Pharmacist-Led �Personalized Medicine Approaches �in T2DM

Dr Jazlina Liza Binti Dato Jamaluddin

Senior Pharmacist

Genetic Pharmacy, Hospital Kuala Lumpur

1

Introduction

2

Hospital Kuala Lumpur (HKL) is the largest hospital under the Ministry of Health (MOH).

HKL Genetic Department was established in 2009 which is the first genetic & rare disease treatment center in Malaysia.

The Supply

of

Genetic & Rare Disease Therapy throughout Malaysia

Direct supply

SPUB

UMP

Serves as the main referral center for genetic & rare diseases for the country.

HKL Genetic Pharmacy manage drugs procurement & supply to genetic & rare disease patients throughout country.

Selected centers

Hospitals

Direct to patients

Introduction

What is Pharmacogenomic?

• branch of pharmacology that use the influence of genetic variation on drug response in patients by correlating gene expression or single-nucleotide polymorphisms with a drug's efficacy or toxicity¹.
• It aims to develop rational means to optimize drug therapy, with respect to the patients genotype, to ensure maximum efficacy with minimal adverse effects¹.
• Such approaches promise the advent of personalized medicine, in which drugs and drug combinations are optimized for each individual's unique genetic makeup¹.

3

With genotyping technologies now widely available and decreasing in cost, implementing pharmacogenomics into clinical practice — widely regarded as one of the initial steps in mainstreaming genomic medicine — is currently a focus in many countries worldwide².

1. T P A, M SS, Jose A, Chandran L, Zachariah SM. Pharmacogenomics: the right drug to the right person. J Clin Med Res. 2009 Oct;1(4):191-4. doi: 10.4021/jocmr2009.08.1255. Epub 2009 Oct 16. PMID: 22461867; PMCID: PMC3299179.
2. Pirmohamed, M. Pharmacogenomics: current status and future perspectives. Nat Rev Genet 24, 350–362 (2023). https://doi.org/10.1038/s41576-022-00572-8

Next Generation Sequencer (NGS) – Illumina NextSeq 550

Pharmacogenomics Trend Around The World

4

5

Pharmacogenomics Services in Hospitals Abroad

6

Pharmacogenomic Service Essentials

Personnel

• Clinical Genetic Specialist
• Genetic Counselor
• Clinical Pharmacogenomic Pharmacist

​

Facilities

• Genetic Department
• Genetic lab
• Patient database

7

• To offer patients pharmacogenomic testing that may help explain past medication responses as well as guide current and future medication therapy.
• To offer pharmacogenomic test result interpretation for patients.
• To provide pharmacogenomic consultation to patients prior treatment.

Services

Governance of Pharmacogenomics

8

Pharmacogenomics Implementation Guide

9

Kabbani D et. al. (2023). Pharmacogenomics in practice: a review and implementation guide.

Pharmacogenomics Services Planning in Pharmacy Department HKL

10

Genetic Pharmacy Service Development Plan

11

New services being planned

Existing services

Pharmacogenomic Services

12

PGx: Pharmacogenomic; EMR: Electronic Medication Record; Rx: Preskripsi; OPD: Out-Patient Department

• Drug selection based on patient genetics
• Real-time drug alert trigger system in transcribing(OPD) and prescribing (clinical)

• Patient PGx data can be used throughout the patient's lifetime for all Rx received for that patient.
• PGx consultation

• PGx database for all patients with PGx data
• Automation algorithm
• PGx data intregration into PhIS system

• Based on service, customer and stakeholder needs

• Based on local population

​

​

The process of establishing pharmacogenomics services :

Pharmacogenomics (PGx) services are needed in the process of selecting the most effective drugs (drug response, ADR prevention, drug metabolism, hypersensitivity, etc.) for patients and can be used for all types of acute and chronic diseases.

The HIGHLIGHT of �Pharmacogenomic Services

• Patients will have a DNA record linked to the effectiveness of all drug therapies at HKL. This DNA record is permanently held by the HKL Pharmacy Department and can be used for drug selection throughout the patient's lifetime.

#TreatmentExclusivity

#PowerfulData

#UpgradePharmaceuticalCare

13

PGx Intranet Database

PGx Mobile Apps

Intranet Database

Innovation

System Upgrade

Planning of patient’s genome repository: PGx Intranet Database

14

HKL Patient Repository Pharmacogenomic Database:

• HKL intranet
• Database by disease/drug classes
• Database updates – references: FDA, CPIC, DPWG, etc.
• Individual patient – recruitment, consent, etc.

PGx Mobile Apps

Information:

• Demographic data
• Medication profiles
• Lab results
• PGx data

15

HKL Intranet –

HKL Pharmacy Department

HKL patient PGx database

Pharmacist:

• Medication Therapy Adherence Clinic (MTAC)
• Ward rounds
• In-patient
• Out-patient

Access to patients PGx data:

• Using patient’s IC No.
• Scanning QR code on patient’s Pharmacogenomic Card

Pharmacogenomics Card

Mr. A

HKL Reg. No./IC No.

Kindly scan on the QR code for patient specific drug dosing recommendations.

Pharmacy Dept. Hospital Kuala Lumpur

Development of Pharmacogenomic Data Into Use: Electronic Medical Record Upgrades

• Pharmacy Hospital Information System (PhIS)
• PGx individual database integrated into EMR – upgrades

​

​

​

​

​

16

MOH. Pharmacy Information System (PhIS & CPS). Available at: https://phisportal.moh.gov.my

Development of Pharmacogenomic Data Into Use: Electronic Medical Record Upgrades

17

Genotype: KCNJ11 rs2285676 (genotype CC)

Treatment response: 2x compared to none

Development of Pharmacogenomic Data Into Use: Advantages of PGx Individual Data into EMR Upgrades

18

Better Rx

Screening

Better Rx

Transcribing

Precise Drug Selection

19

Patient-Specific Dose Adjustment

• American College of Medical Genetics and Genomics (ACMG) Technical Standard - Clinical PGx Testing and reporting:

Clinical PGx test reports should not provide patient-specific dosing

• Patient-specific dose adjustment should be done by PGx accredited clinicians and/or pharmacist
• Development of PGx-enriched comprehensive Medication Action Plan (PGx-MAP) – Clinical Decision Support System (CDSS)-USA

Pharmacogenomic Consultation �will be introduced as one of the main Pharmacogenomic Pharmacy Services to patients

20

Type Of Patients That Requires Pharmacogenomics Services

• Expensive treatment
• History of adverse drug reactions
• Complex medication regimens
• Certain diseases ie. genetic, rare diseases, cancer, etc.
• Suspected or known genetic variations that can affect drug metabolism or response

21

Major challenges of implementation

• Lie at the point of delivery into health-care systems, including the modification of current clinical pathways coupled with a massive knowledge gap in pharmacogenomics in the health-care workforce¹.
• Concerns on data confidentiality.

22

1. Pirmohamed, M. Pharmacogenomics: current status and future perspectives. Nat Rev Genet 24, 350–362 (2023). https://doi.org/10.1038/s41576-022-00572-8

Drafting the Code of Conduct

Genetic Information Nondiscrimination Act (GINA) of 2008

An act to prohibit discrimination on the basis of genetic information with respect to health insurance and employment.

Personal Data Protection Act 2010 (PDPA) [Act 709]

Primary legislation governing the protection of personal data in Malaysia, including health data.

23

Confidentiality Guidelines

The Malaysian Medical Council (MMC) has issued guidelines on confidentiality, emphasizing the importance of patient privacy and the need for consent before disclosing information. 

Future Plan: Pharmacogenomics Service Training

Expansion of services involves training in the use of pharmacogenomic data for pharmacy officers at HKL in clinical pharmacy services, all types of Medication Therapy Adherence Clinics (MTACs), outpatient & inpatient pharmacies to further strengthen consultations on the selection of the most effective and accurate medication for patients through patient pharmacogenomic information.

24

Pharmacogenomic Services

Guideline

401 pharmacist

8 Branches

~ 3000 Prescriptions/day

Pharmacogenomic

Services

Code

of

Conducts

PharmacogenomicServices

Training Module

Related documents – ongoing process

Potential

Extension of PGx services to entire MOH hospitals and healthcare clinics nationwide.

25

​

To become a training centre for Malaysia Pharmacogenomic Services, through

1. appointment of preceptors and service training centres, as well as
2. preparation of logbooks and training modules for training purposes.

​

Future ahead

Networking

Opportunities

Success

Connections

Contacts

Career growth

Relationships

Communities

Common interest

​

​

26

Thank you

27