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Assessing medication packaging and labelling appropriateness in Sri Lanka

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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. ResultsOf 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.
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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
[58]. 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 intervieweesknow-
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, 510 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 (20.231.8%).
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 [58], however
labelling of medicines remains sub-optimal (<50%).
In general, medicines packaging was better than medi-
cines labelling, however the criteria set for adequatein
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 (19) 4.3 (18) 4.4 (19) 4.1 (19) 4.1 (18) 4.2 (19) 4.2 (19)
Western medicines (N) 765 1074 980 989 847 1101 5756
Western medicines per household
(mean, range)
3.5 (014) 5.0 (015) 4.7 (015) 4.6 (015) 3.3 (015) 5.2 (014) 4.4 (015)
Traditional medicines per household
(mean, range)
0.8 (05) 0.9 (05) 0.5 (05) 1.3 (07) 0.7 (09) 0.8 (04) 0.8 (09)
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 studiesin 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 membersunderstanding 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 adequatein 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.
Authorscontributions
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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Athuraliya et al. Journal of Pharmaceutical Policy and Practice (2016) 9:38 Page 6 of 6
... While another study conducted by Athuraliya et. al in Sri Lanka in the year 2016 observed that out of 5756 dispensed medicine labels reviewed, only 43.3% were found to be adequately labelled [7]. The interpretation of an adequate labelling of dispensed medicine varies depending on the countries' laws and regulations as well as their social norms. ...
... This discrepancy was most likely caused by the requirements that defined adequate labelling of dispensed medicine in both countries. In the study conducted in Sri Lanka, adequately labelled dispensed medicine must include medicine name, dose and expiration date, and also whether the interviewee could understand the label and how to take the medicine [7]. The understanding of labels and how to take the medicines were solely based on self-reported answers, without any objective assessments of understanding of dosage instructions [7]. ...
... In the study conducted in Sri Lanka, adequately labelled dispensed medicine must include medicine name, dose and expiration date, and also whether the interviewee could understand the label and how to take the medicine [7]. The understanding of labels and how to take the medicines were solely based on self-reported answers, without any objective assessments of understanding of dosage instructions [7]. Whereas in this study, an adequately labelled dispensed medicine was one fully compliant to the labelling of dispensed medicine requirements as per the Malaysian laws and regulations, without any assessment on patient understanding on the medicine labels. ...
Article
Background: The labelling of dispensed medicines (LDM) ensures that optimum therapy is achieved, and medication errors are prevented. In Malaysia, LDM is enforced under Poisons Act 1952. Objective: To explore the knowledge, perception, and practices of community pharmacists (CP) and general practitioners (GP) on LDM. Methods: A cross-sectional study was conducted from April 2019 until March 2020 among CP and GP practising in Sarawak, Malaysia. Sample sizes were 90 and 150 for CP and GP, respectively. A self-administered structured questionnaire which was pre-tested and pilot-tested was employed to explore the knowledge and perception. Practices were assessed by having participants prepare dispensed medicine labels (DML) using simulated patients and prescriptions. Results: 250 participants; 96 CP and 154 GP participated. While most of them perceived that they know the requirements of LDM (n=244; 97.6%), their median knowledge score was poor (57.1%). The median knowledge score of CP (66.7%) was significantly higher (P=0.004) than GP (50.0%). The majority of participants perceived that LDM is important (n= 237; 94.8%) and necessary (n=239; 95.6%%) and perceived that poor compliance to the requirements would lead to medication errors (n=243; 97.2%). Although their knowledge was poor, their median practice score (100.0%) was excellent. There was no correlation between knowledge and perception with the practice on LDM. Conclusion: The majority of CP and GP perceived that LDM is important. Interestingly, although their knowledge of the requirements of LDM was poor, their practices were good. (236 words).
... to avoid medication errors [9][10][11]. Even though various definitions for 'label' or 'labelling' can be found both in legislation as well as in published literature, common elements include the following: any brand, written, pictorial or descriptive matter appearing on or attached to a package of a medicine [1, 6, 8, [12][13][14][15][16]. ...
... Evidence from several studies that investigated levels of compliance to labelling requirements demonstrated that marketed medicines showed varying levels of compliance, including failure to comply, such as the example from the East Africa Community (EAC), which showed varying levels of compliance even in the presence of harmonised medicine regulations [13,16,18]. This is further emphasized by Barton, et al. who cite redundant and non-transparent registration procedures which are widely divergent across countries, including complex country specific labelling requirements and GMP inspections, as problematic for companies to implement. ...
Article
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Introduction The COVID-19 pandemic highlighted an urgent need for harmonised requirements for the regulation of medicines. To fully implement harmonised medicines regulations across Africa, common technical standards of medicine regulations are needed. One such technical standard is the labelling of medicines on outer packaging. In this study, we compared outer packaging labelling requirements and transition terms for harmonization for countries in the Southern African Development Community (SADC) region. Methods Data on legislation and/or regulatory guidelines for medicine outer packaging labelling from National Medicines Regulatory Authorities (NMRAs) were obtained for countries in the SADC region (n = 16) by February 2023. A detailed comparative content analysis was conducted to determine alignment with the requirements of the Southern African Development Community (SADC) harmonised labelling guidelines to assess readiness levels of each country to transition to the SADC harmonised labelling guideline for outer packaging of medicines. Results Content analysis showed at least 11 out of 16 countries require national legal reform to transition to the SADC harmonised labelling guideline. In all cases where countries specified labelling requirements for outer packaging of medicines, these were stipulated in national medicines legislation. Conclusion Even though there is a high level of alignment across the countries in terms of national labelling requirements, most countries in the SADC region would still require national legislative reform to transition to regional harmonised labelling requirements and then ultimately to continental requirements of the African Medicines Agency (AMA).
... Several artemisinin-based combinations are currently used for the first-line treatment of uncomplicated malaria in Côte d'Ivoire, including artemether + lumefantrine (AL), artesunate + amodiaquine (AS + AQ), dihydroartemisinin + piperaquine (DHAP), and artesunate + pyronaridine (ASPY) [5]. The adoption of new treatment policies is confronting several challenges related to inadequate diagnosis and the inappropriate use of drugs due to poor distribution practices, the inadequate labelling of packages, and inappropriate instructions provided to clients on their use [6][7][8]. Thus, to ensure the effective use of new treatment guidelines and recommendations, both the public and private sectors must be involved. However, privatesector involvement in actions and campaigns organized by the National Malaria Control Programme (NMCP) (known locally as the Programme National de Lutte contre le Paludisme, PNLP) is almost non-existent [9]. ...
... Inappropriate use of drugs remains a major public health problem worldwide [19,20]. In developing and low-income countries, inappropriate drug use occurs due to the prescriptions and instructions given to clients on their use [6,7]. Private pharmacies are an important link in promoting access to basic health services: they are the most accessible health facilities available for the management of common diseases [8]. ...
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Background The emergence of resistance to artemisinin derivatives in Southeast Asia constitutes a serious threat for other malaria endemic areas, particularly in Côte d’Ivoire. To delay this resistance, the application of the control measures recommended by the National Malaria Control Programme (NMCP) for a correct management, in the private pharmacies, is a necessity. The purpose of this study was, therefore, to assess the level of knowledge and practices of private pharmacy auxiliary in Abidjan about the management of malaria. Methods A descriptive cross-sectional study was conducted from April to November 2015. It included auxiliaries of private pharmacies in Abidjan. Data collection material was a structured an open pretested questionnaire. Data analysis was carried out using Package for Social Science (SPSS) software version 21.1. Chi square test was used to compare proportions for a significance threshold of 0.05 for the p value. Results A total, 447 auxiliaries from 163 private pharmacies were interviewed. It was noted that the auxiliaries had a good knowledge of clinical signs of uncomplicated malaria (99.1%), biological examinations (54.6% for the thick film and 40.7% for rapid diagnostic tests (RDTs) and anti-malarial drugs (99.3% for artemether + lumefantrine, AL). The strategies of vector control (long-lasting insecticide-treated mosquito nets (LLITNs, Repellent ointments, cleaning gutters, elimination of larvae breeding site and intermittent preventive treatment with sulfadoxine–pyrimethamine (IPTp-SP) in pregnant women were also known by the auxiliaries, respectively 99.8% and 77.4%. However, the malaria pathogen (25.1%) and the NMCP recommendations (e.g. use of AL or AS + AQ as first-line treatment for uncomplicated malaria and IPTp-SP in pregnant women) were not well known by the auxiliaries (28.2% and 26.9% for uncomplicated and severe malaria). Concerning the practices of the auxiliaries, 91.1% offered anti-malarial drugs to patients without a prescription and 47.3% mentioned incorrect dosages. The combination artemether + lumefantrine was the most recommended (91.3%). The delivery of anti-malarial drugs was rarely accompanied by advice on malaria prevention, neither was it carried out on the result of an RDT. Conclusion The epidemiology and the NMCP recommendations for the diagnostic and therapeutic management of malaria, are not well known to auxiliaries, which may have implications for their practices. These results show the need to sensitize and train private pharmacy auxiliaries, and also to involve them in NMCP activities.
... Thus, the existence of proprietary names from all over the world in a small market can increase the potential for the presence of similar names. Additionally, inadequate labeling and packaging of medicines [28], limited resources, limited English proficiency of patients, mistaken illness severity, and poor knowledge of prescribed medications can magnify the situation [29]. However, no published records assess the interchangeability of drug names in the Sri Lankan market. ...
Article
Background: Look-alike sound-alike (LASA) medications have similar pronunciation (phonetic) and/or manifestation (orthographic), which could create confusion among users and challenge the safe use of medicines. The availability of foreign products in local markets aggravates the situation. This study was designed to examine the registered medicine proprietary names in Sri Lanka to discern the presence of similar medicine names in the industry. Methods: A cross-sectional study was conducted on the registered drug proprietary names in Sri Lanka. Using the RAND and RANK functions in Microsoft® excel® 365, a random sample of 385 proprietary names was selected. Two evaluators independently evaluated each proprietary name in the sample against the other registered proprietary names following a stepwise text filtering method. After each filter, the resulting proprietary names were manually examined for identical, similar-looking, and similar-sounding proprietary names to the name under evaluation. The observations were matched, categorized, and collated into ten groups. Results: Among the 385 names evaluated, 138 (35.84%) proprietary names had no similarity to existing other registered proprietary names. The rest of the names (n = 247, 64.15%) were found to be either identical (n = 03 pairs), look-alike (n = 91 pairs), or sound-alike (n = 80 pairs) to the registered proprietary names. Conclusion: The findings revealed the presence of equal and similar proprietary names in the system. A multifactorial strategy led by the National Medicine Regulatory Authority (NMRA) is recommended to minimize the confusing names entering the system. Primarily the NMRA's call for action should include adequate industry guidance with specific guidelines, a significant pre-submission assessment process, and denying approval of LASA proprietary names.
... 8 Information such as patient name, direction for use, medication name and strength, quantity, pharmacy information, and date of dispensing are legally mandated on PMLs. 9,10 However, studies have highlighted that additional labelling information may be useful to patients, 11,12 and that patients perceive a lack of medication-related information on PMLs 13 or on other written materials provided by healthcare institutions. 14 Several patient groups may experience difficulties with PMLs, however older adult patients, aged 60 years and above, in particular are prone to encountering difficulties in reading and understanding PMLs. ...
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Background: Patient preferences for the content and format of prescription medication labels (PMLs, i.e., sticker labels placed on medication bottles/packets at dispensing) have been extensively studied. However, accommodating all preferences on PMLs is impractical due to space limitations. Understanding how patients prioritise the content and format attributes of PMLs can inform improvements while working within PML space constraints. Objectives: We aimed to (1) identify a ranking of medication-related content attributes to be prioritised on PMLs using best-worst scaling (BWS), and (2) determine the relative importance of format attributes when incorporated onto PMLs using discrete choice experiment (DCE), from the perspective of older adult patients in Singapore. Methods: Attributes were informed by our prior qualitative study and PML best practice guidelines. For the BWS component, the assessed content attributes were indication, precautions, interaction or paired medicines, food instructions, side effects, expiry date, and missed dose action, all of which are currently not legally mandated on PMLs in Singapore. A BWS object case was used to rank the content attributes. For the DCE component, in a series of questions, participants were asked to choose between two PML options each time, that varied in the presentation of dosage-frequency instructions, font size, presentation of dosage, presentation of precautions, and font colour of precautions. A mixed logit model estimated the relative utilities of format attribute levels, enabling the calculation of importance scores of the format attributes. Results: The study recruited 280 participants (mean age: 68.8 ± 5.4 years). The three most-preferred content attributes were indication, precautions and interaction or paired medicines. The top three format preferences were tabular style presentation of dosage-frequency instructions, large font size and precautions in red colour. Conclusions: Healthcare institutions should consider improving their PMLs based on the leading content and format preferences voiced by older adult patients. The methodology adopted in the study can also be used for aligning the content and format of other patient education materials with patient preferences.
... Patients' comprehensibility to written drug information is very crucial in long term management of diseases and in determining drugs outcome. Several studies have evaluated the drug labels and Patients Package Inserts (PPIs) from patient perspective around the globe such as the U.S.A, Malaysia, Ethiopia, Si Lanka and Brazil [1][2][3][4][5][6]. Also, various studies conducted from Arabic regions such as Saudi Arabia and Egypt [7,8]. ...
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Background. The safe use of medicines largely relies on consumers reading the labeling and packaging carefully and accurately, and being able to comprehend and act on the information presented. We aimed to conduct local study on consumers' perceptions, attitudes and use of written drug information. Methods. A survey included 200 adults of the public in 13 community pharmacies and one main hospital (the University Hospital) in Tripoli city of Libya, using a structured interview technique. Results. The results showed that 73% of participants read drug labels with variation from always (39.72 %) to rarely (10.95%). About 42.46% of pharmacy customers read the Patients Package Inserts (PPIs) routinely, however; 53.42% of them faced difficulties in understanding the labelling. Foreign languages and small font sizes of written information were the most barriers to participants` comprehensibility (44.69 %, 34%) respectively. The findings indicated that 59 % of the respondents were used to obtain information from pharmacists. Despite the relatively high rate of reading to drug labels among pharmacy customers; more than half of them were unable to interpret information correctly. Conclusion. The study demonstrated the need for the implementation of educational and awareness programs for patients by pharmacists to improve the health literacy of medication labels. Steps must be taken to ensure that medicines in Libyan market are supplied with bilingual and non-technical language labels.
... Good dispensing practices ensure that medication is delivered to patients with appropriate directions in a pack which preserves the potency of the drug up to the time of use [48]. Compounding, then, is akin to the preparation of unlicensed drugs, both sterile and non-sterile, with the intention to fulfill patient-specific needs which are not covered by licensed medications. ...
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The objective of the study was to analyze and compare public hospital pharmacy practices in Pakistan and Norway. In addition, the study intended to identify the challenges to improving the public hospital pharmacy system and to propose recommendations that could help reform the practice to enhance patient safety and compliance. A cross-sectional study was conducted to understand public hospital pharmacies' organizational structure and determine their practices in Norway and Pakistan. The results of the research showed differences in 11 main areas of the pharmacy systems of the sampled hospitals. When compared to Norway, the study found that the public hospital pharmacy system in Pakistan could be improved in nine main areas. The results show that hospital pharmacies in Pakistan could benefit from the experience of similar international structures in relation to universal standards and practices.
... A few studies have assessed on labelling of medicines in the post-marketing setting. Among the few reported, in Sri Lanka, Athuruliya et al., [15], Manchanayake et al.,[16], and TSJ Janani et al., [17] have assessed the completeness, readability and understandability of dosing instructions in the dispensing labels dispensed by pharmacists. Further, Saheeha et al., reported information provided in Patient Information Lea ets (PIL) lacked important medicine information and was incompatible with known common references [18]. ...
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Background Labelling of medicines can greatly impact the quality and safety of medicine use. Regulatory requirements of labelling must be met in a country. Aim This study was set out to assess the availability of vital information, and adherence to local regulatory guidelines as specified by the Guidelines on Labelling of Medicines (GLM) V1.0 of the National Medicines Regulatory Authority (NMRA), Sri Lanka in primary and secondary labels of medicines used in a selected state hospital. Methods An observational, descriptive, cross-sectional study was conducted on a random sample of 300 medicine labels using an online random number generator and considering the annual estimation list for state hospitals as total population (1032 medicines). A checklist was developed based on NMRA guidelines, selected medicine labels were obtained from the study hospital and were reviewed against the checklist. Results Among 300 labels assessed, 171(57%) were orals, 108(36%) were injectables, and 21(7%) were external preparations or local applications. Almost 40% were substandard medicine labels which did not include at least one of the essential information required by the regulations, and the strength was not indicated in the primary display panel of 5.3% of medicines. Further, 5.0% of labels of different strengths of the same medicine or different medicines of same manufacturer looked alike. However, 89.6% complied with the recommended format of the generic name followed by its pharmaceutical form and strength, and 84.0% specified its pharmacopeial monograph. Conclusion Although most labels contained basic medicines information, majority did not completely fulfil the regulatory requirements specified in GLM V1.0 which could challenge both quality and safety of medicine use. Divergence from the specified standards was observed throughout the study, which challenges the safe and quality use of medicines.
Article
Background Proper medication labeling is essential to meet regulatory requirements and guarantee the safety of patients using the medication. This study aimed to observe the status of primary labeling of medicines manufactured and marketed by Nepalese pharmaceutical industries.MethodsA prospective study was conducted between June 2022 to October 2022 in Kathmandu Medical College. Total of 372 primary labeling of medicines manufactured by Nepalese pharmaceutical companies were assessed as required by Drug Standard Regulation, 2043 (1986 AD) of Nepal.ResultsThis study assessed the primary labeling of 372 medications produced by 46 pharmaceutical companies in Nepal. Most of the primary labeling had stated manufacturing company's name, address, and country, the production serial number for the drug, and recommended storage methods. But only 22(5.9%) of them specified the sub-category and appropriate drug classification was found on 352(94.6%) primary label.Conclusions The current study revealed that the status of the primary labeling is satisfactory as majority of the label contained the essential criteria required by Drug Standard Regulation, 2043 (1986 AD) of Nepal.
Article
Background Compliance towards the requirements of labelling of dispensed medicine (LDM) among private primary health care facilities ensures appropriate use of medicines. Aim This study aimed to examine the rate of compliance towards the requirements of LDM among retail pharmacies (RPs) and private medical clinics (PMCs). Methods A cross-sectional study was conducted from April 2019 to January 2020 across all inspected premises in Sarawak. Publics who attended RPs and PMCs and having medicines dispensed, have their medicine labels examined for compliance towards the requirements of LDM upon exiting the premises. Their verbal consents were obtained and the compliance score were recorded into self-developed data collection forms. Compliance rate was the percentage of requirements on the examined medicine labels that fulfil the requirements under Regulation 12 of Poisons Regulations 1952. Results A total of 414 LDM were examined, with 135 from RPs and 279 from PMCs. The full compliance towards the requirements of LDM among RPs and PMCs were 23.7% and 41.6%, respectively. The median compliance score of PMCs (0.83) was significantly higher (P<0.001) than RPs (0.67). The requirements of LDM with the lowest compliance was name of medicine (53.1%), followed by name of patient (31.9%) and date of dispensing (25.6%). Conclusion The full compliance rate on the requirements of LDM among RPs and PMCs were low. More stringent enforcement and public education on their rights for fully compliant medicine labels could improve the compliance.
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In low- and middle-income countries (LMIC) in Asia, pharmacies are often patients’ first point of contact with the health care system and their preferred channel for purchasing medicines. Unfortunately, pharmacy practice in these settings has been characterized by deficient knowledge and inappropriate treatment. This paper systematically reviews both the performance of all types of pharmacies and drug stores across Asia’s LMIC, and the determinants of poor practice, in order to reflect on how this could best be addressed. Poor pharmacy practice in Asia appears to have persisted over the past 30 years. We identify a set of inadequacies that occur at key moments throughout the pharmacy encounter, including: insufficient history taking; lack of referral of patients who require medical attention; illegal sale of a wide range of prescription only medicines without a prescription; sale of medicines that are either clinically inappropriate and/or in doses that are outside of the therapeutic range; sale of incomplete courses of antibiotics; and limited provision of information and counselling. In terms of determinants of poor practice, first knowledge was found to be necessary but not sufficient to ensure correct management of patients presenting at the pharmacy. This is evidenced by large discrepancies between stated and actual practice; little difference in the treatment behaviour of less and more qualified personnel and the failure of training programmes to improve practice to a satisfactory level. Second, we identified a number of profit maximizing strategies employed by pharmacy staff that can be linked to poor practices. Finally, whilst the research is relatively sparse, the regulatory environment appears to play an important role in shaping behaviour. Future efforts to improve the situation may yield more success than historical attempts, which have tended to concentrate on education, if they address the profit incentives faced by pharmacy personnel and the regulatory system.
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Rational drug use requires that patients receive medication appropriate to their clinical needs, in doses that meet their individual requirements, for adequate period of time and at lowest cost to them and their community. The study was designed to assess rational drug use using World Health Organization (WHO) core drug use indicators in Dessie Referral Hospital, North East Ethiopia. Cross sectional study design was employed to conduct the study from May 15 to 30, 2012. Data was collected retrospectively by using structured observational check list for prescribing and patient care indicators, respectively. The result showed that the average number of drugs per encounter, percentage of encounters with antibiotics, percentage of encounters with injections and percentage of drugs with generic name were 1.79, 48.2, 42 and 89.2%. Results of patient care indicator studies indicated average consultation time of 4.04 min, average dispensing time of 51.6 s, 92.6% of drugs were actually dispensed, 13.65% adequately labeled and 65% of patients retrieved the dose and frequency of administration of the dispensed drugs. Except average number of drugs per encounter, other indicators showed more or less potential drug use problems as compared to WHO criteria.
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Purpose: To explore the perceptions' of dispensers regarding dispensing practices and the salient factors affecting dispensing practices in three major cities of Pakistan - Islamabad, Peshawar and Lahore. Methods: A qualitative study with snowball sampling technique was used to identify fifteen dispensers working in community pharmacies in Islamabad, Peshawar and Lahore. Semi-structured interviews were conducted with the dispensers until the point of saturation was obtained. The interviews which focused on three major components, namely dispensing practices, regulation and influencing factors, and suggestions for improvements were audio-taped, transcribed verbatim and analyzed. Results: Thematic content analysis of the interview components yielded further seven major themes which were services provided at community pharmacies, quality of service provided by community pharmacies, expectation from community pharmacies, who was responsible for dispensing, obstacles to appropriate dispensing practices, laws and factors governing pharmacy practice in Pakistan, and strategies to improve current dispensing practices. Conclusion: All respondents in the different cities agreed that there was a shortage of pharmacists leading to their roles being taken over by the non-professionally qualified personnel working in community pharmacies. They also agreed that implementation of laws governing pharmacy practice in Pakistan is weak. These two main factors were considered to be responsible for the low quality services provided at community pharmacies. © Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, 300001 Nigeria.
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Background and objective Appropriate use of drugs is one essential element in achieving quality of health and medical care for patients and the community. The study aims to measure the performance of 10 primary health care centers (PHCCs) in Alexandria, Egypt regarding the use of drugs using the WHO/INRUD drug use indicators: prescribing, patient care and facility-specific indicators. Subject and methods One-thousand prescribing encounters were investigated for a period from January to December 2010. Three-hundred patients and 10 pharmacists were interviewed. Data entry and analysis were conducted using SPSS version 19. Mean, median and SD were measured. An ANOVA test was applied. Results Prescribing indicators were within optimal or slightly below the optimal value except encounters with antibiotics prescribed that were higher than the optimal value. The difference between PHCCs was statistically significant for all prescribing indicators (P = 0.000). Concerning patient care indicators, average consultation and dispensing times were short, and there was no drug labeling at all. The difference between PHCCs was significant for all patient care indicators except the percentage of drugs labeled and patient’s knowledge of correct dosage. Both facility-specific indicators were below the optimal value. Conclusion Prescribing indicators were below optimum except average drugs/encounter and encounters with injection prescribed. Patient care indicators were below the optimal level especially for average consultation dispensing times and drug labeling. Facility-specific indicators were below optimum.
Article
This study was conducted to assess the drug use patterns at four government hospitals from major cities of Pakistan by using WHO drug use indicators. Results showed that on average, 3.53 drugs were being prescribed per encounter. Percentage of antibiotics prescribed was 69.9% and the use of injection was 34.95%. Only 39.5% drugs were being prescribed by their generic names. Mean consultation time and dispensing time in the four hospitals were 3.64 minutes and 51.91 seconds respectively. Only about73.47% of prescribed drugs was being actually dispensed. On the average, only 3.96% prescriptions were adequately labelled and 54.98% of the patients were found to have adequate knowledge regarding drug dose. Availability of drugs was also not satisfactory though; greater but not all drugs were being prescribed from EDL. The results indicate that there is urgent need for improving rational drug use, availability of drugs and educate the patients about drug use. Key words: Rational drug use, WHO, Teaching hospitals, Pakistan.
Article
The objective of the study is to evaluate drug utilization for the treatment of hypertension attending an urban primary heath care center. A prospective observational study was conducted for a period of 06 months at Urban Primary Health Care Center, Guntur and the data collected was analyzed for various drug use indicators. A total of 47 prescriptions were collected with 40% belonging to males and 60% to females. The average number of drugs per prescription ranged from 1 to 3. 72.5% of generics and 92% of essential drugs were prescribed. The Beta blockers were commonly prescribed to the patients who were attending to the health center followed with calcium channel blockers. No instruction was given on how to administer the drugs in 74.7% of the total prescriptions. This study has revealed that beta blockers were the most utilized anti-hypertensive drugs. The incidence of polypharmacy was low, generic and essential drug prescriptions were high which depicted that the drug use in this zone was quite rational.
Article
In low and middle income countries private pharmacies are considered a valuable resource for health advice and medicines in many communities. However the quality of the service they provide has often been questioned and is unclear. This paper reviews the evidence regarding the quality of professional services from private pharmacies in low and middle-income countries. A literature search (computer and hand searches) was undertaken to identify all studies which included an assessment of the quality of some aspect of private pharmacy services in low and middle income countries. 30 studies were identified which spanned all regions in the developing world. These included 9 which examined the scope and/or quality of a range of professional services, 14 which assessed the quality of advice provided in response to specific symptoms and 7 which investigated the supply of medicines without a prescription. A range of methods were employed, in particular, questionnaire surveys with staff and/or clients and assessment of practice using simulated client methodology. Whilst many authors identified a potential for pharmacies to contribute more effectively to primary health care, virtually all studies identified deficiencies in the quality of current professional practice. In particular authors highlighted the lack of presence of pharmacists or other trained personnel, the provision of advice for common symptoms which was not in accordance with guidelines and the inappropriate supply of medicines. The evidence-base regarding the quality of professional services from pharmacies in low and middle income countries is limited, but indicates that standards are often deficient. If pharmacists are to contribute effectively to health care, the barriers to the provision of higher quality care and ways in which these might be overcome must be identified and examined.
Article
Three researchers posed as clients in 28 pharmacies in the capital of Sri Lanka. Tetracyclin, a prescription-only drug, could be obtained in all pharmacies without a doctor's prescription. No information was provided with its sale. Personnel in the pharmacies had no pharmaceutical qualification and knew little about the products they sold. They obtained most of their drug-related information from commercial/sales representatives.
Article
The aim was to study the practices of public and private pharmacies in the Savannakhet province, Lao PDR, in relation to defined aspects of good pharmacy practice (GPP) and rational use of drugs (RUD). The study design was cross-sectional using structured interviews and observations. A total of 105 drug sellers (31% and 4% had pharmacy education at public and private pharmacies, respectively) were interviewed, and the pharmacies were inspected. In addition, 576 customers were interviewed immediately after the drug transaction and all their drug purchases were recorded. Facility, patient-care and prescribing indicators covering aspects of GPP and RUD were used to measure and compare the quality of services of the pharmacies. The results showed that public pharmacies differed significantly from private pharmacies, with lower mean scores for availability of essential drugs (5.1 vs 6.4), 95% confidence interval (CI -2.23, -0.34) and essential materials (5.6 vs 6.9, 95% CI -2.40, -0.20), and with a higher percentage of antibiotics dispensed (34% vs 24%, P<0.02), as well as more injections (31% vs 7%, P < 0.001) and drugs per customer (2.4 vs 1.4, 95% CI 0.84, 1.16). More drug purchases were decided by health workers at public pharmacies than at private pharmacies (92% vs 16%). At public pharmacies, significantly more drugs were prescribed from the National Essential Drug List (76% vs 56%, P=0.004), and more drugs had an international non-proprietary name (67% vs 35%, P<0.001). There was no significant difference regarding order in the pharmacy, oral information and drugs adequately labelled at the public pharmacies compared with the private pharmacies. In spite of the differences shown, both public and private pharmacies performed suboptimally in relation to several aspects of GPP and RUD. The lack of essential drugs, essential materials, information on drug use and adequate drug labelling all contribute to irrational use of drugs. Interventions are needed to improve practice and drug use.