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2005 Edition Report on Drug Administration Procedure & Practices ...

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Quality Complaints <strong>on</strong> Pharmaceutical Items5.9 A quality complaint regarding a pharmaceutical item is defined as c<strong>on</strong>cern that is raised <strong>on</strong>discrepancies in efficacy, appearance, packaging, possible c<strong>on</strong>taminati<strong>on</strong> or any othercircumstances observed that may jeopardize or cause reas<strong>on</strong>able doubt <strong>on</strong> the routine andintended utilizati<strong>on</strong> of that item.5.10 In order to provide safe and effective pharmaceutical items to all patients, the qualitycomplaints should be handled in a systematic manner. The procedure must be complied withand all cases of quality complaints must be reported by using the standard report form. Fordetailed procedure, Appendix 17 should be referred to.5.11 Whenever an alert with batch suspensi<strong>on</strong> is issued, immediate acti<strong>on</strong> must be taken toquarantine all affected batches in all stores both within and outside pharmacy in the hospital.Close liais<strong>on</strong> with nursing staff should be maintained in order that the situati<strong>on</strong> is fullyunderstood by all parties c<strong>on</strong>cerned. All subsequent recommendati<strong>on</strong>s including productsuspensi<strong>on</strong>, replacement, withdrawal or recall should be executed immediately and to allward levels.<strong>Drug</strong> Recall5.12 Pharmacists must comply immediately with any warning or recall about defective medicines.A drug recall system must be maintained so that all problematic batches can be traced andretrieved in order to protect patients from any harmful effects due to defective medicines.5.13 All drugs should preferably be kept in their original c<strong>on</strong>tainers with their unique lot/batchnumber. If it is necessary for drugs to be transferred to another c<strong>on</strong>tainer, such as pre-packs,the retraceable lot/batch number should be marked <strong>on</strong> the label of the drug item.5.14 When a drug recall is activated, pharmacy must notify all parties c<strong>on</strong>cerned immediately,such as the unit head and nurse-in-charge, of the product to be recalled, the reas<strong>on</strong> for itsrecall and the batch number involved.5.15 All affected stock must be quarantined pending further instructi<strong>on</strong>s.43

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