ORIGINAL PAPER
Nig. J. Pharm. Res. 2019, 15 (1) pp 107-114
ISSN 0189-8434, e-ISSN 2635-3555 Available online at http://www.nigjpharmres.com
Pediatric Suspension Usage & Reconstitution Practices of Mothers in Zaria,
Northwestern Nigeria
A. B. OLORUKOOBA*1A-F, S. N. ABDU-AGUYE2A-F, A. A. OLORUKOOBA3A-C, L. O. INIAGHE4A-F
1
Department of Pharmacology & Therapeutics, Faculty of Pharmaceutical Sciences, Ahmadu Bello University,
Zaria, Nigeria
2
Department of Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmaceutical Sciences, Ahmadu Bello
University, Zaria, Nigeria
3
Department of Pediatrics, Ahmadu Bello University Teaching Hospital, Shika, Zaria, Nigeria
4
Department of Pharmacology, Faculty of Pharmacy, University of Benin, Nigeria
A – research concept and design; B – collection and/or assembly of data; C – data analysis and
interpretation; D – writing the article; E – critical revision of the article; F – final approval of article.
Abstract
Background: Dry powders for suspension are a common type of drug formulation used for children. Studies have
shown that mothers and/other caregivers often have difficulties correctly reconstituting these powders, and accurately
measuring out doses.
Objectives: To describe the pediatric suspension usage practices, reconstitution techniques and medication related
knowledge of mothers attending the antenatal clinic of Ahmadu Bello University Medical Center, Zaria, Kaduna state.
Methods: A data collection instrument was used to interview 101 conveniently sampled women in October 2018.
After answering the questions in three sections of the instrument, respondents were given a bottle of water and a
medicine bottle containing flour. They were then asked to show the researchers how they would normally reconstitute
a suspension, and asked to measure out specific doses using a measuring cup.
Results: Almost 40% of mothers stored reconstituted medication in the fridge, and less than 20% would administer a
forgotten dose when they remembered and continue with the previous dosing times. Regarding reconstitution
techniques, 26.7% of mothers initially shook the bottle to loosen the dry powder before adding water, and 39.6%
added water in two steps. Less than 10% of respondents could correctly measure 7.5 mL using a measuring cup. Over
40% of them could not accurately calculate medication dosing times in the hypothetical scenario provided to assess
their medication related knowledge.
Conclusion: The results show that some of the usage practices and reconstitution techniques of the mothers were sub-
optimal. Pharmacists can help mothers reconstitute suspensions as part of their pharmaceutical care responsibilities.
Keywords: Mothers, Nigeria, Pediatric suspensions, Reconstitution technique
INTRODUCTION marketed in ready to use form like in the case of
pediatric Ibuprofen and Co-trimoxazole suspensions,
Oral suspensions are a common dosage form for or come in powder form for reconstitution just before
pediatric medications. They offer several benefits like use.
making the administration of child-specific doses Given the prevalence of several infectious diseases
easier and eliminating difficulties associated with (IHME, 2018) and malaria (WHO, 2017) in Nigeria, it
getting children to swallow tablets (Juárez-Olguín et would be expected that anti-infective medicines are
al, 2008). In addition, the oral suspensions of certain very commonly used in children. Children are
medications are more rapidly and better absorbed than particularly vulnerable to infections because of their
their solid oral dosage forms (Tan, 1995). Depending developing immune system, and infectious diseases
on the active ingredient(s) present, suspensions can be account for a sizeable portion of the country’s under-
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five mortality rate (Fadare et al., 2015). It is therefore measuring out doses. One study in Taiwan, reported
not surprising that several studies on pediatric drug that only 2% of caregivers were able to correctly
utilization patterns within the country, have reported identify steps to reconstitute antibiotic suspensions
that antibiotics and antimalarials are some of the most after reading the medication leaflets (Hu et al., 2013).
prescribed medicines for children (Fadare et al., 2015; Another study carried out in Canada reported
Nduka et al., 2017). One study carried out in the relatively similar findings, with 46% and 56% of
pediatric clinic of a tertiary hospital in southwestern caregivers incorrectly reconstituting two different
Nigeria reported that the most prescribed drugs were pediatric antibiotic suspensions (Berthe-Aucejo et al.,
antibiotics-in over 70% of patients-and antimalarials 2016). Similarly, problems have also been reported
(Fadare et al., 2015). Another study on pediatric with caregiver medication measurement practices
prescribing patterns in two teaching hospitals in south when using a variety of medication measuring devices.
eastern Nigeria reported similar results (Nduka et al., Estimates of caregiver error rates from these studies
2017). In both studies, the most commonly prescribed range from 50% - 80% (Almazrou et al., 2014; Berthe-
antibiotics were the penicillins and cephalosporins; the Aucejo et al., 2016; Yin et al., 2016).
pediatric formulations of which are marketed as To the best of our knowledge, no study has been
powders for reconstitution. Similarly, several of the carried out to assess caregiver reconstitution and
most commonly used antimalarials for children-drugs medication measurement within Nigeria.
in the Artemisinin Combination Therapy (ACT) class Consequently, the aim of this study was to describe the
(Udoh et al., 2013; Fadare et al., 2015) also come in pediatric suspension usage practices, reconstitution
powder form. techniques and medication related knowledge of
Several studies have shown that mothers and/ other mothers attending antenatal clinic at Ahmadu Bello
caregivers often have difficulties correctly University Medical Center, Zaria, Kaduna state.
reconstituting pediatric suspensions and accurately
METHODOLOGY
Study Site
This study was carried out at Ahmadu Bello Data Collection Instrument
University Medical Centre, a secondary hospital A data collection form was designed for the study. The
which offers a variety of general and specialist first section of the instrument collected data on the
medical services and serves the population of Samaru demographic characteristics of the participants
and environs in Zaria, Kaduna State. The antenatal including age, highest level of education completed
clinic of the hospital was chosen because one of the and number of children. The second section contained
study objectives was to assess reconstitution technique questions that aimed at assessing respondents’
of mothers. Hence, we wanted to recruit women when practices when reconstituting, using and storing oral
they did not have any child/children present to distract suspensions. This section contained a mix of open and
them. close ended questions. The third section contained a
“yes or no” checklist that was used to assess the
Study Design and Sample Size Calculation women’s suspension reconstitution and measurement
The study was a prospective observational study. All techniques. This checklist was created from a training
of the women attending antenatal clinic at the study video on how to reconstitute pediatric suspensions,
site were eligible to participate if they provided verbal created by the National University Hospital in
consent, currently had at least one child aged five years Singapore (NUHS, 2017). Finally, the fourth section
or below, had completed primary level education at the contained seven questions that tried to assess
minimum and understood either English or Hausa. A respondents’ abilities to comprehend, calculate and
sample size could not be calculated for the study process patient-specific information about paediatric
because there were no records of the total number of medications. A hypothetical scenario was created
women attending the clinic at any given time. Women around a bottle of paracetamol syrup. In addition to
could walk in on any of the four clinic days per week, other questions, mothers were asked about the
and be attended to. Thus, no sample size was indication of the drug and asked to calculate dosing
calculated and recruitment was time based. times if the drug was to be administered at eight hourly
Consequently, data was collected all through the intervals etc. (See Table 1 for the questions asked in
month of October 2018 (four days per week, for four this section).
weeks).
Data Collection
Data was collected by interviewing respondents. All
women attending the antenatal clinic during the study
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period were initially approached by the investigators and 7.5 mL doses using a measuring cup that had 2.5
and asked whether they had other kids. If they mL, 5 mL and 10 mL markings. If they correctly
answered yes, they were then asked about the age of carried out a step on the checklist, a “yes” response
their youngest child. If the child was less than five was recorded, otherwise a “no” was written.
years, they were informed about the study objectives The seven questions in section four had right or wrong
and invited to participate. If they agreed, they were answers. Two photographs were printed out and used
then asked the questions in sections one and two of the as props for some of the questions in the section. The
data collection instrument. Answers to the open-ended first photograph showed the front packaging of a bottle
questions in section two, were transcribed verbatim. of paracetamol syrup containing both brand and
For the checklist in section three, a specially designed generic names, and the strength of the drug in mg/5
label for a hypothetical drug containing written mL. The second picture showed the ingredient side of
reconstitution instructions was created for the study. the packaging of a paracetamol-containing cough
This label was stuck on glass medicine bottles and two preparation. Women would be given one of the
tablespoonfuls of maize flour put into each bottle. relevant pictures and allowed to study it for a while,
Each mother was given one of these flour containing before they were asked the question they needed it to
medicine bottles and a bottle of water and asked to answer. They were allowed to study the prop(s) for as
show the researchers how she would normally long as they wanted, and were encouraged not to
reconstitute a suspension at home. After guess, and instead-admit they were unsure.
reconstitution, they were asked to measure out 5 mL
Table 1: Questions asked to assess medication related knowledge of the mothers
1. What drug does the medicine in the picture contain? (First Picture) ______________
2. What symptoms can it be used to treat? _____________________________________
A doctor tells you to give your child 5 mL of this medicine every 8 hours.
If you give your child the first dose at 7 a.m. in the morning, what time should you administer
3. The second dose ________
4. The last dose ___________
A container of this medicine contains 50 mL of syrup.
5. Do you have enough syrup to use for five days, if you use it the way the doctor recommended in the
previous question? ___________________________________________
On the carton of this medicine, you see the following instruction “Do not use this medicine with other
paracetamol containing products”.
6. Your child develops catarrh and you buy a new medicine for him (Second Picture). Should you give
your child both medicines at the same time? ________________________________
If the expiry date of a medicine is 19/06/18.
7. Is the medicine safe for use? __________________
STATISTICAL ANALYSIS respondent was unsure. For the second question in this
Data was coded and entered into a Microsoft Excel section, if a woman provided at least one correct
2013 sheet (Microsoft Corp, US) for analysis, and answer for the use of paracetamol syrup, she was
descriptive statistics (frequencies & percentages) used scored the whole point. A total score/8 was then
to report the results obtained. Data from the open- calculated for each participant.
ended questions in the second section was analyzed One-way Analysis of Variance (ANOVA) test was
using summative qualitative content analysis by used to test for statistically significant differences in
grouping similar responses together and quantifying mean medication knowledge score (dependent
them. For the seventh questions in the fourth section, variable) across the various demographic sub-groups
“1” point was assigned for every correct answer, while (independent variables).
“0” was given for every wrong answer or if the
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RESULTS
Demographic Characteristics of Respondents mostly government employed (44.6%), and 36.6% of
Half (48.5%) of the mothers were aged between 26-30 the mothers had at least one child. For those who
years. Around 40% had completed either a Bachelor’s earned an income, majority of the mothers fell into the
degree /Higher National Diploma (38.6%). They were income bracket of N18, 001 - N50, 000 (Table 2).
Table 2: Demographic Characteristics of Respondents
Characteristic Variable n (%)
Age range (years) Less than 25 16 (15.8)
26-30 49 (48.5)
31-35 22 (21.8)
Above 36 14 (13.9)
Highest educational level completed Primary School 4 (4.0)
Senior Secondary School 25 (24.8)
NCE/OND 17 (16.8)
Bachelor’s degree/HND 39 (38.6)
Masters 12 (11.9)
PhD 4 (4.0)
Occupation Government employed 45 (44.6)
Self employed 11 (10.9)
Stay at home mum 23 (22.8)
Student 22 (21.8)
Number of children 1 37 (36.6)
2 24 (23.8)
3 22 (21.9)
4 or more 18 (17.8)
Income < 18, 000 NGN 2 (3.7)*
NGN 18, 000 – N50,000 30 (55.6)
NGN 50, 001 –N100, 000 4 (7.4)
> N100, 001 NGN 18 (33.3)
NCE-National Certificate of Education, OND-Ordinary National Diploma, HND-Higher National Diploma, PhD- Doctoral Degree,
NGN-Nigerian Naira, * Values in cell do not sum up to total because only women who were working responded to the question
Majority of the mothers (n=93, 92.1%) reported they normally did if they forgot to give their children
having used at least one medication in dry powdered a dose of suspension at the right time, different actions
form that required reconstitution within the last six were reported, though 19 (18.8%) respondents said
months. When asked about the reason for use of these they had never forgotten to give a dose before. Almost
medicines, most of them (n=77, 82.8%) said they were half (48.8%) of those who answered the question said
prescribed for a wide variety of ailments. they would give the dose when they remembered, and
Respondents said they obtained information on how to adjust subsequent timing (Table 3). In the same vein,
reconstitute these dry powders from health care when asked what they would do if their child vomited
providers or vendors at point of purchase (n=47, immediately after a dose of suspension, most of the
46.6%), or from the drug packaging and/ information mothers (74.3%) said they would repeat at least some
leaflets (n=47, 46.6%). When asked whether they had of the dose (Table 3). However, the actual quantity of
ever used leftover reconstituted suspension for another dose they would re-administer varied widely and was
illness, 98 of them (97%) said no. dependent on several factors including the quantity of
Many of the mothers (62.4%) did not keep drug seen in the vomitus. In addition, while some
reconstituted suspensions in the refrigerator (Table 3). mothers would repeat the vomited drug immediately,
These women reported that they kept the suspensions others would wait for up to an hour before re-
in various locations including on tables, in baskets or administering the medication.
cupboards, and even under beds. When asked what
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Table 3: General Suspension Usage Practices of Respondents
Variables n (%)
Type of water used to reconstitute dry powder Bottled water 60 (59.4)
Sachet water 23 (22.8)
Boiled and then cooled water 18 (17.8)
Storage location of reconstituted suspension Refrigerator 38 (37.6)
Others 63 (62.4)
Respondents action if they forgot to give their child a dose of Skip dose 27 (32.9)*
suspension at the right time Give dose on remembering, 40 (48.8)
and adjust timing of
subsequent doses
Give dose on remembering, 15 (18.3)
and continue with usual timing
Respondents action if their child vomited immediately after Would repeat dose 75 (75.8)*
taking a dose of suspension Would not repeat dose 24 (24.2)
* Values in cell do not sum up to total because some respondents did not answer
Reconstitution & Measurement Techniques (67.3%) did not read these instructions (Table 4).
Despite the fact that there were detailed reconstitution Similarly, most of them did not first shake the bottle
instructions written on the medication label that was to loosen the powder (73.3%), add water in two steps
designed for the study, majority of the mothers (60%) or correctly measure out 7.5 mL (86.1%).
Table 4: Reconstitution & Measurement Technique of Respondents
Assessment items Yes No
n (%) n (%)
1. Read instructions on label 33 (32.7) 68 (67.3)
2. Shook bottle to loosen powder 27 (26.7) 74 (73.3)
3. Added water halfway to the mark 40 (39.6) 61 (60.4)
4. Shook bottle to mix the suspension while looking out for clumps 79 (78.2) 22 (21.8)
5. Added up the remaining water to the required mark 40 (39.6) 61 (60.4)
6. Correctly measured out estimated 5 mL volume at eye level 58 (57.4) 43 (42.6)
7. Correctly measured out estimated 7.5 mL volume at eye level 14 (13.9) 87 (86.1)
Assessment of Medication Related Knowledge
Total scores in this section ranged from 3-7, and the Using the One-Way Analysis of Variance (ANOVA)
average score was 5.2. All of the mothers were able to test, there was no statistically significant difference in
correctly identify Paracetamol and state at least one average total scores across the various respondent age
correct indication for use of the drug. Majority of them groups (p=0.64). No differences in mean total test
were also able to correctly identify the scores were also seen when the scores were stratified
contraindication in question six (91.1%), and correctly into groups based on the number of children the
interpret the expiry date in question seven (96%). women had (p=0.24), or the highest educational level
Conversely, they generally performed poorly on they had completed (p=0.99)
questions requiring calculation (Figure 1).
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Medication identification 100%
Knowledge of drug indication 100%
Dosage timing 1 58.4%
Dosage timing 2 52.4%
Dosage calculation 24.8%
Identify contraindication 91.1%
Understand expiry date 96%
% Correct
FIGURE 1: Correct responses to the questions assessing medication related knowledge
DISCUSSION
The aim of this study was to describe the pediatric Missed doses-either due to forgetfulness or vomiting
suspension usage practices, reconstitution techniques in the recipient can affect the efficacy of anti-infective
and medication related knowledge of respondents. treatment (NHS, 2016). Almost half of the mothers in
From our results, less than half of the mothers stored this study said that they would give a forgotten dose
reconstituted medication in the fridge, and less than immediately they remembered, and adjust subsequent
one-fifth would administer a forgotten dose when they dose timings. Ideally, when the dose of an anti-
remembered and continue with the previous dose infective drug is missed, that dose should be
timings. With regards to reconstitution and administered to the child as soon the mother
measurement techniques, majority of them did not remembers, and the normal dosing schedule
initially shake the bottle to loosen the dry powder, or maintained (NHS, 2016). Similarly, with regards to
add water in two steps. In addition, very few vomiting-majority of mothers in this study said they
respondents could correctly measure 7.5 mL using the would repeat the vomited dose. However, the actual
measuring cup. Finally, while all of the mothers were quantity of dose they would re-administer varied
able to correctly identify Paracetamol and state at least widely, and was generally based on maternal
one correct indication for use of the drug, they did not discretion. Other studies have also reported sub-
do very well on the questions requiring calculations. optimal medication re-administration practices by
Dry powders for suspension require clean water for mothers/caregivers after vomiting occurs in sick
reconstitution, and proper storage conditions to children (Sil et al., 2017; Hassan et al., 2018). The
maintain their stability (Al-Ramahi et al., 2015). current consensus from experts is to re-administer the
While most mothers in this study used appropriate entire dose of vomited medication if it is visible in the
sources of purified water, many of them admitted to vomitus or if vomiting occurs within 15 minutes or
storing reconstituted medication outside the fridge. A less after ingestion of the dose (Kendrick et al., 2012).
study in Palestinian mothers reported similar Suspension reconstitution and dose measurement
findings,-with almost half of their respondents also not errors are very common sources of medication
storing reconstituted suspensions in refrigerators (Al- administration errors in pediatrics (Berthe-Aucejo et
Ramahi et al., 2015). While refrigeration might not be al., 2016). Interestingly, while almost half of mothers
necessary for suspensions used for relatively short said they obtained information on how to reconstitute
periods (three days or less), it is essential for others - suspensions from written instructions on packaging or
especially antibiotics that may be used for longer medication bottles, only around a third actually read
periods. A study has shown that pediatric antibiotic the instructions on the bottle given to them during the
suspensions stored at room temperatures within the assessment. Given the large number and varieties of
country rapidly degrade and lose potency over a period suspensions available within the country, mothers
of one week (Nwokoye et al., 2012). This highlights reconstituting suspensions without first reading
the need for pharmacists to provide adequate instructions may be potentially harming their children.
directions to mothers/caregivers on how to properly Most of the mothers also did not first shake the bottle
store medication. to loosen the powder. This can cause difficulties in
forming a homogenous suspension (Berthe-Aucejo et
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al., 2016). Similarly, while a few suspensions require to do some calculations (Wallace et al., 2012; Ubavić
a fixed volume of water to be added in a single step, et al., 2018)
others do not. For these other suspensions, adding Limitations of this study include the fact that women
water in two steps allows for better mixing and the from only one hospital were surveyed and no sample
final solution is more likely to be of the desired size could be calculated, thus potentially limiting the
concentration (Berthe-Aucejo et al., 2016). Many of generalizability of the results. In addition, as earlier
the mothers in this study did not add water in two mentioned, we were unable to measure the actual
steps. Furthermore, when mothers were asked to volume of suspension measured out by respondents.
measure out 5 and 7.5 mL doses using a measuring Thus, we only visually assessed measurement
cup, several of them did not measure either dose at eye technique.
level. While we were unable to quantify the actual
doses measured by the mothers, wide variations in CONCLUSION
measured doses could be clearly seen. Others studies The results of this study suggest sub-optimal
have reported that parental dosing errors are more knowledge of correct usage practices as well as
common with medication cups than with other types reconstitution and measurement techniques by several
of medication measuring devices, and overdosing mothers at the study site. Pharmacists can help
when using cups is more likely (Sobhani et al., 2008; mothers reconstitute suspensions as part of their
Almazrou et al., 2014; Yin et al., 2016). pharmaceutical care responsibilities, and better
If medicines are to be used safely and effectively in counsel them on proper suspension storage and
children, mothers/caregivers need to be able to measurement techniques. This may help to reduce
understand and comply with medication related potential medication errors that could arise from
information and/instructions (Bailey et al., 2009). incorrect reconstitution, unsuitable storage conditions
Mothers in this study were able to correctly identify a etc.
drug commonly used in children (Paracetamol) and
state at least one correct indication for use of the drug. DECLARATIONS
Majority of them were also able to correctly identify Ethical approval
the contraindication in the provided scenario and Ethical approval was sought for and obtained from the
correctly interpret expiry dates. They however had Human Research Ethics Committee of Ahmadu Bello
difficulties in correctly estimating dosing times and University before the study began (Approval number:
calculating drug quantity. Similar results have been ABUCUHSR/2018/UG/003). In addition, no
reported by other studies on the topic, all of which potentially identifying information was collected from
have reported that parents/caregivers have difficulties the mothers.
with “implicit” directions/ directions that require them
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Conflict of Interest: None declared
*Address for correspondence: Amina B. Olorukooba
Received: 12 December, 2018
Department of Pharmacology & Therapeutics, Faculty of
Pharmaceutical Sciences, Ahmadu Bello University, Zaria, Accepted: 08 February, 2019
Nigeria
Telephone: +234805 766 5703
E-mails: aolorukooba@gmail.com
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