
The Genetic Information Nondiscrimination Act of 2008
https://www.eeoc.gov/statutes/genetic-information-nondiscrimination-act-2008
Challenges?

Healthcare professional Knowledge and population awareness
Relatively new science! Healthcare professionals including pharmacists
Need more confidence in
-identifying eligible patients
-interpreting results
-seeking resources for data collection
Pharmacogenomics Competencies in Pharmacy Practice: A Blueprint for Change. J Am Pharm Assoc (2003).
2017 Jan-Feb; 57(1): 120–125
Challenges?

Challenges?
From a study in 2017
McMurdo A.,Abou Alwan R., Mayo PR. and Hamdy DA
Implementation of Pharmacogenomics in Community
Pharmacies in Alberta: Perceptions and Challenges.

Challenges?

Actions taken towards this challenge:
-Universities started to implement PGX competencies into their pharmacy curricula
2017 Jan-Feb; 57(1): 120–125
-CE units , conferences and educational materials are now targeting practicing pharmacists
-Few research grants involving service implementation and pear education are already in place
(Dalia Hamdy et al 2020-2022)
Challenges?

Resources
-PharmGKb
https://www.pharmgkb.org/
-CPIC
https://cpicpgx.org/
Challenges?

Implementation of PGX in therapy management
Important questions?
The enzymes, transporters and the receptors involved in the questioned drug PK and PD
Do they carry different alleles with different functionalities (different genotypes leading to
different phenotypes)?
Do we have enough research and guidelines through our resources for proper dosing once the
drug-gene interaction have been identified?

A patient was using CBZ for 4 months and stopped for problems with
insurance coverage and hospitalization periods.The dr. wants to restart him
again on CBZ.The dr. phones you and asks that he heard about an available
pharmacogenomic test that is needed for this pt.? Would you strongly
recommend doing the test ? For what gene? Why/why not?
1. The patient did the test and those were the results
CYP2D6 *4/*7, CYP2C19*1/*17, CYP2C9*1/*1,
VKORC1 AA, HLA-B*15:02 positive

https://www.pharmgkb.org/chemical/PA448785

If we know that voriconazole is used for ttt of
invasive fungal infections in cancer patients.
Also that trough concentrations <2 mcg/ml is
associated with worse clinical outcomes?What
are the CPIC guidelines for a pt. with
CYP2C19 *1/*17?
https://www.pharmgkb.org/guidelineAnnotation/PA166161537

THANKYOU!
Dalia A. Hamdy (19 November 2020)
31

The role of pharmacists in personalization of therapy in light of Globalization

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