Patient safety incident reports related to traditional Japanese Kampo medicines: medication errors and adverse drug events in a university hospital for a ten-year period

Abstract

BackgroundKampo medicine is traditional Japanese medicine, which originated in ancient traditional Chinese medicine, but was introduced and developed uniquely in Japan. Today, Kampo medicines are integrated into the Japanese national health care system. Incident reporting systems are currently being widely used to collect information about patient safety incidents that occur in hospitals. However, no investigations have been conducted regarding patient safety incident reports related to Kampo medicines. The aim of this study was to survey and analyse incident reports related to Kampo medicines in a Japanese university hospital to improve future patient safety.MethodsWe selected incident reports related to Kampo medicines filed in Toyama University Hospital from May 2007 to April 2017, and investigated them in terms of medication errors and adverse drug events.ResultsOut of 21,324 total incident reports filed in the 10-year survey period, we discovered 108 Kampo medicine-related incident reports. However, five cases were redundantly reported; thus, the number of actual incidents was 103. Of those, 99 incidents were classified as medication errors (77 administration errors, 15 dispensing errors, and 7 prescribing errors), and four were adverse drug events, namely Kampo medicine-induced interstitial pneumonia. The Kampo medicine (crude drug) that was thought to induce interstitial pneumonia in all four cases was Scutellariae Radix, which is consistent with past reports. According to the incident severity classification system recommended by the National University Hospital Council of Japan, of the 99 medication errors, 10 incidents were classified as level 0 (an error occurred, but the patient was not affected) and 89 incidents were level 1 (an error occurred that affected the patient, but did not cause harm). Of the four adverse drug events, two incidents were classified as level 2 (patient was transiently harmed, but required no treatment), and two incidents were level 3b (patient was transiently harmed and required substantial treatment).ConclusionsThere are many patient safety issues related to Kampo medicines. Patient safety awareness should be raised to prevent medication errors, especially administration errors, and adverse drug events in Kampo medicine.

Investigation of the characteristics of medication errors and adverse drug reactions using pharmacovigilance data in China

“…The data reported in previous reports show that up to 56% of ADEs were attributed to MEs ( Bates et al, 1995a , Kunac and Tatley, 2011 , Tanti et al, 2013 ). A Japanese study reported that of all the 103 ADE cases that received traditional Japanese Kampo medication in one hospital, 99 were MEs and only 4 were ADRs ( Shimada et al, 2017 ). These studies prove the crucial role of MEs in ADEs.…”

“…Later, Zafar et al, established a streamlined interface design technique to improve the reporting rates of ADEs and MEs in the USA ( Zafar et al, 2008 ). Currently, several studies use the spontaneous reporting system to investigate MEs and ADRs in ADE in New Zealand ( Kunac and Tatley, 2011 ), Japan ( Shimada et al, 2017 ), the USA ( Carnovale et al, 2018 ), and Germany ( Koberle et al, 2018 ). All these reports agreed that the direct use of data from the spontaneous reporting system in the pharmacovigilance center to detect MEs and ADRs is convenient method.…”

Effect of kamikihito on platelet count: Retrospective pilot study

“…Currently, kampo medicine is integrated into Japan's national health management system. The Ministry of Health, Labour, and Welfare has approved 147 herbal medicinal extract formulations and one herbal medicinal ointment, along with 187 crude kampo drugs, which are used in the National Health Insurance program . Kamikihito ( Jia‐Wei‐Gui‐Pi‐Tang ; KKT) is a kampo extract formulation containing 14 crude drugs: Ginseng Radix, Atractyloides Rhizoma, Poria, Bupleuri Radix, Zizyphi Semen, Longan Arillus, Astragali Radix, Angelicae Radix, Gardeniae Fructus, Polygalae Radix, Zizyphi Fructus, Glycyrrhizae Radix, Sanssureae Radix, and Zingiberis Rhizoma.…”

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

“…Therefore, Kampo medicine is different from traditional Chinese and Korean medicines [ 3 ]. In Japan, Kampo medicines are integrated into the national health care system; 148 Kampo extract formulations and 187 types of crude drugs are approved by the Ministry of Health, Labour and Welfare and are used under the national health insurance programme [ 4 , 5 ]. Kampo medications are available over the counter (OTC) and are the most frequently used complementary and alternative medicine therapies in Japan according to surveys of Japanese physicians [ 6 – 9 ].…”

“…Despite the common prescription of Kampo medications by Japanese physicians, there are no standard education programmes in medical schools and few postgraduate education programmes on Kampo medicines in Japan [ 3 , 10 , 11 ]. Given that a recent Japanese study reported some concerns regarding patient safety in relation to Kampo medications [ 4 ], it is important to ascertain the safety of the Kampo medications prescribed by physicians. Furthermore, given that adverse drug events are common in elderly patients due to multi-morbidity and polypharmacy [ 12 – 15 ], the appropriate use of Kampo medications by elderly patients is particularly important.…”