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Prevalence of the Potentially Inappropriate Kampo Medications

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Prevalence of the Potentially Inappropriate Kampo Medications Komagamine and Hagane BMC Complementary and Alternative Medicine (2018) 18:155 https://doi.org/10.1186/s12906-018-2228-3 RESEARCH ARTICLE Open Access Prevalence of the potentially inappropriate Kampo medications to be used with caution among elderly patients taking any prescribed Kampo medications at a single centre in Japan: a retrospective cross-sectional study Junpei Komagamine1* and Kazuhiko Hagane2 Abstract Background: Few studies have investigated the prevalence and characteristics of potentially inappropriate Kampo medication use among elderly ambulatory patients taking any prescribed Kampo medications. Methods: A retrospective cross-sectional study was conducted using electronic medical records. All patients aged 65 years or older who continued visiting internal medicine physicians and were prescribed any Kampo medications from January 2015 to March 2015 were included. The primary outcome was the proportion of patients taking any potentially inappropriate Kampo medications that should be used with caution (hereafter referred to as UWC Kampo medications). The medication appropriateness was evaluated based on the 2015 Japan Geriatrics Society guidelines. Results: Eighty eligible patients were identified. The mean age was 76.7 years, 45 patients (56.2%) were female, the mean Charlson Comorbidity Index was 1.7, the median number of non-Kampo medications used was 5.0, and the median number of Kampo medications used was 1.0. The proportion of patients taking any UWC Kampo medications was 28.8% (95% confidence interval, 18.6 to 38.9%). Medications containing Glycyrrhizae radix for chronic kidney disease or loop diuretics were the most common UWC Kampo medications. Compared with patients who did not take any UWC Kampo medications, patients who did take such medications used aconite compositions more frequently (p = 0.04) and were more likely to have uncontrolled hypertension (p = 0.02) and chronic kidney disease (p < 0.001). In a multivariable analysis, no predictive factors for the use of UWC Kampo medications were identified. Conclusions: Approximately one-fourth of the elderly patients taking any prescribed Kampo medications took at least one UWC Kampo medication, although the association between UWC Kampo medications and adverse events remains unclear. When physicians prescribe medications containing Glycyrrhizae radix to elderly patients, chronic kidney disease and the use of loop diuretics should be evaluated. Keywords: Elderly, Kampo, Japanese herbal medicine, Potentially inappropriate medication * Correspondence: [email protected] 1Department of Internal Medicine, National Hospital Organization Tochigi Medical Center, 1-10-37, Nakatomatsuri, Utsunomiya, Tochigi 3208580, Japan Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Komagamine and Hagane BMC Complementary and Alternative Medicine (2018) 18:155 Page 2 of 7 Background were prescribed at least one potentially inappropriate Kampo medicine is a form of traditional Japanese herbal Kampo medication to be used with caution (hereafter medicine. It was introduced to Japan from China denoted as UWC Kampo medications) among elderly 1500 years ago and was developed into a unique form of ambulatory patients who were regularly prescribed any Japanese medicine over a long period in Japanese prac- Kampo medications. We also evaluated the factors tice and culture [1–3]. Therefore, Kampo medicine is associated with the UWC Kampo medications. This different from traditional Chinese and Korean medicines study was approved by the Medical Ethical Committee [3]. In Japan, Kampo medicines are integrated into the of National Hospital Organization Tochigi Medical national health care system; 148 Kampo extract formula- Center (No. 29–10) and was conducted in accordance tions and 187 types of crude drugs are approved by the with the Declaration of Helsinki. The need for individual Ministry of Health, Labour and Welfare and are used informed consent was formally waived by the Medical under the national health insurance programme [4, 5]. Ethical Committee of National Hospital Organization Kampo medications are available over the counter Tochigi Medical Center because the study used data (OTC) and are the most frequently used complementary collected from medical records and the patients were not and alternative medicine therapies in Japan according to contacted. surveys of Japanese physicians [6–9]. Despite the common prescription of Kampo medi- Participants and inclusion criteria cations by Japanese physicians, there are no standard All consecutive ambulatory patients aged 65 years or education programmes in medical schools and few older who had appointments with internal medicine postgraduate education programmes on Kampo medi- physicians from January 1, 2015, to March 31, 2015, cines in Japan [3, 10, 11]. Given that a recent Japanese were retrospectively screened. This study included only study reported some concerns regarding patient safety in patients who had 3 or more visits to internal medicine relation to Kampo medications [4], it is important to as- physicians within a year before the index visit and who certain the safety of the Kampo medications prescribed by were prescribed at least one Kampo medication on two physicians. Furthermore, given that adverse drug events or more consecutive visits. Over-the-counter Kampo are common in elderly patients due to multi-morbidity medications were excluded. Patients with missing data and polypharmacy [12–15], the appropriate use of Kampo regarding medications prescribed at other hospitals were medications by elderly patients is particularly important. excluded. During the study period, 1035 ambulatory Nonetheless, to our knowledge, no studies have investi- patients aged 65 years or older were identified. Nine gated the appropriateness of the Kampo medications hundred fifty-five patients were excluded for a variety of prescribed by physicians as part of typical care in Japan. reasons (895 for a lack of regular use of Kampo medica- Thus, our aim was to determine the prevalence of and the tions and 60 for missing data on medications prescribed factors associated with the use of potentially inappropriate at other hospitals). Thus, a total of 80 patients were Kampo medications among elderly patients who take any included in the final analysis. prescribed Kampo medication. Data collection Methods The data were collected using the electronic medical Study design and location records of National Hospital Organization Tochigi The National Hospital Organization Tochigi Medical Medical Center. All available electronic medical records Center is a 350-bed community hospital in the Tochigi from September 2014 to the time of the index visit were Prefecture of Japan. The centre is one of the two largest reviewed. Information regarding age, gender, past med- acute care hospitals in the area and serves approximately ical history, the Charlson Comorbidity Index (CCI) [16], 0.5 million individuals. At our hospital, the internists office blood pressure, non-Kampo medications, and mainly practise Western medicine but occasionally use Kampo medications was retrieved. All prescriptions Kampo medicine, depending on the patients’ and physi- from our hospital were covered by the hospital database, cians’ preferences. No physicians receive formal training but prescriptions from other hospitals were not covered. in Kampo medicine after graduation from a medical uni- Therefore, prescriptions from other hospitals were versity. The aim of this study was to determine the identified based on medical record documentation by prevalence and characteristics of elderly patients who physicians in our hospital. The non-Kampo medica- were prescribed potentially inappropriate Kampo medi- tions included oral medications, inhalers, injections, cations. A retrospective, single-centre, cross-sectional and as-needed medications. However, eye drops, intra- study was conducted using the electronic medical records nasal infusers, OTC drugs, and topical medications of National Hospital Organization Tochigi Medical Center. were excluded, along with medications that were indi- The primary outcome was the proportion of patients who cated for apparent transient disease and those that Komagamine and Hagane BMC Complementary and Alternative Medicine (2018) 18:155 Page 3 of 7 were not prescribed on 2 or more consecutive visits. Long-term use of gardenia composition was defined as For example, antitussive medications for the common the use of gardenia for more than 3 years because the cold and antibiotic agents for pharyngitis were not term “a few years”, which is used in the 2015 Japan included. The numbers of non-Kampo and Kampo Geriatrics Society guidelines [17], is ambiguous. medications were counted separately. Statistical analysis The sample size was determined based on the following Outcome measures information. The interval between consecutive regular The primary
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