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  1. Shakeel S, Hassali MA, Rehman H, Rehman AU, Muneswarao J
    Int J Gen Med, 2020;13:1075-1082.
    PMID: 33204142 DOI: 10.2147/IJGM.S266545
    Background: Pharmacists being the drug experts need to be well aware of the applied handling of biosimilar medicines (BSMs). They are an integral educator, trailblazer, and advocate of biosimilar integration across all clinical settings. Therefore, the current study was conducted to assess the pharmacists' knowledge, attitude, and practices of integrating BSMs into clinical practice.

    Methods: The cross-sectional study was conducted from August 2019 to November 2019. The community pharmacies, clinical and academic settings in Karachi were approached for gathering the responses of pharmacists towards BSMs and interchangeable products using a 30-item survey form. Pearson correlation and independent sample t-test were used to identify the relationship among independent variables and the responses, considering p values <0.05 as statistically significant.

    Results: Overall, there were 305 survey forms used with a response rate of 87.14%. More than 80% of the respondents have good knowledge about the definition, characteristics, safety and efficacy, compatibility, cost issues, and utilization of BSMs. Around half of the respondents (48.9%, [95% CI 46.6-51.2]) were confident in using BSMs in clinical practice. However, they were concerned about the BSM's safety profile (45.2%, [95% CI 42.1-48.3]), quality (30.2%, [95% CI 28.3-32.1]), and efficacy issues (32.3%, [95% CI 31.2-37.5]).

    Conclusion: The findings revealed that pharmacists were well informed about the BSMs. However, some of the responses to the attitude demonstrated a lack of understanding of the application of that knowledge. The respondents persuaded that advanced patterns of diseases, product marketing stipulations, and need for better patient care drives higher demand for developing BSMs and were enthusiastic about gaining more insight to integrate BSMs into routine clinical practice.

  2. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Hashmi F
    PMID: 32218355 DOI: 10.3390/ijerph17072209
    Developed countries have established pharmacovigilance systems to monitor the safety of medicines. However, in the developing world, drug monitoring and reporting are facing enormous challenges. The current study was designed to explore the challenges related to the understanding and practices of physicians in reporting adverse drug reactions in Lahore, Pakistan. Through the purposive sampling technique, 13 physicians were interviewed. All interviews were audio-recorded, transcribed verbatim, and analyzed for a thematic content analysis. The thematic content analysis yielded six major themes: (1) Familiarity with medication safety and adverse drug reaction (ADR) concept, (2) Knowledge about pharmacovigilance activities, (3) Practices related to ADR reporting, (4) Barriers impeding ADR reporting, (5) Acknowledgement of the pharmacist's role, and (6) System change needs. The majority of the physicians were unaware of the ADR reporting system; however, they were ready to accept practice changes if provided with the required skills and training. A lack of knowledge, time, and interest, a fear of legal liability, poor training, inadequate physicians' and other healthcare professionals' communication, and most importantly lack of a proper reporting system were reported as barriers. The findings based on emerging themes can be used to establish an effective pharmacovigilance system in Pakistan. Overall, physicians reported a positive attitude towards practice changes, provided the concerned authorities support and take interest in this poorly acknowledged but most needed component of the healthcare system.
  3. Muneswarao J, Hassali MA, Ibrahim B, Saini B, Ali IAH, Verma AK
    Respir Res, 2019 Aug 14;20(1):183.
    PMID: 31412856 DOI: 10.1186/s12931-019-1159-y
    Asthma is a heterogeneous lung disease, usually characterised by chronic airway inflammation. Although evidence-based treatments are available in most countries, asthma control remains suboptimal, and asthma-related deaths continue to be an ongoing concern. Generally, it is believed that between 50 to 75% of patients with asthma can be considered as having mild asthma.Previous versions of Global Initiative for Asthma (GINA) suggested that mild asthma in adults can be well managed with either reliever medications, for example, short-acting beta2 agonists (SABA) alone or with the additional use of controllers such as regular low-dose inhaled corticosteroids (ICS). Given the low frequency or non-bothersome nature of symptoms in mild asthma, patients' adherence towards their controller medications, especially to ICS is usually not satisfactory. Such patients often rely on SABA alone to relieve symptoms, which may contribute to SABA over-reliance. Overuse of relievers such as SABAs has been associated with poor asthma outcomes, such as exacerbations and even deaths. The new GINA 2019 asthma treatment recommendations represent significant shifts in asthma management at Steps 1 and 2 of the 5 treatment steps. The report acknowledges an emerging body of evidence suggesting the non-safety of SABAs overuse in the absence of concomitant controller medications, therefore does not support SABA-only therapy in mild asthma and has included new off-label recommendations such as symptom-driven (as-needed) low dose ICS-formoterol and "low dose ICS taken whenever SABA is taken".The GINA 2019 report highlights significant updates in mild asthma management and these recommendations represent a clear deviation from decades of clinical practice mandating the use of symptom-driven SABA treatment alone in those with mild asthma. While the new inclusions of strategies such as symptom-driven (as-needed) ICS-formoterol and "ICS taken whenever SABA is taken" are based on several key trials, data in this context are still only emergent data, with clear superiority of as needed ICS-formoterol combinations over maintenance ICS regimens yet to be established for valid endpoints. Nevertheless, current and emerging data position the clinical asthma realm at a watershed moment with imminent changes for the way we manage mild asthma likely in going forward.
  4. Rehman AU, Hassali MAA, Harun SN, Abbas S, Muneswarao J, Ali IABH, et al.
    Health Qual Life Outcomes, 2020 May 13;18(1):138.
    PMID: 32404113 DOI: 10.1186/s12955-020-01393-1
    BACKGROUND: Cultural differences affect the administration and results of health status questionnaires. "Cross cultural adaptation" ensures retention of psychometric properties such as validity and reliability at an item and/or scale level.

    OBJECTIVE: To develop a Malaysian version of St George's respiratory COPD specific questionnaire (SGRQ-CM), to evaluate the full spectrum of psychometric properties (reliability, validity and responsiveness), to test the factor structure and to assess minimum clinically important difference for the SGRQ-CM, to be used in population of Malaysia.

    METHODOLOGY: SGRQ-C was translated to Bahasa Malaysia using a standard protocol. 240 COPD patients were included in the study. All patients were followed-up for six months. Construct validity, internal consistency, item convergent validity, test-retest ability, responsiveness, factor analysis and MCID of the Malaysian version of SGRQ-C to be used in population of Malaysia were evaluated.

    RESULTS: The Cronbach alpha coefficient and intraclass correlation coefficients (ICC) for SGRQ-CM were reported as 0.87, and 0.88 respectively. Correlation of SGRQ-CM with CAT, EQ-5D-5 L, mMRC dyspnea scales and FEV1%predicted were reported as 0.86, - 0.82, 0.72 and - 0.42 respectively. Correlation coefficient between the subscales and other clinical and health status measures ranged from r = - 0.35 to r = - 0.87. The MCID was reported as 5.07 (- 2.54-12.67).

    CONCLUSION: The Malaysian version of SGRQ-C has a good psychometric property comparable to those of the original version and has a strong evidence of validity, reliability and responsiveness towards disease severity in Malaysian COPD patients. It can be recommended as a reliable quality of life measure for future research.

  5. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Atif M, Babar ZU
    PMID: 32349339 DOI: 10.3390/ijerph17093039
    The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient's response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.
  6. Shakeel S, Muneswarao J, Abdul Aziz A, Yeong Le H, Abd Halim FS, Rehman AU, et al.
    Antibiotics (Basel), 2021 Dec 04;10(12).
    PMID: 34943702 DOI: 10.3390/antibiotics10121490
    The evaluation of disease progression and onsite therapeutic care choices for community-acquired pneumonia (CAP) patients is vital for their well-being and the optimum utilization of healthcare resources. The current study was conducted to assess physicians' adherence to clinical practice standards and antibiotic prescribing behavior for the treatment of CAP in older people. A prospective study that included 121 consecutive patients admitted for CAP was conducted at Kulim Hospital, Kedah, from March 2020 to August 2020. Medical records including demographic data, comorbidity, physical examination, laboratory or radiologic findings, and drugs used for the treatment of CAP were accessed from bed head tickets (BHT). The mean age for patients was 73.5 ± 6.2 years, 73 (60.3%) and 48 (39.6%) were males and females, respectively. Amoxicillin/clavulanate (19.8%) was the most prescribed antibiotic for non-severe pneumonia followed by ampicillin sodium/sulbactam sodium (6.6%), while in patients with severe CAP beta-lactam + beta lactamase inhibitors (BLIs) with a combination of macrolide were the most common antibiotics prescribed either in patients with (21.4%) or without co-morbidities (8.2%). The average length of stay in the hospital with severe pneumonia was 6-7 days for 23.9% of patients and < 5 days for 21.4% of patients. The duration of intravenous antibiotics in patients with severe pneumonia was 6-7 days for 32.2% of patients. The present findings revealed the adherence of antibiotic prescribing practices to the Malaysian National Antimicrobial Guideline 2019 for CAP therapy among geriatric patients and adherence to the CAP criteria for hospital admissions.
  7. Loh ZC, Hussain R, Ong SC, Saini B, Muneswarao J, Ur-Rehman A, et al.
    J Pharm Policy Pract, 2023 Oct 09;16(1):119.
    PMID: 37814312 DOI: 10.1186/s40545-023-00627-z
    BACKGROUND: The widespread use of short-acting beta-2 agonists (SABA) as an as-needed treatment for asthma is well-established. However, excessive use of SABA has been linked to undesirable outcomes such as increased risk of asthma attacks, exacerbations, and even death. The availability of SABA as an over-the-counter (OTC) medication has contributed to their overuse, leading to undertreated asthma and reduced access to asthma education.

    OBJECTIVE: This systematic review aimed to summarize the prevalence, characteristic features of, and factors contributing to over-the-counter SABA purchase or overuse.

    METHODS: The databases searched included PubMed, Scopus, Springer Link, Google Scholar, CINAHL, and APA PsycArticles. Original research articles reporting the prevalence, characteristics features, and factors regarding over-the-counter SABA use, available as full text, published in English language between the year 2000 and April 2023 were included in this review. Commentaries, letters to editor, review articles, qualitative studies, clinical trials, and conference proceedings were excluded. Data extraction was followed by a review of the quality of studies included and data were then synthesized for meaningful findings. This systematic review had been registered in the PROSPERO with registration number CRD42023421007.

    RESULTS: A total of 18 articles were included. The prevalence range of OTC SABA users in populations were 1.4% to 39.6% and SABA over-users among OTC users were 14% to 66.4%. Factors mostly associated with this behavior were moderate-severe asthma, and less use of preventers. On top of that, not understanding the risk of SABA overuse was clear in many studies that explored this factor.

    CONCLUSION: Over-the-counter purchase and overuse of SABA medication is a common problem, leading to adverse consequences such as uncontrolled asthma and increased healthcare utilization. Addressing these issues requires improved patient education about their conditions and adequate information regarding the potential long-term effects of SABA use by the healthcare providers. Management and education of asthma patients, including regular monitoring and follow-up, can help reduce overuse of SABA medication and prevent negative consequences.

  8. Mohd Rhazi NA, Muneswarao J, Abdul Aziz F, Ibrahim B, Kamalludin A, Soelar SA
    J Asthma, 2023 Aug;60(8):1608-1612.
    PMID: 36650693 DOI: 10.1080/02770903.2023.2169930
    INTRODUCTION: Anti-inflammatory reliever (AIR) with or without regular maintenance delivered through Turbuhaler® has been widely recommended in the GINA strategy document. These patients are not prescribed with additional reliever inhalers, but dependent on Turbuhaler® during acute asthma episodes. The peak inspiratory flow rate (PIFR) is crucial in drug delivery from a dry powder inhaler (DPI) such as Turbuhaler®. Despite its increasing usage, there are some concerns that patients on Turbuhaler® are not able to achieve adequate PIFR during acute exacerbation of asthma.

    OBJECTIVE: This study aimed to assess the PIFR at resistance settings that matched Turbuhaler® in patients with acute exacerbation of asthma.

    METHODOLOGY: A six-month cross-sectional study was conducted at the Emergency Department (ED) of Hospital Sultanah Bahiyah and Hospital Kulim, Kedah, Malaysia. Adult patients diagnosed with mild to moderate acute exacerbations of asthma were recruited. The PIFRs were measured using the In-Check DIAL G16 that was set to simulate the resistance of Turbuhaler® (R3). The PIFRs were assessed before (pre) and after (post) the initial bronchodilator (BD) treatment at the ED. The minimal required PIFR was defined as flow rates ≥ 30 L/min while a PIFR of 60 L/min was considered as optimal.

    RESULTS: A total of 151 patients (81 females and 70 males) were recruited. The mean age was 37.5 years old with a range between 18 and 79 years old. The results showed that 98% (n = 148) of patients managed to achieve the minimal PIFR required for pre-BD. The mean PIFR pre-BD was 60 ± 18.5 L/min and post-BD was 70 ± 18.5 L/min. Furthermore, more than half (54%, n = 82) of the patients recorded PIFR ≥ 60 L/min during pre-BD, and about three-quarters (71%, n = 92) achieved PIFR ≥ 60 L/min post-BD. The PIFR showed a moderate correlation with peak expiratory flow rate (PEFR) (r = 0.55, 95% CI: 0.43-0.65, p 

  9. Loh ZC, Hussain R, Balan S, Saini B, Muneswarao J, Ong SC, et al.
    PLoS One, 2023;18(4):e0283876.
    PMID: 37079594 DOI: 10.1371/journal.pone.0283876
    BACKGROUND: Short-acting β2-agonists (SABA), the most potent and rapid-acting relievers are commonly used to provide quick relief of asthma symptoms. However, there is an increasing concern regarding the misuse of SABA medicines.

    OBJECTIVE: This qualitative systematic review aims to determine, evaluate, and summarize the perceptions, attitudes, and behaviors towards the use of SABA from the patients' perspectives.

    METHODS: The databases searched included PubMed, Scopus, PsycINFO, CINAHL, and Cochrane database. Original research articles reporting the perceptions, attitudes, or behaviors of asthma patients towards the use of SABA, which was available as full text, published in the English language between the year 2000 and February 2023 were included in the review. Commentaries, letters to editor, review articles, and conference proceedings were excluded.

    RESULTS: A total of five articles were included. Six overarching themes were obtained: (1) perceptions on health status; (2) perceptions and attitudes towards the impact of asthma; (3) perceptions towards asthma control; (4) perceptions towards asthma knowledge; (5) risk perceptions; (6) perceptions, attitudes, and behaviors towards the use of SABA.

    CONCLUSION: Despite the fact that SABA could rapidly alleviate asthma symptoms, SABA over-users were less likely to describe their health status and asthma control as 'excellent'. Most SABA over-users did not know that frequent SABA usage would worsen their asthma control, and they exhibited psychological linkage towards the use of SABA. Collaborative efforts between policymakers, healthcare professionals and patients are warranted to reconstruct SABA prescribing practice and usage.

  10. Ur Rehman A, Hassali MAA, Muhammad SA, Shakeel S, Chin OS, Ali IABH, et al.
    Pharmacoecon Open, 2021 Mar;5(1):35-44.
    PMID: 32291727 DOI: 10.1007/s41669-020-00214-x
    BACKGROUND: Chronic obstructive pulmonary disease (COPD) requires long-term pharmacological and non-pharmacological management that encompasses continuous economic burden on patients and society, and also results in productivity losses due to compromised quality of life. Among working-age patients, COPD is the 11th leading cause of work productivity loss.

    OBJECTIVE: The aim of this study was to assess the economic burden of COPD in Malaysia, including direct costs for the management of COPD and indirect costs due to productivity losses for COPD patients.

    METHODOLOGY: Overall, 150 patients with an established diagnosis of COPD were followed-up for a period of 1 year from August 2018 to August 2019. An activity-based costing, 'bottom-up' approach was used to calculate direct costs, while indirect costs of patients were assessed using the Work Productivity and Activity Impairment Questionnaire.

    RESULTS: The mean annual per-patient direct cost for the management of COPD was calculated as US$506.92. The mean annual costs per patient in the management phase, emergency department visits, and hospital admissions were reported as US$395.65, US$86.4, and US$297.79, respectively; 31.66% of COPD patients visited the emergency department and 42.47% of COPD patients were admitted to the hospital due to exacerbation. The annual mean indirect cost per patient was calculated as US$1699.76. Productivity losses at the workplace were reported as 31.87% and activity limitations were reported as 17.42%.

    CONCLUSION: Drugs and consumables costs were the main cost-driving factors in the management of COPD. The higher ratio of indirect cost to direct medical costs shows that therapeutic interventions aimed to prevent work productivity losses may reduce the economic burden of COPD.

  11. Mohd Ali N, Lee CC, Mohd Akhir NSN, Ahmad Izani AS, Leong CT, Muneswarao J, et al.
    J Pharm Bioallied Sci, 2020 04 10;12(2):201-209.
    PMID: 32742120 DOI: 10.4103/jpbs.JPBS_140_19
    Aim and Objective: The success of topical treatment in patients with psoriasis is still below par in Malaysia. The contributing factors include patients' understanding and knowledge about prescribed topical medications. The aim of this study was to assess the effectiveness of color and picture labeling (C and P labeling) in improving the knowledge about topical medications among patients with psoriasis.

    Materials and Methods: An unblinded randomized controlled trial was undertaken at the dermatology clinic of a tertiary care hospital. Consent from the patients fulfilling inclusion criteria were obtained, and they were included in this study. They were randomized into two groups, namely Gp-1 (C and P labeling) and Gp-2 (conventional labeling). Both groups were assessed at week 0, 6, and 12 (visit 1, 2, and 3) using knowledge assessment list and psoriasis severity assessment score. For visit 2 (week 6), reinforcement of their understanding of topical treatment was performed.

    Results: A total of 101 patients were recruited. Only 91 of them completed the study. The mean ages were 44.52 (±16.61) and 45.49 (±15.84) years, with 70.3% males and approximately half Malay ethnics. The changes of knowledge and comparison of Topical Application Assessment Score between the groups showed an incremental raise of significance with every visit (P = 0.006 [week 1], 0.004 [week 6], and 0.002 [week 12]). Psoriasis Area and Severity Index 75 could not draw any conclusion as patients who achieved >75% improvement were inadequate.

    Conclusion: C and P labeling was effective in improving the understanding and knowledge of patients with psoriasis. Both groups showed improvement in body surface area and Dermatology Life Quality Index for every visit; however, it was statistically insignificant.

  12. Muneswarao J, Hassali MA, Ibrahim B, Saini B, Hyder Ali IA, Rehman AU, et al.
    J Allergy Clin Immunol Pract, 2020 10;8(9):3036-3055.
    PMID: 32502547 DOI: 10.1016/j.jaip.2020.05.032
    BACKGROUND: The effectiveness of home visits is well discussed for children with asthma, but limited in adults.

    OBJECTIVE: The present systematic review aimed to investigate the potential role of home visits in improving outcomes among adult patients with asthma.

    METHODS: The systematic review was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. An extensive literature search was conducted using databases such as PubMed, ProQuest, CINAHL, The Cochrane Library, PsycINFO, and Google Scholar from inception to June 2019. The studies included were randomized controlled trials, which reported asthma outcomes in adult patients.

    RESULTS: The literature search yielded 8331 publications, of which 63 studies were selected for full-text review, and of these studies, 9 studies with a total of 2011 patients were included in the final analysis. The included randomized controlled trials reported quality of life, asthma symptoms, exacerbations, health care utilization, and pulmonary function. Improvements in asthma outcomes were observed predominantly in quality of life. The effects on asthma symptom control were inconsistent. The evidence on the impact of home visits in asthma exacerbations and health care utilization was rather limited. There were no significant differences observed between intervention versus control arms in terms of pulmonary function; however, 1 study reported significant improvements in peak expiratory flow rate.

    CONCLUSIONS: Home visits may serve as an adjuvant activity that complements the existing health care system-based initiatives. It may be concluded that home visits have the potential to improve outcomes in adult patients with asthma; however, the randomized controlled trials reviewed in the present systematic review reported several limitations that warrant further investigation.

  13. Muneswarao J, Hassali MA, Ibrahim B, Saini B, Naqvi AA, Hyder Ali IA, et al.
    J Asthma, 2021 09;58(9):1229-1236.
    PMID: 32493083 DOI: 10.1080/02770903.2020.1776728
    OBJECTIVE: The Test of Adherence to Inhalers (TAI) is a validated self-reported questionnaire that can reliably assess adherence to inhalers through patient self-report. However, it was not available in Bahasa Melayu (BM) language, nor has it been validated for use in the Malaysian population. The study aimed, therefore, to translate the 10-item TAI questionnaire into BM and evaluate its psychometric properties.

    METHODS: The translation of the English version of the valid 10-item TAI questionnaire into BM was followed by subjecting it to a series of tests establishing factorial, concurrent and known group validities. Concurrent validity was assessed through Spearman's rank correlation coefficient against pharmacy refill-based adherence scores. Known group validity was assessed by cross-tabulation against asthma symptom control and using chi-square test. The internal consistency of the test scale was determined by a test-retest method using Cronbach's alpha (α) value and intraclass correlation coefficients.

    RESULTS: A total of 120 adult asthma patients participated in the study. A 2-factor structure was obtained and confirmed with acceptable fit indices; CFI, NFI, IFI, TLI >0.9 and, RMSEA was 0.08. The reliability of the scale was 0.871. The test-retest reliability coefficient for the total sum score was 0.832 (p 85%.

    CONCLUSIONS: The scale successfully translated into BM and validated. The 10-item TAI-BM appears fit for use in testing inhaler adherence of Malaysian patients with asthma.

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