Version 1.1 / Date of Issue: 2.09.16 / Issuing Authority: Forensic Science Standards Board (FSSB)

OSAC RESEARCH NEEDS ASSESSMENT FORM

Title of research need: The Role and Impact of Pharmacogenetics and Pharmacogenomics in Forensic 

Toxicology

Keyword(s): Pharmacogenetics, Pharmacogenomics, Pharmacokinetics, Pharmacodynamics, Drug 

Interactions

Submitting subcommittee(s): Toxicology Date Approved: 4/2/18

(If SAC review identifies additional subcommittees, add them to the box above.)

Background Information:

1. Description of research need:

Research is needed to evaluate the role of pharmacogenetics and pharmacogenomics in the field of forensic 

toxicology. Pharmacogenetics investigates genetic differences in metabolic pathways which results in 

variation in individual responses to xenobiotics and effect(s) on the intended therapeutic efficacy and 

potential adverse events (e.g. overdose). Pharmacogenomics is the study of how individual genetic 

polymorphisms may affect the response to drug(s). Research in these areas may provide a greater 

understanding of the role of pharmacogenetics and pharmacogenomics in interpreting drug concentrations 

determined from ante- and post-mortem forensic toxicological analysis. 

2. Key bibliographic references relating to this research need:

1. Nita A. Limdi, David L. Veenstra, Expectations, validity, and reality in pharmacogenetics, In Journal of 

Clinical Epidemiology, Volume 63, Issue 9, 2010, Pages 960-969, ISSN 0895-4356, 

https://doi.org/10.1016/j.jclinepi.2009.09.006.

2. A. Sajantila, J.U. Palo, I. Ojanperä, C. Davis, B. Budowle, Pharmacogenetics in medico-legal context, In 

Forensic Science International, Volume 203, Issues 1–3, 2010, Pages 44-52, ISSN 0379-0738, 

https://doi.org/10.1016/j.forsciint.2010.09.011.

3. Frank Musshoff, Ulrike M. Stamer, Burkhard Madea, Pharmacogenetics and forensic toxicology, In 

Forensic Science International, Volume 203, Issues 1–3, 2010, Pages 53-62, ISSN 0379-0738, 

https://doi.org/10.1016/j.forsciint.2010.07.011.

4. Victor E. Ortega, Deborah A. Meyers, Pharmacogenetics: Implications of race and ethnicity on defining 

genetic profiles for personalized medicine, In Journal of Allergy and Clinical Immunology, Volume 133, Issue 

1, 2014, Pages 16-26, ISSN 0091-6749, https://doi.org/10.1016/j.jaci.2013.10.040.

5. Bhushan M. Kapur, Prateek K. Lala, Julie L.V. Shaw, Pharmacogenetics of chronic pain management, In 

Clinical Biochemistry, Volume 47, Issues 13–14, 2014, Pages 1169-1187, ISSN 0009-9120, 

https://doi.org/10.1016/j.clinbiochem.2014.05.065.

6. Jessica Lam, Karen L. Woodall, Patricia Solbeck, Colin J.D. Ross, Bruce C. Carleton, Michael R. Hayden, 

Gideon Koren, Parvaz Madadi, Codeine-related deaths: The role of pharmacogenetics and drug interactions, 

In Forensic Science International, Volume 239, 2014, Pages 50-56, ISSN 0379-0738, 

https://doi.org/10.1016/j.forsciint.2014.03.018.
Version 1.1 / Date of Issue: 2.09.16 / Issuing Authority: Forensic Science Standards Board (FSSB)

7. Hicks, J., Bishop, J., Sangkuhl, K., Müller, D., Ji, Y., Leckband, S., Leeder, J., Graham, R., Chiulli, D., LLerena, 

A., Skaar, T., Scott, S., Stingl, J., Klein, T., Caudle, K. and Gaedigk, A. (2015), Clinical Pharmacogenetics 

Implementation Consortium (CPIC) Guideline for CYP2D6 and CYP2C19 Genotypes and Dosing of Selective 

Serotonin Reuptake Inhibitors. Clin. Pharmacol. Ther., 98: 127–134. doi:10.1002/cpt.147

8. Hicks, J., Sangkuhl, K., Swen, J., Ellingrod, V., Müller, D., Shimoda, K., Bishop, J., Kharasch, E., Skaar, T., 

Gaedigk, A., Dunnenberger, H., Klein, T., Caudle, K. and Stingl, J. (2017), Clinical pharmacogenetics 

implementation consortium guideline (CPIC) for CYP2D6 and CYP2C19 genotypes and dosing of tricyclic 

antidepressants: 2016 update. Clin. Pharmacol. Ther., 102: 37–44. doi:10.1002/cpt.597

9. Munir Pirmohamed, Pharmacogenetics for the prescriber, In Medicine, Volume 40, Issue 7, 2012, Pages 

362-365, ISSN 1357-3039, https://doi.org/10.1016/j.mpmed.2012.04.005.

10. Bank, P.C., Swen, J.J., Guchelaar. Pharmacogenetic biomarkers for predicting drug response. Expert 

Review of Molecular Diagnostics. Volume 14, Issue 6, 2014, Pages 723-735 

https://doi.org/10.1586/14737159.2014.923759

3a. In what ways would the research results improve current laboratory capabilities?

Forensic Toxicologists may be asked to provide interpretations on the significance of drug concentrations 

determined through laboratory analysis. It is widely known that inter-individual variations in drug 

adsorption, distribution, metabolism, and excretion exists. Specific to forensic toxicology is a lack of 

research regarding the roles of pharmacogenetics and pharmacogenomics in understanding these 

variations. 

3b. In what ways would the research results improve understanding of the scientific basis for the 

subcommittee(s)?

Research in the areas of pharmacogenetics and pharmacogenomics, specific to forensic toxicology, will add 

to the body of knowledge on individual variability, may help to provide insight on the significance of 

variations, and improve interpretive capabilities of forensic toxicologists.

3c. In what ways would the research results improve services to the criminal justice system?

At times, forensic toxicologists are asked to provide scientific information to attorneys, judges, and jurors on 

the role drug(s) may have played in an individual’s impairment or death. Data related to individual 

variations in pharmacodynamics/pharmacokinetic variations and the role 

pharmacogenetics/pharmacogenomics play in these differences is limited. If the body knowledge was 

expanded, forensic toxicologists would be able to provide more comprehensive interpretation to the 

criminal justice system as a whole. 

4. Status assessment (I, II, III, or IV): II Major gap in 

current 

knowledge

Minor gap in 

current 

knowledge

No or limited

current research 

is being conducted

I III
Version 1.1 / Date of Issue: 2.09.16 / Issuing Authority: Forensic Science Standards Board (FSSB)

Existing current 

research is being 

conducted

II IV

This research need has been identified by one or more subcommittees of OSAC and is being provided as an 

informational resource to the community.

Approvals:

Subcommittee Approval date: 4/2/18

(Approval is by majority vote of subcommittee. Once approved, forward to SAC.)

SAC

1. Does the SAC agree with the research need? Yes x No

2. Does the SAC agree with the status assessment? Yes x No

If no, what is the status assessment of the SAC:

Approval date: 4/2/18

(Approval is by majority vote of SAC. Once approved, forward to NIST for posting.)