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T.Preface

The objective of the Project is to further promote medical safety by providing health professionals in pharmacies and the general public with relevant information as well as to share information useful to develop preventive measures by collecting and analyzing
near-miss events from pharmacies and widely providing with the result of analysis.

Various healthcare professionals such as physicians, dentists, pharmacists and nurses are involved in the process of patient care and treatment.
Among the healthcare professionals, pharmacists have responsibilities to dispense and verify prescriptions and drugs and to give medication-related instruction to patients as “drug specialists.”
Pharmacists are also involved in such activities as sales of over the counter (OTC) drugs and in-pharmacy formulations and providing information concerning these products at pharmacies. Pharmacists and registered sales clerks are therefore playing an important role in public healthcare by giving instruction and providing information on self-medication and other treatments to consumers.

Unexpected errors can be made at pharmacies just as at medical institutions and other corporations.
In general, it has been said that pharmacies where serious accidents happen have usually experienced near-miss events that might have resulted in similar accidents in the past.
It has also been said that twenty-nine non-serious, accidents coming after 300 near-miss events generally repeated before a single serious accident occurs.

In the Project to Collect and Analyze Pharmaceutical Near-Miss Events, events with any of the following three categories are collected.

1. A medical error occurred or identified before the health care service was provided to the patient.
 e.g. A wrong medication was prepared, and the error was identified before giving the medication to the patient. Later the correct
 medication was prepared.
2. A medical error that did not affect the patient or required a minor procedure/treatment, which includes disinfection, poultice and
 administration of analgesics.
 e.g. A wrong medication was prepared and given to a patient, but the error was identified before the patient took the medication.
3. A medical error for which the consequence is unknown.
 e.g. A drug with wrong indications (e.g., symptoms to be treated) from those the consumer desired was sold, but thereafter the
 consumer could not be reached.

* In the Project, “health care service” is defined as any and/or all processes related to medical practice (including sales of OTC drugs).

Note: “Accidents” may or may not involve medical negligence.
Excerpted from “Partial Enforcement of the Ordinance to Partially Revise the Ordinance for Enforcement of the Health Service Act” (MHLW HPB Notification; September 21, 2004)

U.Project Outline

1. Background

According to the Health Service Act revised in June 2006, pharmacies are defined as health care facilities like hospitals and clinics. The revised Health Service Act mandates the following safety measures at pharmacies.

1) Establishing guidelines for safety management
2) Staff training for safety management
3) Thorough reporting of accidents on drug dispensing to the pharmacy manager
4) Installing pharmacy practice manual for safe use and management of drugs

2. Current status of near-miss events occurring

About 30% of the near-miss events reported to the Japan Council for Quality Health Care (JCQHC) from medical institutions are related to drugs (2008 Annual Report*). Since more than a half of outpatients have their prescriptions dispensed at pharmacies, quite a number of near-miss events are thought to occur at pharmacies.
* Project to collect Medical Near-miss/Adverse Event Information 2008 Annual Report download

3. Objective

The objective of the Project is to further promote medical safety by providing health professionals in pharmacies and the general public with relevant information as well as to share information useful to develop preventive measures by collecting and analyzing near-miss events from pharmacies and widely providing with the result of analysis.

4. Features of dispensing at pharmacies

Unlike dispensing facilities of hospitals, pharmacies have the following unique features:

1) To discover potential risks of multiplication dispensing of the same drugs or drug-drug interactions because some patients consult physicians at multiple institutions/clinics
2) To sell products other than prescribed drugs, such as OTC drugs and in-pharmacy formulations
3) To switch from a prescribed drug to a generic
4) Pharmacy practice manual for safe use and management of drugs

Other than near-miss events similar to those which happen at medical institutions, near-miss events unique to pharmacies may happen.

5. Examples of near-miss events occurred at pharmacies are released
outline
V.Project Detail

Annual report

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

Pharmaceutical near-miss event analysis table

 No. 1: Drug mix-up due to similar product name  download

 No. 2: Pharmaceutical near-miss events related to high-risk drugs  download

 No. 3: Pharmaceutical near-miss events related to inquiry by pharmacy  download

 No. 4: Pharmaceutical near-miss events related to warfarin potassium  download

 No. 5: Pharmaceutical near-miss events related to insulin  download