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  1. Neoh CF, Hassali MA, Shafie AA, Awaisu A, Tambyappa J
    Curr Drug Saf, 2009 Sep;4(3):199-203.
    PMID: 19534650
    Good medicine labelling practice is vital to ensure safe use of medicines. Non-compliance to labelling standards is a potential source of medication errors. This study was intended to evaluate and compare compliance towards labelling standard for dispensed medications between community pharmacists and general practitioners in Penang, Malaysia. A total of 128 community pharmacies and 26 general practitioners' clinics were visited. Using 'Simulated Client Method' (SCM), data were collected on the medications dispensed upon presentation of hypothetical common cold symptoms. The medications dispensed were evaluated for labelling adequacy. Result revealed that majority of the dispensed medications obtained were not labelled according to regulatory requirements. However, general practitioners complied better than community pharmacists in terms of labelling for: name of patient (p<0.001), details of supplier (p<0.001), dosage of medication (p=0.023), frequency to take medication (p=0.023), patient's reference number (p<0.001), date of supply (p<0.001), special instructions for medication (p=0.008), storage requirements (p=0.002), and indication for medication (p<0.001). Conversely, community pharmacists labelled dispensed medications with the words "Controlled Medicine" more often than did general practitioners (p<0.001). Although laws for labelling dispensed medicines are in place, most community pharmacists and general practitioners did not comply accordingly, thereby putting patients' safety at risks of medication errors.
    Matched MeSH terms: Drug Labeling/standards*
  2. Wang YH, Chen CB, Tassaneeyakul W, Saito Y, Aihara M, Choon SE, et al.
    Clin. Pharmacol. Ther., 2019 01;105(1):112-120.
    PMID: 29569740 DOI: 10.1002/cpt.1071
    Specific ethnic genetic backgrounds are associated with the risk of Stevens-Johnson syndrome / toxic epidermal necrolysis (SJS/TEN) especially in Asians. However, there have been no large cohort, multiple-country epidemiological studies of medication risk related to SJS/TEN in Asian populations. Thus, we analyzed the registration databases from multiple Asian countries who were treated during 1998-2017. A total 1,028 SJS/TEN cases were identified with the algorithm of drug causality for epidermal necrolysis. Furthermore, those medications labeled by the US Food and Drug Administration (FDA) as carrying a risk of SJS/TEN were also compared with the common causes of SJS/TEN in Asian countries. Oxcarbazepine, sulfasalazine, COX-II inhibitors, and strontium ranelate were identified as new potential causes. In addition to sulfa drugs and beta-lactam antibiotics, quinolones were also a common cause. Only one acetaminophen-induced SJS was identified, while several medications (e.g., oseltamivir, terbinafine, isotretinoin, and sorafenib) labeled as carrying a risk of SJS/TEN by the FDA were not found to have caused any of the cases in the Asian countries investigated in this study.
    Matched MeSH terms: Drug Labeling/standards*
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