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  1. Dhabali AA, Awang R, Zyoud SH
    Int J Clin Pharmacol Ther, 2011 Aug;49(8):500-9.
    PMID: 21781650 DOI: 10.5414/cp201524
    BACKGROUND: The prescription of contraindicated drugs is a preventable medication error, which can cause morbidity and mortality. Recent data on the factors associated with drug contraindications (DCIs) is limited world-wide, especially in Malaysia.

    AIMS: The objectives of this study are 1) to quantify the prevalence of DCIs in a primary care setting at a Malaysian University; 2) to identify patient characteristics associated with increased DCI episodes, and 3) to identify associated factors for these DCIs.

    METHODS: We retrospectively collected data from 1 academic year using computerized databases at the Universiti Sains Malaysia (USM) from patients of USM's primary care. Descriptive and comparative statistics were used to characterize DCIs.

    RESULTS: There were 1,317 DCIs during the study period. These were observed in a cohort of 923 patients, out of a total of 17,288 patients, representing 5,339 DCIs per 100,000 patients, or 5.3% of all patients over a 1-year period. Of the 923 exposed patients, 745 (80.7%) were exposed to 1 DCI event, 92 (10%) to 2 DCI events, 35 (3.8%) to 3 DCI events, 18 (2%) to 4 DCI events, and 33 patients (3.6%) were exposed to 5 or more DCI events. The average age of the exposed patients was 30.7 ± 15 y, and 51.5% were male. Multivariate logistic regression analysis revealed that being male (OR = 1.3; 95% CI = 1.1 - 1.5; p < 0.001), being a member of the staff (OR = 3; 95% CI = 2.5 - 3.7; p < 0.001), having 4 or more prescribers (OR = 2.8; 95% CI = 2.2 - 3.6; p < 0.001), and having 4 or more longterm therapeutic groups (OR = 2.3; 95%CI = 1.7 - 3.1; p < 0.001), were significantly associated with increased chance of exposure to DCIs.

    DISCUSSION AND CONCLUSIONS: This is the first study in Malaysia that presents data on the prevalence of DCIs. The prescription of contraindicated drugs was found to be frequent in this primary care setting. Exposure to DCI events was associated with specific socio-demographic and health status factors. Further research is needed to evaluate the relationship between health outcomes and the exposure to DCIs.
    Matched MeSH terms: Pharmacoepidemiology/methods*
  2. Shin JY, Shin E, Jeong HE, Kim JH, Lee EK
    Pharmacoepidemiol Drug Saf, 2019 03;28(3):362-369.
    PMID: 30648304 DOI: 10.1002/pds.4717
    PURPOSE: Regulatory discrepancies may exist in pharmacovigilance (PV) structure, process, and outcome status worldwide. Our study's objective was to survey the current status of PV in each regulatory body in the Asia-Pacific Economic Cooperation (APEC) region.

    METHODS: A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries.

    RESULTS: Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea.

    CONCLUSION: We have identified substantial variations in the structures, processes, and outcomes of PV status among the countries of the APEC region. Therefore, efforts to reduce variations in the PV administration and regulation are warranted for harmonization of PV within the APEC region.

    Matched MeSH terms: Pharmacoepidemiology
  3. Rajaratnam K, Xiang YT, Tripathi A, Chiu HF, Si TM, Chee KY, et al.
    J Clin Psychopharmacol, 2016 Dec;36(6):716-719.
    PMID: 27753726
    In this study, we sought to examine factors associated with dosing of antidepressants (ADs) in Asia. Based on reported data and clinical experience, we hypothesized that doses of ADs would be associated with demographic and clinical factors and would increase over time. This cross-sectional, pharmacoepidemiological study analyzed data collected within the Research Study on Asian Psychotropic Prescription Pattern for Antidepressants from 4164 participants in 10 Asian countries, using univariate and multivariate methods. The AD doses varied by twofold among countries (highest in PR China and RO Korea, lowest in Singapore and Indonesia), and averaged 124 (120-129) mg/d imipramine-equivalents. Average daily doses increased by 12% between 2004 and 2013. Doses were significantly higher among hospitalized patients and ranked by diagnosis: major depression > anxiety disorders > bipolar disorder, but were not associated with private/public or psychiatric/general-medical settings, nor with age, sex, or cotreatment with a mood stabilizer. In multivariate modeling, AD-dose remained significantly associated with major depressive disorder and being hospitalized. Doses of ADs have increased somewhat in Asia and were higher when used for major depression or anxiety disorders than for bipolar depression and for hospitalized psychiatric patients.
    Matched MeSH terms: Pharmacoepidemiology
  4. Zyoud SH, Awang R, Sulaiman SA, Al-Jabi SW
    Pharmacoepidemiol Drug Saf, 2010 May;19(5):511-7.
    PMID: 20333776 DOI: 10.1002/pds.1940
    Acetaminophen poisoning is a common clinical problem, and early identification of patients with more severe poisoning is key to improving outcomes.
    Matched MeSH terms: Pharmacoepidemiology
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