Abstract
In April 2009, Japan Council for Quality Health Care (JCQHC) launched the Project to Collect Incidents within Community Pharmacies, a national project of self-and-voluntary reporting of incidents among community pharmacies. While there have been several studies and projects to collect and analyze incident reports among a set number of community pharmacies across the globe, it is still rare for an incident collecting project to exist at a national level. This paper introduces the new project in Japan. A retrospective analysis of community pharmacy participation across the country and cause of reported incidents based on the data released by JCQHC. Among the total number of reported incidents (1,460 cases), the most frequently reported incidents were related to the task of filling out prescriptions (92.0%). The most frequently answered cause of the incident was due to a “failure to check thoroughly” with 1,293 (96.3) out of 1,343 reported cases of incidents from community pharmacies. In a comparison of incidents reported between hospital pharmacies and community hospitals, both types of pharmacies reported a “failure to check thoroughly” as the leading cause of incidents. In hospital pharmacies, however, only 3,265 (84.7%) cases out of 3,857 were reported with “failure to check thoroughly” as the cause of incident. The rates between hospital pharmacy and community pharmacy for this cause differed significantly (P < 0.05). As the main cause of incidents was due to “the failure to check thoroughly”, the need for confirmation systems within community pharmacies has become ever more evident.
Introduction
Medical malpractice continues to be a topic of importance around the world as well as in Japan.
In the case of Japan, adverse events and incident cases in community pharmacies were particularly overlooked. While adverse drug events has been monitored and studied as a part of pharmaceutical risk management within medical facilities such as clinics and hospitals, similar patient safety measures were not practiced in community pharmacies. One reason for this is that there were few laws regulating patient safety management within community pharmacies in the past. Another is that incidents and accidents (case numbers, the content and the cause), which are the basis for patient safety, had not been studied and therefore the importance of patient safety or the priority issues within community pharmacies had not been made clear.
This implies that the basic steps in patient safety management: 1) to understand the context of the incidents and adverse events, 2) to conduct an analysis of the cause, 3) to create preventative measures, 4) to implement the strategies and 5) to re-evaluate the process and procedure, 1 were not practiced in community pharmacies across Japan.
Though incidents have the potential of leading to grave accidents, more attention and time has been given to analyzing actual adverse events. As a consequence, incidents were often neglected and understudied. In patient safety management, however, it is equally as important to examine incidents as much as accidents.
Bearing in mind the information above, the Japanese Ministry of Health Labor and Welfare started a project for incident reporting among all community pharmacies across the country in April 2008. This project was later carried out by Japan Council for Quality Health Care (JCQHC), a third party hospital appraisal organization, in April 2009. 2
While there have been studies to collect and analyze incidents across the globe, they have only examined a certain set number of pharmacies at a regional level. In contrast, the incident collection project by JCHQC is conducted at the national level in Japan. Analyzing the data from the project and grasping the situation at large in Japan, is thus regarded as beneficial information not only for Japan but also for other countries in implementing national level incident reporting projects. 3 The reports of the project, however, have only been released in Japanese and cannot be widely shared across the globe. Therefore, using the case data from the reports released by JCHQC, this study analyses the current situation of incidents among community pharmacies in Japan and discusses ways to advance risk management in community pharmacies.
Materials and Methods
Subject
JCQHC started the Project To Collect Incidents within Community Pharmacies a , a nationwide project to collect incidents from voluntarily participating community pharmacies since April 2009. There were 1,774 community pharmacies participating as of December 2009.
The flow of the incident reporting among community pharmacies is as shown in Figure 1 (modified from the flow figure on the JCQHC homepage).
Project to collect incident events information within community pharmacies operated by JCQHC
Under this project, the information collected by JCQHC are:
potentially erroneous medical procedures identified before actually performed for patients, erroneous medical procedures performed but did not affect patients' conditions, erroneous medical procedures performed with unknown effects upon patients.
Reporting is conducted online within a month of incident identification.
Materials
Data from two community pharmacy incident reports released by JCQHC were used in this study. The reports are as follows:
Report No.1, based on 175 incident cases reported from April to June 2009 4 and
Report No.2, based on 1285 incident cases reported from July to December 2009. 5
In addition, we also referred to data from the annual report 6 published in October of 2010.
In this study, we also used data reported from hospital pharmacies to compare the rate of incident based on their causes between hospital pharmacies and community pharmacies. For the hospital pharmacies, incident data was extracted from the “prescription and pharmaceutical management” section in the reports No. 19 7 and No. 20 8 of Project To Collect Medical Near-Miss/Adverse Event Information, whereas the incident data for community pharmacies was extracted from the cause of incident section related solely to prescription in the reports No. 1 and 2 mentioned above.
Community pharmacies refer to independently registered pharmacies, whereas hospital pharmacies include pharmacies within the following institutions: National Center for Advanced and Specialized Medical Care, National Leprosy Sanatorium, hospitals under the National Hospital Organization, university hospitals, Special Functioning Hospitals and other medical institutions under registration process.
The number of participating hospitals in this project is 1,210, during the period of May to November of 2009. The number of reported incidents was 127,247, of which 3,857 were related to prescription and hospital pharmacies. These 3,857 cases of incidents from hospital pharmacies were used in the analysis to compare the cause of incidents between hospital pharmacies and community pharmacies.
While hospitals have had legal requirements for risk management since 2002 and incident collection project since 2005, community pharmacies were only mandated to implement risk management strategies in 2007, and the incident collection project was only launched in 2009. Therefore, as the project for community pharmacy is relatively new, with only a few reported cases, we conducted our analysis to the capacity that it was allowed.
Statistical analysis
All statistical analysis was performed with SPSS Statistics 18 software. χ2 tests were used where appropriate.
Results
The total number of reported incidents was 1,460 cases.
In an analysis of cases per days of the week, there was no statistical difference between each weekday from Monday through Friday.
Types of incidents related to the task of filling out a prescription
Types of incidents related to the task of filling out a prescription
Types of incidents reported consisted of 92.0% (1,343/1,460 cases) related to the task of filling out a prescription, 7.3% related to confirmation with the physician, and 0.7% related to medical devices. The breakdown of all incidents related to the task of filling out a prescription, are shown in Table 2.
Types of incidents related to the task of filling out a prescription
Types of incidents related to the task of filling out a prescription
The cause of incidents is as shown in Table 3. The most frequently answered cause of the incident was related to the reporters' actions, with the greatest due to “a failure to check thoroughly.” As shown in Table 4 with a comparison of the cause of incidents between hospital pharmacies and community pharmacies, the greatest cause for both types of pharmacies were “failure to check thoroughly”, with 1,293 (96.3%) out of 1,343 reported cases of incidents from community pharmacies and 3,265 (84.7%) cases out of 3,857 from hospital pharmacies. These rates, however, differed significantly (P < 0.05).
Cause of Incidents (multiple answers)
Cause of Incidents (multiple answers)
Comparison of the cause of incidence related to filling out prescriptions among hospital pharmacies and community pharmacies (multiple-answers)
a Calculation includes only the types of cause in common for both hospital pharmacies and community pharmacies
b P values are based on Chi squared test. Those with P value of 5% are marked with * and highlighted
Incident identifier was broken down into the following categories: 65.6% were identified by colleagues of the same job category, followed by 18% by the person liable for the incident, 7.8% identified by the patients, 5.5% by co-workers of a different job category, 2.4% the patients' family, 0.1% other patients, and 0.6% by others.
Discussion
In Japan, MHLW has started a project to collect incident reporting from community pharmacies since April 2008. This study is an analysis of incident cases reported from participating community pharmacies in this project.
The number of reported cases per days of the week and per hours of the day
During the period of this study, there were 1,460 reported cases from the 1,774 participating pharmacies, of which there was no statistical difference of case reported between each weekday from Monday through Friday.
In terms of incident occurrence based on the hours of the day, there were more incidents between the hours of 10 o'clock to 12 o'clock. In practice, there needs to be a closer examination of other factors such as numbers of patients and prescriptions at the time of the incident. While such an analysis is not possible due to the limitation of information provided from the data used, at the very least, a finding of high incident reporting hours was made. At this point, a call for caution in relation to the hours of the day may have some significance.
Types of incidents reported
Out of the total number of reported incidents (1,460 cases), 92.0% (1,343 cases) were related to tasks of filling out prescription. Under this category, miscount (43.9%), wrong dosage form (16.1%), and wrong medication (13.5%) were most frequently reported.
One possible reason for miscount of medication is the feasibility of long-term prescription in Japan. For instance, cases of three months worth of prescription are allowed for patients of chronic diseases. While long term prescription is said to offer greater convenience to the patients, it also heightens the risk in terms of patient safety and requires another look at the cautionary details. Another possible reason for miscount, may be due to the difference in number of pills per sheet, depending on the products.
In this study, both cases of over-counting and under-counting were reported that included incidents that could have led to major accidents. For instance, there was a case of 60 days worth of allergy medication that was to be prescribed, yet 90 days worth was prepared. In another case, 80 counts of diabetes treatment pill were to be prescribed, yet only 60 were actually prepared.
Attempting to explain the cases of wrong dosage form, a large number of the same pharmaceutical products made in various forms or dosages may be a cause. The risk of adverse events with wrong dosage is comparatively higher than with the wrong form of the same medication. In this study alone, there were several incidents of wrong dosage with insulin. As such, preventative measures against filling out the prescription with the wrong dosage are crucial, since the degree of gravity will be much higher in the case that adverse event did occur.
In the case of wrong medication altogether, “look-alike” products with similar names, especially based on the first several letters, could be the cause. Another cause may be “sound-alike”, where the similar sounding product names are mistaken. In the study, the following cases were found for “look-alike”: the mix-up of Urinorm® (benzbromarone, an uricosuric agent) and Urief® (silodosin, a drug for urinary disorder); Preran® (trandolapril, an antihypertensive drug) and Prelon® (prednisolone, an adrenal cortical steroid). For “sound-alike” products, the following cases were reported: Omepral® (omeprazole, an antiulcer drug) and Olmetec® (olmesartan medoxomil, an antihypertensive drug); Tegretol® (carbamazepine, an antiepileptic drug) and Theodur® (theophylline, a bronchodilator).
Because of such reasons, it has been encouraged to add active ingredients on the labelling. Such a labelling is sure to continue and grow in the future, following the reports of JCQHC.
In Japan, prescriptions are written with the brand names rather than the generic names. This may be a possible cause for the incidents reported above. As such, an improvement measure is desired in ways of writing prescriptions.
The cause of incident
The most frequently answered cause of the incident was related to the actions of the person liable for the incident, with the greatest due to “a failure to check thoroughly”. One reason for this may be the level of activity that the pharmacies face, or a failure to double check the prescription due to lack of staff. Community pharmacies tend to have less staff than hospital pharmacies, with some staffing only one pharmacist on call. With only one pharmacist it is difficult to properly double check the prescription. As a countermeasure, there could be an increase in staff to distribute the workload and the burden as well as to double check each other's work.
This, however, may not agree with the community pharmacies' financial situation and may not be realistic. Also an additional staff is not necessarily needed, as community pharmacies have peak hours and are not necessarily busy at all times. As an alternative, then, seeking understanding and assistance from the patients may be a possible solution. For example, asking patients to return after a certain time at the time of prescription submission will allow for dispersion of time for prescription. This may hinder upon patient's convenience, but also has several advantages such as the decrease in waiting time and sufficiency in time and explanation for patient consultation. Sufficient patient consultation is crucial in terms of patient safety as well.
As the exact number of total prescription is not reported in the JCHQC project, it is difficult to get the rate of incident per number prescriptions. In the future, incident collecting project should consider these points and obtain the necessary information to analyze incidents. Also, each nation that is conducting the incident reporting project should consider these points when implementing such a project.
Another possible reason for “a failure to check thoroughly”, may be due to the lack of detailed confirmation system within community pharmacies. In fact, because community pharmacies had a significantly greater rate of incidents due to the lack of confirmation as shown in Table 4, an observation can be made that community pharmacies lack a sound system that hospital pharmacies have in place. While community pharmacies were only mandated to implement risk management strategies in 2007, hospitals have had legal requirements for risk management since 2002. Because of this, hospital pharmacies have a stronger risk management strategy in place whereas community pharmacies can be regarded as still developing their systems.
In order to address this, community pharmacies may adapt several systems from hospital pharmacies. There are also several confirmation systems that have been proven effective in preventing errors, such as confirming the list of items by pointing at them one by one, or by saying the names of the items out loud. Such systems should be under consideration for incorporation within community pharmacies.
In essence it has become clear in this study that more than half of the incidents were preventable with a thorough confirmation, and that a fool-proof confirmation system within community pharmacies is highly needed.
Persons who identified the incident
In this study it has become apparent that 7.8% and 2.4 % of all incidents were identified by the patients and the patients' family respectively, totaling 10.2%. This implies that about 10% of prepared prescriptions contained an actual error where the wrong number, dosage, or medication was administered to patients.
As a result, we now know that patients and their families have a major role in preventing adverse events. In order to prevent adverse events it is crucial to engage medical professionals in safety measures, however, it is also equally as important to engage the patients, since no matter how careful one becomes, human error is inevitable. As a proposal, patients should be well informed and educated regarding their medication so that the patients will check the prescription upon receiving it and confirm with the community pharmacy upon any doubt. Such an engagement of patients in prevention of adverse events is not only for community pharmacies but for all patient safety.
As for the reporting method, currently the pharmacy staff has complete autonomy to decide and prepare the reports. However, since patients themselves also identify incidents, a system for direct patient reporting of incidents should be incorporated in the future. Also the degree of incidents should be reported and analyzed, since some incidents are grave and have the potential of leading to adverse events while some others do not.
In conclusion, an analysis on incidents within community pharmacies across Japan and an observation on accident prevention were made using JCQHC data.
It has become clear through an analysis of incidents reported, that the task of filling out prescriptions requires extra caution, especially in terms of miscount of medication. Also, as the main cause of the incident was due to “the failure to check thoroughly”, the need and the importance for confirmation systems within community pharmacies have become ever more evident.
It would have a great significance for improving the policies behind community pharmacies if each nation could engage and also release the data of such projects on incident collection.
Footnotes
a
Project to Collect Incidents within Community Pharmacies is a new project that follows the Project To Collect Medical Near-Miss/ Adverse Event Information, implemented by JCQHC under the leadership of the Japanese MHLW. While a collection and analysis of incident reports of medical service facilities other than community pharmacies have been practiced from early on, incidents within community pharmacies, however, were not a part of the original project and only started to be collected under this new project in April 2009.