dispensijg rye and ear meds Study Notes

Dosage Forms & Labelling

Dosage Forms Overview

  • Dosage forms are critical in pharmaceutical applications as they determine the route of administration and the bioavailability of the medication.

Specific Dosage Forms

  • Otic Drops: Used in ear applications.

    • Example product: CIPRODEX

    • Active Ingredients: Ciprofloxacin 0.3% and Dexamethasone 0.1%

    • Formulation Type: Sterile Otic Suspension

    • Volume: 7.5 ml

    • NDC Code: 0065-8533-02

    • Dispensing Status: Rx Only

  • Ophthalmic Drops and Ointments: Used for eye treatments.

    • Example product: CIPRODEX with similar details as above.

    • NDC Code: 0065-530-42

    • Dispensing Status: Rx Only

Labelling Requirements

  • Labelling of otic and ophthalmic drugs must be precise to ensure proper use.

Administration Instructions

Leading Verbs

  • For Eye Drops: Use the verbs “Instil” or “Place” when providing instructions.

  • For Ear Drops: Use the verbs “Place” or “Put”.

  • For Eye or Ear Ointment: Use the verb “Apply”.

  • Ambiguous Usage: For products applicable in both eyes and ears, provide clear instructions differentiating the intended site to prevent misuse.

  • Clarification Advice: Users should be encouraged to clarify instructions if there is any uncertainty regarding the application site.

Auxiliary Labels for Ophthalmic & Otic Products

  • Important Information: Auxiliary labels serve to give additional crucial information such as:

    • Check Discard After Dates: Ensuring medication is not used past its safe usage period.

    • Suspensions: Require labels that advise users to “shake well before use” to ensure suspension consistency.

    • Storage Conditions: Instructions on how to store the product both before and after its opening.

    • External Use Restrictions: Clearly indicate that medications labeled for external use should not be used internally.

Labelling Details for Ophthalmic & Otic Drops

  • Types of Labels: Generally, two labels are required:

    • Regular Label: Contains standard label information; affixed to the outer container or box of the medication.

    • Short Label: A smaller label attached to the actual drug package containing essential information:

    • Prescription number

    • Patient name

    • Instructions (sig)

    • Drug ID line

    • Quantity

    • Drug product name (can be brand or generic)

    • Strength of the medication

    • Dosage form

    • Manufacturer’s 3-letter code

  • Multiple Packages: If there are multiple packages involved, split labels and small labels are necessary; plan label production beforehand to avoid issues.

Calculating Days Supply for Medications

  • Eye Drops: Utilize the formula of 20 drops equating to 1 mL to calculate how long a bottle will last based on the patient's usage frequency.

  • Eye Ointments: Generally, durations of therapy are predefined (e.g., typically 10 days), which can easily serve as the days supply. If there is no specific duration, make a reasonable estimation based on the medication's expiry date post-opening.

  • Ear Drops: Also utilize the 20 drops = 1 mL formula for calculations.

  • Usage Context: Assess whether the eye drops are for ongoing treatment (such as for glaucoma) or for a short-term issue (like an eye infection). This understanding is essential for accurately determining the days supply of the medication.