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S. P. Bhatt M.Pharm., Ph.D.
Dept. of Pharmacology & Clinical Pharmacy
K.B. Institute of Pharm. Edu. & Res.
– Health care
– Pharmacist as health care provider
• Most of time
– Categorization and causes of medication errors.
– Detection and prevention of medication errors.
– Role of pharmacist.
• Going to doctors and the pharmacist does not
always lead to cure.
• Health care delivery is not infallible. Errors are
common in most health care systems.
• Medicines are effective but side effects are
– adverse reaction
– adverse event
• IMPROVING MEDIACTION safety has been an
important part of the history and professional
attention of pharmacist for several decades
even though this has been a topic of public
interest only recently.
• Research by the pharmacist as long as related
to work in patient safety.
• As increasing in number of prescription and
over the counter medicines, number of victim
to error is increasing. It proves still Errors are
• It is reported to be the seventh most cause of
death of overall.
Relation between error and effect
• Relationship between medication errors and
adverse drug events.
• Bates et.al. reported the frequency of
medication errors using a multidisciplinary
approach, to classify these errors by type, and
to determine how often medication errors are
associated with adverse drug events (ADEs)
and potential ADEs.
Bates DW et. Al. Relationship between medication errors and adverse drug events. J Gen
Intern Med. 1995;10(4):199-205.
• For Years, medical and nursing students have
been taught Florence Nightingale's dictum—
first, do no harm. Yet evidence from a number
of sources, reported over several decades,
indicates that a substantial number of patients
suffer treatment-caused injuries while in the
• Research related to medication use safety
began to be published in the literature
• In 1964- Schimmel reported that 20% of
patients admitted to a university hospital
medical service suffered iatrogenic injury and
that 20% of those injuries were serious or
• Recent medical progress has brought dramatic advances in methods
of diagnosis and treatment. With each new advance, however,
reports of adverse reactions have soon followed. The occurrence of
occasional reactions is now considered to be an accustomed and
almost predictable hazard rather than evidence of improper
Schimmel EM. The Hazards of Hospitalization Ann Intern Med. 1964;60(1):100-110.
• Steel et al -- 36% of patients admitted to a
university medical service in a teaching hospital
suffered an iatrogenic event, of which 25% were
serious or life threatening. More than half of the
injuries were related to use of medication.
• In 1991 Bedell et al reported the results of an
analysis of cardiac arrests at a teaching hospital.
They found that 64% were preventable. Again,
inappropriate use of drugs was the leading cause.
Eye catching and important- Results
of the Harvard Medical Practice Study
• Adverse events occurred in 3.7 percent of the hospitalizations .
• 27.6 percent of the adverse events were due to negligence Although 70.5
percent of the adverse events gave rise to disability lasting less than six
• 2.6 percent caused permanently disabling injuries and percent led to
• The percentage of adverse events attributable to negligence increased in
the categories of more severe injuries (Wald test χ2 = 21.04, P<0.0001).
• Using weighted totals, we estimated that among the 2,671,863 patients
discharged from New York hospitals in 1984 there were 98,609 adverse
events and 27,179 adverse events involving negligence.
• Rates of adverse events rose with age (P<0.0001). The percentage of
adverse events due to negligence was markedly higher among the elderly
Some meaningful terms and its
• Individuals perceptions interpreted from
different standpoints delineate errors.
• Patients, professionals, managers and health
policy makers will ascribe different meaning to
• Therefore, it is necessary to understand some
meaningful terms and its classification.
What exactly is it?
• Errors in philosophical ways has been defined
as “to err is human” but all mistakes are not
under the same heading.
• Synthesizing and interpreting the findings in
literature pertaining to error in health care is
complicated due to absence of standardized
• Essential terms are defines;
• Important but are not synonymous.
• Classification can helps us to make sense of
world, helps to understand, and assesses
• Numerous attempts to develop classification
of error. But one of the problems with
classifying error is that there are so many
ways of doing
Medical error vs Medication error
• Hofer and colleagues address the issues of
what a medical error.
– A patient scheduled for an amputation of the right
leg has the left leg removed.
– A patient is discharged from the hospital after
myocardial infarction without having a b-blocker
• Matz Robert has defined an error.
Allen EL & Barker KN
• Types of medication errors are defined, error
detection techniques are described, and the
validity of several medication error studies is
• A medication error is generally defined as:
“a deviation from the physician's medication
order as written on the patient's chart. In
hospitals, medication errors occur at a rate of
about one per patient per day”
Allan EL. Barker KN. Fundamentals of medication error research. Am J Hosp Pharm.
• But James Reason developed a well
recognized system for human error
classification based on observation from
industries that have become reliable.
• Categorized into five broad stages:
– Dispensing, and
• Causes of errors were explored.
• The model had its origin in 1987-8 during the
writing of Human Error (Reason 1990).
– The original intention for the book was to provide an essentially cognitive
psychological account of the nature, varieties, and the mental sources of human
• A model used in risk analysis and risk
management, including aviation, engineering and
healthcare. It likens human systems to multiple
slices of swiss cheese, stacked side by side.
• Propounded by Dante Orlandella and James T.
Reason of the University of Manchester, and has
since gained widespread acceptance.
• Reason hypothesized that most accidents can
be traced to one or more of four failure
domains: organizational influences,
supervision, preconditions and specific acts.
Preconditions for unsafe acts include fatigued
air crew or improper communications
• SCM AS A MEANS OF COMMUNICATION.
• Other model: Mark model.
• Ishikawa diagram/ Fishbone diagram,
Error arise for two reasons
• Active failure
– Active failures are
unsafe acts committed
by people who are in
direct contact with the
– They take a variety of
form as given in BOX:1
• Latent condition.
– Latent conditions are
within the system.
– They can affect the rate
at which employees
execute active failure
and its associated risk
Keep in Mind
• Active errors may be the dominant factor: latent conditions are
clearly important, but sometimes people really just slip up,
• The causal link, or even the connection, between distant latent
conditions and accidents are often tenuous, and only visible with
the benefit of hindsight,
• Latent conditions can always be identified, with or without an
• Some latent conditions may be very difficult to control, or take
many years to address,
• Misapplication of the model can shift the blame backwards, from a
‘blame the pilot’ to ‘blame the management’ culture,
• Highlighting management problems may hide very real human
factors issues, like the impact of emotion on performance, and
hamper the research needed to better understand human fallibility.
Disadvantages of the Reason model
• It does not account for the detailed interrelationships among
• Without these distinct linkages, the results are too vague to
be of significant practical use.
• Model is insufficiently specific regarding the nature of the
holes in the cheese and their inter-relationships.
Risk: Factors associated with increasing the likelihood of adverse health outcome
a knowledge based error due to an incorrect thought process or analysis
Lapse: a failure to execute an action due to a routine behaviour being misdirected
Negligence Negligent adverse events represent a subset of preventable adverse events that
satisfy legal criteria used in determining negligence.
Active error: Failure at the level of the frontline operator
Latent error: Failure that tend to be removed from the direct control of the operator and include
things like poor design, mistake in maintenance and bad decisions.
Error The failure, for reason which are preventable, of a planned action to be completed as
intended or use of wrong plan to achieve aim
Any injury related to the use of a drug
Failure to perform an appropriate action
Performing an inappropriate action
Lessons from psychological
and human factors research
• The subject of human error has long fascinated psychologists and others,
but both the development of theory and the pace of empirical research
accelerated in response to the dramatic technological advances that
occurred during and after World War II.
• These theory development and research activities followed two parallel
and intersecting paths:
– human factors research and cognitive psychology.
A THEORY OF COGNITION
• Most errors result from aberrations in mental functioning. Thus, to
understand why errors occur we must first understand normal cognition.
• Reason captures the main themes of cognitive theory and is consistent
with empirical observation.
• "schematic control mode“ – definite process.
• Rasmussen and Jensen describe a model of performance based on
concept of cognition that is particularly well suited for error analysis.
• They classify human performance into three levels:
– (1) skill-based, which is patterns of thought and action that are governed by
stored patterns of preprogrammed instructions (schemata) and largely
– (2) rule-based, in which solutions to familiar problems are governed by
stored rules of the "if X, then Y“ variety; and
– (3) knowledge-based, or synthetic thought, which is used for novel
situations requiring conscious analytic knowledge.
• Reason and Rasmussen classified error at each
– The skill, rule and knowledge-based model.
• Skill-based errors are called "slips."
– These are unconscious glitches in automatic activity.
– Slips are errors of action.
• Rule based and knowledge based errors, by
contrast, are errors of conscious thought and are
• The mechanisms of error vary with the level.
• Skill-based activity is automatic.
• Occurs when there is a break in the routine while
attention is diverted. The actor possesses the
requisite routines; errors occur because of a lack
of a timely attentional check.
• In brief, slips are monitoring failures. They are
• A common mechanism of a slip is capture, in
which a more frequently used schema takes over
from a similar but less familiar.
Types of slip
• Description error, in which the right action is
performed on the wrong object,
– such as pouring cream on a pancake.
• Associative activation errors result from mental
associations of ideas, such as answering the
phone when the doorbell rings.
• Loss of activation errors are temporary memory
losses, such as entering a room and no longer
remembering why you wanted to go there. Loss
of activation errors are frequently caused by
Factors affecting slips
• A variety of factors can divert attentional control and make slips more likely.
– Physiological factors
• include fatigue, sleep loss, alcohol, drugs, and illness. Psycho¬
– psychological factors include other activity ("busyness"), as well as
• such as boredom, frustration, fear, anxiety, or anger.
• All these factors lead to preoccupations that divert attention.
• Psychological factors, though considered "internal" orendogenous, may also
be caused by a host of
– External Factors,
• such as overwork, interpersonal relations, and many other forms of
– Environmental factors, such as noise, heat, visual stimuli, motion, and
– other physical phenomena, also can cause distractions that divert
attention and lead to slips.
• Environmental factors, such as noise, heat,
visual stimuli, motion, and other physical
phenomena, also can cause distractions that
divert attention and lead to slips.
• Rule-based errors usually occur during
problem solving when a wrong rule is
chosen—either because of a misperception of
the situation and thus, the application of a
wrong rule or because of misapplication of a
rule, usually one that is strong (frequently
used), that seems to fit adequately.
• Errors result from misapplied expertise.
• Knowledge-based errors are much more complex.
The problem solver confronts a novel situation
for which he or she possesses no preprogrammed
• Errors arise because of lack of knowledge or
misinterpretation of the problem. Pattern
matching is preferred to calculation, but
sometimes we match the wrong patterns.
• Certain habits of thought have been identified
that alter pattern.
• One such process is biased memory.
• Decisions are based on what is in our memory,
but memory is biased toward
overgeneralization and over regularization of
• Familiar patterns are assumed to have
universal applicability because they usually
work. We see what we know.
• Paradoxically, memory is also biased toward
overemphasis on the discrepant. A
Mistake continue… another
• The availability heuristic- the tendency to use
the first information that comes to mind.
• Related are confirmation bias- the tendency to
look for evidence that supports an early
working hypothesis and to ignore data that
• Overconfidence- the tendency to believe in
the validity of the chosen course of action and
to focus on evidence that favors it.
• Rule-based and knowledge-based functioning are
affected by the same physiological, psychological, and
environmental influences that produce slips.
• stress: not a bad, at certain level improves performance.
It has long been known that "a little anxiety improves
• In 1908, Yerkes and Dodson showed that performance is
best at moderate levels of arousal.
• Poor performance occurs at both extremes: boredom
• Coning of attention under stress is the tendency in an
emergency to concentrate on one single source of
information, the "first come, best preffred.
Take home question:
– Theory of error: Relation of aviation model and
The American Society of
Hospital Pharmacists (ASHP) 1982
• a medication error as
`a dose of medication that deviates from the
physician's order as written in the patient's
chart or from standard hospital policy and
ASHP - Nine categories of medication
1. Omission error;
2. Unauthorized drug error;
3. Wrong dose error;
4. Wrong route error;
5. Wrong rate error;
6. Wrong dosage form error;
7. Wrong time error;
8. Wrong preparation of a dose;
9. Incorrect administration technique.
• The incorrect drug selection for patient.
• Errors in this category are fairly broad, but
generally focus on inappropriate drug
selection, dose, dosage form selection, or
route of administration, and prescribing of
• Lack of knowledge of the prescribed drug, its
recommended dose and the patient
information leads to prescribing error.
Prescription and prescribing mean?
• Prescribing is the process whereby a doctor, nurse or other
registered professional authorises use of medications or
treatments for a patient and provides instructions about
how and when those treatments should be used.
• Although the term commonly refers to orders for
medicines, the concept can equally encompass laboratory
tests, medical imaging, psychological treatments, eye
glasses, eating and exercise regimes or other instructions
to help optimise health and wellbeing
• Physicians are socialized in medical school and
residency to strive for error- free practice.
• There is a powerful emphasis on perfection, both
in diagnosis and treatment.
• In everyday hospital practice, the message is
equally clear: mistakes are unacceptable.
• Physicians are expected to function without error,
• An expectation that physicians translate into the
need to be infallible.
• Cultivating a norm of high standards is, of
course, highly desirable. It is the counterpart
of another fundamental goal of education:
developing the physician's sense of
responsibility for the patient.
– If you are responsible for everything that happens
to the patient, it follows that you are responsible
for any errors that occur.
– Physicians do not have the power to control all
aspects of patient.
Prescribing error continue..
• Thirty three percent of studies reported
prescribing errors and the error prevalence
ranged from 29.8% to 47.8% in different
• Prescribing errors varied in different studies
depending on their units of observations;
38.4% to 47.8% in medical Charts, 29.8% to
37.2% in patients, and 35.1% in administered
• In 2000, Studies carried out in US hospitals
suggest that prescribing errors occur in 0.4–
Prescribing error – Risk factors
• Illegible hand writing
• Inaccurate history taking
• Use of abbreviation
• Inappropriate information
in haphazard writing
• Work load.
• Level of seniority and
• Ward/medicine specialty.
• Working environment,
• Physical and mental well
• Lack of knowledge are
Error: wrong duration
• Treatment duration, therapeutic
– Cyanocobalamin12 -- 1 mg by intramuscular
injection do same (duration not limited)
• Treatment duration, toxicity
– Digoxin 0.5 mg intravenously, then 0.25 mg
intravenously every 4 h (duration not limited)
• Drug interaction
– Erythromycin ordered for patient taking cisapride
• Duplicative therapy:
– Atenolol ordered for patient taking metoprolol
• No indication:
– Vancomycin hydrochloride ordered for patient with Enterobacter infection
– Inj amikacine ordered for patient with UTI.
• Combination products
– Propoxyphene napsylate and aspirin instead of propoxyphene napsylate with
• Wrong drug, same class:
– Clarithromycin 500 mg once, then 250 mg for 4 d instead of Azithromycin
• Wrong drug, linked therapies:
– Potassium 40 mEq intravenously instead of Furosemide 40 mg intravenously
– Timolol maléate eye drops for patient with severe asthma
• Unusual/atypical drug, drug use, or route
– Tobramycin 80 mg every 8 h ordered to be given
intravenously instead of by nebulization
– Abbreviations Bisacodyl ordered "PT" (per tube)
instead of "PR" (per rectum)
– Dosage form Betamethasone sodium
phosphate/acetate suspension ordered to be given
• Wrong dosage form
– Aqueous penicillin 1.2 million units by intramuscular
Injection ordered for pharyngitis
• Sound-alikes, similar dose Atrovent (ipratropium
bromide) inhaler ordered instead of Alupent
• Sound-alikes, dissimilar dose Dicloxacillin 100 mg
• doxycycline 100 mg
• Failure to specify dosage form Theophylline 800
mg daily without specifying sustained-release
• Brand name lacking suffix/prefix.
– Allergy, same class Oxacillin sodium ordered for
patient with documented penicillin allergy
– Allergy, related class Ibuprofen ordered for patient
with documented aspirin allergy
– Wrong patient Antibiotics ordered in wrong
• Organizational factors like
– Attitudes of team members,
– Rate of rotation of staff absence of self hierarchical
positions, and absence of self awareness about
prescribing error may contribute12-15.
– Moreover, physicians’ do not routinely screen drug-
– In an analysis of 424 randomly selected visitors of
hospital emergency department, 47% led to added
medication and in 10% of the visits in which at least
one medication was added.
• Beers MH, Storrie m, Lee G. Potential adverse drug interactions in the emergency room. Ann Intern Med
• Dean B and colleague --- Most mistakes were
made because of slips in attention, or because
prescribers did not apply relevant rules.
• Doctors identified many risk factors-
– work environment, workload, whether or not they
were prescribing for their own patient,
communication within their team, physical and
mental well-being, and lack of knowledge.
• Organisational factors were also identified, and
– Inadequate training, low perceived importance of
prescribing, a hierarchical medical team, and an
absence of self-awareness of errors.
Dean B, Schachter M, Vincent C, Barber N. Causes of prescribing errors in hospital inpatients: a
prospective study. Lancet. 2002;359(9315):1373-8
Transcription – error
• A specific type of data entry error that is
commonly made by human operators or by
optical character recognition programs (OCR).
• Human transcription errors are commonly the
result of typographical mistakes, putting
fingers in the wrong place during touch typing
is the easiest way to ascertain this error.
• Transcribing medication orders is when someone
transfers a physician's prescription order to a
medication administration record.
• The transcription of the prescription is the second
most important step in the medication process
because any minor error could lead to trouble for
the patient taking the medicine. Transcription
always receives heavy scrutiny.
• In general, transcription errors, failure to
communicate essential information, and the use of
drugs or doses inappropriate for the individual
patient were considered prescribing errors;
Clear the concept
• Transposition errors are commonly mistaken for
transcription errors, but they should not be confused.
• Transposition errors occur when characters have
“transposed”—that is, they have switched places.
• Transposition errors are almost always human in origin.
• The most common way for characters to be transposed
is when a user is touch typing at a speed that makes
them input one character, before the other.
• This may be caused by their brain being one step ahead
of their body.
• Ana and colleague reported transcription
deviations, - mean of 5.37 errors per patient
(SD 4.49, 95 percent CI 5.05-5.69).
• In absolute terms, there were 4,067
transcription errors out of a possible 33,468
(12.15 percent, 95 percent CI 11.80-12.50).
• Continuing a GP’s prescribing error when writing a patient’s drug
chart on admission to hospital.
• Transcribing a medication order incorrectly when rewriting a
patient’s drug chart.
• Writing “milligrams” when “micrograms” was intended.
• Writing a prescription for discharge medication that unintentionally
deviates from the medication prescribed on the inpatient drug
• On admission to hospital, writing a medication order that
unintentionally deviates from the patient’s pre-admission
• Dispensing error occur at any stage of the
dispensing process, from the receipt of the
prescription to the delivery of the
• It can also be defined as “dispensed and filled
prescription that contains one or more
deviation from the prescriber’s written order.
Error in dispensing
Classiﬁcation of dispensing errors
Incorrect drug Dispensing a drug that is different to that prescribed. Excludes generic or
therapeutic substitution authorised by written hospital policy.
incorrect strength Dispensing a dose unit containing the wrong amount
of the correct drug, without an appropriate adjustment to the dosing
Incorrect dosage form Dispensing the correct drug in a dosage form
different to that prescribed. This includes supplying a modiﬁed release
formulation when a standard formulation was prescribed.
Dose added Dose added Dispensing a larger quantity of medication to that
Missing doses Missing doses Dispensing a smaller quantity of medication to that
Missing doses Missing doses Dispensing a smaller quantity of medication to that
Omission of item Failure to dispense a prescribed item.
Other content error Any other content error not included in the above
Dispensing a medication that has exceeded its expiry date or has been
stored at a temperature different to that required, or for which the
primary packaging is damaged.
Any other content error not included in the above categories.
Documentation and mechanical error.
Communication failure ambiguous, incomplete or confusing prescription, illegible writing and
unreadibility, typographic and phonetic similarity in name
Problem in labeling and
similar label and packages in size, shape and color
Working environment inadequate space poor lighting noise high temperature
interruption and distraction work overload
inadequate space to store drugs
little time on individual prescription handling
Drug information lack of health care professionals and physicians information about
Absence of protocol and sops, negligence of management, low morals, unfamiliar tasks, unawareness of risk
factors and design of pharmacy.
• The prescription is responsible fore conveying
information about prescribed drug and its
usage in a way that any one reading it may
fully understand the instructions.
• Ambiguous, incomplete or confusing
prescription may lead to poor understanding
of fundamental information for correct drug
dispensing and delivery of prescription.
• Prescription readability problems are well
known as a cause of medication errors.
• Manual writing may complicate the distinction
between two drugs with similar names.
• Many drugs have similar names or drug names
may sound and pronounce similar that lead to
confusion particularly when they are delivered
through same route of administration.
• “Livoxin (Levofloxacine)” and “Lanoxin (Digoxin)”
are examples of names which when written or
readout look similar
• Further emphasis need to prescribe with generic
• Similar drug names are responsible for one third
of medication error reported in the United States
• Capital E and F
• 1 and L
• L and I
• U and micro
• C and e
Problem related to drug labeling and
• Problems related to drug labeling and packaging are the second
most reported category in the most frequent medication error
reported in the USPMERP ad are responsible about 20% of
• Wrong on label
– Drug/form on label
– Patient name
– Quality and information
– Selection error related to above all
– Bagging error : wrong name on bag, address, item omitted, extra items
Critical in life saving drugs
• Pharmacist can be affected by their work
environment in which that can increase or
decrease the rate of dispensing error.
• Pharmacist performs tasks that are at times
somewhat repetitive, yet require high level of
professional training and optimal performance
under considerable time constrain.
• Four sociotechnical areas are applied to
community practice there are believed to
influence cognitive functions when processing
• Previous studies from community practice
describe errors in
– work flow,
– interruption and distraction.
• Mass merchants and supermarkets typically
offer one stop shopping for medicaments,
groceries and other generalized medicines.
While independently owned pharmacies are
smaller store offering specialty items and
services in health care.
• Light is critical to human functioning.
• It allows us to see things and perform activities.
• Improper illumination affects activities and tends to
• Buchanan and colleagues studied the effects of
lightening level on dispensing error in a high
volume army out patient pharmacy.
• They found out that error rate were reduced when
work surface level were high.
• Certain types of noise and sounds have been
found to reduce the occurrence of dispensing
error. Unpredictable sounds, controllable sounds
and noise had a lower dispensing error.
– Telephone interruption
– Staff/visitors/chatting with neighbor and address
– Customer/patient query
– Busy over-the-counter trade
– Other distraction – blow horn, transport, cherr up
• No of persons
– LESS or no skilled person/staff
– Too much prescription load
– Time of the day
– Not usual dispenser
– Poor relationship with overall job dissatisfaction
– Inadequate breaks between work periods.
– System design,
– Time and seasons
– Other trading
• Practice makes man perfect then
– Do busy pharmacist make mistakes?
– Many studies have assessed relationship between
prescription workload and dispensing errors.
• The latest advents in technological and
pharmaceutical sectors led to frequent changes in
information relating to drug use and safety.
• It is a dangerous practice to use traditional or
virtual book, out dated information sources,
websites and other unreliable material to surpass
the information. Pharmacist must keep abreast
with latest in the field of medicine from the
reliable and convenient sources of information.
• Updating the information will help to maintain
professional rapport as well helpful in patient
• The National Coordinating Council for
Medication Error Reporting and Prevention
(NCC MERP) is an independent body
comprised of 27 national organizations.
• In 1995, USP spearheaded the formation of
the National Coordinating Council for
Medication Error Reporting and Prevention
• No patient will be harmed by a medication
• To maximize the safe use of medications and
to increase awareness of medication errors
through open communication, increased
reporting and promotion of medication error
What is a Medication Error?
– "A medication error is any preventable event that may
cwhile the medication is in the control of the health care
ause or lead to inappropriate medication use or patient
harm 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."
Medication Error Index
• Medication Error Index classifies an error
according to the severity of the outcome,
NCC MERP Index for Categorizing Medication
Take home questions
• Recommendations to Enhance Accuracy of
• Prepare the list of dangerous abbreviations.
• Councils recommendations
– cover in how to prevent
Work environment Physical environment
New or local staff
Engage with some other
activityTeam members Communication
Physical health, fatigue, psychology,
Complex clinical diseases
Language and communication gap
Out side – inside
• The administration of a medicine is a common
but important clinical procedure.
• It is the manner in which a medicine is
administered that will determine to some extent
whether or not the patient gains any clinical
benefit, and whether they suffer any adverse
effect from their medicines.
• The medication process is complex and involves a
number of different individuals and disciplines,
thereby increasing the risk of error.
• Because nurses are directly and consistently
involved in the administration phase of the
medication process, they experience the distress of
potentially committing an error.
• Since nurses are intimately involved in the delivery of
medications and are ultimately responsible during the
medication administration phase, it is important not
only for nursing but also all health care providers to
understand factors contributing to medication
administration errors and factors leading to the
discovery of potential medication administration
literature on errors specific to drug
• 400 people die or are seriously injured in
adverse events involving medical devices;
• nearly 28 000 written complaints are made
about aspects of clinical treatment in
• the NHS pays out approximately 400 million a
year in settlement of clinical negligence
• It is clear from the literature on errors specific
to drug administration that there is further
room for improvement.
Recall and add
• Allen & Barker (1990) use terminology which
is almost identical to Cooper (1995) who
suggest an error is:
– ‘A dose of medication that deviates from the
physician’s medication order on the patients
chart.’ (Cooper 1995, p. 488).
Barker & McConnell --1962
– ‘The administration of the wrong medication,
drug, diagnostic agent, chemical or treatment
requiring the use of such agents, to the wrong
patient or at the wrong time or failure to
administer such agents at the specified time or in
the manner prescribed or normally considered as
Barker & McConnell (1962) in their commonly cited study is more detailed and
wide ranging but also lacks specific reference to incorrect prescribing:
• Barker and McConnell’s definition can, however,
include such related procedures as incorrect
handwashing (hand washing that is not in
accordance with local practice) prior to giving an
• Bates (1996), it is argued that in organizations
outside the health care sector, the most common
cause of errors is the production process or
system rather than the individuals working within
Nurse - administration
• Mathematical skills of nurses
• Length of nursing experience
• Knowledge of medications
• Length of nursing rosters
• Workload, staffing levels and delivery systems
• Single vs multiple number of nurse administration.
• Policy and procedure
• Distraction and interruptions
• Quality of prescriptions
• Media, system and political influences
• Personal- individual factors
Self - administration
• Personal-individual factors
• Environmental factors
Nurse - administration
• Mathematical skills of nurses
– Poor mathematical skills in individual nurses can
contribute to increasing the risk of error.
– Situation may be exacerbated in specialist areas
such as paediatrics, where more complex
mathematical calculations may be needed to
– Calculation error in this speciality is not confined
to nurses but is also apparent in health care
• Nurses actually make conceptual errors
related to a particular problem, i.e. they fail to
construct a logical approach to dealing with a
specific arithmetical problem before the
actual calculation is begun.
• Nurse’s knowledge should be sufficient to afford
competence in the administration of drugs.
• The variables that affect level of knowledge include
length of experience, and the level and recency of
relevant professional education.
• Length of nursing experience is not necessarily a
significant variable in relation to level of
knowledge, neither is educational background, the
latter point being further supported by the
Bindler R. & Bayne T. Medication calculation ability of registered nurses. J Nurs Scholarship 1991;23 (4): 221–224.
• Nurses with more educational qualifications
held a better knowledge of medications.
• Kawamura: In a Japanese study of 2800 error
reports, poor knowledge of recent graduates
is identified as a key factor in intravenous drug
Boggs P, Brown-Molnar CS, De Lapp TD. (1988) Nurse’s Drug Knowledge. Western
Journal of Nursing. 1988;10(1):84–93.
Kawamura H. (2001) The approaches to factors which cause medication error. Japanese
Journal of Cancer and Chemotherapy. 2001;28(3): 304–309.
Length of nursing experience
• Practice makes man perfect. If so
• are errors being made by experienced staff as
opposed to more junior staff?
• Years of experience have no bearing on
nurse’s mathematical ability in calculating
• Interestingly, experienced nurses tended to
have greater confidence in their ability but did
not demonstrate a greater ability.s
• Nurses new to either the job or the hospital in
which they work are more likely to make
errors but are also more likely to report errors.
• However, the occurrence of errors increases as
the familiarity of the professional
administering the drug decreases.
• Staff moving from one clinical area to another
may also be susceptible unless they have
moved to a very similar setting.
• Moreover, length of time qualified cannot be
considered in isolation when identifying risk.
• During the induction of a new member of
staff, the nature of their previous experience
should also be analysed in the context of their
Length of nursing rosters
• Type of roster – days,
nights, or twilight shifts
can contribute towards
raising the risk of error.
• Several studies have
suggested the type of
roster and the risk of
• In mind?
• Relationship between
number of hours
worked and the rate of
• More medication errors
can occur during the
day or night
More medication errors can occur
during the day??? Simply-logically
• Increased number of prescriptions issued and
altered or a lower rate of detection during the
night, perhaps due to a higher level of fatigue.
• It is known that humans are not normally night-
• The nature of error is also different across time
– daytime errors more commonly involved wrong drug,
dose or preparation;
– night-time errors more commonly involved wrong
time, rate or administration method
Workload, staffing levels and delivery
• Important and a sensitive factor.
• The politico-legal, and economic ramifications
of claiming that more drug errors occur if
health professionals are working to a low
staff– patient ratio and that some sort of
threshold of safety can be established, are
• Workload affect error rates.
Conclusion from Roseman and Booker
• Assessed the effects of a range of workload
• They found errors increased in line with the
number of shifts worked by agency staff but
errors decreased when shortfalls in staffing
levels were covered by permanent staff
working extra hours.
Roseman C. Booker JM. Workload and environmental factors in hospital medication
errors. Nursing Research. 1995:44(4):226–230.
• Taunton et al (1994) claim, as a result of
studying patient outcomes – inclusive of drug
error, that there is no relationship between
medication errors and workload.
• It would then be unwise to simply assume that
excess workload in terms of extra hours
worked has an essentially deleterious effect
on the rate of error.
Single nurse administration
• Single nurse administration does not
necessarily increase the number of errors.
• If the variable discusses before is present.
Error by single may possible therefore require
double check. Don’t you think so?
• Jeanes & Taylor in 1992 reported that single
nurse administration does not necessarily
increase the number of errors.
• Ross et al in 2000 demonstrated that most
reported drug errors occurred despite drugs
being checked by two practitioners,
nevertheless the perception remains that
double checking is a robust safeguard against
Policy and procedure
• Poor interpretation
• Many drug errors arise as a result of failure to
• Lack of adherence to specific guidelines.
• Heavy workload and rapid patient turnover
Distraction and interruptions
• Errors is also dependent upon the nature of the
• Drugs are often administered in chaotic settings.
• Conklin et al 1990 reported in a study based
questionnaire to 175 nurses to establish their
views on the contributory factors on in drug
error and founded that 32% of the sample
believed that distractions and interruptions were
a key factor.
Quality of prescriptions
• Failures in communication can sometimes relate
directly to poorly written prescriptions.
• Farrar found and reported that the error rate
among doctors in writing prescriptions at
discharge was 7%.
• Lyons et al – 1998- used specific software to scan
the legibility of 38 doctors’ handwriting in
comparison with 54 other health workers
(including 32 nurses).
– They found that doctors produced the least legible
handwriting but that this was confined to letters
rather than numbers.
Methodologies used to study
• Direct observation method
– With some confirming the error once the medication
administration round had finished (n = 8)
– Observation with chart review
– Interviews  for prospective and retrospective error
• Prospective self-reporting methods such as
– Log books
– error (e.g. incident) reports
– drug administration view
• Prospective methods
– errors through routine activity or chart review
– Interview and blend of all
– directly observing staff activity
– informal conversations with staff
• Retrospective methods
– interviews questionnaires/surveys
– Focus groups
• The presence of an error after the observation
• Self-report data
Methodologies used to study
• Prospective chart review
• Direct observation
• Error reports
• Focus groups
• Self-report survey
• Self-report anonymous
• Semi-structured individual
• Self-report survey
questionnaire and chart
• Self-report survey
• Independent review of
• informal and formal
• Structured interview
interviews and coding
• Prospective procedure
• listening to nurse
by independent review
• Questionnaire survey—
section asking what
factors contributed to
• Specific question on
error with narrative
• Confidential self-
reporting survey tool.
• Staff interviewed by a researcher using both
closed- and open-ended questions to
determine contributory events and conditions
and possible contributory factors.
• Direct observation and third party observation
Drugs Commonly Associated with Medication Errors
DRUG TYPE EXAMPLES OF COMMON ERRORS
Analgesics Over sedation, over dose, Wrong route of administration
Failure to monitor heart rate, respiration, and blood pressure
Allergic reactions in patients with documented allergy
Antibiotics Overuse when symptoms do not warrant use, Wrong antibiotic or dose or
both, monitoring failure and allergy documentation
Over dose and specific
Anticoagulants Inadequate therapeutic dosing, No evaluation of findings from laboratory
testing of blood values, such as international normalized ratio
Diuretics Overdose, Lack of monitoring electrolytes
Use in people without diabetes, Overdose of intravenous or injectable
medications, including duplicate dosing , Drug substitution or wrong type
of insulin, Mistaking for insulin application, brand and storage
NSAIDS Extended use, leading to serious gastrointestinal complications such as
bleeding and perforation , Overdose because NSAIDs are contained in
many over-the-counter products, Taking excessive amounts, leading to
hepatotoxicity, acute renal failure, or death
Examples of Situations Requiring Hypervigilance to Avoid
• Inadequate patient information
– Clinical team unaware of known allergies or all current medications taken by the patient
• Inability to monitor
– Vital signs or laboratory values not checked before calculating dose or administering
• Multiple chronic conditions
– Failure to recognize abnormal laboratory results and poor diagnosis
• Number of medications & unfamiliarity with medication
– Patient taking multiple medications misses or doubles a dose
– Not doing required follow-up laboratory testing, such as with anticoagulants or antiepileptics
• Monitoring effect of treatment
• Switching route of administration
– Not having a therapeutic dose when switching from IV to PO
• Drug require manipulation
– Inaccurate dosing when splitting, crushing, or
suspending a medication
• Drug dosing require calculation
– Miscalculation of dose for age or weight especially
when wt and age are discordant
– Mistaking teaspoonful for a tablespoonful and vice
• Handwriting of prescription
– Incomplete information
– Written for an incorrect dosage form or strength
– Illegible order or signature
– Decimals leading to mistaken dosing
– Nonstandard terminology
– Wrong dose, route, or frequency
– Calculation of drug dose depending on weight
– Administration of medications to neonates in intensive care
– Dosing errors, especially for IV administration
– Patients taking multiple drugs, having depressive symptoms or
poor health status, being female, or making several out patient
visits in the past year are at greater risk for medication errors
– Patient does not understand and follow the prescribed regimen
– Elderly are more sensitive to effects of medication, and
adjustments in dose may be necessary.
– Women who are pregnant or lactating given medications not
approved for them
How to prevent
• Recommendations for Preventing Medication
– Organizational and Departmental
– Patient and care giver
– Pharmaceutical manufacturer
Organizational and Departmental
• Organizational policies and procedures should
be established to prevent medication errors.
• Development of the policies and procedures
should involve multiple departments,
including pharmacy, medicine, nursing, risk
management, legal counsel, and
• The formulary system, the P&T committee should be responsible for formulating
policies regarding the evaluation, selection, and therapeutic use of drugs in
organized health-care settings.
• Care and consideration must be given in hiring and assigning personnel involved in
medication ordering, preparation, dispensing, administration, and patient
education. Policies and procedures should be developed that ensure adequate
personnel selection, training, supervision, and evaluation.
• Ensure proper interviewing, orientation, evaluation of competency, supervision,
and opportunities for continuing professional and technical education.
• Sufficient personnel must be available to perform tasks adequately. Policies and
procedures should ensure that reasonable workload levels and working hours are
established and rarely exceeded.
• Suitable work environments should exist.
• Lines of authority and areas of responsibility within the hospital should be clearly
defined for medication ordering, dispensing, and administration.
• Ongoing, systematic program of quality improvement and peer review with
respect to the safe use of medications.
• Responsible staff for processing drug orders should have routine access to
appropriate clinical information about patients (including medication, allergy, and
hypersensitivity profiles; diagnoses; pregnancy status; and laboratory values) to
help evaluate the appropriateness of medication orders.
• Pharmacists should maintain medication profiles for all patients, both inpatients
and ambulatory patients, who receive care at the hospital.
• The pharmacy department must be responsible for the procurement, distribution,
and control of all drugs used within the organization. Adequate hours for the
provision of pharmaceutical services must be maintained; 24-hour pharmaceutical
service is strongly recommended in hospital settings.
• In the absence of 24-hour pharmaceutical service, access to a limited supply of
medications should be available to authorized nonpharmacists for use in initiating
urgent medication orders.
• When 24-hour pharmacy service is not feasible, a pharmacist must be available on
an “on-call” basis.
• The pharmacy manager (or designee), with the assistance of the P&T committee
(or its equivalent) and the department of nursing, should develop comprehensive
policies and procedures that provide for efficient and safe distribution of all
medications and related supplies to patients.
• Except in emergency situations, all sterile and nonsterile drug products should be
dispensed from the pharmacy department for individual patients.
• The storage of nonemergency floor stock medications on the nursing units or in
patient-care areas should be minimized. Particular caution should be exercised
with respect to drug products that have commonly been involved in serious
medication errors or whose margin of safety is narrow, such as concentrated forms
of drug products that are intended to be diluted into larger volumes (e.g.,
concentrated lidocaine and potassium chloride for injection concentrate).
• All drug storage areas should be routinely inspected by pharmacy personnel to
ensure adequate product integrity and appropriate packaging, labelling, and
• Drug products and other products for external use be stored separately from drug
products for internal use.
• The pharmacy director and staff must ensure that all drug products used in the
organizational setting are of high quality and integrity.
• The use of a patient’s own or “home” medications should be avoided to the fullest
• All discontinued or unused drugs should be returned to the department of
pharmacy immediately on discontinuation or at patient discharge.
• Discharged patients must not be given unlabeled drug products to take home.
• Counsel patient on discharged or take home medicnies.
• Where possible, the use of technological innovations such as bar coding is
• Adequate drug information resources should be available for all health-care
providers involved in the drug use process.
• Standard drug administration times should be established for the hospital by the
• Develop a list of standard abbreviations approved for use in medication ordering.
• A review mechanism should be established.
• The pharmacy department, in conjunction with nursing, risk management, and the
medical staff, should conduct ongoing educational programs to discuss medication
errors, their causes, and methods to prevent their occurrence.
Recommendations for Prescribers.
• To determine appropriate drug therapy, prescribers should stay abreast of the
current state of knowledge through literature review, consultation with
pharmacists, consultation with other physicians, participation in continuing
professional education programs, and other means.
• Prescribers should evaluate the patient’s total status and review all existing drug
therapy before prescribing new or additional medications to ascertain possible
antagonistic or complementary drug interactions.
• prescribers should be familiar with the medication ordering system.
• Drug orders should be complete.
• Care should be taken to ensure that the intent of medication
orders is clear and unambiguous.
• Write out instructions rather than using nonstandard or
• Do not use vague instructions, such as “take as directed,”
• Specify exact dosage strengths (such as milligrams) rather
than dosage form units (such as one tablet or one vial).
• Prescribe by standard nomenclature, using the drug’s generic
• Always use a leading zero before a decimal expression of less
than one (e.g., 0.5 ml). Conversely, a terminal zero should
never be used (e.g., 5.0 ml).
• Spell out the word “units” (e.g., 10 units regular insulin) rather
than writing “u,”
• Use the metric system.
• Written drug or prescription orders (including signatures) should be
legible. Prescribers with poor handwriting should print or type medication
or prescription orders if direct order entry capabilities for computerized
systems are unavailable.
• A handwritten order should be completely readable.
• Verbal drug or prescription orders (that is, orders that are orally
communicated) should be reserved only for those situations in which it is
impossible or impractical for the prescriber to write the order or enter it in
• The prescriber shsuld dictate verbal orders slowly, clearly, and articulately
to avoid confusion.
• When possible, drugs should be prescribed for administration by the oral
route rather than by injection.
• Observe and instruct special SE/ADR/Allergy
• Prescribers should follow up and periodically evaluate the need for
continued drug therapy for individual patients.
• Practice “hold” and “stop order”
Recommendations for Pharmacists
• Participate in drug therapy monitoring
• Stay abreast of the current state of knowledge
• Offer information and advice about therapeutic drug regimens and the
correct use of medications
• Familiar with the medication ordering system and drug distribution
• Never assume or guess the intent of confusing medication orders
• Pharmacists should maintain orderliness and cleanliness in the work area
and perform one procedure at a time
• Review an original copy of the written medication order.
• Use of automated devices is checked by manual or technological means.
• Dispense medications in ready to-administer dosage forms whenever
• Review the use of auxiliary labels
• Ensure that medications are delivered to the patient-care
area in a timely fashion after receipt of orders, according
to hospital policies and procedures.
• Observe how medications are actually being used in
patient-care areas to ensure that dispensing and storage
procedures are followed
• Review medications that are returned to the department
• Preview and provide advice on the content and design of
pre-printed medication order forms or sheets.
• Maintain records
• Electronic prescribing may help to reduce the
risk of prescribing errors resulting from
illegible hand writing.
• Computer generated and transacted order
system eliminates complex issues of transfer
of prescription and typographical problems.
However, effects of such systems on patient
outcomes remain understudied.
Recommendations for Nurses
• Familiar with the medication ordering and use
• Review patients’ medications with respect to
desired patient outcomes, therapeutic
duplications, and possible drug interactions.
• Verify order before administration
• Follow rule of right.
• When standard drug concentrations or dosage
charts are not available, dosage calculations, flow
rates, and other mathematical calculations
should be checked by a second individual
• Verify multiple drug entry and prescription
• Understand and explain use, care and caution on
the use of devises use in.
• Talk with patients or caregivers to ascertain that
they understand the use of their medications and
any special precautions or observations that
might be indicated.
• When a patient objects to or questions whether a
particular drug should be administered, the nurse
should listen, answer questions, and (if
appropriate) double check the medication order
and product dispensed before administering it to
ensure that no preventable error is made
Patients and Personal Caregivers.
• Inform and communicate
• Feel free to ask question
• Learn medicine and use.
• Adhere and take medicine.
Pharmaceutical Manufacturers and
• Involve pharmacists, nurses, and physicians in
decisions about drug names, labelling, and
• Look-alike or sound-alike trademarked names
and generic names should be avoided.
• Similar proprietary appearances of packaging
and labelling should be avoided, because look-
alike products contribute to medication errors.
• Special instructions should be highlighted on
• The most prominent items on the product
label should be information in the best
interest of safety.
• Appropriate packing
• Company communicate to health care
Use of technology to minimise error
• Health information technologies
– electronic prescribing,
– electronic health records,
– computerized provider order entry (CPOE),
– bar coding,
– automated drug-dispensing systems, and unit dosing
• Potentially reduce medication errors
• The most extensively studied of these
technologies is CPOE, which has been shown in
many studies to reduce medication errors.
Information technology Benefits Barrier
Provides patient information
to guide drug selection and
Not widely available or
Reduces errors related to
Systems may be
incompatible outside an
organization or institutionReduces errors related to use
of abbreviations and name
Legible prescription Patient data not up to date
Integrates drug formularies
Provides clinical decision-
making support with alerts
and reminders as prescriber
enters an order
High cost of
Double checks an order
before it goes forward
Not widely available
Assists with converting oral to
Take home question
• Automated prospective drug utilization review
• Electronic medication administration and
Information technology Benefits Barrier
Holds medications at a
specific location and allows
dispensing only to a specific
Not linked with bar coding
and electronic information
Helps to assess the full range
of medications a patient is
No communication with
Assesses drug allergies Doesn't fully assess
because of limited data
Identifies inappropriate drug
from adverse drug events
Ifs specific to the patient Restocking error
User's key is necessary for
User input error
Pharmacy review is part of
Information technology Benefits Barrier
Changes appearance of
medications to avoid errors
associated with similar
looking or similarly spelled
Cost of repackaging
Uses only one name and one
look for each drug, or uses
New packaging may not be
Is not mandated
Bar coding Automated record of medication
administration to specific patients
Check regulatory status
Verifies medications and
Administration on most drugs
Used in dispensing and
Cost of scanners
Counters the misreading of drug
names and dosages
Can introduce human error by
requiring manual loading of
equipment and bar-code
Limited and scanner bar cod
Packaging changes needed for bar
codes on unit doses
Problematic for doses such as half a
Cases and Example
Photograph showing almost similar looking ampoules of Inj. Ondoc-2 (Ondansetron) and Inj. Tramadoc
(Tramadol Hydrochloride) Inj ONDOC-2 (Ondansetron) is manufactured by Morepen Laboratories Ltd.
with embossed printing in red colour whereas inj TRAMADOC (Tramadol Hydrochloride) is
manufactured by Pharma Concepts, also with embossed printing in red colour
• Look-alike medications are identified and stored
HOW SIMILAR IS TOO SIMILAR/EXACT
• Visiting a website for same is easy but working
on the same to keep record and put it in
practice may difficult.
• Flood of medicine in pharmacy: How many
• A patient was administered 80 units of insulin
instead of the prescribed 8 units.
• The patient required emergency treatment
• The prescription chart was unclear. The
abbreviation ‘U’ was used for unit, which was
misread as a 0.
• A newly qualified staff nurse on a hospital
ward administered a Medication Dobutamine
to a patient via a IVF when it was prescribed
to be administered the patient required
monitoring, but was not harmed.
• A 78 year old man with human immunodeficiency virus (HIV)
accessed our hospital and was brought to our attention in August
2011 for severe renal failure. Clinical history revealed that he had
been taking highly active antiretroviral therapy with
lamivudine/abacavir and fosamprenavir since 2006.
• In April 2011 due to an augmentation in creatinine plasma levels, a
reduction in lamivudine dosage to 100 mg/day and the prescription
of abacavir 300 mg/day became necessary.
• Unfortunately, the patient took both lamivudine and abacavir
therefore the association of the two medications
(lamivudine/abacavir) lead to asthenia and acute renal failure
within a few days.
• Conclusions: This case emphasizes the importance about how
physicians must pay very careful attention during drug prescription,
most particularly, as far as elderly patients are concerned. In fact,
communication improvement between physicians and patients can
prevent increase of adverse drug reactions related to drug
dispensing, with consequential reduction of costs in the healthcare
L. Gallelli et.al. A case of adverse drug reaction induced by dispensing error.
Journal of Forensic and Legal Medicine. 2012; 19: 497-498
• A Pittsburgh pharmacist mistranscribes a
telephone Rx, which calls for two 0.25-mcg
Rocaltrol pills four times per day. Confusing
milligrams and micrograms, she writes down
two 0.5-mg pills four times per day. The
patient receives a dosage more than 2,000
times the recommended maximum. He is now
totally disabled, suffering from complex partial
seizures. The jury awards him $8 million in
• A Florida R.Ph. dispenses Cycrin, a female
hormone, instead of the Coumadin
prescribed. The patient takes the wrong drug
for 11 days before his wife discovers the error.
Two days later, he suffers a stroke and,
subsequently, a heart attack. In a coma, he
now resides in a special care facility. The
drugstore chain's insurance company agrees
to pay $6 million to settle the lawsuit.
• An South Carolina pharmacist dispenses
Glynase 6 mg instead of the Ritalin precribed.
The patient, a seven-year-old girl, ingests 16
times the recommended Glynase starting dose
for adult diabetes patients. She suffers
permanent brain damage and is mentally
retarded. The jury awards $16 million to care
for the child and to punish the drugstore
Disclosure of error
• There are few research work has been
reported in literature about the error.
• We have to think how strong and robust are
our reporting systems?
• Disclosure will be continue….