Abstract
Introduction
Inappropriate prescribing (IP) occurs when pharmacotherapy does not meet accepted medical standards. 1 IP has been correlated with poor compliance, increased risk of drug–drug interactions and adverse drug reactions, and increased economic burden.2-10 As a result, IP among elderly people has become an important public health issue worldwide. 2
There are several definitions of IP. O’Connor et al 11 defined it as having 3 major domains: (a) misprescribing, (b) overprescribing, and (c) underprescribing. Several recent studies concluded that the prevalence of IP and its risk factors vary with population characteristics, study settings, drug policies, and the definitions used.12-15
There are several tools used to detect IP in elderly people, 16 such as Beers’ criteria, 17 the Screening Tool of Older Persons’ potentially inappropriate Prescriptions (STOPP) and the Screening Tool to Alert doctors to Right Treatment (START),18,19 and the Improved Prescribing in the Elderly Tool (IPET). 20
A recent study showed that the STOPP/START criteria have high sensitivity for detecting potential drug-related problems 21 and are more sensitive in detecting IP than Beers’ criteria. 22
Since the prevalence of IP has been correlated with patient age, 14 and the need for home medical care for elderly people in developed countries such as Japan is predicted to continue increasing in the future, IP among elderly home care patients is an important issue for developed countries with aging societies.
To the best of our knowledge, while several previous studies have assessed the prevalence and risk factors associated with IP as identified by the STOPP/START criteria 22 among elderly patients, no study has yet been conducted among elderly home care patients. 22 This study aims to address these issues among elderly home care patients in Japan.
Methods
This cross-sectional study enrolled all patients aged 65 years or older who received regular home visiting services from Yamato Clinic between May 2013 and June 2013. Yamato Clinic provides ambulatory care and home visiting services for community residents, with five doctors specialized in family medicine. None of the 5 doctors was familiar with the STOPP/START criteria.
Ethics Statement
The study was approved by the ethics committee of the Mito Kyodo General Hospital and was conducted according to the principles expressed in the Declaration of Helsinki.
Data Collection
We included all patients who were 65 years or older and who satisfied the inclusion criteria. Our inclusion criteria were as follows: (a) patients received home visiting services regularly for at least 1 month and (b) patients had been regularly prescribed medications from Yamato Clinic, excluding topical drugs.
We used electronic medical records to collect patients’ background information, which included age, sex, estimated glomerular filtration rate (eGFR; mL/min), serum albumin (mg/dl), availability of oversight regarding ambulation and drug use, underlying medical conditions, whether they lived with or without family, and whether or not they utilized a home visiting pharmacist or nurse. We verified prescriptions that had been regularly prescribed by Yamato Clinic between May 2013 and June 2013.
Statistical Analysis
We defined the polypharmacy as the concurrent use of 6 or more prescriptions, 12 and the IP as having 2 domains: (a) potentially inappropriate medications (PIMs), which include misprescribing and overprescribing and (b) underprescribing. A PIM was defined as having occurred when at least 1 of the 65 original STOPP criteria (Table 1) was met, while underprescribing was designated by the occurrence of at least 1 of the 22 original START criteria (Table 1). Differences in variable distributions between patients who experienced PIMs or underprescribing and those who did not were compared using Student’s t test for continuous variables and Pearson’s χ2 test or Fisher’s exact test for categorical variables.
STOPP/START Screening Criteria. 18
Abbreviations: STOPP, Screening Tool of Older Persons’ potentially inappropriate Prescriptions; START, Screening Tool to Alert doctors to Right Treatment; CNS, central nervous system; NSAID, nonsteroidal anti-inflammatory drug; ACE, angiotensin-converting enzyme; FEV1, forced expiratory volume in 1 second; DMARD, disease-modifying antirheumatic drug.
To examine the influence of factors associated with PIMs and underprescribing, we used a multivariate logistic regression analysis. For logistic regression analysis, patient age was categorized into 3 groups: 65 to 74, 75 to 84, and ≥85 years.
Multivariate logistic regression analysis was used to calculate odds ratios (ORs) and 95% confidence intervals after controlling simultaneously for potential confounders. Regardless of univariable association, we forced several risk factors into the fully adjusted multivariate logistic regression analysis because of known associations with PIMs or underprescribing.
All analyses were conducted using SPSS-J (version 21.0; IBM, Tokyo, Japan).
Results
Demography
Eighty-nine patients (52 females) were included in this study. Table 2 shows patient background information in detail. The mean patient age was 84.9 ± 7.9 years. The main underlying medical conditions were constipation in 56 patients (62.9%), hypertension in 51 patients (57.3%), and dementia in 41 patients (46.1%).
Patient Background (N = 89).
Polypharmacy
The prevalence of polypharmacy was 60.7%. By the univariable analyses of the associations between patient background, underlying medical conditions and polypharmacy, significant correlations with polypharmacy were found for age (P = .039), eGFR <60 mL/min (OR = 3.894, P = .003), utilizing a home visiting pharmacist (OR = 4.327, P = .017), constipation (OR = 2.753, P = .024), dementia (OR = 0.321, P = .011), diabetes mellitus (OR = 4.491, P = .018), and hyperuricemia/gout (P = .039).
Potentially Inappropriate Medications
According to the STOPP criteria, 40.4% of the study population had at least one PIM. By the univariable analyses of the associations between patient background, underlying medical conditions and PIMs, significant correlations with PIMs were found for eGFR < 60 mL/min (OR = 3.056, P = .012), serum albumin <3.5 g/dL (OR = 0.315, P = .019), constipation (OR = 3.989, P = .005), hypertension (OR = 2.912, P = .019), heart failure (OR = 4.712, P = .01), hyperuricemia/gout (OR = 10.4, P = .016), and polypharmacy (OR = 11.273, P < .001). The most frequent STOPP criteria identified in the present study were (a) calcium-channel blockers with chronic constipation (18 patients, 20.2%); (b) long-term, long-acting benzodiazepines (9 patients, 10.1%); and (c) long-term use of nonsteroidal anti-inflammatory drugs for symptom relief of mild osteoarthritis (6 patients, 6.7%).
Underprescribing
According to the START criteria, 60.7% of the study population experienced at least one instance of underprescribing. By the univariable analyses of the associations between patient background, underlying medical conditions and underprescribing, significant correlations with underprescribing were found for eGFR <60 mL/min (OR = 3.894, P = .003), utilizing a home visiting pharmacist (OR = 6.8, P = .003), osteoporosis (OR = 5.333, P = .007), diabetes mellitus (P < .001), atrial fibrillation (OR = 9.714, P = .012), hyperuricemia/gout (P = .039), and polypharmacy (OR = 8.529, P < .001). The most frequent START criteria identified in the present study were (a) metformin with type 2 diabetes ± metabolic syndrome (15 patients, 16.9%), (b) calcium and vitamin D supplementation in patients with known osteoporosis (14 patients, 15.7%), and (c) angiotensin-converting enzyme inhibitors with chronic heart failure (8 patients, 9%).
Independent Risk Factors for PIMs and Underprescribing
Table 3 shows the logistic regression analysis examining the influence of factors associated with PIMs and underprescribing. Risk factors for PIMs were hypertension, constipation, and polypharmacy, while those for underprescribing were osteoporosis and polypharmacy.
Multivariate Logistic Regression Analysis of Risk Factors Associated With PIMs and Underprescribing.
Abbreviations: PIM, potentially inappropriate medication; STOPP, Screening Tool of Older Persons’ potentially inappropriate Prescriptions; START, Screening Tool to Alert doctors to Right Treatment; OR, odds ratio; 95% CI, 95% confidence interval.
Concurrent use of 6 or more medications.
Discussion
To the best of our knowledge, the present study is the first to explore the prevalence and risk factors associated with IP, as identified by STOPP/START criteria, among elderly home care patients.
This study demonstrated 2 important findings: (a) the prevalence of PIM and underprescribing among elderly home care patients in Japan may be high and (b) risk factors for IP included not only polypharmacy but also several underlying medical conditions.
First, we found the high prevalence of PIMs among elderly home care patients in Japan. Calcium-channel blockers with chronic constipation, which is the one of the frequent STOPP criteria occurring in the present study, could contribute to the prevalence of PIMs in the present study. This result may have 2 explanations. The first is the higher incidence of coronary spasm in Japan compared with Western countries. 23 Japanese doctors may therefore tend to use calcium-channel blockers more frequently. The second reason is that practice guidelines for hypertension in Europe and the United States tend to recommend diuretics and angiotensin-converting enzyme inhibitors as first-choice treatments for hypertension,24,25 whereas those in Japan generally recommend calcium channel blockers. 26
We also found the high prevalence of underprescribing among elderly home care patients in Japan. One possible reason for this result may derive from the therapeutic guidelines for type 2 diabetes in Japan. Although the several therapeutic guidelines for type 2 diabetes in the world concluded that metformin therapy should be initiated concurrently with lifestyle interventions at the time of diagnosis, 27 treatment guidelines for diabetes in Japan do not emphasize the use of metformin. 28 In addition, the product information associated with metformin in Japan states that the drug should be used very carefully in elderly diabetic patients based on the higher risk of complications in this population.
The other interesting finding of this study was that the risk factors for IP included not only polypharmacy but also several underlying medical conditions. Although polypharmacy is major risk factor for IP in previous studies in other countries and settings,12,13,15,29 the underlying medical conditions as risk factors may reflect the local factor. In this study, the risk factors for PIMs were hypertension, constipation, and polypharmacy, whereas those for underprescribing were osteoporosis and polypharmacy. The one possible reason for several underlying medical conditions as risk factor of IP among elderly home care patients in Japan is prescribing habits of Japanese doctor.
The prescribing habits may be affected by national drug formularies, national practice guidelines, and continuing medical education. These drug formularies, practice guidelines, and medical education for several medical conditions in Japan may not catch up with the evidence and consensus included in the STOPP/START criteria. The other possible reason may be that the present study evaluated the prescribing habits of only several doctors in one institution, and therefore our results may not be fully generalizable as home care setting in Japan.
This study had 3 limitations, referred to above. First, our study may not be representative of elderly home care patients in Japan because it was carried out in only one institution. Second, the sample in this study was relatively small. Third, the number of doctors who prescribed medications to the study population was relatively small. These limitations restrict the generalizability of our results.
In conclusion, the prevalence of IP among elderly home care patients could be high, and the risk factors for IP included not only polypharmacy but also specific underlying medical conditions.
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Research funds for this study were provided by a Clinical Research Grant from St. Luke’s Life Science Institute.
