TY - JOUR AU1 - Suzuki,, Ryoji AU2 - Hasegawa,, Takashi AB - Purpose Results of an evaluation of a one-dose package medication support system (ODP-MSS) for medication support and telecare home monitoring of elderly persons are reported. Methods ODP-MSS units were provided to 10 elderly patients living at home, with adherence assistance provided by family members or other medication supporters in response to telephone alerts. In addition, ODP-MSS units were installed in 2 group homes. At the end of the designated study periods, device data logs were analyzed, and study participants were interviewed or surveyed regarding the impact of ODP-MSS use. Results Overall, 2 patients were reported to have missed medication doses due to forgetfulness; in both cases, alerted medication supporters called the patients and reminded them to take their medicine. Five home-dwelling patients and 5 supporters reported that the ODP-MSS provided useful reminders; 4 patients and 7 supporters indicated that calls to supporters were useful as a telecare home monitoring system. Eleven group home staff members reported that the ODP-MSS was useful in reducing medication errors and the need for medication assistance. Conclusion An ODP device plus follow-up calls from a medication supporter helped prevent missed doses resulting from patients’ forgetfulness and may serve as a useful component of telecare home monitoring for elderly people living independently at home. The ODP device was also useful for reducing the burdens associated with medication support and medication errors on staff members of group homes for elderly patients with dementia. electronic pillbox, home monitoring, medication adherence, medication assistance, reminder system, telecare Elderly patients who reside at home often face a significant challenge in remembering to take their medications. A study found that compared with other patients, outpatients with chronic diseases (e.g., heart disease, stroke) whose medications were dispensed in one-dose packages (ODPs, in which all of the medicines to be taken at the same time are packaged together) were less likely to miss doses due to forgetfulness.1 Notably, short-term medications (e.g., antibiotics for acute infections) cannot be dispensed in ODPs if the ODPs are prepared too infrequently; in such cases, the short-term medication must be taken separately from drugs in ODPs. Physicians and pharmacists have suggested the use of ODPs for patients who experience difficulty in remembering to take medications, and community pharmacists have additionally suggested the use of a weekly medication calendar. Systems aiming to reduce the consequences of forgetfulness should focus on allowing patients to take their medication as prescribed, a seemingly simple behavior known as medication adherence.2 The available methods for measuring adherence can be categorized as direct (e.g., directly observed therapy) and indirect (e.g., electronic medication monitors).3 The use of an electronic bottle cap–based medication event monitoring system (MEMS), which records the number of times the medication bottle is opened, is considered a reliable indirect method for evaluating patient adherence and investigating the relationship between blood pressure and medication adherence in hypertensive patients.4–7 However, in Japan, medications are often prescribed in blister packages or ODPs, which makes methods such as MEMS use inapplicable. The use of automatic pill dispensers is another method that has been found to improve medication adherence in elderly patients with mild cognitive impairment as well as patients with chronic heart failure.8,9 However, automatic pill dispensers typically contain only 28 exceedingly small compartments and are therefore difficult to use when multiple medications must be taken. By contrast, the MD.2 medication dispenser (Philips Lifeline) contains 42 cups intended for as many dosage times and may require refilling no more frequently than every 2 weeks.10–12 However, elderly adults may find it difficult to refill the cups themselves. Overall, many medication support tools, including those described above, are reported by elderly people as being difficult to refill and can be considered troublesome.13,14 Accordingly, we considered the possibility of a device that would help assemble ODPs and enable individuals to take medicine in the long term; such a device would be useful in improving medication adherence by elderly patients. In 2015, there were approximately 34 million elderly people in Japan, of whom around 6 million lived alone.15 Gokalp and Clark16 noted that telemonitoring interventions tend to improve the quality of care for elderly people and proposed that such interventions be considered for monitoring medication adherence and illness-related physiological parameters. Additionally, telecommunication has been considered as a method for improving medication adherence during hypertension treatment.17 Researchers have used a combination of sensors (e.g., infrared, door-opening) to monitor the habits of elderly people who lived independently or alone at home and found that certain activities of daily living (ADLs) can be monitored to effectively identify possible anomalies.18,19 Similarly, in Japan, there is a business service that sends monitoring information by e-mail to families about elderly people’s use of utilities such as natural gas and electricity in order to identify possible anomalies in their behavior. A device for monitoring elderly patients living at home while also supporting medication adherence would likely be effective for improving the care of elderly people. KEY POINTS In an evaluation involving small populations of elderly patients living at home or in group homes, a one-dose packaging medication support system (ODP-MSS) helped reduce missed doses due to forgetfulness; for 8 of 10 home-dwelling patients, medication adherence during the study period was 100%. Device-generated telephone alerts enabled medication supporters to counteract missed doses due to forgetfulness and provide telecare home monitoring. ODP-MSS use helped reduce medication errors and the burden of medication support on facility staff. The use of electronic medication administration records might also be useful for reducing medication errors and improving efficiency in residential eldercare homes.20 A study of 36 healthcare facilities indicated that wrong timing, omission, wrong dosage, and unauthorized drug administration were the most frequent medication errors.21 Additionally, numerous caregivers feel burdened by the provision of medication assistance as well as by medication errors.22 Thus, the use of an ODP device in eldercare facilities might reduce the likelihood of medication errors and the concomitant burden on individuals. We developed and evaluated an ODP medication support system (ODP-MSS) to aid in medication support and telecare home monitoring services for elderly persons living at home. Furthermore, we applied the ODP-MSS in group homes for elderly adults with dementia to see if it could help reduce the burdens associated with medication assistance and medication errors on staff members. Methods ODP-MSS. The ODP-MSS was conceived by one of the authors. It is a pill dispenser in which single doses of several medications intended to be taken at the same time are sealed in single film bags that are rolled onto a rotating drum; the system can dispense a maximum of 6 ODP doses per day for 60 days (Figures 1 and 2). Patients can fill the ODP-MSS themselves, but because of the long refill cycle, medications meant for short-term treatment cannot be included and must be taken separately from the items in the ODPs. When an ODP gets jammed in the ODP-MSS, the patient can open the cover of the device and remove the ODP. Most patients place the device near the telephone in their living room. This system uses a 100V alternating current and a diverging telephone line, because many of the homes where elderly Japanese people reside do not have Internet access. The ODP-MSS is currently marketed as the Fukkun FS-2000 Medication Support System (Ishigami Factory Co. Ltd., Hanamaki City, Japan). Figure 1 View largeDownload slide Medication roll drum, which contains a maximum of 60 days of continuous one-dose packages. This example shows a drum dedicated to morning dose packages for use in a home. Figure 1 View largeDownload slide Medication roll drum, which contains a maximum of 60 days of continuous one-dose packages. This example shows a drum dedicated to morning dose packages for use in a home. Figure 2 View largeDownload slide One-dose package medication support system (ODP-MSS). One-dose packages (ODPs) are available in widths of 60, 70, 80, and 90 mm and a height of 70 mm. An ODP-MSS type that can administer 2 doses of ODPs per day is shown. A pharmacist can change the packaging width during medicine preparation, and a patient, family member, or pharmacist can set the roll drums of ODPs. This ODP-MSS device measures 295 mm in width, 185 mm in depth, and 220 mm in height and weighs 4 kg. Optional settings can increase the dispensing of ODP medication to a maximum of 6 packages per day. Figure 2 View largeDownload slide One-dose package medication support system (ODP-MSS). One-dose packages (ODPs) are available in widths of 60, 70, 80, and 90 mm and a height of 70 mm. An ODP-MSS type that can administer 2 doses of ODPs per day is shown. A pharmacist can change the packaging width during medicine preparation, and a patient, family member, or pharmacist can set the roll drums of ODPs. This ODP-MSS device measures 295 mm in width, 185 mm in depth, and 220 mm in height and weighs 4 kg. Optional settings can increase the dispensing of ODP medication to a maximum of 6 packages per day. The system is set to remind individuals to take medicine in reference to mealtimes: specifically, a musical alert (which lasts for 10 minutes, followed by a 5 minute–long repeat alert that occurs at a 15-minute interval after the first alert is stopped) sounds when it is time for the patient to take medication. If the patient misses a dose due to forgetfulness during the set period (30 minutes after the start of the first alert), a voice message stating “The medicine hasn’t been taken” is sent via telephone to 1 or more medication supporters. The telephone numbers of up to 5 medication supporters can be registered with each ODP-MSS unit. When a supporter’s telephone number is changed, the patient or family can program the new number using the operation panel. If the first contacted medication supporter fails to answer the telephone, the second or a subsequent medication supporter will receive the same call. Because up to 5 supporters can be called, it is believed that there will nearly always be someone to take the call. Upon receiving a call, the medication supporter calls the patient to remind him or her to take the medicine. In this way, the ODP-MSS can prevent missed doses due to forgetfulness. The system also allows medication supporters to verify the patient’s health status by telephone. Furthermore, patients who intend to leave the house can press a “going-out” switch, which predispenses the next ODP. When the going-out switch is pressed more than twice, a voice message (“Going out”) is automatically transmitted to medication supporters via telephone. The medication supporter then calls the patient to verify this information (e.g., “Are you going out?”). In this way, the ODP-MSS also serves as a telecommunication tool. The ODP-MSS contains internal memory that allows for the storage of data related to taking medication (e.g., whether the necessary medication is removed), automatic calling, and going out (e.g., whether and when the going-out switch is pressed). Thus, medication adherence can be determined by examining the internal memory. For instance, when a patient misses a dose due to forgetfulness, the ODP is retracted into the ODP-MSS 2 hours later, and the event is recorded in the device’s memory as a failure to take the medicine. This memory can be accessed via a USB cable and evaluated by a physician or pharmacist on a personal computer. The ODP-MSS can also be supplemented with a light-based signal for a person with hearing difficulties and a push switch to allow a person to contact a supporter if he or she feels ill. Study participants. Participants in the ODP-MSS evaluation were 10 elderly patients and 20 medication supporters (2 per elderly patient). The patient inclusion criteria were as follows: a current prescription for an ODP medicine, frequent medication forgetfulness according to both patients and family members, and an ability to self-administer medicine (or a need for only slight assistance). The exclusion criteria were lack of a prescription for an ODP medicine, significant dementia that would hinder self-administration, and a need for considerable assistance with taking medications. Per the inclusion criteria for medication supporters, all participants were relatives or neighbors of the patients and had the ability to call or visit a patient’s home when contacted by the ODP-MSS. Before beginning the evaluation, we confirmed the appropriateness of the ODPs in each ODP-MSS. We determined medication adherence by examining data from the internal memory of the ODP-MSS. Two group homes (9 patients per home) specializing in care for elderly patients with dementia participated in the study. In these homes, care staff typically administered the patients’ medications after dispensing from ODP-MSS units. Furthermore, prior to the evaluation a community pharmacist changed participating patients’ ODP drums from a “continuous ODP” configuration (i.e., a single roll dedicated only to morning-dose packages) to a “repeated-ODP” configuration (i.e., a single roll dedicated to dispensing morning, noon, and evening doses). A single ODP-MSS was used for repeated-ODP dispensing to each of 3 elderly patients in each group home. The experiments were conducted in Hanamaki City and Kamaishi City in the Iwate Prefecture of Japan. The experimental protocols were approved by the medical ethics committee of Gunma University or Iwate Prefectural University. Evaluations. Patients at home. The experiment was conducted from June 2013 to September 2016. We installed the ODP-MSS device in each patient’s home and programmed the medication times and the medication supporters’ telephone numbers. At the beginning of the experiment, we recorded the details of the medication regimen. The patients used the ODP-MSS at the time of initial programming. If a patient missed doses due to forgetfulness, the medicine supporter wrote the date, time, and patient’s health condition in the entry sheet and called the patient. At the end of the experiment, the participants and medication supporters were interviewed about instances of missed doses due to forgetfulness and the usefulness of the ODP-MSS and telecare home monitoring. Further, we analyzed the data log of medications taken or not taken, as well as automatic calling, from the memory of the ODP-MSS. Patients in group homes. The experiment was conducted from October 2014 to March 2015. We installed the ODP-MSS devices in the 2 group homes’ staff stations and set the medication times. At the beginning of the experiment, we interviewed several staff about medication support and mistakes in medicine consumption, and 15 staff members were given an opportunity to use the ODP-MSS. At the end of the experiment, we administered a questionnaire survey to staff members to elicit their views on topics such as the usefulness of the ODP-MSS for reducing medication assistance and medication errors and continued use of the ODP-MSS. Results Patients at home. The demographic data and baseline medication data of the 10 patients (mean ± S.D. age, 80.3 ± 6.6 years) are shown in Table 1. Patients 1–7 lived in Hanamaki City, while patients 8–10 lived in Kamaishi City. Table 1 Demographic and Baseline Medication Data of Patients Living at Homea Patient No. Sex and Age (yr) Living Arrangement Medical Problem(s) Medication Medication Supporter(s) No. Days Supply Prescribed No. Pills/ODP Management No. Remaining ODPsb 1 M (85) With family HTN, MI 30 B: 6 D: 3 Self 18 2 sons 2 M (66) With family DM, angina pectoris 28 B: 6 L: 1 D: 4 Self 6 Self, wife 3 F (85) With family HTN, arrhythmia 60 B: 5 D: 8 Self 0c Daughter, other relative 4 F (85) With family HTN, Alzheimer’s disease 28 B: 4 D: 1 Family 1 Son, other relative 5 M (76) Alone Stroke 63 B: 7 D: 1 Self 48 Pharmacist, daughter 6 M (74) With family DM, cardiac disease 60 B: 11 L: 1 D: 1 Self 1 Wife, daughter 7 M (82) With family Cardiac disease 30 B: 5 D: 3 Self 5 Son, son’s wife 8 F (86) Alone HTN 14 B: 5 L: 3 D: 1 Self 5 Pharmacist 9 M (76) With family HTN 90 B: 4 L: 1 D: 4 Self 7 Self, wife 10 F (88) Alone HTN 7 B: 13 D: 6 Pharmacist 0 Daughter, pharmacist Patient No. Sex and Age (yr) Living Arrangement Medical Problem(s) Medication Medication Supporter(s) No. Days Supply Prescribed No. Pills/ODP Management No. Remaining ODPsb 1 M (85) With family HTN, MI 30 B: 6 D: 3 Self 18 2 sons 2 M (66) With family DM, angina pectoris 28 B: 6 L: 1 D: 4 Self 6 Self, wife 3 F (85) With family HTN, arrhythmia 60 B: 5 D: 8 Self 0c Daughter, other relative 4 F (85) With family HTN, Alzheimer’s disease 28 B: 4 D: 1 Family 1 Son, other relative 5 M (76) Alone Stroke 63 B: 7 D: 1 Self 48 Pharmacist, daughter 6 M (74) With family DM, cardiac disease 60 B: 11 L: 1 D: 1 Self 1 Wife, daughter 7 M (82) With family Cardiac disease 30 B: 5 D: 3 Self 5 Son, son’s wife 8 F (86) Alone HTN 14 B: 5 L: 3 D: 1 Self 5 Pharmacist 9 M (76) With family HTN 90 B: 4 L: 1 D: 4 Self 7 Self, wife 10 F (88) Alone HTN 7 B: 13 D: 6 Pharmacist 0 Daughter, pharmacist a OPD = one-dose package, M = male, HTN = hypertension, MI = myocardial infarction, F = female, B = after breakfast, D = after dinner, DM = diabetes mellitus, L = after lunch. b OPDs remaining at start of experiment. More packages indicated worse medication adherence. c Wrong dose of after-breakfast or after-dinner medication. View Large Table 1 Demographic and Baseline Medication Data of Patients Living at Homea Patient No. Sex and Age (yr) Living Arrangement Medical Problem(s) Medication Medication Supporter(s) No. Days Supply Prescribed No. Pills/ODP Management No. Remaining ODPsb 1 M (85) With family HTN, MI 30 B: 6 D: 3 Self 18 2 sons 2 M (66) With family DM, angina pectoris 28 B: 6 L: 1 D: 4 Self 6 Self, wife 3 F (85) With family HTN, arrhythmia 60 B: 5 D: 8 Self 0c Daughter, other relative 4 F (85) With family HTN, Alzheimer’s disease 28 B: 4 D: 1 Family 1 Son, other relative 5 M (76) Alone Stroke 63 B: 7 D: 1 Self 48 Pharmacist, daughter 6 M (74) With family DM, cardiac disease 60 B: 11 L: 1 D: 1 Self 1 Wife, daughter 7 M (82) With family Cardiac disease 30 B: 5 D: 3 Self 5 Son, son’s wife 8 F (86) Alone HTN 14 B: 5 L: 3 D: 1 Self 5 Pharmacist 9 M (76) With family HTN 90 B: 4 L: 1 D: 4 Self 7 Self, wife 10 F (88) Alone HTN 7 B: 13 D: 6 Pharmacist 0 Daughter, pharmacist Patient No. Sex and Age (yr) Living Arrangement Medical Problem(s) Medication Medication Supporter(s) No. Days Supply Prescribed No. Pills/ODP Management No. Remaining ODPsb 1 M (85) With family HTN, MI 30 B: 6 D: 3 Self 18 2 sons 2 M (66) With family DM, angina pectoris 28 B: 6 L: 1 D: 4 Self 6 Self, wife 3 F (85) With family HTN, arrhythmia 60 B: 5 D: 8 Self 0c Daughter, other relative 4 F (85) With family HTN, Alzheimer’s disease 28 B: 4 D: 1 Family 1 Son, other relative 5 M (76) Alone Stroke 63 B: 7 D: 1 Self 48 Pharmacist, daughter 6 M (74) With family DM, cardiac disease 60 B: 11 L: 1 D: 1 Self 1 Wife, daughter 7 M (82) With family Cardiac disease 30 B: 5 D: 3 Self 5 Son, son’s wife 8 F (86) Alone HTN 14 B: 5 L: 3 D: 1 Self 5 Pharmacist 9 M (76) With family HTN 90 B: 4 L: 1 D: 4 Self 7 Self, wife 10 F (88) Alone HTN 7 B: 13 D: 6 Pharmacist 0 Daughter, pharmacist a OPD = one-dose package, M = male, HTN = hypertension, MI = myocardial infarction, F = female, B = after breakfast, D = after dinner, DM = diabetes mellitus, L = after lunch. b OPDs remaining at start of experiment. More packages indicated worse medication adherence. c Wrong dose of after-breakfast or after-dinner medication. View Large The experiment in Hanamaki was conducted in 2 different periods, which enabled patients 4 and 5 to participate in both of the experiments described in this article. The patients experienced no issues with their abilities to use the ODP-MSS and hear an alert. The stated reasons for using the ODP-MSS were as follows: Patients 1, 2, 6, 7, and 9 reported being concerned about their disease when they missed doses due to forgetfulness; patients 3 and 4 had taken wrong doses when attempting to self-manage their medication, which caused their families to choose to use the ODP-MSS; and patients 5, 8, and 10 had experienced difficulties in medication adherence and lived alone, which led their pharmacists to advise them to use the ODP-MSS. Further, in patient 10’s case, a pharmacist had visited the patient’s home once per week and set the ODPs according to a medication calendar before ODP-MSS use. When the experiment began, the ODP-MSS units of all 10 patients contained undispensed packages due to previously missed doses or consumption of the wrong dosage. Most patients chose a relative as their first supporter. Patients 2 and 9 selected themselves as the first supporter. However, patients 5 and 8 both selected their pharmacist as the first supporter because they lived alone. Themes suggested by experimental data.Table 2 shows the experimental data obtained during the mean experimental period, the mean ± S.D. duration of which was 91.5 ± 53.9 days. These data can be summarized into the following themes: (1) most patients had 100% medication adherence, (2) patients who had missed doses due to forgetfulness took medicine after the medication supporter called, (3) patients could not take the medication when they left the home, and (4) an irregular lifestyle interrupted routine taking of medications. Table 2 Experimental Outcomes of ODP-MSS Use by Patients Living at Homea Patient No. Experimental Duration (days) Dose Time No. Doses Initially Forgotten No. Automatic Calls to Supporter No. Doses Eventually Taken Medication Adherence (%) 1 92 10:30 a.m. 0 …b 92 100 7:00 p.m. 0 … 92 2 93 7:20 a.m. 0 0 93 97.8 12:00 noon 2 2 91 5:45 p.m. 0 0 93 3 95 8:00 a.m. 0 0 95 100 8:00 p.m. 0 0 95 4 185 7:30 a.m. 0 0 185 100 6:30 p.m. 3 3 185 5 183 9:00 a.m. 0 0 183 100 9:30 p.m. 5 5 183 6 64 9:00 a.m. 0 0 64 100 1:00 p.m. 0 0 64 7:00 p.m. 0 0 64 7 67 7:30 a.m. 0 0 67 100 6:30 p.m. 0 0 67 8 30 12:00 noon 2 2 30 100 6:00 p.m. 0 0 30 10:00 p.m. 0 0 30 9 74 8:00 a.m. 1 1 74 100 1:00 p.m. 0 0 74 6:00 p.m. 1 1 74 10 32 9:30 a.m. 4 2 28 87.5 8:30 p.m. 4 2 28 Patient No. Experimental Duration (days) Dose Time No. Doses Initially Forgotten No. Automatic Calls to Supporter No. Doses Eventually Taken Medication Adherence (%) 1 92 10:30 a.m. 0 …b 92 100 7:00 p.m. 0 … 92 2 93 7:20 a.m. 0 0 93 97.8 12:00 noon 2 2 91 5:45 p.m. 0 0 93 3 95 8:00 a.m. 0 0 95 100 8:00 p.m. 0 0 95 4 185 7:30 a.m. 0 0 185 100 6:30 p.m. 3 3 185 5 183 9:00 a.m. 0 0 183 100 9:30 p.m. 5 5 183 6 64 9:00 a.m. 0 0 64 100 1:00 p.m. 0 0 64 7:00 p.m. 0 0 64 7 67 7:30 a.m. 0 0 67 100 6:30 p.m. 0 0 67 8 30 12:00 noon 2 2 30 100 6:00 p.m. 0 0 30 10:00 p.m. 0 0 30 9 74 8:00 a.m. 1 1 74 100 1:00 p.m. 0 0 74 6:00 p.m. 1 1 74 10 32 9:30 a.m. 4 2 28 87.5 8:30 p.m. 4 2 28 a ODP-MSS = one-dose package medication support system. b Patient’s home did not have telephone service. View Large Table 2 Experimental Outcomes of ODP-MSS Use by Patients Living at Homea Patient No. Experimental Duration (days) Dose Time No. Doses Initially Forgotten No. Automatic Calls to Supporter No. Doses Eventually Taken Medication Adherence (%) 1 92 10:30 a.m. 0 …b 92 100 7:00 p.m. 0 … 92 2 93 7:20 a.m. 0 0 93 97.8 12:00 noon 2 2 91 5:45 p.m. 0 0 93 3 95 8:00 a.m. 0 0 95 100 8:00 p.m. 0 0 95 4 185 7:30 a.m. 0 0 185 100 6:30 p.m. 3 3 185 5 183 9:00 a.m. 0 0 183 100 9:30 p.m. 5 5 183 6 64 9:00 a.m. 0 0 64 100 1:00 p.m. 0 0 64 7:00 p.m. 0 0 64 7 67 7:30 a.m. 0 0 67 100 6:30 p.m. 0 0 67 8 30 12:00 noon 2 2 30 100 6:00 p.m. 0 0 30 10:00 p.m. 0 0 30 9 74 8:00 a.m. 1 1 74 100 1:00 p.m. 0 0 74 6:00 p.m. 1 1 74 10 32 9:30 a.m. 4 2 28 87.5 8:30 p.m. 4 2 28 Patient No. Experimental Duration (days) Dose Time No. Doses Initially Forgotten No. Automatic Calls to Supporter No. Doses Eventually Taken Medication Adherence (%) 1 92 10:30 a.m. 0 …b 92 100 7:00 p.m. 0 … 92 2 93 7:20 a.m. 0 0 93 97.8 12:00 noon 2 2 91 5:45 p.m. 0 0 93 3 95 8:00 a.m. 0 0 95 100 8:00 p.m. 0 0 95 4 185 7:30 a.m. 0 0 185 100 6:30 p.m. 3 3 185 5 183 9:00 a.m. 0 0 183 100 9:30 p.m. 5 5 183 6 64 9:00 a.m. 0 0 64 100 1:00 p.m. 0 0 64 7:00 p.m. 0 0 64 7 67 7:30 a.m. 0 0 67 100 6:30 p.m. 0 0 67 8 30 12:00 noon 2 2 30 100 6:00 p.m. 0 0 30 10:00 p.m. 0 0 30 9 74 8:00 a.m. 1 1 74 100 1:00 p.m. 0 0 74 6:00 p.m. 1 1 74 10 32 9:30 a.m. 4 2 28 87.5 8:30 p.m. 4 2 28 a ODP-MSS = one-dose package medication support system. b Patient’s home did not have telephone service. View Large Adherence. Checking the internal memory of the ODP-MSS and the entry sheet of medication supporters showed that 8 out of 10 patients had 100% medication adherence. Additionally, patient 4 shifted from family-managed to self-managed medication administration after using the ODP-MSS. Medication supporters. Patient 5 missed doses due to forgetfulness 5 times after dinner. However, the first medication supporter (a pharmacist) called this patient, and the patient subsequently took his medicine on each occasion. The pharmacist further confirmed that the patient’s condition was good. Being away from home. Patient 2 missed doses due to forgetfulness twice after lunch, both of which instances caused the ODP-MSS to call the first medication supporter (in this case, that was the patient himself). However, as the patient had already gone out at the time of the call, he could not take the medication at that time. Patient 4 missed doses due to forgetfulness 3 times after dinner; all of these missed doses occurred because the patient had left or was preparing to leave the house with her family. In all 3 instances, the ODP-MSS transmitted the missed-dose message to the first medication supporter (a son), and the patient took the medicine after returning home. Interruptions. Patient 8 moved to a different place of residence, which affected her adherence. Patient 10 continually missed doses because of forgetfulness due to an irregular lifestyle. Interview findings. The results of the interviews with patients and medication supporters are shown in Tables 3 and 4, respectively. These data could be summarized into the following themes: (1) the device provided a useful reminder to take medicine, (2) the medication supporter’s call was useful as a telecare home monitoring system, and (3) medication supporters felt that the telephone function was a burden but still important in the context of a patient who felt ill. Details regarding each derived theme are provided below. Table 3 Results of Interviews of Patients Living at Homea Patient No. Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Patient Comments 1 Not useful …b Could take medicine even without ODP-MSS 2 Not useful … ODP-MSS did not improve adherence, because missed doses were due to forgetfulness when going out 3 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 4 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 5 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 6 Not useful … Could take medicine even without ODP-MSS 7 Useful … Could take medicine even without ODP-MSS 8 Not useful Useful Could take medicine even without ODP-MSS; believed that supporter (pharmacist) was troubled that he or she was called 9 Useful … ODP-MSS not needed, because patient did not go out much; device was troublesome because patient received telephone call if going-out switch was pushed twice. Patient No. Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Patient Comments 1 Not useful …b Could take medicine even without ODP-MSS 2 Not useful … ODP-MSS did not improve adherence, because missed doses were due to forgetfulness when going out 3 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 4 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 5 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 6 Not useful … Could take medicine even without ODP-MSS 7 Useful … Could take medicine even without ODP-MSS 8 Not useful Useful Could take medicine even without ODP-MSS; believed that supporter (pharmacist) was troubled that he or she was called 9 Useful … ODP-MSS not needed, because patient did not go out much; device was troublesome because patient received telephone call if going-out switch was pushed twice. a ODP-MSS = one-dose package medication support system. b No response due to lack of telephone service (patient 1) or because calls from supporter were not answered (patients 6, 7, and 9). View Large Table 3 Results of Interviews of Patients Living at Homea Patient No. Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Patient Comments 1 Not useful …b Could take medicine even without ODP-MSS 2 Not useful … ODP-MSS did not improve adherence, because missed doses were due to forgetfulness when going out 3 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 4 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 5 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 6 Not useful … Could take medicine even without ODP-MSS 7 Useful … Could take medicine even without ODP-MSS 8 Not useful Useful Could take medicine even without ODP-MSS; believed that supporter (pharmacist) was troubled that he or she was called 9 Useful … ODP-MSS not needed, because patient did not go out much; device was troublesome because patient received telephone call if going-out switch was pushed twice. Patient No. Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Patient Comments 1 Not useful …b Could take medicine even without ODP-MSS 2 Not useful … ODP-MSS did not improve adherence, because missed doses were due to forgetfulness when going out 3 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 4 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 5 Useful Useful ODP-MSS’s musical alert was useful in calling attention to dose time 6 Not useful … Could take medicine even without ODP-MSS 7 Useful … Could take medicine even without ODP-MSS 8 Not useful Useful Could take medicine even without ODP-MSS; believed that supporter (pharmacist) was troubled that he or she was called 9 Useful … ODP-MSS not needed, because patient did not go out much; device was troublesome because patient received telephone call if going-out switch was pushed twice. a ODP-MSS = one-dose package medication support system. b No response due to lack of telephone service (patient 1) or because calls from supporter were not answered (patients 6, 7, and 9). View Large Table 4 Results of Interviews With Medication Supportersa Supporter No. Supporter Type Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Supporter Comments 1 Son Useful …b Patient did not miss doses due to forgetfulness because of the musical alert 3 Daughter Useful Useful Patient did not take the wrong dosage while using the ODP-MSS; supporter was able to cooperate with other supporters 4 Son Useful Useful ODP-MSS was easy to use because it dispensed multiple doses in 1 package; wanted to continue using ODP-MSS; able to cooperate with other supporters 5 Pharmacist Useful Useful Able to confirm that patient’s condition was good by calling; heavy sense of responsibility regarding the patient when patient felt ill 6 Wife … … Patient did not need to use ODP-MSS 8 Pharmacist Not useful Useful Patient did not use ODP-MSS well; would like to see how ODP-MSS works in scenario of patient living with family 9 Wife Useful Useful Received a call from ODP-MSS indicating that patient had not taken medicine before going out 10 Daughter Not useful Useful Patient had cerebral infarction 1 year ago, and cognitive function had decreased thereafter; would have preferred if ODP-MSS had been introduced before patient’s cognitive function worsened; patient slept even if an alert sounded because her lifestyle was irregular Pharmacist Not useful Useful Telephone function of ODP-MSS was a burden, especially at night; timing of introduction important for promoting effective use of ODP-MSS; patients who show poor cognitive function could not use ODP-MSS; patient’s irregular daily schedule made setting medication times difficult Supporter No. Supporter Type Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Supporter Comments 1 Son Useful …b Patient did not miss doses due to forgetfulness because of the musical alert 3 Daughter Useful Useful Patient did not take the wrong dosage while using the ODP-MSS; supporter was able to cooperate with other supporters 4 Son Useful Useful ODP-MSS was easy to use because it dispensed multiple doses in 1 package; wanted to continue using ODP-MSS; able to cooperate with other supporters 5 Pharmacist Useful Useful Able to confirm that patient’s condition was good by calling; heavy sense of responsibility regarding the patient when patient felt ill 6 Wife … … Patient did not need to use ODP-MSS 8 Pharmacist Not useful Useful Patient did not use ODP-MSS well; would like to see how ODP-MSS works in scenario of patient living with family 9 Wife Useful Useful Received a call from ODP-MSS indicating that patient had not taken medicine before going out 10 Daughter Not useful Useful Patient had cerebral infarction 1 year ago, and cognitive function had decreased thereafter; would have preferred if ODP-MSS had been introduced before patient’s cognitive function worsened; patient slept even if an alert sounded because her lifestyle was irregular Pharmacist Not useful Useful Telephone function of ODP-MSS was a burden, especially at night; timing of introduction important for promoting effective use of ODP-MSS; patients who show poor cognitive function could not use ODP-MSS; patient’s irregular daily schedule made setting medication times difficult a ODP-MSS = one-dose package medication support system. b No response due to lack of telephone service at patient’s home (supporter 1) or nonresponse to interview question (supporter 6). View Large Table 4 Results of Interviews With Medication Supportersa Supporter No. Supporter Type Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Supporter Comments 1 Son Useful …b Patient did not miss doses due to forgetfulness because of the musical alert 3 Daughter Useful Useful Patient did not take the wrong dosage while using the ODP-MSS; supporter was able to cooperate with other supporters 4 Son Useful Useful ODP-MSS was easy to use because it dispensed multiple doses in 1 package; wanted to continue using ODP-MSS; able to cooperate with other supporters 5 Pharmacist Useful Useful Able to confirm that patient’s condition was good by calling; heavy sense of responsibility regarding the patient when patient felt ill 6 Wife … … Patient did not need to use ODP-MSS 8 Pharmacist Not useful Useful Patient did not use ODP-MSS well; would like to see how ODP-MSS works in scenario of patient living with family 9 Wife Useful Useful Received a call from ODP-MSS indicating that patient had not taken medicine before going out 10 Daughter Not useful Useful Patient had cerebral infarction 1 year ago, and cognitive function had decreased thereafter; would have preferred if ODP-MSS had been introduced before patient’s cognitive function worsened; patient slept even if an alert sounded because her lifestyle was irregular Pharmacist Not useful Useful Telephone function of ODP-MSS was a burden, especially at night; timing of introduction important for promoting effective use of ODP-MSS; patients who show poor cognitive function could not use ODP-MSS; patient’s irregular daily schedule made setting medication times difficult Supporter No. Supporter Type Usefulness of ODP-MSS Usefulness of Telecare Home Monitoring Supporter Comments 1 Son Useful …b Patient did not miss doses due to forgetfulness because of the musical alert 3 Daughter Useful Useful Patient did not take the wrong dosage while using the ODP-MSS; supporter was able to cooperate with other supporters 4 Son Useful Useful ODP-MSS was easy to use because it dispensed multiple doses in 1 package; wanted to continue using ODP-MSS; able to cooperate with other supporters 5 Pharmacist Useful Useful Able to confirm that patient’s condition was good by calling; heavy sense of responsibility regarding the patient when patient felt ill 6 Wife … … Patient did not need to use ODP-MSS 8 Pharmacist Not useful Useful Patient did not use ODP-MSS well; would like to see how ODP-MSS works in scenario of patient living with family 9 Wife Useful Useful Received a call from ODP-MSS indicating that patient had not taken medicine before going out 10 Daughter Not useful Useful Patient had cerebral infarction 1 year ago, and cognitive function had decreased thereafter; would have preferred if ODP-MSS had been introduced before patient’s cognitive function worsened; patient slept even if an alert sounded because her lifestyle was irregular Pharmacist Not useful Useful Telephone function of ODP-MSS was a burden, especially at night; timing of introduction important for promoting effective use of ODP-MSS; patients who show poor cognitive function could not use ODP-MSS; patient’s irregular daily schedule made setting medication times difficult a ODP-MSS = one-dose package medication support system. b No response due to lack of telephone service at patient’s home (supporter 1) or nonresponse to interview question (supporter 6). View Large Device usefulness. Five patients and 5 medication supporters reported during interviews that the ODP-MSS provided a useful reminder to take medicine at the time of the alert. However, cognitive impairment and cognitive decline over time may pose complex issues in terms of proper ODP-MSS use. Patient 10 reported not being able to use the ODP-MSS. Her medication supporter (a daughter) wished that the ODP-MSS had been introduced before the patient’s cognitive function had worsened and speculated that the patient might then have used the device. For some patients, the ODP-MSS was incompatible with lifestyles and sleep cycles. Patient 2 often missed doses due to forgetfulness, and because he typically went out in the afternoon, he could not take missed medication doses until he returned home. Patients 6 and 8 responded that the set times of the ODP-MSS did not match their actual mealtimes; accordingly, they pressed the going-out switch before the set times and took medicines after doing so. Patient 10 slept even if an alert sounded, because her lifestyle was irregular. Value of telephone calls. Four patients and 7 medication supporters responded that the calls to medication supporters (and supporters’ consequent calls to patients) were useful as a telecare home monitoring method and for reassuring the supporter of the patient’s health condition. Patients 4 and 5 and their supporters, as well as patient 3’s first supporter (a daughter), indicated that they would continue to use the ODP-MSS. Burden on supporters. Patient 10’s supporter felt that the telephone function of the ODP-MSS was a burden, especially at night. The pharmacist who provided medication support for patient 5 noted that providing direct medication support to patients might be a problem, because pharmacists usually do not visit patients’ homes or communicate with patients’ families. He additionally reported that this role placed a burden on both the pharmacist and the medication supporter. However, he nevertheless noted that the responsibility was important in the context of a patient feeling ill. Patients in group homes. The experiment’s duration was 145 days. Data from the 2 group homes showed that the device markedly reduced (1) the time required to arrange medication administration, (2) the need for medication assistance, and (3) medication errors. Arranging medication administration. Before the ODP-MSS was introduced, 2 care staff members took 2 hours each week during the night shift to construct ODPs and set the medication calendar. At the beginning of the experiment, the ODP-MSS units were programmed such that the device’s alarm sounded for 10 minutes to alert patients that it was time for medications to be given. However, this alarm was found to distress the patients, and it was deactivated for the remainder of the experiment. There was only 1 instance of a staff member forgetting to distribute a patient’s medicine. Medication assistance. Among 15 respondents to the questionnaire administered to staff members, 11 reported that the ODP-MSS was useful or somewhat useful for reducing the need for medication assistance, and 11 responded that the system was useful or somewhat useful for reducing medication errors (Table 5). Most respondents were willing to continue using the ODP-MSS. However, 6 staff members at 1 group home reported that the ODP-MSS often became jammed by an ODP; in 1 instance, they were unaware of the problem when distributing subsequent doses because the device alert had been deactivated. These 6 staff members answered that they would not continue to use the ODP-MSS. Table 5 Results of Questionnaire Administration to Care Staffa Question and Reponse No. Responses Spontaneous Comments What is your job category? None  Manager 1  Care worker 12  Other 2 How useful was ODP-MSS for reducing medication assistance? None  Useful 4  Somewhat useful 7  Not useful 3  No response 1 How useful was ODP-MSS for reducing medication errors? • Mistakes in preparation disappeared. • Once, when an ODP medicine was caught in the ODP-MSS, the staff did not notice when distributing the next medicine.  Useful 5  Somewhat useful 6  Not useful 3  No response 1 Would you like to continue using this system from now on? • It is useful for simplifying work. • When the ODP contains a large quantity of medicine (powdered medicine), it can become caught inside the ODP-MSS.  Yes 7  Maybe 1  No 6  No response 1 Other comments • The ODP-MSS was easy to use, so I did not worry. • Herbal medicine cannot be made into an ODP, and I was required to expend more time and effort. Question and Reponse No. Responses Spontaneous Comments What is your job category? None  Manager 1  Care worker 12  Other 2 How useful was ODP-MSS for reducing medication assistance? None  Useful 4  Somewhat useful 7  Not useful 3  No response 1 How useful was ODP-MSS for reducing medication errors? • Mistakes in preparation disappeared. • Once, when an ODP medicine was caught in the ODP-MSS, the staff did not notice when distributing the next medicine.  Useful 5  Somewhat useful 6  Not useful 3  No response 1 Would you like to continue using this system from now on? • It is useful for simplifying work. • When the ODP contains a large quantity of medicine (powdered medicine), it can become caught inside the ODP-MSS.  Yes 7  Maybe 1  No 6  No response 1 Other comments • The ODP-MSS was easy to use, so I did not worry. • Herbal medicine cannot be made into an ODP, and I was required to expend more time and effort. a ODP = one-dose package, ODP-MSS = one-dose package medication support system. View Large Table 5 Results of Questionnaire Administration to Care Staffa Question and Reponse No. Responses Spontaneous Comments What is your job category? None  Manager 1  Care worker 12  Other 2 How useful was ODP-MSS for reducing medication assistance? None  Useful 4  Somewhat useful 7  Not useful 3  No response 1 How useful was ODP-MSS for reducing medication errors? • Mistakes in preparation disappeared. • Once, when an ODP medicine was caught in the ODP-MSS, the staff did not notice when distributing the next medicine.  Useful 5  Somewhat useful 6  Not useful 3  No response 1 Would you like to continue using this system from now on? • It is useful for simplifying work. • When the ODP contains a large quantity of medicine (powdered medicine), it can become caught inside the ODP-MSS.  Yes 7  Maybe 1  No 6  No response 1 Other comments • The ODP-MSS was easy to use, so I did not worry. • Herbal medicine cannot be made into an ODP, and I was required to expend more time and effort. Question and Reponse No. Responses Spontaneous Comments What is your job category? None  Manager 1  Care worker 12  Other 2 How useful was ODP-MSS for reducing medication assistance? None  Useful 4  Somewhat useful 7  Not useful 3  No response 1 How useful was ODP-MSS for reducing medication errors? • Mistakes in preparation disappeared. • Once, when an ODP medicine was caught in the ODP-MSS, the staff did not notice when distributing the next medicine.  Useful 5  Somewhat useful 6  Not useful 3  No response 1 Would you like to continue using this system from now on? • It is useful for simplifying work. • When the ODP contains a large quantity of medicine (powdered medicine), it can become caught inside the ODP-MSS.  Yes 7  Maybe 1  No 6  No response 1 Other comments • The ODP-MSS was easy to use, so I did not worry. • Herbal medicine cannot be made into an ODP, and I was required to expend more time and effort. a ODP = one-dose package, ODP-MSS = one-dose package medication support system. View Large Discussion ODPs and medication calendars have been used previously for medication support along with other measures that have been described as effective in previous studies, such as follow-up care via telephone23 and Web conferencing.24 Additionally, focus group participants indicated that medication mismanagement was a major issue for themselves and their friends, relatives, and neighbors.25 The findings of the present study confirmed the usefulness of the ODP-MSS as well as ODP-MSS–directed follow-up calls from a medication supporter for counteracting missed doses due to forgetfulness as a system of telecare home monitoring. Patients 4 and 5 used the device continuously for more than 2 years. However, we found that patients who often go out would need a modified system—for example, using both the calling function of the ODP-MSS and a pillbox kept on hand. Furthermore, individuals with irregular mealtimes could use the going-out switch to remove medication. In a similar study of ODPs, 6 participants (mean age, 65.3 years) completed a full 14-day assessment of ODP dispenser use.26 Participants voiced concerns regarding the handling of medication changes if pouches became stuck in the dispenser, which was locked and required a key to open. In addition, participants experienced external pressure because they were required to be at home at specific times. In contrast, with the ODP-MSS, patients, family members, or pharmacists were responsible for replenishing the ODPs. Additionally, the patient could press the going-out switch and remove a fixed dose of medicine before leaving home. In the event of a power outage, the ODP-MSS can be opened without a key so that patients can open the cover and take the medication. In this way, the ODP-MSS is easy to use and does not place a considerable burden on patients. Overall, we believe that the ODP-MSS is easy to fill and program, is likely to see continued use by patients, and can be used for effective home monitoring. It may even be superior in those respects to other tools with limited applicability, such as an MEMS system, which can only be used with medication bottles5–8; automatic pill dispensers, which are difficult to use with multiple medications9,10; and the MD.2 device, which makes it difficult for the elderly to refill the medication cups.11–13 In 2016, the Ministry of Health, Labour and Welfare of Japan introduced a family pharmacy program with the aim of reducing the amounts of leftover medicine. Additionally, family pharmacies have been requested to function as a social access point during various life and environmental events or disasters.27 Pharmaceutical care differs from traditional medication use in that the former is an explicitly outcome-oriented, cooperative, systematic approach to drug therapy that targets not only clinical outcomes but also ADLs and other dimensions of health-related quality of life.28 We have defined an “area cooperation unit” as the telecare home monitoring of an elderly person with cooperation from a pharmacist, medication supporters (e.g., family members, neighbors, medical and care staffs), and communication tools (e.g., ODP-MSS, telephone).29 Therefore, both the pharmacist’s cooperation and the ODP-MSS can be considered to contribute to a family pharmacy program and pharmaceutical care. However, in this study, the pharmacists reported a heavy sense of responsibility regarding patients who feel ill. Therefore, we must consider the scope of responsibility when pharmacists or family members not resident in the patient’s home become supporters. Previously, elderly patients living in nursing homes exhibited better drug-taking behaviors than did those living independently at home.30 In our study, the total staff time required for filling and programming ODP-MSS units was reduced from more than 2 hours to less than 10 minutes, and mishaps were decreased from several instances to 1 instance. Therefore, the ODP-MSS was useful for reducing the burden of medication support and medication errors on group home staff members. In this way, the ODP-MSS was considered effective in nursing homes and group homes for elderly patients with dementia, particularly facilities with few nursing staff. However, it should be noted that because the musical alert had been stopped, staff members did not notice when an ODP became jammed in the system. This finding suggests that the staff should check the devices before each medication time point. Nevertheless, a clear benefit of the ODP-MSS is that the ODP jams can be usually confirmed without opening the cover. Furthermore, in the event of a jam, the only maintenance necessary is to open the cover and remove the medicine, which does not take much time. Several limitations of the ODP-MSS were identified by users (e.g., device jamming, patients feeling obligated to stay home during medication administration times, supporters receiving too many calls). We plan to apply the lessons learned through our evaluation of a small population of patients to further improve the product. Additionally, the limitations of the study included the small number of cases and comparatively good rate of patient medication adherence. Furthermore, the patients all had rather different diseases. In future studies, it will be necessary to increase the number of cases and experiments with regard to specific diseases (e.g., hypertension,5–8 mild cognitive impairement,9 chronic heart failure10). Further, it will be necessary to evaluate whether the ODP-MSS can be applied to hemiplegic patients, as it can be used with 1 hand. Conclusion An ODP device plus follow-up calls from a medication supporter helped prevent missed doses resulting from patients’ forgetfulness and may serve as a useful component of telecare home monitoring for elderly people living independently at home. The ODP device was also useful for reducing the burdens associated with medication support and medication errors on staff members of group homes for elderly patients with dementia. Acknowledgments The authors gratefully acknowledge Ichiro Abe, Takeshi Takahashi, Daikazu Sato, Kazuhiro Ozuchi, Tetsuya Oikawa, and Fumihiko Takemasa for their assistance in developing the ODP-MSS, as well as Editage for English language editing of the article manuscript. Disclosures This study was supported financially by the Program for Revitalization Promotion. Funding was provided by JST and Qualcomm Wireless Reach. The authors have declared no potential conflicts of interest. References 1 Shibamiya T Obara T Tanaka K et al. Current status of taking medication dispensed in one-dose package among outpatients . J Drug Interact Res . 2009 ; 33 : 15 – 9 . 2 Vrijens B Greest S Hughes DA et al. A new taxonomy for describing and defining adherence to medications . Br J Clin Pharmacol . 2012 ; 73 : 691 – 705 . Google Scholar Crossref Search ADS PubMed 3 Osterberg L Blaschke T . Adherence to medication . N Engl J Med . 2005 ; 353 : 487 – 97 . 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TI - Evaluation of a one-dose package medication support system for community-based elderly patients and eldercare facilities JF - American Journal of Health-System Pharmacy DO - 10.2146/ajhp170176 DA - 2018-05-01 UR - https://www.deepdyve.com/lp/oxford-university-press/evaluation-of-a-one-dose-package-medication-support-system-for-0lLSYA03Wp SP - e202 VL - 75 IS - 9 DP - DeepDyve ER -