Transcript Medication safety

PHCL 429
Lobna Al Juffali,Msc
1.
Distinguish between a medication misadventure, an
adverse drug event (ADE), an adverse drug reaction
(ADR)
2.
Identify and assess medication errors
3.
Given a scenario, perform an assessment of causality,
severity, and preventability of an ADE using tools
provided within the lecture.
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Defintions
Medication Error
Adverse Drug Events
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Providing of the best-known quality of care consistently
to the appropriate patients in the safest manner
possible.
medication safety involves:
• error prevention,
• effective and consistent application of
pharmaceutical care principles and knowledge in
the care of patients.
Hippocrates
To err is
human
First Do
no harm
First
do no
harm
Person based
Approach
To err
is
human System based
approach
negligence,
carelessness,
recklessness,
forgetfulness, or
lack of focus or
motivation.
people will make
mistakes and focuses on
building safeguards into
our systems to prevent
errors from occurring or
to limit the damage that
occurs as the result of an
error.
Corrective measures
are directed at the
individual and
include disciplinary
actions and fingerpointing.
Corrective
measures
how and why the
safeguards within
the system failed.
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Learning from our mistakes
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Taking steps to prevent similar events in the future
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The released by the IOM in late 1999 focused attention
on medical error
This report was the first in a series of reports
produced by the Quality of Health Care in America
project initiated by the IOM in 1998.
The report estimated that
the number of deaths due to
• Medical errors 44,000–98,000 each year.
• Medication errors 7000 patients each year /at acost
of$7 billion annually.
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The IOM report substantially changed the direction of
the approach to medication safety.
what is the size of the problem ?
How to better understand and correct the
problem ?
1.
To establish a national focus, creating leadership, research,
tools, and protocols to enhance knowledge related to
safety.
2.
To use data generated from mandatory and voluntary
reporting to identify and learn from errors with the goal of
making our system safer for patients.
3.
Increase in standards and expectations for improvements
4.
The creation of safety systems within health care
organizations through the implementation of safe practices
at the level of delivery of care
Medication Misadventure:
An iatrogenic hazard or incident
1.
That is a an inherent risk when medication therapy is
indicated
2.
That is created through either omission or
commission by the administration of a medicine or
medicines
3.
Whose outcome may or may not be independent of
the preexisting pathology or disease
4.
That may be attributable to error
5.
That is always unexpected or undesirable.
An injury from a medicine
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A is any preventable event that has the potential to lead
to inappropriate medication use or patient harm. while
the drug is in the control of the health care
professional, patient, or consumer.
refer to any unexpected, unintended, undesired, or
excessive response to a medicine
1.
2.
3.
4.
5.
6.
7.
8.
9.
That requires discontinuing the drug
Requires changing the drug therapy
Requires modifying the dose
Admission to the hospital
Prolong stay in the hospital
Needs supportive treatment
Complicates diagnosis
Negatively affects prognosis
Result in temporary or permanent harm or death
Allergic reactions and idiosyncratic reactions are
considered ADRs under this definition.
is an expected ,well known reaction that results in the
little or no change in patient management
E.G dry mouth ,drowsiness
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Medication misadventure include all things can go
wrong with the drug use (A)
ADEs related to drug therapy(B)
ADRs subset of ADEs unexpected adverse reaction not
related to an error (new allergy) (C)
is ADEs resulting from a medication error, Example
include reactions resulting from an unintentional
overdose (D)
Side effects subset from ADEs but are excepted and
unavoidable
Medication error that do not reach the patient (E)
C
ADR
D
B
ADE
Side effects
Adverse Drug
Events
resulting from
Medication
Errors
E
Medication
errors
A
Medication Misadventures
Latent conditions
are those that either produce errors or allow errors to
occur either continuously or under certain
circumstances
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Active failures
are errors in caregiver performance or violations of
standards of care (or both) that are allowed within the
system and environment.
How Does a System Fail?
“Swiss Cheese” Model
Pharmacist order
review
Nurse order review
Patient education and
communication
Active failure
Prescribing erro
Patient monitoring
dverse Drug Event
Holes are
system failures
Slices of cheese are steps in
the process
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Errors are not the result of an individual failure, but
of a systems failure.
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Type of Event (categories of medication error)
Step of medication Use Process
The five Rights
Causality assessment
Severity Assessment
Prescribing Error
Incorrect drug selection (based on indications, contraindications,
known allergies, existing medication therapy, and other factors),
dose, dosage form, quantity, route, concentration, rate of
administration, or instructions for use of a medication product
ordered or authorized by Physician
Omission Error
The failure to administer
an ordered dose to a patient
before the next scheduled dose, if any.
Wrong Time Error
Administration of medication outside a pre-defined time interval
from its scheduled administration time.
Improper Dose Error
Administration to the patient of a dose that
is greater than or less than the amount
ordered by the prescriber or administration
of duplicate doses to the patient.
Example: one or more dosage units in
addition
to those that were ordered.
Wrong Medication - Preparation Error
Medication product incorrectly formulated or
manipulated before administration. E.g incorrect
dilution
Wrong Administration Technique Error
Inappropriate procedure or improper
technique in the administration of a
medication.
Example: wrong route/site or rate
of administration
Wrong dosage form error
Administration to the patient of a drug product in a different
dosage form than ordered by the prescriber.
Unauthorized drug error
Administration to the patient of a drug not authorized by a legitimate
prescriber for the patient.
This includes wrong drug, a dose given to the wrong patient,
unordered drugs, and doses administered outside a stated set of
clinical guidelines or protocols.
Deteriorated drug error
Administration of a drug that has expired
or for which the physical or chemical
dosage-form integrity has been compromised. This includes
expired drugs and improperly stored drugs.
Monitoring Error
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.
Compliance Error
Inappropriate patient behavior regarding
adherence to a prescribed medication regimen.
Other Medication Error
Any medication error that does not fall into
one of the above pre-defined categories.
Prescribing
Dispensing
Administration
Systems and management control
Monitoring
Right Patient
Right Route
Right Dose,
Right Time
Right
Medication
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Root cause analysis is a formal, systematic method of
identifying the fundamental cause(s) of an event.
Root cause analysis is a process to identify the factor(s)
that cause a variation in performance and should have
the following
A document providing a framework for a root cause
analysis and action plan can be downloaded from
JCAHO’s Web site at
www.jcaho.org/sentinel/rcaform3.xls.
Definitions
Harm
Impairment of the physical, emotional, or psychological
function or structure of the body and/or pain resulting
therefrom.
Monitoring
To observe or record relevant physiological or psychological
signs.
Intervention
May include change in therapy or active medical/surgical
treatment.
Intervention Necessary to Sustain Life
Includes cardiovascular and respiratory support (e.g., CPR,
defibrillation, intubation, etc.)
Circumstances or
events that have the
capacity to cause error
Category A
NO
NO
Category B
Did an actual error
occur?
Yes
Did the error reach the
patient?
Yes
Did the error contribute
to or result in patient
death
Category C
NO
Was intervention to
preclude harm or
extra monitoring
required?
NO
NO
NCC MERP Index for Categorizing
Medication Errors Algorithm
Was the patient
harmed?
Category
F
Yes
Category
E
Did the error require an
intervention necessary
to sustain life?
Category D
NO
NO
Was the harm
permanent?
Was the harm
Temporary?
NO
Yes
Category H
NO
Did it require
initial or
prolonged
hospitalization
?
Yes
Yes
Yes
Yes
Category I
Yes
Category G
High Alert Medications
Medication that have a higher likelihood of causing injury
if they are misused.
Errors with these medications are not necessarily more
frequent – just that their consequences may be more
devastating.
1.Insulin
2.Opiate /narcotic analgesics
3.Potassium injection and sodium chloride solutions
4.Intravenous anticoagulants
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Sound-alike, look-alike medications account for an
estimated 25- 30% of medication errors.
These refer to names of medications, which due to
their spelling, may look similar to other medications’
names, and the distribution/administration of these
medications may be prone to errors. Also refer to
product labeling/packaging.
These refer to names of medications, which due to
their pronunciation, may sound similar to other
medications’ names, and the
distribution/administration of these medications may
be prone to errors.
Example
Dianben ® and Diovan®
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Prozac ® and Proscar®
Several preventative strategies exist to help reduce the
chance of these errors, one of which is Tall Man
Lettering.
- Examples of Tall Man Lettering:
Chlorpromazine …ChlorproMAZINE
Chlorpropamide ... ChlorproPAMIDE
 Store in different locations
in pharmacies and patient care units.
 Involve patients and
their caregivers.
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Medication Names Should be Written In Full
Abbreviations Are Not Permitted
The listed recommendations are applied to all orders and all
medication related documentation (e.g., handwritten or on preprinted forms).
They should never be used in medical documentation.
Place adequate space between the full medication name, dose and
unit of measure.
Purinethol
Propythiouracil
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Adopt a system-oriented approach to medication error
reduction
Everyone is involved in safety (individual practitioners
& organizational leadership).
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Make the medication errors visible.
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Minimize the consequence of medication errors.
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Report, analyze and share medication error incidents.
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Promote a Culture– in reporting medication errors.
Implement a unit dose system.
Have the Pharmacy supply High-Alert intravenous
medications
Do Not store concentrated electrolytes solutions
(potassium, magnesium, and phosphate) on patient
care units.
Ensure the availability of Pharmacist during patient
care rounds.
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Disclosure of errors that alter the planned delivery of
care should be divulged to the patient whenever
possible.
The potential negative effects should be discussed, as
should the plan to monitor for and ameliorate any
potential harmful effects.
Patients should be told the facts of the occurrence and,
if asked, the individuals involved.
If facts are unknown or unclear, the patient should be
informed of this and told that an active process is in
place to determine what happened and why.
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An explanation of how The error occurred, without
making excuses, can help the patient understand why
things did not go as planned.
Do not minimize the nature or potential for harm from
the error.
Of importance, an apology should be offered
complete acceptance of responsibility by the
organization.
Most important, patients and families want to know that
something is being done to prevent the same or similar
errors in the future.
Fear of litigation should not influence behaviors toward,
or information provided to, the patient or family
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Adverse drug reactions may be assessed through many
different criteria including:
• Pharmacological relationship
• Causality
• Preventability
• Severity.
Each of these assessments is designed
• to further clarify the nature of the ADR
• determine the most likely causative agent
• the appropriate management
• likelihood for reoccurrence
• the expected clinical course.
used to better understand the nature of the ADR and the
events leading to its occurrence.
 Type A reactions
 Type B reactions
 Type C reactions
 Type D reactions
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are those that result from an extension of the drug’s
pharmacological activity and is expected to occur with
increasing doses of the drug.
• An example of such a reaction would be morphineinduced respiratory depression.
• Are associated with high morbidity and low
mortality
• dose-dependent and alleviated by dose reduction
(EXAGGERATION)
• are predictable and thus preventable.
• It has been estimated that more than 70% of all ADR
are type A reactions.
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are those events that have no relationship to the drug’s
pharmacological activity or the dose administered.
(allergies).
An example of such a reaction is penicillin-induced
anaphylaxis or phenytoin-induced Stevens-Johnson
syndrome.
These events are considered unpredictable and
therefore unpreventable.
associated with low morbidity and high mortality,
(IDIOSYNCRATIC)
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Type C (reactions associated with long-term drug use)
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type D (carcinogenicity and teratogenicity)
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Adverse drug reaction causality is based on the assessment
of several key criteria of drug use,
• the temporal relationship of the ADR to drug
administration,
• temporal relationship of ADR resolution on drug
discontinuation,
• and/or treatment with an antagonist,
• rechallenge,
• serum drug concentrations,
• prior history of that event in the same patient.
This information is reviewed in the context of previous
medical literature reports of the same or a similar ADR with
the same or similar drugs to determine the likelihood of that
drug producing the ADR.
Yes
No
1. Are there previous conclusive reports of this reaction?
+1
0
0
2. Did the adverse event appear after the suspected drug
was administered?
+2
-1
0
0
0
+2
-1
0
5. Are there alternative causes (other than the drug) that
could on their own have caused the reaction?
-1
+2
0
6. Did the reaction reappear when a placebo was given?
-1
+1
0
7.Was the drug detected in the blood (or other fluids) in
concentrations known to be toxic?
+1
0
0
8. Was the reaction more severe when the dose was
increased or less severe when the dose was decreased?
+1
0
0
9.Did the patient have a similar reaction to the same or
similar drugs at any previous exposure?
+1
0
0
10. Was the adverse event confirmed by any objective
evidence?
+1
0
0
Naranjo Algorithm
3. Did the adverse reaction improve when the drug was
discontinued or a specific antagonist was administered?
4. Did the adverse reaction reappear when the drug was readministered?
Total Score:
≥9 definite; 5–8 probable; 1–4 possible; ≤0 doubtful
Do not
Know
Score
+1
Total Score
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In general ADE that are preventable they are medication Errors
In certain circumstances, the risk of a preventable adverse event
is outweighed by the benefit of therapy (e.g., chemotherapyinduced bone marrow suppression).
Adverse events that are unpreventable (and thus unexpected) are
true ADRs.
If the response to any of the following question is yes, the ADR
may have been potentially preventable.
Was the drug involved in the ADR not considered appropriate for
the patient’s clinical condition?
❑ Yes ❑ No
Were the dose, route, and frequency of administration not
appropriate for the patient’s age, weight, and disease state?
❑ Yes ❑ No
Were required therapeutic drug monitoring or other necessary
laboratory tests not performed?
❑ Yes ❑ No
Was there a history of allergy or previous reactions to the drug?
❑ Yes ❑ No
Was a drug interaction involved in the reaction?
❑ Yes ❑ No
Was a toxic serum drug level documented?
❑ Yes ❑ No
Was poor compliance involved in the reaction?
❑ Yes ❑ No
A patient with a documented hypersensitivity to
ampicillin may be expected to have a similar reaction
to piperacillin. If we administer piperacillin, with the
knowledge of a prior ampicillin allergy
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Which type of reaction is that? A or B
Is it considered preventable or not?
Is it a ADR or a medication error?
Type B
Preventable
Medication error
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severity of an ADR are subjective measures that
categorize the event as either severe, moderate, or
mild.
Outcome
(harm) Level
Drug Therapy
Required to Treat
an Event
Level of care
Resolution
Laboratory
Monitoring
None (1)
None (1)
No change (1)
Within 24-48 hrs (1)
None or one-time
monitoring (1)
Minor Injury (2)
OTC medication (2)
Add precautions
(2)
Within 72 hrs (2)
monitoring 24-72
hrs (2)
Moderate Injury
(3)
One prescription
medication (3)
Elevated level of
care (3)
Within one week
(3)
Monitoring >72 hrs
up to one week (3)
Serious injury
(10)
Two prescription
medication (4)
Elevated to critical
care(10)
Within 1 month
(10)
Monitoring >
1week up to 1
month (4)
Permanent
injury(15) or
death (20)
> Two prescription
medication (5)
Elevated to critical
care and
resuscitation
required (15)
Within 3
months(15)
Monitoring
for> 1 month(5)
Scores: ≤5 = mild; 6–9 = mild/moderate; 10–14 = moderate; 15–19 =
moderate/severe; ≥20 = severe.
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Number of concomitant drugs administered,
Dose,
Administration route, and delivery mechanism
Patient age,
Disease state,
Renal or hepatic function,
Gender,
genetics
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The drug itself
 Drugs with a narrow therapeutic window,
 Toxic metabolites,
 Significant drug interactions,
 significant dose-related toxicities are more
likely to produce a significant ADR.
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Drug classes commonly associated with significant
ADRs include
antimicrobials, anticonvulsants, analgesics,
chemotherapeutic agents, anticoagulant agents, and
sedative/hypnotic agents.
Specific agents shown to be problematic include
digoxin, each of the aminoglycosides, vancomycin,
warfarin, meperidine, morphine, and oxycodoneacetaminophen combination products.
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concurrently
retrospectively.