DRUG USE BEHAVIORS AND POTENTIAL RISK OF HEPATOTOXICITY: A CASE STUDY OF PARACETAMOL IN CHIANG MAI
DOI:
https://doi.org/10.69598/tbps.13.2.25-40Keywords:
paracetamol, use behavior, potential risk of hepatotoxicityAbstract
Paracetamol is an antipyretic and analgesic medication commonly used and considered to be safe. It is therefore classified as a nonprescription drug and is available in drugstores and convenience stores. However, reports regarding unsafe use of paracetamol are increasing, leading to risks for people using this medication. This research aimed to survey the behavior of use and potential risks of hepatotoxicity from paracetamol among people in Chiang Mai in order to reflect the pattern of use of this well-known and easily accessible drug. A cross-sectional descriptive study design was used, and data were collected from interviews in 2014. The subjects were people living in Chiang Mai aged between 18-80, who had taken or were currently taking paracetamol, and who were willing to participate in the study. Out of the 416 people included, most used paracetamol for the relief of fever or headaches, accounting for 85.3 and 75.2 percent respectively. Most of the subjects (51.9 percent) took 2 tablets of 500 milligrams of paracetamol each time. Regarding intervals of administration, the subjects used various methods including every so many hours, or at meal times. Labels or leaflets are important sources of information about paracetamol. 40.4 percent of users read the label every time they bought the drug, whereas 47.6 percent read the label occasionally. In terms of purchasing behavior, most users (77.9 percent) purchased less than 30 tablets at a time. The potential of hepatotoxicity from paracetamol were mostly found among those consuming greater than 4 grams per day (29.8 percent), followed by concomitant use with other drugs containing paracetamol (26.7 percent). Minimal potential included the use of paracetamol in combination with alcoholic beverages (6.3 percent) and malnutrition (1.0 percent). In conclusion, even though paracetamol is a common medication with which most Thais are familiar, some users still take it incorrectly leading to potential of hepatotoxicity. Healthcare professionals, in particular pharmacists, should therefore provide patient education on the safe use of the medication regularly.
References
2. Angtrakool P, Yoongthong W, Wongpoowarak P, Thanawuth N, Kitikannakorn N, Assawamakin A, et al. The development of risk management of medicines in Thailand: A case study of Paracetamol. FDA Journal. 2017;61-74. (in Thai)
3. Mazer M, Perrone J. Acetaminophen-induced nephrotoxicity: pathophysiology, clinical manifestations, and management. J Med Toxicol. 2008;4:2-6.
4. McGill MR, Jaeschke H. Metabolism and disposition of acetaminophen: recent advances in relation to hepatotoxicity and diagnosis. Pharm Res. 2013;30:2174-87.
5. James LP. Acetaminophen pathology and clinical presentation of hepatotoxicity. In Neil Kaplowitz N, DeLeve LD, editors. Drug-Induced Liver Disease. 3 rd ed. Elsevier Inc, 2013;331-41.
6. James LP, Mayeux PR, Hinson JA. Acetaminophen-induced hepatotoxicity. Drug Metab Dispos. 2003;31:1499-506.
7. Larson AM, Polson J, Fontana RJ, Davern TJ, Lalani E, Hynan LS. Acetaminophen-induced acute liver failure: results of a United States multicenter, prospective study. Hepatology. 2005;42:1364-72.
8. Ging P, Mikulich O, O'Reilly K.M. Unexpected paracetamol (acetaminophen) hepatotoxicity at standard dosage in two older patients: time to rethink 1 g four times daily? Age Ageing. 2016:1-2.
9. Kurtovic J, Riordan SM. Paracetamol-induced hepatotoxicity at recommended dosage. J Intern Med. 2003;253:240-43.
10. Chuaychai A, Saetan A, Apiromruck N, Kwuatong N, Kaewmanee W. Prevalence of patients with the risk of receiving overdosed paracetamol from dosage instruction in a 250 bed hospital in the south. Thai Journal of Pharmacy Practice. 2016;8:303-8. (in Thai)
11. Zimmerman HJ, Maddrey WC. Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure. Hepatology. 1995;22:767-73.
12. Lauterburg BH, Velez ME. Glutathione deficiency in alcoholics: risk factor for paracetamol hepatotoxicity. Gut. 1988;29:1153-7.
13. Kuffner EK, Dart RC, Bogdan GM, Hill RE, Casper E, Darton L. Effect of maximal daily doses of acetaminophen on the liver of alcoholic patients: a randomized, double-blind, placebo-controlled trial. Arch Intern Med. 2001;161:2247-52.
14. Zenger F, Russmann S, Junker E, Wuthrich C, Bui MH, Lauterburg BH. Decreased glutathione in patients with anorexia nervosa. Risk factor for toxic liver injury? Eur J Clin Nutr. 2004;58:238-43.
15. Watkins PB, Kaplowitz N, Slattery JT, Colonese CR, Colucci SV, Stewart PW, Harris SC. Aminotransferase elevations in healthy adults receiving 4 grams of acetaminophen daily: a randomized controlled trial. JAMA. 2006;296:87-93.
16. Drug Safety and Risk Management Advisory Committee. Acetaminophen overdose and liver injury-background and options for reducing injury [monograph on the Internet]. USFDA; 2010[cited2016 June 16]. Available form : https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DrugSafetyandRiskManagementAdvisoryCommittee/UCM164897.pdf
17. Schmidt LE, Dalhoff K. The impact of current tobacco use on the outcome of paracetamol poisoning. Aliment Pharmacol Ther. 2003;18:79-85.
18. Boudreau DM, Wirtz H, Von Korff M, Catz SL, St John J, Stang PE. A survey of adult awareness and use of medicine containing acetaminophen. Pharmacoepidemiol Drug Saf. 2013;22:229-40.
19. US Food and Drug Administration. Joint Meeting of the Drug Safety and Risk Management Advisory Committee with the Anesthetic and Life Support Drugs Advisory Committee and the Nonprescription Drugs Advisory Committee: Meeting Announcement. [monograph on the Internet] 2009. [cited 2016 June 16]. Available from: https://www.fda.gov/AdvisoryCommittees/Calendar/ucm143083.htm.
20. Kawmune P, Chattakul W. Knowledge and risk of people in Muang District, Chiang Mai Province regarding analgesics [special problem]. 2012 Chiangmai University. (in Thai)
21. Micromedex® Healthcare Series, [Database on the internet]. Colorado:Thomson Reuters (Healthcare). DRUGDEX® system, Acetaminophen; [cited 2016 June 16]. Available from: https://www.thomsonhc.com
22. Manley J, Taddio A. Acetaminophen and ibuprofen for prevention of adverse reactions associated with childhood immunization. Ann Pharmacother. 2007;41:1227-32.
23. De Oliveira GS Jr, Castro-Alves LJ, McCarthy RJ. Single-dose systemic acetaminophen to prevent postoperative pain: a meta-analysis of randomized controlled trials. Clin J Pain. 2015;31:86-93.
24. HFocus [monograph on the Internet]. 2014 [cited 2016 June 16]. Available from: https://www.hfocus.org/ content/2014/10/8324 (in Thai)
25. Notification of the Ministry of Public Health (No 7) B.E. 2560 (2017). [cited 2016 May 10]. Available from: https://203.157.72.106/fulltext2/. (in Thai)
26. Beleyn B, Vermeersch S, Kulo A, Smits A, Verbesselt R, de Hoon JN, et al. Estradiol and weight are covariates of paracetamol clearance in young women. Gynecol Obstet Invest. 2014;77:211-6.
27. FDA Drug Safety Communication: Prescription Acetaminophen Products to be Limited to 325 mg Per Dosage Unit; Boxed Warning Will Hightlight Potential for Severe Liver Failure [monograph on the Internet]. 2011[cited 2016 June 13]. Available from: https://www.fda.gov/Drugs/DrugSafety/ucm23982.htm.
28. Stephen G, Derry S, Moore RA. Paracetamol (acetaminophen) for acute treatment of episodic tension-type headache in adults. [database on the Internet]. Cochrane Database Syst Rev 2016. [cited 2016 May 10]. Available from: www.cochranelibrary.com
29. Ponpol P. Fact sheet: paracetamol [mon
ograph on the Internet] FDA Thailand; 2009 [cited 2017 May 10]. Available from: https://db.oryor.com/databank/data/ printing//521120_Factsheet (in Thai)
30. Hawton K, Bergen H, Simkin S, Dodd S, Pocock P, Bernal W, et al. Long term effect of reduced pack sizes of paracetamol on poisoning deaths and liver transplant activity in England and Wales: interrupted time series analyses. BMJ 2013;346:f403.
31. Putkong S, Panpakdee O, Malathum P, Kawamatawong T. Factors related to self-care behavior for medication use and perceived asthma control in older persons with asthma. Rama Nurse J.2011;17:309-27. (in Thai)
32. Kingthong K, Treesak C, Sangjam P. A comparison of dose of paracetamol syrup products with references. Dialogue Pharm Health Care Pract. 2014;1:13-9. (in Thai)
33. Li G, Hu H, Dong Z, Xie J, Zhou Y. Urban and suburban differences in hypertension trends and self-care: three population-based cross-sectional studies from 2005-2011. PLoS ONE 10: e0117999.
34. Heo S, Moser DK, Lennie TA, Riegel B, Chung ML. Gender differences in and factors related to self-care behaviors: a cross-sectional, correlational study of patients with heart failure. Int J Nurs Stud. 2008;45:1807-15.
35. Bertakis KD, Azari R, Helms LJ, Callahan EJ, Robbins JA. Gender difference in the utilization of health care services. J Fam Prac. 2000;147.
36. Joni LS, Cheryl PL, Leonard EE. Rural/Urban variation in diabetes self-care and quality of care in a national sample of US adults with diabetes. Diabetes Educ. 2011;37:254-62.
37. Brackett CC, Bloch JD. Phenytoin as a possible cause of acetaminophen hepatotoxicity: case report and review of the literature. Pharmacother. 2000;20:229-33.
38. Teixeira J, Mota T, Fernandes JC. Nutritional evaluation of alcoholic inpatients admitted for alcohol detoxification. Alcohol Alcohol. 2011;46:558-60.
39. Hayward KL, Powell EE, Irvine KM, MartinJH. Can paracetamol (acetaminophen) be administered to patients with liver impairment? Br J Clin Pharmacol. 2016;81:210-22.
40. Chandok N, Watt KD. Pain management in the cirrhotic patient: the clinical challenge. Mayo Clin Proc. 2010;85:451-8.
Downloads
Published
How to Cite
Issue
Section
License
All articles published and information contained in this journal such as text, graphics, logos and images is copyrighted by and proprietary to the Thai Bulletin of Pharmaceutical Sciences, and may not be reproduced in whole or in part by persons, organizations, or corporations other than the Thai Bulletin of Pharmaceutical Sciences and the authors without prior written permission.
