Assessing medication packaging and labelling appropriateness in Sri Lanka

Abstract

BackgroundThere 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.MethodsPackaging 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).ConclusionsInadequate 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.Electronic supplementary materialThe online version of this article (doi:10.1186/s40545-016-0091-5) contains supplementary material, which is available to authorized users.

Patients’ ability to read and understand dosing instructions of their own medicines – a cross sectional study in a hospital and community pharmacy setting

“…It is also important to note that, a patient’s ability to read a simulated dispensing label may not be completely indicative of the readability and comprehensibility of their own medications labels [ 20 ]. Among the few reported, is a considerably large study conducted by Athuruliya et al , [ 21 ] where completeness and understandability of dosing instructions given with dispensing labels were assessed in a house-hold survey. However, understandability of dosing instructions were assessed as a simple yes/no question without using objective criteria which the authors highlight as a limitation [ 21 ].…”

“…Among the few reported, is a considerably large study conducted by Athuruliya et al , [ 21 ] where completeness and understandability of dosing instructions given with dispensing labels were assessed in a house-hold survey. However, understandability of dosing instructions were assessed as a simple yes/no question without using objective criteria which the authors highlight as a limitation [ 21 ]. Unaka et al, [ 12 ] assessed written instructions provided at discharge by a hospital medication service but the study was limited to paediatric medication charts.…”

Assessment of primary labeling of medicines manufactured by Nepalese pharmaceutical industries

“…For instance, labeling “swallow tablet as a whole without breaking or cursing” on controlled released tablets and “tablets should be chewed before swallowing” on chewable tablets are needed to ensure that patients use it in the intended manner. Studies in SriLanka [ 6 ] and Malaysia [ 7 ] have also reported insufficient labeling of dispensed medicines as required by the regulatory authorities. The study done in SriLanka used WHO manual for household survey, and included both Western and traditional medicine but did not evaluate repackaging by family members and their understanding of medication administration instruction [ 6 ].…”

“…Studies in SriLanka [ 6 ] and Malaysia [ 7 ] have also reported insufficient labeling of dispensed medicines as required by the regulatory authorities. The study done in SriLanka used WHO manual for household survey, and included both Western and traditional medicine but did not evaluate repackaging by family members and their understanding of medication administration instruction [ 6 ]. Similarly, study in Malaysia used simulated client method to explore labeling requirement of dispensed medicine using a case of common cold but limits itself to single simulated case, observer bias and being a pilot study [ 7 ].…”

“…Evidences demonstrate that marketed pharmaceutical products have, at times, failed to meet the standard labeling requirements [ 4 , 5 ]. Moreover, studies have also claimed that dispensed pharmaceutical medicines lacked the prescribed labeling requirements [ 6 , 7 ]. As there are inadequacies in identification and reporting of such requirements in Nepal, Department of Drug Administration (DDA), which is the national medicine regulatory authority, should be more vigilant on such issues [ 8 – 10 ].…”