presentation on commonly used advisory labels on medication and need of this

1. CAUTIONARY
AND
ADVISORY LABELS
(CALS)
B y Kiran Sharma
KIET School of Pharmacy

2. CALs
Cautionary and advisory labels (Cals) are
sometimes added (with the dispensing label) to a
medicine dispensed by the pharmacist to the patient.
Standard cautionary and advisory labels offer advice
but are not exhaustive.
The labels are not a substitute for adequate counseling
by prescribers and dispensers (most medicines are
dispensed by pharmacists) but are intended to
reinforce essential information the patient needs to
know.
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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3. 2 Types of CALs
* for providing advice regarding medication use
*for warning consumers about undesirable effects
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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4. Recommended label wording
can offer advice about:
 Timing of doses in relation to food
 Completing the course of treatment
 What has to be done if a dose is missed
 The correct storage of a medicine
 Dissolution of the medicine in water before
taking it
 Limits to the number of tablets that should
be taken in a given time
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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5. Recommended label wording
can offer warnings about:
 Effects of the medicine on driving or work




(e.g. through drowsiness)
Foods or medicines that should be avoided
Avoidance of exposure of the skin to sunlight
or sun lamps
Medicines that can discolor the urine
Medicines that can stain clothes or skin
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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6. Some Examples
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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7. Example
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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8. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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9. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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10. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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11. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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12. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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13. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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14. Kiran Sharma, KIET School of Pharmacy
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15. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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16. Kiran Sharma, KIET School of Pharmacy
11/12/2013
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17. Updating the CALs
 Addition of a new label statement;
 Amendment to the wording of an existing label
statement;
 Deletion of a label statement;
 Application of an existing statement to a new
substance or class of substances;
 Application of a new label statement to a
substance or a class of substances;
 Removal of the requirement for an advisory
statement for a substance or class of substances.
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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18. THANKS
Kiran Sharma, KIET School of Pharmacy
11/12/2013
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