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Pediatric Syrup Caps: How Safe? Contamination and Pediatric Dosing Concerns with Syrup Caps-CAPCONS Study

Authors:
  • Dr Varsha's Health Solutions
  • Abbott Nutrition

Abstract

Introduction: Currently, no standard practice or recommendation is available for cleaning or sterilizing the syrup caps. With an objective to understand the hygiene practice followed by parents with regard to the use of pediatric syrup caps, a market research study was conducted. Methods: The details of children recently prescribed syrups for various conditions were collected and the parents/guardians were interviewed using a specifically designed 10 point questionnaire. The syrup caps were collected and sent for bacterial analysis. A detailed report on the hygiene practices followed by the parents on syrup caps was prepared. Results: A total of 500 subjects were interviewed. Washing the caps with tap water was the preferred method used to clean the cap before use (80%). After the use, majority of subjects used tap water (78%) for washing followed by boiling (17%), purified water (5%) and others (1%). Among all the caps washed with tap water, 2% had serious contaminants and 82% showed bacillus only; while among those who boiled, none had any contamination. The contamination with a significant organism capable of causing human infection was found in 9.4% caps. Bacillus was observed in 81.4% (407/500) of caps. The contamination with Bacillus was more when the subjects had put back the cap on the syrup bottle (83.3%). Conclusion: Our findings suggest that syrup caps for pediatric use can be contaminated if not properly sterilized; hence a standard hygiene protocol or alternatives to caps must be designed for better and hygienic mode for syrup administration.
78 Indian Journal of Clinical Practice, Vol. 26, No. 2, July 2015
PEDIATRIC
Pediatric Syrup Caps: How Safe? Contamination
and Pediatric Dosing Concerns with Syrup Caps-
CAPCONS Study
NARAYANAN VARSHA*, KADHE GANESH, JAIRAM APARNA
ABSTRACT
Introduction: Currently, no standard practice or recommendation is available for cleaning or sterilizing the syrup caps. With
an objective to understand the hygiene practice followed by parents with regard to the use of pediatric syrup caps, a market
research study was conducted. Methods: The details of children recently prescribed syrups for various conditions were collected
and the parents/guardians were interviewed using a specically designed 10 point questionnaire. The syrup caps were collected
and sent for bacterial analysis. A detailed report on the hygiene practices followed by the parents on syrup caps was prepared.
Results: A total of 500 subjects were interviewed. Washing the caps with tap water was the preferred method used to clean the
cap before use (80%). Aer the use, majority of subjects used tap water (78%) for washing followed by boiling (17%), puried
water (5%) and others (1%). Among all the caps washed with tap water, 2% had serious contaminants and 82% showed bacillus
only; while among those who boiled, none had any contamination. The contamination with a signicant organism capable of
causing human infection was found in 9.4% caps. Bacillus was observed in 81.4% (407/500) of caps. The contamination with
Bacillus was more when the subjects had put back the cap on the syrup bole (83.3%). Conclusion: Our ndings suggest that
syrup caps for pediatric use can be contaminated if not properly sterilized; hence a standard hygiene protocol or alternatives
to caps must be designed for beer and hygienic mode for syrup administration.
Keywords: Contamination, bacillus, syrup caps
*Senior Medical Advisor
AVP, Medical Affairs
Wockhardt Ltd., Wockhardt Towers
Bandra Kurla Complex, Mumbai, Mumbai, Maharashtra
Chief of Operations and Immunology
SRL Labs, Udyam, Ranade Road, Shivaji Park, Mumbai, Maharashtra
Address for correspondence
Dr Varsha Narayanan
Senior Medical Advisor
Wockhardt Ltd., Wockhardt Towers,
Bandra Kurla Complex, Mumbai - 400 051, Maharashtra
E-mail: vnarayanan@wockhardt.com
Medicines in form of syrup are in use since
1976.1 Syrup caps are commonly used to
administer medicines to children. Most of the
syrups given to children are sweet and sticky due to
sugar base in order to aid compliance.2, 3 The le over
syrup droplets on the caps or the sides of the bole
lids might serve as a source of microbial contamination.
Scarce information is available about the magnitude of
this contamination and the eects per se. Bacteria like
bacillus which are environmentally widely distributed
are a common cause of contamination.4,5 The strains
of bacillus including Bacillus subtilis are strongly
proteolytic and the main producers of the food spoilage
enzymes.6 Microbial infections are not only caused by
the presence of micro-organisms alone but also by their
metabolites or toxins released, which are harmful even
if present in minute quantity.7 A potential infection
hazard may be caused by organisms transferred
through ngers and other surfaces; e.g. a stainless steel
bowl or a clean laminate surface.8
There is a lack of awareness about maintaining adequate
hygiene for the syrup caps. Currently, no standard
practice or recommendation is available for cleaning or
sterilizing the syrup caps to maintain hygiene. Further,
dosing errors by parents are highly prevalent with
caps compared with droppers, calibrated spoons, or
syringes.9
At present, no data is available to understand the
hygiene practices followed by parents while using
syrup caps and presence of contaminants, if any
following these hygiene practices. We conducted a
market research study to understand the hygiene
practice followed by parents with regard to the use of
pediatric syrup caps.
PEDIATRIC
79
Indian Journal of Clinical Practice, Vol. 26, No. 2, July 2015
METHODOLOGY
Study Population
The pediatricians from 10 Indian cities viz. Ahmedabad,
Bangalore, Bhubhaneswar, Cochin, Coimbatore, Delhi,
Jaipur, Mumbai, Mysore and Patna were identied.
Around 25% of the children were < 2 years of age, 40%
were between 2 to 4 years and 35% were ≥ 4 years.
Around 60% children were from urban areas and 20%
each from semi-urban and rural areas.
Analysis of the Objective
This was a survey with the objective to study and
understand hygienic and dosing practices of various
populations with regard to syrups and assess
the contamination status of the syrup caps. The
percentage of syrup caps showing microbiological
contamination was assessed. Laboratory analysis of
these bacteria was done to correlate the contamination
to the kind of cleaning and hygienic practices assessed
through a questionnaire. The caps were analyzed
for general contamination with Bacillus subtilis and
serious contaminants including Klebsiella pneumniae,
Acinetobacter baumanni, E coli, Pseudomonas aeruginosa,
Serratia and E. fecalis.
Study Design and Procedure
The present study of 500 patients was a market
research study. An initial pilot study was conducted in
two cities with a total population of 50 to validate the
questionnaire, assess the microbiological contamination
rate and help in calculating sample size for the main
study. The questionnaire was validated with feedback
from the interviewer and the parents with respect to
ambiguity/clarity of questions and ease in answering
and inclusion of any other information which the parent
desired to give. Only aer validating the questionnaire
for consistency and clarity in responses, questionnaire
was adapted for the nal study.
Ethics commiee opinion and approval was taken for
the study. The data base which included only name
and contact number of the patients who had been
prescribed syrups for various causes was taken in the
most condential manner from the pediatricians in
each of the 10 cities. The parents of the subjects were
contacted rst on telephone and their consent and
approval was taken aer explaining nature of the survey
and questionnaire (Appendix 1). Thereaer, it was
ascertained from the parent as to when will the course
of their syrup prescription be over and accordingly
suitable appointment was taken from the parent. At
the visit, the parent lled out the questionnaire and the
syrup caps were collected in a sterile container and sent
to a diagnostic laboratory (SRL Diagnostics) in each city
for bacterial analysis. A common protocol was followed
for the collection and transfer of caps and evaluation
of contaminants. To maintain condentiality, a specic
code was given to each questionnaire and the sterile
container in which the cap was sent.
Information was sought regarding the name/brand of
the medicine, dosage schedule, condition or indication
of syrup prescribed, frequency of children requiring
syrup etc. The data on the questionnaire was recorded
and analyzed and a detailed report on the hygiene
practices followed by the parents on syrup caps was
prepared.
Statistical Analysis
The sample size was calculated by assuming 90%
expected cases of bacterial growth with 3% margin of
error and 95% condence interval (CI). Based upon
these assumptions the sample size was estimated to be
385. The sample size of 500 was considered to estimate
bacteria growth prevalence with high precision and to
perform exploratory statistical analysis. The formula
used to calculate the sample size (N) was [Z2 * p (1-p)] /d2
where N is sample size, Z is statistic for 95% level
of condence (Z = 1.96), p is expected proportion of
bacteria growth (0.90), d is margin of error (0.03).
The proportions of cases with bacteria growth and
serious bacteria growth were calculated with associated
95% CI. The association between storage method,
cleaning methods, class (Urban, Semi Urban and Slum)
and the contaminants’ growth was tested for statistical
signicance using Chi- Squared test.
RESULTS
Subjects
A total of 500 subjects were interviewed (10% from
each city).
Condition/Indication of the Syrup Prescribed
The pediatricians had prescribed around 34 dierent
types of medicines. The syrup was majorly prescribed
to the subjects having cough (38%); followed by fever
(26%) and cold (18%). The frequency of a disease in
majority of children was four times a year. The maximum
dose recommended by the pediatricians was < 2 mL
(49%), 3 times a day (51%) and for 1 to 5 days (54%).
PEDIATRIC
80 Indian Journal of Clinical Practice, Vol. 26, No. 2, July 2015
Overall, 92% of subjects were comfortable with the
usage of the caps for administering syrup.
Microbial Contamination
Amongst all the caps analyzed, contamination with
a signicant organism capable of causing human
infection was found in 9.4% caps. Bacillus was observed
in 81.4% (407/500) of caps. The proportion of observed
bacterial growth was 91% (95% C.I: 88.49%, 93.51%).
The proportion of observed serious contaminant
growth was 2.4% (95% C.I: 1.06 %, 3.74%).
Methods of Cleaning Caps Before and After Use
Table 1 shows the response of the subjects to the
questionnaire asked during the study. Washing the caps
with tap water was the preferred method used to clean
the cap before use (80%). Majority of subjects used tap
water (78%) for washing caps aer use followed by
boiling (17%), puried water (5%) and others (1%).
Around 21% subjects mentioned that the calibrated
spoon was hygienic and easy to use, while 7% of the
respondents were looking for a beer option for syrup
administration.
Organisms Detected vs. Methods of Storing Caps
After Use Figure 1
Aer cleaning, 72% subjects put back the cap on
the bole, 15% subjects kept the cap in open and
3% subjects kept the cap in a closed space (drawers,
cupboards etc) along with other kitchen articles. Only
9% subjects kept the cap in a fridge and 1% in a specic
and separate box/closed container. More contamination
with bacillus growth was observed when the subjects
had put back the cap on the syrup bole (83.3%).
Organisms Detected vs. Method Used to Clean
the Syrup Cap Before the Next Usage
The percentage of subjects who washed the cap before
the next usage was 94% (80%: tap water, 3%: boiling,
17%: puried water). Among all the caps washed
Table 1. Response to the Questionnaire Asked During
Study
Questions Yes (%) No (%)
Was the overall Cap usage comfortable 92 8
Any difcult in reading the markings on the
cap ?
28 72
When the cap was empty 33 67
When the cap was lled with syrup 85 15
Cap kept at eye level while lling the syrup 64 36
Left over syrup in Cap after pouring in
child’s mouth
46 54
Spillage encountered while giving to child 94 6
Was Cap cleaned immediately after use
Was Cap cleaned again before giving the
next dose
94 6
Preference on an alternate mode of giving
the syrup like the Calibrated Spoon shown
87 13
Would you be happy if you were informed
about a standard way of maintaining
hygiene of the Cap/Spoon along with the
information on the syrup
94 6
Putback on the bottle
10
0
20
30
40
50
60
70
80
83.3
No. of patients (%)
Method of storage
91.1
80
20
4.4 4.4
00 0
72.4
53.3
26.7
13.3
6.7
17.1
9.2
8.1 6.4 2.2 1.3
90
100
Kept in open Kept in closed space/
covered
Kept in fridge Kept in box
Bacillus No growth Other organism Serious contamination
Figure 1. Contamination vs methods of storing caps aer use.
PEDIATRIC
81
Indian Journal of Clinical Practice, Vol. 26, No. 2, July 2015
with tap water, 2% had serious contaminants and 82%
showed bacillus only; while among those who boiled,
none had serious contaminants.
Organisms detected vs socio- economic class (Urban,
semi urban and slum). The association between class
and bacteria growth was statistically signicant
(p <0.05). More bacillus growth (253/300) was observed
in the syrup caps used in the urban class. The percentage
of serious contaminants was more in the caps used by
semi urban (3%) and slum (3%) class compared to the
urban class (2%).
DISCUSSION
Administering medications to children with syrup caps
is a common practice. In the present study, children were
receiving medications for cough, fever, cold, vomiting,
dehydration, weakness, etc. Other studies have also
identied cough as the most common problem in the
children especially of preschool age.10,11
Mugoyela et al conducted a study on microbial
contamination of non- sterile pharmaceuticals in public
hospital seings and reported that all the tested products
were microbiologically contaminated with half of the
tested products heavily contaminated predominantly
with Klebsiella, Bacillus, and Candida species. Of the
tested tablets and other formulations, cough syrups
were the most heavily contaminated with a bacterial
load of 6.0 × 103 cfu/mL.12 Further, when tested for
antibiotic sensitivity, the isolated Bacillus and Klebsiella
species were resistant to most of the antibiotics. Though,
some previous studies have recognized and tested
pharmaceutical products for microbial contamination
and the related health hazards,13,14 hardly any study
has tried to study the mode of administration of drugs
and associated contamination. The present study was
a market research survey that showed that the large
percentage of syrup caps used to administer medicine
to children was contaminated most frequently with
Bacillus. Bacillus subtilis is a common contaminant
found in dust and soil. These aerobic spore-forming
bacteria produce heat-labile cytotoxic substances and
have important spoilage and/or toxigenic potential.6
In addition, we also observed serious contaminants
like Klebsiella pneumoniae, Acinetobacter baumanni, E coli,
Pseudomonas aeruginosa, Serratia and E. fecalis in the
caps. These serious contaminants can cause various
healthcare-associated infections. Acinetobacter causes a
variety of diseases, ranging from pneumonia to serious
blood or wound infections.15 E.coli can cause diarrhea
or illness outside of the intestinal tract.16 Klebsiella can
cause pneumonia, bloodstream infections, wound or
surgical site infections, and meningitis.17 Pseudomonas
aeruginosa causes ear infections, especially in children,
and skin rashes.18 P. aeruginosa also causes infections in
immunocompromised patients.19 The presence of these
contaminants underscores the need of proper handling
of the syrup caps and awareness among the users about
the hygienic practices associated with their use.
In order to minimize the risks caused by these
contaminants, it is necessary to follow proper hygienic
procedures. But, there is a paucity of information and
non-availability of a standardized protocol for cleaning
the syrup caps. In our study, we observed that all the
respondents followed their own hygiene practices with
regards to syrup caps usage. Majority of subjects used
tap water for cleaning the syrup caps; consequently
more contamination was found in those caps. In a
recent study by de Abreu et al, bacterial species like
Pseudomonas aeruginosa, and Enterococcus feacalis that
are the major agents for nosocomial infections, were
isolated from tap water.20 In another study by Ribero et
al Pseudomonas spp. were isolated from the tap drinking
water produced from karstic hydrosystems.21 Ahmad et
al analyzed the quality of drinking water from dierent
sources like hand pumps, tube wells and tap water and,
observed P. aeruginosa (26.67%) and Klebsiella pneumonia
(40%) as the most common contaminants. These species
also showed greater multiple antibiotic resistances.22
Sterilization of the caps through boiling was followed
by a miniscule of the subjects. Boiling of the heat
resistant items in water helps in reducing pathogen
load to a great extent.23 No serious contaminants was
seen when the subjects boiled the caps in our study.
Sterilization in boiling water has historical precedence
and is the safest method of sterilization that is used to
kill all pathogens.24 Therefore, we recommend that the
syrup caps be sterilized through boiling in water before
usage.
We also studied the storage paern of the syrup caps
before next usage and presence of contamination in
these stored caps. Majority of subjects aer the syrup
usage had kept the cap back onto the bole and only 1%
had kept the cap in a specic and separate box/closed
container. Keeping the caps back on to the bole resulted
in more contamination possibly due to the surrounding
dust. In a previous study, Justin- Tema et al interviewed
400 traditional herbalists using a questionnaire to
establish the stage at which contamination takes place
during the processing of herbal medicine preparations.
They found that the 72% of subjects were aware that
dust was a source of harmful contaminants for their
PEDIATRIC
82 Indian Journal of Clinical Practice, Vol. 26, No. 2, July 2015
medicines, while 91.5 % of subjects felt storage of
medicines in a clean environment could avoid dust.25
This indicates that though most of the people are aware
of dust as the source of most common contaminant but
proper education and reinforcing hygienic practices
might help to nurture the habit of storing syrup caps
in a separate closed box away from dust.
Alternate methods have been suggested previously to
administer syrups. Shadnia et al recommended the use
of child-resistant containers for dispensing syrup and
adding a coloring agent or special avour to the syrup.26
We suggest the use of a calibrated spoon stored in a
separate re-sealable pouch as an alternate to the use of
syrup caps. The use of calibrated spoons might also help
in reducing dosing error that is reported to be the most
frequent medication error.27 Additional instructions
on proper washing and sterilization of the calibrated
spoon might also help prevent the contamination that
we observed in the syrup caps. We tried to review if the
subjects of our study were comfortable using syrup caps
or were looking for alternate methods. We found that a
fairly high number of subjects (92%) were comfortable
with the usage of the caps that indicated the acceptance
of the caps for feeding syrup among the subjects, but
at the same time they are willing to try the calibrated
child friendly spoon (87%) or other alternative options
for feeding the syrup to the child. Respondents wanted
to have standard instructions on how to maintain the
hygiene of caps/spoon along with the syrup.
Summarizing, the present survey was planned to
primarily assess the hygienic practices of Indian parents
during syrup administration to their children. It was
noted that many parents are not maintaining adequate
hygiene for administration of pediatric medicine by
caps. We observed common contaminants like Bacillus
and some serious contaminants in the caps used to
administer medicine to children. We did not measure
the bacterial load of these contaminant bacteria in the
caps. Although, studies suggest that the concentration
of contamination presenting threat to an individual’s
health is unknown.28 We suggest that a standard
protocol must be designed for beer and hygienic mode
for syrup administration. Further, our results indicate
an urgent need to educate patients on the hygienic
practices followed during storage and dispensing of the
syrup medicines especially in children. A home based
hygiene counseling and education can also be planned.
As it was seen that no contamination was present when
caps were boiled or stored in a specic closed place
away from other articles, a standardized protocol for
boiling and using a calibrated spoon with a possible zip
pouch for storage can be suggested in order to maintain
proper hygiene. The calibrated spoon must be washed
with 2-3 drops of detergent and placed back into the
zip pouch. Before the next usage, the spoon must be
sterilized in boiling water. The sticker on the syrup
boles or the leaets highlighting hygiene instructions
on usage of the medicine could be helpful.
To our knowledge, this is the rst study to analyze
the contamination of syrup caps and understand
the hygiene practice followed by parents. A beer
understanding of the indoor contamination and
following hygienic practices could help in preventing
harmful eects in future.
Key Messages
Many parents are not maintaining adequate hygiene
for administration of pediatric medicine by caps. Syrup
caps can be contaminated if not properly sterilized. We
suggest that a standard protocol must be designed for
beer and hygienic mode for syrup administration.
Acknowledgements
The authors acknowledge Knowledge Isotopes Pvt. Ltd.
(www.knowledgeisotopes.com) for the writing support.
Contribution of Authors
Varsha Narayanan has contributed in the literature
search, clinical studies, experimental studies,
data acquisition, data analysis, statistical analysis,
manuscript preparation, manuscript editing. Varsha
Narayanan and Ganesh Kadhe have substantial
contribution to the conception, design, and denition of
intellectual content. Varsha Narayanan, Ganesh Kadhe
and Dr. Aparna Jairam have reviewed and approved
the manuscript.
Dr. Ganesh Kadhe is the guarantor for this article, and
takes responsibility for the integrity of the work as a
whole.
Conflict of Interest
None of the authors of the above manuscript has any
conict of interest which may arise from being named
as an author on the manuscript.
The authors did not get compensation for their eorts
and time in cash or kind from the sponsor. This study
is not inuenced by any product or brand associated
with Wockhardt or any other company, and is an
independent study.
PEDIATRIC
83
Indian Journal of Clinical Practice, Vol. 26, No. 2, July 2015
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