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   2021| April-June  | Volume 13 | Issue 2  
    Online since May 26, 2021

 
 
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ORIGINAL ARTICLES
Serum metabolic disturbances associated with acute-on-chronic liver failure in patients with underlying alcoholic liver diseases: An elaborative NMR-based metabolomics study
Umesh Kumar, Supriya Sharma, Manjunath Durgappa, Nikhil Gupta, Ritu Raj, Alok Kumar, Prabhat N Sharma, VP Krishna, R Venkatesh Kumar, Anupam Guleria, Vivek A Saraswat, Gaurav Pande, Dinesh Kumar
April-June 2021, 13(2):276-282
DOI:10.4103/JPBS.JPBS_333_20  
Objectives: Acute-on-chronic liver failure (ACLF), which develops in patients with underlying alcoholic liver disease (ALD), is characterized by acute deterioration of liver function and organ failures are secondary to that. The clear understanding of metabolic pathways perturbed in ALD-ACLF patients can greatly decrease the mortality and morbidity of patients through predicting outcome, guiding treatment, and monitoring response to treatment. The purpose of this study was to investigate the metabolic disturbances associated with ACLF using nuclear magnetic resonance (NMR)-based serum metabolomics approach and further to assess if the serum metabolic alterations are affected by the severity of hepatic impairment. Materials and Methods: The serum-metabolic profiles of 40 ALD-ACLF patients were compared to those of 49 age and sex-matched normal-control (NC) subjects making composite use of both multivariate and univariate statistical tests. Results: Compared to NC, the sera of ACLF patients were characterized by significantly decreased serum levels of several amino acids (except methionine and tyrosine), lipid, and membrane metabolites suggesting a kind of nutritional deficiency and disturbed metabolic homeostasis in ACLF. Twelve serum metabolic entities (including BCAA, histidine, alanine, threonine, and glutamine) were found with AUROC (i.e., area under ROC curve) value >0.9 suggesting their potential in clinical diagnosis and surveillance. Conclusion: Overall, the study revealed important metabolic changes underlying the pathophysiology of ACLF and those related to disease progression would add value to standard clinical scores of severity to predict outcome and may serve as surrogate endpoints for evaluating treatment response.
  1,024 48 -
Prospective, randomized, open-label, blinded end point, two-arm, comparative clinical study to evaluate the efficacy and safety of a Fixed Ayurvedic Regimen (FAR) as add-on to conventional treatment in the management of mild and moderate COVID-19 patients
Arun Gupta, Sasibhushan Vedula, Ruchi Srivastava, Sanjay Tamoli, Narendra Mundhe, DN Wagh, Sanjay Batra, Manoj Patil, Hiren Baburao Pawar, Rajiva K Rai
April-June 2021, 13(2):256-267
DOI:10.4103/jpbs.jpbs_242_21  
Background: The traditional healthcare systems are being avidly looked into in the quest for effective remedies to tackle the menace of COVID-19 pandemic. Objective: This was a prospective randomized, controlled open-label, blinded end point (PROBE) study to evaluate the efficacy and safety of a fixed ayurvedic regimen (FAR) as an add-on to conventional treatment/standard of care (SOC) in the management of mild-to-moderate COVID-19 infection. Methodology: A total of 68 patients were recruited who consumed either FAR + SOC (n = 35) or SOC only (n = 33) for 28 days. Primary outcomes assessed were mean time required for clinical recovery and proportion of patients showing clinical recovery between the groups. Secondary outcomes assessed included mean time required for testing SARS-CoV-2 negative, change in clinical status on World Health Organization (WHO) ordinal scale, number of days of hospitalization, change in disease progression and requirement of oxygen/intensive care unit admission/ventilator support/rescue medication, health status on WHO quality of life (QOL) BREF, and safety on the basis of occurrence of adverse event/serious adverse event (AE/SAE) and changes in laboratory parameters. Results: Patients consuming FAR as an add-on SOC showed faster clinical recovery from the day of onset of symptoms by 51.34% (P < 0.05) as compared to SOC group. A higher proportion of patients taking FAR recovered within the first 2 weeks compared to those taking only SOC. It was observed that 5 times more patients recovered within 7 days in FAR group when compared to SOC (P < 0.05) group. An earlier clinical recovery was observed in clinical symptoms such as sore throat, cough, loss of taste, and myalgia (P < 0.05). Improvement in postclinical symptoms such as appetite, digestion, stress and anxiety was also observed to be better with the use of FAR. Requirement of rescue medications such as antipyretics, analgesics, and antibiotics was also found to be reduced in the FAR group (P < 0.05). FAR showed a significant improvement in all the assessed domains of QOL. None of the AEs/SAE reported in the study were assessed to be related to the study drugs. Further, FAR did not produce any significant change in the laboratory safety parameters and was assessed to be safe. Conclusion: FAR could be an effective and safe add-on ayurvedic regimen to standard of care in the management of mild and moderate COVID-19 patients. CTRI number: CTRI/2020/09/027914.
  736 51 -
SHORT COMMUNICATION
Drug information services in low-resource setting: a responsibility of pharmacists or pharmacologists or both the professions conjointly
Amol N Patil, M Praveen Kumar, Rohitash Yadav, Sourabh Kosey, Tapan Behl, J Kumaravel
April-June 2021, 13(2):283-290
DOI:10.4103/jpbs.JPBS_748_20  
Objective: The objective of this study was to assess the pharmacy professionals' understanding and viewpoints on drug information center (DIC) services and differences, if any, with pharmacologist's survey conducted earlier. Materials and Methods: An electronic cross-sectional knowledge, practice, and attitude survey was carried out. A questionnaire in the form of the hyperlink was sent to pharmacy professionals through e-mail, Facebook messenger, and WhatsApp. Factors linked to pharmacy professionals' vision in expanding countrywide DIC services were studied with logistic regression in R. Results: A total of 125 pharmacy professionals responded. The participant believing in the published literature as a standard reference for establishing and running the DIC services; participants identifying more challenges in the day-to-day DIC functioning; and participants believing in the ability of DIC in reducing morbidity, mortality, and cost of care had 4.76 (95% confidence interval [CI] = 0.97–6.44), 4.24 (95% CI = 0.97–6.44), and 2.43 (95% CI = 0.97–6.44) times association with good knowledge score. Good attitude scores were discovered of participants working in fully and partially functional DIC (odds ratio [OR] = 9.66, CI = 0.97–6.44 and OR = 9.49, CI = 0.97–6.44) to participants not involved in DIC duties. The participant who understood DIC services' real purpose had 2.83 (95% CI = 0.97–6.44) times association with good practice scores. Overall, pharmacy professionals carried better attitude scores, but lesser knowledge, and practice scores than pharmacology professionals. Conclusion: Lower knowledge and practice score of pharmacy professionals asks for training in critical appraisal of published literature and due modifications in graduate and postgraduate curricula. A collaborative approach between pharmacists and pharmacologists is needed to improve the quality of drug information services and evidence-based medicine practice in low-resource countries like India.
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REVIEW ARTICLES
A narrative review of antiviral drugs used for COVID-19 pharmacotherapy
Subodh Kumar, Manoj K Saurabh, Vikas Maharshi, Dibyajyoti Saikia
April-June 2021, 13(2):163-171
DOI:10.4103/jpbs.JPBS_498_20  
Purpose: A number of research articles has been published evaluating safety and efficacy of drugs against COVID-19. This study was undertaken to collate and review the information regarding common proposed anti- viral drugs for easy reference. Methods: The literature was search was done using terms like severe acute respiratory syndrome or SARS-CoV-2 or 2019-nCoV or SARS-CoV or COVID-19 in combination with drugs or treatment or pharmaco-therapy using PubMed and google scholar to identify relevant articles. Results: Despite showing good early results, hydroxychloroquine and lopinavir-ritonavir has not shown clinical benefit in randomized controlled trials. However lopinavir in combination with other drugs specially interferon is being investigated. Remdesivir has shown positive effect in terms of clinical improvement and continued to being investigated alone or in combination with other drugs. Favipiravir has shown mixed results and more data from adequately powered study is needed to prove its efficacy. Conclusions: Many drugs which showed positive effect in initial studies could not replicate the same benefit in large randomized controlled trials. There is need to evaluate efficacy and safety of drugs based on high quality evidence before allowing it to be used in general population.
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ORIGINAL ARTICLES
Formulation and evaluation of levofloxacin and betamethasone ophthalmic emulgel
Hiba Sabah Sabry, Athmar Dhahir Habeeb Al-Shohani, Sura Zuhair Mahmood
April-June 2021, 13(2):205-211
DOI:10.4103/jpbs.JPBS_338_20  
Objective: Drug delivery to ocular tissues is challenging due to rapid removal of instilled drug due to low resident time in ocular tissues. The aim of the study was to formulate an ophthalmic emulgel that delivers two drugs (betamethasone sodium phosphate [BSP] and levofloxacin). The new combination will allow the simultaneous administration and extended release of the two drugs which potentially improve resident time in ocular tissues, patient compliance, and adherence to treatment. Materials and Methods: Formulations containing different gelling agents at different concentrations were prepared to choose the optimum combination regarding physical properties and release. The emulgel formulations F1, F2, F3, and F4 were made using gelling agent 1% and 2% xanthan gum, 1% carbopole 934, and 2% methyl cellulose, respectively. F5 was formulated using 2% methyl cellulose with double the amount of poloxamer 188 as emulsifying agent. All the formulations were examined regarding their physical appearance, pH, viscosity, drug content, and in vitro drug release. The optimum formula was also examined for antibacterial activity. Results: The results demonstrated that F5 was the optimum formulation having a proper physical characteristics and release profile of both drugs, 96% and 90% for BSP and levofloxacin, respectively, compared to other formulations and commercial eye drops. Conclusion: Simultaneous and extended release of the two drugs was achieved using one formulation of emulgel. The ability to deliver hydrophilic and hydrophobic drug through the same formulation without the need to use two drops will improve patient compliance and hence patient adherence to treatment.
  552 23 -
An in vitro study to determine the physicochemical, mechanical, and antibacterial properties of a novel spirulina containing controlled release intrapocket drug delivery system
Supriya Mishra, Lynn Johnson, Kuldip Singh Sangha, Vineeta Gupta, Sangita Agarwal, Shikha Rajput
April-June 2021, 13(2):178-187
DOI:10.4103/jpbs.JPBS_446_20  
Context: Periodontitis is primarily an inflammatory condition caused by an array of microorganisms present in dental plaque. Elimination or adequate suppression of periodontal pathogens in the subgingival microflora is essential for adequate periodontal healing to take place. The development of subgingivally placed controlled delivery systems has provided the possibility of effective intrapocket concentration levels of antibacterial agents for an extended period of time, resulting in an altered subgingival flora and enhanced healing of the attachment apparatus. Although a number of synthetic antimicrobial agents are being used as local drug delivery, currently, pharmaceutical technology development has focused on the ingredients derived from nature. Natural phytochemicals have proven to be worthy substitutes of their synthetic and chemical-laden counterparts owing to their extensive natural activity, advanced safety margins, and inferior costs so that they can be of huge benefits, especially to the lower socioeconomic population around the world and spirulina platensis (SP) is one such emerging remedy. Aims: The aim of the study was to develop three controlled release drug delivery systems containing different concentrations of SP to be used inside the periodontal pockets. The study also aimed to determine the antimicrobial activity of all the three concentrations of SP drug delivery system against major periodontopathic microorganisms and to test the physicochemical properties of the delivery system that exhibited maximum antimicrobial efficacy so that the suitability of its use inside the periodontal pocket could be determined. Settings and Design: The study was an in vitro experimental design. Subjects and Methods: Three different controlled release SP hydrogels (4%, 6%, and 12%) to be used inside the periodontal pockets were developed and antibacterial properties against periodontal pathogens were assessed. The hydrogel exhibiting maximum antimicrobial efficacy was then tested of physicochemical and mechanical properties to determine its suitability of its use inside the periodontal pocket. Statistical Analysis Used: Data were analyzed using one-way analysis of variance. Post hoc Tukey honestly significant difference test was used for comparison within the group and between the different groups. Results: 12% SP hydrogel was found to have maximum antimicrobial efficacy against major periodontal pathogens, and its physicochemical and mechanical properties were also optimum to be used inside the periodontal pocket. Conclusions: 12% SP hydrogel can act as a promising adjunct to periodontal mechanical therapy and may also reduce the chances of more invasive periodontal surgical procedures.
  482 34 -
REVIEW ARTICLES
Bidirectional relationship between covid-19 and diabetes: Role of renin–angiotensin–aldosterone system and drugs modulating it
Razia Khanam
April-June 2021, 13(2):149-154
DOI:10.4103/jpbs.JPBS_508_20  
Numerous reports have suggested that diabetic patients are at high risk for the development of severe symptoms of coronavirus disease-2019 (COVID-19). However, a few studies have recently proposed that the relationship between diabetes and COVID-19 is bidirectional, as severe acute respiratory syndrome-coronavirus-2 also has the capability to induce diabetes. Various mechanisms have been identified and proposed to be involved in this binary association. In this review, the importance and impact of renin–angiotensin–aldosterone system (RAAS) in this two-way association of COVID-19 and diabetes has been summarized. The role and effect of drugs modulating RAAS directly or indirectly has also been discussed, as they can majorly impact the course of treatment in such patients. Further reports and data can present a clear picture of RAAS and its modulators in restoring the balance of dysregulated RAAS in COVID-19.
  452 38 -
Targeting to brain tumor: Nanocarrier-based drug delivery platforms, opportunities, and challenges
Ladi Alik Kumar, Gurudutta Pattnaik, Bhabani Sankar Satapathy, S Swapna, Dibyalochan Mohanty
April-June 2021, 13(2):172-177
DOI:10.4103/jpbs.JPBS_239_20  
Cancer is a class of disorder characterized by anomalous growth of cells escalating in an uncontrolled way. Among all the cancers, treatment of cancerous brain tumors has been a tough challenge for the research scientists. Moreover, the absence of early-stage symptoms delays its diagnosis, consequently worsening its severity. Conventional treatments such as surgery, radiation, and chemotherapy are still linked with several limitations. The therapeutic effect of most of the anticancer drugs is highly restricted by their inability to pass the blood–brain barrier, low solubility, limited therapeutic window, and so on. Alarming incidences of brain cases associated with low survival rate across the globe coupled with the inefficiency of current treatment strategies have forced the formulation scientists to investigate nanotechnology-based advanced therapeutic approaches to tackle the disease. Various nanoplatforms such as polymeric nanoparticles (NPs), nanoliposomes, dendrimers, carbon nanotubes, and magnetic NPs have been reported in the past years to improve the drug administration into brain tumor cells and to minimize their off-target distribution for lesser side effects and better treatment outcomes. The review presents updated information on the nanocarrier-based drug delivery systems reported in the past few years for the treatment of brain tumor along with new advancements in this field. It also throws some light on the recent challenges faced in the practical field for the successful clinical translation of such nanodrug carriers along with a discussion on the future prospects.
  364 38 -
Antimicrobial potential of naturally occurring bioactive secondary metabolites
Khaled S Allemailem
April-June 2021, 13(2):155-162
DOI:10.4103/jpbs.JPBS_753_20  
The use of traditional medicines of natural origin has been prevalent since ancient times globally as the plants produce a great diversity in their secondary metabolites. The naturally occurring bioactive constituents in food and other plant materials have shown widespread attention for their use as alternative medicine to prevent and cure microbial growth with the least toxic manifestations. The inclusion of these contents revealed their crucial role to improve the therapeutic efficacy of the classical drugs against various pathogenic microorganisms. Furthermore, several metabolites have also been explored in combination with antimicrobial agents to overcome the problems associated with drug resistance. This current review discusses the antimicrobial activities of secondary metabolites as well as their role in drug sensitivity against multiple-drug resistant pathogenic microbes.
  356 31 -
ORIGINAL ARTICLES
Acute oral toxicity evaluation of andrographolide self-nanoemulsifying drug delivery system (SNEDDS) formulation
Arba Pramundita Ramadani, Yandi Syukri, Elma Hasanah, Afrizal Wahyu Syahyeri
April-June 2021, 13(2):199-204
DOI:10.4103/jpbs.JPBS_267_19  
Context: Andrographolide (AND) is an active compound of well-known medicinal plant Andrographis paniculata. It has been widely published for various activities. AND is difficult to develop into dosage form due to its poor solubility and bioavailability. This problem could be solved by using self-nanoemulsifying drug delivery system (SNEDDS) for its formulation. However, the increase of bioavailability might result in potential toxicity as a large amount of drug is absorbed. Aims: The aim of this study is to evaluate the acute potential toxicity using Organization for Economic Cooperation and Development (OECD) test: 401 methods. Subjects and Methods: The OECD 401 method employs groups of animals treated by a single dose or repeated dose (<24 h) of the drug with three variances of doses. In this study, thirty male Wistar rats were divided into five groups which consisted two groups of control and three groups of AND SNEDDS formulation (500, 700, and 900 mg/kg body weight [BW], respectively). Intensive observation of toxicity symptom was performed during the first 30 minutes followed by periodic observation for 14 days. Posttermination, histopathological examination of the liver and kidney was conducted to confirm the toxicity symptoms. To determine the level of toxicity, the lethal dose 50 (LD50) value was calculated at the end of the study. Results: The result showed that all groups presented similar toxicological symptoms such as salivation, lethargy, and cornea reflex. However, based on histopathological examination, there were abnormalities, but still in an early stage. The toxicological symptom that emerged seems related to the SNEDDS formulation with lipophilic properties. Furthermore, the value of LD50 was 832.6 mg/kg BW (po). Conclusions: The AND SNEDDS formulation was slightly toxic in male Wistar rats po.
  353 28 -
Evaluation of community pharmacists' professional practice and management of patient's respiratory conditions
Raja'a A Al-Qudah, Rana Abu-Farha, Maram M Al-Ali, Nour S Jaradaneh, Mohamed Izham Mohamed Ibrahim
April-June 2021, 13(2):212-219
DOI:10.4103/jpbs.JPBS_534_20  
Objectives: We assessed the extent of community pharmacists managing respiratory conditions and their ability to make differential diagnoses between the common cold and allergic rhinitis. Methods: A simulated patient technique was used to achieve the study objectives. Thirty community pharmacies were randomized to be visited by a patient with allergic rhinitis symptoms, followed by a patient with common cold symptoms, and vice versa. One simulated patient visited the 15 pharmacies assigned to allergic rhinitis. Then, after 3–4 days, the pharmacies were revisited by a second simulated patient using the same symptoms; likewise, a simulated patient visited the other 15 pharmacies with common cold symptoms. Then, these pharmacies were revisited by the other simulated patient with the common cold symptoms. Descriptive statistics and correlation analyses were carried out using SPSS at alpha 0.05. Results: Fifteen pharmacies were used for the common cold scenario and 15 for the allergic rhinitis scenario (a total of 30 visits per scenario). Pharmacists showed overall poor skills in asking questions for differential diagnosis between the two conditions. No significant difference was found in the overall differential diagnosis score between the two groups (P = 0.744). The overall adherence to the labeling standard score was low, with an average of 2.38 (standard deviation [SD] = 2.50) out of 11, with no significant difference between the two scenarios (P = 0.332). The overall adherence score to the counseling standard was low, with an average of 2.93 (SD = 3.74) out of 15, with no significant difference between the two scenarios (P = 0.586). Conclusion: The simulated patient technique approach revealed a lack of ability of pharmacists in Amman, Jordan, to make differential diagnoses between the common cold and allergic rhinitis. In addition, pharmacists lacked the ability to carry out their role with respect to the management of the common cold and allergic rhinitis, including treatment recommendations, adherence to medicine labeling standards, and adherence to the counseling standard.
  296 17 -
Prescription pattern of empirical antibiotic therapy in the burn unit of a tertiary care setting in the Kingdom of Saudi Arabia
Khaja Moinuddin, Deemah Sattam Alanazi, Bushra Abdulrahman Alsomali, Maram Alotaibi, Parthasarathy Jaganathan Parameaswari, Sheraz Ali
April-June 2021, 13(2):188-192
DOI:10.4103/jpbs.JPBS_478_20  
Background: It is crucial to follow rational prescribing practices while prescribing antibiotics for burn patients, thus leading to better patient outcomes. The objective of this study was to assess the initiation of empirical antibiotics in the burn unit. Methods: A prospective cross-sectional study was conducted in a large tertiary care setting of the Kingdom of Saudi Arabia between August 2016 and December 2018. Results: A total of 102 hospitalized burn patients were included in this study, of whom 84 (82.4%) were males. Burns were classified as first degree, second degree, third degree, or fourth degree depending on their severity and extent of penetration into the skin. The majority (81.3%) of the patients suffered from flame burn, followed by scald (9.85), chemical (6.9%), and electrical (2%) types of burns. Broad-spectrum antibiotic such as piperacillin/tazobactam (40.57%) was the most common empirically prescribed antibiotic. In 35 patients (34.3%), there was a change in antibiotic after culture findings. Conclusion: This study demonstrated that 40% of antibiotic therapy decisions followed the recommended clinical guidelines. This study also found that Gram-negative microorganisms such as Pseudomonas aeruginosa and Methicillin-resistant Staphylococcus aureus were ubiquitous in our burn unit. The study results will facilitate to develop antibiogram for our study setting, thus reducing antibiotic resistance. Further studies are needed to explore the extent and consequences of irrational antibiotic prescriptions in critically ill burn patients.
  284 21 -
Role of hematological and immunological parameters in COVID-19 patients
Avanindra Kumar, Shipra Sepolia, RH Shilpa, Gilda Rezayani, Soni Kumari, Aastha , Shivangi Gupta
April-June 2021, 13(2):238-243
DOI:10.4103/jpbs.JPBS_655_20  
Background: The ongoing pandemic of coronavirus disease 2019 (COVID-19) which was caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has led to efforts from the medical and scientific community in understanding the biological basis of COVID-19 pathophysiological mechanisms. Thus, analysis of various hematological and immunological parameters may be helpful for COVID-19 infection evaluation for risks involved and effectiveness in management. Aim: The aim of this study was to analyze the role of various hematological and immunological parameters in patients infected with SARS-CoV-2. Materials and Methods: This retrospective analysis was performed on 300 patients who tested positive for SARS-CoV-2 by quantitative reverse transcription–polymerase chain reaction analysis. All participants of the study were divided into – (a) Group I: patients with mild symptoms and normal chest radiographic findings; (b) patients with moderate disease presenting with fever and cough along with other respiratory symptoms, and (c) patients suffering from severe disease. Data collection was done from all patients at the time of hospital admission for hematological and immunological parameters – (a) total leukocyte count, (b) lymphocyte count, (c) lymphocytic subset count, (d) lactate dehydrogenase (LDH) levels, (e) D-dimer, (f) C-reactive protein (CRP), and (g) ferritin levels. SPSS 22.0 software was used for determining P values by independent t-test and Chi-square test. Results: The median age was 65 years (interquartile range –57–71 years). While comparing white blood cell and lymphocyte counts, extremely significant P values were obtained. D-dimers and ferritin levels demonstrated extremely significant P values while both LDH and CRPs showed statistical significance. Correlation of lymphocytic subsets showed extreme significance in total lymphocyte counts in mild-to-moderate as compared to severely infected patients while both CD4+ and CD8+ counts demonstrated statistical significance in mild-moderate infected cases. Statistical significance was noted in D-dimer, CRP, and LDH levels also. Conclusion: Assessment of hematological and immunological parameters can be used to plan the management of COVID-19 patients.
  276 28 -
Effect of pharmacist-led intervention on progression of diabetic complications at two tertiary care hospitals of Malaysia
Muhammad Zahid Iqbal, Amer Hayat Khan, Syed Azhar Syed Sulaiman, Aznita Ibrahim, Nor Shaffinaz Binti Yusoff Azmi, Muhammad Shahid Iqbal, Fahad I Al-Saikhan, Salah-Ud-Din Khan, Eldowaik Mohamed Salah Saad
April-June 2021, 13(2):193-198
DOI:10.4103/jpbs.JPBS_488_20  
Background and Objective: Diabetes mellitus is a chronic disease which can lead to different complications in patients if not treated properly. An appropriate intervention from health care providers is needed to stop and decrease the progression of diabetic complication in diabetic patients. This study aimed to measure the effect of pharmacist intervention on improvement in sign and symptoms and progression of diabetic complications in diabetic patients. Methodology: Diabetic patients were randomly selected and divided into two groups from two tertiary care hospitals. Control group contained those 200 patients who were receiving usual treatment from hospitals. In contrast, the intervention group included those 200 patients who were receiving conventional treatment from hospitals together with separate counselling sessions with pharmacists from Diabetes Medication Therapy Adherence Clinic departments. The study continued for 1 year and two follow-up visits for both groups. A prevalidated data collection form was used to measure the improvement in sign and symptoms and progression of diabetic complication in diabetic patients. Statistical Package for the Social Sciences (SPSS) version 24 was used to analyze the data. Results: The average hemoglobin A1c (HbA1c) values decreased up to 1.43% in the control group and 2.82% in the intervention group. The intervention group showed significant improvement in HbA1c between groups (P < 0.05). The results of univariate and multivariate regression analysis showed that a statistically significant (P < 0.001) improvement was observed in all the predictors of diabetic complications among in the intervention group when compared with the control group. Conclusion: Statistically significant reduction in the sign and symptoms of diabetic complications was observed in the intervention group at the end of 1 year. The progression of diabetic neuropathy was significantly reduced in the pharmacist intervention group.
  270 14 -
Assessment of a pharmacovigilance module: An interventional study on knowledge, attitude, and practice of pharmacy students
Subish Palaian, Mohamed Izham Mohamed Ibrahim, Pranaya Mishra, Pathiyil Ravi Shankar
April-June 2021, 13(2):248-255
DOI:10.4103/jpbs.JPBS_528_20  
Background: The aim of the study was to assess the impact of a pharmacovigilance module on the knowledge, attitude, and practice (KAP) of pharmacy students and elucidate their feedback on the module. Methodology: Bachelor of pharmacy students at Pokhara University, Nepal, were assessed for their baseline KAP on drug safety and related issues using a KAP questionnaire (Cronbach alpha 0.70) consisting of 25 questions. Students' baseline KAP was assessed and after that, they were grouped into either control (2nd and 4th year) or test (1st and 3rd year) groups. The later received the pharmacovigilance training in three 1-h sessions spread over 6 months at 0, 90, and 180 days; the sessions covered introduction to pharmacovigilance, theoretical aspects of pharmacovigilance, and adverse drug reaction reporting procedures. KAP scores and student feedback were analyzed at 5% significance level. Results: A total of 124 students (control = 56 and test = 68) were studied. The median (interquartile ranges [IQRs]) of the baseline scores prior to grouping the students into control and test groups was 20 (18.25–21.00) for knowledge, 19.5 (18.00–21.00) for attitude/practice, and 39 (37.00–41.00) for the total score. Males (n = 81) had a slightly higher median score of 40 (37–42) than females (n = 43), who had a median score of 38 (36–41). The KAP score for the control group was 40 (38–42) at baseline, 42 (20–44) during first follow-up, 41.5 (40–44) during second follow-up, and 41 (39–44.5) during third follow-up. For the test group, upon intervention, the KAP scores improved from 39 (36.25–40.75) at baseline to 42 (39.50–44.00) at the 1st follow-up, 43 (41–45) at the 2nd follow-up, and 44 (42–45) at the 3rd follow-up (P < 0.001). The median feedback score (IQR) was 86 (81.5–90.0). Conclusions: Pharmacy students had good attitude/practice scores and relatively poor knowledge scores at baseline, which improved postintervention. Student feedback about the module was positive.
  242 19 -
Community pharmacists' awareness toward their roles in healthcare and interaction with general practitioners: A cross-sectional study
Alamin Hassan Mohamed Alamin Alabid, Mohamed Izham Mohamed Ibrahim, Mohamed Azmi Hassali, Subish Palaian
April-June 2021, 13(2):220-229
DOI:10.4103/jpbs.JPBS_680_20  
Introduction: There is a paucity of data on the extended role of community pharmacists (CP) in Malaysia. This study is aimed to evaluate CPs awareness toward their roles in healthcare and interaction with general practitioners (GPs). Materials and Methods: A cross-sectional design using a validated questionnaire was conducted nationwide among randomly selected Malaysian CPs. The questionnaire consisted of consisted of 32 questions with three sections. The Cronbach's alpha measure for the scale on awareness was 0.494 and 0.724 for the interaction between CPs and GPs. Descriptive statistics were reported. The Chi-square test, Mann–Whitney test, Kruskal–Wallis test, and post hoc analyses were applied at the alpha level of 0.05. Results: Of the 127 CPs who filled out the responses, 57.5% (n = 73) mentioned that they rarely or never interacted with GPs. Many CPs (n = 106, 83.5%) were aware of their role in providing patient education, and 109 (85.8%) indicated that they could suggest nonprescription medicines to patients, whereas 88 respondents (69.3%) were aware that they could suggest alternative medicines. A total of 117 respondents (92.1%) indicated their willingness to perform selected screening tests and identify and prevent prescription errors. A considerable number of CPs (n = 76, 59.8%) were aware of their ability to design and regulate prescribed regimens, and 89 (70.1%) showed their willingness to monitor these regimens. The total average score of the CPs' awareness toward their roles in providing healthcare for the 16 activities/items and the value of the interaction mean score was 12.00 (±2.92), with a median score of 12.00 (interquartile range: 9.5–14.5). Conclusions: Malaysian CPs are fully aware of their role in providing healthcare and pharmaceutical care. Though the majority of them were willing to provide extended services, they are often unable to perform these roles due to the lack of interprofessional collaboration, lack of time, and absence of remuneration for their extended services. Training programs, practice guidelines, and professional service fee may encourage CPs to perform more extended services.
  218 12 -
Metformin use in gestational diabetes: Awareness, attitude, and practice among healthcare professionals in Malaysia
Nur Aizati Athirah Daud, Syed Ghouse Mohiuddin, Yi Ping Ong, Faridah Yusof, Fadhleena Yusoff, Sabariah N Harun, Siti Maisharah S. Ghadzi
April-June 2021, 13(2):230-237
DOI:10.4103/jpbs.JPBS_542_20  
Background: Metformin has been added in the Malaysian clinical practice guideline (CPG) as one of the first-line options in the management of gestational diabetes mellitus (GDM); however, the uptake on this practice among healthcare professionals is unknown. Objective: The objective of the study is to determine the awareness, attitude, and practice and their predictors on the use of metformin for GDM among healthcare professionals in Malaysia. Materials and Methods: This was a multicenter, cross-sectional study in three tertiary hospitals in Malaysia. Medical doctors and pharmacists working in several departments were invited to participate in a survey using self-administered questionnaires. Results: From 350 questionnaires distributed, 225 were completed by medical doctors (43.1%), pharmacists (40.4%), and specialists (7.5%). Less than 30% of them were aware on the option of using metformin as one of the first-line agents in GDM. Education level, department, and profession were found to be associated with the awareness level (P = 0.016, P = 0.004, and P = 0.001, respectively). 70.2% of the respondents showed a positive attitude toward metformin use in GDM. Only 64 (28.4%) of the respondents have prescribed/dispensed metformin for GDM before, although more than half will consider doing so in the future. Having postgraduate qualifications increased the likelihood of having a good awareness (odds ratio [OR]: 2.44, 95% confidence interval [CI] 1.23–4.85) and to consider prescribing/dispensing metformin for GDM patients (OR: 2.27, 95% CI 1.08–4.78). Conclusion: Despite a positive attitude toward metformin use in GDM among healthcare professionals in Malaysia, their awareness level on this practice was low as they currently prefer the use of insulin over metformin.
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Melatonin–caffeine combination modulates gamma radiation-induced sperm malformations in C57BL/6 male mice at sublethal dose of gamma radiation
Ritu Kushwaha, Dhruv K Nishad, Aseem Bhatnagar, Roop Krishen Khar
April-June 2021, 13(2):268-275
DOI:10.4103/jpbs.JPBS_303_20  
Aims: The aim of this study was to assess the protective effect of the melatonin–caffeine combination against γ radiation-induced alterations in the morphological characteristics of sperms. Settings and Design: C57BL/6 male mice (n = 30) were randomly divided into five groups: control, radiation (2 Gy), melatonin (100ὕmg/kg body wt.) + radiation (2 Gy), caffeine (30ὕmg/kg body wt.) + radiation (2 Gy), melatonin–caffeine (100–30ὕmg/kg body wt.) + radiation (2 Gy). Materials and Methods: All the mice were sacrificed 24h postirradiation, and cauda epididymis was collected. In this study, sperm concentration along with any abnormality in their morphology (amorphous heads, pinheads, hookless, coiled tails, midpiece defect, and tail-less) was observed in the control and treatment group of animals. Results: Radiation exposure (2 Gy) considerably decreases the sperm count when compared with the control group. However, pretreatment with melatonin and melatonin–caffeine combination before gamma irradiation increased the sperm count (P < 0.05), but with caffeine alone could not produce a significant difference. The higher rate of abnormal sperms was observed in the γ-irradiated mice when compared with the control group (P < 0.05). Besides, the numbers of sperm that are hookless and coiled tails were significantly increased after irradiation. Melatonin significantly reduced the number of sperm with amorphous heads and coiled tails. Melatonin–caffeine combination further reduced sperm malformations when compared with the melatonin + 2 Gy radiation and caffeine + 2 Gy radiation group. Conclusions: This study suggests that caffeine exerts a protective effect when given in combination with melatonin against gamma irradiation in sperms of C57BL/6 mice and could be a potent combination for the development of radioprotector.
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The prevalence role of monocyte chemoattractant protein-1 in hashimoto's thyroiditis via various stimuli mechanisms
Israa Burhan Raoof, Raghad Abdulmahdi Mohsin, Zahraa Ahmed Okhti
April-June 2021, 13(2):244-247
DOI:10.4103/jpbs.JPBS_746_20  
Hashimoto's thyroiditis (HT) is an autoimmune disease occurred at any age especially in the 30 and 50 years of patient, with time thyroid gland is lost its function, as the lymphocytes produce inflammatory cytokines, have a direct effect on the thyroid gland function. The monocyte chemoattractant protein (MCP) produced by the podocyte and monocyte in response to these stimuli and has a role in the feedback based on thyroid hormones therefore MCP is increased secretion depending on thyroid hormones; also it's increased with enlargement of adipocyte tissue, i.e., in patients with high body mass index (BMI), there is a relationship between Hashimoto's disease and obesity, that has an effect on the thyroid gland function. Obesity have important role on thyrostimulated hormones (TSHs), as it has a great effect on metabolism and expansion of the thyroid gland; researchers have previously found that obese individuals have higher serum TSH levels. The results of the study have reported that MCP 1, TSH, and BMI levels were highly significant increased in sera of G2 compared with G1, while T3 and T4 levels were highly significant decreased in sera of G2 compared with G1 in referring to G1: Healthy control group while G2: HT patients.
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