Abstract
With the increase in utilization of alternative medications to manage cancer treatment-related side effects, pharmacovigilance of alternative drug therapies, specifically herbal supplements, has become of increasing importance in the oncologic setting. This chapter focuses on the pharmacovigilance of herbal supplements in the setting of cancer drug therapy and explores national and international drug policies that have been employed to mitigate adverse herbal supplement events (AHEs). This chapter examines common drug-herbal supplement interactions, discusses the mechanisms behind these interactions, and investigates several common pharmacovigilance reporting methods clinicians can use to report adverse events. This chapter will also describe policies and strategies that can be employed to monitor use of these alternative drug therapies, and examines global harmonization efforts to reduce AHEs in the cancer setting. The safety of herbal medicines has emerged as an international public health priority, and we explore how oncology providers may directly apply the knowledge garnered herein to help guide their clinical management of oncology patients utilizing alternative medications.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Pharmacovigilance. Available at http://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/.
Hazell L, Shaki SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–6.
Pal SN, Duncombe C, Falzon D, Olsson S. WHO strategy for collecting safety data in public health programmes: complementing spontaneous reporting systems. Drug Saf. 2013;36(2):75–81.
Varallo FR, Guimarães Sde O, Abjaude SA, Mastroianni Pde C. Causes for the underreporting of adverse drug events by health professionals: a systematic review. Rev Esc Enferm USP. 2014;48(4):739–47.
Aggarwal BB, Kunnumakkara AB, Harikumar KB, Tharakan ST, Sung B, Anand P. Potential of spice-derived phytochemicals for cancer prevention. Planta Med. 2008;74:1560–9.
Kasliwal R. Spontaneous reporting in pharmacovigilance: strengths, weaknesses and recent methods of analysis. J Clin Prev Cardiol. Available at http://www.jcpcarchives.org/full/spontaneous-reporting-in-pharmacovigilance–strengths-49.php.
Guidance Document for Industry—Reporting Adverse Reactions to Marketed Health Products. Available at https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/guidance-document-industry-reporting-adverse-reactions-marketed-health-products-health-canada-2011.html.
Increased use of oral chemotherapy drugs spurs increased attention to patient compliance. J Oncol Pract. 2008;4(4):175–7. https://doi.org/10.1200/jop.0843002.
Partridge AH, Avorn J, Wang PS, et al. Adherence to therapy with oral antineoplastic agents. J Natl Cancer Inst. 2002;94:652–61.
Weingart SN, Brown E, Bach PB, et al. NCCN task force report: oral chemotherapy. J NCCN. 2008;6:S1–15.
Fasinu PS, Bouic PJ, Rosenkranz B. An overview of the evidence and mechanisms of herb-drug interactions. Front Pharmacol. 2012;30(3):69. https://doi.org/10.3389/fphar.2012.00069.
Borrelli F, Izzo A. Herb-drug interactions with St John’s wort (Hypericum perforatum): an update on clinical observations. AAPS J. 2009;11:710.
Frye RF, Fitzgerald SM, Lagattuta TF, et al. Effect of St John’s wort on imatinib mesylate pharmacokinetics. Clin Pharmacol Ther. 2004;76:323–9.
Whqlibdoc.who.int [homepage on the Internet]. Geneva: World Health Organization. 1973. Handbook of resolutions and decisions of the World Health Assembly and Executive Board. Available from: http://whqlibdoc.who.int/wha_eb_handbooks/9241652063_Vol2.pdf.
Essential Medicines and Health Products. Available at http://www.who.int/medicines/areas/quality_safety/safety_efficacy/National_PV_Centres_Map/en/.
WHO guidelines on safety-monitoring of herbal medicines in pharmacovigilance systems. Available at http://apps.who.int/medicinedocs/documents/s7148e/s7148e.pdf.
Herbal Medicinal Products. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000208.jsp.
Dietary Supplement Products and Ingredients. Available at https://www.fda.gov/food/dietarysupplements/productsingredients/.
Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, of Holding Operations for Dietary Supplement; Small Entity Compliance Guide. Available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/DietarySupplements/ucm238182.htm.
Uppsala Monitoring Centre. Available at https://www.who-umc.org/.
Shetti S, Kumar CD, Sriwastava NK, Sharma IP. Pharmacovigilance of herbal medicines: current state and future directions. Pharmacognosy Magazine. 2011;7(25):69.
Committee on Herbal Medicinal Products (HMPC). Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000264.jsp.
Americans Spend $30Â Billion a Year Out-of-Pocket on Complementary Health Approaches. Available at https://nccih.nih.gov/research/results/spotlight/americans-spend-billions?nav=rss.
Nahin RL, Barnes PM, Stussman BJ. Expenditures on complementary health approaches: United States, 2012 (433Â kb pdf). National Health Statistics Reports. Hyattsville, MD: National Center for Health Statistics; 2016.
Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2006;29(5):385–96 Epub 2006/05/13.
Richardson M, Sanders T, Palmer J. Complementary alternative medicine use in a comprehensive cancer center and the implications for oncology. J Clin Oncol. 2000;18:2505–14.
Hoffman KB, Demakas AR, Dimbil M, Tatonetti NP, Erdman CB. Stimulated reporting: the impact of US food and drug administration-issued alerts on the adverse event reporting system (FAERS). Drug Saf. 2014;37(11):971–80.
Layton D, Hazell L, Shakir SA. Modified prescription-event monitoring studies: a tool for pharmacovigilance and risk management. Drug Saf. 2011;34:e1–9.
Barnes J. Quality, efficacy and safety of complementary medicines: fashions, facts and the future. Part II: efficacy and safety. Br J Clin Pharmacol. 2003;55(4):331–40.
Tascilar M, de Jong FA, Verweij J, Mathijssen RH. Complementary and alternative medicine during cancer treatment: beyond innocence. Oncologist. 2006;11(7):732–41.
McKoy JM, Haleem AS, Liebling DB. Herbal supplements: boon or bane for older cancer patients? Available at http://ascopubs.org/doi/abs/10.1200/jco.2011.29.15_suppl.e16633.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2019 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Liebling, D.B., Cordova, E., Deng, G., McKoy, J.M. (2019). Pharmacovigilance of Alternative Medications in the Cancer Setting. In: McKoy, J., West, D. (eds) Cancer Policy: Pharmaceutical Safety. Cancer Treatment and Research, vol 171. Springer, Cham. https://doi.org/10.1007/978-3-319-43896-2_3
Download citation
DOI: https://doi.org/10.1007/978-3-319-43896-2_3
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-43894-8
Online ISBN: 978-3-319-43896-2
eBook Packages: MedicineMedicine (R0)