ISFI :

”THE SEMINAR ON APPLICATION OF DRUG DEVELOPMENT AND CURRENT

ISSUE OF SAFETY”

HOTEL MILLENIUM, JAKARTA JULY 22nd 2009

CLINICAL USE OF DRUG

FOR PATIENT SAFETY

Dr. Adib A. Yahya, MARS

President of IHA

AGENDA

BASIC CONCEPT OF PATIENT SAFETY

MEDICATION ERROR

MEDICATION-RELATED RISK MANAGEMENT

BASIC CONCEPT OF PATIENT SAFETY

PRIMUM, NON NOCEREFIRST, DO NO HARM

HIPPOCRATES’S 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

Latent Failures Active Failures

( “sharp end “ )-Procedure-Professionalism

-Team

-Individual

-Environment

-Equipment

•Emergency

•Diagnose

•Pemeriksaan

•Pengobatan

•Perawatan

1. PATIENT

2. TASK AND

TECHNOLOGY

3. INDIVIDUAL

4. TEAM

5. WORK

ENVIRONMENT

Planning,

Designing ,

Policy-making,

Communicating

Management

Decisions/

Organisational

Processes

Error

Producing

Conditions

Violation

Producing

Conditions

Error

Violation

Organisational &

Corporate Culture

Contributary Factors

Influencing

Clinical Practice

TaskDefence

Barriers

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 regardingpatient 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

Administering

Failure points where medication errors occurFailure points where medication errors occur

TranscribingPrescribing Dispensing

39% 12% 11% 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

Lotrison or Lotrimin ?Coumadin or Kemadrin ?

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 RPh’s 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, wrong-

procedure 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

CONCLUSIONPharmacists 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, 2006–2007