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    Guidelines For Shelf-Life of Medical Products

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    Arvenaa Subramaniam
    This document provides general guidelines for shelf-life of medicinal products used in Changi General Hospital. It outlines shelf-life recommendations based on assumptions around storage conditions and contamination. The guidelines specify shelf-life timeframes for various drug categories including oral solid and liquid dosage forms, extemporaneous preparations, injections, vaccines, eye preparations, external creams and solutions, intravenous fluids, and milk feeds. Staff are responsible for adhering to the shelf-life recommendations in this document.

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    Guidelines For Shelf-Life of Medical Products

    Uploaded by

    Arvenaa Subramaniam
    163 views3 pages
    This document provides general guidelines for shelf-life of medicinal products used in Changi General Hospital. It outlines shelf-life recommendations based on assumptions around storage conditions and contamination. The guidelines specify shelf-life timeframes for various drug categories including oral solid and liquid dosage forms, extemporaneous preparations, injections, vaccines, eye preparations, external creams and solutions, intravenous fluids, and milk feeds. Staff are responsible for adhering to the shelf-life recommendations in this document.

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    Guidelines for Shelf-life of Medical Products

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    This document provides general guidelines for shelf-life of medicinal products used in Changi General Hospital. It outlines shelf-life recommendations based on assumptions around storage conditions and contamination. The guidelines specify shelf-life timeframes for various drug categories including oral solid and liquid dosage forms, extemporaneous preparations, injections, vaccines, eye preparations, external creams and solutions, intravenous fluids, and milk feeds. Staff are responsible for adhering to the shelf-life recommendations in this document.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    163 views3 pages

    Guidelines For Shelf-Life of Medical Products

    Uploaded by

    Arvenaa Subramaniam
    This document provides general guidelines for shelf-life of medicinal products used in Changi General Hospital. It outlines shelf-life recommendations based on assumptions around storage conditions and contamination. The guidelines specify shelf-life timeframes for various drug categories including oral solid and liquid dosage forms, extemporaneous preparations, injections, vaccines, eye preparations, external creams and solutions, intravenous fluids, and milk feeds. Staff are responsible for adhering to the shelf-life recommendations in this document.

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    © All Rights Reserved
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    Download as pdf or txt
    of 3

    PHARMACY GUIDELINES CHANGI GENERAL HOSPITAL

    TITLE : DOCUMENT NO : REV NO :


    General Guidelines for shelf-life of GL/PHA/02 03
    Medicinal Products
    EFFECTIVE DATE : PAGE :
    21 March 2011 1 of 3
    DOCUMENT OWNER: APPROVAL:
    Pharmacist Pharmacy Manager

    1.0 OBJECTIVE

    To serve as a general guide for shelf life of medicinal products that are used in the
    hospital based on the following assumptions:

    1.1 Light sensitive items are stored in amber/light-proof containers


    1.2 Items are stored in a cool, dry place or as recommended by manufacturer
    1.3 Caps and closures are tightly closed after use
    1.4 Items that have deteriorated eg. discoloration, change in smell or consistency
    are not to be used
    1.5 Items to be used in sterile conditions are to be discarded once opened
    1.6 Items are not contaminated during use

    2.0 SCOPE

    This guideline outlines the actions and responsibilities of the staff using medicinal
    products in the hospital.

    3.0 DEFINITIONS

    Nil

    4.0 REFERENCES

    4.1 Product Information Leaflets


    4.2 British Pharmacopoeia 1988 Volumes I & II. Her Majestys Stationary Office,
    London, UK
    4.3 Handbook of Injectable Drugs 14th Edition. Lawrence A. Trissel. American
    Society of Health-System Pharmacists
    4.4 Martindale, the Extra Pharmacopoeia 33rd Edition. The Pharmaceutical Press,
    London, UK
    4.5 The Pharmaceutical Codex 11th Edition 1979. The Pharmaceutical Press, UK

    5.0 GUIDELINE DETAILS

    5.1 Oral solid dosage forms:


    a) To follow manufacturers expiry date.
    b) GTN tablets: Discard 2 months from date of opening.

    5.2 Oral liquid dosage forms:


    a) To follow manufacturers expiry date or 6 months from date of opening
    whichever is shorter.
    b) Reconstituted liquid dosage forms to follow manufacturers recommended shelf-life.
    PHARMACY GUIDELINES CHANGI GENERAL HOSPITAL
    TITLE : DOCUMENT NO : REV NO :
    General Guidelines for shelf-life of GL/PHA/02 03
    Medicinal Products
    EFFECTIVE DATE : PAGE :
    21 March 2011 2 of 3

    5.3 Extemporaneous preparations:


    Expiry date on label (as recommended by literature)

    5.4 Nebuliser solutions:


    a) To follow manufacturers recommended shelf-life or 1 month from date of opening if
    no recommendation given from manufacturer
    b) Nebuliser ampoules: To follow drug labels or manufacturers recommended shelf-
    life or 24 hours after opening whichever is shorter.

    5.5 Single-dose injections:


    To discard after single use

    5.6 Multi-dose injections (except insulins):


    To follow manufacturers recommended shelf-life or 1 month from date of
    opening if no recommendation given from manufacturer

    5.7 Insulins:
    a) To follow manufacturers recommended shelf-life

    Expiry Date (After First Opening) Insulin Preparations


    4 weeks Humalog, Humulin, Lantus, Novorapid,
    Novomix preparations
    6 weeks Actrapid, Insulatard, Mixtard preparations

    5.8 Intravenous infusion fluid:


    To follow manufacturers recommended shelf-life or 24 hours whichever is
    shorter.

    5.9 Vaccines:
    a) To follow manufacturers recommended shelf-life or
    b) with preservative: 3 hours after opening
    c) without preservative: 1 hour after opening
    d) Oral poliomyelitis vaccine: 3 hours after opening

    5.10 Eye preparations:


    a) To follow manufacturers recommended shelf-life or 1 month from date of
    opening whichever is shorter.
    b) Preservative-free preparations
    Refresh / Refresh Plus: discard unused portion
    Tears Naturale PF: 12 hours after opening of vial

    5.11 External Creams / Ointments:


    To follow manufacturers recommended shelf-life or 6 months whichever is
    shorter.

    5.12 External Solutions


    a) For use on patients: To follow manufacturers recommended shelf-life or 1 month
    from date of opening whichever is shorter.
    PHARMACY GUIDELINES CHANGI GENERAL HOSPITAL
    TITLE : DOCUMENT NO : REV NO :
    General Guidelines for shelf-life of GL/PHA/02 03
    Medicinal Products
    EFFECTIVE DATE : PAGE :
    21 March 2011 3 of 3

    b) Lidocaine (10mg/dose) pump spray 10% (Xylocaine): To follow manufacturers


    recommended shelf-life or 6 months from date of opening whichever is shorter.
    c) For disinfection of equipment/ bench tops etc: To follow manufacturers
    recommended shelf-life or 6 months from date of opening whichever is shorter.

    5.13 Milk Feeds

    a) To follow manufacturers recommended shelf-life or 24 hours (in the fridge) from


    time of opening whichever is shorter.

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