manual on management of drugs

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To request institutions to inform the withdrawn quantity to the Director/MSD on or before the specified date. To inform SPC, the quantity and the institutions having the withdrawn stocks for replacement or reimbursement of the cost of the same by the supplier. To request SPC for reimbursement of the cost of unused quantity of the withdrawn product. To deduct the cost of the withdrawn item from the payment due to SPC, if the reimbursement of cost is not completed within five months from the date of request to SPC. ‣ Procedures to be followed by the Institution. To inform the quantity withdrawn from use to the Director/MSD on or before the specified date, to enable Director/MSD to obtain replacement or reimbursement of the cost. It is the responsibility of the PDHS, RDHS and respective Heads of Institutions to ensure the withdrawn stocks are kept in safe custody to be inspected by SPC, MSD or the supplier. (C) Discontinue to use the Containers which show the defect (the defect will be indicated in the circular) Store the containers which show the defect separately. Inform Director/MSD, Director/MT&S the quantity available with defects at the institution for further action. Table 7: Minimum amount of dosage units required (sample size) for issuing a complete report is given below. 43
DOSAGE FORM STRENGTH / VOLUME Tablets / Capsules Suppositories / Pessaries Tablets / Capsules Suppositories / Pessaries Infusions Less than or equal to 5mg More than 5mg Less than or equal to 200ml SAMPLE SIZE 200 Tablets / Capsules suppositories / Pessaries 100 Tablets/Capsules suppositories / Pessaries 20 units Infusions More than 200ml 15 units Injections Less than or equal to 3ml 85 vials/ampoules Injections More than 3ml 65 vials/ampoules Powder for Injection Less than or equal to 2mg 85 vials Powder for Injection More than 2mg 65 vials Eye / Ear Drops / Nasal Drops Mixtures / Elixirs / Oral Suspension / Syrups Applications / Tinctures Oral Rehydration Salts (ORS) - 45 containers - 06 unopened containers - 02 containers - 25 packets In case of requesting to test for microbial contamination or discolouration in bulk packs, at least two (02) unopened containers should be sent. More samples may be requested in addition to the amounts indicated above, when necessary. 44
Page 2 and 3:
MANUAL ON MANAGEMENT OF DRUGS SECON
Page 4 and 5:
MESSAGE BY THE SECRETARY/ MINISTRY
Page 6 and 7:
ACKNOWLEDGEMENT It is a great pleas
Page 8 and 9: Dr. J. M. J. Munasinghe Dr. K. C. L
Page 10 and 11: ABBREVIATIONS AD CP CDD CDDA D(F) D
Page 12 and 13: CONTENTS Message by the Hon. Minist
Page 14 and 15: X Form for Drug sample for quality
Page 16 and 17: CHAPTER 1 INTRODUCTION 1.Ensuring a
Page 18 and 19: 3.The expenditure on drugs has been
Page 20 and 21: of poisons, opium, and dangerous dr
Page 22 and 23: (Medical Technology & Supplies) No
Page 24 and 25: c) NDQAL for quality assurance of d
Page 26 and 27: Deputy Director General (Finance) D
Page 28 and 29: (d) The Institutional Drug Therapeu
Page 30 and 31: CHAPTER 4 ESTIMATION OF ANNUAL REQU
Page 32 and 33: Step 2 Identify the stock available
Page 34 and 35: In the case of institutions under t
Page 36 and 37: oard appointed by him and a report
Page 38 and 39: Head of the Institution may add any
Page 40 and 41: ii. Injections costing Rs. 25.00 or
Page 42 and 43: 42. Delivery schedules are planned
Page 44 and 45: CHAPTER 6 CARE IN PRESCRIBING DRUGS
Page 46 and 47: CHAPTER 7 DISTRIBUTION AND LOGISTIC
Page 48 and 49: the institution. Records of the inv
Page 50 and 51: RMSD or institutional stores, the o
Page 52 and 53: CHAPTER 8 QUALITY ASSURANCE OF DRUG
Page 54 and 55: ioavailability. Further, in apprais
Page 56 and 57: x. Details of any preservative adde
Page 60 and 61: 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 112 and 113:
Unsatisfactory clinical response, a
Page 114 and 115:
Local Agents of supplier (on reques
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