manual on management of drugs

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Unsatisfactory clinical response, adverse reactions and bad storage conditions: In respect of all problems of vaccines and sera relating to unsatisfactory clinical responses, adverse reactions and exposure to bad storage conditions has to be reported within 24 hours by telephone and followed up with samples as specified below with detail report relevant to the product (lot number, expiry date, manufacture etc.), storage conditions, maintenance of the cold chain, reactions caused, dosage applied etc (sample sending form appears in annexure XVI can be used) addressed to the National Control Laboratory (Head / Dept of Vaccine Quality Control, MRL Contact No. 2698660, 2693532-4 Res. 2597723). Advice and approval regarding further use of the batches should be sought from the Epidemiologist for all EPI vaccines and from the Director Medical Supplies Division for all Non-EPI vaccines. Please note that the NCL should be contacted prior to sending the samples. Sample size for Q.A test- (1) Single dose vials: sterility test - 5 vials, safety test - 20 vials (2) Multiple dose vials: sterility test - 3 vials, safety test - 3 vials N.B. To be sent in a vaccine carrier maintaining cold chain with copies of all relevant documents. (2) Same procedure should be followed as pharmaceuticals regarding the handling of product recalling. Organization structure of the National Control Laboratory of Vaccines DGHS Technical Advisory Committee DDG (LS) D/MRI D\MT&S Head / NCL 97 Dept of Vaccine QC
ANNEXURE XVIII Circular No.WMS-02/66/2007 RETURN OF QUALITY FAILED MEDICAL SUPPLIES TO MSD The matter of recovery of cost of quality failed medical supplies was discussed at Public Accounts Committee (PAC) meeting of the Parliament. PAC has instructed that State Pharmaceuticals Corporation (SPC) should either obtain free replacement or recover the cost of quality failed (batch withdrawal / product withdrawal) items from the relevant supplier. SPC has a difficulty in recovering the cost of items as quality failed stocks are not returned to them before the expiry of performance bond of the supplier. Suppliers are requesting for withdrawn items for free replacement or to reimburse the cost. Accordingly SPC has requested to return to them any stocks of medical supplies withdrawn from use due to quality failures, in order to obtain free replacement or recover the cost of items from manufacturer /supplier. In view of these facts, this matter has to be treated as a priority. However considering the transport difficulties and non availability of adequate storage space at MSD at present, it has been decided that any withdrawn stock from use should be stored separately at the institution (not to send to MSD as informed by circular No.WMS-01/63/2007) and SPC or 98
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MANUAL ON MANAGEMENT OF DRUGS SECON
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MESSAGE BY THE SECRETARY/ MINISTRY
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ACKNOWLEDGEMENT It is a great pleas
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Dr. J. M. J. Munasinghe Dr. K. C. L
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ABBREVIATIONS AD CP CDD CDDA D(F) D
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CONTENTS Message by the Hon. Minist
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X Form for Drug sample for quality
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CHAPTER 1 INTRODUCTION 1.Ensuring a
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3.The expenditure on drugs has been
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of poisons, opium, and dangerous dr
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(Medical Technology & Supplies) No
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c) NDQAL for quality assurance of d
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Deputy Director General (Finance) D
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(d) The Institutional Drug Therapeu
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CHAPTER 4 ESTIMATION OF ANNUAL REQU
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Step 2 Identify the stock available
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In the case of institutions under t
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oard appointed by him and a report
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Head of the Institution may add any
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ii. Injections costing Rs. 25.00 or
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42. Delivery schedules are planned
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CHAPTER 6 CARE IN PRESCRIBING DRUGS
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CHAPTER 7 DISTRIBUTION AND LOGISTIC
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the institution. Records of the inv
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RMSD or institutional stores, the o
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CHAPTER 8 QUALITY ASSURANCE OF DRUG
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ioavailability. Further, in apprais
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x. Details of any preservative adde
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To request institutions to inform t
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CHAPTER 9 STORAGE OF DRUGS. 1. Prop
Page 62 and 63: xi. Storage of vaccine in the refri
Page 64 and 65: CHAPTER 10 MONITORING OF CONSUMPTIO
Page 66 and 67: ii. VEN analysis ( See annexure XV
Page 68 and 69: 9. Monitoring of quality of drugs;
Page 70 and 71: alance as per ledger, actual balanc
Page 72 and 73: 1.3 In case of institutions coming
Page 74 and 75: Ampoules should be crushed and buri
Page 76 and 77: ANNEXURE I1: Main functions of Medi
Page 78 and 79: I - Annual stock holding cost as a
Page 80 and 81: Anti Rabies cell culture vaccine. (
Page 82 and 83: unobservable (animal dead, killed,
Page 84 and 85: on D0, D3, D7, D14 & D30. 6.1.2 For
Page 86 and 87: All patients who receive rabies PET
Page 88 and 89: Monthly return for vaccine consumpt
Page 90 and 91: Death in the house / outside a Medi
Page 92 and 93: 2.2 In case of major exposures: 2.2
Page 94 and 95: ANNEXURE - V MyNo……/…../….
Page 96 and 97: Advertisement Screening Unit Unit o
Page 98 and 99: ANNEXURE VIII (To be amended To: My
Page 100 and 101: ANNEXURE X ……………………
Page 102 and 103: 6. Quality failure of registration
Page 105 and 106: ANNEXURE XIII Lot Card SR No……
Page 107 and 108: ANNEXURE XV VEN Analysis This analy
Page 109: Sample Guidelines for VEN Category
Page 114 and 115: Local Agents of supplier (on reques
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