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R E S E A R C H Open Access
Assessing medication packaging and
labelling appropriateness in Sri Lanka
N. Athuraliya
1
, E. J. Walkom
2*
, S. Dharmaratne
3
and J. Robertson
2
Abstract
Background: There is substantial evidence of poor dispensing practices with inadequate packaging and labelling
of medicines, and limited advice on their usage in low and middle-income countries (LMICs). We examined the
labelling and packaging of medicines identified during a survey of 1322 households in six regions of Sri Lanka
between 2010 and 2013 conducted using the World Health Organization (WHO) methodology for household
surveys. We compared medicines obtained from public and private sources and asked interviewees if they
understood how to take the medicines.
Methods: Packaging was considered adequate when the primary package was an envelope or closable container
holding only one medicine. Adequate labels were legible and included medicine name, dose and expiration date.
Interviewers assessed whether respondents knew how to take the medicines.
Results: Of 1322 households, 1253 households (94.8%) had at least one medicine; 84% were classified as western
medicines and 16% traditional medicines. Of 5756 western medicines identified, 82.1% were adequately packaged,
43.3% adequately labelled and 41.4% both adequately packaged and labelled. Participants stated that they
understood the label and knew how to take 96% of the medicines. Private medicine sources had more adequately
packaged medicines than public sources (87.7% vs 73.5%; OR 2.58, 95% CI 2.23, 2.99) and more adequately labelled
medicines (52.2% vs 27.4%; OR 2.90, 95% CI 2.57, 3.26).
Conclusions: Inadequate packaging and labelling of medicines remain a concern in Sri Lanka. Commitment to
Good Pharmacy Practices, investments in staff education and training and adequate dispensing resources
(containers and labels), particularly in the public sector, are needed to address sub-optimal dispensing practices.
Ageing populations with more chronic diseases requiring polypharmacy and complex medicine regimens increase
the need for appropriately packaged and labelled medicines.
Keywords: Medicines, Packaging, Labelling, Dispensing, Pharmacy practice, Low-middle income countries
Background
Medicines are central to health care and the most com-
monly used therapeutic intervention to manage acute
and chronic conditions. The rational or responsible use
of medicines depends on an appropriate clinical diagno-
sis and selection of the appropriate medicines in the cor-
rect dose and duration at the lowest cost to patients [1].
Good dispensing practices ensure that the medicine is
delivered to the patient with clear instructions in a pack-
age that maintains the potency of the medicine up to the
time of use [2]. Desirable and acceptable forms of
packaging for different pharmaceutical dosage forms
have been defined, however the high costs and poor
availability of suitable containers can compromise dis-
pensing practices in some settings [2].
Medicine containers should provide a surface for
attaching or writing a label with identifying details and
instructions for use. In addition, dispensers have a re-
sponsibility to ensure that patients understand how to
take their medicines [2]. However, there is substantial
evidence of poor dispensing practices, inadequate pack-
aging, labelling, instruction and advice on usage and,
storage of medicines in low and middle-income coun-
tries (LMICs) [3].
* Correspondence: Emily.Walkom@newcastle.edu.au
2
Department of Clinical Pharmacology, School of Medicine and Public
Health, The University of Newcastle, Newcastle, Australia
Full list of author information is available at the end of the article
© The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Athuraliya et al. Journal of Pharmaceutical Policy and Practice (2016) 9:38
DOI 10.1186/s40545-016-0091-5
Country situational analyses conducted in South East
Asia in Bhutan, India, Indonesia, Myanmar, Nepal, and
Timor-Leste have documented the frequent use of small
plastic bags as packaging, sometimes writing the number
of tablets per day and dosage frequency on a separate,
unattached slip of paper, or no labelling of dispensed
medicines at all [4]. Studies conducted in Egypt, Northern
Nigeria, Pakistan and Ethiopia have reported between 0
and 13.7% of dispensed medicines with adequate labels
[5–8]. Yet in these same studies 55 to 94% of patients
were reported to have adequate knowledge of the correct
dose of the medicine.
In many LMICs the private sector is an important
source of medicines, and may be the first point of con-
tact with the health care system and preferred channel
for purchasing medicines [3]. However, questions have
been raised about the quality of services provided.
There is evidence of a lack of pharmacists or other
trained personnel in these facilities, provision of advice
that is not in accord with treatment guidelines, in-
appropriate supply of medicines and insufficient coun-
selling [3, 9, 10].
The aim of this study was to examine the situation in
Sri Lanka with regards to medicines labelling and pack-
aging and to determine if there were differences in dis-
pensing practices between public and private sources of
medicines. In addition, we assessed interviewees’know-
ledge of how to take the medicines identified.
Methods
We conducted a study of access to medicines for acute
and chronic illness in 2010/2011 (Kandy district) and
2012/13 (Colombo, Ampara, Monaragala, Polonnaruwa
and Rathnapura districts), using the World Health
Organization (WHO) methodology for household sur-
veys [11]. Six administrative divisions (districts) were
chosen from the 25 districts of Sri Lanka. An initial
feasibility study was conducted in Kandy district. Colombo
(capital) district was chosen as per the WHO guidelines.
The remaining districts were divided into clusters based
on the poverty level criteria, childhood anaemia, popula-
tion density, and percentage of rural and urban popula-
tions within the district and selected to ensure inclusion
of districts of different socio-economic status.
Thirty public health care facilities distributed across
the six districts were randomly selected. The study
population consisted of clusters of households at a given
distance (<5, 5–10 and >10 km) from the reference
health facilities. Thirty households in six clusters around
each reference health care facility are recommended to
be interviewed, i.e. a national sample of 900 households.
We used six pairs of interviewers who were Sociology,
Biology or Pharmacy graduates and trained to collect the
information. Training was guided by the WHO training
tools (WHO Manual for household surveys; PowerPoint
slide presentation). Supervision of interviewers and re-
view of completed questionnaires were undertaken by
two of the researchers (SD, NA).
As part of the data collection for household surveys,
participants were asked by the interviewers to show all the
medications present in their home at the time of the inter-
view. Details were recorded for up to 20 medicines per
household. The medicine was identified where possible
and respondents were asked where they obtained the
medicine: family/friend; public hospital; NGO/mission
hospital; public health centre or dispensary; private health
care provider; traditional healer; private pharmacy; drug
seller and ‘Other’. Medicines were classified as western or
traditional. We report here on packaging and labelling of
medicines obtained in the public and private sector, i.e.
public hospital; public health centre or dispensary; pri-
vate health care provider; private pharmacy. The label-
ling of traditional medicines is more complex and less
subject to regulation and standardization, therefore a
detailed analysis of the packaging and labelling of trad-
itional medicines was beyond the scope of this study.
WHO household study definitions of adequate pack-
aging and labelling were applied. The primary packaging
for the medication was assessed and considered ad-
equate if the package was an envelope or a closable
container, and contained only one medicine. The inter-
viewer recorded whether the label on the medicines was
legible (included medicine name, dose and expiration
date), and also whether the interviewee could under-
stand the label and how to take the medicine.
Descriptive statistics (%) are used to summarise re-
sults. Differences between groups are presented as Odds
Ratios (OR) with 95% confidence intervals (CI) and were
calculated using StatsDirect Version 3 (2016).
Results
There were 1322 households from six regions of Sri
Lanka included in the study. Most households had at
least one medication to show the interviewer (94.8%,
average 5 medicines per household, 4 western and 1
traditional). A total of 6856 medicines were identified;
84% (5756) were classified as western medicines and
16% (1085) traditional medicines (Table 1). Data used to
conduct this analysis are available in Additional File 1.
Of the 5756 western medicines, the majority (n= 4725,
82.1%) were deemed adequately packaged, while less
than half of the medicines assessed (43.3%) were ad-
equately labelled. Only 2385/5756 (41.4%) medicines had
both adequate packaging and labelling. Participants re-
ported understanding the instructions for using almost
all medicines (95.6%).
A greater proportion of western medicines sourced from
private facilities were adequately packaged compared to
Athuraliya et al. Journal of Pharmaceutical Policy and Practice (2016) 9:38 Page 2 of 6
those obtained from public facilities (87.7% vs 73.5%;
OR 2.58, 95% CI 2.23, 2.99; Table 2). Medicines issued
from both private and public sectors were mostly
contained in envelopes, plastic bags or glass bottles (see
Figs. 1 and 2). In some of the public facilities, the
packaging was unsatisfactory. Although not very
frequent, an example of unsatisfactory packaging in-
cluded the use of a sheet of paper to wrap tablets and
capsules (Fig. 3).
Private health facilities were more likely to have sup-
plied medicines with adequate labels than public facil-
ities (52.2% vs 27.4%; OR 2.90, 95% CI 2.57, 3.26); often
with the label written on the envelope containing the
medicine. The use of slips of paper inside medicine con-
tainers was common in public hospitals. In some public
facilities where papers were used to wrap medicines, the
label was usually written directly on the folded paper.
Only 25.9% of medicines issued by public sector facil-
ities were determined to be both adequately packaged
and adequately labelled compared to 50% of medicines
obtained from the private sector. This observation of
better packaging and labelling in the private sector was
consistent across the six regions (Table 2). A greater
proportion of medicines issued by public sector facilities
were correctly labelled in Colombo region (41.5%) com-
pared to other regions (20.2–31.8%).
Discussion
The results of this study confirm previous observations
of problems in dispensing practices in Sri Lanka and
other LMICs, with notable differences in the quality of
dispensing practices in the public and private sectors. In
absolute terms the level of adequately labelled medicines
was better than reported in studies conducted in Egypt,
Northern Nigeria, Pakistan and Ethiopia [5–8], however
labelling of medicines remains sub-optimal (<50%).
In general, medicines packaging was better than medi-
cines labelling, however the criteria set for ‘adequate’in
both cases was quite low. An adequate label was one
that was considered legible with the medicine name,
dosage regimen and expiry date. This level of detail falls
well short of current recommendations for labelling of
outpatient medicines in high-income countries [12].
An adequate package was an envelope or closable
container and containing only one medicine. We could
not assess how long the medicines may have remained
packaged this way; in busy health facilities staff may
pre-package medicines into smaller units for individual
patient use to facilitate the dispensing process. The im-
plications of longer-term storage in envelopes and plas-
tic bags on medicine potency are unclear. The use of
folded sheets of paper to package some medicines from
public facilities may indicate an acute shortage of
Table 2 Adequacy of packaging and labelling of western medicines issued by public and private facilities and by district
Surveyed districts in Sri Lanka (n,%)
Ampara Colombo Kandy Monaragala Polonnaruwa Rathnapura Total
Medicines obtained from Public facilities
Total medicines 453 284 336 439 478 425 2415
Adequate Label 106 (23.4) 118 (41.5) 68 (20.2) 100 (22.8) 152 (31.8) 117 (27.5) 661 (27.4)
Adequate Packaging 320 (70.6) 213 (75.0) 234 (69.6) 322 (73.3) 359 (75.4) 325 (76.5) 1773 (73.5)
Both Adequate 106 (23.4) 109 (38.4) 64 (19.0) 97 (22.1) 134 (28.0) 115 (27.1) 625 (25.9)
Medicines obtained from Private facilities
Total medicines 232 687 549 473 287 590 2818
Adequate Label 128 (55.2) 440 (64.0) 288 (52.5) 229 (48.4) 138 (41.8) 247 (41.9) 1470 (52.5)
Adequate Packaging 217 (93.5) 655 (95.3) 492 (89.6) 412 (87.1) 251 (87.5) 444 (75.3) 2471 (87.7)
Both Adequate 127 (54.7) 438 (63.8) 266 (48.5) 219 (46.3) 127 (44.3) 234 (39.7) 1411 (50.1)
Public = public hospital, health centre or dispensary; Private = private health care provider or pharmacy
Table 1 Household characteristics and medicines by surveyed district
Ampara Colombo Kandy Monaragala Polonnaruwa Rathnapura Total
Households surveyed (N) 216 213 210 216 255 212 1322
Persons per household (mean, range) 4.3 (1–9) 4.3 (1–8) 4.4 (1–9) 4.1 (1–9) 4.1 (1–8) 4.2 (1–9) 4.2 (1–9)
Western medicines (N) 765 1074 980 989 847 1101 5756
Western medicines per household
(mean, range)
3.5 (0–14) 5.0 (0–15) 4.7 (0–15) 4.6 (0–15) 3.3 (0–15) 5.2 (0–14) 4.4 (0–15)
Traditional medicines per household
(mean, range)
0.8 (0–5) 0.9 (0–5) 0.5 (0–5) 1.3 (0–7) 0.7 (0–9) 0.8 (0–4) 0.8 (0–9)
Athuraliya et al. Journal of Pharmaceutical Policy and Practice (2016) 9:38 Page 3 of 6
proper material for dispensing at least in some facilities.
Such practices may not be limited to public facilities,
with a previous WHO situational analysis in Sri Lanka
reporting instances of private pharmacies dispensing
medicines in envelopes, sometimes made of old news-
paper; and in a few of the facilities there was no label-
ling of medicines [13].
The high proportion of respondents indicating they
understood the label and how to take the medicines was
in contrast to the findings on adequate packaging and
labelling. However, this is a consistent finding of pub-
lished studies—in spite of poor labelling and presumably
little time for contact with dispensing personnel. It is
difficult to compare our results with other studies due to
differences in definitions. In some studies, patients stat-
ing they knew the dose was considered a positive re-
sponse [7], while in others, patients had to be able to
repeat at least the dose and frequency of medication ad-
ministration [6]. We did not have the level of detail to
compare awareness of dosing for prescription medicines
Fig. 1 Example of medicines sourced from private facilities
Fig. 2 Example of medicines sourced from public facilities
Athuraliya et al. Journal of Pharmaceutical Policy and Practice (2016) 9:38 Page 4 of 6
versus other medicine types in the household or levels of
knowledge of dosage regimens for new medicines com-
pared to medicines taken previously. Babu et al. reported
that only 57.3% of patients taking antihypertensive
medicines had adequate knowledge of their dosage
schedule [14]. Adherence to prescribed medicine regi-
mens is important if patients are to achieve the desired
clinical benefits of their treatment. We made no assess-
ment of the appropriateness of the medicines present
in the household.
There were a number of limitations inherent in the de-
sign of this primarily descriptive survey. The assessment
of medicines packaging and labelling occurred in family
homes, and it is possible that medicines may have been
re-packaged for convenience by household members and
not kept in original packaging. Assessment of the house-
hold members’understanding of how to take their medi-
cines was limited to a simple yes/no response. There
was no objective assessment of understanding of dosage
instructions. Assessment of adequate labelling and pack-
aging was made according to the WHO Manual for
Household Surveys [11]. The standard for adequate la-
belling and packaging may not be considered adequate
in other developed countries.
There has been increasing emphasis on effective drug
regulatory procedures and good manufacturing practices
(GMP) in medicines production and improved procedures
for medicines storage and distribution to try to ensure that
only quality-assured medicines are in circulation. However
problems in dispensing practices remain [3, 15]. A notable
feature of many of the studies is the short dispensing
times and minimal interactions between dispensers and
patients reported [13]. Syhakhang and colleagues found
no differences in medicines adequately labelled in public
and private pharmacy practices in one province of Lao
PDR [16]. We cannot account for the differences observed
in this study but there were suggestions of more acute
shortages of appropriate dispensing materials in some of
the public sector institutions.
There is evidence that training can improve dispensing
practices [17]. However, education alone is unlikely to
produce sustainable changes. Incentives, greater compli-
ance with agreed professional pharmacy practice stan-
dards and technology solutions including electronic
prescription systems that generate labels with standard
patient information will all contribute to improved dis-
pensing practices. Good Pharmacy Practice guidelines
provide a quality management framework and a strategic
plan for developing pharmacy services [18]. Preparing,
obtaining, storing, securing, distributing, administering,
dispensing and disposal of medical products are key
functions. Much work and investment in staff and re-
sources will be required in LMICs for pharmacists to
fulfil these functions. However, as LMICS face ageing
populations, the double burden of communicable and
non-communicable chronic diseases, polypharmacy and
more complex medicine regimens, the imperatives to
provide quality pharmacy services grows.
Fig. 3 Example of unsatisfactory packaging using paper to wrap medicines
Athuraliya et al. Journal of Pharmaceutical Policy and Practice (2016) 9:38 Page 5 of 6
Conclusions
There were significant differences in the quality of label-
ling and packaging of western medicines in the public
and private sectors in this study. In general, medicines
packaging was better than medicines labelling, however
the criteria set for ‘adequate’in both cases were quite
low, and well below those in current recommendations
for Good Pharmacy Practices. Organizational constraints
are likely to have contributed to the problems observed
with inadequate dispensing resources (containers and la-
bels), particularly in the public sector. Low staffing levels
will also limit the ability of trained staff to provide in-
structions to patients and carers on how to take the
medicines.
The results of this study highlight the need for training
and continuing education in Good Pharmacy Practices
in Sri Lanka and other LMICs with similar problems
with packaging and labelling of dispensed medicines.
The goal is to ensure that medicines are delivered to the
patient with a label providing clear instructions on ad-
ministration and a package that maintains the potency
of the medicine up to the time of use. Ageing popula-
tions with more chronic diseases requiring polyphar-
macy and complex medicine regimens increase the need
for appropriately packaged and labelled medicines.
Additional file
Additional file 1: Excel data file with raw data used in this analysis.
(XLSX 1051 kb)
Abbreviations
CI: Confidence intervals; GMP: Good manufacturing practices; LMIC: Low and
middle-income countries; OR: Odds ratio; WHO: World Health Organization
Acknowledgements
We would like to thank all the participants who gave their time freely for this
research and the data collectors who conducted the interviews for this study.
Funding
Funding for this study was provided from research funds from the University
of Newcastle.
Availability of data and materials
The datasets supporting the conclusions of this article are included within
the article and its additional files.
Authors’contributions
All authors contributed to the design of the study and analysis and interpretation
of the data. JR wrote the first draft of the manuscript. EJW, NA and SD provided
critical comment on the manuscript. All authors approved the submission of the
final manuscript.
Competing interests
The authors declare that they have no competing interests.
Consent for publication
Not applicable.
Ethics approval and consent to participate
This study was approved by the Research Ethics Committees of The University
of Newcastle, Australia (approval number H-2010-1263) and the University of
Peradeniya, Sri Lanka (approval numbers 2010/EC/36 and 2011/EC/33).
Author details
1
Department of Medicine, The Maitland Hospital Clinical School, 550-560
High Street, Maitland 2320, NSW, Australia.
2
Department of Clinical
Pharmacology, School of Medicine and Public Health, The University of
Newcastle, Newcastle, Australia.
3
Medical Education Unit, Faculty of Medicine,
University of Peradeniya, Peradeniya, Sri Lanka.
Received: 24 September 2016 Accepted: 15 November 2016
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