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  1. Balan S, Koo K, Muhamad Hamdan MD, Lee SV
    Explor Res Clin Soc Pharm, 2022 Dec;8:100188.
    PMID: 36281358 DOI: 10.1016/j.rcsop.2022.100188
    BACKGROUND: Special approval medicines (SAMs) are medicines used with approval from the Director General of Health Malaysia when the therapeutic options within regulatory and formulary boundaries appear unsuitable or ineffective to treat the patients.

    OBJECTIVES: To examine and characterize the use of SAMs among children in a Malaysian tertiary care hospital.

    METHODS: The named-patient basis SAM application forms, cover letter, pharmacist review summary and patient monitoring forms available at the Pharmacy Department between 1st January 2019 and 31st December 2020 were reviewed. Unprocessed, unapproved and stock-basis applications were excluded. The outcome measures were categories, scope, off-label use and cost of SAM. Per-patient data were analyzed descriptively.

    RESULTS: Overall, 1010 patients (mean age of 8.7 ± 5.6 years) were involved in 328 SAMs applications. The most common SAMs pharmacological groups were nervous system (n = 371, 36.7%) and antineoplastic and immunomodulating agents (n = 332, 32.9%). Top three SAMs were melatonin (11.5%), scopolamine (7.6%) and cholecalciferol (7.1%). A total of 837 (82.9%) and 513 (50.8%) patients were involved in the SAMs applications for non-formulary and unregistered medicines, respectively. Unregistered, non-formulary medicines were applied for 47.3% (n = 478) of the patients. The majority of the scope for SAMs (64.7%) were to substitute the available alternatives in the national formulary which were ineffective or sub-optimal for the patients. Among the 262 patients with repeat applications, 93.8% reported disease or symptom improvement while 1.9% experienced side effects. Up to 17% of SAMs analyzed in this study were used for off-label indications. The total cost of the SAMs was RM8,748,358.38 (USD 2,090,418.86).

    CONCLUSION: The use of SAMs among children in this hospital involved unregistered, non-formulary medicines used to substitute the available alternatives in the formulary. A concerted effort is warranted in exploring supplementary mechanisms to enhance the medicine registration process and formulary system towards facilitating enhanced provision of treatment for children.

  2. Koo K, Nagayah R, Begum S, Tuan Mahmood TM, Mohamed Shah N
    Complement Ther Med, 2020 Mar;49:102355.
    PMID: 32147044 DOI: 10.1016/j.ctim.2020.102355
    OBJECTIVE: Globally, the use of complementary and alternative medicines (CAMs) for children with atopic eczema (AE) is gaining popularity. At present, information on the pattern of CAM use in Malaysia among children with AE is limited. This study aimed to investigate the pattern of CAM use in children with AE and factors associated with its use.

    METHODS: This was a cross-sectional survey conducted at a tertiary care centre in Kuala Lumpur, Malaysia among parents of children with AE aged ≤ 12 years using validated questionnaires including Beliefs about Medicines Questionnaire (BMQ-General) and Patient-Oriented Eczema Measure (POEM) scale.

    RESULTS: In total, 173 parents were recruited. The prevalence of CAM use over the last 12-month period was 46.8 %. The most commonly used CAM was Ruqyah (Islamic prayer), followed by Malay herbs, virgin coconut oil, nutritional therapy and homeopathy. AE severity from parental perspective was the major predictor of CAM use based on multiple logistic regression analysis. Parents of children with 'clear or almost clear' (adjusted OR 0.06; 95 % CI 0.01-0.54; p = 0.012) and 'mild' (adjusted OR 0.15; 95 % CI 0.03-0.85; p = 0.032) eczema were less likely to use CAM than those with 'very severe eczema'.

    CONCLUSION: CAM use was prevalent among children with AE. Its use was significantly associated with AE severity from a parental perspective. Healthcare providers may need to enquire parents about CAM use for their child during routine clinic appointment.

  3. Tan T, Ong WS, Rajasekaran T, Nee Koo K, Chan LL, Poon D, et al.
    PLoS One, 2016;11(5):e0156008.
    PMID: 27231951 DOI: 10.1371/journal.pone.0156008
    PURPOSE: Elderly cancer patients are at increased risk for malnutrition. We aim to identify comprehensive geriatric assessment (CGA) based clinical factors associated with increased nutritional risk and develop a clinical scoring system to identify nutritional risk in elderly cancer patients.

    PATIENTS AND METHODS: CGA data was collected from 249 Asian patients aged 70 years or older. Nutritional risk was assessed based on the Nutrition Screening Initiative (NSI) checklist. Univariate and multivariate logistic regression analyses were applied to assess the association between patient clinical factors together with domains within the CGA and moderate to high nutritional risk. Goodness of fit was assessed using Hosmer-Lemeshow test. Discrimination ability was assessed based on the area under the receiver operating characteristics curve (AUC). Internal validation was performed using simulated datasets via bootstrapping.

    RESULTS: Among the 249 patients, 184 (74%) had moderate to high nutritional risk. Multivariate logistic regression analysis identified stage 3-4 disease (Odds Ratio [OR] 2.54; 95% CI, 1.14-5.69), ECOG performance status of 2-4 (OR 3.04; 95% CI, 1.57-5.88), presence of depression (OR 5.99; 95% CI, 1.99-18.02) and haemoglobin levels <12 g/dL (OR 3.00; 95% CI 1.54-5.84) as significant independent factors associated with moderate to high nutritional risk. The model achieved good calibration (Hosmer-Lemeshow test's p = 0.17) and discrimination (AUC = 0.80). It retained good calibration and discrimination (bias-corrected AUC = 0.79) under internal validation.

    CONCLUSION: Having advanced stage of cancer, poor performance status, depression and anaemia were found to be predictors of moderate to high nutritional risk. Early identification of patients with these risk factors will allow for nutritional interventions that may improve treatment tolerance, quality of life and survival outcomes.

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