Project to Collect and Analyze
Pharmaceutical Near-Miss Event
Information2009 Annual Report

October 5, 2010

Japan Council for Quality Health Care
Division of Adverse Event Prevention

Table of Contents
Foreword ............................................................................................................ 1
Issuing the 2009 Annual Report ......................................................................... 3
Project to Collect and Analyze Pharmaceutical Near-Miss Event
Information ......................................................................................................... 5

I

Outline of Project to Collect and Analyze
Pharmaceutical Near-Miss Event Information ..................11
1 Background of Pharmaceutical Near-Miss Event Information
Collection ........................................................................................ 11
2 Outline of the Project to Collect and Analyze Pharmaceutical
Near-Miss Event Information...........................................................12[1] Objective ................................................................................................... 12[2] Collection of pharmaceutical near-miss event information ...................... 12[3] Publication of pharmaceutical near-miss event information .................... 13

II

Current Reporting Status....................................................15[1] Participating pharmacies........................................................................... 15[2] Number of reports ..................................................................................... 16[3] Details of reports ....................................................................................... 21[4] Tabulation according to product name ...................................................... 33

III Analysis of Pharmaceutical Near-Miss Information ..........39[1] Pharmaceutical near-miss events related to similar drug names .............. 39[2] Pharmaceuticall near-miss events related to similar efficacies ................. 44[3] Pharmaceutical near-miss events related to high-risk drugs..................... 49[4] Pharmaceutical near-miss events related to inquiries about
prerscription ............................................................................................. 52[5] Pharmaceutical near-miss events related to particular drugs.................... 58

IV Pharmaceutical Near-Miss Information to Be Shared........69
Document 2: Information to be collected.......................................................... 90
Document 3: Pharmaceutical near-miss event analysis table .......................... 96

Foreword
Tetsuo Ihara
President
Japan Council for Quality Health Care
In Japan, what is expected of health care has become more advanced and diversified with changes incommon disease prevalence and advances in medical technologies. Public interest in and demand for
health care has been increasing in recent years due to the changing social structure. In this context,
quality assurance in the health care system is more emphasized than quantity maintenance, making it
an important task to provide accurate health care information to the general public as well as topromote and ensure the provision of quality health care. The Japan Council for Quality Health Care
(JCQHC) should therefore play an important role in improving the quality of health care in Japan.
Regarding quality health care services, public expectations and interest in promotion of medical safety
and prevention of medical accidents have especially grown. As a neutral third-party organization, theJCQHC evaluates the care process to ensure the quality and safety of health care services at hospitals
based on the predetermined criteria in a third-party hospital evaluation and accreditation project. As ofnow, about 30% of Japanese hospitals (over 40% of total hospital beds in the country) are
JCQHC-accredited.
The five-year-old Project to Collect and Analyze Pharmaceutical Near-Miss/Adverse Event
Information is another project of the JCQHC. Pharmaceutical near-miss/adverse event information iscollected from the participating medical institutions in the Project since 2004 to prevent medical
accidents and to promote medical safety. Since about 30% of reported events are related to drugs,
indicating that a considerable number of medical near-miss events may be occurring at pharmacies.
According to the recently revised Health Service Act, pharmacies are now defined as health carefacilities like hospitals and clinics. Now that promotion of medical safety is an important
responsibility of pharmacies, we should learn from medical near-miss information reported bypharmacies and share the lessons nationwide.
After the Project to Collect and Analyze Pharmaceutical Near-Miss/Adverse Event Information andother activities of the JCQHC had been recognized by organizations and agencies involved in safety
management at pharmacies, the JCQHC inaugurated the Project to Collect and Analyze
Pharmaceutical Near-Miss Event Information from Pharmacies in 2008. The registration ofpharmacies to participate in the Project and collection of pharmaceutical near-miss information
occurred or identified at pharmacies started in April 1, 2009.
Collected pharmaceutical near-miss information is widely available to health care facilities, thegeneral public, relevant organizations and administrative organizations in forms of case database,periodic reports and near-miss information to be shared. The JCQHC deeply appreciates theparticipating pharmacies and those committed to the Projects for their cooperation in collection ofpharmaceutical near-miss information.
The 2009 annual report was prepared herein based on past half-year reports. The annual report
includes near-miss events reported from April to December 2009, analyses of individual themes andnear-miss information to be shared that will be useful for medical safety promotion. The JCQHC
hopes the annual report will be beneficial to pharmacies and help the general public understandcurrent nationwide efforts to promote the medical safety in Japan. Your suggestions for improvementof the JCQHC’s activities to provide useful information will be greatly appreciated.
The JCQHC is determined to maintain public trust in healthcare services and improve the quality of
medical care and its safety through various projects, including the evaluation and accreditation of
medical services provided at hospitals. The JCQHC appreciates your understanding and cooperation.

⎯1⎯

⎯2⎯

Issuing the 2009 Annual Report
Kikuo Nomoto
Director
Japan Council for Quality Health CareThe Division of Adverse Event Prevention inaugurated the Project to Collect and Analyze
Pharmaceutical Near-Miss Event Information in October 2008 to further promote medical safetymeasures by widely providing information useful for development of medical safety measures at
pharmacies as well as by providing information to the general public. The Project has been carryingout based on over five years of our experience in the Project to Collect and Analyze Pharmaceutical
Near-Miss/Adverse Event Information, in which pharmaceutical near-miss/adverse event information
has been collected, analyzed and published in periodic reports and monthly medical safety information
and workshops to improve the reporting quality. Since numerous events relating to drugs have beenreported, we have particularly tabulated near-miss events involving drugs and prepared and provided
multiple medical safety informations specifically related to drugs. Our experience is now used in the
Project to Collect and Analyze Pharmaceutical Near-Miss Event Information.
The objective of collecting and analyzing pharmaceutical near-miss information is to create asafety-oriented culture at pharmacies. It is important to collect a wide range of relevant information
and use it to promote medical safety. In terms of creating a safety-oriented culture, it is not necessarily
correct to view an increase in the number of reports as an actual increase in medical accidents ornear-miss events, i.e., safety at pharmacies declined.
Medical near-miss events involving drug dispensing activities that may also occur at hospitals andclinics as well as near-miss events that particularly occurred at pharmacies such as those identified
after making inquiries to hospitals and clinics and related to drug sales are subject to reporting in the
Project. In addition medical errors with unknown consequences are also subject to reporting. The
scope of reporting is thus determined to widely collect medical near-miss information frompharmacies. Since reports from pharmacies are the basis of the Project, the JCQHC deeply appreciates
the cooperation of the pharmacies that have been reporting near-miss events. The participating
pharmacies are encouraged to report near-miss events in accordance with the project outline andregulation in order to provide readers of the annual report with appropriate information on near-missevents occurring in Japan.
The Division of Adverse Event Prevention ensures anonymity of reported information to create anenvironment for safe reporting of pharmaceutical near-miss events by pharmacies. We hopepharmacies will understand the Project will not put reporting pharmacies at any disadvantages andactively participate in the Project, which is a nationwide effort to prevent medical accidents at
pharmacies. We have received positive responses from the participating medical institutions to theProject to Collect and Analyze Medical Near-Miss/Adverse Event Information carried out in the samelight, including an opinion that participation in the Project indicates proactive intension of the instituteto promote medical safety.
The 2009 annual report includes medical near-miss events reported during the period from the launchof the Project in April 2009 to December of the same year. The report basically consists of the contentsof published reports but also contains analyses based on five themes and near-miss event information
on drugs listed in the National Health Insurance price list for less than one year. Figures and tables
included in the annual report are mostly available on our website in different designs that can be easily
posted at pharmacies or used in in-house workshops. We hope that pharmacy managers, those
responsible for medical safety and pharmacy staff will share the information provided in the annual
report for promotion of medical safety at individual pharmacies.
We will increase our efforts to enhance the content of project reports for prevention of medical adverse
events and promotion of medical safety in Japan. Your understanding and cooperation is appreciated.

⎯3⎯

⎯4⎯

Project to Collect and Analyze
Pharmaceutical Near-Miss Information
Focusing on the 2009 report
Shin Ushiro
Manager of Medical Adverse Event Prevention Division
Japan Council for Quality Health Care

1. Foreword
Thank you for your continuous understanding and cooperation in this project.
The 2009 Annual Report includes medical near-miss events that occurred or were identified at
pharmacies and reported from April to December 2009. The 2009 Annual Report comprises thesemiannually reports published so far and analyses of individual themes for prevention. I hope you
will share the information contained in the 2009 Annual Report with the safety manager and the staff
members at your pharmacy.
If you are reading the 2009 Annual Report or browsing our website as healthcare service users, I hope
you will understand the types and details of the medical near-miss events that occurred at thepharmacies and those that occurred at the medical institutions and that are identified based on inquiries
from pharmacists to physicians as well as the attempts of the pharmacies and the medical institutions
to prevent recurrence of medical accidents.
The current statuses of the Project to Collect Pharmaceutical Near-Miss Information from Pharmacies
and other relevant projects are introduced below.

2. About the 2009 Annual Report
1) Number of reports
Total of 1,460 pharmaceutical near-miss events were reported from April to December 2009 (page16). The number of reported near-miss events included in the 2009 Annual Report is small since
the project has just started. However, the number has been steadily increasing. Over 1,000
near-miss events are reported as of now monthly at one year after the launch of the project. I
deeply appreciate your cooperation in this project and hope you review the scope of reporting
provided in “I-2 Summary of the Project to Collect and Analyze Pharmaceutical Near-Miss
Information” in the 2009 Annual Report (page 12) and report relevant near-miss events topromote medical safety in Japan.
It is not easy for the pharmacies to identify pharmaceutical near-miss events that fall into thescope of reporting, clarify the fact without lack of important information, summarize and report
the near-miss events and continue reporting in high quality. JCQHC has experienced that thequality of medical adverse event reports had been improving through repeated reporting activities
and medical adverse event analysis exercises provided at workshops in the Project to Collect
Medical Near-miss Adverse Event Information. I encourage you to participate in this project toimprove your skills to identify and report pharmaceutical near-miss events and promote medical
safety at pharmacies.
2) Current reporting status“II Current Reporting Status” includes the summary of reported cases, details of most frequently
reported drugs, effects on prescription after inquiries, analyses of the reasons for inquiries and⎯5⎯information based on which inquiries were made and tabulations of causes of near-miss events.
Drugs prescribed in the reported cases, wrong drugs used, replaced drugs, names of drugs
identified as related products to near-miss event and number of reports and the tabulation specificto generics are also included. Since the number of reports may increase with the sales of the drug,
the order of drugs on data presentation does not necessarily correspond with the extent ofassociated risks. We hope the information will be effectively used for further promotion of drug
safety at dispensing pharmacies and drug manufacturing sites.
“Drugs newly listed for less than one year in the NHI price list but not considered as newly-listed
drugs” (page 34), which is not available in our semiannual reports, is also included.
Pharmaceutical near-miss events involving drugs newly listed in the NHI price list but notconsidered as newly-listed drugs (new drugs listed for less than one year) and drugs with changed
names were reported and tabulated in the annual report. We hope the information will be used
together with the tabulation of newly-listed drugs for prevention of medical accidents.
3) Analysis of pharmaceutical near-miss events
The 2009 annual report analyzed the reported near-miss events according to the following fivethemes.
(1)

Pharmaceutical near-miss events related to similar drug names (page 39 to 43)(2)

Pharmaceutical near-miss events related to similar efficacies (page 44 to 48)(3)

Pharmaceutical near-miss events related to high-risk drugs (page 49 to 51)(4)

Pharmaceutical near-miss events related to inquiries about prescription (page 52 to 57)(5)

Pharmaceutical near-miss events related to particular drugs (page 58 to 68)(i)

Warfarin potassium(ii)

InsulinIn this first annual report of the Project, similar drug names and high-risk drugs were selected asthemes by referring to those selected for the Project to Collect and Analyze Medical
Near-Miss/Adverse Event Information. The analysis of near-miss events involving inquiries,
which is unique to pharmacies, is also included to evaluate the cases involving hospital-pharmacy
coordination. The analysis of near-miss events involving particular drugs focused on warfarin
potassium and insulin. Details of the near-miss events are introduced according to release/no
release of the drug, and pharmaceutical near-miss events occurred due to multiple drug strengths
are analyzed.
4) Pharmaceutical near-miss information to be shared
Information that needs to be widely shared is selected by experts and posted on the website every
month with the expert’s opinion “the point of the case.” Such information is included in theannual report (page 69 to 89). Details of individual near-miss events are available on the Projectto Collect and Analyze Pharmaceutical Near-Miss Information website. Click the “public data
search” button and enter the case number to browse. Three to four cases of pharmaceuticalnear-miss events to be shared are posted on the website every month. Posting of new information
is notified to participating pharmacies through e-mail newsletters. The posted information is
included in periodic semiannual reports as well as in the annual report. The selected near-missevents will provide important information to pharmacies. We hope they will be thoroughly
reviewed and used for review and improvement of activities at pharmacies.

⎯6⎯3. Pharmaceutical near-miss information analysis table
The 2009 annual report consists of over 100 pages. The data are analyzed according to the five themes
and presented in detail in texts and tables. While deliverables from the Project to Collect and Analyze
Medical Near-Miss/Adverse Event Information should generally contain a large volume of
information as the 2009 annual report does since so much information has been reported, somedeliverables should contain selected information so that busy healthcare professionals can use it intheir daily practice. An example of the latter is medical safety information.
The budgetary scale of the Project to Collect and Analyze Pharmaceutical Near-Miss Information
does not allow development of deliverables such as medical safety information. However,“pharmaceutical near-miss information to be shared” mentioned earlier consists of selected
information as does medical safety information prepared in the Project to Collect and Analyze Medical
Near-Miss/Adverse Event Information. The contents of the 2009 annual report shown in the figures
and tables in the sections of the individual themes are also presented as “Pharmaceutical Near-Miss
Information Analysis Table” [(i) to (v) below] in different designs and forms that can be easily posted
at pharmacies or used in in-house workshops. A colored version is available on the website.
(i)

Drug mix-ups due to similar drug names (page 97)(ii)

High-risk drugs reported in pharmaceutical near-miss events (page 98)(iii)

Prescription changes made after making inquiries and reasons for making inquiries(page 99)

(iv)

Pharmaceutical near-miss events related to warfarin potassium (page 100)(v)

Pharmaceutical near-miss events related to insulin (page 101)

The analysis tables were prepared based on the concept of medical safety information in the Project toCollect and Analyze Medical Near-Miss/Adverse Event Information, which is to include selected
information and be presented in colors and formats that appeal to the eye and draw attention. We hope
the analysis tables will be printed out and posted at pharmacies or used for information sharing among
pharmacy staff or practical training for pharmacy students.

4. Current status and challenges of the Project to Collect and Analyze
Pharmaceutical Near-Miss Event Information
The registration of pharmacies and information collection in the Project started in April 2009. The
number of participating pharmacies has been increasing. More than 3,000 pharmacies are registered asof July 2010, nearing the target number of 5,000 to 10,000. However, the proportion of participating
pharmacies is only 5.6% of 53,304 pharmacies in Japan (the 2008 Health Administration Activity
Report). Unregistered pharmacies are encouraged to understand the objective of the Project to prevent
medical accidents at pharmacies and participate in the Project activities. The cooperation of theparticipating pharmacies in recruiting unregistered pharmacies is appreciated.
The number of reported near-miss events has also been increasing. Currently 1,500 to 2,000 near-missevents are reported every month. While useful information that is later selected as pharmaceuticalnear-miss information to be shared has been reported, the sections of “Background and Causes” and“Improvement Measures” are blank in many of the reports. Improvement of reporting quality will be a
future challenge as well as increasing the number of participating pharmacies and reported near-missevents. The participating pharmacies are encouraged to review “Case Report Data Entry Guidelines”
on the Project to Collect and Analyze Pharmaceutical Near-Miss Information website(https://www.yakkyoku-hiyari.jcqhc.or.jp/pdf/text_report_guide.pdf) to ensure proper reporting.
Commonreportingerrorsareshown
in“Reporting
Precautions”⎯7⎯(http://www.yakkyoku-hiyari.jcqhc.or.jp/pdf/ask_report.pdf) sent to participating pharmacies inJanuary 2010.

5. Information provision on the website
In parallel with the review of the Project to Collect and Analyze Medical Near-Miss/Adverse Event
Information in 2008, the Project to Collect and Analyze Pharmaceutical Near-Miss Event Information
was developed based on the knowledge and experience gained through the operation of the former.
Publication of near-miss events reported in the Project to Collect and Analyze Pharmaceutical
Near-Miss Information on the website started last year, ahead of the new system for the Project toCollect and Analyze Pharmaceutical Near-Miss/Adverse Event Information started in January this year.
Information provided on the website is a large volume as well as high transparency. Over 6,000
near-miss events have been published to date. The searchable website enables the users to pick out
whatever near-miss events interest them.
Publication of a large number of near-miss events is just as important as providing information on
individual near-miss events to be used to ensure medical safety at pharmacies. Provision of
information on selected near-miss events with experts’ comments and points to consider is describedabove in “2-4) Pharmaceutical near-miss information to be shared.”
A list of participating pharmacies and published semiannual tabulation reports and annual reports arealso included in the 2009 annual report.

6. Coordination with the Project toNear-Miss/Adverse Event Information

Collect

andAnalyze

MedicalThe Division of Adverse Event Prevention launched the Project to Collect and Analyze Medical
Near-Miss/Adverse Event Information in October 2004 to prevent occurrence and recurrence of
medical accidents. The 21st report and the 2009 annual report were published in July and August 2010,
respectively. In 2009, 2,064 medical adverse events and 241,939 near-miss events were reported by
medical institutions. The situations of drug-related near-miss events, specifically, “drug dispensing,”“drug prescription/administration” and “drug dispensing/management,” took up 26.4% of the reported
medical near-miss events. Many of the reports were similar to medical near-miss events that occurredat pharmacies. The 2009 annual report also contains individual drug-related themes such as “events
related to drugs,” “events related to chemotherapy” and “infarction and hemorrhage in patients treatedwith warfarin potassium for coagulability management” to provide useful information to medical
institutions as well as to pharmacists working at pharmacies. In the section of “5. Medical near-missevents involving particular drugs: 1) Warfarin potassium,” the near-miss events analyzed under thetheme “Infarction and bleeding in patients treated with warfarin potassium for coagulability
management” are presented as “(5) Cases reported by medical institutions.” Medical safety
information from the Project to Collect and Analyze Medical Near-Miss/Adverse Event Information isprovided in the sections of other theme analyses to develop deliverables that can be shared by both
Projects and help medical institutions and pharmacies share useful information. Near-miss/adverse
events involving drugs should be analyzed in an integrated manner to develop proper medical safetymeasures rather than separately analyzed by medical institutions and pharmacies.
The Project to Collect and Analyze Medical Near-Miss Adverse Event Information started to preparemonthly medical safety information in 2006 to provide information through fax and on the website.
Medical Safety Information No. 45 “Bone marrow suppression due to antirheumatic (methotrexate)
overdose: the second report” was issued in August 2010. Other drug-related medical safety
information such as “Drug mix-up,” “Drug administered at a wrong dose level due to discrepancy ininterpretation of the prescription” and “Drug administered at a wrong dose level due to discrepancy ininterpretation of the prescription: the second report” had also been issued. We hope the medical safety
information provided on the website will be used for recurrence prevention at pharmacies. Since the⎯8⎯contents of the 2009 annual report will be useful for in-house pharmacies and hospitals, the JCQHC
will inform medical institutions of the issuance of the report.
Taking advantage of the integrated collection of medical near-miss/adverse event information frommedical institutions and pharmacies, the JCQHC will provide especially valuable information forprevention of medical accidents involving drugs.

7. Postscript
The JCQHC will improve the contents of Project reports and effectively provide information toprevent medical accidents and promote medical safety in Japan. Your understanding and cooperationin the JCQHC’s projects will be deeply appreciated.

⎯9⎯⎯ 10 ⎯

I

Outline of Project to Collect andPharmaceutical Near-Miss Event Information

Analyze

The objective of the Project to Collect and Analyze Pharmaceutical Near-Miss Event Information fromPharmacies is to further promote the medical safety measures by collecting, analyzing and providing
pharmaceutical near-miss information reported by pharmacies.
The outline of the information collection activities in the Project is described below.

1

Background of Pharmaceutical Near-Miss Event Information
Collection“The Law to Amend the Medical Service Law to Establish a System that Provides High Quality
Medical Care” (Law No. 84, June 2006) positions pharmacies as “health care facilities” and stipulates
they must establish a system to ensure medical safety by “appointing a manager” and “developing an
operating procedure.”
As the Law came into effect, a grant project (the Project to Collect and Analyze Pharmaceutical
Near-Miss Event Information) was started by the Ministry of Health, Labour and Welfare in 2008.
Considering the importance of the Project to promote medical safety, the JCQHC decided to take overthe project operation in June 2008.
Launched on October 1, 2008, the Project started recruiting pharmacies and collecting pharmaceuticalnear-miss information on April 1, 2009 after several months of preparation.

⎯ 11 ⎯

I Outline of Project to Collect and Analyze Pharmaceutical Near-Miss Information

2

Outline of the Project to Collect and Analyze Pharmaceutical
Near-Miss Event Information[1]

Objective

The objective of the Project is to collect, analyze, and provide pharmaceutical near-missinformation reported by pharmacies to widely share information useful to develop medical safetymeasures with pharmacies and to provide information to the general public to further promote
medical safety measures.

[2]

Collection of pharmaceutical near-miss event information(1)

Participating organizations

Pharmacies(Note) are recruited to participate in the Project.
(2)

Pharmaceutical near-miss information to be reported

The following pharmaceutical near-miss event information is subject to reporting. In the Project,“health care service” is defined as any and all processes related to medical practice.
(i)

A medical error occurred or identified before the health care service is provided to thepatient(ii)

A medical error that did not affect the patient or required a minor procedure/treatment,
which includes disinfection, poultice and administration of analgesics(iii)

A medical error whose consequence is unknown

The Project collects information on pharmaceutical near-miss events involving drugs ordesignated insured medical materials occurred or identified at pharmacies.
(3)

Due date and reporting method

Participating pharmacies should report identified pharmaceutical near-miss events defined in theprevious section on the exclusive reporting web page via Internet (SSL communication) within
one month of identifying the near-miss event.
(4)

Report form

See “Document 2: Information to be collected.”(Note) Pharmacies are defined as places where pharmacists perform drug preparation/dispensing activities for the purpose of sales orprovision. However, dispensaries at hospitals, clinics and veterinary hospitals are not included. (See Article 2-11 of thePharmaceutical Affairs Law)

⎯ 12 ⎯

I Outline of Project to Collect and Analyze Pharmaceutical Near-Miss Information[3]

Publication of pharmaceutical near-miss event information(1)

Tabulation

Tabulation is performed by the JCQHC Medical Adverse Event Prevention Division.
(2)

Publication of tabulation/analysis

The data is published in annual reports and on the JCQHC website(Note) to provide information toconcerned parties and the general public.

(Note) See the JCQHC “Project to Collect and Analyze Medical Near-Miss Information from Pharmacies” website.
(http://www.yakkyoku-hiyari.jcqhc.or.jp/)⎯ 13 ⎯

⎯ 14 ⎯

II

Current Reporting Status[1]

Participating pharmacies
Pharmacies participating in the Project to Collect and Analyze Pharmaceutical Near-Miss Event
Information are summarized in the tables below.
1. Number of participating pharmacies
Number of pharmacies(Note)
1,774

Number of participating pharmacies

2. Changes in the number of registrations of participating pharmacies
2009
Jan.

Feb.

Mar.

Apr. May.

Jun.

Jul.

Aug.

Sep.

Oct.

Nov.

Dec.

Number of newly
participating pharmacies
Number of pharmacies
that withdrew

⎯

⎯

⎯

211

200

495

324

82

103

142

142

75

⎯

⎯

⎯

0

0

0

0

0

0

0

0

0

Accumulated total

⎯

⎯

⎯

211

411

906

1,230 1,312 1,415 1,557 1,699 1,774

3. Participating pharmacies in each prefecture
Prefecture

Number ofpharmacies

Number ofpharmacies

Prefecture

Number ofpharmacies

Hokkaido

339

Tokyo

128

Shiga

28

Kagawa8

Aomori44

Kanagawa

102

Kyoto

28

Ehime

45

Iwate

39

Niigata

53

Osaka

51

Kochi

40

Miyagi33

Yamanashi

3

Hyogo

30

Fukuoka

30

Akita

49

Nagano

14

Nara

27

Saga

6

Yamagata

34

Toyama4

Wakayama

21

Nagasaki

4

Fukushima

55

Ishikawa

5

Tottori

15

Kumamoto

12

Ibaragi

15

Fukui

2

Shimane

14

Oita

33

Tochigi

89

Gifu

10

Okayama32

Miyazaki

3

Gunma

61

Shizuoka

21

Hiroshima

45

Kagoshima

24

Saitama

32

Aichi

35

Yamaguchi

34

Okinawa

5

Chiba

47

Mie

13

Tokushima

12

Total

Prefecture

Number ofpharmacies(Note) Number of pharmacies as of December 31, 2009⎯ 15 ⎯

Prefecture

1,774II Current Reporting Status[2]

Number of reports
Pharmaceutical near-miss events reported by the pharmacies are summarized below.
1. Total number of reports
Tabulation for 2009
From April to December

Reporting month
Number of participating pharmacies

1,774

Number of reporting pharmacies

159

Number of published near-miss events

1,460

2. Number of monthly reports
2009
Jan.

Feb.

Mar.

Apr.

May.

Jun.

Jul.

Aug.

Sep.

Oct.

Nov.

Dec.

Number of participating
pharmacies

⎯

⎯

⎯

211

411

906

1,230 1,312 1,415 1,557 1,699 1,774

Number of reports

⎯

⎯

⎯

18

66

91

155

206

204

181

245

294

Number of publishednear-miss events

⎯

⎯

⎯

18

66

91

155

206

204

181

245

294

3. Number of participating pharmacies and reports by number of pharmacists
Number of pharmacists(full-time basis)

Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

1

272

66

2

569

207

3

386

150

4

215

524

5

121

66

6

69

137

7

46

148

8

35

132

9

18

9

10

15

0

11 or above

28

21

Total

1,774

1,460

⎯ 16 ⎯

II Current Reporting Status

4. Number of participating pharmacies and reports by number of prescription
receipts
Number of prescription receipts(monthly)

Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

0-500

212

14

501-1000

362

104

1001-1500

367

130

1501-2000

339

165

2001-2500

164

133

2501-3000

116

481

3001-3500

60

168

3501-4000

66

1294001 or above

88

136

Total

1,774

1,460

5. Number of participating pharmacies and reports by number of prescription
drugs stocked in pharmacy
Number of prescription drugs
stocked in pharmacy

Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

0

1

0

0-100

3

0

101-50012522501-1000

855

449

1001-1500

523

791

1501-2000

206

173

2001-2500

42

192501-3000

1503001 or above

4

6

1,774

1,460

Total

⎯ 17 ⎯

II Current Reporting Status

6. Number of participating pharmacies and reports by number of generics
stocked in pharmacy
Number of generics stockedin pharmacy

Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

0

1

0

0-100

604

215

101-500

962

1,236

501-1000205

91001-1500

101501-2000

00

2001-2500002501-3000

003001 or above

1

0

1,774

1,460

Total

7. Number of participating pharmacies and reports by over-the-counter (OTC)
drugs stocked in pharmacy
Number of OTC drugs
stocked in pharmacy

Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

0

170

594

1-10

246

58

11-50

488

257

51-100239

156

101-15077

216

151-20074

32

201-2504437251-3006140

301-50017843

500-1000135201001 or above

62

7

Total

1,774

1,460

⎯ 18 ⎯

II Current Reporting Status

8. Number of participating pharmacies and reports by number of medical
institutions issuing prescriptions
Number of medical institutions
issuing prescriptions

Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

0

1

0

1-10

377

201

11-20

415

546

21-30

286

241

31-40

185

86

41-50

179

169

51-60

84

20

61-70

64

45

71-80

53

119

81-90

23

0

91-10032

0101 or above

75

33

Total

1,774

1,460

9. Number of participating pharmacies and reports by proportion of dispensed
generics
Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

Proportion of dispensed generics
< 10%

19

1

10% to < 20%43

20

20% to < 30%

153

153

30% to < 40%

566

444

40% to < 50%

464

556

50% to < 60%

258

56

60% to < 70%

171

200

70% to < 80%70

28

80% to < 90%25

2

90% or above

5

0

1,774

1,460

Total

⎯ 19 ⎯

II Current Reporting Status

10. Number of participating pharmacies and reports by administrative division
Number of participating pharmacies

Number of reports

April to December 2009

April to December 2009

Administrative division
Hokkaido

339

113

Tohoku254

121

Kanto/Koshinetsu

544

428

Tokai/Hokuriku

90

26

Kinki

185

175

Chugoku/Shikoku

245

554

Kyushu/Okinawa

117

43

Total

1,774

1,460

11. Number of participating pharmacies by number of reports
Number of reports

Number of participating
pharmacies

April to December 2009

April to December 2009

0

1,615

1-5

121

6-10

17

11-20

10

21-30

5

31-40

1

41-50

1

51 -or above

4

Total

1,774

⎯ 20 ⎯

II Current Reporting Status[3]

Details of reports
One thousand four hundred and sixty medical near-miss events reported by pharmacies from
April 1 to December 31, 2009 are tabulated below.
1. Month of occurrenceMonth of occurrence
January

Number of reports
2
1

February
March

2

April

47

May

68

June

123

July

220

August173

September

169

October

252

November

221

December

182

Total

1,460

300
250
200
150
100
50
0
Jan.Feb. Mar.Apr. May.Jun.Jul. Aug. Sep.Oct. Nov.Dec.

The number of reports made in each month is shown. Since the start of pharmaceuticalnear-miss event information collection in April 2009, the number of reports has been
increasing with the number of participating pharmacies.
SundaySaturday80
5.5%

2. Day of occurrence
Day of occurrence
Sunday11
0.8%

Number of reports
11

Monday290

Tuesday263

Wednesday

297

Thursday223

Friday296

Saturday

80

Total

1,460

Friday296
20.3%

Monday290
19.9%

Tuesday263
18.0%

Thursday223
15.3%
Wednesday
297
20.3%

The number and proportion of reports made on each day of the week are presented. The
number of reports is evenly distributed from Monday through Friday.

⎯ 21 ⎯

II Current Reporting Status

3. Time of occurrenceTime of occurrence
0:00-1:59

Number of reports
0

600
550

2:00-3:59

5500

4:00-5:59

0450

6:00-7:59

0

8:00-9:59

145

400
350

10:00-11:59

533

12:00-13:59

352

14:00-15:59

221

16:00-17:59

141

18:00-19:59

32

20:00-21:59

9

22:00-23:59

0
22

Total

1,460

250
200
150
100
50
0
0:00 2:00 4:00 6:00 8:00 10:0012:0014:0016:0018:0020:00 22:00
1:59 3:59 5:59 7:59 9:59 11:5913:5915:5917:5919:5921:59 23:59

Unknown

Unknown300

The number of reports made in each two-hour time frame is presented. Reports made in the
10:00-11:59 time frame were most frequent.
4. Whether the drug was dispensed and extent of treatment
Drug dispensing
Extent of treatment
Dispensed, minor treatment
Dispensed, no treatment
Dispensed, unknown
Not dispensed
Total

Dispensed, minor treatment
7
0.5% Dispensed, no treatment
105
7.4%

Number ofreports
7
108
253
1,092

Dispensed,
unknown
253
17.3%

1,460

Not dispensed
1,092
74.8%

Drugs were dispensed in 25.2% of 1,460 near-miss events (368 near-miss events). Mild
treatment was required in 0.5% (7 near-miss events).

⎯ 22 ⎯

II Current Reporting Status

5. Summary of near-miss events
Summary ofnear-miss events
Drug dispensing

1,343

Inquiry aboutprescription

107

Designated insured
medical material

10

Drug sales
Total

Designated insured medical material
100.7%Inquiry aboutprescription
107
7.3%

Number of reports

0
1,460

Drug dispensing
1,343
92.0%

The number and proportion of reports are presented according to a summary of the near-missevent. “Drug dispensing” took up 92.0% (1,343 near-miss events), and “inquiry” made tophysicians took up 7.3% (107 near-miss events). No near-miss event involved “drug sales.”⎯ 23 ⎯

II Current Reporting Status

1) Drug dispensing
SituationDrugdispensing

Numberofreports

Specifics
Failure to dispense

102

Error in prescription check
Error in weighing
Wrong quantity
Error in packing
Wrong strength/dosage
form
Drug mix-up
Use of wrong information
sheet
Wrong information on
package sheet
Providing wrong description
on medication bag

35
20
590
71

Others (drug release)

35

Situation

Numberofreports

Specifics

Error in filling thecassette
Contamination withManagement
foreign object
Expiration
Others (management)
Patient misidentification
Providing wrong
explanation
Drug release
Neglecting to release
medication
Others (drug release)
Total

216
181
6
8

4
1
2
3
7
6
10
6
1,343

40

600
500

400

300

200

100

Others (drug release)

Neglecting to dispense medication

Providing wrong explanation

Patient misidentification

Others (management)

Expiration

Contamination with foreign object

Error in filling the cassette

Others (drug release)

Providing wrong description on medication bag

Wrong information on package sheet

Use of wrong information sheet

Drug mix-up

Wrong strength/dosage form

Error in packing

Wrong quantity

Error in weighing

Error in prescription check

Failure to dispense0

The number of reports related to drug dispensing is presented according to a summary of thenear-miss event. “Wrong quantity” (590 near-miss events) was most frequent, followed by“wrong strength/dosage form” (216 near-miss events) and “drug mix-up” (181 near-missevents).

⎯ 24 ⎯

II Current Reporting Status2) Inquiry about prescription
How the patient might havebeen affected if the drug wasused according to the original
prescription

Number ofreports

Patient might have sufferedhealth hazard

59

No health hazard would haveoccurred but the intended
efficacy would not have been
expected

48

Total

107

Reason for making inquiry
Based on the prescription alone

Number ofreports
45

Based on the prescription andinformation available at thepharmacy

37

Others

25
Total

107

Change of drug

Number ofreports
36

Change of usage

15

Change of dose

16

Change of quantity

16

Deletion of drug

13

Others11

Specifics of change

Total

No health hazard
would haveoccurred but theintended efficacy
would not havebeen expected
48
44.9%

Others25
23.4%

Based on theprescription alone
45
42.1%

Based on theprescription andinformation available
at the pharmacy
37
34.6%

Others11
10.3%
Deletion of
drug
13
12.1%
Change ofquantity
16
15.0%

107

Patient might havesuffered healthhazard59
55.1%

Changeof dose16
15.0%

Change of drug
36
33.6%

Changeof usage15
14.0%

One hundred and seven near-miss events involving inquiries are sorted out by how the patient
might have been affected if the drug was used according to the original prescription, the reason
for making an inquiry and the specifics of a change, and the number and proportion of reports
are presented. Near-miss events for which “the patient might have suffered a health hazard”
took up 55.1% (59 near-miss events). Near-miss events for which inquiries were made “basedon the prescription alone” took up 42.1% (45 near-miss events) while 57.9% (62 near-missevents) involved inquiries made based on information other than the prescription. Near-missevents involving “change of drug” were most frequent (33.6%; 36 near-miss events).

⎯ 25 ⎯

II Current Reporting Status

3) Designated insured medical material

1Expiration

0

Others(management)

0

Patient
misidentification0

Providing wrong
explanations

0

Neglecting torelease medication

0

Others (drugrelease)

0

Total

10

1

0
Others (drug release)

Others (drugdispensing)2

Neglecting to release medication

5

Providing wrong explanation

Material mix-up

Patient misidentification

0

Others (management)

Mix-up of
information sheet

3

Expiration

3

Others (drug dispensing)Wrong strength

Material mix-up

0

Mix-up of information sheet

Drug release

Wrong quantity

4

Wrong strength

Management

0

Wrong quantity

Drugdispensing

Error inprescription check5

Error in prescription check

Failure to dispense

Numberofreports
1

Failure to dispense

Specifics ofnear-miss event

Situation

The number of reports on near-miss events involving designated insured medical materials ispresented according to a summary of the near-miss event. “Material mix-up” (5 near-missevents) and “wrong strength” (3 near-miss events) were included.
4) Drug sales
Wrong product
Providing wrong products
Providing wrong information
Expiration
Others
Total

Number ofreports000
00

The number of reports on near-miss events involving drug sales is presented. No report wasmade.

⎯ 26 ⎯

II Current Reporting Status

6. Age of patients

0-10

Number ofreports
87

11-20

55

Age of patients

21-30

44

31-40

104

41-50

129

51-60

191

61-70

305

71-80

358

81-90

159

91-10020

101-1100

111-1200

121-1300130 or above

0

Multiple patients

8

Total

91-100
20
1.4%

81-90
159
10.9%

Multiple patients
8
11-20
0.5%
55
3.8%
21-30
0-10
44
87
3.0%
6.0%

71-80
358
24.5%

31-40
104
7.1%
41-50
129
8.8%

61-70
305
20.9%

51-60
191
13.1%

1,460

The number and proportion of reports are presented by age of patients. “71-80” (24.5%; 358
reports) and “61-70” (20.9%; 305 reports) were most frequent.
7. Sex of patients

Male

Number ofreports
675

Female777

Sex of patients

Multiple patients

8

Total

1,460

Multiple patients8
0.5%

Female
777
53.2%

Male
675
46.2%

The number and proportion of reports are presented by sex of patients. “Male” patients wereinvolved in 46.2% (675 reports) while “female” patients were involved in 53.2% (777 reports).

⎯ 27 ⎯

II Current Reporting Status

8. First person to findFirst person to find the error
Person who made the error

Number ofreports
263

Coworker with same job
description

958

Coworker with different job
description

80

Patient

114

Family/caregiver

35

Other patient

1

Family/Other
caregiver patient
Others
35
35
9
2.4%
2.4%
Coworker with
0.6%
different job
description
80
Patient
Person who
5.5%
114
made the error
7.8%
263
18.0%

9

Others
Total

1,460

Coworker with same job
description
958
65.6%

The number and proportion of reports are presented by first person to find the error.
“Coworker with same job description” was the most frequent first person to find the error(65.6%; 958 reports).
9. Person who made the error
Person who made the error
Pharmacist
Registered distributor

Others23
1.0%

Number ofreports
1,775
8

Clerk

610

Others

23

Clerk
610
25.2%

2,416
Note: “Person who made the error” may be morethan one.

Pharmacist
1,775
73.5%
Registered
distributor
8
0.3%

The number and proportion of reports are presented by person who made the error.
“Pharmacist” was the most frequently reported person who made the error (73.5%; 1,775
reports).

⎯ 28 ⎯

II Current Reporting Status

10. Cause of near-miss event
Items
Neglecting to check
Delayed (neglect of) reporting
Behavior of the person who made theIncomplete recording
error
Lack of coordination
Inadequate (neglect of) explanation to the patient
Misjudgment
Lack of knowledge
Inadequate skills
Busy hours
Human factor
Unusual physical conditions
Unusual psychological conditions
Others (human factor)
Computer system
Drugs
Background/system/
environmental factor
Environmental Facilities/utilities/equipment
ArticlesPatient factor
Others (environmental/equipment)
Education/training
SchemeOthersFlaw in the rules
OthersTotal
Note: “Cause of near-miss event” may be more than one.

Number ofreports
1,335
3
15
32
20
39
92
118
210
9
55
69
49
78
14
5
8
14
81
31
35
59
2,371

1,400
1,200
1,000
800
600
400
200

OthersFlaw in the rules

SchemeEducation/training

Patient factor
Others(environmental/equipment)

ArticlesFacilities/utilities

Drugs

Computer system

Unusual psychologicalconditions
Others (human factor)

Unusual physical conditions

Busy hours

Inadequate skills

Lack of knowledge

Lack of coordination
Inadequate (neglect of)
explanation to the patient
Misjudgment

Incomplete recording

Delayed (neglect of) reporting

Neglecting to check0

The number of reports is presented by cause of near-miss event. “Neglecting to check” (1,335
reports) was most frequent, followed by “busy hours” (210 reports) and “inadequate skills”(118 reports).

⎯ 29 ⎯

II Current Reporting Status

11. Specifics of near-miss event × cause of near-miss event
Drug
dispensing

Inquiry

Designatedinsured medical
material

1,293

32

10

0

1,335

Delayed (neglect of) reporting

2

1

0

0

3

Incomplete recording

9

6

0

0

15

Lack of coordination

23

9

0

0

32

Inadequate (neglect of) explanation
to the patient

20

0

0

0

20

Misjudgment

36

3

0

0

39

Lack of knowledge

74

17

1

0

92

Inadequate skills

112

4

2

0

118

Busy hours

201

6

3

0

210

Unusual physical conditions

8

0

1

0

9

Unusual psychological conditions

54

1

0

0

55

Others (human factor)

52

16

1

0

69

Computer system

35

14

0

0

49

Drugs

63

14

1

0

78

Facilities/utilities

11

3

0

0

14

Articles

5

0

0

0

5

Patient factor

6

2

0

0

8

Others (environmental/equipment)

9

4

1

0

14

Education/training

63

15

3

0

81

Scheme

27

4

0

0

31

Flaw in the rules

33

2

0

0

35

Others

18

41

0

0

59

194

23

0

2,371

Specifics of near-miss event
× cause of near-miss event
Neglecting to check

2,154
Total
Note: “Cause of near-miss event” may be more than one.

Drug
sales

Total

“Neglecting to check” was most frequent regardless of the specifics of the incident. Other
causes of incidents included “busy hours” for incidents involving drug dispensing and “lack ofknowledge” and “education/training” for incidents involving inquiries.

⎯ 30 ⎯

II Current Reporting Status

12. Person who made the error × cause of near-miss event
Person who made the error
× cause of incident

Pharmacist

Registered
distributor

1,617

8

569

16

2,210

Delayed (neglect of) reporting

6

0

3

0

9

Incomplete recording

25

0

16

2

43

Lack of coordination

67

1

34

2

104

Inadequate (neglect of) explanation
to the patient

28

0

8

2

38

Misjudgment

61

0

18

2

81

Lack of knowledge

145

1

60

6

212

Inadequate skills

189

1

53

1

244

Busy hours

313

1

73

3

390

Unusual physical conditions

13

0

5

0

18

Unusual psychological conditions

71

2

17

3

93

Others (human factor)

109

1

41

9

160

Computer system

81

2

37

1

121

Drugs

112

1

25

2

140

Facilities/utilities

18

0

1

3

22

Articles

8

0

3

0

11

Patient factor

9

0

2

1

12

Others (environmental/equipment)

26

0

7

1

34

Education/training

136

1

43

6

186

Scheme

46

2

12

0

60

Flaw in the rules

52

1

23

4

80

Others

79

0

24

4

107

68

4,375

Neglecting to check

Clerk

Others

3,211
22
1,074
Total
Note: “Person who made the error” and “cause of near-miss event” may be more than one.

Total

“Neglecting to check” was most frequent regardless of the person who made the error. “Busyhours” was the second most frequent cause of near-miss events for pharmacists.

⎯ 31 ⎯

II Current Reporting Status

13. Specifics of near-miss event × drug dispensing, extent of treatment
Drug dispensed

Specifics of near-miss event
× drug dispensing, extent of treatment

Drug notdispensed

Total

Minor
treatmentNotreatment

Unknown

Drug dispensing

7

108

248

980

1,343

Inquiry

0

0

0

107

107

Designated insured medical material

0

0

5

5

10

Drug sales

0

0

0

0

0

7

108

253

1,092

1,460

Total

Of near-miss events in which drugs were dispensed, 108 resulted in “no treatment” while 7
required “minor treatment.”
14. Day of occurrence × time of occurrence
Day of occurrence× time of occurrence

SundayMondayTuesday

WednesdayThursdayFridaySaturdayTotal

0:00-1:59

0

0

0

0

0

0

0

0
5

2:00-3:59

0

0

3

1

0

1

0

4: 00-5:59

0

0

0

0

0

0

0

0

6:00-7:59

0

0

0

0

0

0

0

0

8:00-9:59

1

33

23

26

25

23

14

145

10:00-11:59

3

111

99

97

77

107

39

533

12:00-13:59

3

76

59

79

49

71

15

352

14:00-15:59

2

44

40

45

33

50

7

221

16:00-17:59

0

16

25

34

28

35

3

141

18:00-19:59

2

3

7

8

6

6

0

32

20:00-21:59

0

1

3

1

3

0

1

9

22:00-23:59

0

0

0

0

0

0

0

0

Unknown

0

6

4

6

2

3

1

22

Total

11

290

263

297

223

296

80

1,460

Pharmaceutical near-miss events were most frequently reported in the 10:00-11:59 time frame
regardless of the day of the week.

⎯ 32 ⎯

II Current Reporting Status[4]

Tabulation according to product name
1. Near-miss events involving ethical drugs (1,964 reports)(Note 1)(Most frequently reported products)
Product name
Loxonin Tablets

Number ofreports
18

Product name
Amaryl 1 mg

Warfarin Tablets 1 mg

17

Diovan Tablets 40 mg

Norvasc Tablets 5 mg

16

Mohrus Tape 20 mg

Mohrus Pap 30 mg

15Alosenn

Micardis Tablets 40 mg

14

Mucosta Tablets 100

Number ofreports

Olmetec Tablets 20 mg

13

12

The 10 most frequently reported products are presented.
1) Near-miss events involving generics (301 reports)(Note 2)(Most frequently reported products)
Product name

Number ofreports

Gasport Tablets 20 mg
Kentan Tablets 60 mg

Product name
Magmitt Tablets 250 mg

Number ofreports
5

11

Methycobal Tablets 500 µg
Bayaspirin Tablets 100 mg
Kary Uni Ophthalmic Suspension
0.005%
Magmitt Tablets 330 mg

10Magmitt Tablets 500 mg

98
7

MS Onshippu “TAIHO”, SP
Troches “MEIJI”, Azunol Gargle
Liquid 4%, Calonal Tablets 200,
Sorentmin Tablets 0.25 mg, Telgin
G Dry Syrup 0.1%, Nelurolen
Tablets “5”, Voglibose Tablets 0.3
mg “SW”, U-Pan Tablets 0.5 mg

4The 10 most frequently reported generics are presented.
2) Near-miss events involving newly listed drugs(Note 3) (15 reports)
Product name
Co-DIO Combination Tablets MD

Number ofreports
3

Cravit Tablets 250 mg
Co-DIO Combination Tablets EX
Tapros Ophthalmic Solution
0.0015%
Apidra Inj. SoloStar
Cravit Tablets 500 mg

Product name

Number ofreports

Pirespa Tablets 200 mg
Micombi Combination Tablets AP

2

Micombi Combination Tablets BP
Lumigan Ophthalmic Solution
0.03%

1

1

New drugs listed in the NHI price list for less than one year are presented.

(Note 1) The number of reports refers to the number of entries made for each product name reported as “prescribed drug,” “mixed-up drug,”“changed drug” or “related drug” in incidents involving “drug preparation” or “inquiry.”(Note 2) The reports on “generics” or “newly listed drugs” were included in the reports on “ethical drugs.”(Note 3) Newly listed drugs are defined as new drugs listed in the NHI price list for less than one year.

⎯ 33 ⎯

II Current Reporting Status

3) Drugs newly listed in the NHI price list but not considered as newly-listed
drugs
Only new drugs listed in the NHI price list for less than one year are considered as
newly-listed drugs in the Project. However, other drugs listed for less than one year are alsotabulated.
(1)

Near-miss events involving generics (12 reports)
Product name

Amlodipine Tablets 2.5 mg “CH”
Galantase Powder 50%
Gesin Tablets 25 mg
Ketoten Nasal Solution 0.05%
Threenofen Tablets 60 mg
Cefcapene pivoxil hydrochloride
Tablets 100 mg “SAWAI”(2)

1

Product name

Number ofreports

Felnabion Pap 70
Brotizolam OD
Tablets 0.25 mg “TAIYO”
Lansoprazole OD
Tablets 15 mg “TOWA”
Levemir FlexPen
Levofloxacin
Tablets 100 mg “YD”
Lobu Tablets 60 mg

Near-miss events involving change of dosage form (13 reports)
Product name

Urief Tablets 4 mg
Norvasc OD Tablets 5 mg
Urief Tablets 2 mg

(3)

Number ofreports

Number ofreports
9
3
1

Near-miss events involving pharmacopoeial dispensing (3 reports)
Product name

Magnesium oxide
MARUISHI
Lactose hydrate YOSHIDA

Number ofreports
2
1⎯ 34 ⎯

1

II Current Reporting Status(4)

Near-miss events involving change of product name (96 reports)
Product name

Mucosta Tablets 100 mg

Number ofreports
7

Isodine Gargle Solution 7%

6

NovoRapid FlexPen

5

Alosenn GranuleTelgin G Dry Syrup 0.1%
Nu-Lotan Tablets 50 mg

4

Pursennid Tablets 12 mg
U-Pan Tablets 0.5 mg
Nu-Lotan Tablets 25 mg
Hirudoid Lotion 0.3%
Mucosal Dry Syrup 1.5%

3Melbin Tablets 250 mg
Loxonin Tablets 60 mg
Antebate Ointment 0.05%
Xalatan Eye Drops 0.005%
Hirudoid Cream 0.3%

2

Hirudoid Soft Ointment 0.3%
Mucosolvan Tablets 15 mg
Mohrus Tape 20 mg
PL Combination Granule
Asthphyllin Tablets
Adoair 100 Diskus

1

Adoair 500 Diskus
Adoair 500 Diskus 60 for Inhalation
Alimezine Syrup 0.05%⎯ 35 ⎯

Product nameAntebate Cream 0.05%
Kremezin Capsules 200 mg
Gentacin Ointment 0.1%
Sawadol L Tablets 20 mg
Cephadol Tablets 25 mg
Sofratulle Pap 10 cm
Tarivid Otic Solution 0.3%
Toledomin Tablets 25 mg
Neuer Capsules 200 mg
NovoRapid 30 Mix PenFill
Banan Tablets 100 mg
Bisolvon Tablets 4 mg
Humulin R Cartridge
Humulin R Kit
Humalog Mix 25 MirioPen
Humalog MirioPen
Farom Dry Syrup for Pediatric10%
Proranon Ophthalmic Solution 0.1%
Penfill 30 R
Myser Ointment 0.05%
Madopar Combination Tablet
Meiact MS Fine Granule 10%
U-Pan Tablets 1.0 mg
Locoid Cream 0.1%
Locoid Ointment 0.1%

Number ofreports1

II Current Reporting Status

2. Near-miss events involving designated insured medical materials (12reports)(Note)(Most frequently reported products)
Product name
NanoPass Needle
PenNeedle 32G Taper
PenNeedle
PenNeedle 30G 8 mm

Number ofreports
4
3

Product name

Number ofreports

Micro Fine Plus

1

Micro Fine Plus 31G

1

Micro Fine Plus 31G × 5 mm

1

Micro Fine Plus 31G × 8 mm

1

The designated insured medical materials involved in the reported near-miss events arepresented.
3. Near-miss events involving drug sales (0 report)(Most frequently reported products)
Product name
N/A

Classification of related drug
Ethical drug

Number ofreports0

Number ofreports
0First-class OTC drug

0

Designated second-class OTC drug

0Second-class OTC drug

0

Third-class OTC drug

0

Products reported in near-miss events involving drug sales are presented. No near-miss event
involving drug sales was reported.

(Note) The number of reports refers to the number of entries made for each product name reported as “designated insured medical
material,” “mixed-up designated insured medical material,” “related designated insured medical material” or “related drug” inincidents involving “designated insured medical material” or “drug sales.”⎯ 36 ⎯

II Current Reporting Status

4. Product names by outline of near-miss event
1) Drug dispensing{ Prescribed drug (418 reports)(Note 1){ Mixed-up drug (418 reports){ Related drug (961 reports)(Most frequently reported products)
Product name

Number of reports
Prescribed drug

Mixed-up drug

Related drug

Warfarin Tablets 1 mg

0

3

13

Mohrus Pap 30 mg

3

7

5

Micardis Tablets 40 mg

5

5

4

Norvasc Tablets 5 mg

1

4

9

Loxonin Tablets

3

1

9

Mohrus Tape 20 mg

0

2

11

Diovan Tablets 40 mg

2

6

5

The top five products reported in the near-miss events involving “drug dispensing” aretabulated as prescribed drugs, mixed-up drugs or related drugs.
2) Inquiry{ Prescribed drug (117 reports)(Note 2){ Changed drug (50 reports)(Most frequently reported products)
Product name

Number of reports
Prescribed drug

Changed drug

Loxonin Tablets

4

1

Mucosta Tablets 100

41

Blopress Tablets 821

Blopress Tablets 421

Casodex Tablet 80 mg

1

2

Amaryl 1 mg Tablet

2

1

The top five products reported in the near-miss events involving “inquiry” are tabulated asprescribed drugs or changed drugs.

(Note 1) In the “drug preparation” category, the number of reports on “prescribed drug” and “mixed-up drug” may not be consistent since“the prescribed drugs” did not correspond to “the mixed-up drugs”.
(Note 2) In the “inquiry” category, the number of reports on “prescribed drug” and “changed drug” may not be consistent since only“prescribed drug” was reported if “change of usage,” “change of dosage,” “change of quantity” or “deletion of drug” was selected.

⎯ 37 ⎯

II Current Reporting Status

3) Designated insured medical material{ Prescribed designated insured medical material (8 reports){ Mixed-up designated insured medical material (8 reports){ Related designated insured medical material (2 reports)(Most frequently reported products)
Prescribed designatedinsured medical
material
1

Number of reports
Mixed-up designatedinsured medical
material
2

Related designatedinsured medical
material
1

PenNeedle 32G Taper

2

2

0

PenNeedle

02

1

PenNeedle 30G 8 mm

2

1

0

Micro Fine Plus

1

0

0

Micro Fine Plus 31G

1

0

0

Micro Fine Plus 31G × 5 mm

1

0

0

Micro Fine Plus 31G × 8 mm

0

1

0

Product name

NanoPass Needle

The top five products reported in the near-miss events involving “designated insured
medical material” are tabulated as prescribed designated insured medical material, mixed-up
designated insured medical material or related designated insured medical material.

⎯ 38 ⎯

III Analysis
ofInformation[1]

Pharmaceutical

Near-Miss

Event

Pharmaceutical near-miss events related to similar drug names
Of the pharmaceutical near-miss events reported from April 1 to December 31, 2009, 181
near-miss events involved “drug mix-up.” After excluding 10 near-miss events that apparently
did not involve “drug mix-up,” 171 near-miss events were analyzed.
The reported drugs with names with similar first letters were tabulated. Forty-one near-missevents involved drugs with names for which at least the first two letters were identical, and 28
near-miss events involved drugs with names for which at least the first three letters wereidentical.
The names of the reported drugs and their efficacies are shown below.
1) Drugs with names for which at least the first two letters were identical (notincluding those with at least three identical first letters)
Prescribed drug

Major efficacy

Mixed-up drug

Major efficacy

Asverin Tablets 20

Analgesic, antipruritic,
astringent, antiphlogistic
Anti-tussive/expectorant

MS Onshippu｢TAIHO｣
Astomin Tablets 10 mg

Cravit Tablets

Synthetic antibacterial

Klaricid Tablets 200 mg

Primobolan Tablets 5 mg

Anabolic steroid

Primperan Tablets 5

Preran 1 mg Tablet

Hypotensive

Bezatate SR Tablets 200

Hypolipidemic

Magmitt Tablets 330 mg

Antacid

Mucodyne Tablets 500 mg

Expectorant

Mevalotin Tablets 5

Hypolipidemic

Prelon Tablets 1 mg
Bezatol SR Tablets 200
mg
Maglax Tablets 330 mg
Mucosta Tablets 100
mg
Mevan Tablets 5

Analgesic, antipruritic,
astringent, antiphlogistic
Anti-tussive
Having a primary action
against gram-positivebacteria and mycoplasma
Other agent for digestiveorgansAdrenal hormone

Urinorm Tablets 25 mg

Gout treatment

Urief Tablets 4 mg

MS Reishippu ｢TAIHO｣

Hypolipidemic
Antacid
Peptic ulcer treatment
Hypolipidemic
Other agent for urogenitaland anal organs* Near-miss events searched by identical first letters (two or three) of drug names were categorized as “similar
drug names” while those searched by identical first four digits of YJ codes were categorized as “similar
efficacies.” Therefore, some near-miss events may be included in both categories.

⎯ 39 ⎯

III Analysis of Pharmaceutical Near-Miss Information

2) Drugs with names for which at least the first three letters were identical(1)

Drug names and major efficaciesNote:
Prescribed drug

Major efficacy

Mixed-up drug
Amlodipine Tablets 5 mg
“SANDOZ”
Amlodipine Tablets 2.5 mg CH
Omeprazole Tablets 10 mg“AMEL”

Amlodin OD Tablets 5 mg

Vasodilator

Amlodin Tablets 2.5 mg

Vasodilator

Omepral Tablets 10

Peptic ulcer treatment

Clarith Tablets 200

Having a primary action
against gram-positivebacteria and mycoplasma

Klaricid Tablets 200 mg

Slow-K Tablets 600 mg

Mineral preparation (othermineral preparation)

Slow-Fe Tablets 50 mg

Tarivid Ophthalmic Ointment
0.3%
Tsumura Kamishoyosan Extract
Granules for Ethical Use
Tsumura Keishikashakuyakuto
Extract Granules for Ethical Use
Tsumura Goreisan Extract
Granules for Ethical Use
Tsumura Shikokeishito Extract
Granules for Ethical Use
Tsumura Shouseiryuto Extract
Granules for Ethical Use
Tsumura Daikenchuto Extract
Granules for Ethical Use
Tsumura Hachimijiogan Extract
Granules for Ethical Use
Tsumura Hangekobokuto Extract
Granules for Ethical Use

Ophthalmic agent
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine

Tarivid Otic Solution 0.3%
Tsumura Yokukansan Extract
Granules for Ethical Use
Tsumura Shikokeishito Extract
Granules for Ethical Use
Tsumura Gorinsan Extract
Granules for Ethical Use
Tsumura Shikokeishikanyoto
Extract Granules for Ethical
Use
Tsumura Bakumonto Extract
Granules for Ethical Use
Tsumura Choreito Extract Fi
Granules for Ethical Use
Tsumura Mashiningan Extract
Granules for Ethical Use
Tsumura Orengedokuto Extract
Granules for Ethical Use
Tsumura Makyoyokukanto
Extract Granules for Ethical
Use
Tsumura Maoto Extract
Granules for Ethical Use
Tsumura Keishikashakuyakuto
Extract Granules for Ethical
Use

Major efficacy
Vasodilator
Vasodilator
Peptic ulcer treatment
Having a primary action
against gram-positivebacteria and mycoplasma
Mineral preparation (ironcompound includingorganic iron oxide)
Agent for otic and nasal
use
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine
Herbal medicine

Tsumura Boiogito Extract
Granules for Ethical Use

Herbal medicine

Tsumura Maobushisaishinto
Extract Granules for Ethical Use

Herbal medicine

Tsumura Shakuyakukanzoto
Extract Granules for Ethical Use

Herbal medicine

Neurotropin Tablets 4 Units

Antipyretic / analgesic /antiphlogistic

Neurovitan Tablets

Multiple vitamins (notincluding vitamin A/D
combination)

Adrenal hormone

Predonin Tablets 5 mg

Adrenal hormone

Adrenal hormone

Predonin Tablets 5 mg

Adrenal hormone

Peptic ulcer treatment

Lansoprazol-OD 15 mg TAIYO

Peptic ulcer treatment

Prednisolone Tablets TAKEDA 5
mg
Prednisolone Tablets 1 mg
(Asahi Kasei)
Lansoprazole-OD Tablets 15 mg“TOWA”
Rinderon-V Cream 0.12%

Analgesic, antipruritic,
astringent, antiphlogistic(Corticosteroid)

Rinderon-VG Lotion

Rinderon-V Ointment 0.12%

Analgesic, antipruritic,
astringent, antiphlogistic(Corticosteroid)

Rinderon-VG Ointment 0.12%

Herbal medicine
Herbal medicine
Herbal medicine

Analgesic, antipruritic,
astringent, antiphlogistic(Antibiotic andcorticosteroid combination)
Analgesic, antipruritic,
astringent, antiphlogistic(Antibiotic andcorticosteroid combination)

1% Dihydrocodein Phosphate
1% Codein Phosphate
Anti-tussive/expectorantAnti-tussive/expectorant
Powder “FUSO”
Powder ”FUSO”
Zinc Oxide Ointment
Analgesic, antipruritic,
Zinc Oxide (10%) Simple
Analgesic, antipruritic,“YOSHIDA”
astringent, antiphlogistic
Ointment ”NIKKO”
astringent, antiphlogistic* Near-miss events searched by identical first letters (two or three) of drug names were categorized as “similar drug names”
while those searched by identical first four digits of YJ codes were categorized as “similar efficacies.” Therefore, somenear-miss events may be included in both categories.

Note:“Major efficacy” refers to the drug classification indicated by the first three digits of the YJ code.

⎯ 40 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information(2)

Twelve of 28 reported drugs with names that had at least three identical first letterswere herbal medicines. The herbal medicines and their product number werecompared between the prescribed drugs and the mixed-up drugs. The remarks sections
for the drugs with the same last digit of the product code and similar package color
have a remark “same color.”
Prescribed drug

Tsumura Kamishoyosan Extract
Granules for Ethical Use
Tsumura Keishikashakuyakuto
Extract Granules for Ethical Use
Tsumura Goreisan Extract Granules
for Ethical Use
Tsumura Shikokeishito Extract
Granules for Ethical Use
Tsumura Shouseiryuto Extract
Granules for Ethical Use
Tsumura Daikenchuto Extract
Granules for Ethical Use
Tsumura Hachimijiogan Extract
Granules for Ethical Use
Tsumura Hangekobokuto Extract
Granules for Ethical Use
Tsumura Boiogito Extract Granules
for Ethical Use
Tsumura Maobushisaishinto Extract
Granules for Ethical Use
Tsumura Shakuyakukanzoto Extract
Granules for Ethical Use

Product
number
24
60
17
10
19
100
7
16
20
127
68

Mixed-up drug
Tsumura Yokukansan Extract
Granules for Ethical Use
Tsumura Shikokeishito Extract
Granules for Ethical Use
Tsumura Gorinsan Extract
Granules for Ethical Use
Tsumura Shikokeishikanyoto
Extract Granules for Ethical Use
Tsumura Bakumonto Extract
Granules for Ethical Use
Tsumura Choreito Extract Granules
for Ethical Use
Tsumura Mashiningan Extract
Granules for Ethical Use
Tsumura Orengedokuto Extract
Granules for Ethical Use
Tsumura Makyoyokukanto Extract
Granules for Ethical Use
Tsumura Maoto Extract Granules
for Ethical Use
Tsumura Keishikashakuyakuto
Extract Granules for Ethical Use

Product
number54
10

Remarks
Same
color
Same
color

56
11
29
40

Same
color
Same
color

126
15
78
27

Same
color

60

3) Improvement measures reported from the pharmacies(1)

Review of the procedure{ The person who dispenses the drug should say the drug name aloud to the patient.
Instead of saying, “This is an herbal medicine,” he/she should say, “This is an herbal
medicine No. XX called YYY” to clearly communicate the product number and name.
{ The product name should be included in the heading of the medication record so thaterrors made during drug dispensing can be detected during verifications.
{ A warning “Currently taking YYY” should be included in the medication record in aclearly visible manner.
{ Document the current medications in the patient’s medication notebook so that thepatient can check his medications.
{ Ensure cross-checking of the dispensed drugs and the prescription.
{ If an alternative drug was included in the previous prescription, notify the dispensary
and document the product name in a copy of the current prescription when entering the
medication data.

⎯ 41 ⎯

III Analysis of Pharmaceutical Near-Miss Information(2)

Review of the checking system{ Drugs should be checked three times, specifically, at the time of dispensing,verification and giving instructions to the patient, even if only a few drugs are
dispensed.
{ Product names should be thoroughly read. The sheet number and the drug name shouldbe cross-checked with the prescription when dispensing an herbal medicine.
{ These who are in charge of verification should perform parallel verifications ofprescriptions and dispensed drugs in accordance with the procedure. Drug names
should be thoroughly read and marked to indicate the completion of checking
especially when herbal medicines are dispensed.
{ When switching to a generic, the prescription should be carefully read aloud by tracing
the drug names with a finger.
{ Drugs should always be checked by reading their names aloud and pointing to themwith a finger.
(3)

Review of the drug placement{ Drugs that can be easily mixed-up should be placed separately.
{ Warning labels should be placed on similar drugs.
{ Strengths and drug names should be double-checked. Frequently used drugs should be
stored at eye level.
4) Discussion
One hundred and seventy-one of 181 reported near-miss events involving drug mix-up wereanalyzed. Forty-one near-miss events involved drugs with at least two identical first lettersof the names, and 28 near-miss events involved drugs with at least three identical first lettersof the names.
Nine of 13 near-miss events (69.2%) involved drugs with different efficacy with names that
had only two identical first letters. The proportion was larger compared with seven of 16
near-miss events (43.8%) involving drugs with names that had at least three identical first
letters, excluding herbal medications. Some drugs, e.g., a gout treatment Urinorm and an
agent for urogenital and anal organs Urief, were reported in multiple near-miss events (threetimes).
Twelve of 28 near-miss events (42.9%) involved mix-up of herbal drugs with names that
had at least three identical first letters. The product names of herbal medicines include thename of the manufacturer so that the first three letters of the product names are frequently
identical. One half of the near-miss events involved the same package color due to theidentical last digit of the product codes in addition to similar drug names.
Some drug names sound similar rather than having identical first letters. “Almarl Tablets
10” and “Acemail Tablets 10” are confusing just as “Anafranil Tablets 10 mg” and “Tofranil
Tablets 10 mg” are.

⎯ 42 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information

5) Summary
One hundred and seventy-one of 181 reported near-miss events involving “drug mix-up”
were analyzed, and 41 near-miss events (24.0%) involved similar drug names. As reportedby the pharmacies, possible improvement measures include accurate checking of drug
names as well as multiple checking at the time of drug dispensing, verification and giving
instructions to the patient. Placement of drugs should be changed as necessary. Separate
storage shelves may be used, for example.
The Drug Compounding Guidelines of the Japan Pharmaceutical Association provides achecking procedure for dispensed drugs, such as “First, thoroughly read the three essential
elements of the prescribed drug, i.e., the product name, the dosage form and the strength(content) unit, to identify the drug and cross-check with the prepared drug.” (Excerpted
from page 267, the Drug Compounding Guidelines [the 12th revision]) The recommended
procedure may be integrated in the operating procedure at the pharmacy.
6) References
1.

Japan Council for Quality Health Care Project to Collect and Analyze Medical
Near-Miss/Adverse Event Information 2006 Annual Report{ Medical adverse events involving drugs are analyzed. Misuse of drugs due to similar
product names is reported.

2.

Medical Safety Information No. 4 “Drug Mix-Up”{ Medical safety information (see below for an example) is available on the Japan
Council for Quality Health Care Project to Collect and Analyze Medical
Near-Miss/Adverse Event Information website (http://www.med-safe.jp/).

<Reference: Medical Safety Information No. 4 “Drug Mix-Up”>⎯ 43 ⎯

III Analysis of Pharmaceutical Near-Miss Information[2]

Pharmaceutical near-miss events related to similar efficacies
Of the pharmaceutical near-miss events reported from April 1 to December 31, 2009, 181
near-miss events involved “drug mix-up.” After excluding 10 near-miss events that apparently
did not involve “drug mix-up,” 171 near-miss events were analyzed.
The reported drugs with similar efficacies were tabulated. The tabulation of drugs with at least
four identical first digits of the YJ codes included 103 drugs.
The names of the reported drugs and their efficacies(Note) are shown below.
1) Drugs with identical first four to six digits of the YJ code(not including drugs with identical first seven digits)
Prescribed drug

Mixed-up drug

Benzodiazepine
Alprazolam Tablets 0.4 mg TOWA

Sukarnase Tablets 1 mg

Other hypnosedative and anxiolytic
Zopicool Tablets 10

Myslee Tablets 10 mg

Other antipyretic/analgesic/antiphlogistic
Loxonin Tablets

Soleton Tablets 80

Imipramine
Anafranil Tablets 10 mg (high-risk drug)

Tofranil Tablets 10 mg (high-risk drug)

Other psychoneurotic agent
Tetramide Tablets 10 mg (high-risk drug)

Depas Tablets 0.5 mg (high-risk drug)

Jzoloft Tablets 25 mg (high-risk drug)

Toledomin Tablets 25 mg (high-risk drug)

Other ophthalmic agent
Kary Uni Ophthalmic suspention 0.005%

Hyalein Ophthalmic Solution 0.1%

Hyalein Ophthalmic Solution 0.1%

Proranon Ophthalmic Solution 0.1%

Hyalein Ophthalmic Solution 0.1%

Kary Uni Ophthalmic Solution 0.005%

Tarivid Ophthalmic Ointment 0.3%

Cravit Ophthalmic Solution 0.5%

Niflan Ophthalmic Solution 0.1%

Kary Uni Ophthalmic Solution 0.005%

Tapros Ophthalmic Solution 0.0015%

Lumigan Ophthalmic Solution 0.03%

Other agent for otic and nasal use
Livostin Nasal Solution 0.025 mg 112 metered sprays

Alroyer Nasal

Other diuretic
Luprac Tablets 4 mg

Diart Tablets 30 mg(Note) “Major efficacy” refers to the drug classification indicated by the first four digits of the YJ code.

⎯ 44 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information

Prescribed drug

Mixed-up drug

Other hypotensive
Atelec Tablets 10

Artist Tablets 10 mg

Diovan Tablets 40 mg

Micardis Tablets 40 mg

Micardis Tablets 40 mg

Nu-LOTAN Tablets 50 mg

Micardis Tablets 40 mg

Diovan Tablets 40 mg

Other hypolipidemic
Lipitor Tablets 5 mg

Lochol Tablets 20 mg

Lipitor Tablets 10 mg

Pravatin Tablets 10

Codein (exempt narcotic)
1% Dihydricodein phosphate powder ”FUSO”

1% Codeine Phosphate Powder ”FUSO”

H2 blocker
Stogar Tablets 10

Gasport Tablets 20 mg

Miscellaneous agent for digestive organs
Nauzelin Tablets 10

Primperan Tablets 5

Oradol S Lozenge 0.5 mg

SP Troches “MEIJI”

Pancreatic hormone
Lantus SoloStar (high-risk drug)

Apidra Inj. SoloStar (high-risk drug)

Other hemorrhoid treatment
Proctosedyl Ointment

Posterisan Forte (ointment)

Borraza-G Ointment

Posterisan Forte (ointment)

Corticosteroid
Dermovate Scalp Lotion 0.05%

Methaderm Lotion 0.1%

Locoid Ointment 0.1%

Antebate Ointment 0.05%

Methaderm Cream 0.1%

Ledercort Cream 0.1%

Antebate Ointment

Dermovate Ointment 0.05%

Other analgesic, antipruritic, astringent, antiphlogic
Zinc Oxide Ointment “YOSHIDA”

Zinc Oxide (10%) Simple Ointment ｢NIKKO｣

Inteban Solution 1%

Napageln Lotion 3%

Mohrus Pap 30 mg

Seltouch Pap 70

Felnabion Pap 70

Adofeed Pap 40 mg

MS Reishippu “TAIHO”

MS Onshippu ｢TAIHO｣

Miscellaneous blood/body fluid pharmaceutical product
Prorenal Tablets 5 µg

Dornalin Tablets 20 µg⎯ 45 ⎯

III Analysis of Pharmaceutical Near-Miss Information

Prescribed drug

Mixed-up drug

Other diabetes treatment
Starsis Tablets 90 mg (high-risk drug)

Voglibose Tablets 0.3 mg SW (high-risk drug)

Seibule Tablets 50 mg (high-risk drug)

Voglibose OD Tablets 0.3 mg SAWAI (high-risk drug)

Miscellaneous other metabolic drug
Benet Tablets 2.5 mg

Bonalon Tablets 5 mg

Other allergy treatment
Aplatin Tablets 20 mg

Azeptin Tablets 1 mg

Talion Tablets 10 mg

Claritin Tablets 10 mg

Herbal medicine
Tsumura Kamishoyosan Extract Granules for Ethical
Use

Tsumura Yokukansan Extract Granules for Ethical Use

Tsumura Keishikashakuyakuto Extract Granules for
Ethical Use

Tsumura Shikokeishito Extract Granules for Ethical
Use

Tsumura Goreisan Extract Granules for Ethical Use

Tsumura Gorinsan Extract Granules for Ethical Use

Tsumura Shikokeishito Extract Granules for Ethical
Use

Tsumura Shikokeishikanyoto Extract Granules for
Ethical Use

Tsumura Shakuyakukanzoto Extract Granules for
Ethical Use

Tsumura Keishikashakuyakuto Extract Granules for
Ethical Use

Tsumura Shouseiryuto Extract Granules for Ethical
Use

Tsumura Bakumonto Extract Granules for Ethical Use

Tsumura Daikenchuto Extract Granules for Ethical
Use

Tsumura Choreito Extract Granules for Ethical Use

Tsumura Hachimijiogan Extract Granules for Ethical
Use

Tsumura Mashiningan Extract Granules for Ethical
Use

Tsumura Hangekobokuto Extract Granules for Ethical
Use

Tsumura Orengedokuto Extract Granules for Ethical
Use

Tsumura Boiogito Extract Granules for Ethical Use

Tsumura Makyoyokukanto Extract Granules for
Ethical Use

Tsumura Maobushisaishinto Extract Fine Granule
Tsumura Maoto Extract Granules for Ethical Use(ethical drug)* The product names of the listed drugs were tabulated based on their YJ codes and may not be consistent withthe drug names used in the “text information.”* Unlike other drugs, “herbal medicines” may have the same first four digits of the YJ codes even if they havedifferent efficacies.
* Near-miss events involving “drug mix-up” searched by identical first letters (two or three) of drug names werecategorized as “similar drug names” while those searched by identical first four digits of YJ codes werecategorized as “similar efficacies.” Therefore, some near-miss events may be included in both categories.
* “High-risk drug” refers to a drug requiring safety management, e.g., medication management and assistanceappropriate for the patient’s living environment and recuperation status. Drugs listed in “II. Drugs in thefollowing therapeutic areas that may require special cautions when administered” in the “Operation Guidelines
for Pharmacological Management of High Risk Drugs (version 1)” issued by the Japan Pharmaceutical
Association in November 2009 were used as a reference for defining high-risk drugs.

⎯ 46 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information

3) Improvement measures reported by the pharmacies(1)

Review of the procedure{ The product name should be included in the heading of the medication record so thaterrors made during drug dispensing can be detected during verification.
{ Instead of saying, “This is an herbal medicine,” he/she should say, “This is an herbal
medicine No. XX called YYY” to clearly communicate the product number and name.
{ Document the current medications in the patient’s medication notebook so that thepatient can check his medications.
{ Multi-tasking should be avoided. What can be completed now should be completed.
{ The original drug should be kept in mind when preparing a generic.
{ The post-treatment check system should be strengthened.
(2)

Review of the check system{ Picking should be performed, or the drug should be pointed at with a finger and its
name should be read aloud before packaging.
{ Prescriptions received via fax should be thoroughly checked with the originals when
they are filed.
{ Drugs should be prepared after checking them with other staff members.
{ Pharmacists should keep in mind that patients may check their medication differently
from how pharmacists do at the time of drug release.
{ Drugs should be repeatedly checked, even if they have been checked during
verification.
{ Drugs should be checked during verification and checked again before handing them topatients.
(3)

Review of the placement{ Warning labels should be placed on similar drugs.
4) Discussion
One hundred and seventy-one of 181 reported near-miss events involving drug mix-up wereanalyzed. One hundred and three near-miss events involved drugs with YJ codes for which
the first four or more digits were identical.
Drug mix-ups were evenly reported among a wide variety of efficacies, including “herbal
medicine,” “corticosteroid” and “other analgesic, antipruritic, astringent, antiinflammatory.”
Some drugs were high-risk drugs that require careful management for safety.

⎯ 47 ⎯

III Analysis of Pharmaceutical Near-Miss Information

5) Summary
One hundred and seventy-one of 181 reported near-miss events involving “drug mix-up”
were analyzed, and 103 near-miss events involved similar efficacies. The number ofnear-miss events was larger compared with the 41 near-miss events involving drugs withnames whose first two or more letters were identical.
As the Drug Compounding Guidelines of the Japan Pharmaceutical Association point out,
pharmacists with little experience in drug dispensing as well as experienced pharmacists
have made errors reported in the medial near-miss events involving drugs with similar
efficacies. As reported by the pharmacies, review of the procedure to ensure detection oferrors by other staff members will be necessary. Checking the drugs with the patient anddocumenting the dispensed drugs in the patient’s medication notebook may be effective.
6) References
1.

Japan Council for Quality Health Care Project to Collect and Analyze Medical
Near-Miss/Adverse Event Information 2006 Annual Report{ Medical adverse events involving drugs are analyzed. Misuse of drugs due to similar
efficacies is reported.

⎯ 48 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information[3]

Pharmaceutical near-miss events related to high-risk drugs
1) The definition of high-risk drug
In this analysis, a “high-risk drug” is defined as a drug requiring safety management, e.g.,
medication management and assistance appropriate for the patient’s living environment andrecuperation status. The following drugs listed in “II. Drugs in the following therapeuticareas that may require special cautions when administered” in the “Operation Guidelines for
Pharmacological Management of High Risk Drugs (version 1)” issued by the Japan
Pharmaceutical Association in November 2009 were used as a reference for defining
high-risk drugs.
(i) Anti-cancer drug(iv) Anti-coagulant(vii) Psychoneurotic agent(x) Immunosuppressant(ii) Anti-arrhythmic(v) Digitalis(viii) Diabetes treatment(xi) Anti-HIV drug(iii) Anti-epileptic(vi) Theophylline(ix) Pancreatic hormone

2) Reported high-risk drugs and number of reports
The reported drugs were searched for using the first three or four digits of the YJ codes forthe same therapeutic areas of the high-risk drugs listed in 1). For the drugs for which no YJ
code for the therapeutic area was available, the first three or four digits of the YJ codes for
similar therapeutic areas were used for the search.
Therapeutic area of high-riskdrug(i)Anti-cancer drug

Corresponding therapeutic area
and YJ code
Anti-cancer drug (N/A)(ii)

Anti-arrhythmic (212)Anti-arrhythmic(iii)

Anti-epileptic

Anti-epileptic (113)(iv)

Anti-coagulant

Anti-coagulant (333)(v)

Digitalis

Digitalis (2113)(vi)

Theophylline

Similar therapeutic area and YJ
code
Anti-tumor drug (42)

Xanthine (2251)(vii) Psychoneurotic agent

Psychoneurotic agent (117)(viii) Diabetes treatment

Diabetes treatment (396)(ix)

Pancreatic hormone

Pancreatic hormone (2492)(x)

ImmunosuppressantImmunosuppressant (N/A)
Note

Adrenal hormone (245)(xi) Anti-HIV drug
Antiviral drug (625)Note: Antiviral drugs with HIV infection as one of the target diseases listed in the section of “Indications” inthe package insert⎯ 49 ⎯

III Analysis of Pharmaceutical Near-Miss Information

Of the pharmaceutical near-miss events reported from April 1 to December 31, 2009, 153
drugs were high-risk drugs according to the definition used for this analysis. The following
table presents the frequently reported drugs.
(Most frequently reported drugs)
Product name
Major efficacy(Note)
Warfarin Tablets 1 mg
Anticoagulant
Amaryl Tablet 1 mg
Diabetes treatment
Depas Tablets 0.5 mg
Psychoneurotic agent
Zyprexa Tablets 5 mg
Psychoneurotic agent
Predonin Tablets 5 mg
Immunosuppressant
Paxil Tablets 10 mg
Psychoneurotic agent
Depakene-R Tablets 200
Anti-epileptic
Paxil Tablets 20 mg
Psychoneurotic agent
Lanirapid Tablets 0.05 mg
Digitalis
Theodur Tablets 100 mg
Xanthine
NovoRapid FlexPen
Pancreatic hormone
NovoRapid 30 Mix FlexPen
Pancreatic hormone
Seroquel Tablets 25 mg
Psychoneurotic agent
Jzoloft Tablets 25 mg
Psychoneurotic agent
Mexitil Capsules 50 mg
Anti-arrhythmic
Novolin 30 R FlexPen
Pancreatic hormone
Diabetes treatment
Voglibose Tablets 0.3 mg "SW"Basen OD Tablets 0.2
Diabetes treatment
Basen OD Tablets 0.3
Diabetes treatment
Actos Tablets 15
Diabetes treatment
Actos Tablets 30
Diabetes treatment
Contomin Sugar-Coated Tablets 12.5 mg
Psychoneurotic agent
Amoxan Capsules 10 mg
Psychoneurotic agent
Tetramide Tablets 10 mg
Psychoneurotic agent
Risperdal Tablets 2 mg
Psychoneurotic agent
Risperdal Oral Solution 1 mg/mL
Psychoneurotic agent
Seroquel 100 mg Tablets
Psychoneurotic agent
Zyprexa Tablets 10 mg
Psychoneurotic agent
Zyprexa Zydis Tablets 5 mg
Psychoneurotic agent
Lanirapid Tablets 0.1 mg
Digitalis
Mexitil Capsules 100 mg
Anti-arrhythmic
Celestamine combination Syrup
ImmunosuppressantNovolin R FlexPen
Pancreatic hormone
Humalog Mix 25 MirioPen
Pancreatic hormone
Warfarin Tablets 0.5 mg
Anticoagulant
Hirudoid Lotion 0.3%
Anticoagulant
Amaryl Tablets 3 mg
Diabetes treatment
Medet Tablets 250 mg
Diabetes treatment
Starsis Tablets 90 mg
Diabetes treatment
Seibule Tablets 50 mg
Diabetes treatment
UFT combination Capsules 100 mg
Anti-cancer drug
Note: “Major efficacy” refers to the therapeutic area of the reported high-risk drug.

⎯ 50 ⎯

Number of reports
16
10
8
7
7
6
5
5
5
5
5
5
4
4
4
4
4
4
4
4
4
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3
3

III Analysis of Pharmaceutical Near-Miss Event Information

3) Discussion
One hundred and fifty-three pharmaceutical near-miss events involved high-risk drugs witha variety of therapeutic areas. According to the product name-based tabulation of “ethicaldrugs,” the most frequently reported high-risk ethical drugs included Warfarin Tablets 1 mg
(most frequent), Amaryl Tablets 1 mg (13th), Depas Tablets 0.5 mg (22nd), Zyprexa Tablets 5
mg (27th) and Predonin Tablets 5 mg (27th).
4) Summary
The high-risk drugs defined for this analysis are identical to those listed in the “Operation
Guidelines for Pharmacological Management of High Risk Drugs (version 1)” issued by theJapan Pharmaceutical Association as drugs especially requiring precautions concerning use.
Special cautions should be exercised when preparing and dispensing these drugs, including
pharmacological management and giving instructions to patients. These drugs should be“checked” and “watched” as well as stored separately from other drugs. Review of the audit
procedure and collection of information from patients will also be necessary.

⎯ 51 ⎯

III Analysis of Pharmaceutical Near-Miss Information[4]

Pharmaceutical near-miss events related to inquiries about prescription
Of the pharmaceutical near-miss events reported from April 1 to December 31, 2009, 107
near-miss events involved “inquiries.”
1) Analysis of reasons for making inquiries
Number and proportion ofnear-miss events (%)
45 (42.0%)

Reason for making the inquiry
Based on the prescription alone
Based on the prescription and the information available at the pharmacy

37(34.6%)

Others25(23.4%)

Total

107

(100.0%)

The reported 107 near-miss events were categorized by “reason for making the inquiry.”
Inquiries were made based on the prescription alone in 45 near-miss events, based on theprescription and the information available at the pharmacy in 37 near-miss events, and basedon other reasons in 25 near-miss events.
<Reference: 2000 Analysis and Evaluation in “Survey on Inquiries Made by Pharmacies”(Note) >Detection of potential error

1987

1998

2000

Based on the prescription alone

72.4%

51.9%

46.6%

Based on the medication record

15.8%

19.3%

17.3%

Based on the patient interview

7.5%

27.9%

32.0%

Others

4.3%

0.9%

4.1%

2) Analysis of specifics of changes

Change of drug

Number of near-missevents36

Change of usage

15

Change of dose

16

Specifics of change

Change of quantity

16

Deletion of drug

13

Others

11

Total

107

The reported 107 near-miss events were categorized by “specifics of change.” Drugs werechanged in 36 near-miss events, and the dose or the quantity was changed in 16 near-missevents each. Nine of 11 near-miss events categorized as “others” involved additional
medications.

(Note)

See Nakamura K. 2000 Analysis and Evaluation in “Survey on Inquiries Made by Pharmacies”. Journal of the Japan Pharmaceutical
Association 54(4).

⎯ 52 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information(1)

The near-miss events involving “inquiries” are shown with “specifics of change” inthe left column and “reason for making the inquiry” in the top row of the following
table.
Reason for making
the inquiry

13

Based on theprescription and theinformation available
at the pharmacy
14

Change of usage

8

4

3

15

Change of dose

8

4

4

16

Change of quantity

13

3

0

16

Specifics of change
Change of drug

Based on theprescription
alone

OthersNumber ofnear-miss
events936

Deletion of drug

2

9

2

13

Others

1

3

7

11

Total

45

37

25

107

Drugs or quantities were frequently changed after making inquiries based on “theprescription alone.” Drugs were frequently changed or deleted after making inquiries
based on “the prescription and the information available at the pharmacy.” Drugs werechanged or other actions were taken after making inquiries based on “others” includinginterviewing the patient.
(2)

The following tabulations i) to iii) were performed for the category “change of drug,”
which was most frequent in the reported near-miss events involving “inquiries.”i)

The reported near-miss events involving inquiries were tabulated by type of change
based on product names reported in “near-miss events involving drugs.” Specifically,changes of strengths/dosage forms were categorized as “changed to different
strength/dosage form,” and changes of product names (not including changes ofstrengths/dosage forms) were categorized as “changed to different product name.”
Type of change

Changed to different strength/dosage form
Changed to different product name

Number of near-missevents
12
24

Total

36

Twelve near-miss events were categorized as “changed to different strength/dosage
form,” and 24 near-miss events were categorized as “changed to different productname” (not including changes of strengths/dosage forms).

⎯ 53 ⎯

III Analysis of Pharmaceutical Near-Miss Informationii) The reported near-miss events involving “inquiries” were shown with “type ofchange” in the left column and “reason for making the inquiry” in the top row in thefollowing table.
Reason for making theinquiryType of change
Change to different
strength/dosage form
Change to different productnameBased on theprescription
alone

Based on theprescription and theinformation available
at the pharmacy

OthersNumber ofnear-miss
events

7

5

0

12

6

9

9

24

13

14

9

36

Total

Of 12 reported pharmaceutical near-miss events involving “change of drug,” inquiries
were made based on information other than the prescription in five near-miss events(41.7%) categorized as “changed to different strength/dosage form.” Inquiries weremade based on information other than the prescription in 18 of 24 (75.0%) near-missevents categorized as “changed to different product name.”iii) Twenty-four near-miss events categorized as “changed to different product name”
were further categorized into “similar efficacy” and “different efficacy.” Similar
efficacy refers to YJ codes whose first four or more digits are identical.

Similar efficacy

Number of near-missevents9Different efficacy

15

Similarity of efficacy

Total

24

The originally prescribed drug was changed to other drug with a similar efficacy innine near-miss events and to other drug with a different efficacy in
15 near-miss events. The reason for making the inquiry, the product name (efficacy)
and the details of the near-miss events are shown below for the 15 near-miss events inwhich the prescribed drug was changed to a drug with a different efficacy.
Reason for making
the inquiry

Product name(efficacy)

Details

Contraindication for coadministration (1 near-miss event)
Based on theprescription and theinformation available
at the pharmacy{ Prescribed drug
Unipron Suppository 100(Other antipyretic/analgesic/antiphlogic){ Changed to
Anhiba pediatric Suppository 200
mg(Aniline)⎯ 54 ⎯

Baccidal Tablets for Children and Unipron
Suppository were prescribed for the patient at
the same time. The pharmacist casually readthe package insert of Baccidal since it was thefirst time to dispense the drug at the pharmacy
and found concurrent use of Baccidal andUnipron was contraindicated. An inquiry was
made, and the prescription of Baccidal waschanged to Anhiba Suppository.

III Analysis of Pharmaceutical Near-Miss Event Information

Reason for making
the inquiry

Product name(efficacy)

Details

Multiple prescriptions (3 near-miss events)
Based on theprescription alone{ Prescribed drug
Seibule Tablets 25 mg(Other diabetes treatment){ Changed to
Melbin Tablets 250 mg(Biguanide)

Based on theprescription and theinformation available
at the pharmacy{ Prescribed drug
Carnaculin Tablets 50(Circulating hormone){ Changed toMerislon(Other motion sickness medication)

Others{ Prescribed drug
Cefcapene pivoxil hydrochloride
100 mg “SAWAI”(Cephem antibiotic){ Changed to
Levofloxacin Tablets 100 mg“YD”(Pyridone carboxylic acids)

Seibule Tablets 25 mg was additionallyprescribed to the patient using Voglibose OD
Film 0.2 QQ. Both drugs have the same
α-glucosidase inhibitory action. An inquiry was
made to the physician, and he replied he had
forgotten the patient had been using Voglibose.
Seibule was changed to Melbin Tablets.
The concomitant drugs prescribed to the newpatient included Kallikrein. An inquiry was
made because Carnaculin Tablets 50 with thesame efficacy was prescribed. Carnaculin
Tablets 50 was deleted, and Merislon wasadded to the prescription.
Cefcapene pivoxil hydrochloride had beenprescribed. During the treatment, the pharmacy
found the original drug Flomox had also beenprescribed at other medical institution. An
inquiry was made to the prescribing physician,and cefcapene pivoxil hydrochloride waschanged to Levofloxacin Tablets YD. The
prescribing physician gave an order todiscontinue Flomox.

Adverse drug reaction (4 near-miss events)
Based on theprescription and theinformation available
at the pharmacy{ Prescribed drug
Meiact MS Tablets 100 mg(Cephem antibiotic){ Changed to
Cravit Tablets(Pyridone carboxylic acids)

Based on theprescription and theinformation available
at the pharmacy{ Prescribed drug
Tannalbin “WHEY”(Tannic acid){ Changed to
Lopemin Capsules 1 mg

The patient sought treatment for recurrent
cystitis and received a prescription. Meiact had
been prescribed before but switched to Cravit
due to drug eruption. The medication record
was overlooked, and Meiact was prescribedagain. An inquiry was made, and Meiact waschanged to Cravit.
The patient was allergic to milk according to acomment in the medication record. An inquiry
was made because the prescription included
Tannalbin, which was later changed to
Lopemin Capsules 1 mg.

(Other antidiarrhetic, antiflatulent)

Others{ Prescribed drug
Etodolac Tablets 200 “KN”
(Other antipyretic/analgesic/antiphlogic){ Changed toVoltaren Gel 1%(Other antipyretic, antipruritic, astringent,
antiphlogic)

Others{ Prescribed drug
Loxonin Tablets(Other antipyretic/analgesic/antiphlogic){ Changed toVoltaren Tablets 25 mg(Phenylacetic acid)⎯ 55 ⎯

Etodolac Tablets 200 KN was prescribed to thepatient treated for cancer at another medical
institution. According to the medication record
brought by the patient, the current medication
included TS1 Capsules 25, Leucon Tablets 10
mg, Azunol Gargle Solution 4% and Mohrus
Tape 20 mg. An inquiry was made to theprescribing physician because of potential
leukocytopenia. Etodolac Tablets werediscontinued and switched to Voltaren Gel.
The patient complained he had difficultyurinating because of Loxonin Tablets. An
inquiry was made regarding the prescription of
Loxonin, which was later switched to Voltaren
Tablets 25 mg.

III Analysis of Pharmaceutical Near-Miss Information

Reason for making
the inquiry

Product name(efficacy)

Details

Data entry error (6 near-miss events)
Based on theprescription alone{ Prescribed drug
Mevan Tablets 5(Other hypolipidemic){ Changed to
Banan Tablets 100 mg(Cephem antibiotic)

Based on theprescription alone{ Prescribed drug
Asverin Tablets 10(Other anti-tussive/expectorant){ Changed to
Asthphyllin Combination Tablets(Other anti-tussive)

Based on theprescription and theinformation available
at the pharmacy{ Prescribed drug
Urief Tablets 4 mg
(Other agent for urogenital and anal organ){ Changed to
Urinorm Tablets 50 mg(Other gout treatment)

Others{ Prescribed drug
Aspara-CA Tablets 200(Organic calcium){ Changed to
Aspara Potassium Tablets 300 mg(Other mineral preparation)

Others{ Prescribed drug
Loxonin Tablets(Other antipyretic/analgesic/antiphlogic)

Mucosta Tablets 100(Other peptic ulcer treatment){ Changed to
Medicon Tablets 15 mg(Dextromethorphan)Dasen 5 mg tablets(Other enzyme preparation)

Others{ Prescribed drug
Amaryl tablets 1mg(Sulfonylurea){ Changed toAlmarl Tablets 10

The prescription for cold medication included ahypolipidemic. The product name was Meban,
and no titer information was available. The
pharmacist suspected it should have been
Banan Tablets and made an inquiry. It turned
out the drug should have been an antibiotic
Banan Tablets.
The prescribed dose of Asverin was only 10
mg while other drugs were prescribed in adultdoses. An inquiry was made to the hospital,
and a data entry error of a clerk was identified.
Asverin should have been Asthphyllin
Combination Tablets.
The prescription for the female patient
included Urief (4). An inquiry was made to thephysician since the drug was not intended forfemale patients. Urief should have been
Urinorm (50). The physician wrote “Urinorm(50)” in the patient’s medical chart. There musthave been a data entry error when theprescription was prepared.
The patient came to the pharmacy with theprescription, which included Aspara-CA(prescribed for the first time). Asked how thephysician described the newly prescribed drug,
the patient said, “He did not say calcium would
be added to my prescription.” An inquiry was
made. Aspara-CA should have been Aspara
Potassium Tablets.
The patient requested the physician toprescribe the same cold medications he used
last year. Loxonin × 1 tablet and Mucosta × 1
tablet for 20 days to be used when having feveror pain were prescribed. When the medications
were about to be dispensed, the patient said,“These are not what I wanted.” An inquiry was
made, and the prescription was changed to
Medicon × 3 tablets and Dasen 5 mg × 3
tablets t.i.d. for seven days.
Amaryl Tablets 1 mg was prescribed instead of
Almarl Tablets 10. The prescription error was
found both by the patient and the pharmacy. An
inquiry was made, and the prescription waschanged.

(β-blocker)

Prescription of off-label drug (1 near-miss event)
Based on theprescription alone{ Prescribed drug
Kenacort-AG Ointment(Antibiotic/corticosteroid combination){ Changed toKenalog in orabase 0.1%
(Unclassifiable gastrointestinal treatment)⎯ 56 ⎯The dermatologist prescribed Kenacort-AG
Ointment (to be used orally). Oral use of the
drug was found off-label after checking the
package insert and making an inquiry to the
manufacturer. An inquiry was made, andKenacort was changed to Kenalog.

III Analysis of Pharmaceutical Near-Miss Event Information

3) Summary
Of 107 near-miss events involving inquiries about prescription, inquiries were made basedon comprehensive information including that from sources other than the prescription in 62
near-miss events (58.0%). Of 15 near-miss events involving change of the prescribed drug
to another drug with different product name and efficacy, inquiries were made based on
information other than the prescription in 11 near-miss events (73.3%). Use of theprescribed drug may have resulted in health hazards in the patients in many of the near-missevents, in which inquiries were made due to contraindication for coadministration or toprevent adverse drug reactions. Potential health hazards were avoided because thepharmacies checked the medication records and patient information when they prepared the
drugs. Information from prescriptions and other sources should be comprehensively used
when verifying prescriptions.

⎯ 57 ⎯

III Analysis of Pharmaceutical Near-Miss Information[5]

Pharmaceutical near-miss events related to 2 specific drugs
1) Warfarin potassium(1)

Occurrence of near-miss events

Of the pharmaceutical near-miss events reported from April 1 to December 31, 2009, 19
near-miss events involved warfarin potassium according to the YJ codes of the drugs.
The 19 near-miss events are tabulated according to “outline of near-miss events,”“situation,” “specifics of near-miss events or change” and “whether the drug wasdispensed.”
The prescribed drugs were dispensed in four near-miss events and not dispensed in 15
near-miss events. The tabulation according to “specifics of near-miss event or change”
showed “wrong quantity” was most frequent (10 near-miss events) followed by “drugmix-up” (3 near-miss events).
Outline ofnear-missevent

Situation

Specifics of near-miss event orchangeWrong quantity

Drugdispensing

Inquiry
about
prescription

Whether the drug wasdispensed
Not
Dispensed
dispensed
3
7

Total
(near-missevent)
10

Wrong packaging

0

1

1

Wrong strength/dosage form

1

0

1

Drug mix-up

0

3

3

Management

Error in filling the cassette

0

1

1

Drug release

Patient misidentification

0

1

1

Change of dose

0

1

1

Change of quantity

0

1

1

Total

4

15

19

Drug
dispensing⎯ 58 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information(2)

Details of the near-miss events(i)

Four near-miss events in which the drug was dispensed

The extent of treatment is shown in the following table, and the dose of dispensed
warfarin potassium compared with the dose intended by the physician was categorized
into low, moderate and high for the four near-miss events in which the drug was“dispensed.”
The extent of treatment was “minor” in one near-miss event, “no treatment” in 0
near-miss events and “unknown” in three near-miss events. The warfarin potassium dosecompared to the intended dose was low in three near-miss events and high in one
near-miss event.
The details of the near-miss events are shown below.

Extent oftreatment

Comparison with thewarfarin potassium
dose intended by thephysician

Details of the near-miss event[Details of the near-miss event, wrong quantity; 3 near-miss events]
Unknown

Low

Forty-five warfarin tablets (1.5 tablets × 30 days) weredispensed instead of 75 warfarin tablets (2.5 tablets × 30 days).
The pharmacist did the arithmetic in her head. The prepareddrugs were not checked.

Unknown

Low

When packing warfarin 1 mg and warfarin 0.5 mg using a
packaging machine, one packet worth of warfarin did not fall
into the packet paper and remained in the machine.
The pharmacy was busy with a lot of patients, and no thoroughcheck was performed. The verification was performed by one
pharmacist instead of two before release the drug.

Unknown

Low

Prepared packets contained one warfarin 1 mg tablet eachinstead of three tablets. The family of the patient found theerror before the patient had taken the drug.

[Details of near-miss event, wrong strength/dosage form; 1 near-miss event]Minor
treatmentHigh

The prescription was changed from warfarin 1 mg × 0.5 tablet
to warfarin 0.5 mg × 1.5 tablet; however, warfarin 1 mg × 1.5
tablet was prepared.
The warfarin dose increase was not thoroughly confirmed
during the conversation with the patient, and the drug was
prepared based on the pharmacist’s assumption.

⎯ 59 ⎯

III Analysis of Pharmaceutical Near-Miss Information

ii)

Fifteen near-miss events in which the drug was not dispensed

The dose of dispensed warfarin potassium compared with the dose intended by thephysician was categorized into low, moderate and high for 15 near-miss events in which
the drug was “not dispensed.”
The warfarin potassium dose compared to the intended dose was low in seven near-missevents, high in six near-miss events and the same in two near-miss events. In the lattertwo near-miss events the warfarin dose was unchanged but the generic was mixed up
with the original drug.
The details of the near-miss events are shown below.
Comparison with thewarfarin potassium dose
intended by the physician

Details of the near-miss events[Details of the near-miss event, wrong quantity; 7 near-miss events]
High

Fifty-six packets of warfarin 0.5 tablets were prepared instead of 28
packets.

High

The prescribed warfarin 1 mg × 0.6 tablet × 21 days was prepared as a
0.5 tablet and a crushed 0.1 tablet. A 0.1 warfarin tablet × 21 days shouldhave been crushed. However, 2.4 tablets were crushed instead of 2.1
tablets due to neglecting to check the quantity.
The inspecting pharmacist started to perform other tasks, and neglected
to check the quantity.

High

Warfarin 1 mg × 0.5 tablet × 28 packets were prepared instead of 14
packets.

Low

One tablet was prepared instead of 1.5 tablet.

Low

Due to an error in packaging machine operation, only one tablet of
warfarin was put into the machine instead of four tablets.
The machine operation was somewhat difficult, and the pharmacist did
not completely know how to use it.

Low

Twenty-eight tablets were prepared instead of 56 tablets.

Low

Pre-packed 0.25 tablet was mixed up with 0.75 tablet.

[Details of near-miss event, drug mix-up; 3 near-miss events]
High

When it should have been Onealfa × 1 tablet, warfarin 1 mg × 1 tablet
was prepared because the pharmacist mistakenly assumed the drug was
warfarin based on how the name sounded. The error was found during
the verification.

Same

Warfarin Potassium Tablets 0.5 mg HD were prepared instead of
Warfarin Tablets 0.5 mg.
Checking was neglected.

Same

Warfarin Tablets 1 mg was prepared instead of Warfarin Potassium
Tablets 1 mg HD.

[Details of near-miss event, wrong packaging; 1 near-miss event]Low

One and one-quarter tablet was packaged instead of 1.75 tablet.

[Details of near-miss event, error in filling the cassette; 1 near-miss event]
Low

Lasix Tablets 40 mg were packed into the cassette of the tablet
packaging machine for Warfarin Tablets 1 mg. One packet of Lasix was
prepared by mistake.
The pharmacist was confused because Lasix Tablets 40 mg was alsoprescribed.

⎯ 60 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information

Comparison with thewarfarin potassium dose
intended by the physician

Details of the near-miss event[Details of near-miss event, patient misidentification; 1 near-miss event]
Los

Drugs are usually placed in separate trays for each patient. However, theone dose packets for the patient were put into the tray of another patient.
The wrong medications were almost dispensed because one dose packets
had also been dispensed for the other patient. The error was found during
the pre-release verification.
There was a series of patients requiring long-term prescriptions and one
dose packets of multiple drugs. The one dose packets for the patientwere mistakenly put into the tray of the other patient after preparing andinspecting them. Multiple pharmacists prepared drugs for multiple
patients at the same time because one dose packets of long-termprescription drugs (28 to 90 days) took time for packing and verificationand simultaneous drug dispensing for multiple patients was unavoidable.

[Specifics of change, change of dose; 1 near-miss event]High

The patient received the prescription of one 5-mg tablet + two 1-mg
tablets at the first visit after his discharge from the special hospital. The
pre-admission prescription was 5 mg × 0.5 tablet. An inquiry was madebecause it was a sudden dose increase. The hospital replied through thereception that the prescription was unchanged from the one issued at theprevious hospital and therefore correct. The drug was prepared but
another pharmacist assumed 5 mg had been misread as 0.5 mg. Anotherinquiry was directly made to the physician. The prescribed 5 mg × 0.5
tablet had been prepared as 0.5 mg × 1 tablet and 1 mg × 2 tablets for theconvenience of the hospital.
1) The pharmacist thought he/she was convinced because he/she had
made an inquiry even though some doubts remained.
2) The rule to directly make inquiries to physicians was not thoroughly
observed.

[Specifics of change, change of quantity; 1 near-miss event]High

Regarding the usage of Warfarin Tablets 1 mg, the intention of thephysician to use Warfarin 8 mg on Day 1 and 2 mg on the followingdays was known after making an inquiry. Warfarin 8 mg was to be usedon the following days according to the pre-inquiry prescription.
It was an error of data entry on the electronic medical chart.

⎯ 61 ⎯

III Analysis of Pharmaceutical Near-Miss Information(3)

Near-miss events involving errors due to multiple strengths

Of 19 reported near-miss events, two events involved errors due to multiple strengths of
warfarin potassium.
The details of the near-miss events are shown below.
Details of near-miss event [specifics of near-miss event, inquiry]
The patient received the prescription of one 5-mg tablet + two 1-mg tablets at the first visit after his discharge
from the special hospital. The pre-admission prescription was 5 mg × 0.5 tablet. An inquiry was made because it
was a sudden dose increase. The hospital replied through the reception that the prescription was unchanged fromthe one issued at the previous hospital and therefore correct. The drug was prepared but another pharmacist
assumed 5 mg had been misread as 0.5 mg. Another inquiry was directly made to the physician. The prescribed 5
mg × 0.5 tablet had been prepared as 0.5 mg × 1 tablet and 1 mg × 2 tablets for the convenience of the hospital.
Prescribed drug
Warfarin Tablets 5 mg
[Pre-admission][During hospitalization][After discharge]

Warfarin Tablets 5 mg × 0.5 tablet

Warfarin Tablets 0.5 mg × 1 tablet
Warfarin Tablets 1 mg × 2 tablets

Warfarin Tablets 5 mg × 1 tablet
Warfarin Tablets 1 mg × 2 tablets

Content of warfarin potassium
2.5 mgContent of warfarin potassium
2.5 mgContent of warfarin potassium
7 mg

Details of near-miss event [specifics of near-miss event, drug dispensing]
The prescription was changed from Warfarin 1 mg Tablets × 0.5 tablet to Warfarin 0.5 mg Tablets × 1.5 tablet;
however, Warfarin 1 mg Tablets ×1.5 tablet was prepared.
[Previous prescription][Current prescription][Drug prepared by the pharmacist]

Warfarin Tablet 1 mg × 0.5 tablet

Warfarin Tablet 0.5 mg × 1.5 tablet

Warfarin Tablet 1 mg × 1.5 tablet

Content of warfarin potassium
0.5 mgContent of warfarin potassium
0.75 mg

Content of warfarin potassium
1.5 mg⎯ 62 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information(4)

Improvement measures reported by the pharmacies

Documentation of prescription information in medication notebooks should be thoroughly
ensured to communicate the information to the past and present hospitals.
Observe the rules for drug dispensing and verification, and two pharmacists should always
check the prepared drugs.
Place a reminder on the drawer for additional checking.
Ensure thorough checking of packed drugs.
Use a calculator to do even easy calculation for conversion.
(5)

Near-miss events reported by medical institutions

The Japan Council for Quality Health Care Project to Collect and Analyze Medical
Near-Miss/Adverse Event Information 2009 Annual Report includes analyses of near-missevents involving warfarin potassium.(Note)
Fifty-four near-miss events involving warfarin potassium were reported between October
2004 and December 2009. Patients had infarction or hemorrhage during an examination, asurgery or a treatment procedure in 22 near-miss events (see Reference). The use of
warfarin potassium and the blood coagulability of the patient were not known in advancein five of the near-miss events. The improvement measures proposed by the reporting
medical institutions included “thorough provision and exchange of information on patientsusing oral warfarin potassium.” The Annual Report summarizes, “Management of patientsusing oral warfarin potassium and scheduled for an examination, a surgery or a treatment
procedure needs to be determined based on the use of the drug and the blood coagulability
to prevent infarction and hemorrhage associated with the medical procedures.”<Reference: Availability of information on use of oral warfarin potassium and blood coagulability of patientsscheduled for examination, surgery or treatment procedure>
Availability of
information
Available

Infarction(incident)

Hemorrhage(incident)

Others(incident)

2

3

0

No
disability(incident)
0

Unknown(incident)

Total(incident)

1

6

Not available

8

9

1

0

0

18

Total

10

12

1

0

1

24

Excerpted from Figure III-2-45 (page 313) in the Japan Council for Quality Health Care Project to Collect andAnalyze Medical Near-Miss/Adverse Event Information 2009 Annual Report(Note) See the Japan Council for Quality Health Care Project to Collect and Analyze Medical Near-Miss/Adverse Event Information 2009
Annual Report for details of the reported medical adverse events.

⎯ 63 ⎯

III Analysis of Pharmaceutical Near-Miss Information

In the Japan Council for Quality Health Care Medical Safety Information No. 36“Insufficient Confirmation of relevant information at the time of dental extraction,” atooth extraction procedure performed by a dentist who checked the blood coagulation test
performed half a year ago and resulted in blood transfusion in a patient using oral warfarin
potassium was reported. The improvement measures proposed by the reporting medical
institution included, “the physician in charge of the patient should communicate necessary
patient information when the patient receives dental treatment.”（Medical Safety Information No. 36 “Insufficient Confirmation of relevant information at the time of dental
extraction,”）(6)

Summary

Drugs were not dispensed in many of the near-miss events involving warfarin potassium.
Most of these near-miss events involved “wrong quantity.” Some reported errors due tomultiple strengths. If warfarin potassium is dispensed at doses higher than intended by thephysician, health hazards may occur due to overdose. Being a high-risk drug, warfarin
potassium should therefore be prepared more carefully compared with other drugs.
“(5) Near-miss events reported by medical institutions” excerpted from the analysis in the
Project to Collect and Analyze Medical Near-Miss/Adverse Event Information 2009
Annual report introduces thorough provision and exchange of information on the patient’s
condition as one of the improvement measures proposed by the reporting medical
institution. Pharmacies should also ensure active coordination with medical institutions byproviding information on the medication status and concomitant drugs of patients using
oral warfarin potassium in their medication notebooks.
Also see “IV Pharmaceutical Near-Miss Event Information to Be Shared” in this Annual
Report (page 69 to 89) for the reported near-miss events involving warfarin potassium.

⎯ 64 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information

2) Insulin(1)

Occurrence of near-miss events

Of the pharmaceutical near-miss events reported from April 1 to December 31, 2009, 27
near-miss events involved insulin according to the YJ codes of the drugs involved. The
prescribed drugs were dispensed in 14 near-miss events. Compared with the data
presented in “4. Whether the drug was dispensed and extent of treatment” (page 22), theproportion of dispensing/drug release errors was larger (14/27 near –miss events).
Whether the drug was dispensed andextent of treatment in the near-missevents involving insulin

Whether the drug was dispensed andextent of treatment in all the reported
medical near-miss events
Dispensed, minor treatment
7
Dispensed, no0.5%
treatment108
7.4%

Not dispensed
13
48.1%

Dispensed, notreatment
5
18.5%

Dispensed,
unknown
253
17.3%

Dispensed,
unknown933.3%

Not dispensed
1,092
74.8%

The reported 19 near-miss events are tabulated according to “specifics of near-missevent,” “situation,” “specifics of near-miss event or change” and “whether the drug wasdispensed.”“Wrong strength/dosage form” (nine events) was most frequent followed by “drugmix-up” (five events) among “specifics of near-miss event or change.”
Outline ofnear-missevent

Situation

Specifics of near-miss eventor change
Failure to dispense
Wrong quantity

Drugdispensing

Drugdispensing

Drug release
Inquiry

Whether the drug wasdispensed
Not
Dispensed
dispensed
0
3
1

0

Total
(near-missevent)
3
1

Wrong strength/dosage form

5

4

9

Drug mix-up
Providing wrong description on
medication bag
Others

2

3

5

2

0

2

3

0

3

Neglect of drug release

1

0

1

Change of drug

0

2

2

Change of dose

0

1

1

Total

14

13

27

⎯ 65 ⎯

III Analysis of Pharmaceutical Near-Miss Information(2)

Summary of near-miss events

Details of 14 near-miss events in which the drug was dispensed are shown by extent oftreatment in category and text.
The extent of treatment was “minor treatment” in 0 near-miss events, “no treatment” infive near-miss events and “unknown” in nine near-miss events.
Details of near-miss event

Details of near-miss event (text information)[Extent of treatment, no treatment] 5 near-miss events
Wrong quantity“NovoRapid FlexPen × 1 and Lantus SoloStar × 3” were prescribed but“NovoRapid FlexPen × 2 and Lantus SoloStar × 6” were dispensed.
The patient did not use the drugs.
Wrong strength/dosage
Insulin 30R was prepared and dispensed instead of insulin R.
form
Wrong strength/dosage
The patient had been using Humalog Mix 25 Kit, but the drug was switched toform
MirioPen. The change was overlooked, and Kit was dispensed. The error was
found by another pharmacist during the inventory check on the next day. The
patient was contacted immediately. He/she came to the pharmacy to exchange
Kit to MirioPen. The pharmacy apologized and explained how to use MirioPen
to the patient.
Drug mix-up
NovoRapid was dispensed by mistake instead of prescribed NovoRapid 30
Mix for the last time but one. The patient thought the drug must have beenswitched and used NovoRapid. The last time NovoRapid 30 Mix wasdispensed according to the prescription, the patient used it. This time thepatient talked to the physician who told him the medication had not beenchanged. The error was found when the hospital contacted the pharmacy.
Others (prescription error
The prescription issued by the current hospital included NovoRapid 30 Mix
made by physician)FlexPen, which should have been NovoRapid 300 FlexPen. NovoRapid 30
Mix FlexPen was prepared and dispensed to the patient’s caregiver because thedosage and administration was not unusual. The patient found the prescription
error before using the drug and contacted the pharmacy.
[Extent of treatment, unknown] 9 near-miss events
Wrong strength/dosage
Novolin 30R was dispensed instead of Novolin R. The patient later told theformpharmacy he had used up the dispensed drug.
Wrong strength/dosage
Humalog MirioPen was dispensed instead of prescribed Humalog Mix 25
form
MirioPen. The error was found when the patient later told the pharmacy thedispensed drug was different from what he usually used. The drug was not
used, and no health hazard occurred.
Wrong strength/dosage
InnoLet 30R was dispensed instead of InnoLet R.
form
Drug mix-up
The patient visited the pharmacy to exchange the drug because it was different
from what he usually used. A prescription check found PenFill 30R was
dispensed by mistake instead of PenFill R. Fortunately the patient found theerror and did not use the drug.
Providing wrong
Wrong number of PenFill N 300 units, 20 units instead of 18 units in the
documentation onmorning, was documented on the medication bag. (The dose was switched in
medication bag
the current prescription)
Providing wrong
PenFill R was entered instead of PenFill 30R but the drug was correctly
documentation on
prepared according to the prescription.
medication bag
OthersThe patient left his prescription for processing at the pharmacy around noon
(neglect of drug release)
and went to have lunch. The pharmacy temporarily kept only the insulin in the
refrigerator because the patient was not there when his name was called. The
pharmacy forgot to dispense the insulin when the patient returned from lunch.
Others (data entry error)
The Levemir units were changed from previous 7 units to 6 units. When thechanged units were entered into the system, the “7” was not deleted. The
prescription said 67 units. The error was found during the prescription check.
The pharmacy contacted the patient who knew the correct dose was 6 units.
Neglect of release
The medication bag was found in the refrigerator.

⎯ 66 ⎯

III Analysis of Pharmaceutical Near-Miss Event Information(3)

Product names reported in the near-miss events involving wrong strength/dosage formor drug mix-up

Fourteen of 27 reported near-miss events involved “wrong strength/dosage form” or “drugmix-up.” The drug was dispensed in seven near-miss events and not dispensed in the otherseven near-miss events.
Reported product names of insulin, whether the drug was dispensed and number of reports
are shown below.
Prescribed drug

Mixed-up drug

Number of reports[Dispensed] 7 near-miss events
PenFill R 300

PenFill 30R 300

2

InnoLet R

InnoLet 30R

1

NovoRapid 30 Mix FlexPen

NovoRapid FlexPen

1

Novolin R FlexPen

Novolin 30R FlexPen

1

Humalog Mix 25 MirioPen

Humalog Mix 25 Kit

1Humalog Mix 25 MirioPen

Humalog MirioPen

1

NovoRapid FlexPen

NovoRapid 30 Mix FlexPen

2

NovoRapid 30 Mix PenFill

NovoRapid 30 Mix FlexPen

1

NovoRapid 300 FlexPen

NovoRapid 30 Mix FlexPen

1

Novolin R FlexPen

InnoLet R

1

Novolin R Flexpen

Novolin 30R FlexPen

1

Lantus SoloStar

Apidra Inj SoloStar

1[Not dispensed] 7 near-miss events(4)

Improvement measures reported by the pharmacies{ Post a reminder for strength check.
{ Check the type of injection together with the patient.
{ Create labels for individual insulin and attach to the back of the prescription whendispensing, verifying and release the drug.
{ Be sure to check the units when dispensing the drug. The units should also be checked
together with the patient when released.
{ The picture of the drug should also be checked before release to avoid overlooking
when checking the drug dispensing record.

⎯ 67 ⎯

III Analysis of Pharmaceutical Near-Miss Information(5)

Summary

The drug was “released” more frequently in the reported near-miss events involving
insulin compared with all reported near-miss events. Errors in dispensing and release of
the high risk drug insulin may result in serious accidents. The improvement measures
reported by the pharmacies included posting of a reminder for strength check andchecking of the type of injection together with the patient. “Comments on Precautions
concerning Dispensing of Insulin and Explanation to be Given upon Release (Usage andStorage)”(Note) prepared and published by the Japan Pharmaceutical Association
recommends, “the name of insulin should be thoroughly checked to the last letter.”
Including the recommendation in the operating procedure at the pharmacy will bebeneficial.

(Note)

See Comments on Precautions concerning Preparation of Insulin and Explanation to be Given upon Dispensing (Usage and Storage)of the Japan Pharmaceutical Association (http://www.nichiyaku.or.jp/contents/kaiken/pdf/insulin_h21.pdf).

⎯ 68 ⎯

IV Pharmaceutical Near-Miss Event Information to Be
SharedOf the pharmaceutical near-miss events reported from April 1 to December 31, 2009, the incidents to
be widely shared as useful information for medical safety management(Note 1) were selected in thissection.
Case 1: a near-miss event involving wrong strength/dosage form of an injection (Case No.
000000000005)
Details of the incident
Novolin 30R was dispensed instead of Novolin R. The patient later told the pharmacy he had used up the dispensed
drug.
Background/cause of the incident(The incident occurred) probably because the drug was hastily handed to the patient who told the pharmacist he
wanted his medication now, ready to go home after his dialysis treatment. The basics were neglected.
Improvement measures proposed by the pharmacy
Stick to the basics. Cross-check the drug with the prescription. Stay calm.

Other information
None

The point of the casez Special cautions need to be exercised since errors involving insulin may result in serious accidents.
z Other incidents involving easily mixed up insulin injections were also reported.
y NovoRapid 300 FlexPen and NovoRapid 30 Mix FlexPen (Case No. 000000000099 and 000000000107)
y Humalog Mix 25 MirioPen and Humalog MirioPen (Case No. 000000000136)
y PenFill 30R and PenFill R (Case No. 000000000141)
z Information on insulin is included in Medical Safety Information (No. 1 and No. 6) on the Japan Council for
Quality Health Care Project to Collect and Analyze Medical Near-Miss/Adverse Event Information website.(Note 2)(Note 1) Details of the individual incidents are available on the Project to Collect and Analyze Pharmaceutical Near-Miss Information
website. Click the “public data search” button and enter the case number to browse.
(Note 2) See the Japan Council for Quality Health Care Project to Collect and Analyze Medical Near-Miss/Adverse Event Information
website (http://www.med-safe.jp/).

⎯ 69 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 2: a near-miss event involving mix-up of oral medications (Case No. 000000000006)
Details of the incident
Instead of lactose, magnesium oxide was added as an excipient to Rise Granules 10%.
Background/cause of the incident
The weighed and pre-packed medication was not inspected for its contents.
Improvement measures proposed by the pharmacy
Drugs should be inspected by a person other than the one who prepared them. Verifications should be performed by
two or more pharmacists. Dispensed drugs and dispensing processes should be checked for their correctness.

Other information
None

The point of the casez Errors in dispensing of powder medications are difficult to find.
z A specific verification system for powder medications should be used. If such a system is not available, thoroughchecking at the time of dispensing should be ensured.

Case 3: a near-miss event involving an error in drug release and patient misidentification (Case No.
000000000041)
Details of the incident
The name of Patient A was called but Patient B came to the drug release counter. The drug was dispensed without
checking the patient’s name. Patient A and Patient B were on the same medications. The patient misidentification was
found because Patient A was still in the waiting room.
Background/cause of the incident
The pharmacy was busy because it was before Golden Week. The pharmacist rushed to dispense drugs to the waiting
patients. The error occurred probably because the pharmacist neglected to check the patient’s name.
Improvement measures proposed by the pharmacy
Patients’ names must be checked again at the drug release counter.

Other information
None

The point of the casez Checking the patient’s name at the pharmacy may be difficult because the family of the patient may come to pickup the medication. Distributing numbered tags to patients who come to fill their prescriptions to check theiridentifications later may be effective for prevention of patient misidentification.

⎯ 70 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 4: a near-miss event involving an inquiry about change of dose (Case No. 000000000147)
Details of the incident
The patient received the prescription of one 5-mg tablet + two 1-mg tablets at the first visit after his discharge fromthe special hospital. The pre-admission prescription was 5 mg × 0.5 tablet. An inquiry was made because it was asudden dose increase. The hospital replied through the reception that the prescription was unchanged from the one
issued at the previous hospital and therefore correct. The drug was prepared but other pharmacist assumed 5 mg had
been misread as 0.5 mg. Another inquiry was directly made to the physician. The prescribed 5 mg × 0.5 tablet had
been prepared as 0.5 mg × 1 tablet and 1 mg × 2 tablets for the convenience of the hospital.
Background/cause of the incident
1) The pharmacist was convinced because he/she had made an inquiry even though some doubts remained.
2) The rule to directly make inquiries to physicians was not thoroughly followed.
Improvement measures proposed by the pharmacy
Avoid making inquiries through hospital receptions as much as possible. Ensure documentation of medication records
in medication notebooks. *The information on the patient’s medication was not thoroughly communicated to theformer and the current hospitals. (The patient was discharged with the medications prescribed during his
hospitalization. The details of the medications were not provided in the patient information sheet given to the current
hospital, however, and the pharmacy had to rely on the information provided by the patient alone.)

Other information
Prescribed drug: Warfarin Tablets 5 mg

The point of the casez Special cautions need to be exercised since errors involving warfarin may result in serious accidents.
z Warfarin Tablets have multiple strengths, e.g., 0.5 mg, 1 mg and 5 mg, which may possibly result in prescription
or dispensing of Warfarin with a wrong strength. Make specific inquiries, e.g., “the prescribed quantity seems to
be too much.”⎯ 71 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 5: a near-miss event involving mix-up of oral medications (Case No. 000000000175)
Details of the incident
Adrenal hormone was almost dispensed by mistake instead of hypotensive.
Background/cause of the incident
The two types of drugs were stored on the same shelf side by side.
Improvement measures proposed by the pharmacy
The drugs are now stored separately

Other information
Prescribed drug: Preran 1 mg Tablets
Mixed-up drug: Prelon Tablets 1 mg

The point of the casez An ACE inhibitor Preran 1 mg Tablets were mixed up with a synthetic adrenal hormone Prelon Tablets 1 mg. The
drug names were quite similar.
z Separate handling procedures for general drugs and high-risk drugs, storing drugs according to their efficacies andplacing warning labels against similar drug names are desired.

⎯ 72 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 6: a near-miss event involving an inquiry on change of drug (Case No. 000000000293)
Details of the incident
The prescription for the female patient included Urief (4). An inquiry was made to the physician since the drug was
not intended for female patients. Urief should have been Urinorm (50). The physician wrote “Urinorm (50)” in thepatient’s medical chart. There must have been a data entry error when the prescription was prepared.
Background/cause of the incident
Was the prescribing hospital busy? We don’t know.
Improvement measures proposed by the pharmacy
Ensure a thorough checking system for prescription data entry and verifications, e.g., double-checking, at the medical
institution as well as at the pharmacy.

Other information
None

The point of the casez The prescription error made by the physician was found at the pharmacy. It was possibly an error in spelling of the
drug name or in drug selection from the prescription drug master files due to the similar drug names. A checking
system for in-house prescriptions at the time of issuing extramural prescriptions, a prescription system to selectdrugs from the prescription drug master files prepared separately for different efficacies and warning labels
against similar drug names are desired.

Case 7: an inquiry involving mix-up of oral medications (Case No. 000000000308)
Details of the incident
Urief was prepared instead of Urinorm.
Background/cause of the incident
The drug was prepared based on the pharmacist’s assumption.
Improvement measures proposed by the pharmacy
Drug names should be read to the last letter.

Other information
None

The point of the casez The pharmacist mixed up the drugs at the time of dispensing. Urinorm Tablets 50 mg and Urief Tablets 4 mg areboth powerful drugs. Storage of drugs according to their efficacies and warning labels against similar names arealso desired for powerful drugs. Currently Urief 2 mg and 4 mg are being switched from capsules to tablets.
Pharmacists should keep in mind Urief Capsules and Urief Tablets are both available now.

⎯ 73 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 8: a near-miss event involving a wrong strength/dosage form of oral medication (Case No.
000000000330)
Details of the incident
Mevalotin 10 mg was prepared instead of Mevalotin 5 mg. The error was overlooked during the verification, andMevalotin 10 mg was dispensed. The error was found when the patient called the pharmacy. The dispensed drug was
exchanged, and the pharmacy apologized to the patient.
Background/cause of the incident
The drug dispensing/verification error occurred because the pharmacy had almost always been releasing Mevalotin 10
mg. Mevalotin 10 mg and 5 mg were stored one above the other.
Improvement measures proposed by the pharmacy
A comment to use precautions was entered into the receipt processing computer and the medication record. The
arrangement of the drug shelves was changed.

Other information
None

The point of the casez People tend to be pulled toward usualness and frequentness. An “assumption” leads to errors because not all
information is checked. Errors become frequent as we rush. Even experienced people can make errors.
Verifications should be performed with these facts in mind.

Case 9: a near-miss event involving a wrong strength/dosage form of external medication (Case No.
000000000342)
Details of the incident
Dermovate Ointment was prepared instead of Dermovate Cream.
Background/cause of the incident
No data
Improvement measures proposed by the pharmacy
No data

Other information
None

The point of the casez Drug mix-up may be caused due to similar appearances or names of drugs. Multiple strengths or dosage forms of
the same drug may also cause a mix-up. Drug mix-up due to similar appearances can be prevented by storing the
drugs on separate shelves. Other types of mix-up can be decreased by always reading prescriptions carefully.

⎯ 74 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 10: a near-miss event involving a wrong strength/dosage form of injection (Case No.
000000000377)
Details of the incident
The patient had been using Humalog Mix 25 Kit, but the drug was switched to MirioPen. The change was overlooked,
and Kit was dispensed. The error was found by other pharmacist during the inventory check on the next day. The
patient was contacted immediately. He came to the pharmacy to change the Kit to MirioPen. The pharmacy
apologized and explained how to use MirioPen to the patient.
Background/cause of the incident(The error was caused by) the pharmacist’s assumption based on the long-term use of Kit by the patient. The hospital
did not notify the pharmacy that Kit had been replaced with MirioPen in the formulary.
Improvement measures proposed by the pharmacy
Prescriptions should be checked without assumption.

Other information
None

The point of the casez People tend to make assumptions based on what has been going on. Physicians should be reminded of the humannature and provide information clearly with emphasis when prescriptions are changed so that pharmacists will nothave to make inquiries without knowing whether it is a prescription error or a prescription change.

⎯ 75 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 11: a near-miss event involving an error in verification of prescription of oral medication (CaseNo. 000000000569)
Details of the incident
The prescription for a patient with glaucoma had been changed but not all the staff at the pharmacy knew it.
Background/cause of the incident
The medication record had a tag indicating the patient had glaucoma; however, the tag was overlooked. The
prescription change had not been properly recorded, and not all the pharmacists knew about the change.
Improvement measures proposed by the pharmacy
Ensure medication recording. Raise awareness.

Other information
Related drug: Myslee Tablets 10 mg

The point of the casez Many drugs are contraindicated for treatment of glaucoma and prostate hypertrophy. Many patients do not knowwhat type of glaucoma they have. Medication management based on patient interviews at the pharmacy isimportant. The condition of the patient may have to be checked with the physician in some cases. When checking
the concomitant drugs the patient should be interviewed about his current oral medications as well as all otherdrugs he/she is using and all health foods he/she is eating.

⎯ 76 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 12: a near-miss event involving a wrong strength/dosage form of oral medication (Case No.
000000000645)
Details of the incident
The patient who had already filled his prescription came to the pharmacy and said, “This is not what I have been
taking.”Background/cause of the incident
The product had a two-dimensional bar code, which is read to enter the prescription data. No one remembered thetablets had been switched to the combination tablets. Changed prescriptions are to be highlighted when the data areentered manually; however, the highlighted information was overlooked. The patient came to the pharmacy to receive
medication guidance three days later. The pharmacist was distracted because he/she needed to contact the physician
about the poultice prescribed to the patient, which was different from what the patient wanted.
Improvement measures proposed by the pharmacy
Manually entered data and data added after reading bar codes should be highlighted to raise caution. Strengths should
be circled with a blue pen to raise caution about wrong strengths during data verification. If the current prescription isdifferent from the previous one, enter an “S” for a newly prescribed drug and a “D” for an unchanged drug. Provide
comments as well.

Other information
Prescribed drug: Eviprostat Combination Tablets DB
Mixed-up drug: Eviprostat Tablets

The point of the casez In July 2008, Eviprostat Combination Tablets DB went on sale and Eviprostat Tablets changed its name to
Eviprostat Combination Tablets SG. Many drugs have lately changed their names to increase medical safety.
However, not knowing about the change of drug names may result in drug dispensing errors. Pharmacies shouldmake sure to obtain the latest information and share this among staff members.

⎯ 77 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 13: a near-miss event involving a wrong strength/dosage form of oral medication (Case No.
000000000646)
Details of the incident
The prescription was changed from warfarin 1 mg × 0.5 tablet to warfarin 0.5 mg × 1.5 tablet; however, warfarin 1 mg
× 1.5 tablet was prepared.
Background/cause of the incident
The warfarin dose increase was not thoroughly confirmed during the conversation with the patient, and the drug was
prepared based on the pharmacist’s assumption.
Improvement measures proposed by the pharmacy
Place a reminder for repeated checking on the warfarin drawer.

Other information
None

The point of the casez Prescriptions of Warfarin need special precautions since warfarin overdose may result in death. Warfarin dose
may be changed frequently, and the strength or the dosage form may also be changed. Warfarin potassium, thenonproprietary name of Warfarin, has multiple strengths such as 0.5 mg tablets, 1 mg tablets, 2 mg tablets, 5 mg
tablets and fine granule 0.2%. Which strength to use is at the discretion of individual medical institutions?
Prescriptions should be carefully read when dispensing warfarin. Drug mix-up can be prevented by changing theshelf arrangement or by placing reminders. Early detection of errors based on frequent inventory checking is also
necessary.

⎯ 78 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 14: a near-miss event involving an inquiry about a change of drug (Case No. 000000000689)
Details of the incident
The patient came to the pharmacy with the prescription, which included Aspara-CA (prescribed for the first time).
Asked how the physician described the newly prescribed drug, the patient said, “He did not say calcium would be
added to my prescription.” An inquiry was made. Aspara-CA should have been Aspara Potassium Tablets.
Background/cause of the incident
The patient had been taking Slow-K. Aspara Potassium was to be added to his prescription. The pharmacist shouldhave guessed Aspara CA may have been mixed up with Aspara Potassium during the verification and checked withthe patient. Although additional Aspara CA was unexpected based on the patient’s medication record, the pharmacist
casually thought the drug was prescribed for a newly diagnosed disorder.
Improvement measures proposed by the pharmacy
When a prescription is changed and questions arise, the pharmacist should always check with the patient to see if the
explanation he received from the physician is consistent with the prescription. Inquiries should be made when any
inconsistency is found.

Other information
None

The point of the casez Physicians may confuse drug names when writing prescriptions because some drugs have similar names or
efficacies. The intention of the physician, which is unclear based on the prescription, may be understood after
talking to the patient. Potential health hazards may be prevented by making inquiries if any questions arise while
talking to the patient or checking the medication record.

⎯ 79 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 15: a near-miss event involving drug release (categorized as “Others”) (Case No.
000000000788)
Details of the incident
A clerk entered Biofermin R (powder) instead of Biofermin R Tablets into the receipt processing computer by
mistake. The pharmacist dispensed Biofermin R Tablets as prescribed. However, the medication bag said Biofermin R(powder), which was given to the patient together with the information sheet for Biofermin R (powder) because thepharmacist did not know about the data entry error.
Background/cause of the incident
The new clerk had been in the office for less than a month. The pharmacist dispensed the drug without checking the
drug dispensing record, the information sheet or the medication bag. The clerk did not know there were two types ofBiofermin R and different dosage forms for children and adults. The name Biofermin R is confusing. It should bechanged to Biofermin R Powder or Biofermin R Fine Granule.
Improvement measures proposed by the pharmacy
Thorough pre-release check of drug dispensing records will be ensured. The clerk received information on thestrengths of Biofermin.

Other information
None

The point of the casez It was an error in entering the dosage form into the computer. In the Japan Council for Quality Health Care
Hospital Accreditation(Note) process, availability of a system in which physicians check data entered by
non-physicians is evaluated. Pharmacies should also have a similar system in which pharmacists check data
entered by clerks to ensure consistencies of entered data and contents of prescriptions.
z Other incidents involving errors in entering a drug strength or a patient’s name in the computer were reported.
y The prescription for Patient A was entered into the receipt processing computer as that for Patient B who has
the same family name. (Case No, 000000000766)
y The quantity of the drug substance (5 mg, or 1 g as the quantity in the prepared medication) was entered as thequantity of prepared medication, and the drug information sheet containing the wrong information was given
to the patient. (Case No. 000000000770)(Note) See the Japan Council for Quality Health Care website (http://www.jcqhc.or.jp/).

⎯ 80 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 16: a near-miss event involving mix-up of oral medications (Case No. 000000000820)
Details of the incident
In October a prescription was received through fax. Acarbose Tablets had been switched from Glucobay Tablets anddispensed until the previous prescription; however, a clerk found the current prescription said, “No generics” when
he/she entered the data into the computer. The clerk asked the pharmacist if the current prescription was correct. The
pharmacist thought the current prescription had some error because the patient had been requesting generics.
However, he/she checked the past prescriptions to make sure. The past prescriptions had allowed generics until Julybut disallowed generics after that. Glucobay Tablets were prescribed in July and September; however, Acarbose
Tablets (generic) were dispensed both times because the instruction not to use generics was overlooked. Since thepatient had been requesting generics, the pharmacy made an inquiry to the medical institution, asking if there had
been an error in the instructions. The medical institution replied the prescription had been changed to disallow
generics since July because the patient’s condition had been aggravated.
Background/cause of the incident
Calculation, drug dispensing and verification had been performed without checking the instructions not to use
generics in the prescription because the generic had been dispensed for months upon the request of the patient.
Improvement measures proposed by the pharmacy
Once an original drug is switched to a generic, pharmacists tend to assume generics are also allowed in laterprescriptions and neglect to check the prescriptions. When preparing generics, the prescriptions should be checked byboth a clerk and a pharmacist to see if generics are allowed.

Other information
None

The point of the casez A generic was prepared because the pharmacy did not realize the prescription allowing generics had been changed
to one disallowing generics. In most cases original drugs are switched to generics. Pharmacists should keep inmind that switching back to the original drug (disallowing generics) is rare but possible in some cases dependingon the patient’s condition. The name of the physician is usually printed in the section indicating generics are
disallowed but his/her seal may be missing. The signature section is in the bottom of the prescription, whichshould be considered as one of the important check items during prescription verifications.

⎯ 81 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 17: a near-miss event involving an inquiry about a change of drug (Case No. 000000000911)
Details of the incident
The prescription for cold medication included a hypolipidemic. The product name was Meban, and no titer
information was available. The pharmacist suspected it should have been Banan Tablets and made an inquiry. It turned
out the drug should have been antibiotic Banan Tablets.
Background/cause of the incident
The prescription was handwritten by the physician who made an error based on his assumption. Errors such as drug
mix-up due to similar names and omission of drug strengths have occurred, and there was no checking procedure forprescriptions prepared by physicians.
Improvement measures proposed by the pharmacy
A computer system should be introduced. Review the in-house procedure and include a checking procedure. If a
computer system cannot be introduced, the physician should memorize drug strengths as part of drug names.

Other information
None

The point of the casez It was a drug selection error due to similar drug names, which was caused by the absence of the efficacies andstrength of the concomitant drugs in the prescription. While ordering systems usually have a function to prevent
errors in selection of prescribed drugs (e.g., requirement to enter at least the first three letters of the drug name),
receipt processing computers may not have such a function. Data are entered into the computer by clerks at some
hospitals. Whether the traditional warning system for physicians is adequate is now being discussed. Pharmacists
should keep in mind that errors in selection of prescribed drugs may occur in prescriptions printed out fromcomputer systems and make inquiries as necessary.

⎯ 82 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 18: a near-miss event involving an inquiry about change of drug (Case No. 000000001012)
Details of the incident
The patient sought treatment for recurrent cystitis and received a prescription. Meiact had been prescribed before but
switched to Cravit due to drug eruption. The medication record was overlooked, and Meiact was prescribed again. An
inquiry was made, and Meiact was changed to Cravit.
Background/cause of the incident
Meiact had been prescribed by one physician and switched to Cravit by other physician. The error occurred probably
because the physicians had prepared the prescriptions in different manners.
Improvement measures proposed by the pharmacy
An environment to thoroughly share and use information should be reestablished, e.g., uniform requirements forprescription contents should be established.

Other information
None

The point of the casez The medication record containing the patient information, which is one of the advantages of separation of drug
release and prescribing functions, could have been used to prevent health hazards. Accumulation of incidents suchas this reminds us it is important for patients to have their pharmacy and pharmacist.

⎯ 83 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 19: a near-miss event involving an inquiry about change of drug (Case No. 000000001044)
Details of the incident
The prescription brought by ShimoXX (male) was the prescription for ShimoYY (female). The prescription
misidentification was found because the medication notebook submitted with the prescription was of ShimoXX. The
hospital misidentified the patient and issued the prescription by mistake.
Background/cause of the incident
The family names of the patients both started with “Shimo.” The patients were around the same age. Althoughpatients see their physicians themselves, they may not go to hospital receptions, prescription counters or pharmacies.
Often the family of the patient picks up medications, and the patient cannot be identified based on the sex alone.
Improvement measures proposed by the pharmacy
Prescriptions should always be cross-checked with medication notebooks or health insurance cards at pharmacies.
Improvement measures that had been taken at the hospital were unknown; however, the error was notified to thehospital.

Other information[Cause of the incident]
The prescription check was neglected. The pharmacy was busy. The patient was partially responsible. Education,
training and rules were inadequate.

The point of the casez The incident is similar to the one reported last year in which the patient received and took the medication prepared
for another patient at the insurance pharmacy, fell unconscious and was hospitalized. Inadequate education andtraining of hospital staff was included as one of the causes of the incident; however, the error should have been
prevented at the pharmacy.

⎯ 84 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 20: a near-miss event involving an error in filling the cassette of oral medications and oral
medication management (Case No. 000000001047)
Details of the incident
One dose packets were prepared using a tablet packaging machine. Amaryl Tablets 3 mg was being packed. During
the process the cassette of Amaryl Tablets 3 mg was filled with Amaryl Tablets 1 mg, and the packing was continued.
The packets were only checked for the quantity of contents, and the packing error was unnoticed. Next day Amaryl
Tablets 1 mg were found in the cassette of Amaryl Tablets 3 mg. Amaryl Tablets 1 mg were packed in six of 42
packets.
Background/cause of the incident
The error occurred during the busy hours. The name of the drug, the quantity and the name of the pharmacist who
filled the cassette are usually recorded but was neglected because the pharmacy was busy. The post-packing
verification failed to identify the error although the inspecting pharmacist intended to check the packets for wrong
contents.
Improvement measures proposed by the pharmacy
When filling the tablet packaging machine in the middle of the packing procedure, place the empty package sheet on
the tray to make sure what drug is being packed.

Other information
None

The point of the casez It was an incident involving a tablet packaging machine. Amaryl Tablets 1 mg and Amaryl Tablets 3 mg are quite
different in size and color. The inadequate final verification of the drug requiring priority management is aconsiderable problem. Improvement measures should include correction of potential problems at the time ofpacking and final verifications. While tablet packaging machines shorten drug dispensing time, they areassociated with certain packing errors and cassette defects. Medical near-miss incidents will continue to occur
unless thorough final verifications are ensured.

⎯ 85 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 21: a near-miss event involving mix-up of oral medications (Case No. 000000001178)
Details of the incident
Claritin Tablets 10 mg × 2 tablets × 15 days were prepared instead of Talion Tablets 10 mg × 2 tablets b.i.d. × 15 days.
Background/cause of the incident
The pharmacist performed picking while talking on the phone. He/she read the drug name “Talion” aloud but had
Claritin in her hand. He/she knew the two drugs could easily be confused but still made the error because he/sheneglected to check the prepared drug.
Improvement measures proposed by the pharmacy
Always perform self-verifications.

Other information
None

The point of the casez The pharmacist prepared the drug while talking on the phone. The incident shows multitasking can make people
careless and lead to people easily making errors. When a drug dispensing process is interrupted by other activities,
the pharmacist should start the process all over again.
z Talion Tablets 10 mg and Claritin Tablets 10 mg come in similar package sheets and have the same efficacy andstrength. Caution should be exercised to avoid confusion at the time of picking as well as packing.
z Drug mix-up was reported in other incidents. Drug mix-up can be effectively prevented by “reading aloud thedrug name written in the prescription and in the package sheet,” “placing cassettes as far away from the drug
shelves as possible” and “placing a warning against confusion with other strength/dosage form.”⎯ 86 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 22: a near-miss event involving a wrong quantity of oral medication (Case No. 000000001200)
Details of the incident
Altat Capsules 75 were prepared in the wrong quantity.
Background/cause of the incident
It was a drug dispensing error made by a pharmacist who was sick.
Improvement measures proposed by the pharmacy
Pharmacists should be careful when they are sick and have to prepare drugs. They should avoid preparing drugs when
they are sick, if possible.

Other information
None

The point of the casez The pharmacist was sick and made a calculation error when preparing capsules. In other reported incidents
involving a wrong quantity of tablets, capsules, packets or solution, the pharmacist “thought he/she took out theright drug,” “thought it was correct,” “was multitasking” or “thought it was the right drug.” Pharmacists should be
more careful when preparing drugs or have other pharmacist take over their duty when they are sick.
z Errors can be prevented by “taking calculation memos of the quantity specified in the prescription and reading
aloud the quantity during picking,” “performing a verification after a certain interval if the pharmacist needs toprepare and inspect the drug alone” and “counting the number of package sheets to check the entire quantity.”
Keeping these things in mind will help pharmacists prevent errors in their daily practice.

⎯ 87 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 23: a near-miss event involving an inquiry about change of quantity (Case No. 000000001280)
Details of the incident
Regarding the usage of Warfarin Tablets 1 mg, the intention of the physician to use Warfarin 8 mg on Day 1 and 2 mg
on the following days was known after making an inquiry. Warfarin 8 mg was to be used on the following days
according to the pre-inquiry prescription.
Background/cause of the incident
It was an error in data entry into the electronic medical chart.
Improvement measures proposed by the pharmacy
Errors should be corrected after making inquiries.

Other information
None

The point of the casez It was an error in data entry into the electronic medical chart. Overdose was prevented by the pharmacist who
made an inquiry about the quantity. Warfarin is one of the “drugs especially requiring safety management”
according to the “Operating Procedure for Safe Drug Use.” Promptly making inquiries to prescribing physicians
whenever pharmacists have any questions about Warfarin prescriptions to prevent an overdose is one of themeasures to prevent accidents such as the one reported in this incident.

⎯ 88 ⎯

IV Pharmaceutical Near-Miss Event Information to Be Shared

Case 24: a near-miss event involving an inquiry about deletion of a drug (Case No. 000000001399)
Details of the incident
PL Combination Granules was prescribed to the patient treated for glaucoma. The drug was deleted after making an
inquiry.
Background/cause of the incident
The drug was prepared and inspected without checking the prescription and almost dispensed to the patient. The
contraindicated drug check was inadequate. Checking of the medication record and the patient profile was neglected.
Improvement measures proposed by the pharmacy
Medication records and patient profiles should be thoroughly checked when preparing additional drugs, which should
be dispensed after confirming they are safe to use in the patient.

Other information
None

The point of the casez The medication record and the information on contraindicated drugs were used to prevent health hazards. The
incident shows one of the advantages of separation of release and prescribing functions. Checking the “medication
notebook” and interviewing the patient may help pharmacists confirm the contents of prescription, understand the
medication history and current oral medications prescribed at other medical institutions and prevent possible
health hazards as in this incident.

⎯ 89 ⎯

Document 2: Information to be collected

Document 2: Information to be collected[I. Basic information](Numerical data:

Year of occurrence

years)

Month of occurrence
January

February

March

April

May

June

July

AugustSeptember

OctoberNovember

DecemberDay of occurrence
SundayMondayTuesday

WednesdayThursdayFridaySaturdayTime of occurrence
0:00 − 1:59

2:00 − 3:59

4:00 − 5:59

6:00 − 7:59

8:00 − 9:59

10:00 − 11:59

12:00 − 13:59

14:00 − 15:59

16:00 − 17:59

18:00 − 19:59

20:00 − 21:59

22:00 − 23:59

Unknown
Whether the drug was dispensed and extent of treatmenty Dispensed

Not dispensed

Minor treatment

No treatment

Unknown

Summary of the incident
Drug dispensing→

Go to [1. Drug dispensing]

Inquiry→

Go to [2. Inquiry]

Designated insured medical material→

Go to [3. Designated insured medical material]

Drug sales→

Go to [4. Drug sales]

Number of patients
One
years
Age
Male
FemaleSex
Two or moreFirst person to find the error
Person who madeCoworker with the samethe error
job description
Other patient
Others ()

Coworker with adifferent job description

Patient(

Family/caregiver

Person who made the error (number of persons)Pharmacist(

Others: job description)

Registered distributor

(

)

(

)

(

)

⎯ 90 ⎯Clerk)

Document 2: Information to be collected[1. Drug dispensing]Situation

Specifics of incident

Drug dispensing
Dispensing of oral medication
Dispensing of external medication
Dispensing of injection
OthersDrug dispensing
Failure to dispense
Error in weighing
Error in filling the cassetteDrug mix-up
Wrong information on
package sheet
Others ()

Management
Management ofManagement oforal medication
external medication
Management of injection

Management
Error in filling the cassette
Expiration

Error in prescription check
Wrong quantity
Wrong strength/dosage form
Mix-up of information sheet
Providing wrong description on
medication bag

Contamination with foreign
objectOthers ()

OthersDrug release
Drug release

Drug release
Patient misidentification
Neglecting to dispense
medication

Providing wrong explanation
Others ()(Drug information)(i)Fill out the following sections if “Error in weighing,” “Wrong strength/dosage form” or“Drug mix-up” under “Drug dispensing” was selected in “Summary of the incident.”

Number of drugs involved

Change* To change the number of drugs involved, enter the correct number and press the“Change” button.

Prescribed drug

Mixed-up drug

MHLW code

MHLW code

Product nameProduct nameMarketing approval holder

Marketing approval holder(ii)

Fill out the following sections if an item other than “Error in weighing,” “Wrongstrength/dosage form” or “Drug mix-up” under “Drug dispensing” was selected in“Summary of the incident.”

Number of drugs involved

Change* To change the number of drugs involved, enter the correct number and press the“Change” button.

Related drug
MHLW code
Product nameMarketing approval holder⎯ 91 ⎯

Document 2: Information to be collected[2. Inquiry about prescription]
Possible effect on the patient if the drug had been taken as instructed in the original prescription
Health hazards may have occurred.
No health hazards would have occurred but the efficacy intended by the physician would not be expected.
Reason for making the inquiry
Based on the prescription alone
Based on the prescription and the information available at the pharmacy
Others (ex. a claim filed by the patient)

Specifics of change
Change of drug

Change of usage

Deletion of drug

Others (Change of dose

Change of quantity)(Drug information)
Number of drugs involved

Change* To change the number of drugs involved, enter the correct number and press the“Change” button.

Prescribed drug

Changed drug

MHLW code

MHLW code

Product nameProduct nameMarketing approval holder

Marketing approval holder⎯ 92 ⎯

Document 2: Information to be collected[3. Designated insured medical material]
Situation

Specifics of near-miss event

Drug dispensing
Drug dispensing

Drug dispensing
Failure to dispense
Wrong quantity
Mix-up of information sheet
Others ()

Management

Management

Management

Expiration

Drug release

Error in prescription check
Wrong strength
Material mix-up

Others ()

Drug release

Drug release

Patient misidentification
Neglecting to dispense
medication

Providing wrong explanation
Others ()(Designated insured medical material)(i)Fill out the following sections if “Wrong strength” or “Material mix-up” under “Drugdispensing” was selected in “Summary of the incident.”

Designated insured medical
materials involved

Change* To change the number of designated insured medical materials involved, enter thecorrect number and press the “Change” button.

Prescribed designated insured medical material

Mixed-up designated insured medical material

MHLW code

MHLW code

Product nameProduct nameMarketing approval holder

Marketing approval holder(ii)

Fill out the following sections if the item other than “Wrong strength” or “Material mix-up”
under “Drug dispensing” was selected in “Summary of the incident.”

Designated insured medical
materials involved

Change* To change the number of designated insured medical materials involved, enter thecorrect number and press the “Change” button.

Related designated insured medical material
MHLW code
Product nameMarketing approval holder⎯ 93 ⎯

Document 2: Information to be collected[4. Drug sales]
Specifics of the incident
Wrong product
Others (Providing wrong information

Expiration)(Drug information)
Number of drugs involved

Change* To change the number of drugs involved, enter the correct number and press the“Change” button.

Related drug
MHLW code
Product nameMarketing approval holder{ Classification
Ethical drug
Designated second-class
OTC drug
Third-class OTC drugFirst-class OTC
drug
Second-class OTC
drug⎯ 94 ⎯

Document 2: Information to be collected[II. Information on cause of incident]
Cause of the incident (multiple answers acceptable)[Related to the behavior of the person who made the error]
Neglecting to check
Delayed (neglect of) reporting(Note 1)
Incomplete recording
Lack of coordination(Note 2)
Inadequate (neglect of) explanation to the patient
Misjudgment[Background/system/environmental factor]
Human factor
Lack of knowledge

Inadequate skills

Busy hours
Unusual physical conditions
Unusual psychological conditions

Others ()

Environmental/equipment
Computer system(Note 3)

Drugs(Note 4)(Note 5)

Facilities/utilities

Articles(Note 6)

Patient factor

Others (Education/training

Scheme(Note 7)

Flaw in the rules
Others (Note 1: Reporting refers to communication within the institution.
Note 2: Coordination refers to communication between multiple institutions.
Note 3: Computer system refers to a receipt processing computer or an inventory management system.
Note 4: Drugs include similar drug names and appearances
Note 5: Facilities/utilities include placement of drugs on the shelves.
Note 6: Patient factor includes similar appearance and names of patients.
Note 7: Scheme refers to an operation-related scheme such as an operation flow.

[III. Text information]
Information on the medical near-miss incident (required)
Specifics of the incident

Information on the medical near-miss incident (optional)
Background/cause

Improvement measures⎯ 95 ⎯))

Document 3: Pharmaceutical near-miss event analysis table

Document 3: Pharmaceutical near-miss event analysis table
Pharmaceutical near-miss event analysis tables can be seen in color at the Project to Collect andAnalyze Pharmaceutical Near-Miss Information website.

⎯ 96 ⎯

Document 3: Pharmaceutical near-miss event analysis table⎯ 97 ⎯

Document 3: Pharmaceutical near-miss event analysis table⎯ 98 ⎯

Document 3: Pharmaceutical near-miss event analysis table⎯ 99 ⎯

Document 3: Pharmaceutical near-miss event analysis table⎯ 100 ⎯

Published on October 5, 2010
2009

Project to Collect and Analyze Pharmaceutical
Near-Miss Event Information 2009 Annual Report
Edited by

Japan Council for Quality Health Care

Published by

Japan Council for Quality Health Care
Toyo Bldg., 1-4-17 Misaki-cho, Chiyoda-ku,
Tokyo 101-0061
Telephone: 03-5217-0281

Printed by

Daiwa Sogo Insatsu K.K.

ISBN978-4-902379-23-5 c0047