Papers by Binaya Sapkota, BPharm, PharmD

Journal of Pharmaceutical Policy and Practice, 2022
Background: Pharmacists in high-income countries routinely provide efficient pharmacy or pharmace... more Background: Pharmacists in high-income countries routinely provide efficient pharmacy or pharmaceutical care services that are known to improve clinical, economic, and humanistic outcomes (ECHO) of patients. However, pharmacy services in low-and middle-income countries, mainly South Asia, are still evolving and limited to providing traditional pharmacy services such as dispensing prescription medicines. This systematic review aims to assess and evaluate the impact of pharmacists' services on the ECHO of patients in South Asian countries. Methods: We searched PubMed/Medline, Scopus, EMBASE, CINAHL, and Cochrane Library for relevant articles published from inception to 20th September 2021. Original studies (only randomised controlled trials) conducted in South Asian countries (published only in the English language) and investigating the economic, clinical (therapeutic and medication safety), and humanistic impact (health-related quality of life) of pharmacists' services, from both hospital and community settings, were included. Results: The electronic search yielded 430 studies, of which 20 relevant ones were included in this review. Most studies were conducted in India (9/20), followed by Pakistan (6/20), Nepal (4/20) and Sri Lanka (1/20). One study showed a low risk of bias (RoB), 12 studies showed some concern, and seven studies showed a high RoB. Follow-up duration ranged from 2 to 36 months. Therapeutic outcomes such as HbA1c value and blood pressure (systolic blood pressure and diastolic blood pressure) studied in fourteen studies were found to be reduced. Seventeen studies reported humanistic outcomes such as medication adherence, knowledge and health-related quality of life, which were found to be improved. One study reported safety and economic outcomes each. Most interventions delivered by the pharmacists were related to education and counselling of patients including disease monitoring, treatment optimisation, medication adherence, diet, nutrition, and lifestyle.

Medicine, 2022
The medication therapy management (MTM) pharmacists follow the philosophy of pharmaceutical care ... more The medication therapy management (MTM) pharmacists follow the philosophy of pharmaceutical care to address individualistic medication therapy requirements in their practice settings. The present study aimed to introduce the pharmacist-delivered MTM services among type 2 diabetes mellitus patients at a tertiary care hospital in Nepal. Cross-sectional study was conducted at Patan Hospital, Lalitpur, Nepal, among 200 patients with type 2 diabetes mellitus from July to December 2019. The intervention included maintenance of medication profile for individual patients, and then MTM service was proposed based on 5 core elements of MTM services proposed by the American Pharmacists Association. Both antidiabetic and non-antidiabetic medicines were coded as per the anatomic, therapeutic, and chemical classification and defined daily dose assignment 2020 for documentation. The Charlson Comorbidity Index was used to index comorbidities. The drug interaction profile was checked with the Medscape Drug Interaction Checker. Both fasting and postprandial blood sugar levels were significantly associated with age (P-values <.000 for both), baseline symptom (P-values .012 and .003 respectively), and diet plan proposed (P-values .049 and .011 respectively). Maximum cases of drug interactions requiring close monitoring were between metformin and insulin regular (i.e., 11, 5.5%). This was a novel initiative of the MTM services in a resource constraint country like Nepal and can show a clue for the pharmacists targeting such services in other similar settings. Abbreviations: CCI = Charlson Comorbidity Index, FBG = fasting blood glucose, HCCs = health care costs, MTM = medication therapy management, OHAs = oral hypoglycemic agents, PBG = postprandial blood glucose, T2DM = type 2 diabetes mellitus.

Advances in Medical Education and Practice, 2022
Continuing pharmacy education (CPE) is an educational way for pharmacy professionals to develop c... more Continuing pharmacy education (CPE) is an educational way for pharmacy professionals to develop competency in providing quality pharmaceutical care to patients. The CPE program helps maintain up-to-date knowledge and skills, increase the professionalism of pharmacists, and positively impact patient health outcomes. However, the concept and practice of CPE are still in their infancy in Nepal. Nepal's conventional pharmacy education system involves didactic lectures focusing more on theoretical learning than practical and experiential approaches, leading to the generation of pharmacists theoretically knowledgeable but practically non-competent to deliver pharmaceutical care services in independent practice settings. Additionally, in the absence of CPE, the professionals might miss updated information on new therapies, technologies, and approaches in patient management. The community and hospital pharmacies in Nepal are often business-oriented rather than service, and may not even be staffed by pharmacists, so the CPE programs are rarely conducted for the pharmacy professionals. Hence, the present commentary aimed to explore the status of CPE and its barriers or challenges in implementation and to suggest solutions in Nepal.

Patient Preference and Adherence, 2022
Background: Control of high blood pressure and prevention of cardiovascular complications among h... more Background: Control of high blood pressure and prevention of cardiovascular complications among hypertensive patients depends on patients' adherence to therapy. The Hill-Bone Compliance to High Blood Pressure Therapy Scale (HBCTS) is one of the most popular scale to assess hypertensive patients' adherence behaviour. Unfortunately, no questionnaire in the Nepalese language is available to date to assess adherence to anti-hypertensive therapy. Aim: To translate, culturally adapt and validate the English original version of the HBCTS into Nepalese language to measure treatment adherence of Nepalese hypertensive patients. Methods: The cross-sectional study was conducted to translate, culturally adapt and validate the HBCTS into Nepalese version. The standard translation process was followed and was evaluated among 282 hypertensive patients visiting selected primary healthcare centers (PHCCs) of Kathmandu district, Nepal. Cronbach's alpha was measured to assess the reliability of the tool. Exploratory factor analysis using principal component analysis with varimax rotation was used to evaluate structural validity. Results: The mean±SD age of 282 participants was 58.49±12.44 years. Majority of participants were literate (75.2%), and consumed at least one anti-hypertensive medication per day (85.5%). Nearly half (42.2%) of the participants had a family history of hypertension, and almost half (48%) of them had comorbid conditions. Mean ±SD score for overall adherence was 17.85±3.87 while those of medication taking, reduced salt taking, and appointment keeping subscales were 10.63±2.55, 4.16±1.12 and 3.06±1.07, respectively. Kaiser Meyer Olkin (KMO) was found to be 0.877. Exploratory factor analysis revealed a three-component structure; however, the loading of components into medication adherence, reduced salt intake and appointment keeping constructs were not identical to the original tool. Cronbach's alpha score for the entire HBCTS scale was 0.846. The translated Nepali version of the HBCTS demonstrated acceptable reliability and validity to measure adherence to antihypertensive therapy among hypertensive patients in clinical and community settings in Nepal.

Cost Effectiveness and Resource Allocation, 2022
Background: Afghanistan, a low-income landlocked country, is continuously suffering from domestic... more Background: Afghanistan, a low-income landlocked country, is continuously suffering from domestic war and conflicts; the country struggles to provide quality healthcare services, including affordable medicinal products in the required quantity. Moreover, the quality standards of domestic pharmaceutical companies have not been established yet. One of the internationally recognized guidelines for monitoring manufacturing processes in pharmaceutical companies is Good Manufacturing Practice (GMP), recommended by World Health Organization (WHO). Therefore, this study aimed to assess whether a pharmaceutical company in Kabul, Afghanistan adheres to the GMP standards established by WHO. Method: A descriptive cross-sectional study was conducted to assess the WHO-delineated GMP compliance of 25 pharmaceutical companies in Kabul, Afghanistan. The inspection checklist was developed by Afghanistan's National Medicine and Healthcare Products Regulatory Authority (NMHRA) using the WHO-delineated GMP guidelines. In addition, direct observation, interviews with respective delegates, and documentation reviews were conducted to collect research data. Result: Only 38.33% (1.14 ± 1.08) of GMP contents were complied. Personnel 66.67% (2 ± 1.15) and materials 58.67% (1.76 ± 1.11) were the most commonly complied components, whereas the product recall 12.98% (0.39 ± 0.85), quality assurance 16.44% (0.49 ± 0.81) and quality control laboratory 28.35% (0.85 ± 1.12) were the least complied ones. Conclusion: None of the GMP components was fully adhered to by the pharmaceutical companies in Kabul, Afghanistan. Quality control and assurance should be implemented immediately, including validation and qualification practices.

Generic medicines are being promoted in many countries for their added benefits over branded drug... more Generic medicines are being promoted in many countries for their added benefits over branded drugs, such as reduced price, therapeutic equivalence, and convenience to the patients. However, generic prescribing is still not up to the optimum level in Nepal to assure access to costeffective, quality medicines to the public and to reduce the overall economic burden and practicerelated errors of medications. This review aimed to discuss the current scenario of generic medicine, generic prescribing, hurdles on the one hand, and potentials ways in promoting generic medicine usage and generic prescribing in Nepal on the other. Extensive literature on generic medicine usage and generic prescribing practice in Nepal was reviewed. This review found some of the major challenges to be addressed for the proper implementation of generic medicine prescribing, and utilization. These challenges include lack of facilities and competency to assure therapeutic equivalence of different brand-name medicines, lack of understanding about generic medicines among health care providers (HCPs) and the public, and lack of stringent regulation towards promoting generic medicines. Rational pharmaceutical promotion and awareness about generic medication to the medical students are also inevitable towards promoting the practice of generic medicines. The practice of generic medicine and generic prescribing is not possible without the assurance of therapeutically equivalent generic alternatives. The study recommended the prompt effort of the regulatory authority to enforce the generic prescribing and generic substitution policy through strengthening policies, procedures and laboratory testing to assure citizens' right to access to cost-effective, and affordable quality medicine, as the Nepal's National Health and Drug Policy mandated.

This commentary article highlights the status of clinical pharmacy education in Nepal, explores t... more This commentary article highlights the status of clinical pharmacy education in Nepal, explores the challenges and solutions in sustainably reintroducing Post-Baccalaureate Doctor of Pharmacy (PharmD, Post-Bac) in Nepal, as was previously launched by Kathmandu University (KU) Department of Pharmacy in 2010, and suggests a few prospects forward. Clinical pharmacy practice has remained on the sidelines and subordinate to physicians in Nepal. KU launched the PharmD (Post-Bac.) as a postgraduate program to establish the professional identity of clinical pharmacists in the country. However, despite unremitting efforts, the program did not thrive long and held since 2014. This paper aimed to explore challenges that remained at the forefront of the program and provide possible solutions for its reintroduction. The KU produced three batches of PharmD Post-Bac. graduates and now the revival of the program is crucial. Undoubtedly, a well-trained clinical preceptor can bring significant changes in the quality and competency of the PharmD graduates. Advocacy programs to foster the role of clinical pharmacists in the patient care services and revisiting of Bachelor of Pharmacy (BPharm) curriculum to complement the necessity of the PharmD program are needed. The non-sustenance of the PharmD program is emblematic of the dire mosaic that the clinical pharmacists are facing while delivering patient-oriented services in the country. Hence, strategies need to be formulated for the revival and sustainability of the program.

Journal of Travel Medicine, 2021
Rationale for Review: Heterologous prime-boost doses of COVID-19 vaccines ('mix-and-match' approa... more Rationale for Review: Heterologous prime-boost doses of COVID-19 vaccines ('mix-and-match' approach) are being studied to test for the effectiveness of Oxford (AZD1222), Pfizer (BNT162b2), Moderna (mRNA-1273) and Novavax (NVX-CoV2373) vaccines for COVID in 'Com-Cov2 trial' in UK, and that of Oxford and Pfizer vaccines in 'CombivacS trial' in Spain. Later, other heterologous combinatios of CoronaVac (DB15806), Janssen (JNJ-78436735), CanSino (AD5-nCOV), and other were also being trialed to explore their effectiveness. Previously, such a strategy was deployed for HIV, Ebola virus, malaria, tuberculosis, influenza, and hepatitis B to develop the artificial acquired active immunity. The present review explores the science behind such an approach for candidate COVID-19 vaccines developed using eleven different platforms approved by the World Health Organization.

Background The conventional one-size-fits-all approach has been criticized for almost all drugs u... more Background The conventional one-size-fits-all approach has been criticized for almost all drugs used especially for chronic diseases, including gout. The present study was aimed to explore the need of individualization and optimization of the dose of anti-gout medications among gout patients. Methods Cross-sectional study was carried out among 384 randomly selected new gout patients visiting two gout treatment centers at Lalitpur Metropolitan City, Nepal and who were taking antigout medications. Patients not taking anti-gout medications and not showing willingness to participate were excluded. The eGFR was calculated with the CKD Epidemiology Collaboration (CKD-EPI) creatinine equation (2009). Doses to be individualized were decided based on the Renal Drug Handbook and verified with the BNF 80. Data were analyzed via R 4.0.3 by applying the multinomial logistic regression to analyze statistical significance of risk with various predictors, and considering a p-value <0.05 statistically significant. Comorbidities were coded as per the ICD-11 coding and medicines were coded according to the WHO Guidelines for ATC classification and DDD assignment 2020. Results The high risk of progression to CKD increased in the age range 54-63 and �84 years by 17.77 and 43.02 times, respectively. Also, high risk increased by 29.83 and 20.2 times for the overweight and the obese respectively. Aceclofenac 100mg was prescribed for maximum patients (30.5%). Need of dose individualization was realized in 30 patients, with maximum (7) in case of etoricoxib 90mg. Various glucocorticoids were prescribed for 36.9% patients, out of whom 3.8%required dose individualization and 15.9% patients with xanthine oxidase inhibitors, out of whom 1.3% required dose individualization.

Background: The majority of cancer patients undergoing chemotherapy show neutropenic condition wh... more Background: The majority of cancer patients undergoing chemotherapy show neutropenic condition which is a common side effect of myelosuppressive chemotherapy diagnosed as the reduced complete blood cell count. Such cancer patients have a higher risk of febrile neutropenia. The present study aimed to validate whether there was a risk of neutropenia in cancer patients receiving chemotherapy at Bhaktapur Cancer Hospital, Nepal. Methods: Cross-sectional study was performed among 203 cancer patients of all age groups who attended Bhaktapur Cancer Hospital from May 2018 to January 2019 and who received a chemotherapy course. Patients receiving at least one cycle of chemotherapy as the first-line treatment were included. Statistical analysis was performed using SPSS 25. Loglinear analysis was used to analyze more than 2×2 categories among the grades and outcome of neutropenia. Multinomial logistic regression was applied to analyze the impact of various predictor variables such as chemotherapy cycles, grades of neutropenia, and gender on the outcome of neutropenia. Variation in the absolute neutrophil count (ANC) level at various days of chemotherapy cycles was assessed with the multivariate analysis of variance (MANOVA). The p-value <0.05 was considered significant at each condition. Results: The main cancer type during the study period was breast cancer (41, 20.2%). Out of 163 neutropenic patients, 149 had severe neutropenia and 14 had mild neutropenia. Most patients were continued up to the 6th cycle of chemotherapy. There was significant association between the grade of neutropenia and the outcome of the condition (p-value 0.017). There were significant relations of the grade of neutropenia and smoking habit with the recovering status (p values 0.033 and 0.001, respectively). The absolute neutrophil count (ANC) level increased and decreased inconsistently (statistically non-significantly) in between treatment period of day 1 to 52. Conclusion: Chemotherapy-induced neutropenia was a common occurrence. Majority (133, 66.5%) grade 4 neutropenic patients were recovering after the chemotherapy cycles. The physicians are warranted that they be ready for any unpredictable situation during chemotherapy treatment.
Background: The quality of life (QoL) of patients with lung cancer (LC) may be affected by diseas... more Background: The quality of life (QoL) of patients with lung cancer (LC) may be affected by disease-related limitations such as patients' functioning, the severity of symptoms, financial problems resulting along with the side effects of the treatment. The objective of this study was to translate LC-specific QoL questionnaire EORTC QLQ-LC29 into Nepalese language for Nepalese LC patients.

Background: Pharmacovigilance (PV) knowledge and attitudes among health care professionals (HCPs)... more Background: Pharmacovigilance (PV) knowledge and attitudes among health care professionals (HCPs) directly affect the practice of PV and reporting of adverse drug reactions (ADRs) in a hospital. The main aim of the study was to assess the impact of an education intervention on the knowledge and attitude of HCPs attached to the regional PV center in an oncology based hospital of Nepal. Methods: A pre-post intervention questionnaire-based study was conducted amongst HCPs, i.e. nurses and pharmacists of an oncology based hospital of Nepal. A 21-item pretested PV questionnaire (twelve and four statements for assessing knowledge and attitude respectively) was used before and after an educational intervention among 89 HCPs working in the hospital. SPSS version 21.0 was used to analyze pre-and post-survey data with descriptive and inferential statistics. The knowledge and attitude scores before and after educational intervention were analyzed with Wilcoxon rank-sum test. Results: After the educational intervention, the mean score for knowledge about PV and ADR increased from [mean ± S.D] 6.90 ± 2.527 (pre-test) to 11.36 ± 1.189 (post-test, p < 0.001). There were significant improvements after an educational intervention in attitude from 1.80 ± 0.932 (pre-test) to 3.61 ± 0.556 (post-test, p < 0.001). Twenty-one (23.6%) of participants responded that they lacked the time to report ADR, while 12 (13.5%) replied that there was no remuneration for reporting ADR. Approximately 24% of them recommended frequent pharmacovigilance awareness programs via continuing medical education or other similar kinds of workshops for improvement of pharmacovigilance.
Objective: To assess the variation in price among different brands of anticancer medicines availa... more Objective: To assess the variation in price among different brands of anticancer medicines available in hospital pharmacies at Nepalese cancer hospitals. Methods: The price of different brands of the same anticancer medicines available in the hospital pharmacies of two cancer hospitals was assessed. Prices of different dosage forms such as a single tablet, capsule and vial were calculated. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical industries was determined, and the percentage variation in price was calculated. The prices of medicines (brands) were also compared with the price determined by the government where available.

Background: Patients with diabetes mellitus have a high risk of atherothrombotic events. Diabetes... more Background: Patients with diabetes mellitus have a high risk of atherothrombotic events. Diabetes contributes for initiation and progression of microvascular and macrovascular complications. Shortened activated partial thromboplastin time (aPTT) values may reflect hypercoaguable state, which is associated with increased thrombotic risk and adverse cardiovascular events. Increased level of fibrinogen is common in type II diabetes. The present study was conducted to study the aPTT and fibrinogen levels in diabetics in a tertiary care Teaching Hospital of Nepal. Methods: Observational study was performed at outpatients visiting Pathology Department at Tribhuvan University Teaching Hospital from August 5 to September 7, 2012. Research protocol was approved by Institutional Review Board at Tribhuvan University Institute of Medicine. Altogether 90 people who came to the hospital during study period and who met inclusion criteria were selected, out of which 72 were diabetics and 18 were normal controls. Diabetic cases were identified via verbal interview with patients themselves and review of laboratory findings and diagnosis performed by their physicians. Diabetics with a diabetic history of more than one year and stabilized with antidiabetic medicines such as insulin, metformin, glibenclamide, and gliclazide and diabetics with controlled diabetes as revealed by HbA 1c in the range 6.2-7% were taken for the study purpose. Data were analyzed with chi square test and Fischer's exact test (when each cell frequency was less than 5) using Statistical Package for Social Sciences 17. Results: Maximum (53; 73.6%) diabetics and all non-diabetics had aPTT in the range 26-40 seconds. Maximum (51; 70.8%) patients had fibrinogen beyond 351 whereas all non-diabetics had fibrinogen in the range 151-350. Mean aPTT values of the diabetic patients and non-diabetic persons were 29.88 ± 4.89 seconds and 32.44 ± 2.25 seconds respectively. Mean fibrinogen values of the diabetic patients and non-diabetic persons were 388.57 ± 60.90 mg/dL and 320.89 ± 10.20 mg/dL respectively. Test data identified in results were statistically significant for aPTT (p value 0.000) and fibrinogen (p value 0.000) between the diabetics and non-diabetics. Conclusions: Diabetics have an increased level of fibrinogen and relatively shortened aPTT as compared to the non-diabetic patients.

Background: Warfarin is widely used for the prevention and treatment of cardiac, thromboembolic a... more Background: Warfarin is widely used for the prevention and treatment of cardiac, thromboembolic and hypercoagu-lable diseases. Since warfarin is a narrow therapeutic index medicine, it requires close monitoring when used in the outpatient setting and on long term basis. Warfarin has been found to be associated with a number of complications especially bleeding. Patients' knowledge on warfarin can improve anticoagulation control with decrease in adverse drug reaction and other associated complications. The objective was to assess knowledge level of warfarin therapy among its users and to provide adequate education and counseling to the patients. Methods: In the present cross sectional study, 34 patients on warfarin were interviewed. Patients' knowledge on warfarin was assessed using a validated Anticoagulation Knowledge Assessment (AKA) questionnaire comprising 29 questions. Each correct answer scored 3.45 points whereas an incorrect answer scored zero point. Patient who answered at least 21 questions correctly or scored (21 × 3.45 = 72.4 %) was considered to have adequate level of knowledge or have obtained a passing score. Association between independent variables and AKA score was assessed using Pearson Chi square test or Fisher's exact test for categorical variables. Patients were counseled regarding proper warfarin use by the researcher pharmacists at the end of each data collection schedule. Results: Of the 34 patients, only 5.8 % (n = 2) achieved a passing score whereas 94.1 % (n = 32) failed to achieve the passing score. 67.6 % of the patients (n = 23) achieved a score below 50 %. More than 50 % of the patients incorrectly answered 15 questions in the questionnaire. None of the patients scored 100 %. No significant association was found between age, gender of patients and total warfarin score. A significant association (p < 0.05) was found between duration of warfarin therapy and total warfarin score. Conclusions: Warfarin knowledge was poor among the patients. Hence, regular counseling with timely assessment of their understanding was felt necessary.

Background: Chronic kidney disease is a public health problem with an increasing incidence and pr... more Background: Chronic kidney disease is a public health problem with an increasing incidence and prevalence, poor outcomes, and high cost. Patient involvement forms the keystone in the management of chronic kidney disease. This study evaluated effects of pharmacist-provided counseling in dialysis patients in terms of their knowledge, attitude, and practice outcomes. Methods: A total of 64 patients with chronic kidney disease were enrolled into the prospective, pre-post study based on the inclusion and exclusion criteria. The knowledge, attitude, and practice of patients regarding chronic kidney disease were assessed and recorded via baseline questionnaire. Case group patients were counseled regarding chronic kidney disease, their medication, diet, and lifestyle, and they were also provided with informative leaflet, whereas in the control group patients, the pharmacist did not intervene. After 1-month intervention, knowledge, attitude, and practice scores of patients of both groups were measured using the same knowledge, attitude, and practice questionnaire. Effectiveness of counseling on case group patients was evaluated by comparing the mean knowledge, attitude, and practice scores before and after counseling by paired t-test. Results: Mean knowledge, attitude, and practice scores before intervention were 8. 16 ± 4.378, 38.19 ± 3.217, and 6.69 ± 0.896, respectively, and these scores were changed to 13.75 ± 3.510, 38.78 ± 3.035, and 6.91 ± 0.777, respectively, after the intervention (p < 0.05).
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Papers by Binaya Sapkota, BPharm, PharmD