CLINICAL USE OF DRUG

FOR PATIENT SAFETY

Dr. Adib A. Yahya, MARS

President of IHA

ISFI :
THE SEMINAR ON APPLICATION OF DRUG DEVELOPMENT AND CURRENT
ISSUE OF SAFETY
HOTEL MILLENIUM, JAKARTA JULY 22nd 2009

AGENDA
BASIC CONCEPT OF PATIENT SAFETY

MEDICATION ERROR
MEDICATION-RELATED RISK MANAGEMENT

BASIC CONCEPT OF PATIENT SAFETY

PRIMUM, NON NOCERE

FIRST, DO NO HARM

HIPPOCRATESS TENET
(460-335 BC)

TO ERR IS HUMAN CORRIGAN, KOHN AND DONALDSON

US ACADEMY OF SCIENCES / INSTITUTE OF MEDICINE,
2000
1984 New York -2.9% of admissions suffered an adverse event, 58% of

which were preventable

1992 Colorado and Utah - 3.7% of admissions suffered an adverse event,
53% of which were avoidable
Over 33.6Mn US hospital admissions pa between 44,000 and
98,000 avoidable deaths occur
8th most frequent cause of death
ahead of AIDS (16,516 deaths pa),
breast cancer (42,297 deaths pa) and
motor car accidents (43,458 deaths pa)
Total cost to the US economy of avoidable deaths due to
healthcare error $17 - $29 Bn pa
HRRI.Healthcare Risk Resources International

Organisational &
Corporate Culture

Contributary Factors
Influencing
Clinical Practice

Management
Decisions/
Organisational
Processes

Error
Producing
Conditions

Error

Violation
Producing
Conditions

Violation

Latent Failures
1.

PATIENT

2.

TASK AND
TECHNOLOGY

Policy-making,

3.

INDIVIDUAL

Communicating

4.

TEAM

5.

WORK
ENVIRONMENT

Planning,
Designing ,

Task

Active Failures
( sharp end )
Emergency
Diagnose
Pemeriksaan
Pengobatan
Perawatan

Defence
Barriers

-Procedure
-Professionalism
-Team
-Individual
-Environment
-Equipment
Adapted from Reason (revised)

FACTORS INFLUENCING CLINICAL PRACTICE AND

CLINICAL OUTCOMES

Patient factors
- Condition (complexity and
seriousness)
- Language and communication
- Personality and sosial factors

Task factors
- Task design and clarity of process
- Availability and use of protocols
- Availability and use of test results

Individual staff factors

- Knowledge and skills
- Motivation,physical and mental health

Team factors
- Verbal and written communication
- Supervision and seeking help
- Leadership

Work environment
- Staffing levels and skill mix
- Workload and shift pattern
- Design, availibility and
maintenance of equipment

Organisation and management

- Financial resources and
constraints
- Organisational structure
- Policy standards and goals
- Safety culture and priorities

Institutionsl context
- Economic and regulatory context
- Social attitude to risk

Vincent et al, BMJ 1998; 316:1154-7 (revised)

What is a safety culture?

A safety culture is where staff within an organisation have
a constant and active awareness of the potential for
things to go wrong.

Being open and fair means sharing information openly

and freely, and fair treatment for staff when an incident
happens.
The systems approach to safety acknowledges that the
causes of a patient safety incident cannot simply be linked
to the actions of the individual healthcare staff involved.

In a Hospital :
Because there are
hundreds of
medications, tests
and procedures,
and many patients
and clinical staff
members in a
hospital, it is quite
easy for a mistake
to be made. . . .

MEDICATION ERROR

Medication error
Drug therapy is becoming more complex.
The potential for adverse drug events and
medication errors is a reality.
They occur in all parts of the medication
use system.

Every error is potentially tragic and

costly in both human and economic
terms, for patients and professionals
alike.

Significance of medication error and

adverse drug events

Approximately 5% of all patients admitted to the

hospitals experienced a medication error
during their hospital stay
Based on the number of medication errors, one
medication error occurred approximately
every 23 hours

COMMON CAUSES OF MEDICATION ERRORS

The most common factors associated with
medication errors were :
- The problem was related to knowledge regarding
drug therapy.
- The problem was related to knowledge regarding
patient factors that affect drug therapy.
- The problem was associated with
calculations,decimal points, or unit and rate
expression.
- The problem was related to nomenclature
(incorrect drug name, incorrect dosage form
or incorrect abbreviation).

Top 20 types of medication

errors were alleged in claims:

1. Incorrect dose
2. Medication inappropriate for medical condition
3. Failure to monitor for drug side effects
4. Communication failure between physician and patient
5. Failure to monitor for drug levels
6. Lack of knowledge of medication
7. Most appropriate medication not used
8. Inappropriate length of treatment
9. Failure to monitor drug effects
10. Inadequate medication history

Top 20 types of medication . . . .

11. Inadequate charting
12. Failure to note allergy
13. Failure or delay in ordering laboratory test
14. Inappropriate administration
15. Communication failure between physician
and other provider
16. Error in writing prescription
17. Patient noncompliant
18. Failure to read medical record
19. Pharmacy error
20. Communication failure between physician
and pharmacist

MEDICATION-RELATED
RISK MANAGEMENT

THE POTENTIAL RISKS

To counter those potential risks, everyone along the medication
path needs a system of checks and double-checks to ensure
that:
- the drug and dose ordered is appropriate and safe for the
particular patient at that particular time;
- that the drug and dose prepared is what was ordered;
- that the administering clinician receives the drug and dose
that was ordered;
- that the patient receives the drug and dose as ordered;
- that the patient is monitored for any adverse drug
reaction.

THE GOAL OF MEDICATION RISK MANAGEMENT

The goal of medication risk management is to ensure the safety of the
patients receiving the medication(s) and the quality of their care.
Effective medication risk management should facilitate:
reduction of adverse practice variation, errors, side effects, and misuse;
standardization of equipment and processes related to medication
management across the organization;
use of evidence-based (including expert consensus-based) good
practices;
management of critical processes and risks associated with medication;
integration of medication management into performance and safety
improvement activities; and
proper use of the medication by patients through education activities

Strategies to Reduce Risk

When looking to reduce risks, there are three basic
questions:
1. What is the process?
2. Where are the risk points?
3. What can you do to mitigate impacts of
risk points?
Whenever a process is changed, the risk point is altered,
and the process must be reassessed.

Changing the process might occur whenever there are

changes in people, equipment, sequence, or location.

Medication Process Flow Diagram

Failure points where medication errors occur

Prescribing

39%

Transcribing

12%

Dispensing

11%

Administering

38%
JAMA 1995 Jul 5,274(1):29-34

Why do medication errors occur ?

Wrong drug
Wrong Dose
Similar names
Similar labeling/packaging
Transcription error
Omission error

Arjaty/IMRK/2008

Poor handwriting

Coumadin or Kemadrin ?
Lotrison or Lotrimin ?

Doxorubicin or Daunorubicin ?

Pentobarbital or Phenobarbital ?

Arjaty/IMRK/2008

STANDARDIZED ABBREVIATIONS

Examples

Intended dose of 4 units in patient history interpreted as

44 units. U should be written out as unit.

Intended dose of .4 mg interpreted as 4 mg from medication order.

Should be written as 0.4 mg.

Intended recommendation of less than 10 was interpreted as 4.

< should be written out as less than.

Hospital Strategies
Hospitals and other health care organizations work to reduce medication
errors by using technology, improving processes, zeroing in on errors that
cause harm, and building a culture of safety.
Pharmacy intervention:
It was a challenge for health care providers to ensure that patients
continued taking their regularly prescribed medicines when they
entered the hospital,
"Surgeons are not typically the original prescribers,

Computerized Physician Order Entry (CPOE):

Studies have shown that CPOE is effective in reducing medication
errors.
It involves entering medication orders directly into a computer
system rather than on paper or verbally.

Using Technology to Reduce Medication error

Computerized Physician Order Entry (CPOE):

CPOE is effective in
reducing medication errors.
It involves entering
medication orders directly
into a computer system
rather than on paper or
verbally.

electronic Medication Administration Program

(eMap), helps prevent errors by linking the bar
code technology with electronic patient
medication profiles.
The system is designed to achieve the
five rights:
Right patient
Right drug
Right dose
Right time
Right route of administration

Pharmacists Play Key Role

in Patient Safety
The traditional image of a pharmacist is
someone who compounds and dispenses
medications in a retail setting.
That image, as well as the pharmacist's
role in health care, is changing

 Clinical pharmacists may participate in all stages of

the medication use process, including drug
ordering, transcribing, dispensing, administering,
and monitoring.
role of a senior pharmacist participating fully in
intensive care unit rounds and available
throughout the day in person or by page for
questions.
ward pharmacy service that examined order sheets for
new therapies and carried out checks that were
formerly performed in the pharmacy.

Pharmacists may also play a role at the time of

discharge.

Presence of Pharmacist on Rounds

Rate of ADEs caused by prescribing errors decreased
72% when a RPh made rounds with the patient care team, spent
the rest of the morning in ICU, and was on call for unit's
staff the rest of day
78% fewer preventable ADEs occurred among patients when
RPh participated in medical rounds
Number of errors decreased by about 50% through the RPhs
daily participation in rounds
(1) Leape LL et al. JAMA. 1999; 282:267-70.
(2) Kucukarslan et al. Arch Intern Med. 2003; 163:2014-8.
(3) Scarsi et al. Am J Health-Syst Pharm. 2002; 59:2089-92.

The JCI 2007

International Patient Safety Goals
1.

Identify patients correctly

2.

Improve effective communication

3.

Improve the safety of high-alert medications

4.

Eliminate wrong-site, wrong-patient, wrongprocedure surgery

5.

Reduce the risk of health care-associated

infections

6.

Reduce the risk of patient harm from falls

High-alert Drugs and Drug Classes

What drugs present extra risk?
The following are the top 10 drug classifications
found in claims in the study:
1. Antibiotics
2. Glucocorticoids
3. Narcotic and non-narcotic analgesics and
narcotic antagonists
4. NSAIDs
5. Topicals, dermatologicals and ophthalmologicals
6. Cardiac and antihypertensive medications
7. Minor tranquilizers, muscle relaxants and
sedatives
8. Major tranquilizers
9. Anticoagulants
10. Other

CONCLUSION

Pharmacists Enhance Patient Safety

Ways in which pharmacists expertise and participation on
the healthcare team can help prevent errors :
Utilizing pharmacists as integral members of the patient
care team as experts in medication-use safety and quality;
Encouraging patients to keep an up-to-date list of all their
medications;
Consulting with patients about their medications at key
points, including during clinical decision making and at
hospital discharge;
Developing reliable drug information for health professionals
and consumers;
Encouraging the use of standardized electronic
technologies for prescribing and record keeping;

FINAL WORD

Safe care is not an option.

It is the right of every patient
who entrusts their care to our Healthcare systems
Sir Liam Donaldson,
Chair, WHO World Alliance for Patient Safety,
Forward Programme, 20062007