Login Register Cart 0
Generic placeholder image

Current Drug Safety

Editor-in-Chief

ISSN (Print): 1574-8863
ISSN (Online): 2212-3911

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Variability of Pharmacogenomics Information in Drug Labels Approved by Different Agencies and its Ethical Implications

Author(s): Müberra Devrim Güner*, Perihan Elif Ekmekci and Berra Kurtoglu

Volume 17, Issue 1, 2022

Published on: 27 July, 2021

Page: [47 - 53] Pages: 7

DOI: 10.2174/1574886316666210727155227

Price: $65

Abstract

Aims: The aim of this study was to determine if there are discrepancies among various agency-approved labels for the same active ingredient and where the labels approved by the Turkish Medicines and Medical Devices Agency (TMMDA) stand regarding the inclusion of PGx and discuss these ethical implications.

Background: The efficacy and safety of drugs can be improved by rational prescription and personalization of medicine for each patient. Pharmacogenomics information (PGx) in Drug Labels (DL) is one of the important tools for the personalization of medications because genetic differences may affect both drug efficacy and safety. Providing adequate PGx to patients has ethical implications.

Objective: The study aims to evaluate PGx in the DLs approved by TMMDA and other national agencies provided by the Pharmacogenomics Knowledgebase.

Methods: DL annotations from the Pharmacogenomics Knowledgebase and DLs approved by the TMMDA were analyzed according to information and action levels, which are “testing required”, “testing recommended”, “actionable”, and “informative”.

Results: There are 381 drugs listed in PharmGKB drug label annotations with pharmacogenomics information, and 278 of these have biomarkers. A total of 242 (63.5%) drugs are approved and available in Turkey. Of these, 207 (85.5%) contain the same information as in or similar to that in the labels approved by the other agencies. The presence and level of information varied among the DLs approved by different agencies. The inconsistencies may have an important effect on the efficacy and the safety of drugs.

Conclusion: These findings suggest a need for the standardization of PGx information globally because it may not only affect the efficacy and safety of medications but also essential ethical rules regarding patient rights by violating not sufficiently sharing all available information.

Keywords: Medical ethics, clinical safety, health policy, pharmacogenomics information, drug labels, patient rights, personalized medicine.

« Previous Next »
[1]
Bishop JR. Pharmacogenetics. Handb Clin Neurol 2018; 147: 59-73.
[http://dx.doi.org/10.1016/B978-0-444-63233-3.00006-3] [PMID: 29325628]
[2]
Nebert DW. Pharmacogenetics and pharmacogenomics: why is this relevant to the clinical geneticist? Clin Genet 1999; 56(4): 247-58.
[http://dx.doi.org/10.1034/j.1399-0004.1999.560401.x] [PMID: 10636440]
[3]
European Medicine Agency. 2001. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/position-paper-terminology-pharmacogenetics_en.pdf [Accessed: 28 May 2020].
[4]
Jain KK. Personalized medicine. Curr Opin Mol Ther 2002; 4(6): 548-58.
[PMID: 12596356]
[5]
Mirsadeghi S, Larijani B. Personalized medicine: Pharmacogenomics and drug development. Acta Med Iran 2017; 55(3): 150-65.
[PMID: 28282716]
[6]
Meyer UA. Drugs in special patient groups: Clinical importance of genomics in drug effects. New York: McGraw Hill 2000; pp. 1179-205.
[7]
Ingelman-Sundberg M. Pharmacogenetics: An opportunity for a safer and more efficient pharmacotherapy. J Intern Med 2001; 250(3): 186-200.
[http://dx.doi.org/10.1046/j.1365-2796.2001.00879.x] [PMID: 11555122]
[8]
Evans WE, Relling MV. Pharmacogenomics: Translating functional genomics into rational therapeutics. Science 1999; 286(5439): 487-91.
[http://dx.doi.org/10.1126/science.286.5439.487] [PMID: 10521338]
[9]
Roses AD. Pharmacogenetics and future drug development and delivery. Lancet 2000; 355(9212): 1358-61.
[http://dx.doi.org/10.1016/S0140-6736(00)02126-7] [PMID: 10776762]
[10]
Ingelman-Sundberg M, Sim SC, Gomez A, Rodriguez-Antona C. Influence of cytochrome P450 polymorphisms on drug therapies: Pharmacogenetic, pharmacoepigenetic and clinical aspects. Pharmacol Ther 2007; 116(3): 496-526.
[http://dx.doi.org/10.1016/j.pharmthera.2007.09.004] [PMID: 18001838]
[11]
Food and Drug Administration 2013. Available from: https://www.fda.gov/drugs/science-and-research-drugs/table-pharmacogenomic-biomarkers-drug-labeling [Accessed on 28 May 2020]
[12]
Shoshi A, Müller U, Shoshi A, Ogultarhan V, Hofestädt R. KALIS - an ehealth system for biomedical risk analysis of drugs. Stud Health Technol Inform 2017; 236: 128-35.
[PMID: 28508788]
[13]
Weinshilboum RM, Wang L. Pharmacogenomics: Precision medicine and drug response. Mayo Clin Proc 2017; 92(11): 1711-22.
[http://dx.doi.org/10.1016/j.mayocp.2017.09.001] [PMID: 29101939]
[14]
Eichelbaum M, Ingelman-Sundberg M, Evans WE. Pharmacogenomics and individualized drug therapy. Annu Rev Med 2006; 57: 119-37.
[http://dx.doi.org/10.1146/annurev.med.56.082103.104724] [PMID: 16409140]
[15]
Shepherd G, Mohorn P, Yacoub K, May DW. Adverse drug reaction deaths reported in United States vital statistics, 1999-2006. Ann Pharmacother 2012; 46(2): 169-75.
[http://dx.doi.org/10.1345/aph.1P592] [PMID: 22253191]
[16]
Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients. BMJ 2004; 329(7456): 15-9.
[http://dx.doi.org/10.1136/bmj.329.7456.15] [PMID: 15231615]
[17]
European Commission 2009. Available from: https://ec.europa.eu/health/sites/default/files/files/eudralex/vol-2/c/smpc_guideline_rev2_en.pdf [Accessed 5 May 2020].
[18]
Ehmann F, Caneva L, Prasad K, et al. Pharmacogenomic information in drug labels: European medicines agency perspective. Pharmacogenomics J 2015; 15(3): 201-10.
[http://dx.doi.org/10.1038/tpj.2014.86] [PMID: 25707393]
[19]
Frueh FW, Amur S, Mummaneni P, et al. Pharmacogenomic biomarker information in drug labels approved by the United States food and drug administration: Prevalence of related drug use. Pharmacotherapy 2008; 28(8): 992-8.
[http://dx.doi.org/10.1592/phco.28.8.992] [PMID: 18657016]
[20]
Republic of Turkey Ministry of Health. Turkish medicines and medical devices agency Available from: https://www.titck.gov.tr/kubkt [Accessed on 14 April 2020].
[21]
RX Media Pharma Interactive Pharmaceuticals Information Source. Available from: https://www.eczanet.com/ [Accessed on 14 April 2020]
[22]
Pharm GKB. Drug label information and legend. Available from: https://www.pharmgkb.org/labelAnnotations [Accessed on 14 April 2020].
[23]
Haga SB, Mills R, Moaddeb J. Pharmacogenetic information for patients on drug labels. Pharm Genomics Pers Med 2014; 7: 297-305.
[PMID: 25342916]
[24]
Pai SA, Kshirsagar N. A critical evaluation of pharmacogenetic information in package inserts for selected drugs marketed in india and its comparison with us FDA-approved package inserts. J Clin Pharmacol 2016; 56(10): 1232-42.
[http://dx.doi.org/10.1002/jcph.720] [PMID: 26873003]
[25]
Reis-Pardal J, Rodrigues A, Rodrigues E, Fernandez-Llimos F. Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics. Pharmacogenomics J 2017; 17(6): 488-93.
[http://dx.doi.org/10.1038/tpj.2016.40] [PMID: 27241061]
[26]
Schuck RN, Grillo JA. Pharmacogenomic Biomarkers: An FDA perspective on utilization in biological product labeling. AAPS J 2016; 18(3): 573-7.
[http://dx.doi.org/10.1208/s12248-016-9891-4] [PMID: 26912182]
[27]
Zhu Q, Freimuth RR, Pathak J, Durski MJ, Chute CG. Disambiguation of PharmGKB drug-disease relations with NDF-RT and SPL. J Biomed Inform 2013; 46(4): 690-6.
[http://dx.doi.org/10.1016/j.jbi.2013.05.005] [PMID: 23727027]
[28]
Preskorn SH, Hatt CR. How pharmacogenomics (PG) are changing practice: Implications for prescribers, their patients, and the healthcare system (PG series part I). J Psychiatr Pract 2013; 19(2): 142-9.
[http://dx.doi.org/10.1097/01.pra.0000428559.01953.73] [PMID: 23507814]
[29]
Haga SB, Thummel KE, Burke W. Adding pharmacogenetics information to drug labels: Lessons learned. Pharmacogenet Genomics 2006; 16(12): 847-54.
[http://dx.doi.org/10.1097/01.fpc.0000236322.88433.ac] [PMID: 17108808]
[30]
Shekhani R, Steinacher L, Swen JJ, Ingelman-Sundberg M. Evaluation of current regulation and guidelines of pharmacogenomic drug labels: Opportunities for improvements. Clin Pharmacol Ther 2020; 107(5): 1240-55.
[http://dx.doi.org/10.1002/cpt.1720] [PMID: 31715018]
[31]
Tan-Koi WC, Leow PC, Teo YY. Applications of pharmacogenomics in regulatory science: A product life cycle review. Pharmacogenomics J 2018; 18(3): 359-66.
[http://dx.doi.org/10.1038/tpj.2017.47] [PMID: 29205206]
[32]
Beauchamp TL, Childress JF. Principles of biomedical ethics. New york oxford university press 2001; pp. 57-103.
[33]
Brezis M, Israel S, Weinstein-Birenshtock A, Pogoda P, Sharon A, Tauber R. Quality of informed consent for invasive procedures. Int J Qual Health Care 2008; 20(5): 352-7.
[http://dx.doi.org/10.1093/intqhc/mzn025] [PMID: 18625699]
[34]
Kureshi F, Jones PG, Buchanan DM, Abdallah MS, Spertus JA. Variation in patients’ perceptions of elective percutaneous coronary intervention in stable coronary artery disease: Cross sectional study. BMJ 2014; 349: g5309.
[http://dx.doi.org/10.1136/bmj.g5309] [PMID: 25200209]
[35]
Rose D, Russo J, Wykes T. Taking part in a pharmacogenetic clinical trial: Assessment of trial participants understanding of information disclosed during the informed consent process. BMC Med Ethics 2013; 14: 34.
[http://dx.doi.org/10.1186/1472-6939-14-34] [PMID: 24025622]
[36]
Madadi P. Ethical perspectives on translational pharmacogenetic research involving children. Paediatr Drugs 2015; 17(1): 91-5.
[http://dx.doi.org/10.1007/s40272-014-0111-3] [PMID: 25504355]
[37]
Zakinova A, Long-Boyle JR, French D, et al. A practical first step using needs assessment and a survey approach to implementing a clinical pharmacogenomics consult service. J Am Coll Clin Pharm 2019; 2(3): 214-21.
[http://dx.doi.org/10.1002/jac5.1062] [PMID: 32391517]
[38]
Elewa H, Alkhiyami D, Alsahan D, Abdel-Aziz A. A survey on the awareness and attitude of pharmacists and doctors towards the application of pharmacogenomics and its challenges in Qatar. J Eval Clin Pract 2015; 21(4): 703-9.
[http://dx.doi.org/10.1111/jep.12372] [PMID: 25929423]
[39]
Amara N, Blouin-Bougie J, Bouthillier D, Simard J. On the readiness of physicians for pharmacogenomics testing: An empirical assessment. Pharmacogenomics J 2018; 18(2): 308-18.
[http://dx.doi.org/10.1038/tpj.2017.22] [PMID: 28607504]
[40]
Chua EW, Kennedy MA. Current state and future prospects of direct-to-consumer pharmacogenetics. Front Pharmacol 2012; 3: 152.
[http://dx.doi.org/10.3389/fphar.2012.00152] [PMID: 22934000]

Rights & Permissions Print Cite
Article Metrics
16
1
© 2024 Bentham Science Publishers | Privacy Policy