Research Article: Characteristics and trends of spontaneous reporting of therapeutic ineffectiveness in South Korea from 2000 to 2016

Date Published: February 28, 2019

Publisher: Public Library of Science

Author(s): Hye-Jun Kim, Han Eol Jeong, Ji-Hwan Bae, Yeon-Hee Baek, Ju-Young Shin, Jed N. Lampe.


Therapeutic ineffectiveness involves drug-related therapeutic failure, inefficacy or resistance and has not been sufficiently studied. Objective of our study was to evaluate reporting trends in therapeutic ineffectiveness by year and describe factors affecting therapeutic ineffectiveness using the Korea Adverse Event Reporting System. Proportion of therapeutic ineffectiveness reports was based on total submitted reports between 2000 and 2016. Utilizing 2016 alone, we compared the characteristics of therapeutic ineffectiveness with age group and gender matching by random extraction. We conducted a logistic regression analysis to estimate reporting odds ratios (ROR) and its 95% confidence intervals (CI) for reports by type of reporters, e.g., doctors, pharmacists, or consumers. We presented most frequent reports by the anatomical main groups and therapeutic subgroups according to the Anatomical Therapeutic Chemical (ATC) classification system. For the 17-years, the proportion of therapeutic ineffectiveness adverse drug reactions reporting ranged from 0.0% to 3.7% between 2000 and 2016. Of 228,939 reports, 2,797 (1.2%) were submitted in 2016. Consumers accounted for 6.92% of reports and doctors accounted for 45.49%, in which, consumers were more likely to report therapeutic ineffectiveness than doctors (adjusted ROR 3.98; 95% CI, 2.92 to 5.41). According to the ATC classification system, “nervous system” was the most frequently reported anatomical group (18.7%) and “parathyroid hormones and analogues” was reported most frequently in the pharmacological subgroup (23.7%). Teriparatide, a drug used to treat osteoporosis, had the most reports (11.0%). Therapeutic ineffectiveness reports may be used as a scientific tool for the reevaluation of respective drugs in order to confirm of its therapeutic effects.

Partial Text

“Therapeutic ineffectiveness” is medicinal ineffectiveness that includes terms such as “drug ineffective”, “inefficacy”, “effect, lack of” or “ineffectiveness” [1]. Unlike controlled clinical trials where subjects are a well-defined and selected population, real-world settings are based on real-life populations, resulting in drug performance that is often unpredictable [2]. Therapeutic ineffectiveness is a common drug-related problem that often involves therapeutic failure, inefficacy or resistance. 16% of hospital admissions occurred due to drug-related problems, of which, more than half (55%) were from therapeutic failure [3].

For the entire study period of 17-years (2000–2016), proportion of therapeutic ineffectiveness ranged from 0.0% to 3.7% (Fig 1). As for therapeutic ineffectiveness characterization in 2016 only, we identified a total of 2,797 (1.2%) therapeutic ineffectiveness reports. To compare the characteristics of reports, we categorized 1,820 age- and gender-matched reports of therapeutic ineffectiveness and 1,820 non- therapeutic ineffectiveness related reports (Fig 2).

Among therapeutic ineffectiveness reported to the KAERS database, the proportion of therapeutic ineffectiveness ranged from 1.0 to 1.3% from 2013 to 2016. We found that consumers were approximately 4-fold more likely to report therapeutic ineffectiveness compared with doctors, and the most frequently reported drugs as having therapeutic ineffectiveness were teriparatide, ciclopirox, and escitalopram. With regards to issues concerning drug safety, AE reports on therapeutic ineffectiveness may be used as scientific evidence and tool for either reevaluation or review of the respective drug by conduction of further clinical trials in order to confirm of its therapeutic effects. To date, despite minimal to even null interest in therapeutic ineffectiveness worldwide, results of this study provides an opportunity for researchers to gain interest in developing future studies, in turn acting as a catalyst for accumulation of findings on top of ours.




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