Medication

Safety
Chapter 6

Group 3
12 Cu, Emmanuel Romeo K.
13 David, Patrick P.
14 de Leon, Jeremia Ydianne
15 de Leon, Princess Marielle R.
16 Del Rosario, Krizia Ashter V.
17 Delmendo, Christine A.

INTRODUCTION
Medication safety are ways in the
prevention of fatalities and detection of
harm when administering medicinal doses.
Know which medications are high risk so
we can take precautions.

STEPS IN MEDICATION
1. PRESCRIBING
2. ADMINISTERING
3. MONITORING

PRESCRIBING
Choosing an appropriate medication for a given
health problem of the patient
Deciding the time, dose and route in
administration of the medication.

ADMINISTERING
obtaining the medication then preparing it by
mixing, labeling or counting
giving the medication to the correct patient with
the prescription having the right instructions for
the time, route and dose

MONITORING
observing the patient to check if the medication
works, any adverse effects occur, or if the patient
uses the drug the right way.

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 Reconciliation
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 hand-written 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

DEFINITIONS
o 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.

o 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.

o 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.

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

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

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

o 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.

o 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.

o 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.

o 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.

o 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.

o 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.

Preventing Medication
Errors
Medication errors occur because of:
Poorly designed medication
labels
Poor personnel
management practices
o Inadequate performance

feedback

Lack of quality
improvement system

Equipment failures
Look-alike or sound-alike
drugs

Sloppy communication

o Illegible handwriting
o Incorrect transcription
o Verbal miscommunications

Distractions and overwork

Poorly designed
medication labels
Poor personnel
management practices
o Inadequate performance
feedback

Institute of Medicine
Recommendations:

Involve patients in the medication use process.

o Rights of patients
o Educating them
o Consulting with them

Consumer-oriented medication should be made available

Health care providers should have assess to:
o Patient information
o Decision-support tools and technologies

Improvement in medication labeling and communicating

methods
Improvement in Health information technology
Congressional funding should be increased:
o To study safe and appropriate medication use
o For Error prevention

Health payers and oversight organizations should be active in

promoting good medication practices.

Institute of Medicine
Recommendations for the pharmacists:
Must keep up with medication literature for drug error
information and take action for prevention
Patient identities must be verified with bar codes
Patients should be educated about ways to prevent medication
errors
Patients should be engaged in managing their own medication
regimens.
Electronic prescribing should be used.
Trivial warnings should be avoided in medication-support
systems.
Prescription filling technology needs to be assessed and improved
Pharmacist should monitor patients with high risk side effects
Pharmacists should routinely review medication records
especially when transitioning between types of care

Culture of Safety
Exists where safety is the key element of
everyones job ( leadership-technicians and unit
secretaries)
Leaders encourage workers to seek out and
implement new ways of ensuring the safety of
patients
Action and words
Take responsibility for protecting the well-being of
patients
Pressure to solve medication problems comes from
technicians, pharmacists and supervisors
Information is shared
(reducing patient risk > disclosure)

Culture of Safety
Culture of blame
o Reporting of medication errors is discouraged by
attempts to find someone to blame and punish
o Risk of reprisal discourages anyone to report them

Ignorance about medication errors = non ending

occurrence
Avoid blaming and focus on identifying the error
in the system that lead to medication errors
Bottom line: patient safety requires a change in
culture of work, medicine, medication use
systems and human interactions

Models of Quality Improvement

Sought by organizations that aspire for
better medication safety
Popular models are as follow:
o Total quality management
o Continuous quality improvement (ex. PDSA
Cycle of Quality Improvement)
o Six-sigma

Principles of these models:

Change must be continuous to satisfy every
patients needs
Safety can be enhanced by improving on the
core processes of the system and addressing
its problem here and not on the
professionals
Quality must be measured to let them know
if quality is improving or is stagnant

PDSA Cycle of Safety Improvement

Plan, Do, Act, Study
Questions needed to be answered:
o What do we want to accomplish?
o How will we know when we are successful?
o What changes will result in success?

Plan
In this step, we clarify the purpose of the
quality improvement effort by having a bottomup approach including everyone, especially the
frontline healthcare workers.
We develop here the description or the cause of
the problem before formulating an action plan,
and if possible, a back-up plan.

Do
Plans are enforced into actions during this stage.
They maybe done in a small scale form so as to
let them eventually adjust to their plan.
Data as well as unexpected problems or
outcomes must be documented for further
studying on the next stage.

Study
We evaluate the product of stage two here.
Re-evaluation occurs here to see if the
outcome meets the expectations of the plan.
If they see the change as a good effect towards
the betterment of the patients, they may allow
it to be added to the system.

Act
The change that was planned is now in action
here. They re-assess and monitor it again to se
if it acts as efficiently as they thought.
If that change does not meet with what the
team wants, the will formulate once again a
plan and develop the desired outcome.

MEASURES OF HEALTH CARE

QUALITY
DONABEDIAN
STRUCT
URE

PROCESS

OUTCOME

STRUCTURES
These are measures of the presence of
something that is reasonably associated
with quality
These are desirable for assessing the
quality of health care because they are
easy to measure
The problem 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) Formulary system
2) Effective human resources management
3) Adequate staffing
4) Suitable work environments
5) Lines of authority and areas of responsibility
6) 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)Computerized Prescriber Order Entry
14)Medication references
15)Standard drug administration times
16)Standard abbreviations
17)Review mechanism
18)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
The quality of safety 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

Monitoring, reporting, and

communicating
ADR-Monitoring and reporting
programs
All institutions should have a comprehensive
ADR-monitoring and reporting program
Any surveillance program should be
conducted both concurrently and
prospectively.

I. Concurrent Surveillance
System
During drug therapy
A. Forms:
1. Based on reports of suspected ADRs by
pharmacists, nurses, physicians, or
patients.
2. Alerting orders

Alerting Orders
Prescriptions which alert pharmacists that
an ADR may have occurred and that an
investigation needs to be conducted.
A. Types:
1. Tracer Drugs
2. Abrupt discontinuation or decrease in
dosage
3. Stat orders for laboratory assessments of
therapeutic drug levels

Tracer Drugs
Commonly used to treat ADRs
Ex. Orders for immediate doses of
antihistamines, epinephrine, and
corticosteroids

When tracer drugs are used, an ADR may

have occurred.

Abrupt discontinuation or
decrease in dosage of a drug
Because of a negative reaction to the medication

Stat orders for laboratory

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

II. Prospective Surveillance

System
Before drug therapy
Focuses on monitoring high-risk drugs or
patients with a high risk for ADRs

Examples of high risk drugs:

Arenergic agonists(IV)
epinephrine
Adrenergic antagonists(IV)
propranolol, metoprolol
Anesthetics ketamine
Antithrombotics warfarin
Cardioplegic solutions
Chemotherapeutic agents
Hypertonic dexrtrose
Dialysis solutions
Epidural and intrathecal
medications
Hypoglycemic agents (P.O.)
Inotropic agents digoxin,
milrinone

Insulin
Methotrexate for nononcologic use
Sedatives midazolam
Narcotics/opiates
Neuromuscular blocking
agents succinylcholine
Nitroprusside
Oxytocin(IV)
Potassium chloride and
sodium chloride for injection
Promethazine(IV)
Radiocontrast agents
Total parenteral nutrition

Populations at greatest risk for ADRs are

those with the most trouble adjusting to
the negative consequences
1. Pediatric patients
- Less predictable ADRs
- Lack of clinical trials

2. Elderly
- Polypharmacy, multiple prescribers, adherence
problems, changes in renal function, metabolism,
sensitivity

3. Oncology patients
- Exposure to highly toxic regimens
- Immunocompromised

What to do when ADRs occur?

1. Prescribers, nurses, and pharmacists should be
notified. Notification should also be made to the
pharmacy surveillance for analysis and recording.
2. Attempts should be made to determine the cause
or causes of each suspected ADR using the
patients medical records, circumstances of the
adverse event, and what might be found in any
literature review
Ideally, a systematic method for assigning the
probability of the ADR should be used to categorize
each ADR.
Serious or unexpected ADRs should be reported to the
FDA ,or the drugs manufacturer, or both.

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.
Is meant to be conducted each time a patient
transitions across departments, locations, or
other location.

Medication reconciliation process

Step 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.
Step 2: Clarification
- The medication and dosage are checked for
appropriateness

Step 3: Reconciliation
- Clinical decisions are then made based upon a
comparison of newly prescribed medications against
what was prescribed previously. Changes to
pharmacotherapy are documented in all relevant
records.
Step 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, caregivers, and the patient.) This includes
providing the patient or caregiver with a copy of final
medication list with administration instructions.

National Quality Organizations

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

IHI Institute of Healthcare Improvement

- a not-for-profit organization with a goal of improving health
care throughout the world.
- Major initiatives:
o 100,000 Lives Campaign - Introducing proven best
practices to extend or save as many as 100,000 lives.
o 5 Million Lives Campaign - seeks to prevent 5 million
incidents of medical incidents over a two year period.

 NQF National Quality Forum

- Primary role: Improving health care quality measurement

and reporting.
- 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.

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.
- Conducts the Hospital Quality, Safety Survey, and Hospital
Rewards Program

 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.

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.

 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.

NCQA National Committee for Quality Assurance

- manages the Health Plan Employer Data and Information Set
(HEDIS).
- HEDIS measures are used to provide purchasers and
consumers with information about the quality of healthcare
plans.

 ASHP American Society of Health-System

Pharmacists
- supports health systems pharmacists in quality and safety
through publishing, education, advocacy and guidance
documents.

PQA Pharmacy Quality Alliance

- brings key stakeholders together to agree on strategies for
measuring performance at the pharmacy and pharmacistlevels.
- 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.

References

Minnesota Department of Health, (n.d.). PDSA: Plan-Do-StudyAct. Retrieved February 28, 2016 from
www.health.state.mn.us/divs/opi/qi/toolbox/pdsa.html

Holdford, D. , Brown, T. (2010). Introduction to Hospital and

Health-System Pharmacy Practice. iGroup Press Co., Ltd. ,
Bangkok,Thailand.