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

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PROCEUDRE FOR QUALITY COMPLAINTSONPHARMACEUTICAL ITEMSIntroductionA quality complaint of a pharmaceutical item is defined as concern that is raised ondiscrepancies in efficacy, appearance, packaging, possible contamination or any othercircumstances observed that may jeopardise or cause reasonable doubt on the routine and intendedutilization of that item.This procedure and the standard “Pharmaceutical Product Quality Complaint <strong>Report</strong>Form” are designed to provide a standardised and comprehensive mean for reporting and recordingquality complaints of pharmaceutical items. The report form will also be used as a base forcommunications and correspondences. E-mail should not be used as a mean to report complaint.The report form must be used for all cases of quality complaints. The followingguidelines should be observed in order to proceed and handle such complaints in a systematicmanner. Apart from the head of pharmacy, a co-ordinator should also be nominated to receive andhandle quality complaint promptly. The co-ordinator should be made known and updated to boththe Chief Pharmacist’s Office and all departments within your hospital as a one stop contact oncomplaint matters. The Pharmacist (Procurement) or his delegate Chief Dispenser (Procurement)will be the co-ordinator of complaint at Chief Pharmacist’s Office.Whenever an alert with batch suspension is issued, immediate action must be takento quarantine all affected batches in all stores both within and outside pharmacy. Close liaisionwith nursing staff should be maintained in order the situation is fully understood by all partiesconcerned. All subsequent recommendation including product suspension, replacement,withdrawal or recall should be executed immediately and to all ward levels.Possible ActionsClass IRemoval of all traceable quantity of a product within your hospital.Class IIRetrieval of all affected batches within your hospital and hold in quarantine pendingfurther follow up actions.Class IIIGeneral alert to all users where specific guidelines or procedures needed to befollowed for safety reason.Class IVThe affected batch is released for use.Class VNo immediate action but will keep in view of the development.1
Part I Pharmacy Department1. Receiving the Complaint1.1 The co-ordinator or his delegate must attend to the complaint immediately.1.2 Identify the item concerned, the particular manufacturer in question and record thebatch.1.3 Note and understand the nature, when and how the complaint is identified.1.4 Note the originating Department/Ward, name and rank of the complainant.1.5 Inform the head of pharmacy about the complaint.2. Immediate Action2.1 The head of pharmacy and the co-ordinator must first assess and understand thesituation, collect the complaint sample and decide what actions to be taken.2.2 Start a case file on the complaint.2.3 Alert all pharmacy staff of the situation.2.4 In case where the batch is suspended from use, consolidate the affected batch withinyour hospital and hold in quarantine.2.5 Complete the “Pharmaceutical Product Quality Complaint <strong>Report</strong> Form”. Allrequired details and any immediate actions taken must be documented.2.6 Notify either Pharmacist or Chief Dispenser of the Procurement Section bytelephone before forwarding the completed report form by fax to the ProcurementSection of Chief Pharmacist’s Office.2.7 Make urgent arrangement to despatch the relevant complaint sample and two unitsof the circulating stock of the same batch to Chief Pharmacist’s Office.2.8 Follow-up with the officer previously notified if acknowledgement of complaint byreturn fax is not received.3. Follow-up Action3.1 Continue to monitor the progress of the complaint and follow up with ChiefPharmacist’s Office where necessary.3.2 Inform Chief Pharmacist’s Office on any subsequent actions taken within yourhospital where appropriate.3.3 Observe the recommended action or outcome from Chief Pharmacist’s Office.3.4 Inform and follow-up with the concerned department/ward/personnel on theoutcome of complaint and the progress of any recommended actions.3.5 <strong>Report</strong> to Chief Pharmacist’s Office when recommended action is completed.2
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ForewordMedication safety and provi
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Chapter 6 summarizes the specific r
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Chapter 6Conclusions and Recommenda
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CHAPTER ONETHE WORKING GROUPMEMBERS
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CHAPTER TWOTHE PROGRESS REPORT2.1 P
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CHAPTER THREEAREAS FOR IMPROVEMENT
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Existing In-patient Drug Administra
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CHAPTER FOURRECOMMENDED PRACTICES A
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Drug Name4.11 There should be a hos
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Electronic prescribing (Medication
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4.46 When the use of CM is permitte
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cytotoxic and central intravenous a
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4.72 Special precautions should be
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4.84 To prevent mixing up medicatio
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The Principle of Three checks and F
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4.111 Three-way (red and blue) and
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or their discharge or death, should
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operational requirement but also it
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Quality Complaints on Pharmaceutica
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LEVELSHAHOCE / DTOOLS & MECHANISMDU
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Medication Incident Report<
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Continuing Education6.18 In order t
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APPENDICESAppendix 1Appendix 2Appen
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Hospital Authority Hospital No. : I
Page 56 and 57: Sensitivity:Prescription/ routewith
Page 58 and 59: Appendix 3aLists of HA-wide Approve
Page 60 and 61: DRUGTeniposideABBREVIATIONVM-26Thia
Page 62 and 63: Appendix 3b“Do Not Use Abbreviati
Page 64 and 65: Appendix 4Schedule for the Administ
Page 66 and 67: Appendix 5Mechanism for the Managem
Page 68 and 69: 4. As with all medications, there s
Page 70 and 71: Appendix 6HA Guideline on Safe Mana
Page 72 and 73: 2.1 Concentrated potassium chloride
Page 74 and 75: Appendix 7Supply of Antidotes and D
Page 76 and 77: 複本 Antidotes and emeg drug lis
Page 78 and 79: Appendix 8Guidelines for Supply of
Page 80 and 81: substitution with other drugs in ac
Page 82 and 83: Appendix 9Samples of the Line Label
Page 84 and 85: Appendix 10Guidelines on the use of
Page 86 and 87: Appendix 11Guidelines on Patient Se
Page 88 and 89: Operational Guidelines7. The operat
Page 90 and 91: COC(N) Paper 12/2004Approved by COC
Page 92 and 93: 7.4 Evaluation Record and report th
Page 94 and 95: DISPOSAL OF HOSPITAL PHARMACEUTICAL
Page 96 and 97: Appendix 14Guidelines on the Handli
Page 98 and 99: Appendix 15Medication Incident <str
Page 100 and 101: Hospital Authority Medication Incid
Page 102 and 103: QUALITY ASSURANCE IN DRUG THERAPYHO
Page 104 and 105: Fig. 1: ADR voluntary reporting sys
Page 108: Part II Procurement Section, CPO1.
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