Sri Lanka’s public healthcare system is state-funded, and medications are provided free of charge to patients. All medicines imported are procured through the State Pharmaceutical Corporation (SPC) [13]. Medical Supplies Division (MSD) is the main responsible organization to distribute medicines to state hospitals all over the country [13]. The National Medicines Regulatory Authority (NMRA) is the legislative framework that provides the legal authority to regulate and control the use of medicines with respect to its registration, manufacture, importation, sale (wholesale and retail), labelling, transportation, advertising, distribution of samples, testing (through National Medicine Quality Assurance Laboratory) and disposal of expired /outdated medicines [13]. Given the large reliance on imports, every aspect of medicine control is to be sought through regulatory frameworks. However, divergence from the specified standards was observed throughout the study, which challenges the safe use of medicines.
Labelling errors are under-reported unless they result in serious injury or death [19]. Safety can be achieved through properly designed systems, processes, and tasks, which will reduce the possibility of errors [19]. Evaluation of safety is determined by means of non-experimental research, whereas efficacy is measured by a set of experimental, randomized control trials and blinded trials [20]. To curtail the possibility of error, medicine labels should be easy to read, identify and devoid of non-essential information. Labels are the first point of interaction between a medicinal product and a healthcare professional or patient [3]. The role of medicine labels is to enable the correct identification of medicine and to communicate sufficient information to the users. Similarly, the primary display panel is most likely to be spotted and read out at the time of dispensing or use. Therefore, practitioners and patients rely on the information provided on it.
In this study, it was revealed that around 40% of substandard medicine labels were available in the hospital at the time of the study. This finding is compatible with the study that evaluated a sample of medicine labels from four developing countries which were supplied by U.S.A pharmaceutical manufacturing companies. Further, it concluded that half of the labels were either entirely appropriate or had relatively small problems, and the other half variated significantly and seriously from the standard [21].
About 10.4% of labels did not align with the presentation requirement of the official or generic name in the recommended format by NMRA (i.e., metformin tablets BP 500 mg). Good Label and Package Practices Guide for Prescription Drugs, Canada mentioned that “The Proximity Compatibility Principle specifies that all information relevant to a common task or mental operation should be displayed close together” [3]. Also, it was noted that 5.3% of labels did not mention the strength of the medicine following its generic name on the primary display panel, instead, it was mentioned under the composition. As some individual medicines are available in multiple strengths this may be easily misinterpreted. This is crucial because indicating the strength of medicine is a rudimentary necessity of a medicine label, and this finding signifies the importance of post-marketing surveillance, and manufacturers should be held accountable for the labels submitted for approval and should comply with the regulatory guidelines throughout the lifetime of the medicine in the market.
In addition, 84.0% of products specified their pharmacopeial monograph, which is necessary to reflect the quality standard of the medicine. A few medicines (8.6%) claimed their pharmacopoeial standard under the composition, however, it was not mentioned in the primary display panel of the label. Also, in one medicine label, British Pharmacopoeia (BP) standard was claimed under the composition, however, the Indian Pharmacopeia (IP) was mentioned in the primary display panel along with the generic name of the medicine which was contradictory. This is very alarming and shows the negligence and irresponsibility of manufacturers. This finding emphasizes the importance of education, awareness, and penalties for inadequate or substandard labelling. Even though NMRA has initiated enforcement activities [14], maintaining its sustainability is still a challenge.
It was observed, that 5% of the medicines had similar label designs, colour and appearance. Among them, there were multiple strengths of the same medicine, and among different medicines from the same manufacturer. The similarity of label design may not be easily distinguished therefore increasing the chance of errors. Therefore, the choice of colour is one of the main factors to be considered in designing medicine labels. Even though NMRA has mandated LRPs in the GLM V1.0, substandard medicine labels were seen in practice. These manufacturers should be identified and notified of this practice promptly. Thus, this finding provides an insight into the gap between policy and practice.
Safety warnings such as “keep all medicines out of reach of children”, and any other special warnings or precautions that may be necessary for the user should be mentioned on the label. However, this information was frequently absent in many labels, which highlights the need of enforcing regulations and post-marketing surveillance.
GLM V1.0 states that the date of expiry in clear terms (month/year), storage temperature, and other special storage precautions should be given on the label. However, it was noted that many different formats and multiple ways of expression of information were used. One label lacked the date of expiry, and a barcode was seen on the label instead, however, barcode readers may not be available in some dispensing settings, to trace the expiry date of medicines. Also, the expiry date is vital information that needs to be communicated to the users. In many instances, it was observed that a specific storage temperature was not mentioned, instead some ambiguous information such as “Store at a temperature not exceeding 300C; Store in a cool dry place; Protect from light” was provided. In practice, it was observed that many users do not have knowledge to store the medicines correctly and tend to refrigerate medicines or store them in extremely high-temperature conditions. Eventually, they consume deteriorated medicines. Therefore, it is necessary to conduct quality control studies on spot samples available in the market. It is encouraging that the NMRA has started the post-marketing surveillance and enforcement activities recently [14], however, sustainability of these actions is necessary.
This study is the first of its kind in a Sri Lankan State hospital setting which assessed the extent of labelling adherence to local regulatory guidelines. Even though this study was based on a single study setting, these results would be generalizable to the entire country as this is a representative sample of the whole state sector. However, it should be acknowledged that we couldn’t able to cross compare with the manufacturer's labels given for registration and the labels on the containers which could be a limitation of the study.