CLINICAL ISSUES :: DRUG TESTING AND MONITORING Medicine Type Antibiotics Heart drug Anti-seizure drug


Autoimmune disease Bipolar disorder


Example


Vancomycin, Gentamycin, Amakacin


Digoxin, Procainamide, Lidocaine Phenytoin, Phenobarbital Cyclosporine, Tacrolimus Lithium, Valproic acid


Table 2. Examples of medicine types requiring therapeutic monitoring.


analytical method used for the confirmatory drug test must combine gas (GC) or liquid (LC) chromatographic separation and mass spectrometric (MS) identification. Urine specimens must undergo a specimen preparation process (i.e., extraction) prior to GC/MS analysis and may require preparation prior to LC/MS/MS analysis.


Therapeutic drug monitoring Some therapeutic drugs also need testing in certain circum- stances. Therapeutic drug monitoring is required to measure the amount of a medicine or its metabolites in the blood/ plasma or serum at a specific time point to determine if a patient’s drug concentrations are within the therapeutic range and are neither subtherapeutic nor potentially toxic. It is used to determine the best dosages for patients on certain hard-to-dose medicines.16 Some of the most common medicines that need monitoring


are shown in Table 2. The methods used for therapeutic drug monitoring are


high performance liquid chromatography (HPLC), HPLC combined with mass spectrometry, or immunoassays such as enzyme immunoassay (EIA), fluorescence polarization immunoassay (FPIA), and microplate enzyme-linked immu- nosorbent assay (ELISA).


Deaths due to drug overdoses have been on the rise for years in the United States, but the COVID-19 pandemic worsened the situation further.


Conclusion Drug abuse devastates families and is a great menace for the society. Drug addiction in individuals results in broken families, increased crime, accidents, death, overburdened jails and prisons, reduced employee productivity, increased costs on foster care, healthcare, and treatment. As prevention is better than cure, all efforts should be made


to prevent drug abuse in individuals. Strict supervision by parents of their children, family-based, school-based and community-based programs to educate on the ill effects of drug abuse and how to control mind and temptations should be followed. Moreover, early and accurate detection of substance abuse is


essential and the first step towards identification and treatment of the individuals under influence of drugs.


REFERENCES


1. Guidelines for ATC classification and DDD assignment. World Health Organization Collaborating Centre for Drug Statistics Methodology. Published 2011. Accessed October 27, 2022. https://www.whocc.no/ filearchive/publications/2011guidelines.pdf.


2. USP Medicare model guidelines v. 7.0. United States Pharmaco- poeia. Accessed October 27, 2022. https://www.usp.org/sites/default/ files/usp/document/our-work/healthcare-quality-safety/uspmmg_ v7_0_w_exampledrugs_rev170206.pdf.


3. Drugs and the Brain. National Institute on Drug Abuse. Published July 10, 2020. Accessed October 27, 2022. https://www.drugabuse.gov/ publications/drugs-brains-behavior-science-addiction/drugs-brain.


4. Key substance use and mental health indicators in the United States: Results from the 2019 National Survey on Drug Use and Health (HHS Publication No. PEP20-07-01-001, NSDUH Series H-55). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Substance Abuse and Mental Health Services Administration. Published 2020. Accessed October 27, 2022. Retrieved from https://www.samhsa.gov/data/.


5. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. Provisional drug overdose death counts. National Center for Health Statistics. Published 2022. Accessed October 27, 2022. https://www.cdc.gov/nchs/nvss/vsrr/ drug-overdose-data.htm.


6. Tice P, Lipari R, Van Horn S. Substance Use among 12th Grade Aged Youths, by Dropout Status. Rockville, MD: Center for Health Statistics and Quality, Substance Abuse and Mental Health Administration. Pub- lished August 15, 2017. Accessed October 27, 2022. https://www.sam- hsa.gov/data/sites/default/files/report_3196/ShortReport-3196.html.


7. Chen CY, Storr CL, Anthony JC. Early-onset drug use and risk for drug dependence problems. Addict Behav. 2009;34(3):319-22. doi: 10.1016/j.addbeh.2008.10.021.


8. Lander L, Howsare J, Byrne M. The impact of substance use disor- ders on families and children: from theory to practice. Soc Work Public Health. 2013;28(3-4):194-205. doi: 10.1080/19371918.2013.759005.


9. Simmons LA, Havens JR, Whiting JB, Holz JL, Bada H. Illicit drug use among women with children in the United States: 2002-2003. Ann Epidemiol. 2009;19(3):187-93. doi: 10.1016/j.annepidem.2008.12.007.


10. Shankaran S, Lester BM, Das A, Bauer CR, Bada HS, Lagasse L, Higgins R. Impact of maternal substance use during pregnancy on childhood outcome. Semin Fetal Neonatal Med. 2007;12(2):143-50. doi: 10.1016/j.siny.2007.01.002.


11. Fowler JS, Volkow ND, Kassed CA, Chang L. Imaging the addicted human brain. Sci Pract Perspect. 2007;3(2):4-16. doi: 10.1151/spp07324.


12. Goldstein RZ, Volkow ND. Dysfunction of the prefrontal cortex in addiction: neuroimaging findings and clinical implications. Nat Rev Neurosci. 2011;20;12(11):652-69. doi: 10.1038/nrn3119.


13. Hadland SE, Levy S. Objective Testing: Urine and Other Drug Tests. Child Adolesc Psychiatr Clin N Am. 2016;25(3):549-65. doi: 10.1016/j. chc.2016.02.005.


14. Drug Scheduling. DEA. Published July 10, 2018. Accessed October 27, 2022. https://www.dea.gov/drug-information/drug-scheduling.


15. Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs. Department of Health and Human Services Substance Abuse & Mental Health Services Administration (SAMHSA). Revised March 2018. Accessed October 27, 2022. https://www.samhsa. gov/sites/default/files/workplace/mro-guidance-manual-oct2017_2.pdf.


16. Mabilat C, Gros MF, Nicolau D, Mouton JW, et al. Diagnostic and medical needs for therapeutic drug monitoring of antibiotics. Eur J Clin Microbiol Infect Dis. 2020;39(5):791-797. doi: 10.1007/s10096-019-03769-8.


Rajasri Chandra, MS, MBA is a global marketing leader with expertise in managing upstream, downstream, strategic, tactical, traditional, and digital marketing in biotech, in vitro diagnostics, life sciences, and pharmaceutical industries. Raj is an orchestrator of go-to-market strategies driving complete product life cycle from ideation to commercialization.


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