3. OBJECTIVES
To understand the basics about the Medication Errors, Adverse Drug
Events, Adverse drug reactions and State what percentage of adverse
medical events are caused by medications
List out the causes of Medication Errors, Adverse Drug Events,
Adverse drug reactions
List and define the types of medication errors Distinguish between
medication errors, adverse drug events and potential adverse drug
events
List the most common systems failures that cause adverse drug
events
To report and analyze the Medication Errors, Adverse Drug Events,
Adverse drug reactions
5. What is an adverse drug event (ADE)?
• An adverse drug event is “an injury resulting from the use
of a drug. Under this definition, the term ADE includes
harm caused by the drug (adverse drug reactions and
overdoses) and harm from the use of the drug (including
dose reductions and discontinuations of drug therapy).”1
Adverse Drug Events may results from medication errors
but most do not.
What is an adverse drug reaction (ADR)?
• An adverse drug reaction is a “response to a drug which is
noxious and unintended and which occurs at doses
normally used in man for prophylaxis, diagnosis, or therapy
of disease or for the modification of physiologic function.”
Note that there is a causal link between a drug and an
adverse drug reaction. In sum, an adverse drug reaction is
harm directly caused by the drug at normal doses, during
normal use.
6. • How does an ADR differ from a side effect or
allergy?
• An allergy is an adverse drug reaction mediated
by an immune response (e.g., rash, hives). A side
effect is an expected and known effect of a drug
that is not the intended therapeutic outcome.
The term “side effect” tends to norminalize the
concept of injury from drugs.
• It has been recommended that this term should
generally be avoided in favor of adverse drug
reaction.
7.
8.
9. • Safety: Freedom from accidental injuries.
• Error: The failure of a planned action to be completed as intended (i.e.
error of execution) or the use of a wrong plan to achieve an aim (i.e.
error of planning).Errors may be errors of commission or omission, and
usually reflect deficiencies in the systems of care.
• Adverse event: An injury related to medical management, in contrast
to complications of disease. Medical management includes all aspects
of care, including diagnosis and treatment, failure to diagnose or treat,
and the systems and equipment used to deliver care. Adverse events
may be preventable or non-preventable.
• Preventable adverse event: An adverse event caused by an error or
other type of systems or equipment failure.
• “Near-miss” or “close call”: Serious error or mishap that has the
potential to cause an adverse event but fails to do so because of
chance or because it is intercepted. Also called potential adverse event.
10. • A Medication Error is an error (of commission or omission) at any step along the pathway
that begins when a clinician prescribes a medication and ends when the patient actually
receives the medication.
• An Adverse Drug Event (ADE) is defined as harm experienced by a patient as a result of
exposure to a medication.
• Event: Any deviation from usual medical care that causes an injury to the patient or poses a
risk of harm. Includes errors, preventable adverse events, and hazards (see also incident).
• Incident (or adverse incident): Any deviation from usual medical care that causes an injury
to the patient or poses a risk of harm. Includes errors, preventable adverse events, and
hazards.
• Potential adverse event: A serious error or mishap that has the potential to cause an
adverse event but fails to do so because of chance or because it is intercepted (also called
“near miss” or “close call”).
• Latent error (or latent failure): A defect in the design, organization, training or maintenance
in a system that leads to operator errors and whose effects are typically delayed.
11. MEDICATION ERROR
• “any preventable event that may cause or lead to
inappropriate medication use or patient harm while
the medication is in the control of the health care
professional, patient, or consumer. Such events
may be related to professional practice, health care
products, procedures, and systems, including
prescribing, order communication, product
labeling, packaging, and nomenclature,
compounding, dispensing, distribution,
administration, education, monitoring, and use”
• Errors are usually unintentional and preventable.
12. TYPES OF MEDICATION ERRORS
• Prescribing errors
• Omission errors
• Improper dose errors
• Unauthorized drug errors
• Deteriorated drug errors
• Wrong time errors
• Wrong dosage form errors
• Wrong drug preparation errors
• Wrong administration technique errors
• Monitoring errors
• Compliance errors
13. FACTORS THAT MAY INFLUENCE
MEDICATION ERRORS
Factors associated with health care professionals
• Lack of therapeutic training
• Inadequate drug knowledge and experience
• Inadequate knowledge of the patient
• Inadequate perception of risk
• Overworked or fatigued health care professionals
• Physical and emotional health issues
• Poor communication between health care
professional and with patients
14. Factors associated with patients
• Patient characteristics (e.g., personality,
literacy and language barriers)
• Complexity of clinical case, including multiple
health conditions, polypharmacy and high-risk
medications
Factors associated with tasks
• Repetitive systems for ordering, processing
and authorization
• Patient monitoring (dependent on practice,
patient, other health care settings, prescriber)
15. Factors associated with the work environment
• Workload and time pressures
• Distractions and interruptions (by both primary
care staff and patients)
• Lack of standardized protocols and procedures
• Insufficient resources
• Issues with the physical work environment (e.g.,
lighting, temperature and ventilation)
Factors associated with medicines
• Naming of medicines
• Labelling and packaging
16. Factors associated with computerized information systems
Difficult processes for generating first prescriptions (e.g.
drug pick lists, default dose regimens and missed alerts)
Difficult processes for generating correct repeat
prescriptions
Lack of accuracy of patient records
Inadequate design that allows for human error
Primary-secondary care interface
Limited quality of communication with secondary care
Little justification of secondary care recommendations
19. Why should I report?
• Medication errors are an important preventable cause of morbidity
and mortality. If errors are reported,
• corrective measures can be undertaken to prevent them. This will
improve the safety of the patients.
MOREOVER, MEDICATION ERROR REPORTING IS BLAME FREE.
Are there issues concerning the confidentiality of
the patient / person committing error?
• There are absolutely no issues regarding confidentiality as the
identifier information (like name, hospital
• number) of either the patient or the person committing the error
need not be reported. The details of the
• reporter are optional and when furnished, will be kept confidential.
What to report?
• All medication errors should be reported. Even potential errors
(events that have potential to cause error) can
• be reported. A few examples of medication errors are given above.
Please do remember that there is no blame and you
can report any medication error committed by
anyone.
20. Who can report?
• Any health care professional (doctors, nurses,
pharmacists and allied health care professionals)
can report
• medication errors.
When to report?
• Whenever you come across a medication error,
committed by self or anyone, you can report.
There is no strict
• timeline within which it should be reported. But
it is advisable to report immediately.
How to report?
21. Potential solutions
• A number of studies have explored ways to improve
the quality of prescribing in primary care. However,
outcomes are heterogeneous and few studies have
specifically focused on medication errors. Reducing
medication errors and improving medication safety
requires a systems approach.
• Strategies employed include using health care
professionals, computer technology and educational
programmes, often within multifaceted interventions.
There is also an emphasis on the elderly population.
Some interventions have targeted specific clinical
areas, such as infectious diseases and appropriate
antibiotic use.
22. Potential solutions
• Medication reviews and reconciliation
• Automated information systems
• Education
• Multicomponent interventions
23. Medication reviews and
reconciliation
• Medication review is a process of patients` medicines evaluation in
order to improve the health outcomes and mitigate the drug-
related problems. A systematic review of 38 studies of primary care
interventions designed to reduce medication related adverse events
found that most successful interventions included a medication
review conducted by a pharmacist or other clinicians, or focused on
multicomponent interventions, which had a medication review by a
primary care professional as one component.
• Medication reconciliation is the formal process of establishing and
documenting a consistent, definitive list of medicines across
transitions of care and then rectifying any discrepancies. Increased
medication discrepancies at discharge are associated with an
increased number of prescribed medications, underscoring the
need to address polypharmacy as a multifaceted threat to patient
health.
• The accuracy of medication information on discharge summaries is
generally poor
24. Automated information systems
• A review of 10 randomized trials of computerized
interventions found a reduction in medication errors in half
of the studies. Computerized provider order entry (CPOE)
with decision support may be effective if targeted at a
limited number of potentially inappropriate medications
and is designed to reduce the alert burden by focusing on
clinically-relevant warnings.There is substantial evidence
which supports the use of CPOE to decrease the frequency
of medication errors in the in-patient setting.
• One study found that the likelihood of error occurrence
was decreased by 48% when an order was processed via
CPOE. However, there is additional research needed to link
a decrease in medication errors to a decrease in patient
harm.
25. Education
• As outlined in another monograph in this
Technical Series, educating health care
providers is a key element to improve safety in
primary care. This holds true in reducing
medication errors where education is often
part of multicomponent interventions
26. Multicomponent interventions
• Many studies include more than one
intervention. Evidence supports the use of
multifaceted approaches for improving
medication practices. In a review of 10 studies on
improving the appropriateness of polypharmacy
in the elderly, nine studies involved complex
interventions (the remaining one employed
computer decision support). Overall, there were
reductions in inappropriate prescribing and the
number of adverse drug events
27. What Can Health Care Professionals Do to
Improve Medication Use Safety?
• Traditional methods
• Unit dose drug distribution systems:
• Intravenous mixture systems:
• Practices for safe medication use system
• Clinical Pharmacy Programmes
28. Intravenous admixture systems:
• IV push (nurses prepare and administer the dose directly using a syringe)
• Volume control chambers (a container between an IV solution and the IV
tubing into which medicines can be added for infusion)
• Pharmacy prepared minibags/glass bottles (medicines are added to a
small volume of IV fluid under sterile conditions in the pharmacy)
• Spring-loaded syringe-based system (a device that uses a spring to put
pressure on the plunger of a syringe to facilitate delivery of a dose)
• Point-of-care activated system (a plastic bag containing IV fluid and a
special port for directly attaching a vial of medicine for mixing at the
bedside)
• Outsourced piggyback systems (a central pharmacy prepares IV containers
containing medicines and delivers these to the hospital for use)
• Manufacturer’s container (a glass vial that allows for reconstitution of the
dose and direct administration to the patient from the vial using an IV set)
• Premixed and frozen minibags (pre- made IV solutions containing the
medicines, some of which are frozen because of limited stability)
29. Practices for safe medication use
system include:
• Formulary management and medication use policy
• Implement standardised infusion concentrations based on local and
national practices that are appropriate for most practice settings
• Establish comprehensive IV medication administration policies with
standardised administration times, upper and lower dosage limits,
and administration rates
• Prescribing and ordering
• Use standardised orders (paper or electronic) for IV medicines
• Prescribe standardized infusion diluents, concentrations and units
(preferably commercially available products)
• Storage
• Differentiate look-alike medicines, including separate storage
locations (LASA)
30. • Prohibit or impose tight security precautions on stocking
concentrated injectable products and more than one concentration
of an IV medicine on patient care units
• Preparation and dispensing
• Dispense IV medicines in a ready-to- administer form that does not
require manipulation before administration to the patient
• Standardise the process for compounding sterile preparations, with
procedures to minimise unnecessary interruptions and distractions,
trace and verify the accuracy of compounding, and provide for
pharmacist checking of accuracy administering
• Require independent double-checks and documentation of
administration of selected high-alert medicines
• Monitoring medication use
• Have antidotes, supportive medicines, dosing and administration
information and resuscitation equipment immediately available in
patient care areas
• Establish standard operating procedures for communication
