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  1. Saleh MS, Hong YH, Muda MR, Dali AF, Hassali MA, Khan TM, et al.
    Eur J Hosp Pharm, 2020 05;27(3):173-177.
    PMID: 32419939 DOI: 10.1136/ejhpharm-2018-001679
    Objective: The increase in antimicrobial resistance and the lack of new antimicrobial agents in drug discovery pipelines have called for global attention to mitigate the problem of antimicrobial misuse. While an antimicrobial stewardship (AMS) programme has been implemented in Malaysia, the perception and practices of public hospital pharmacists remain unknown. The aim of this study was to determine the perception and practices of Malaysian public hospital pharmacists towards the AMS programme in the state of Selangor, Malaysia.

    Methods: A cross-sectional study, using a validated 23-item self-administered questionnaire, was conducted among pharmacists from 11 public hospitals in the State of Selangor, Malaysia, from December 2016 to January 2017. All public hospital pharmacists (n=432) were invited to participate in the survey. A 5-point Likert scale was employed in the questionnaire; the perception section was scored from 1 (strongly disagree) to 5 (strongly agree) while the practice section was scored from 1 (never) to 5 (always). Both descriptive and inferential statistical analyses were used to analyse data.

    Results: Of the 432 pharmacists surveyed, 199 responded, giving a response rate of 46.0%. The majority of the respondents agreed (n=190, 95.5%) that the AMS programme improves patient care at their hospitals (median=5; IQR=1). Slightly less than half of the respondents indicated that a local antibiotic guideline was established in their hospitals (median=3, IQR=2.5), and had taken part in antimicrobial awareness campaigns to promote optimal use of antimicrobials in hospitals (median=3, IQR=1).

    Conclusions: Overall, the perception and practices of the surveyed hospital pharmacists towards AMS programme were positive. National antibiotic guidelines, which take into consideration local antimicrobial resistance patterns, should be used fully to improve antimicrobial usage and to reduce practice variation. Collaboration among healthcare professionals should be strengthened to minimise the unfavourable consequences of unintended use of antimicrobial agents while optimising clinical outcomes.

  2. Rosli R, Dali AF, Abd Aziz N, Abdullah AH, Ming LC, Manan MM
    Front Pharmacol, 2017;8:27.
    PMID: 28228724 DOI: 10.3389/fphar.2017.00027
    Despite limited evidence on safety and efficacy of drug use in neonates, drugs are extensively used in this age group. However, the availability of information on drug consumption in neonates, especially inpatient neonates, is limited. This paper systematically reviews published studies on drug utilization in hospitalized neonates. A systematic literature review was carried out to identify observational studies published from inception of databases used till August 2016. Four search engines, namely Medline, CINAHL, Embase, and PubMed, were used. Publications written in English that described drug utilization in neonatal wards were selected. Assessment of the data was based on the category of the study design, the objective of study and the method used in reporting drug consumption. A total of 20 drug utilization studies were identified, 12 of which focused on all drug classes, while the other eight evaluated antimicrobials. Studies were reported in Europe (n = 7), the United States (n = 6), India (n = 5), Brazil (n = 1), and Iran (n = 1). Substantial variance with regard to study types (study design and methods), data source, and sample size were found among the selected studies. Of the studies included, 45% were cross-sectional or retrospective, 40% were prospective studies, and the remaining 15% were point prevalence surveys. More than 70% of the studies were descriptive studies, describing drug consumption patterns. Fifteen per cent of the descriptive studies evaluated changes in drug utilization patterns in neonates. Volume of units was the most prevalent method used for reporting all drug categories. The ATC/DDD system for reporting drug use was only seen in studies evaluating antimicrobials. The most commonly reported drugs across all studies are anti-infectives for systemic use, followed by drugs for the cardiovascular system, the nervous system and the respiratory system. Ampicillin and gentamicin were the most prescribed antimicrobials in hospitalized neonates. The present review reveals that neonates are exposed to a high number of drugs and various methods are used to report drug consumption in this age group. The best measure of drug consumption to quantify prevalence of drug use in neonates remains to be identified and additional research in this area is warranted.
  3. Rosli R, Dali AF, Aziz NA, Ming LC, Manan MM
    Front Pharmacol, 2017;8:30.
    PMID: 28239351 DOI: 10.3389/fphar.2017.00030
    Spontaneous adverse drug reactions (ADRs) reporting is a useful source of drug safety information in infants as only adult patients are routinely tested in clinical trials. This study was aimed to evaluate the spontaneously reported ADRs using WHO Adverse Reaction Terminology and to identify the common drugs associated with ADRs in children under 2 years of age. A retrospective analysis of ADR data for children below 2 years old from 2000 to 2013 was conducted using the data extracted from Malaysia's national pharmacovigilance database, QUEST2 System. From 2000 to 2013, Malaysia's National Pharmaceutical Control Bureau received a total of 11,932 reports for children from various healthcare facilities in Malaysia. 14.0% (n = 1667) of the ADRs reported for those children were related to children under 2 years old. The data retrieved was analyzed in terms of age, gender, source of reporting, type of reporters, suspected medicines and characteristics of ADRs (category, onset, severity, and outcomes). A total of 1312 ADRs reported in 907 ADR reports were analyzed. The most common ADRs reported were skin appendage disorders (60.1%), and the most frequently reported symptoms were rash (n = 215), maculopapular rash (n = 206), urticaria (n = 169), erythematous rash (n = 76), and pruritus (n = 58). In general, drugs from antibacterials for systemic use (58.8%) appeared to be the most common contributors to ADRs in children below 2 years old. Penicillins and other β-Lactam Antibacterials accounted for more than 40% of all drugs implicated in ADRs. The majority of ADRs were subacute reactions that occurred within 24 h of exposure to the drug. A high proportion of ADRs was classified as mild, and most victims had no sequela. Only one fatality was seen. There were 10 cases for each symptom, namely erythema multiforme and Stevens-Johnson Syndrome, observed in this study. A large proportion of ADRs in children under 2 years old were mainly caused by drugs from antibacterial for systemic use, with most of the ADRs manifesting in skin reactions. This study also reveals rare cutaneous ADRs experienced by Malaysian children under the age of 2, which constitutes a crucial cause of harm among children.
  4. Ibrahim NH, Maruan K, Mohd Khairy HA, Hong YH, Dali AF, Neoh CF
    J Pharm Pharm Sci, 2017;20(1):397-406.
    PMID: 29145934 DOI: 10.18433/J3NW7G
    PURPOSE: To systematically review studies on cost-effectiveness of implementing Antimicrobial stewardship programmes (ASP) in the hospital setting.

    METHODS: A systematic literature search was performed using electronic databases, such as EMBASE, PubMed/Medline, CINAHL, NHS and CEA Registry from 2000 until 2017. The quality of each included study was assessed using Joanna Briggs Institute Critical Appraisal Checklist for Economic Evaluations and Consolidated Health Economic Evaluation Reporting Standards Statement checklist.

    RESULTS: Of the 313 papers retrieved, five papers were included in this review after assessment for eligibility. The majority of the studies were cost-effectiveness studies, comparing ASP to standard care. Four included economic studies were conducted from the provider (hospital) perspective while the other study was from payer (National Health System) perspective. The cost included for economic analysis were as following: personnel costs, warded cost, medical costs, procedure costs and other costs.

    CONCLUSIONS: All studies were generally well-conducted with relatively good quality of reporting. Implementing ASP in the hospital setting may be cost-effective. However, comprehensive cost-effectiveness data for ASP remain relatively scant, underlining the need for more prospective clinical and epidemiological studies to incorporate robust economic analyses into clinical decisions. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

  5. Ahmad Hamdi AH, Dali AF, Mat Nuri TH, Saleh MS, Ajmi NN, Neoh CF, et al.
    Front Pharmacol, 2017;8:410.
    PMID: 28744215 DOI: 10.3389/fphar.2017.00410
    Recent clinical trials have shown that while bivalirudin exhibits similar efficacy with heparin, it offers several advantages over heparin, such as a better safety profile. We aimed to evaluate the efficacy and safety of bivalirudin use during Percutaneous Coronary Intervention (PCI) in the treatment of angina and acute coronary syndrome (ACS). We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, PubMed, EMBASE, and Science Direct from January 1980 to January 2016. Randomized controlled trials (RCTs) comparing bivalirudin to heparin during the course of PCI in patients with angina or ACS were included. Outcome measures included all-cause mortality, myocardial infarction, revascularisation, stent thrombosis, stroke, and major bleeding. The selection, quality assessment, and data extraction of the included trials were done independently by four authors, and disagreements were resolved by consensus. Pooled relative risk (RR) estimates and 95% confidence intervals (CIs) were calculated. A total of 12 RCTs involving 44,088 subjects were included. Bivalirudin appeared to be non-superior compared to heparin in reducing all-cause mortality, myocardial infarction, revascularisation, and stroke. Bivalirudin appeared to be related to a higher risk of stent thrombosis when compared to heparin plus provisional use of a glycoprotein IIb/IIIa inhibitor (GPI) at day 30 (RR 1.94 [1.16, 3.24] p < 0.01). Overall, bivalirudin-based regimens present a lesser risk of major bleeding (RR 0.56 [0.44-0.71] p < 0.001), and Thrombolysis In Myocardial Infarction (TIMI) major bleeding (RR 0.56 [0.43-0.73]) compared with heparin-based regimens either with provisional or routine use of a GPI. However, the magnitude of TIMI major bleeding effect varied greatly (p < 0.001), depending on whether a GPI was provisionally used (RR 0.42 [0.34-0.52] p < 0.001) or routinely used (RR 0.60 [0.43 -0.83] p < 0.001), in the heparin arm. This meta-analysis demonstrated that bivalirudin is associated with a lower risk of major bleeding, but a higher risk of stent thrombosis compared to heparin.
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