Ethical, Legal and Privacy Issues

Question 1

Purpose of PGx Testings

Answer 1

Provide evidence for PGx variation
Improve healthcare outcome by enhancing selection and dosing
Provide rationale for stratification of subjects in clinical studies in humans
Facilitate PGx research and development

Question 2

PGX in comparison with traditional genetic testings

Answer 2

Disease risk vs safety and efficacy
Implication: familial or risk of genetic discrimination
Sensitive information, interpretation of data, cost, education to patients

Question 3

PGx in comparison with other clinical testings

Answer 3

Less regulation as needed for genetic testing

Question 4

To offer a PGx testing

Answer 4

Weigh benefits vs risk
Can have a negative effect on outcome of therapy and possibly delay therapy
COSTLY!

Question 5

Implication and problems in clinical practices

Answer 5

Test positive but don’t have a way to treat or handle that

Only treatment doesn’t work or isn’t safe so no effective therapy is available

Question 6

Negative effects of PGx deficiency in pts

Answer 6

Depression
Anxiety
Pt knows deficiency affects response or side effects
Pts may request a drug with a contraindication

Question 7

Conventional approaches based on

Answer 7

Age, sex, race, etc
Disease status
Comorbidity
Physiology/pathology (pregnancy, kidney/liver function)

Question 8

PGX approaches add on approaches:

Answer 8

PK characterstics (ADME, disease independent) (differentiating people)
PD characteristics (disease subtype) (differentiating disease)

Question 9

Benefits of PGx approach

Answer 9

Improve efficacy
Avoid side effects
Improve outcome

Question 10

Risk and problems with PGx approach

Answer 10

Orphan population
Unequal distribution of risk
Denial of therapy

Question 11

Economical consideration with PGx approach

Answer 11

Blockbuster drugs
Incentive for develop drugs for good responders not poor or for most prevalent genotype
Selection of population for clinical trials

Question 12

Approval of Race-Targeted Drug BiDil

Answer 12

First drug approved
Fixed-dose combination of isosorbide and hydralazine
For heart failure, adjunct for black pts
Failed with negative publicity

Question 13

Benefits of race in PGx approach

Answer 13

Improve efficacy and avoid side effects

Improved outcomes

Question 14

Risk and problems of race drugs in PGx approach

Answer 14

Higher cost
Privacy
Discrimination

Question 15

Access to therapy and PGx testing

Answer 15

Pt preference may not align with willingness to get tested or test results

Question 16

Physician challenges to pts and PGx testing

Answer 16

Pts may decline but still wish to have the drug

Pt undergoes test but request a drug with contraindication

Question 17

Risk and problems with pts and PGx testing

Answer 17

Benefits vs harm
Alternate drugs
Refusual to prescribe
Pts acceptance of testing
Cost

Question 18

Testing in children

Answer 18

Pediatric Research Equity Act
Best Pharmaceuticals for Children Act
6 month exclusivity (marketing incentive)

Question 19

PG consideration in children

Answer 19

Changes in gene expression
Metabolizing enzymes
Pediatric disease differences
Minimal risk trials

Question 20

Increased Medical Liability

Answer 20

Failure to consider testing
AE of med lawsuits
Needs for testing before drug can be prescribed

Question 21

Lyme Vaccine

Answer 21

LYMerix
Led to autoimmune arthritis in pts with HLA DR4+ and did not test for it
Withdrawn

Question 22

Medical Liability

Answer 22

Malpractice
Informed consent
Product liability

Question 23

Medical Liability in PGx Manufacturers

Answer 23

Drug label including genetic risk
Design-defect (test kits and info about it)
Failure to test enough

Question 24

Medical Liability in PGx Physicians

Answer 24

Failue to order a test for screening
Misinterpret results
Failure to provide genetic counseling or worn family
Drug label and test requirements

Question 25

Pharmacists + Omnibus Budget Reconciliation Act

Answer 25

If a pharmacists is aware or learns that pt with a particular genetic variant may be at risk of AE but doesn't tell them = breach of duty

Question 26

Pharmacists is responsible for

Answer 26

bring obvious errors to the attention of the patient or physician

Question 27

Ancillary information goal is to

Answer 27

balance benefits and risk even if you cannot explore all benefits

Question 28

Risks

Answer 28

One gene may be involved in more than one disease, more than one drug, more than one individual

Question 29

Informed consent

Answer 29

Written or verbal consent | If PGX is considered different then might not need IC

Question 30

Formal consent is needed, if:

Answer 30

Familial implication Ancillary information needed Risk of discrimination Laws

Question 31

Familial implication

Answer 31

Disclosure of results to family members (potential harms and confidentiality) Consent form the pt Benefits vs risk

Question 32

Individuals ______ own their own health data or stored tissue specifmesn

Answer 32

DO NOT

Question 33

Major issues with access to specimens and PGx data

Answer 33

Human subject protection Informed consent Categories of data and specimens for research

Question 34

Categories

Answer 34

Unidentified Unlinked Coded Identified

Question 35

HIPAA

Answer 35

Health Insurance Portability and Accountability Act

Question 36

HIPAA Privacy Rule

Answer 36

Distinguishes individually identifiable health information (IIHI) from de-identified health information

Question 37

Which information needs informed consent?

Answer 37

IIHI

Question 38

In PGx Research

Answer 38

Follow HIPPA IIHI: informed consent DIIHI: follow coding Previously collected samples: consent (waiver and alterations)

Question 39

Pharmacists + PGx Major Role

Answer 39

``` Safety Potential ADR Provide information on substitutions, concomitant meds, alternate therapy Case management of complex meds Vaccinations Health screening Prescriptions ```

Question 40

PGx Specific + Pharmacists

Answer 40

Ensure proper dosing | Interactions!!!