Pharmacogenomics


 

Pharmacogenetics PGX

Pharmacogenomics or PGX

THE RIGHT MEDICATION EVERY TIME!

YOUR PATIENT’S DNA HAS THE ANSWERS

PERSONALIZE YOUR PATIENT, PERSONALIZE YOUR CARE.

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PGX

Why Should you Prescribe a Pharmacogenomics Test (PGxTest)?

– Condition Not Improving

– Unwanted Side Effects

– Allergic or Adverse Reaction

– Taking Multiple Medications

– On an Anticoagulant Therapy

 

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WHAT YOU SHOULD KNOW ABOUT ENZYME FUNCTION

 and how patients metabolize drugs can determine

which drug and dose are right for them

and help them avoid adverse drug reactions.

ACTIVE DRUGGraphic adapted from Musshoff F, Stamer UM, Madea B. Pharmacogenetics
and forensic toxicology. Forensic Sci Int. 2010;203(1-3):53-62.

FACT: 

Many drugs are considered effective only in a certain

percentage of the population, estimated to be as low as 25%.

FACT: 

Evidence suggests genetics may be one of the most

important factors in determining who will and who won’t

benefit from a particular drug, how much

to prescribe, and what adverse effects to expect. 1

FACT: 

The CYP450 enzyme system is the most important

system affecting drug metabolism.1

FACT: 

Polymorphism can determine how well a CYP450 enzyme

metabolizes a drug—or whether it metabolizes it at all.

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Protect Your Patients from Severe Adverse Drug Reactions

 

MORE THAN 4.5 MILLION ADVERSE
DRUG REACTIONS OCCUR EACH YEAR.1

Over the past few years, there has been a 90% increase in the
number of reported serious adverse drug reactions experienced
by patients.2 Are your patients among them?

The US Food and Drug Administration (FDA) defines a Serious Adverse Drug Reaction
(SADR) as any undesirable or unpredicted medication event that results in death, a
life-threatening condition, hospitalization, disability, or congenital anomaly or that requires
intervention to prevent one of these outcomes.3

ADVERSE REACTIONS AND DRUGS WITH BLACK BOX WARNINGS
SADRs are a significant concern when dealing with prescription drugs with a “Black Box
Warning,” the FDA’s most stringent classification for possible adverse side effects. The
majority of patients may be unaware of these warnings from the FDA. But the best indicator
for individual risk of an SADR for any specific patient is that patient’s own DNA.

AROUND 200 CLASSES Of DRUGS CARRY BLACK BOX WARNINGS
As advances in pharmaceutical technology continue, so does the risk associated with
an individual’s reaction to a particular drug. In 2010 alone, the FDA’s Adverse Events Reporting
System (AERS) logged over 470,000 SADRs, with over 82,000 adverse reactions
leading to death.4 Your patients are counting on you to help protect them from these risks.

GENETIC TESTING AND BLACK BOX WARNINGS
Genetic testing is advised before prescribing many drugs with Black Box Warnings. For
example, in 2010, the FDA announced that patients taking the cardiovascular drug clopidogrel
(Plavix) could have a mutation in the CYP2C19 gene, rendering them less likely
to respond to the drug, which may place them at continued risk for heart attack and
stroke.5 Genetic testing to assess the CYP2C19 genotype can determine whether a patient
is a poor metabolizer.

 

 

 

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OUR PROCESS

 

1 – Physician Prescribes Pharmacogenomics Test

2 – The patient receives an easy to use kit to collect a cheek swab sample

3 – Ship sample to our CLIA certified laboratory

4 – The test results will be ready within 24 hours

5 – Discuss the results with your patient and prescribe the optimal medication and dosage

 

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Published Information

 

Pharmacogenomics

  AMA Pharmacogenomics Report  

Click here to download PDF

FDA Paving Way for Personalized Medicinea

 FDA Paving Way for Personalized Medicine 2013 

Click here to download PDF

The Case for Personalized Medicine

The Case for Personalized Medicine  

Click here to download PDF

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 Pharmacogenomics video from the Mayo Clinic

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Pharmacogenomics Video from Centre for Addiction and Mental Health

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Katie Couric’s Notebook: Pharmacogenomics (CBS News)

 

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1. Sarkar U, Lopez A, Maselli JH, Gonzales R. Adverse drug events in U.S. adult ambulatory medical care. Health Serv Res 2011;46(5):1517-1533.
2. Institute for Safe Medication Practices. Quarterwatch: Monitoring MedWatch Reports. www.ismp.org/quarterwatch/default.aspx.
3. FDA Guidance for Industry: Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological
Products. October 2011. www.fda.gov/downloads/Drugs/…/Guidances/ucm075096.pdf.
4. FDA Adverse Events Reporting System (FAERS) Statistics: Patient Outcomes by Year. July 2011. www.fda.gov/drugs/guidancecomplianceregulatoryinformation/
surveillance/adversedrugeffects/ucm070461.htm.
5. FDA Announces New Boxed Warning on Plavix. www.fda.gov/newsevents/newsroom/pressannouncements/ucm204253.htm.
6. Güzey C, Spigset O. Genotyping as a tool to predict adverse drug reactions. Curr Top Med Chem 2004;4(13):1411-1421.