Medicine Label Research Articles

WHO guidelines for quality control of herbal medicines: From cultivation to consumption

WHO guidelines serve as a comprehensive framework for ensuring the safety, efficacy, and quality of herbal products throughout their lifecycle, from cultivation to consumption. Here's why adherence to these guidelines is crucial. By following WHO guidelines, manufacturers can implement practices that minimize the risks associated with herbal medicines, including contamination, adulteration, and variability in potency. This helps protect public health and ensures that consumers can use herbal products with confidence. Quality control measures recommended by WHO contribute to the consistency and reliability of herbal medicines. Standardization of production processes and the establishment of quality parameters help maintain the potency and efficacy of herbal products, leading to more predictable therapeutic outcomes. Adherence to WHO guidelines facilitates compliance with regulatory requirements established by national authorities and international bodies. Regulatory agencies often refer to WHO guidelines when developing regulations for the manufacturing, distribution, and labeling of herbal medicines. Compliance with these guidelines helps manufacturers meet regulatory standards and gain market authorization for their products. WHO guidelines provide a harmonized approach to quality control practices, promoting consistency and uniformity in the assessment of herbal medicines worldwide. This facilitates international trade and ensures that products manufactured in one country meet quality standards accepted globally, fostering trust and confidence among consumers and healthcare professionals. The systematic review highlights the ongoing efforts of WHO to review and update guidelines based on emerging scientific evidence and best practices. Adhering to these evolving guidelines encourages continuous improvement in quality control practices and fosters innovation in the herbal medicine industry.

Особенности политики по развитию государственного контроля за фармацевтическим производством в современной России

The article reveals the policy of development of state control over pharmaceutical production in the Russian Federation at the present stage. The author reveals the concept of control and supervisory activities and defines them as identical based on the goals set for these concepts and methods for achieving them. The principles underlying control and supervisory activities are identified, which are divided into general and special based on belonging to one or more industries. Decomposition of the totality of legal acts regulating the industry of activity is carried out to a separate regulatory requirement, which is defined as a measured unit of compliance with legal norms. The main threats existing at this stage in the pharmaceutical industry, as well as mechanisms aimed at countering these threats, are considered. The experience and problems of introducing control and accounting labeling of medicines in Russia during the COVID-19 pandemic are considered. The author analyzes experience of the annual operation Pangea XIV, carried out jointly by health authorities and law enforcement agencies of several countries and aimed at combating the production and trafficking of counterfeit medicines and medical devices around the world, and also reviews law enforcement under articles related to offenses in the field of production and sales of pharmaceuticals. As a result, there is an increase in the number of offenses in the pharmaceutical industry, and there is an increasing role of information technology in the production and sale of counterfeit pharmaceutical products. At the end of the article, a conclusion is formulated, which lists the main directions for improving control and supervisory activities in the Russian Federation at the present stage. The main means of developing control and supervisory activities is the digitalization of the industry, the main tools of which are development of relevant registers of regulatory requirements and control and accounting labeling of medicines.

Status of Primary Labeling of Medicines Manufactured by Nepalese Pharmaceutical Industries

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.

Compliance with NAFDAC Herbal Medicine Labeling Regulations: A Case Study of Herbal Remedies in Lagos State

Compliance with NAFDAC Herbal Medicine Labeling Regulations: A Case Study of Herbal Remedies in Lagos State

Prevalence of Medications Errors and Factors of Harmful Errors in Neonates and Paediatrics at Tertiary and Paediatric Hospitals: A Multicenter Study

Medication errors (ME) are human mistakes that may occur during drug use, prescribing administration or monitoring. This study aimed to determine the Prevalence of MEs among pediatric patients receiving tertiary treatment in pediatric speciality hospitals and describe their patterns and causes. Three institutions participated in a multicenter retrospective analysis. Reports of all MEs involving paediatrics aged ≤13 years who were hospitalised or visited the Emergency Department or outpatient clinics were reviewed 1 January 2019 - 31 December 2019. The National Coordinating Council for Medication Error Reporting and Prevention classification was used to categorise MEs and to define PRME (category CI) and patient–harming MEs (category EI). A retrospective study was conducted with a total of 318 MEs reported, with an overall prevalence of 0.9 per 1,000 patients. The Prevalence was markedly lower in the CHT (0.35 / 1,000 patients) than in KAMC and KFSH&RC (1.73 and 3.5). The highest rate of MEs was observed in admitted wards (14.69 / 1,000 patients). Most commonly, MEs occurred at the prescribing stage (81.1%), were caused by a physician (83.3%), and were discovered by the pharmacist (85.5%). Improper medication dosage (34.0%), frequency (14.2%), and duration (10.4%) were the three most common forms of MEs. Paediatric inpatient treatment has a significant frequency of MEs, accounting for 24% of hospitalisations. The ME may not get to the patient if independent double-check prescriptions, accurate medication reconciliation of new prescriptions against the previously prescribed, and improved medicine labelling and packaging techniques are used.

Automated abdominal CT contrast phase detection using an interpretable and open-source artificial intelligence algorithm.

To develop and validate an open-source artificial intelligence (AI) algorithm to accurately detect contrast phases in abdominal CT scans. Retrospective study aimed to develop an AI algorithm trained on 739 abdominal CT exams from 2016 to 2021, from 200 unique patients, covering 1545 axial series. We performed segmentation of five key anatomic structures-aorta, portal vein, inferior vena cava, renal parenchyma, and renal pelvis-using TotalSegmentator, a deep learning-based tool for multi-organ segmentation, and a rule-based approach to extract the renal pelvis. Radiomics features were extracted from the anatomical structures for use in a gradient-boosting classifier to identify four contrast phases: non-contrast, arterial, venous, and delayed. Internal and external validation was performed using the F1 score and other classification metrics, on the external dataset "VinDr-Multiphase CT". The training dataset consisted of 172 patients (mean age, 70 years ± 8, 22% women), and the internal test set included 28 patients (mean age, 68 years ± 8, 14% women). In internal validation, the classifier achieved an accuracy of 92.3%, with an average F1 score of 90.7%. During external validation, the algorithm maintained an accuracy of 90.1%, with an average F1 score of 82.6%. Shapley feature attribution analysis indicated that renal and vascular radiodensity values were the most important for phase classification. An open-source and interpretable AI algorithm accurately detects contrast phases in abdominal CT scans, with high accuracy and F1 scores in internal and external validation, confirming its generalization capability. Contrast phase detection in abdominal CT scans is a critical step for downstream AI applications, deploying algorithms in the clinical setting, and for quantifying imaging biomarkers, ultimately allowing for better diagnostics and increased access to diagnostic imaging. Digital Imaging and Communications in Medicine labels are inaccurate for determining the abdominal CT scan phase. AI provides great help in accurately discriminating the contrast phase. Accurate contrast phase determination aids downstream AI applications and biomarker quantification.

What can be learned from Medicine Labelling Initiatives in Asia, with a focus on Antibiotics?

What can be learned from Medicine Labelling Initiatives in Asia, with a focus on Antibiotics?

Evaluation of marketing authorization and labels of medicines in 2021 WHO Model List of Essential Medicines for Children in China, the Russian Federation and Brazil

ObjectiveThis work compares the marketing authorization, labels and dosage forms of medicines in the WHO Model List of Essential Medicines for Children (EMLc) in China, the Russian Federation and Brazil to urge policymakers to pay more attention to paediatric medication.MethodsMedicines were selected from the 8th EMLc. By searching relevant databases, which include different types of medical information in China, the Russian Federation and Brazil, the marketing authorization, labels and dosage forms of paediatric medicines in the three countries were evaluated.ResultsA total of 485 drug products containing 312 active pharmaceutical ingredients listed in the WHO EMLc were evaluated. Among them, 344 products were approved for use in China, 286 in the Russian Federation and 264 in Brazil. Out of the 344 approved medicines, 317 (92.15%) were authorized for paediatric use in China, 224 (78.32%) in the Russian Federation and 218 (82.58%) in Brazil. In terms of guidance information labelling on drug labels, 75.08%, 83.04% and 88.07% of paediatric drugs approved in China, the Russian Federation and Brazil, respectively, clearly indicated the usage and dosage for paediatric use. Additionally, injections and tablets were the most prevalent dosage forms in these three countries.ConclusionThere is still scope for enhancing the marketing authorization and development of dosage forms for paediatric medicines in the three countries. Furthermore, additional measures are being implemented to enhance the information provided on drug labels for children, particularly in China.

Knowledge, Perception, and Practices on the Labelling of Dispensed Medicine among Community Pharmacists and General Practitioners in the State of Sarawak, Malaysia.

The labelling of dispensed medicines (LDM) ensures that optimum therapeutic treatment levels are achieved, and medication errors are prevented. In Malaysia, LDM is enforced under the Poisons Act 1952. To explore the knowledge, perception, and practices of community pharmacists (CP) and general practitioners (GP) on LDM. 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. Proportionate stratified random sampling was employed. A self-administered structured questionnaire pre-tested and pilot-tested was used to explore knowledge and perception. Practices were assessed by having participants prepare dispensed medicine labels (DML) using simulated prescriptions. 250 participants; 96 CP and 154 GP participated. While most of them perceived that they knew the requirements of LDM (n = 244; 97.6%), their median knowledge score was poor (57.1%). The mean knowledge score of CP (62.0%) was significantly higher (P = 0.002) than GP (51.0%). The majority of participants perceived that LDM is important (n = 237; 94.8%) and necessary (n = 239; 95.6%) and perceived that poor compliance with 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 of LDM. 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 sound.

Estimating the impact of label design on reducing the risk of medication errors by applying HEART in drug administration

Medication errors are one of the biggest problems in healthcare. The medicines’ poor labelling design (i.e. look-alike labels) is a well-recognised risk for potential confusion, wrong administration, and patient damage. Human factors and ergonomics (HFE) encourages the human-centred design of system elements, which might reduce medication errors and improve people’s well-being and system performance.ObjectiveThe aim of the present study is twofold: (i) to use a human reliability analysis technique to evaluate a medication administration task within a simulated scenario of a neonatal intensive care unit (NICU) and (ii) to estimate the impact of a human-centred design (HCD) label in medication administration compared to a look-alike (LA) label.MethodThis paper used a modified version of the human error assessment and reduction technique (HEART) to analyse a medication administration task in a simulated NICU scenario. The modified technique involved expert nurses quantifying the likelihood of unreliability of a task and rating the conditions, including medicine labels, which most affect the successful completion of the task.ResultsFindings suggest that error producing conditions (EPCs), such as a shortage of time available for error detection and correction, no independent checking of output, and distractions, might increase human error probability (HEP) in administering medications. Results also showed that the assessed HEP and the relative percentage of contribution to unreliability reduced by more than 40% when the HCD label was evaluated compared to the LA label.ConclusionIncluding labelling design based on HFE might help increase human reliability when administering medications under critical conditions.

Outer packaging labelling of medicines in Southern African Development Community (SADC) countries: comparative analysis of requirements and transition terms for harmonisation

IntroductionThe 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.MethodsData 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.ResultsContent 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.ConclusionEven 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).

Pharmacy services and psychiatric patient satisfaction among community-based health insurance users in Ethiopia.

The development of community-based health insurance (CBHI) was driven by the need to provide economic protection for the poor against unexpected healthcare expenses. This can lead to increased patient satisfaction with their overall care. Maintaining high levels of client satisfaction with pharmacy services is crucial for effectively treating patients with psychiatric disorders. Therefore, the purpose of this study was to assess the impact of pharmacy services on psychiatry patient satisfaction among users of CBHI in the psychiatric setting. A multicenter cross-sectional study was conducted at the psychiatric clinics with a systematic random sampling technique between December 2023 and May 2024. A structured interview questionnaire was used to gather data. Both bivariate and multivariate analysis were employed. In multivariate analysis, variables having a p-value of < 0.05 were deemed statistically significant. A total of 420 participants were enrolled with a response rate of 99.5%. Overall, 261 (62.1%) of the patients reported being satisfied with the pharmacy service. However, a significant number of patients expressed dissatisfaction with certain aspects of the service, such as pharmacist counseling on medication side effects (43.1%), medication interactions (36.9%), and labeling and dispensing of medicines (42.4%). According to the study, living in an urban area [AOR = 2.0; 95% CI (1.25, 3.2); P = 0.04], being between the ages of 18-35 and 36-44 [AOR = 2.7, 95% CI (1.38, 5.3), p = 0.04] and [AOR = 3.3, 95% CI (1.6, 5.7), p = 0.001] respectively. First and second visits to the institution [AOR = 2.2; 95% CI (1.15, 4.4); P = 0.01] and [AOR = 1.9; 95% CI (1.13, 3.3); P = 0.01] respectively. Having two psychiatric disorders [AOR = 1.8, 95% CI (1.07, 3.07), p = 0.02] and all drug availability [AOR = 1.5, 95% CI (1.3, 3.43), p = 0.02], were positively associated with psychiatry patient pharmacy service satisfaction. In this study, the users of CBHI psychiatric patients were generally satisfied with the pharmacy service. Additionally, being urban residency age (18-44 years), first and second visits to the institution, having two psychiatric disorders and all drug availability were found to have a significant impact on psychiatric patient pharmacy services satisfaction.

New exploration of signal detection of Regional Risks from the perspective of data mining: a pharmacovigilance analysis based on spontaneous reporting data in Zhenjiang, China

ABSTRACT Background This study aimed to adopt the conventional signal detection methods to explore a new way of risk identification and to mine important drug risks from the perspective of big data based on Zhenjiang Adverse Event Reporting System (ZAERS). Research design and methods Data were extracted from ZAERS database between 2012 and 2022. The risks of all the reported drug event combinations were identified at the preferred term level and the standardized MedDRA query level using disproportionality analysis. Then, we conducted signal assessment according to the descriptions of drug labels. Results In total 41,473 ADE were reported and there were 12 risky signals. Signal assessment indicates the suspected causal associations in clindamycin-taste and smell disorders, valsartan-hepatic enzyme increased and valsartan-edema peripheral; the specific manifestations of allergic reactions triggered by clindamycin, cefotaxime, cefazodime, ShexiangZhuanggu plaster, ShexiangZhuifeng plaster, and Yanhuning need to be refined in drug labels. In addition, the drug labels of NiuHuangShangQing tablet/capsule, Fuyanxiao capsule, and BiYanLing tablet should be improved. Conclusions In this study, we attempted a new way to find potential drug risks using small spontaneous reporting data. Our findings also suggested the need for more precise identification of allergic risks and the improvement of traditional Chinese medicine labels.

Exfoliative dermatitis; new safety signal detection regarding Meropenem in VigiBase™: A study based on WHO database

Background Cutaneous adverse drug reactions (CADRs) account for nearly one-third of all adverse drug reactions (ADRs), and severe reactions while they are rare, can dramatically affect patients’ quality of life or even cost them their lives. While clinical trials may prove medicine’s effectiveness, they cannot give a thorough picture of the drug’s safety profile. Spontaneous surveillance and data mining techniques provide a promising complementary technique for post-marketing monitoring to detect safety signals. Objective The objective of this research was to assess the data obtained and uploaded to VigiBase about adverse medication responses affecting the skin and surrounding structures, with a specific focus on identifying any possible signals linked with Meropenem that are not currently indicated on the medicine label. Methods A retrospective study involved clinical review and data mining of patients who suffered cutaneous reactions reported to national Pharmacovigilance centers in Iraq and other countries from January 2010 to December 2021; a total of 4,510 reports were found in Iraq and filtered according to several criteria to obtain a safety signal with the most significant impact on public health. To improve the signal quality, all global cases were included in evaluating the detected signal, excluding duplicate and incomplete reports. Results In a total of 65 cases that contained Meropenem as the suspected cause of exfoliative dermatitis (ED), only 53 cases met the inclusion criteria. Assessment of the included cases proved the detection of a new unlabeled signal that links Meropenem to ED. The mean affected age was 59 years, and males outnumbered females (30:23). The combination showed to be statistically significant (IC025, 2.961; PRR025, 8.227; ROR025, 8.244), and causality assessment showed a possible relation in more than 70% of the cases. Conclusion Spontaneous reporting systems, despite their limitations, are vital to pharmacovigilance systems and the identified signal needs further research.

Pharmaceutical pictograms: User-centred redesign, selection and validation.

In an earlier study, several tested International Pharmaceutical Federation (FIP) pictograms did not achieve validity among older adults in Singapore. In this study, for 27 unvalidated FIP pictograms, we (1) developed variants of each pictogram, (2) elicited the most-preferred variant, and (3) assessed the validity of the most-preferred variant among older Singaporeans. In phase 1, up to three variants of the 27 pictograms were developed, based on older adults' feedback from a previous study. In phase 2, the most-preferred variant of 26 pictograms, which had two or three variants, was selected by 100 older participants. In phase 3, the 27 most-preferred variants (including the pictogram with only one variant) were assessed for validity - transparency and translucency - among 278 older participants (10 pictograms per participant). To evaluate transparency, participants were first asked: "If you see this picture on a medicine label, what do you think it means?" for each assigned pictogram. If they responded, they were asked, "How do you know?", and if not, they were told, "Tell me everything you see in this picture". Then, participants were shown their assigned pictograms again, one by one, and the pictogram's intended meaning was revealed to evaluate translucency. Pictograms were classified as valid (≥66% participants interpreted its intended meaning correctly [transparency criterion] and ≥85% participants rated its representativeness as ≥ 5 [translucency criterion]), partially valid (only transparency criterion fulfilled) or not valid. In phase 1, 77 variants of the 27 pictograms were developed. In phase 2, a majority of the most-preferred variants were selected by >50% participants. In phase 3, 10 (37.0%) of the 27 pictograms tested were considered valid, and five (18.5%) were partially valid. A higher proportion of pictograms portraying dose and route of administration and precautions were valid or partially valid, versus those depicting indications or side effects. Contextual redesigning and selection of pharmaceutical pictograms, which initially failed to achieve validity in a population, contributed to their validation. The redesigned validated pictograms from this study can be incorporated into relevant patient information materials in clinical practice.

Pharmaceutical indication pictograms for low literacy viewers: Health literacy and comprehension.

Poor comprehension of pharmaceutical pictograms used on medicine labels or leaflets can compromise understanding of medicine-taking information, potentially causing negative health outcomes. The aim was to assess association of health literacy (HL) with comprehension of pictograms displaying indication and side effect information in a lower literacy, limited English proficiency (LEP) population. Community centre, Makhanda, South Africa. This was a quantitative cross-sectional study using simple random probability sampling. Ninety isiXhosa-speaking adults with a maximum of 12 years schooling, attending primary healthcare clinics were interviewed using structured interviews. Health literacy was assessed using the Health Literacy Test for Limited Literacy populations. Comprehension of 10 locally developed pictograms was evaluated. The mean pictogram comprehension score was 7.9/10, with 8/10 pictograms complying with the International Organization for Standardization criterion of 66.7% correct comprehension. Only 15.6% of participants had adequate HL. A significant association of HL with pictogram comprehension was established (p = 0.002). Pictogram misinterpretation was higher in those with lower HL; adequate HL was associated with superior comprehension. Pictogram comprehension was negatively associated with age (p < 0.006), and positively associated with education (p < 0.001) and English proficiency (p < 0.001). Higher HL was associated with better pictogram comprehension. Low HL, LEP and low education levels are regarded as potential indicators for possible pictogram misinterpretation. This study observed the potential for misinterpretation of medication pictograms. Health professionals should be aware that low HL, limited schooling and limited English proficiency could signal difficulty in fully comprehending pictogram content.

Pharmacists' perception about design and content of medicine labels on prescription services in community pharmacies

Background: Differences in perception among pharmacists and the absence of standards or regulations for labelling prescribed medicines in Indonesia make the labels patients receive have different designs and contents. Incomplete information and insufficient medicine label design can lead to medication errors. Objective: This study aimed to determine the pharmacists’ perception of the design and content of prescribed medicine labels. Method: This study was conducted by survey using an online questionnaire developed based on the "FIP Guidelines for The Labels of Prescribed Medicines" and Regulation of the Minister of Health of the Republic of Indonesia number. 73 the year 2016 concerning Pharmaceutical Service Standards in Pharmacies. Questionnaires were distributed through personal chat and social media groups of community pharmacists. Result: A total of 925 pharmacists from 32 provinces of Indonesia participated in this study. Respondents considered the most important information on the label of prescribed drugs namely instructions for drug use (84.6%), patient name (81.6%), pharmacy name (76.1%), special instructions (71.5%), and pharmacist name (63.9%). For the label’s design, most respondents preferred printed and handwritten labels (61.2%). Conclusion: It can be concluded that different pharmacists' perceptions affect the labelling of prescribed medicines. There is a need for regulations or standards of labelling prescribed medicines.

Assessment of the impact of good pharmacy practices training among drug dispensers in Bangladesh.

Background: Training improves dispensing behavior of drug dispensers in low- and middle-income countries. Between 2018 and 2020, a total of 5,059 Grade C pharmacists, who completed a 3-month training course for availing a "Grade C pharmacist certificate" were trained on Good Pharmacy Practice (GPP) in 11 districts in Bangladesh by Management Sciences for Health (MSH) under Better Health in Bangladesh (BHB) project. We assessed the impact of GPP among trained Grade C pharmacists under the BHB project compared to those who did not receive GPP training under the BHB project (non-trained), and explored the major challenges towards achieving GPP. Methods: We created a database of trained Grade C pharmacists provided by MSH and randomly selected the trained Grade C pharmacists for recruitment following consent. We created another database of the non-trained Grade C pharmacist who were deployed within a 1-km radius of a trained Grade C pharmacist, and randomly recruited one non-trained against one trained Grade C pharmacist. A semi structured questionnaire was administered to obtain information about knowledge of GPP, including guidelines of dispensing medicines, temperature maintenance, medicine storage, counseling customers and labeling medicines. Dispensing behavior was directly observed following a structured tool. Chi-square test (for categorical variables) and independent sample t-tests (for continuous variables) were applied for comparison between the trained and the non-trained Grade C pharmacists. A logistic regression model was applied to explore an association between knowledge and practice between the two groups. Results: Between February and March 2021, 220 trained and 220 non-trained Grade C pharmacists were recruited. Mean age (SD) of the participants was 41years (10.5) and 98.4% were male. Compared to the non-trained, the trained Grade C pharmacists had better knowledge about the guidelines of dispensing medicines (97.7% vs 89.5%, p < 0.001), temperature maintenance (91.8% vs 45.5%, p = 0.001), medicine storage (92.3% vs 40.5%, p = 0.001) counseling customers (99.5% vs 92.3%, p < .001) and labeling medicines (91.0% vs 80%, p < 0.001). General dispensing behavior was observed to be better among the trained than the non-trained with labeling of medicines (63.2% vs 53.4%, p = 0.038), counseling customers (39.1% vs 28.6%, p = 0.021) and using a room thermometer for maintaining ambient temperature in the medicine shops (56.8% vs26.8%, p < 0.001). Bad behavior of the customers (39.5%) and lack of GPP knowledge among Grade C pharmacists (28.6%) were recognized to be challenges towards achieving GPP in Bangladesh. Conclusion: Training led to better knowledge and practices about dispensing medicines among Grade C pharmacists in Bangladesh. Periodic training may promote achieving GPP in Bangladesh.

487 Understanding the Medicines Labelling System in a Tertiary Hospital in Kuwait Using Work Domain Analysis

Abstract Introduction A report by the World Health Organisation highlighted a lack of clarity in medicine labelling regulations in Kuwait and the subsequent risk of patient harm from labelling errors (1). In response, the Undersecretary of the Kuwait Ministry of Health (MOH) issued a ministerial decree governing the labelling of medicines (M.D 4451/2021, June 2021) (2), stipulating a requirement to affix an identification label containing specific patient, medicine, and supplier information on medication packaging. Aim To develop a map of the Medicines Labelling System (MLS) in a tertiary hospital in Kuwait (TH). Methods A Work Domain Analysis (WDA) was conducted using qualitative data from 1) semi-structured interviews with a purposive sample of 10 nurses, 10 patients/caregivers, and 10 pharmacists involved in the delivery or administration of medicines to TH patients, as well as 2) an analysis of medicine labelling documents published by the Kuwaiti MOH and TH. After gaining informed consent, one-to-one semi-structured interviews were conducted in TH, in accordance with the latest COVID-19 prevention procedures. All interviews were audio-recorded and transcribed verbatim. Both deductive – informed by Abstraction Hierarchy (AH), the modelling tool of WDA – and inductive thematic analysis was conducted. Results Thirty participants took part in semi-structured interviews averaging 34 minutes, from which five levels of abstraction in the AH were constructed. The first level, “functional purposes”, describes the reason why any given system exists: for the MLS in TH, they were “compliance with regulations, policies, and protocols of the Kuwaiti MOH and TH” and “providing an identification of medicine issued by ISH pharmacies”. Five aspects of the second level, “values and priority measures”, were identified, including “optimisation of service workflow” and “time-efficient clinical practices.” The third level, “purpose-related functions”, describes the key functions that need to be in place for the MLS to work; these were “the production of medicines labels”, “coordination”, and “management of medicines and resources”. The last two levels in the AH, “object-related functions” and “physical objects”, describe the resources that are required in the MLS, their functionality, and their limitations: there were 16 groups of physical objects, which afforded 19 different functions. Means-ends links showed the crucial relationships and significance between functions at different levels of the AH, the most prominent of which were coordination and communication. Conclusion TH’s MLS is a complex system that was visually represented using an AH, showing the constraints and structure of the work system. The AH constructed a knowledge base. Subsequent analyses of the current system issues may draw on this knowledge, such as a potential analysis of how specific tasks, like the use of labels by nurses within wards, are performed. The limitations of this study included only exploring ‘work as imagined’ (i.e., accounts from healthcare staff and documents), which does not fully capture how the MLS functions on a day-to-day basis. Future work will focus on deepening our understanding of the MLS through observations of work in practice.

Lack of exposure to pharmacogenomics education among the health care providing students in the West Bank of Palestine.

Evaluating the knowledge in pharmacogenomics (PGx) is the first step toward the implementation of PGx testing in clinical practice. This survey aimed to evaluate the knowledge of PGx testing among healthcare providing students at the top-ranked university in the West Bank of Palestine. First an online questionnaire consisting of 30 questions regarding the demographic, knowledge, and attitude toward pharmacogenomics testing was structured and validated. Then the questionnaire was distributed to 1,000 current students from different fields. 696 responses was received. The results showed that almost half of the participants (n=355, 51.1%) have never took any courses about PGx during their university training. Only 81 (11.7%) of the students who took the PGx course stated that it helped them understanding how genetic variations affect drug response. The majority of the students were uncertain (n=352, 50.6%) or disagreed (n=143, 20.6%) that the lectures during university education described the effects of genetic variants on drug response. Although most of the students (70-80%) answered that genetic variants can indeed affect the drug's response, only 162 students (23.3%) responded that VKORC1 and CYP2C9 genotypes influence the response to warfarin. In addition, only 94 (13.5%) students were aware that many medicine labels include clinical information about PGx testing provided by the FDA. It is concluded from the results of this survey that there is a lack of exposure to PGx education associated with poor knowledge of PGx testing among the healthcare providing students in the West Bank of Palestine. It is recommended to include and improve the lectures and courses regarding PGx as this will have a major impact on precision medicine.