“To Err Is Human…”
Alexander Pope
The goal of drug therapy is the achievement of defined
therapeutic outcomes that improve a patient’s
quality of life while Minimizing patient risk
SAFETY
EFFICACY
A Few Shockers….
 100,000 deaths per year in US due to ADRs
(4th highest cause of mortality in USA)

770,000 drug-related injuries yearly
-

Many result in death or other serious outcome
3.99 errors per 1,000 medication orders
56% ordering

34% administration
6% transcription
4% dispensing errors
3.7% of hospitalized patients suffer significant
iatrogenic injuries, typically from errors or negligence

Average of 1.7 mistakes per patient per day in ICU
How Hazardous Is Health Care?
100000
Regulated
Total lives lost per year
Dangerous
(<1/100K)
(>1/1000)
10000
Ultra-Safe
Driving
1000
HealthCare
100
Mountain
Climbing
Bungee
Jumping
10
1
1
10
100
1000
Chemical
Manufacturing
Scheduled
Airlines
Chartered
Flights
10000
100000
Numbers of encounter for each fatality
European
Railroads
Nuclear
Power
1000000
10000000
(Modified from Leape)
Medical error and the Media
Benton County News Tribune 11/99
– Number of physicians
in the US ----- 700,000
– Number of gun owners
in the US ----80,000,000
– Accidental deaths
caused by physicians
per year --- 120,000
– Number of accidental
gun death per year ----1,500
– Average accidental
death per physician
per year -----0.171
– Average deaths per gun
owner per year ------0.0000188
From these calculations, Doctors are approximately 9,000 times
more dangerous than gun owners.
1. True
2. False
Patient Safety - Background

Not a New Problem

1964 - Schimmel
(Ann. Int. Med.)
– 20% of Univ. Hospital Admissions Injured
 20% of those serious/fatal
Patient Safety - Background

California Medical Insurance Feasibility Study
(1974) in 20,864 hospital admissions
4.65 injuries per 100 hospitalization

1981 - Steel
(NEJM)
– 36% of Teaching Hosp. Admissions Injured
 25% of those serious or life threatening
>50% medication related
1999 Institute of Medicine (IOM)
Report

Rate of adverse events in hospitals:
– Colorado/Utah study: 2.9% (8.8% fatal)
– New York study: 3.7% (13.6% fatal)
– Over half were preventable

Extrapolates to 44,000 – 98,000 deaths/year

Total national costs of preventable adverse
events = $17 – 29 billion, half of which are
health care costs
Quality in Australian
Health Care Study

Reviewed 14,179 admissions in 1995

16.6% of admissions had an AE’s
– Permanent disability 13.7%
– Death 4.9%

51% of events preventable
Source – Wilson, 1995
Adverse Events in British Hospitals

10.8% frequency
–
–
–
–

34% serious
6% resulted in permanent injury
8% contributed to death
53% preventable (5% frequency)
extrapolates to 850,000 injuries and ₤1
billion/year
Vincent C. BMJ 2001;322:517
Definition & Classification

Medical Error
Slip/Lapse
Mistake

Adverse Event
Non-preventable
Preventable = Error
Negligent = Medical malpractice
Definition & Classification

Adverse Event
Non-preventable
Preventable = Error
Negligent = Medical malpractice
Definition of Medication Error
"A medication error is any preventable event that may
cause or lead to inappropriate medication use or patient
harm while the medication is in the control of the health
care professional, patient, or consumer. Such events
may be related to professional practice, health care
products, procedures, and systems, including
prescribing; order communication; product labeling,
packaging, and nomenclature; compounding;
dispensing; distribution; administration; education;
monitoring; and use."
National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP).
www.nccmerp.org
Near Miss Events
The potential for harm
may have been present,
but unwanted
consequences were
prevented
because some
recovery action
was taken.
No Harm Events
The event actually
occurred but
no harm was done.
Medication Error
Wrong:
– Patien
t
– Drug
– Dose
– Time
– Route
Types of Medication Errors












Prescribing error
Improper dose error
Wrong time error
Wrong dosage-form error
Wrong drug-preparation error
Wrong administration-technique error
Deteriorated drug error
Unauthorized drug error
Omission error
Monitoring error
Compliance error
Other medication error
Medical Errors by Type
100%
90%
20%
Medication
Errors
39%
39%
80%
Ordering/
Prescribing
70%
60%
38%
38%
Administration
12%
12%
11%
11%
Dispensing
50%
40%
30%
80%
Other
Transcribing
20%
10%
0%
Leape, et al
Common causes of Medication Errors
Common causes of Medication Errors
Illegible handwriting
Drug product nomenclature
look-alike or sound-alike names,
Use of lettered or numbered prefixes and suffixes in drug names
Inappropriate abbreviations used in prescribing
Equipment failure or malfunction
Inaccurate dosage calculation
Improper transcription
Ambiguous strength designation on labels or in packaging
Labeling errors
Excessive workload
Lapses in individual performance
Medication unavailable
Inadequately trained personnel
Look & sound-alike medications
Chemistry roots
USAN stems*
sound-alike/look-alike
Acetazolamide
Acetahexamide
Doxorubicin
Daunorubicin
Anakinra
Amikacin
Chlorpromazine
Chlorpropamide
Nifedipine
Nicardipine
Prednisone
Primidone
Dopamine
Dobutamine
Azithromycin
Erytromycin
Metoclopramide
Metolazone
Hydrocodone
Hydrocortisone
Valacyclovir
Valganciclovir
Vancomycin
Vecuronium
*United States Adopted Name
Look & sound-alike medications
Meltronidazol
Metimazol
mellaril
elavil
Pancreatin
Pancronium
paxil
taxol
Prilosec
Prozac
prilosec
prozac
Oxycontin
Oxycodone
cerebyx
hydroxyzine
hydralazine
oxycontin
celebrex
oxycodone
Alprostadil
Alprazolam
Hydroxyzine
hydralazine
Aricept
Aciphex
alprostadil
alprazolam
Mistaking one vial for
another
TT
Insulin vial
DTP
Dangerous Abbreviations:
U
g
Q.D
Q.O.D
SC
TIW
D/C
HS

Conditions
1- Loud surroundings & Dim lighting
2- Fatigue
3- Excessive workload, Time pressure stress

Routine

Personal problems
Manufacturing

Formulation mishaps

Packaging problems




Mislabeling
Contamination
Wrong drug, dose or concentration
Animal Drug
1936

USA : 107 lethal cases diethylenglycol
was used to solubilize
sulphanilamides
Department of Pharmacy
 Ambulatory Care

Clinical Services

Formulary

Education

Research
Recommendations for Physicians
All Prescribtion documents must be:








legible
Computerized
Brief notation of purpose
Written in metric system (insulin, vitamins)
Age & Weight of patients
Drug name, dosage-form and exact metric weight
Leading zero (.5 mg 0.5 mg)
Avoid use of abbreviations (MOM, HCTZ) and
Latin directions for use
 Not use vague instructions:
“Take as directed” or “Take/Use as needed”
Example
A physician wrote ".5 mg" IV morphine for postoperative pain on a 9-month old. The unit secretary
recorded the order in the MAR as "5 mg." An
experienced nurse followed the directions on the MAR
without question and gave the baby 5 mg of IV
morphine initially and another 5 mg dose two hours
later. About four hours after the second dose, the baby
stopped breathing and suffered a cardiac arrest.
Ordering/Prescribing
verbal orders
Develop protocols for verbal orders to assure that:
– Ordering/prescribing practitioners must be
identified
– Patients must be clearly identified
– Verbal orders must be clear and concise
– Verbal orders from on-site practitioner are taken
only in emergencies
– No verbal orders are taken for chemotherapy
– All verbal orders are repeated for verification
Sample screen 5
Dispensing Errors

Drugs subject to frequent litigation:
-
warfarin (blood thinner)
-
diabetes medications
digoxin (heart medication)
levothyroxine (thyroid medication)
amitriptyline (depression medication)
ear drops
prednisone (oral steroid medication)
Pharmacists Mutual Insurance Company, 1989-June 1997.
www.phmic.com
Identifying Cause(s) of Error:
Root Cause Analysis
Proximate
Cause
Error
System
Factors
No one wants to make a
mistake
human factors
“People make errors, which lead to accidents. Accidents
lead to deaths. The standard solution is to blame the
people involved. If we find out who made the errors and
punish them, we solve the problem. right? Wrong?
The problem is seldom the fault of an individual; it is the
fault of the system. Change the people without changing
the system and the problems will continue.”
Patient Safety and the ‘Just Culture’:
A Primer for Healthcare Executives
Medication errors are
part of a system problem
"Errors must be accepted as evidence
of systems flaws, not character flaws"
(Leape, 1997)
Medication errors can happen
because of
human factors or system failures
We can’t change the human condition
but we can change the conditions under
which humans work
James Reason
Every system is
perfectly designed
to get the results it gets !
Patient Safety
We’re All In It Together
UCH Service Standards Safety, Courtesy, Efficiency and Environment
Patient Safety - Human Error
Identifying Cause of Error:
Latent Conditions
An accident
waiting to
happen...
‫هر چيزي بيش‬
‫از آنچه در ابتدا‬
‫برآورد مي كنيد‬
‫هزينه در بر‬
‫خواهد داشت‬
‫از ميان مشكالتي كه‬
‫قرار است پيش بيايد ‪،‬‬
‫بدترين آنها در بدترين‬
‫زمان ممكن پيش خواهد‬
‫آمد و بسيار بيشتر از حد‬
‫انتظار شما خسارت وارد‬
‫خواهد كرد‪.‬‬
What can hospitals do to Prevent
Medication Errors?
Computerized drug ordering
 Pharmacists on rounds
 Unit dosing
 Limit access to high risk drugs - ie KCl

– Prepare IV solutions in pharmacy

Structural problems
– Staffing
– Fatigue/distraction
 40% pilots vs. 60% MD/RN “I’m OK when tired”
Medication Safety Practices include:










reducing reliance on memory
use of constraints and forcing functions
simplification
standardization
use of protocols and checklists
improve access to information
decreasing reliance on vigilance
reduce hands-off
differentiating products to eliminate lookalikes and sound-alikes
automate carefully
(1)
Reduce Reliance on Memory

Use drug-drug interaction checking
systems


Use computerized order entry

Use computerized patient info

Use guided dose algorithms
Use barcoding on drugs, containers,
medication records, patient wristbands
(2) Simplify
The antidote for complexity is simplification.
Fewer steps lead to fewer errors:



Eliminate transcription of orders
Limit choices of available drugs in pharmacy
Limit dosage strengths and concentration for
each drug


Mix IVs in the pharmacy
Automate dispensing on the unit
(3)
Standardize
Standardization reduces the opportunities for error





Standardize prescribing conventions:
-
no abbreviations
use generic names
use “units” not “u”, etc
Use protocols for complex medication administration
(heparin, insulin, chemotherapy)
Standardize times of drug administration
Store medications in the same place in every
medication room
Use standard equipment, e.g. one kind of pump or
syringe
(5)
Use Protocols and Checklists Wisely
Protocols support standardization.
Checklists serve as reminders of critical
tasks, especially when an omission can
have serious consequences. They reduce
individual variation in practice, but can be
a source of error with indiscriminate
adherence.

Avoid statements that contain negatives

Make sure that everyone has agreed on
protocol or checklist, and is aware that it is
in use

Revisit the protocol or checklist regularly
to evaluate and update
(6)
Improve Access to Information
Lack of information is a common cause of errors.








Have a pharmacist available on nursing units and at
rounds
Use computerized order entry systems
Use computerized laboratory data to be alerted to
abnormal laboratory values
Place laboratory reports and medication records at
bedside
Place protocols and ordering information on
patients’ chart and in medication room where they
are easily accessible
Colour-code wristbands for patients with allergies
Provide patient with list of his/her medications,
doses, and times
Track errors or near misses and report to staff on a
weekly basis
i
Recommendations for Reporting of Errors

A nationwide mandatory reporting system should
be established that provides for the collection of
standardized information by state governments about
adverse events that result in death or serious harm.
Reporting should initially be required of hospitals and
eventually be required of other institutional and
ambulatory care delivery settings. . . .

The development of voluntary reporting efforts
should be encouraged. The Center for Patient
Safety should
Preventing Medical Errors
Recommendations


Create National Center
for Patient Safety
Develop Error Reporting System.
Must guarantee confidentiality!

Raise performance standards
and commitment to safety within
professional groups and accreditation boards.

Implement safety standards
at the patient delivery level.
Canadian Coalition on Medication Incident
Reporting & Prevention
Marketed Health Products Directorate, Health Canada - Chair
Canadian Association of Chain Drug Stores
Canadian Healthcare Association
Canadian Institute for Health Information
Canadian Medical Association
Canadian Nurses Association
Canadian Pharmacists Association
Canada's Research Based Pharmaceutical Companies
Canadian Society of Hospital Pharmacists
College of Family Physicians of Canada
Consumers Association of Canada
Pharmaceutical Issues Committee - participating observer
Institute for Safe Medication Practices Canada
The Royal College of Physicians and Surgeons of Canada
Interesting Web Sites About
ADR & Medication Error
www.who-umc.org
MedWatch
www.fda.gov/medwatch/
The FDA Safety Information and Adverse Event Reporting Program
Home
What’s New?
The UPPSALA MONITORING CENTRE
Products & Services
Projects
Meetings
Publications
Definitions
WHO Programme
About UMC
Promotion & Training
Frequently Asked Questions (FAQs)
Links
Institute for Safe Medication Practices
(ISMP)
www.ismp.org

regulatory and accrediting agencies
professional organizations

practitioners

healthcare organizations


pharmaceutical industry, device
manufacturers, and technology
vendors
ISMP Self-Assessment
Survey

Focuses on 10 key elements (198 questions)
1. Patient Information
2. Drug Information
3. Communication of Drug Orders and other Drug Information
4. Drug Labeling, Packaging and Nomenclature
5. Drug Standardization, Storage, and Distribution
6. Use of Devices
7. Environmental Factors
8. Staff Competency and Education
9. Patient Education
10.Quality Process and Risk Management
National Coordinating Council for
Medication Error Reporting and
Prevention ( NCCMERP )
www.nccmerp.org