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Identification and Prevalence of Adverse Drug Events

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Identification and Prevalence of Adverse Drug Events Open Access Research BMJ Open: first published as 10.1136/bmjopen-2015-007581 on 10 August 2015. Downloaded from Identification and prevalence of adverse drug events caused by potentially inappropriate medication in homebound elderly patients: a retrospective study using a nationwide survey in Japan Mitsuko Onda,1 Hirohisa Imai,2 Yurina Takada,1 Shingo Fujii,1 Takako Shono,1 Yoko Nanaumi3 To cite: Onda M, Imai H, ABSTRACT et al Strengths and limitations of this study Takada Y, . Identification Objectives: A nationwide large-scale survey was and prevalence of adverse conducted to identify the prevalence and causal ▪ drug events caused by The incidence of potentially inappropriate medi- medications of adverse drug events (ADEs) that are potentially inappropriate cation (PIM) use and associated adverse drug medication in homebound caused by potentially inappropriate medications (PIMs) events (ADEs) were evaluated, independent of elderly patients: given to homebound elderly patients, factors associated the views of medical care providers, by conduct- a retrospective study using a with ADEs, and measures taken by pharmacists to ing a nationwide survey of pharmacists who nationwide survey in Japan. manage ADEs and their effects on ADEs. were providing services to homebound elderly BMJ Open 2015;5:e007581. Settings: A questionnaire was mailed to 3321 patients. doi:10.1136/bmjopen-2015- pharmacies nationwide. It asked about the details of ▪ PIMs were prescribed to 48.4% of patients, 007581 PIMs and ADEs of up to 5 patients for whom home visits which is higher than the 2.9–38.5% in previous were provided by a pharmacist. Questionnaire forms were studies based on Beers Criteria 2003, suggesting ▸ Prepublication history for filled in by pharmacists who visited the patients. that our approach identified PIMs that might http://bmjopen.bmj.com/ this paper is available online. Design and participants: Between 23 January and 13 have been previously overlooked. To view these files please February 2013, comprehensive assessment forms were ▪ ADEs were experienced in 8% of patients who visit the journal online sent to 3321 pharmacies. Data collected from 1890 were prescribed PIM, and were mostly related to (http://dx.doi.org/10.1136/ pharmacies including data of 4815 patients were bmjopen-2015-007581). the central nervous system, which could poten- analysed and 28 patients of unknown sex were excluded. tially lead to more serious conditions. This high- Received 4 January 2015 Their average age was 82.7 years. PIMs were identified lights the importance of vigilance for PIM. Revised 25 May 2015 based on the 2003 Beers Criteria Japan. ▪ Responses of visiting pharmacists to ADEs were Accepted 22 June 2015 helpful in preventing serious situations. Home Results: There were 600 patients who did not provide on September 30, 2021 by guest. Protected copyright. valid answers regarding the medications. In the visits by pharmacists should be further remaining 4243 patients, one or more medications that encouraged. were considered to be PIMs had been prescribed to ▪ Despite the relatively low rate of response 48.4% of patients. PIM-induced ADEs were found in 8% (56.9%) to the initial inquiry, and the reporting of these patients by pharmacists during home visits. The means that were rather open to interpretation by top ADE-inducing medications were strong the pharmacist on site, the present study pro- anticholinergic antihistamines, benzodiazepines, sulpiride vides important insights in reducing the use of and digoxin. The most common ADEs associated with PIMs and associated ADEs. benzodiazepines were frequent lightheadedness, somnolence and sleepiness, which increase the risk of falls and subsequent fractures in elderly patients. The pharmacists could reduce the incidence of PIMs and following factors associated with ADEs were identified: consequent ADEs. sex, pharmacist awareness of prescription issues, For numbered affiliations see frequency of visits and time spent at patients’ homes, end of article. and the frequency of detailed checks for patient adverse reactions by pharmacists. Correspondence to Conclusions: The PIM prevalence associated with INTRODUCTION Dr Hirohisa Imai; imaihiro@ home healthcare in Japan was relatively high, as reported There are numerous reports on the evalu- niph.go.jp in previous studies. The present study suggests that ation of prescriptions for elderly patients, Onda M, et al. BMJ Open 2015;5:e007581. doi:10.1136/bmjopen-2015-007581 1 Open Access BMJ Open: first published as 10.1136/bmjopen-2015-007581 on 10 August 2015. Downloaded from based on the Beers Criteria. A systematic review of 19 FAX, and 3321 pharmacies were identified as providers studies—14 of which used the Beers Criteria (the 2003 of home visit services. A second questionnaire was version was used in 11 papers, the 1997 version was used mailed to those pharmacies, which was filled and mailed in 2 papers and the 1991 version was used in 1 paper)— back by a pharmacist who represented their pharmacy on elderly patients in the primary care setting revealed between 23 January and 13 February 2013. On the basis that the median rate of inappropriate medication pre- of the results of a pilot study that was conducted prior to scription was 20.5% among elderly patients 65 years of the present study, which had indicated that each phar- age or older, and that diphenhydramine and amitriptyl- macy provides home visit services to a maximum of five ine were most commonly associated with high-risk patients per month,9 we asked the pharmacies to adverse drug events (ADEs), while propoxyphene and provide details of up to five patients who were recipients doxazosin were often associated with low-risk ADEs.1 of their home visit service (excluding cases of medica- A study of Swiss outpatients based on data collected tion delivery only), regardless of the presence of a pos- from a health insurance company revealed that the sible PIM. When a pharmacy provided home visit prevalence of potentially inappropriate medication services to more than five patients, the pharmacist was (PIMs) according to 2003 Beers Criteria or PRISCUS list asked to describe the most recent five home visit cases. was 21% in patients 65 years of age or older,2 while a Requested patient information included: a physician’s study of 2707 homebound elderly patients receiving order for the home visit (with a summary of the home care in eight European countries revealed that patient’s medical conditions), records of home visits and the average percentage of PIM, according to all expert drug management. panel criteria for community-living elderly persons (Beers and McLeod) was 19.8%.3 ADEs caused by PIMs Data collection in elderly patients are serious drug-related issues. The following variables were studied: patient character- Japan is the most rapidly ageing country among indus- istics (sex, age, primary disease (defined as disease that trialised nations. However, sufficient medical care of had the most impact on the general condition of the elderly patients and control of its costs are common patient), living arrangement, family composition); issues that are shared by many countries. The Japanese number of medications that were being taken; whether government is promoting home healthcare as a national prescribed medication included those in the Beers policy to improve quality of life and control inpatient Criteria list (PIMs); whether the pharmacist had any medical costs associated with the care of elderly patients. experience of discovering PIM-induced ADEs during Several studies have already found clinical and economic visits (ADEs, if any), and details of such an episode advantages of home healthcare over inpatient health- (name of the drug (including specification), daily dose, – care.4 8 An understanding of the prevalence of description of ADEs, care provided by the pharmacist PIM-induced ADEs and factors associated with ADEs in with physician and degree of improvement of ADEs as a http://bmjopen.bmj.com/ elderly patients in home healthcare settings is necessary result of care provided); pharmacist awareness of pre- for establishing safe pharmacotherapy and formulating scription issues (contraindications, duplication, drug policy for optimising medical costs associated with home interactions and unnecessary continuation of treat- healthcare in the future. To date, most prevalence ment); home visit service-related work load (frequency studies have been small-scale studies in which biases are of visits, time spent at patients’ homes); and the fre- difficult to avoid and therefore lack sufficient credibility quency of detailed pharmacist checks for ADEs that or validity. Large-scale studies are needed to obtain were based on test results, vitals and activity of daily accurate and more detailed information. living (ADL). on September 30, 2021 by guest. Protected copyright. The objective of this study was to conduct a nation- wide, large-scale survey to shed light on the occurrence Measurements of PIM-induced ADEs in homebound elderly patients The frequencies of ADEs and their characteristics receiving home healthcare services, and to identify the described in the survey responses were assessed on the drugs that cause such ADEs, factors associated with following factors based on “medications that should be ADEs, measures taken by pharmacists to manage such avoided in elderly individuals regardless of disease or ADEs and the effectiveness of such measures. clinical condition” in the “Beers Criteria: The Japanese V.2003”10: the number and details of ADEs that occurred; the responses of pharmacists to ADEs; and the METHODS degree of improvement in ADEs as a result of such Patients measures. ADEs were classified based on the “Geriatric First, we conducted a screening survey to identify phar- Care Medication Management Manual: ADL and macists who routinely provide home visit services to Medication.”11 elderly patients, by using a questionnaire that was In the present study, we used the 2003 Beers Criteria inserted in selected issues of the Journal of the Japan in Japan, which was independently developed using the Pharmaceutical Association.
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