Internship Exercises 8-10

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    By: Nelson T. Tubon; B.S. Pharm.; B.S.S.Ed; R.Ph.;M.S. Pharm.;Ph.D. B.M.

    INTERNSHIP 1

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    Exercise 8

    Labeling Prescription

    and Medications

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    Key Terms

    Labeling- means all labels and other

    written, printed or graphic matter (1)

    upon any article or any of its

    containers or wrappers (2)

    accompanying such articles

    Outer labelmeans the label on or

    affixed to the outside package of anarticle. Examplecarton label

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    KeyTerms

    Principal display panelmeans the part of

    the label that is most likely to be displayed,

    presented, shown, or examined under

    customary conditions of display for retail sale Cosmeticsmeans articles intended to be

    rubbed, poured, sprinkled, or sprayed on,

    introduced into or otherwise applied to the

    human body or any part thereof for cleansing,beautifying, promoting attractiveness, or

    altering appearance

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    Key Terms

    Auxiliary labelsare placed on drug productcontainers to give the patient, healthcareprovider important information needed forusing the product

    Labelmeans a display of written, printed orgraphic matter upon any article or any of itscontainer or wrappers or attached to oraccompanying such article

    Inner labelmeans the label on or affixed toan immediate container

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    Inpatient

    Label of single unit packages should include

    1. name of the drug

    2. route of administration, unless oral3. strength, if applicable, volume of the product,

    expressed when possible in the metric system

    4. control number and expiration date

    5. if repackaged, identification of the repackager

    6. special storage conditions, if needed

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    Multiple dose

    1. identification of the dispensing

    pharmacy

    2. patients name

    3. date of dispensing

    4. name of the drug

    5. strength

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    Auxiliary labels

    Shake well

    Keep in the refrigerator, Do not Freeze

    Do not use after

    Refrigerate, Shake well, Discard After

    External Use Only

    May cause drowsiness; Alcohol and Operating Car or Machine Warning Do not Drink Alcohol

    Avoid Sun Exposure

    Take with food

    Take on an Empty Stomach

    Finish all this medication

    Do not take Aspirin Keep Out of the Reach of Children

    This prescription May be Refilled _____________ Times

    Cancer Chemotherapy, Dispose of Properly

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    Terms generally employed in

    storage labeling

    1. Cold20C to 80C

    2. Cool80C to 150C

    3. Room temperature200C to 250C

    4. Warm300C to 400C

    5. Excessive heatabove 400C

    6. Protection from freezing

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    By: Nelson T. Tubon; B.S. Pharm.; B.S.S.Ed; R.Ph.;M.S. Pharm.;Ph.D. B.M.

    INTERENSHIP 1

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    Exercise 9

    Drug Labels and

    Packaging

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    KEY TERMS

    Active Ingredientmeans any substance

    of a drug which is intended to furnish

    pharmacologic activity

    Strengthmeans concentration of knownactive drug substance in formulation

    Brand namerefers to the proprietary,

    trade name assigned to the product by the

    drug establishment

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    Pharmacologic categoryrefers to the

    classification of the product based on its

    therapeutic action as specified in the product

    registration Indicationrefers to the approved clinical

    use of the product based on substantial and

    scientifically supported evidence of the

    safety and efficacy of the drug in the givendosage form

    Key Terms

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    Expirationsrefers to the date after which

    the product is not expected to retain its

    claimed safety, efficacy and quality or

    potency or after which it is not permissibleto sell, distribute or use said product

    Net Contentrefers to the total

    amount/quantity/number of the dosage form

    in a certain container of a productexpressed in metric system

    KEY TERMS

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    Batchmeans a specific homogeneous

    quantity of a drug or in a case of drug

    produced according to single manufacturing

    order during the same cycle of manufacture Lot numbermeans any distinctive

    combination of letters or numbers, or both,

    by which the complete history of the

    manufacture, control, packaging anddistribution of a batch or lot of a drug is

    determined

    KEY TERMS

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    Materials approved unitmeans an

    organizational element having the authority

    and responsibility to approve or reject raw

    materials, in process materials, packagingcomponents, and final product

    Generic namerefers to the identification of

    drugs and medicines by their scientifically and

    internationally recognized active ingredient asdetermined by the BFAD of DOH

    KEY TERMS

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    Mode of administrationrefers to the site

    and manner the product is to be introduced

    into or applied on the body

    Precautionsrefers to the instructions andspecial care required in the use of product to

    avoid undesired effects and to ensure the

    safe and effective use of the drug

    KEY TERMS

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    KEY TERMS Storage conditionsrefers to the

    prevailing specified range of temperature,humidity, and other environmental factorswithin optimal stability of the product isensured based on laboratory data

    Date of manufacturefor products otherthan biological products means the date(month and year) during which theprocessing of the product, from which thegoods are to be filled, is completed

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    POWDERS for external use are usually

    described as dusting powders, usually

    contain starch, talc, and zinc stearate

    DRESSINGSexternal applicationsresembling ointment usually used as a

    covering or protection.

    CREAMSviscous liquid or semi-solid

    emulsions of either the oil in water or

    water in oil type

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    1. D

    2. J

    3. G

    4. I

    5. A

    6. C

    7. H

    8. B

    9. E

    10. F

    A.Drug Packaging