The Impact of the Perceived Expatriates` Leadership Styles

Safe Medication use in Paediatrics: A Challenge Related to
Information Capture, Management and Control
Ana Cibotaru and Monique Lortie
Sciences Biologiques, Faculté des sciences, Université du Québec à Montréal,
Montréal, Canada
[email protected]
[email protected]
Abstract: Paediatric studies on iatrogenesis show that adverse drug events constitute the main type of safety
problem. As a large proportion of the drugs used are unlicensed or off label, their prescription and use involve
many supplemental activities, to which the processing of information is central. The aim of this study was to
document problems related to the validation of prescriptions (by the pharmacist) and preparation of the drug (by
the nurse), particularly with regard to three issues: labelling, the use of dosage charts and disposal of the unused
portion of drugs. Method: Drugs presenting difficulties with regard to labelling, the use of dosage charts and
disposal of the unused portion of drugs were identified by a work committee. Three closed-ended questionnaires,
each presenting a set of statements (label: 10; dosage chart: 7; unused portion: 5) rated on a 4-point scale of
agreement, were filled out by ten paediatric nurses and five pharmacists. The validation of prescriptions (n=23
validations of 56 drugs) and the preparation of drugs (n=33) were observed (information taken down/searched
for/checked/exchanged, interruptions, unforeseen events). Results: As for labels, identification of the group or
name of the drug was the item most often assessed as unsatisfactory by both nurses (25% of 72 evaluations)
and pharmacists (34% of 73 evaluations). The dosage charts were assessed as unsatisfactory more often by
nurses (weight or volume units: 34%; age or dose limits: 51%) than by pharmacists. The latter could compensate
by using other sources of information. Observation data show the multiplicity of activities related to the search for
and exchange of information and the frequent interruptions involved. The study shows that capturing and
managing nurses and pharmacist’s knowledge on the difficulties encountered constitutes an approach upstream
of adverse drug events that could effectively complement the usual error-centred approaches.
Keywords: adverse drug events, children’s safety, label, dosage charts, knowledge management, difficulties
1. Introduction
Approximately 10-15% of health interventions lead to iatrogenic events, that is, secondary, unwanted,
and unplanned consequences (Michel et al, 2003; Baker et al, 2004). In the last twenty years,
research in this area has proliferated, and specialised conferences have been organised including the
Healthcare Systems Ergonomics and Patient Safety Conference (since 2005). Although it is more
difficult to situate the importance of iatrogenesis in paediatrics, studies clearly show that adverse drug
events constitute the main type of safety problem (Floret and Gay, 2005).
Normally, prescription drugs include indications that are subject to approval (e.g. dose, route of
administration) for the targeted population (e.g. age, gender), and provide technical and
pharmaceutical instructions (e.g. conservation). Off-label use consists in deviating from the
instructions indicated on the label. This practice has a long history and is replete with examples in
which drugs have been used for purposes other than those intended, including treating other diseases
(Landry, 2011). The present study refers to a group of drugs whose labels do not provide the relevant
indications, or do so in an incomplete way. In addition, these drugs do not usually arrive in a format
that is suitable for young children and infants. The concept of unlicensed use implies a priori that no
official authorisation has been granted for a particular use of the drug in question (e.g. preparing a
solution from tablets). Such drugs may not have been tested for use with children, or require untested
modifications. Although this situation has greatly improved, it remains a problem. For example, in the
study conducted by Conroy et al (2000) in five European countries, approximately half of drug
prescriptions were off-label (84%) or unlicensed (16%). This implies numerous manipulations and
calculations on the part of nurses – in order to prepare the right dose – and validation procedures on
the part of pharmacists.
The transfer of information – that is, communication - is considered a key issue (Perrin and Bloom,
2004), a drug being part of a chain involving various people (physician, pharmacist, nurse, auxiliary,
parent, etc.). The particular context of off-label and unlicensed use means that the prescription and
administration of drugs may be seen as a typical organisational learning context where existing
knowledge needs to be acquired and used and new knowledge created (Boerner et al, 2001) to fill in
the gaps related to missing data in order to improve safety.
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However, present approaches are mostly centred on errors (Napper et al, 2003) since the latter are
seen as avoidable (although adverse drug events are not all avoidable). Their aim is to document the
importance of errors and to better define them (when, where, who, etc.). However, when a problem
involves a high number of possible variables and is partly contextual (a particular drug, for a particular
child, in a particular setting, etc.), studies focusing on a limited number of variables and outcomes
may overlook factors that could be crucial to safety. The more upstream a safety study, the better it
can capture these factors. However, this implies putting the focus on what people know about their
problems or difficulties, a type of knowledge embodied and imbedded in subjects (KMT, 2012). It has
to be extracted in order to feed the flow of information and knowledge.
The aim of this study was to explore how a procedure centred on the difficulties encountered by
nurses and pharmacists in relation to specific prescription validation and drug preparation could help
capture their knowledge on these issues and identify needs and potential solutions.
2. What is known about drug adverse events in paediatrics
Errors may occur in selection (incorrect dosage, form, or the drug itself), calculation, dosing schedule,
route of administration (syringes can be used to administer or prepare the drug), dilution, and volume
(Stheneur et al, 2006). Among these, dosing errors are the most common type of error (Wong et al,
2004). Among dosing errors, calculation errors – and the use of equations in particular - have been
identified by some actors (Lesar, 1998), although others consider that dosage calculations are
standard, easy to perform, and usually do not require a calculator (Stebbing et al, 2007). While the
latter may be true for the majority of drugs used, there are exceptions, such as the drugs used for
anaesthesia, for which Garnerin et al (2007) showed that calculation errors – more common than
handling errors – were certainly not negligible (anaesthesiologists, 9% vs. 6.5%; nurses: 24% vs. 3%).
Dosage charts may also be used to calculate doses according to various factors such as weight, age,
and body surface area. These charts, however, have received less attention.
Drug labels constitute a well-recognised problem. The confusion surrounding the name of drugs and
their administration route was the object of an important and extensively documented report in Europe
(Expert Group on Safe Medication Practices, 2006). The information presentation format and the
possibilities for standardisation have received particular attention (Vredenburgh and Zackowits, 2009).
The vast majority of medications are prepared by nurses, who generally also administer them (Fontan
et al, 2004). This preparation may require many manipulations: dividing/crushing of solid drugs,
dilution in a liquid for small children, dosing with a syringe. Since, for most drugs, the dose to be
prepared is less than the minimum dose available, the unit must be diluted, even double diluted. The
tools used have been shown to not always be appropriate. For example, the smallest available
syringe (1 ml) is still too big (Brion et al, 2002) for some injected doses. Yet, in some cases, the
accuracy of the dosage may be crucial. Also, this leaves unused portions to be managed. Discarding
them – a simple solution – represents a significant cost, in particular for expensive drugs. If stored,
they must be accurately documented.
The average duration of preparation is not long (approximately two minutes for oral solutions and
packets, three minutes for tablets, and five minutes for injections; Fontan et al, 2004), but varies
considerably.
3. Method
3.1 Methodological choices
Current studies tend to focus on iatrogenic events themselves in order to determine their importance
and context of occurrence, namely: who, when, where, in doing what, what went wrong? We opted,
rather, for a descriptive case-study approach – in order to document in a practical and precise way
the factors involved in real-life work situations (Grant, 2012) – and a participatory approach. We also
integrated a safety perspective.
In safety approaches, the focus is on the situation (usually a piece of equipment or a context) which is
selected because it could (or is known to) lead to accidents. A situation is typically subdivided into
smaller elements (operations, phases or parts) and the risk is assessed – not measured – through
three components: exposure (how many people, how often), what can happen or how the procedure
can deviate, and the possible severity or consequence in the case of an accident (Stamatis, 2003).
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These analyses combine documentation of past incidents or accidents with experts’ or operators’
analyses of safety problems. In the present study, the exposure and impact of a wrong dosage (of the
most often used drugs) were assessed by a hospital committee (and the personnel), in order to
identify which drugs to investigate. Drug labels or charts were divided into specific elements or steps,
as for any equipment. At this point, the purpose was not to raise all drug-related difficulties but rather
to identify specific difficulties related to specific drugs.
The results of safety analyses are also used to feed the decision-making process and to orientate the
type of solutions to be developed. The latter are usually specific and technical: redesign, improved
maintenance, improved control, new safety procedures, etc. In fact, it is also their main limit – and
criticism – as they do not take account of more general factors such as the decision-making process.
However, multiplying the number of situations examined, and adding a complementary observation
procedure opens up the perspectives.
Targeting specific drugs and elements was also a methodological choice based on the literature on
questionnaire and elicitation procedures (Vermersch, 1994). We know that it is easier and more
reliable to ask about specific and concrete elements (e.g. the font size on this label for this specific
drug) and that large audits have been shown to be deceptive (Morimoto et al, 2004).
Finally, we chose to anchor the study in the concept of difficulty. It is reasonable to infer that
difficulties increase risks. Difficulties may correspond to the “black swans” referred to by Flyvbjerg
(2006), who advocates the pertinence of identifying problems or deviations through in-depth case
studies. Their identification may help to seek practical solutions to decrease them. When a difficulty is
systematic, it will also provide cues for more generic solutions. However, difficulties are usually
contextual and related to the person and his/her own background.
3.2 Hospital and staff
The study was conducted in a large general hospital in Montréal (685 beds) with a paediatric
department of 39 beds, where 30 nurses and 6 auxiliary nurses worked on three shifts. The pharmacy
consisted of 46 pharmacists and 60 assistants/technicians. The validation of paediatric prescriptions
represented a small portion of the work (1%), and no staff was specifically assigned to this task. Ten
nurses (one auxiliary) and five pharmacists agreed to participate in the study.
3.3 Study
A monitoring committee consisting of eight persons (Head of Paediatrics, Head of Pharmacy, Head of
Clinical Care Unit – Paediatrics and Paediatric Outpatient Clinics; Assistant Director of Nursing –
Clinical and Research Section; Clinical Advisor – Quality of Care and Nursing Services, Department
of Nursing; Quality and Risk Management Advisor; and two clinical nurses) participated in the
organisation, coordination, and follow-up of the study, validation of the questionnaire, and approval of
the preliminary results. A working committee of three persons (Head of Paediatrics, Head of
Pharmacy, Head of Nursing – Paediatrics and Paediatric Outpatient Clinics), who also participated in
the identification of the drugs, ensured day-to-day coordination. Instructions were to identify drugs, for
both the pharmacists and the nurses (21 vs. 18 drugs), that either posed a problem or for which an
error related to labelling, the accompanying dosage chart, or the storage of unused portions could
present significant consequences.
A questionnaire was developed for each topic and the drugs listed were specific to each topic and
each group. Questionnaires were distributed sequentially over a period of eight months. Observations
of prescription validations (n = 23 validations of 56 drugs; usually 1-5 drugs per validation sheet) and
the preparation of 19 drugs (n = 33 observations) were conducted in parallel. Since it was difficult to
predict the nature and occurrence of events, observations took place at various times (n=10). The
drugs observed were not necessarily the same as those listed in the questionnaires.
3.4 Tools
The three closed-ended questionnaires listed a set of statements to be rated on a 4-point scale of
agreement (from "strongly agree" to “strongly disagree"). With some exceptions, statements were
formulated as problems (e.g. the font size is too small). The labelling questionnaire (10 statements;
nurses: 10 drugs; pharmacists: 15 drugs) explored three aspects: format of information presented
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(e.g. contrast, font size), nature of information presented, and difficulties related to use. The dosage
chart questionnaire (7 statements; nurses: 5 drugs; pharmacists: 6 drugs) explored two aspects:
information presented and use (e.g. easy to find). The unused portion questionnaire (7 statements;
nurses: 3 drugs) covered three topics: sources of difficulty, impact on activity, and possibilities for
improvement. Pharmacists were not surveyed on this issue because of a recent policy requiring them
to discard all unused portions within one hour.
Observations were based on the “chronicle of activity” technique used in ergonomics (Guérin et al,
2007). This involved in situ observations, without pre-established grids, in which all actions were
noted along with concomitant events. The resulting raw material was then organised accordingly. The
data also include explanations or spontaneous comments by the observed participants.
Three sources of artefacts were collected: labels (or packaging) of the drugs listed in the first
questionnaire, dosage calculation charts used and drug monographs (online) consulted to complete
information.
3.5 Analyses
Questionnaries: answers were grouped into two categories (agree-disagree) used to rate the
occurrence of a problem. For a given drug or type of problem, degree was calculated as follows:
agree / ( agree + disagree) ×100.
Observations: a technique adapted from the Merseyside Accident Information Model (Ralston et al,
1994) was used. This technique is based on the classification of verbs used to describe an accident.
The observation of an action takes the form of a verb followed by a direct object (who, what) or
indirect object (from whom, from what, with what, where, etc.). Verbs were grouped according to
whether they indicated gathering, actively seeking, verifying, exchanging, or transmitting information.
Events were grouped according to whether they were interruptions or unforeseen events. Frequent
moving about was identified and grouped according to area (indoors or outdoors). This data
organisation made it possible to calculate occurrences and establish links between various elements.
Artefacts: for the labels collected, the number of characters per 0.5 cm was counted. This data was
compared with the dissatisfied responses regarding font size. The analysis was qualitative since a
single label may contain a variety of font sizes. Information from dosage calculation charts and
monographs was classified according to the nature of the information provided or missing.
4. Results
4.1 Labelling
In general, pharmacists printed the labels, while nurses used commercial labels (except for drugs
prepared at the pharmacy). Overall (see Table 1), nurses were more likely to be dissatisfied
compared to pharmacists. For the latter, except regarding contrast, the format of the information did
not often pose a problem; distribution of responses was essentially the same from one drug to
another. Nurses, on the other hand, made clear distinctions between drugs.
The item most often perceived by nurses as unsatisfactory was font size. Analysis of the labels shows
that the critical threshold at which dissatisfaction was apparent was about six characters per 0.5 cm.
Some information was printed at 11 characters per 0.5 cm. By way of comparison, Arial 10 pt. gives
three characters per 0.5 cm and Arial 5 pt. gives six.
Nurses were also significantly more dissatisfied compared to pharmacists regarding the information
provided. Both considered that the information on drug names or groups was unclear.
4.2 Dosage calculation charts
Nurses were more dissatisfied with dosage calculation charts than pharmacists. Nurses were
dissatisfied at least four times out of ten for each item (see Table 1). Pharmacists tended to use
charts provided in books. For example, for four of the drugs, pharmacists consulted the Paediatric
Dosage Handbook with International Trade Names Index (Taketomo et al, 2010). About half of the
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time, both pharmacists and nurses reported having to use another source of information. The most
unsatisfactory information concerned age and dose limits.
Analysis of information provided in the monographs for the 28 drugs surveyed showed that none
indicated complete dosage schedules. Twelve, however, included at least one indication for children's
dosages. For half of these, information on age and weight was incomplete.
4.3 Unused portions
The greatest sources of dissatisfaction concerned workspace layout (lack of space) and available
tools. The processing of unused portions required many operations that hindered work. Nurses
preferred to discard unused portions rather than conserve them. Often, unused portions had to be
discarded regardless because of missing information (e.g. opening or expiration dates).
Table 1: Distribution of unsatisfactory responses for labels and dosage calculation charts
Information
Item
Nurses
Pharmacists
Label
Presentation
Clarity
Use
Presentation
Use
Difficulties
Use
Room for
improvement?
Location
11%
Font
Size too small
Contrast
Name/group
Dosage
Route of administration
Difficult
Emergency (problem)
Confusing
Dosage chart
14%
21%
17%
25%
27%
15%
25%
20%
11%
Lack of information
Layout
Age or dose limits
Weight or volume units
40%
39%
51%
34%
Emergency
57%
Easily accessible
Requires another method
Unused portion
Storage conditions
Tools available
Time
Workspace layout
No. of manipulations required
Difficult
Easy
56%
47%
18%
45%
22%
77%
50%
22%
63%
1%
15%
22%
18%
41%
13%
5%
42%
34%
6%
0%
0%
16%
13%
13%
27%
24%
27%
13%
23%
15%
9%
24%
50%
20%
55%
34%
40%
36%
63%
4.4 Drug validation, preparation, and administration
The work of nurses and pharmacists differs substantially. Observation did not make it possible to
characterise cognitive activity but mainly identified perceptual elements associated with cognitive
activity, such as looking and listening. Activities noted in Table 2 were generally distinguished by the
direct or indirect object used to describe them. As shown in the results, information gathering and
seeking activities were significant and numerous, as were communication activities.
Nurses were distinguished from pharmacists by the objects they used to describe information
gathering or verification, which on the one hand, were greatly varied, and on the other hand, often
concerned non-written information. Perceptive activities were frequent and involved processing
signals of various kinds, for example, assessing a child's condition or deciding where to insert the
needle or how to position oneself. Dose was the most common object of attention. Verbal exchanges
were also notably more frequent.
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Pharmacists, for their part, were rarely information seekers, unlike nurses (e.g. learning more about a
child). In both cases, the transmission of information – mainly written for pharmacists – was significant
in terms of frequency, not in single actions, but rather in multiple actions over time.
The work of processing information was often interrupted. For pharmacists, the main cause was
related to requests for information received mostly in person. A second source related to having to
move around to get something. Among nurses, interruptions from other people were less frequent but
generally required immediate attention because they concerned a child. In fact, the management of
information was most often interrupted by having to move around, for example, to fetch additional
information or tools, or to complete a part of the preparation at another location. Nurses also often
complained about workspace, which they considered inadequate for drug preparation. Frequent
moving around was also reported as interfering with information processing and drug preparation
itself.
Table 2: Information processing activities and contextual elements
Information
Nurses
33 preparations/administrations
Prescription (74)
Monitor (21)
Bracelet (12) Child (3)
Label (11)
Calculator (9)
Dosage chart (7)
Prescription (6)
Written (119)
Oral (51)
Contextual elements
Colleague (29)
Child (24)
Parent (15)
Child (6)
Telephone (3)
Other (4)
Immediately
Gathering, seeking,
computing,
checking,
171
Transmission
170
Verbal
communication
68
Interruptions
13
Answering
10
Moving about
151
Fetching, preparing, discarding,
putting away/back, etc. (119)
Seeking information, answering
questions (32 / 27 external)
Use of computer
Prescriptions
10
Reading (6), taking notes (4)
Pharmacists
23 validations / 56 prescriptions
177
File/computer (74)
Prescription (53)
Book (21)
Calculator (29)
99
Written (90)
Oral (9)
9
Another pharmacist (7)
Technician (1)
Other (1)
Person (22)
Telephone (8)
30
26
5
13
Immediately
Need to search (postponed)
Fetching (book, calculator) (9)
Validating (2)
Being interrupted (2)
115
102
Files
Gathering (53), transferring data
(49)
5. Discussion and avenues for improvement
5.1 Difficulties identified
Over the last 20 years, European institutions (Council of the European Communities, European
Parliament, etc.) have issued various guidelines (e.g. 1992/27/CEE, 2001/83/EC) regarding
information provided on labels and packaging leaflets for medicinal products (drug name, dosage,
pharmaceutical form, etc.). Clearly, problems remain, in particular, the naming of drugs. For
pharmacists, printing their own labels partly solves the problem. However, the lack of contrast on
these printed labels shows that small technical problems have not been captured and relayed in the
system.
Nonetheless, nurses were less often dissatisfied then might have been expected, and observations
revealed that they do not often look at labels, unlike prescriptions. They favour other sources of
information and compensate for the lack of information in different ways, in particular, by consulting
others. Pharmacists can also consult different sources. Communications activities are frequent and
are even a source of interruption and distraction.
Dosage charts present difficulties in significant proportion for both nurses and pharmacists. There
may not be a consensus regarding dosage charts and calculation in the literature. However, who
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better than a user will know whether or not a chart presents a difficulty? Complementary analyses
confirmed that the information provided was insufficient.
Observations provided cues regarding underestimated factors that may be important to consider in
the future: The processing of information was often interrupted, even though both the validation of
prescriptions and preparation of the drug require attention and vigilance. The personnel, especially
the nurses, were often required to move about during the preparation of the dose. This is a typical
symptom of inadequate workspace layout. It also contributed to interrupting the processing of
information and increased the risk of errors.
To summarise the results: the current system is deficient in terms of information: information is
insufficient, wrongly formatted and the conditions in which it is processed are often adverse.
5.2 Methodology
Analyses of safety problems in iatrogenesis remain modelled on epidemiological approaches
developed in health. Their anchoring is downstream, with a focus on outcomes – incidents or errors –
and on the individual. They therefore underestimate the factors linked to the system and their
interactions. Human factors are understood mainly in terms of the role humans play in errors,
although the discipline itself aims to favour a better fit between the components of a system and
human capacities. While the taxonomy of errors is well developed, the characterisation of the
conditions that would be appropriate for validating a prescription or preparing the right dose is vague.
Certainly, very large and strict studies are necessary. However, they necessarily miss details that are
important in terms of understanding safety issues and providing short-term operational solutions.
Flexibility is also important in order to identify unexpected factors, such as workspace layout and
frequent moving about. There is thus also a need for open observation procedures, even though the
subsequent analyses are admittedly more complex.
5.3 Avenues for improvement
Three main features characterise the avenues of prevention proposed in the literature: they are often
of a strategic nature (e.g. positioning safety within the organisation, identifying priorities (Perrin and
Bloom, 2004)); they target outcomes (e.g. recording errors or critical incidents); and they propose
various solutions (e.g. increasing the participation of clinical pharmacists, implementing information
technology or computer-based decision-making (Fernandez and Gillis-Ring, 2003) or improving
communications (Fortescue et al, 2003)). These are complemented by a set of recommendations on
specific issues such as labels.
An organisation learns from mistakes and errors: it can also learn from difficulties, which requires
involving the personnel to capture what they know or don’t know and to seek solutions with them.
Thus, we propose a more modest and hospital-based approach with three aims: 1) identifying missing
information in order to provide what is needed (making information available may be more important
than standardising it; 2) improving the workspace layout in order to favour better continuity in the
processing of information; 3) identifying specific difficulties related to the dosage of drugs with
possible severe consequences. Computer technologies could be used more to favour local or
regional networking to exchange information and less to put standards in place.
Our approach favours simple and specific questions on specific (and limited) points to bring out
difficulties and organise the search for solutions, such as the printing of local labels (as pharmacists
do) to get around the problem of inadequate labels. It would be useful to put in place a learning
process whereby solutions found in one case could be applied to other situations. This will only be
possible, however, if this task is integrated into the work organisation, if adequate time and resources
are allocated to it, and if a local network is favoured.
6. In conclusion
This study shows that information management is central to safety issues in paediatrics. However,
information management cannot be understood unless we go to the source of the activities and
capture the knowledge of those who face these issues on a daily basis.
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