Abstract
Background The misunderstanding of adverse drug reaction labelling information is not conducive to the rational use of drugs. There has been no research on how doctors can effectively transmit information on adverse drug reactions to patients in China. Objective To assess how well patients understand the adverse reactions presented in the labelling of drugs and how much information they want from their doctor regarding the adverse reactions. Setting The study was conducted in secondary medical institutions, tertiary medical institutions and community healthcare centres in Shanghai. Method A cross-sectional self-administered survey was conducted from November 2018 to March 2019. Mixed methods involving paper questionnaires and online surveys (scan a QR code by the WeChat app) were used. Main outcome measure Participants’ demand for adverse reaction information. Results A total of 295 people completed the questionnaires, of which 31.8% of people thought that the greater the number of adverse reactions listed on the label of a drug, the more insecure they felt about that drug. At the same time, 30.13% of people thought that if the adverse reactions listed on a label were undefined, then the drug was safe for use (for example, some Chinese patent medicines). Most of the respondents (45.4%) thought that it was better to give a brief description of possible adverse reactions and to answer patients’ questions in detail only if necessary. Conclusions Most patients wanted doctors to give them a brief introduction to serious and common adverse reactions when they prescribed drugs, and only a small percentage of people wanted to obtain all the information about adverse reactions. It was found that many people misunderstood the contents of the adverse reactions provided on the labels and equated the number of adverse reactions with drug safety.
Similar content being viewed by others
Abbreviations
- ADRs:
-
Adverse drug reactions
- QR:
-
Quick response
References
The People’s Republic of China, Administrative Measures on the Report and Monitoring of Adverse Drug Reactions. 2011. http://www.gov.cn/gongbao/content/2011/content_2004739.htm Accessed 15 Dec 2019.
WHO Technical Report No 498, World Health Organization. 1972. https://apps.who.int/iris/bitstream/handle/10665/40968/WHO_TRS_498.pdf?sequence=1&isAllowed=y. Accessed 15 Dec 2019.
European Commission. Council Directive 92/27/EEC on the labelling of medicinal products for human use and on package leaflets limits. (No. L113 of 31 March 1992). https://www.legislation.gov.uk/eudr/1992/27/pdfs/eudr_19920027_adopted_en.pdf. Accessed 29 Apr 2020.
Lal R, Kremzner M. Introduction to the new prescription drug labeling by the Food and Drug Administration. Am J Health Syst Pharm. 2007;64(23):2488–94.
Yu LX, Woodcock J. FDA pharmaceutical quality oversight. Int J Pharm. 2015;491(1–2):2–7.
Watson KT, Barash PG. The new food and drug administration drug package insert: implications for patient safety and clinical care. Anesth Analg. 2009;108(1):211–8.
Ishiguro C, Misu T, Iwasa E, Izawa T. Analysis of safety-related regulatory actions by Japan’s pharmaceutical regulatory agency. Pharmacoepidemiol Drug Saf. 2017;26(11):1314–20.
Administrative Regulation for the Insert and Packaging Labels of Drug(Revised draft). Center for Drug Evaluation, CFDA. 2020. http://www.cde.org.cn/news.do?method=news_index&frameStr=1. Accessed 30 June 2020.
Li H, Deng J, Deng L, Ren X, Xia J. Safety profile of traditional Chinese herbal injection: an analysis of a spontaneous reporting system in China. Pharmacoepidemiol Drug Saf. 2019;28(7):1002–13.
Wang L, Yuan Q, Marshall G, Cui X, Cheng L, Li Y, et al. Adverse drug reactions and adverse events of 33 varieties of traditional Chinese medicine injections on National Essential medicines List (2004 edition) of China: an overview on published literatures. J Evid Based Med. 2010;3(2):95–104.
Wei RL, Xie YM, Zhang WL.[Analysis on 1 500 adverse reactions of Guizhi Fuling Capsules based on spontaneous response system]. Zhongguo Zhong Yao Za Zhi. 2019;44(7): 1497 – 502 (Chinese).
Zhang YL, Liao X, Liu FM, Wang GQ, Xie YM. [Systematic review on safety of Xianling Gubao capsule]. Zhongguo Zhong Yao Za Zhi. 2017;42(15): 2845-56 (Chinese).
Samojlik I, Mijatović V, Gavarić N, Krstin S, Božin B. Consumers’ attitude towards the use and safety of herbal medicines and herbal dietary supplements in Serbia. Int J Clin Pharm. 2013;35(5):835–40.
Alsayari A, Almghaslah D, Khaled A, Annadurai S, Alkhairy MA, Alqahtani HA, et al. Community pharmacists’ knowledge, attitudes, and practice of herbal medicines in Asir Region, Kingdom of Saudi Arabia. Evid Based Complement Alternat Med. 2018; 2018: 1568139.
Jose J, Jimmy B, Al-Mamari MN, Al-Hadrami TS, Al-Zadjali HM. Knowledge, beliefs and behaviours regarding the adverse effects of medicines in an Omani population: cross-sectional survey. Sultan Qaboos Univ Med J. 2015;15(2):e250-6.
Awad A, Al-Shaye D. Public awareness, patterns of use and attitudes toward natural health products in Kuwait: a cross-sectional survey. BMC Complement Altern Med. 2014;14:105.
El Khoury G, Ramadan W, Zeeni N. Products and dietary supplements: a cross-sectional survey of use, attitudes, and knowledge among the Lebanese population. J Community Health. 2016;41(3):566–73.
Outline of strategic Plan for the Development of Traditional Chinese Medicine. (2016–2030), The State Council, 2016. http://www.gov.cn/zhengce/content/2016-02/26/content_5046678.htm. Accessed 30 Apr 2020.
Ziegler DK, Mosier MC, Buenaver M, Okuyemi K. How much information about adverse effects of medication do patients want from physicians? Arch Intern Med. 2001;161(5):706–13.
Trewin VF, Veitch GB. Patient sources of drug information and attitudes to their provision: a corticosteroid model. Pharm World Sci. 2003;25(5):191–6.
Nair K, Dolovich L, Cassels A, McCormack J, Levine M, Gray J, et al. What patients want to know about their medications. Focus group study of patient and clinician perspectives. Can Fam Physician. 2002;48:104–10.
Acknowledgements
The authors would like to thank all the patients who agreed to participate in this study for their time.
Funding
This work was funded by the Shanghai “Rising Stars of Medical Talent” Youth Medical Talents-Clinical Pharmacist Program. The funding bodies played no role in the study design, data acquisition, analysis, and interpretation or manuscript preparation and submission.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflicts of interest
The authors declare that they have no conflicts of interest.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Zhang, W., Zhang, J., Ma, R. et al. Patient expectations and awareness of information regarding adverse reactions in drug labelling in China. Int J Clin Pharm 43, 174–180 (2021). https://doi.org/10.1007/s11096-020-01127-9
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11096-020-01127-9