Chapter 6

Medication
safety
Presented by GROUP 3
Go, Reagan Tyler L.
Gonzales, Robert Dominic D.
Grande, Ma. Clarmina R.
Guanzon, Ayana Joyce L.
Guico, Louise Erlinda V.

Medication
Safety
KEY TERMS AND DEFINITIONS

Administration Error
An incorrect medication administration that
includes the wrong dose, omitted dose, additional
dose, wrong administration time, incorrect
handling of drugs during administration, and
wrong infusion rate

Adverse drug event

An ADE is an injury, large or small, preventable or
unpreventable, that may be caused by the use or
lack of intended use of a drug.

Adverse drug
reaction
An ADR is a drug related problem that consist of an
unexpected, unintended, undesired, or excessive
response to a drug that requires some type of
medical response (e.g., discontinuing the drug,
changing therapy, making major dose
modifications) or results in a negative outcome
(e.g., hospital admission, prolonged treatment,
harm, disability, death). It may or may not be the
result of a medication error

Allergic reactions
An allergic drug reaction is a type of ADR resulting
from immunologic hypersensitive to drug

Dispensing error
A mistake during the dispensing process where a
patient receives the wrong drug, the correct drug
for the wrong patient, wrong galenic form (e.g.,
tablet for patient who is NPO) or wrong dose

Drug misadventure
An iatrogenic hazard or incident associated with
indicated drug therapy resulting in patient harm
that can be attributable to error, immunologic
response, or idiosyncratic response-consisting of
the sum of medication error, ADRs and ADEs

Drug-related
morbidity
The failure of a drug to achieve its intended health
outcome due to unresolved drug-related problems.
It is a negative outcome associated with an error

Drug-related
problems
DRPs are events associated with drug therapies
that can or do hamper optimal patient health
outcomes.

Error of Commission
An error that results when the patient receives the
correct drug in a way that does not result in
optimal patient outcomes or an incorrect drug
which puts the patient at risk of negative
outcomes

Error of omission
An error that results in a patient failing to receive
a beneficial drug

Idiosyncratic reaction
A type of ADR resulting from abnormal responses
to drugs that are peculiar to individuals

Latent injury
A propensity or predisposition for harm during the
process of care that actually does not result in
patient injury

Medication error
Any error in the medication process (prescribing,
dispensing, administration of drugs), whether
there are adverse consequences or not

Medication
reconiliation
The process of resolving discrepancies as patients
transition across departments (e.g., a medical ICU
to a step down unit), locations (e.g., inpatient to
outpatient), or other places

Monitoring error
The failure to review a prescribed regimen for
appropriateness and detection of problems, or
failure to use appropriate clinical or laboratory
data for adequate assessment of patient response
to prescribed therapy

Outcome
The end result attributable to health care products
or services such as mortality, infection, myocardial
infarction, and plain.

Potential adverse
drug event
A mistake in prescribing, dispensing, or medication
administration that has the potential to cause an
ADE but did not, either by luck or because it was
intercepted

Prescribing error
An incorrect drug, dose, dosage form, quantity,
route, concentration, rate of administration, or
instructions for use that has been ordered or
authorized by a prescribe. It includes illegible
prescriptions or medications orders that has lead
to errors that reach the patient

Process
These are actions associated with quality such as
reviewing patient orders prior to dispensing,
conducting drug use evaluation, and counseling
patient prior to discharge.

Sentinel event
An unexpected occurrence involving actual or
potential death or serious injury. These events
signal the need for immediate investigation and
response.

Side effect
An expected, well-known reaction resulting in
little or no change in patient management (e.g.,
drowsiness or dry mouth associated with certain
antihistamines)

Structure
The presence of something that is reasonably
associated with quality such as pharmacy, a
pharmacist available references, 24-hour pharmacy
service, a formulary, and a computerized
prescriber order entry system.

Transcription and/or
interpretation error
An error in transcribing or interpreting
prescriptions due to causes including
misinterpretation of abbreviations, illegible handwritten prescriptions, or misinterpretation of
spoken prescriptions.

Trigger event
An event occurring during the patient treatment
that causes a latent injury that may become an
actual discernible injury

Introduction

Medication safety has been a priority of

health-system pharmacy practice in recent
years.
Driven by landmark publications including
the Institute of Medicines (IOM) report, To
Err is Human: Building a Safer Health
System, pharmacies have been attempting
to reduce medication risks in institutions.
Medical error is a chronic threat to public
health.

Some of the following findings were

revealed in the report:
Medical
Medical
Medical
Medical
Medical

errors
errors
errors
errors
errors

are
are
are
are
are

common
tragic
expensive
preventable
not fully appreciated

DEFINITIONS
DRUG-RELATED PROBLEMS
DRPs are events associated with drug
therapies that can or do hamper optimal
patient health outcomes.
DRPs include medication errors, adverse
drug reactions, adverse drug events, and
side effects.

DEFINITIONS
MEDICATION MISADVENTURES
A term very similar to DRPs commonly used in
institutional safety studies.
Medication misadventures are iatrogenic
hazards or incidents associated with indicated
drug therapy resulting in patient harm that
can be attributable to error, immunologic
response, or idiosyncratic response.

DEFINITIONS
MEDICATION ERRORS

Are errors or mistakes in the medication use

process (prescribing, dispensing,
administering of drugs) that may result in
negative outcomes.
Not all DRPs are medication errors because
problems in medication use can occur even
when best medication practices are applied.

DEFINITIONS
MEDICATION ERRORS
>By their impacts on patients
>Where they exist in the medication use
system

DEFINITIONS
ADMINISTRATION ERRORS
These occur when patients are administered
something other than that prescribed for the patient
wrong dose,
omitted dose,
additional dose,
wrong administration time,
incorrect handling of drugs during administration, or
wrong infusion rate

DEFINITIONS
DISPENSING ERRORS
Are mistakes made during the dispensing
process where
a patient receives the wrong drug,
the correct drug received by a wrong
patient,
Wrong galenic form,
Wrong dose

DEFINITIONS
PRESCRIBING ERRORS

Occurs when prescriptions have incorrect

drug selection, dose, dosage form, quantity,
rate of administration, or instructions for use
of a drug product.
These include illegible prescriptions or
medication orders that lead to errors that
reach the patient.

DEFINITIONS
MONITORING ERRORS
Results from failure to review a prescribed
regimen for appropriateness or the failure to
use appropriate clinical or laboratory data for
adequate assessment of patient response to
prescribed therapy.

DEFINITIONS
TRANSCRIPTION AND/OR
INTERPRETATION ERRORS
Made during the transcribing or interpreting
of prescriptions due to causes including
misinterpretation of abbreviations, illegible
handwritten prescriptions, misinterpretation
of spoken prescription.

DEFINITIONS
ADVERSE DRUG REACTIONS

Unexpected
Unintended
Undesired
Excessive
>They may or may not be results of medication
errors.
>Allergic reactions and Idiosyncratic reactions are
considered ADRs.

DEFINITIONS
SIDE EFFECTS
Are not ADRs.
They are expected, well-known reactions that
require little or no change in patient management.
>They may or may not be results of medication
errors.
>Allergic reactions and Idiosyncratic reactions are
considered ADRs.

DEFINITIONS
ADVERSE DRUG EVENTS

Are ADRs that result in injury large or small

preventable or unpreventable due to the
use or lack of intended use of a drug.
Expected, well-known reactions to
medications that are severe enough to
require extensive medication
management are ADEs.

Various Types of
Drug-related
Problems

NCC MERP Index for

Categorizing
Medication Errors

Consequences of
Drug-related
Problems

Various Drug-related
Problems associated
with Errors

Types of Medication
Errors

Preventing
Medication Errors

Preventing
Medication Errors

Preventing
Medication Errors

Preventing
Medication Errors

CULTURE OF SAFETY
A culture of safety exists where safety is a key
element to everyones job from the leadership
to the technicians and secretaries.
In a culture of safety, leaders encourage
workers to seek out and implement new ways of
ensuring the safety of the patient which are
done through actions and words.

CULTURE OF SAFETY
In a culture of safety, people are obliged to take
responsibility for protecting the well being of
patients.
A culture of safety tries to avoid blaming
individuals, and instead focuses on identifying
the errors in the system which in turn leads to
more errors.

Models
of Quality
Improvement

ES
A
M
PL

To
ta

lQ
ua
li t
y

EX

Co
Im nt
M
i
n
pr
an
uo
ov

ag
u
em s Q
em
Si
xu
e
en
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lit
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LE
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AN

Total Quality Management

describes a management
approach to longterm
success through customer
satisfaction
all members of an
organization participate in
improving processes,
products, services, and
the culture in which they
work.

Continuous Quality Improvement

focuses on
process
rather than the
individual

THE

PROCESS

Six-Sigma

seeks to improve the

quality of process
outputs by identifying
and removing the causes
of defects (errors) and
minimizing variability in
manufacturing and
business processes.

define
control
improv
e

measu
re
analyz
e

LEAN
is a systemic method for the
elimination of waste within a
manufacture process.

it is the elimination of
any un-necessary cost
that the customer
would not want to pay
for!

TQM

Six-Sigma

CQI
LEAN

Principles
1

The status quo is unacceptable

Status quo harms the patients and wastes money IOM

Safety can be enhanced by improving the core processes

of medication use system.

3 Safety efforts must be patient-centered.

Quality must be measured.

Solutions to safety problems should address the system,

not individuals

The status quo is

unacceptable.

Eliminate duplication, avoid

unnecessary steps, decrease
process time, reduce errors,
simplify the overall process

Principles
Solutions should
be addressed to
the system, not
individuals

Patient-centered
Quality
must be
measured

1. What do
we want to
accomplish?

PDSA

2. How will we know

when we are
successful?

cycle
3. What changes will
result in success?

Step 4: Act on the

results

Step 3: Study
the Impact

Step 1: Plan a
CHANGE

Step 2: Do it
on a small
scale

PLAN.
This step attempts
to clarify the
purpose of the
quality
improvement effort.
Bottom-up
approach is
preferred
typically.

Where everyone involved in the process is

consulted and engaged in change.

Clarify the expected outcomes

What actions will be taken?
When?
Where?
Who will do them?

??
?

This process can be made clear by

mapping out the medication use process

DO.

Implementations must be
done on a small scale to
allow adjustments to the
plan as experience with the
problem is gained.

Questions of interest:
The degree to which the plan is
implemented as designed and anything
unexpected that occurs during the
implementation

STUDY.
This is also
called CHECK
This step studies the effect
of the change on the safety
measure.
Questions of interest:
The degree to which the desired
results are achieved
What new knowledge is gained
What adjustments might need
to be made to improve the
results

ACT.
In this step, the small scale change is

larger level

implemented on a
, and
the entire process of monitoring and
assessment starts over again.
The key is that, once a desired safety goal
is achieved, a new goal is established
that further improves the safety of
patients within the medication use
process.

MEASURES OF HEALTH CARE

QUALITY
STRUCT
URE

PROCES
S

OUTCOM
E

STRUCTURES
These are measures of the presence of something
that is reasonably associated with quality
Structures are desirable for assessing the quality
of health care because they are easy to measure
the number of pharmacist can be counted and the
presence or absence of electronic medical records
can be established easily.
The problem with structures is that their
relationship with quality and patient safety is not
always clear or established.

Structures That Should Be Present for

Ensuring Safe Medication Use
1)
2)
3)
4)
5)
6)

Formulary system
Effective human resources management
Adequate staffing
Suitable work environments
Lines of authority and areas of responsibility
Systematic program of quality improvement and peer
review
7) Clinical information about patients
8) Patient medication profiles
9) Pharmacy department responsibilities
10)Computerized pharmacy systems
11) Unit dose systems
12) Pharmacists access to electronic health records
13) Medication references
14) Standard drug administration times
15) Review mechanism
16) Educational programs

PROCESSES
These are actions reasonably associated with quality such
as the checking of patient medication profiles prior to
dispensing, double checking technician work, and
electronic prescribing.
Better than measuring presence of structures
It is still possible that widely accepted practices are not
always associated with positive patient health
consequences.

Processes Associated with Safe

Medication
Use
1) All drugs should be dispensed from the pharmacy department
2) Storage of nonemergency floor stock medications on the nursing units
or in patient-care areas should be minimized
3) Routine inspections
4) Use of patients own or home medication
5) All unused or discontinued drug should be returned
6) Discharge counseling
7) Pharmacist should clarify any prescription
8) Manual transcription
9) Pharmacists should collaborate with the prescriber
10)Pharmacists should participate in drug therapy monitoring
11)Pharmacists should make themselves available
12)Use of technology and support personnel
13)Checks should conducted on all work
14)Additional checks for high-risk products
15)Ready-to-administer medication dosage forms
16)Manipulation of drugs by nurses
17)Timely delivery of medications
18)Monitoring actual administration
19)Pharmacists should collaborate with nurses
20)Medications returned to the pharmacy should be reviewed

OUTCOMES
Ultimately, the quality of safey systems needs to
be assessed by their impact on patient health
outcomes dissatisfaction, discomfort,
disability, disease, and death.
Achieving positive health outcomes is the real
purpose of having quality structures and
processes.
Hardest to link to safety efforts

Thus,

A mix of STRUCTURE, PROCESS, and OUTCOME

MEASURES be collected to gain a true understanding of
the QUALITY OF HEALTH CARE

Monitoring,
Reporting, and
Communicating

ADR-Monitoring and Reporting Programs

A comprehensive ADR-monitoring and reporting program

should be an integral part of an organizations overall
drug use system.

One form concurrent(during drug therapy) surveillance

system is based on reports of suspected ADRs by
pharmacists, physicians, nurses, or patients.
Another form of concurrent surveillance monitors for
alerting orders.

Alerting Orders
Are prescriptions which alert pharmacists that an ADR may
have occurred and that an investigation needs to be
conducted.
Three types of Alerting Orders:
Tracer drugs
Abrupt discontinuation or decreases in dosage of a drug
Stat orders for laboratory assessment of therapeutic drug
levels

Tracer Drugs
Tracer drugs are commonly used to treat ADRs (e.g.,
orders for immediate doses of antihistamines,
epinephrine and corticosteroids.
When tracer drugs are used, an ADR may have occurred

Abrupt discontinuation or decreases

in dosage of a drug
The assumption being that the discontinuation occurred
because of a negative reaction to the medication

Stat orders for laboratory

assessment of therapeutic drug
levels
Alerts the pharmacist that some concern exists in the mind
of the prescriber that too much or too little drug is in the
patients system

One type of prospective (before drug therapy) surveillance

system focuses on monitoring high-risk drugs or patients
with a high risk of ADRs

High-risk drugs:
Adrenergic agonist (IV) (e.g., epinephrine)
Adrenergic antagonist (IV) (e.g., propanolol,
metoprolol)
Anesthetics (e.g., Ketamine)
Antithrombotics (e.g., Warfarin, low molecular
weight Heparin)
Cardioplegic Solutions
Hypertonic Dextrose
Dialysis Solutions

High-risk drugs:
Epidural and intrathecal medications
Hypoglycemic Agents (P.O)
Inotropic Agents (e.g., digoxin, milrinone)
Insulin
Methotrexate for non-oncologic use
Sedatives (e.g., Midazolam)
Narcotics/ Opiates
Neuromascular blocking agents
(e.g., succinylcholine)

High-risk drugs:
Nitroprusside
Oxytocin
Potassium Chloride and Sodium Chloride for
injection
Promethazine (IV)
Radiocontrast agents
Total parental nutrition

Populations at greater risk for ADRs are those with the

most trouble adjusting to the negative consequences.
Those include the following:

Pediatric patients are at greater risk because drug

responses are less predictable than with adults due to
pharmacokinetic variations.
This problem is aggravated because of the lack of clinical
trials conducted in pediatric populations.

Elderly are at greater risk due to issues of polypharmacy,

multiple prescribers, adherence problems, changes in renal
function and metabolism and greater sensitivity to
medications

Oncology patients commonly suffer ADRs because they are

exposed to highly toxic therapeutic regimens and often are
immunocompromised.

What to do when ADRs occur?

Prescribers, nurses and pharmacists should be notified
~ Notification should be made to the pharmacy
surveillance program for recording and analysis.
~Attempts should be made to determine the cause/s of
each suspected ADR using the patients

medical and medication history, the circumstances of

adverse event, and what might be found in any literature
review.
~Ideally, a systematic method for assigning the probability
of the reported or suspected ADR (e.g., confirmed or
definite, likely, possible and unlikely) should be used to
categorize each ADR.

In case SERIOUS or UNEXPECTED ADRs occur

It should be reported to the FOOD and Drug
Administration(FDA) or the drugs manufacturer (or both).

Medication
Reconciliation

Medication Reconciliation

Is the process of resolving

discrepancies with what the
patient has been taking in the
past with what the patient should
be taking at the moment.

Medication reconciliation is an
opportunity for pharmacist to use
their knowledge and skills to
enhance patient safety by
identifying and resolving drugrelated problems as patients
transition through out the health
care system.

Reconciliation attempts to correct

problems such as:

Omissions in therapy
Medication Duplication
Errors in dosing
Potential drug interactions

Medication Reconciliation Process

1. Verification
~ The most up-to-date list of
medications currently being taken by
the patient within the hospital or other
institution is developed by using one
or more sources of information
brought to the institution.

Sources of Information
pharmacy profile
medical records
patient or caregiver interview
patient medication

2. Clarification
~ The medication and dosages are
checked for appropriateness.
3. Reconciliation
~ Clinical decisions are then made
based upon a comparison of newly
prescribed medications against what
was prescribed previously

4. Transmission
~Therapy changes are
communicated to those people who
need to know about the changes
including providers on both end of
transition (e.g., hospital pharmacist
and community pharmacist,
surgeon, internist. This includes
providing the patient or caregiver
with a copy of final medication list.

NATIONAL
QUALITY
ORGANIZATIONS

NATIONAL QUALITY
ORGANIZATIONS
Institute of Medicine (IOM)
-A component of the National Academy of
Sciences.
MISSION:
serve as adviser to the nation to improve health.
Published works: Crossing the Quality Chasm,
To Err is Human and Preventing Medication
Errors

NATIONAL QUALITY
ORGANIZATIONS
IHI Institute of Healthcare Improvement
-a not-for-profit organization.
Goal: Improve health care throughout the world.
Major initiatives:
100,000 Lives Campaign
Purpose: Introducing proven best practices to extend
or save as many as 100,000 lives.
5 Million Lives Campaign
- seeks to prevent 5 million incidents of medical
incidents over a two year period.

NATIONAL QUALITY
ORGANIZATIONS
NQF National Quality Forum
-endorses consensus-based national standards
for measurement and public reporting of
health care performance data that provide
information about whether care is safe,
beneficial, patient-centered, equitable, and
efficient.
Primary role: Improving health care quality
measurement and reporting.

NATIONAL QUALITY
ORGANIZATIONS
The Leapfrog Group
-a voluntary program of employers.
-uses employer purchasing power to
encourage the health industry to make big
leaps in health care safety, quality, and
customer value.
Hospital Quality and Safety Survey
-asks hospitals to rate themselves on four
leaps of quality and safety practices.

NATIONAL QUALITY
ORGANIZATIONS
The Leapfrog Group
Hospital Rewards Program
-rewards excellent hospitals.
-measures performance in five areas of
effectiveness and affordability.

NATIONAL QUALITY
ORGANIZATIONS
Joint Commission
- an independent, not-for-profit
organization dedicated to improving the
safety and quality of health care
-assesses and accredits the quality of health
systems.
-is the principle accrediting body for the
operation of hospitals and other health care
organizations.

NATIONAL QUALITY
ORGANIZATIONS
CMS Centers for Medicare and
Medicaid Services
- manages Medicare and Medicaid
programs which contracts with a private
Quality Improvement Organization (QIO)
in each state to monitor care to Medicare
beneficiaries.
- sets quality standards that must be met
to be able to serve CMS patients.

NATIONAL QUALITY
ORGANIZATIONS
AHRQ Agency for Healthcare
Research and Quality
-conducts and supports research for the
U.S. Department of Health and Human
Services (HHS).
-sponsors the National Quality
Measures Clearinghouse (NQMC) a
public repository for evidence-based
quality measures and measure sets.

NATIONAL QUALITY
ORGANIZATIONS
NCQA National Committee for Quality
Assurance
-manages the Health Plan Employer Data
and Information Set (HEDIS).
Health Plan Employer Data and
Information Set (HEDIS)
- provide purchasers and consumers with
information about the quality of
healthcare plans.

NATIONAL QUALITY
ORGANIZATIONS
ASHP American Society of HealthSystem Pharmacists
- supports health systems pharmacists
in quality and safety through
publishing, education, advocacy and
guidance documents.

NATIONAL QUALITY
ORGANIZATIONS
PQA Pharmacy Quality Alliance
-brings key stakeholders together to agree on
strategies for measuring performance at the
pharmacy and pharmacist-levels.
-reports information to consumers,
pharmacists, employers, health insurance
plans, and other healthcare decision makers to
make informed choices, improve outcomes
and stimulate the development of new
payment models.